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Akari Therapeutics Plc
Response Received
1 company response(s)
High - file number match
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Akari Therapeutics Plc
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Akari Therapeutics Plc
Response Received
1 company response(s)
High - file number match
↓
Akari Therapeutics Plc
Response Received
1 company response(s)
High - file number match
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Akari Therapeutics Plc
Response Received
2 company response(s)
High - file number match
↓
Company responded
2024-09-30
Akari Therapeutics Plc
References: September 26, 2024
↓
Akari Therapeutics Plc
Response Received
1 company response(s)
High - file number match
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Akari Therapeutics Plc
Response Received
1 company response(s)
High - file number match
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Akari Therapeutics Plc
Response Received
1 company response(s)
High - file number match
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Akari Therapeutics Plc
Response Received
1 company response(s)
High - file number match
↓
Company responded
2021-08-30
Akari Therapeutics Plc
Summary
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Akari Therapeutics Plc
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-12-30
Akari Therapeutics Plc
Summary
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Company responded
2020-12-30
Akari Therapeutics Plc
Summary
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Akari Therapeutics Plc
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-07-24
Akari Therapeutics Plc
Summary
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Company responded
2020-07-24
Akari Therapeutics Plc
Summary
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Akari Therapeutics Plc
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-03-30
Akari Therapeutics Plc
Summary
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Company responded
2020-04-15
Akari Therapeutics Plc
Summary
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Akari Therapeutics Plc
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-10-24
Akari Therapeutics Plc
Summary
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Company responded
2019-10-24
Akari Therapeutics Plc
Summary
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Akari Therapeutics Plc
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-08-12
Akari Therapeutics Plc
Summary
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Company responded
2019-09-06
Akari Therapeutics Plc
Summary
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Akari Therapeutics Plc
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2018-10-25
Akari Therapeutics Plc
Summary
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Company responded
2018-12-06
Akari Therapeutics Plc
References: October 25, 2018
Summary
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Company responded
2019-02-11
Akari Therapeutics Plc
References: December 19, 2018
Summary
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Company responded
2019-02-27
Akari Therapeutics Plc
Summary
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Akari Therapeutics Plc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2018-12-20
Akari Therapeutics Plc
Summary
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Akari Therapeutics Plc
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2018-02-23
Akari Therapeutics Plc
Summary
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Akari Therapeutics Plc
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2017-08-24
Akari Therapeutics Plc
Summary
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Akari Therapeutics Plc
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2015-10-27
Akari Therapeutics Plc
Summary
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Company responded
2015-10-28
Akari Therapeutics Plc
Summary
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Akari Therapeutics Plc
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2012-12-18
Akari Therapeutics Plc
Summary
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Company responded
2013-01-31
Akari Therapeutics Plc
Summary
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Akari Therapeutics Plc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2013-01-09
Akari Therapeutics Plc
Summary
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Akari Therapeutics Plc
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2012-11-30
Akari Therapeutics Plc
Summary
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Akari Therapeutics Plc
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2012-11-14
Akari Therapeutics Plc
Summary
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Akari Therapeutics Plc
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2012-10-11
Akari Therapeutics Plc
Summary
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Akari Therapeutics Plc
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2012-09-21
Akari Therapeutics Plc
Summary
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Akari Therapeutics Plc
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2012-08-22
Akari Therapeutics Plc
Summary
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Company responded
2012-08-31
Akari Therapeutics Plc
Summary
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Akari Therapeutics Plc
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2012-07-25
Akari Therapeutics Plc
Summary
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Company responded
2012-08-08
Akari Therapeutics Plc
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-27 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | 333-292930 | Read Filing View |
| 2026-01-27 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2025-12-01 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2025-07-30 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | 333-289056 | Read Filing View |
| 2025-07-30 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2025-05-12 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2025-05-09 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | 333-287012 | Read Filing View |
| 2024-10-09 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2024-09-30 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2024-09-26 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | 333-282127 | Read Filing View |
| 2024-09-11 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2024-09-11 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | 333-281995 | Read Filing View |
| 2023-10-25 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2023-10-24 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2022-11-07 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2022-10-19 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2021-08-30 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2021-08-23 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2020-12-30 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2020-12-30 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2020-07-24 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2020-07-24 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2020-04-15 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2020-03-30 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2019-10-24 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2019-10-24 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2019-09-06 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2019-08-12 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2019-02-27 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2019-02-11 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2018-12-20 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2018-12-06 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2018-10-25 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2018-02-23 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2017-08-24 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2015-10-28 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2015-10-27 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2013-01-31 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2013-01-09 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2012-12-18 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2012-11-30 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2012-11-14 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2012-10-11 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2012-09-21 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2012-08-31 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2012-08-22 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2012-08-08 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2012-07-25 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-27 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | 333-292930 | Read Filing View |
| 2025-07-30 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | 333-289056 | Read Filing View |
| 2025-05-09 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | 333-287012 | Read Filing View |
| 2024-09-26 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | 333-282127 | Read Filing View |
| 2024-09-11 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | 333-281995 | Read Filing View |
| 2023-10-24 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2022-10-19 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2021-08-23 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2020-12-30 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2020-07-24 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2020-03-30 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2019-10-24 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2019-08-12 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2018-12-20 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2018-10-25 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2017-08-24 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2015-10-27 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2013-01-09 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2012-12-18 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2012-11-30 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2012-11-14 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2012-10-11 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2012-09-21 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2012-08-22 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2012-07-25 | SEC Comment Letter | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-27 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2025-12-01 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2025-07-30 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2025-05-12 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2024-10-09 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2024-09-30 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2024-09-11 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2023-10-25 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2022-11-07 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2021-08-30 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2020-12-30 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2020-07-24 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2020-04-15 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2019-10-24 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2019-09-06 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2019-02-27 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2019-02-11 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2018-12-06 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2018-02-23 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2015-10-28 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2013-01-31 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2012-08-31 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
| 2012-08-08 | Company Response | Akari Therapeutics Plc | United Kingdom | N/A | Read Filing View |
2026-01-27 - UPLOAD - Akari Therapeutics Plc File: 333-292930
January 27, 2026
Abizer Gaslightwala
Chief Executive Officer
Akari Therapeutics, Plc
401 East Jackson St, Suite 3300
Tampa, FL 33602
Re:Akari Therapeutics, Plc
Registration Statement on Form S-1
Filed January 23, 2026
File No. 333-292930
Dear Abizer Gaslightwala:
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 Doris Stacey Gama at 202-551-3188 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Win Rutherfurd, Esq.
2026-01-27 - CORRESP - Akari Therapeutics Plc
CORRESP 1 filename1.htm Akari Therapeutics, Plc 401 East Jackson St, Suite 3300 Tampa, FL 33602 January 27, 2026 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-7553 Re: Akari Therapeutics, Plc Registration Statement on Form S-1 Filed January 23, 2026 (File No. 333-292930) Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Akari Therapeutics, Plc (the " Company ") hereby requests that the effective date of the Company's Registration Statement on Form S-1 (File No. 333-292930) (the " Registration Statement ") be accelerated so that the Company's Registration Statement will become effective at 4:15 P.M., Eastern Time, on January 29, 2026, or as soon thereafter as is practicable. Please contact Gary Emmanuel, Esq. of Greenberg Traurig, P.A, counsel to the Company, at 212 801 9337 to provide notice of effectiveness, or if you have any questions or comments concerning this request. Very truly yours, AKARI THERAPEUTICS, PLC By: /s/ Abizer Gaslightwala Name: Abizer Gaslightwala Title: President and Chief Executive Officer
2025-12-01 - CORRESP - Akari Therapeutics Plc
CORRESP 1 filename1.htm Akari Therapeutics, Plc 401 E Jackson St, Suite 3300 Tampa, FL 33602 December 1, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-7553 Re: Akari Therapeutics, Plc Registration Statement on Form S-1 Filed November 17, 2025 (File No. 333-291596) Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Akari Therapeutics, Plc (the " Company ") hereby requests that the effective date of the Company's Registration Statement on Form S-1 (File No. 333-291596) (the " Registration Statement ") be accelerated so that the Company's Registration Statement will become effective at 5:00 P.M., Eastern Time, on December 2, 2025, or as soon thereafter as is practicable. Please contact Gary Emmanuel, Esq. of Greenberg Traurig, P.A, counsel to the Company, at 212 801 9337 to provide notice of effectiveness, or if you have any questions or comments concerning this request. Very truly yours, AKARI THERAPEUTICS, PLC By: /s/ Abizer Gaslightwala Name: Abizer Gaslightwala Title: President and Chief Executive Officer
2025-07-30 - UPLOAD - Akari Therapeutics Plc File: 333-289056
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 30, 2025 Abizer Gaslightwala President and Chief Executive Officer Akari Therapeutics, Plc 22 Boston Wharf Road FL 7 Boston, MA 02210 Re: Akari Therapeutics, Plc Registration Statement on Form S-3 Filed July 29, 2025 File No. 333-289056 Dear Abizer Gaslightwala: 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 Jessica Dickerson at 202-551-8013 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Gary Emmanuel, Esq. </TEXT> </DOCUMENT>
2025-07-30 - CORRESP - Akari Therapeutics Plc
CORRESP 1 filename1.htm Akari Therapeutics, PLC 22 Boston Wharf Road Fl. 7 Boston, MA 02210 July 30, 2025 Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Akari Therapeutics PLC Registration Statement on Form S-3 File No. 333-289056 VIA EDGAR Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Akari Therapeutics PLC (the " Registrant ") hereby respectfully requests that the effectiveness of the Registration Statement on Form S-3 (File No. 333-289056) of the Registrant (the " Registration Statement ") be accelerated so that the Company's Registration Statement will be declared effective at 5:00 p.m., Eastern Time, on July 31, 2025 or as soon thereafter as may be practicable. The undersigned respectfully requests that it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, Greenberg Traurig, LLP, by calling Win Rutherfurd at (305) 579 0769. The Company hereby authorizes Mr. Rutherfurd to orally modify or withdraw this request for acceleration. Very truly yours, AKARI THERAPEUTICS PLC By: /s/ Torsten Hombeck Name: Torsten Hombeck Title: Chief Financial Officer cc: Win Rutherfurd (Greenberg Traurig, LLP)
2025-05-12 - CORRESP - Akari Therapeutics Plc
CORRESP 1 filename1.htm CORRESP Akari Therapeutics, Plc 22 Boston Wharf Road, FL 7 Boston, MA 02210 May 12, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-7553 Re: Akari Therapeutics, Plc Registration Statement on Form S-3 Filed May 6, 2025 (File No. 333-287012) Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Akari Therapeutics, Plc (the “ Company ”) hereby requests that the effective date of the Company’s Registration Statement on Form S-3 (File No. 333-287012) (the “ Registration Statement ”) be accelerated so that the Company’s Registration Statement will become effective at 4:05 P.M., Eastern Time, on May 14, 2025, or as soon thereafter as is practicable. Please contact Sam Zucker, Esq. of Goodwin Procter LLP, counsel to the Company, at (650) 752-3232 to provide notice of effectiveness, or if you have any questions or comments concerning this request. [ Remainder of the page intentionally left blank ] Very truly yours, AKARI THERAPEUTICS, PLC By: /s/ Abizer Gaslightwala Name: Abizer Gaslightwala Title: President and Chief Executive Officer
2025-05-09 - UPLOAD - Akari Therapeutics Plc File: 333-287012
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 9, 2025 Abizer Gaslightwala President and Chief Executive Officer Akari Therapeutics, Plc 22 Boston Wharf Road FL 7 Boston, MA 02210 Re: Akari Therapeutics, Plc Registration Statement on Form S-3 Filed May 6, 2025 File No. 333-287012 Dear Abizer Gaslightwala: 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 Daniel Crawford at 202-551-7767 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Sam Zucker, Esq. </TEXT> </DOCUMENT>
2024-10-09 - CORRESP - Akari Therapeutics Plc
CORRESP 1 filename1.htm CORRESP October 9, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Joshua Gorsky Re: Akari Therapeutics, Plc Registration Statement on Form S-4 File No. 333-282127 Dear Mr. Gorsky: In accordance with Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Akari Therapeutics, Plc hereby requests that the effective date of the above-referenced Registration Statement be accelerated to, and the Registration Statement become effective on, October 11, 2024, at 4:45 P.M. Eastern Time, or as soon thereafter as practicable. Once the Registration Statement is effective, please orally confirm the event with our counsel, Goodwin Procter LLP by calling Jennifer L. Porter at (445) 207-7806. We also respectfully request that a copy of the written order from the Securities and Exchange Commission verifying the effective time and date of the Registration Statement be sent to our counsel, Goodwin Procter LLP, Attention: Jennifer L. Porter, by email at JPorter@goodwinlaw.com. [Signature page follows] Sincerely yours, Akari Therapeutics, Plc By: /s/ Samir R. Patel, M.D. Samir R. Patel, M.D. Interim President, Chief Executive Officer cc: Rachael M. Bushey, Goodwin Procter LLP Jennifer L. Porter, Goodwin Procter LLP Laura Umbrecht Gulick, Goodwin Procter LLP [Signature Page to Acceleration Request]
2024-09-30 - CORRESP - Akari Therapeutics Plc
CORRESP 1 filename1.htm CORRESP Goodwin Procter LLP One Commerce Square 2005 Market Street, 32nd Floor Philadelphia, PA 19103 goodwinlaw.com +1 445 207 7800 September 30, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Joshua Gorsky Re: Akari Therapeutics, Plc Registration Statement on Form S-4 File No. 333-282127 Dear Mr. Gorsky: This letter is submitted by Akari Therapeutics, Plc (the “Company” or “we”) in response to comments from the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in a letter dated September 26, 2024 (the “Comment Letter”) with respect to the Company’s Registration Statement on Form S-4 (File No. 333-282127) filed with the Commission on September 13, 2024 (the “Form S-4”). The Company is concurrently filing Amendment No. 1 to the Form S-4 (“Amendment No. 1”), which includes changes in response to the Staff’s comments. For your convenience, the Staff’s numbered comments set forth in the Comment Letter have been reproduced in italics herein with responses immediately following each comment. Form S-4 1. Please revise the forepart of the joint proxy statement/prospectus to provide sample calculations of the exchange ratio and per share merger consideration taking into account any material factors and assumptions and include a high and low range. If shareholders will not know the exact exchange ratio or per share merger consideration at the time of the shareholder votes, please revise to state as much. Response to Comment No. 1 The Company acknowledges the Staff’s comment and has revised its disclosure on the first and second pages of the introductory letter to Akari shareholders, the first and second of the introductory letter to Peak Bio stockholders, and pages 3, 12, 24-25, 28, 135-136, 157-158 and 199-200 of the Form S-4 to disclose sample calculations of the exchange ratio taking into account various net cash scenarios of each of Akari and Peak Bio, including high and low ranges. These updated disclosures also expressly state that shareholders will not know the exact exchange ratio or per share merger consideration at the time of the shareholder votes. 2. Please revise the forepart of the joint proxy statement/prospectus to prominently disclose, as you do elsewhere in the registration statement, that the estimated exchange ratio is such that based on the number of Akari ADSs expected to be issued in accordance with the exchange ratio at the consummation of the merger in exchange for the shares of Peak Bio Common Stock, Peak Bio stockholders would own approximately 48%, and Akari shareholders would own approximately 52% of the combined company following the consummation of the Merger, on a fully diluted basis. Response to Comment No. 2 The Company acknowledges the Staff’s comment and has revised its disclosure on the first and second pages of the introductory letter to Akari shareholders, the first and second of the introductory letter to Peak Bio stockholders, and pages 3, 12, 24-25, 28, 135-136, 157-158 and 199-200 of the Form S-4 to disclose prominently that based on the number of Akari ADSs expected to be issued in accordance with the exchange ratio at the consummation of the merger in exchange for the shares of Peak Bio Common Stock, Peak Bio stockholders would own approximately 48%, and Akari shareholders would own approximately 52% of the combined company following the consummation of the Merger, on a fully diluted basis. 3. Please revise the forepart of the joint proxy statement/prospectus to disclose, as you do elsewhere in the registration statement, that the aggregate consideration to be received by the Peak Bio stockholders is assumed to be $22.6 million. Response to Comment No. 3 The Company acknowledges the Staff’s comment and has revised its disclosure on the first and second pages of the introductory letter to Akari shareholders, the first and second pages of the introductory letter to Peak Bio stockholders, and pages 3, 12, 24-25, 28, 135-136, 157-158 and 199-200 of the Form S-4 to disclose that the aggregate consideration to be received by the Peak Bio stockholders is assumed to be $22.6 million. If you should have any questions regarding the enclosed matters, please contact me at (445) 207-7806. Sincerely, /s/ Jennifer L. Porter Jennifer L. Porter, Esq. cc: Rachael M. Bushey, Goodwin Procter LLP Laura K. Umbrecht, Goodwin Procter LLP
2024-09-26 - UPLOAD - Akari Therapeutics Plc File: 333-282127
September 26, 2024
Samir R. Patel, M.D.
Interim President and Chief Executive Officer
Akari Therapeutics, Plc
22 Boston Wharf Road, FL7
Boston, MA 02210
Re:Akari Therapeutics, Plc
Registration Statement on Form S-4
Filed September 13, 2024
File No. 333-282127
Dear Samir R. Patel M.D.:
We have conducted a limited review of your registration statement and have the following
comments.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a comment applies 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 this letter, we may have additional comments.
Registration Statement on Form S-4
General
1.Please revise the forepart of the joint proxy statement/prospectus to provide sample
calculations of the exchange ratio and per share merger consideration taking into account
any material factors and assumptions and include a high and low range. If shareholders
will not know the exact exchange ratio or per share merger consideration at the time of the
shareholder votes, please revise to state as much.
2.Please revise the forepart of the joint proxy statement/prospectus to prominently disclose,
as you do elsewhere in the registration statement, that the estimated exchange ratio is such
that based on the number of Akari ADSs expected to be issued in accordance with the
exchange ratio at the consummation of the merger in exchange for the shares of Peak Bio
Common Stock, Peak Bio stockholders would own approximately 48%, and Akari
shareholders would own approximately 52% of the combined company following the
consummation of the Merger, on a fully diluted basis.
September 26, 2024
Page 2
3.Please revise the forepart of the joint proxy statement/prospectus to disclose, as you do
elsewhere in the registration statement, that the aggregate consideration to be received by
the Peak Bio stockholders is assumed to be $22.6 million.
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.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Joshua Gorsky at 202-551-7836 or Tim Buchmiller at 202-551-3635 with
any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Jennifer L. Porter, Esq.
2024-09-11 - CORRESP - Akari Therapeutics Plc
CORRESP 1 filename1.htm CORRESP Akari Therapeutics, Plc 22 Boston Wharf Road, FL 7 Boston, MA 02210 September 11, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-7553 Attention: Doris Stacey Gama Re: Akari Therapeutics, Plc Registration Statement on Form S-3 Filed September 6, 2024 (File No. 333-281995) Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Akari Therapeutics, Plc (the “Company”) hereby requests that the effective date of the Company’s Registration Statement on Form S-3 (File No. 333-281995) (the “Registration Statement”) be accelerated so that the Company’s Registration Statement will become effective at 4:05 P.M., Eastern Time, on September 13, 2024, or as soon thereafter as is practicable. Please contact Justin S. Platt, Esq. of Goodwin Procter LLP, counsel to the Company, at (212) 459-7340 to provide notice of effectiveness, or if you have any questions or comments concerning this request. [Remainder of the page intentionally left blank] Very truly yours, AKARI THERAPEUTICS, PLC By: /s/ Samir R. Patel, M.D. Name: Samir R. Patel, M.D. Title: Interim President and Chief Executive Officer
2024-09-11 - UPLOAD - Akari Therapeutics Plc File: 333-281995
September 11, 2024
Samir R. Patel
Chief Executive Officer
Akari Therapeutics, Plc
22 Boston Wharf Road FL 7
Boston, MA 02210
Re:Akari Therapeutics, Plc
Registration Statement on Form S-3
Filed September 6, 2024
File No. 333-281995
Dear Samir R. Patel:
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 Doris Stacey Gama at 202-551-3188 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Justin Platt, Esq.
2023-10-25 - CORRESP - Akari Therapeutics Plc
CORRESP
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Akari Therapeutics, Plc
22 Boston Wharf Road FL 7
Boston, MA 02210
October 25, 2023
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Akari Therapeutics, Plc (the “Company”)
Registration Statement on Form F-3 (the “Registration Statement”)
Filed October 20, 2023
File No. 333-275119
Dear Mr. Drory:
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. Eastern Time on October 26, 2023, or as soon thereafter as practicable.
[Signature Page Follows]
Very truly yours,
AKARI THERAPEUTICS, PLC
By:
/s/ Rachelle Jacques
Name:
Rachelle Jacques
Title:
President and Chief Executive Officer
2023-10-24 - UPLOAD - Akari Therapeutics Plc
United States securities and exchange commission logo
October 23, 2023
Rachelle Jacques
Chief Executive Officer
Akari Therapeutics Plc
22 Boston Wharf Road FL 7
Boston, MA 02210
Re:Akari Therapeutics Plc
Registration Statement on Form F-3
Filed October 20, 2023
File No. 333-275119
Dear Rachelle Jacques:
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 Jason Drory at 202-551-8342 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Win Rutherfurd
2022-11-07 - CORRESP - Akari Therapeutics Plc
CORRESP
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Akari Therapeutics, PLC
75/76 Wimpole Street
London W1G 9RT
United Kingdom
November 7, 2022
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Akari Therapeutics, PLC
Registration Statement on Form F-1
File No. 333-267840
VIA EDGAR
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of
1933, as amended, Akari Therapeutics, PLC (the “Registrant”) hereby respectfully requests that the effectiveness of
the Registration Statement on Form F-1 (File No. 333-267840) of the Registrant (the “Registration Statement”) be accelerated
so that it will be declared effective at 4:00 p.m., Eastern Time, on November 8, 2022 or as soon thereafter as may be practicable.
The undersigned respectfully requests that it be
notified of the effectiveness of the Registration Statement by telephone call to our counsel, McDermott Will & Emery LLP, by calling
Richard Bass at (212) 547-5476. The Company hereby authorizes Mr. Bass to orally modify or withdraw this request for acceleration.
‘
Very truly yours,
AKARI THERAPEUTICS, PLC
By:
/s/ Torsten Hombeck
Name: Torsten Hombeck
Title: Chief Financial Officer
2022-10-19 - UPLOAD - Akari Therapeutics Plc
United States securities and exchange commission logo
October 19, 2022
Dr. Torsten Hombeck
Chief Financial Officer
Akari Therapeutics PLC
75/76 Wimpole Street
London W1G 9RT
United Kingdom
Re:Akari Therapeutics PLC
Registration Statement on Form F-1
Filed October 12, 2022
File No. 333-267840
Dear Dr. Torsten Hombeck:
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 Cindy Polynice at 202-551-8707 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Richard Bass, Esq.
2021-08-30 - CORRESP - Akari Therapeutics Plc
CORRESP
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Akari Therapeutics, PLC
75/76 Wimpole Street
London W1G 9RT
United Kingdom
August 30, 2021
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Akari Therapeutics, PLC
Registration Statement on Form F-3
File No. 333-258918
VIA EDGAR
Ladies and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Akari Therapeutics, PLC (the “Registrant”) hereby respectfully
requests that the effectiveness of the Registration Statement on Form F-3 (File No. 333-258918) of the Registrant (the “Registration
Statement”) be accelerated so that it will be declared effective at 4:30 p.m., Eastern Time, on August 31, 2021 or as
soon thereafter as may be practicable.
The undersigned respectfully requests that it be
notified of the effectiveness of the Registration Statement by telephone call to our counsel, McDermott Will & Emery LLP, by calling
Gary Emmanuel at (212) 547-5541. The Company hereby authorizes Mr. Emmanuel to orally modify or withdraw this request for acceleration.
Very truly yours,
AKARI THERAPEUTICS, PLC
By:
/s/
Clive Richardson
Name:
Clive
Richardson
Title:
Chief Executive Officer and
Chief Operating Officer
2021-08-23 - UPLOAD - Akari Therapeutics Plc
United States securities and exchange commission logo
August 23, 2021
Torsten Hombeck
Chief Financial Officer
Akari Therapeutics, Plc
75/76 Wimpole Street
London W1G 9RT
United Kingdom
Re:Akari Therapeutics, Plc
Registration Statement on Form F-3
Filed August 19, 2021
File No. 333-258918
Dear Mr. Hombeck:
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 David Gessert at 202-551-2326 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2020-12-30 - CORRESP - Akari Therapeutics Plc
CORRESP
1
filename1.htm
Akari Therapeutics, PLC
75/76 Wimpole Street
London W1G 9RT
United Kingdom
December 30, 2020
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Akari Therapeutics, PLC
Registration Statement on Form F-3
File No. 333-251673
VIA EDGAR
Ladies and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Akari Therapeutics, PLC (the “Registrant”) hereby
respectfully requests that the effectiveness of the Registration Statement on Form F-3 (File No. 333-251673) of the Registrant
(the “Registration Statement”) be accelerated so that it will be declared effective at 4:00 p.m., Eastern Time,
on December 31, 2020 or as soon thereafter as may be practicable.
The undersigned respectfully requests that
it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, McDermott Will & Emery
LLP, by calling Richard Bass at (646) 531-0797. The Company hereby authorizes Mr. Bass to orally modify or withdraw this request
for acceleration.
Please also provide a copy of the Commission’s
order declaring the Registration Statement effective to Mr. Bass via email to rbass@mwe.com or facsimile to (646) 417 7675 and
via mail at 340 Madison Avenue, New York, NY 10173.
Very truly yours,
AKARI THERAPEUTICS, PLC
By:
/s/ Clive Richardson
Name:
Clive Richardson
Title:
Chief Executive Officer
cc: Richard Bass (McDermott Will & Emery LLP)
2020-12-30 - UPLOAD - Akari Therapeutics Plc
United States securities and exchange commission logo
December 30, 2020
Clive Richardson
Chief Executive Officer and Chief Operating Officer
Akari Therapeutics Plc
75/76 Wimpole Street
London W1G 9RT
United Kingdom
Re:Akari Therapeutics Plc
Registration Statement on Form F-3
Filed December 23, 2020
File No. 333-251673
Dear Mr. Richardson:
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 Jason L. Drory at 202-551-8342 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Richard Bass, Esq.
2020-07-24 - UPLOAD - Akari Therapeutics Plc
United States securities and exchange commission logo
July 23, 2020
Clive Richardson
Chief Executive Officer
Akari Therapeutics, Plc
75/76 Wimpole Street
London W1G 9RT
United Kingdom
Re:Akari Therapeutics, Plc
Registration Statement on Form F-1
Filed July 17, 2020
File No. 333-239923
Dear Mr. Richardson:
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 Life Sciences
cc: Gary Emmanuel, Esq.
2020-07-24 - CORRESP - Akari Therapeutics Plc
CORRESP
1
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Akari Therapeutics, PLC
75/76 Wimpole Street
London W1G 9RT
United Kingdom
July 24, 2020
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Akari Therapeutics, PLC
Registration Statement on Form F-1
File No. 333-239923
VIA EDGAR
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities
Act of 1933, as amended, Akari Therapeutics, PLC (the “Registrant”) hereby respectfully requests that the effectiveness
of the Registration Statement on Form F-1 (File No. 333-239923) of the Registrant (the “Registration
Statement”) be accelerated so that it will be declared effective at 4:00 p.m., Eastern Time, on July 27, 2020 or as soon
thereafter as may be practicable.
The undersigned respectfully requests that
it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, McDermott Will & Emery
LLP, by calling Gary Emmanuel at (212) 547-5541. The Company hereby authorizes Mr. Emmanuel to orally modify or withdraw this request
for acceleration.
Very truly
yours,
AKARI THERAPEUTICS,
PLC
By:
/s/
Torsten Hombeck
Name: Torsten Hombeck
Title: Chief Financial Officer
2020-04-15 - CORRESP - Akari Therapeutics Plc
CORRESP
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Akari Therapeutics, PLC
75/76 Wimpole Street
London W1G 9RT
United Kingdom
April 14, 2020
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Akari Therapeutics, PLC
Registration Statement on Form F-3
File No. 333-237389
VIA EDGAR
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities
Act of 1933, as amended, Akari Therapeutics, PLC (the “Registrant”) hereby respectfully requests that the effectiveness
of the Registration Statement on Form F-3 (File No. 333-237389) of the Registrant (the “Registration Statement”)
be accelerated so that it will be declared effective at 4:30 p.m., Eastern Time, on April 16, 2020 or as soon thereafter as may
be practicable.
The undersigned respectfully requests that
it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, McDermott Will & Emery
LLP, by calling Gary Emmanuel at (212) 547-5541. The Company hereby authorizes Mr. Emmanuel to orally modify or withdraw this request
for acceleration.
Very truly yours,
AKARI THERAPEUTICS, PLC
By:
/s/ Clive Richardson
Name:
Clive Richardson
Title:
Chief Executive Officer and Chief Operating Officer
2020-03-30 - UPLOAD - Akari Therapeutics Plc
March 30, 2020
Clive Richardson
Chief Executive Officer and Chief Operating Officer
Akari Therapeutics Plc
75/76 Wimpole Street
London W1G 9RT
United Kingdom
Re:Akari Therapeutics Plc
Registration Statement on Form F-3
Filed March 26, 2020
File No. 333-237389
Dear Mr. Richardson:
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 Irene Paik at 202-551-6553 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Richard Bass - McDermott Will & Emery LLP
2019-10-24 - UPLOAD - Akari Therapeutics Plc
October 24, 2019
Clive Richardson
Chief Executive Officer
Akari Therapeutics Plc
75/76 Wimpole Street
London W1G 9RT
Re:Akari Therapeutics Plc
Registration Statement on Form F-1
Filed October 15, 2019
File No. 333-234219
Dear Mr. Richardson:
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 Gregory Dundas at (202) 551-3436 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Gary Emmanuel, Esq.
2019-10-24 - CORRESP - Akari Therapeutics Plc
CORRESP
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Akari Therapeutics, PLC
75/76 Wimpole Street
London W1G 9RT
United Kingdom
October 24, 2019
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Akari Therapeutics, PLC
Registration Statement on Form F-1
File No. 333-234219
VIA EDGAR
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities
Act of 1933, as amended, Akari Therapeutics, PLC (the “Registrant”) hereby respectfully requests that the effectiveness
of the Registration Statement on Form F-1 (File No. 333-234219) of the Registrant (the “Registration Statement”)
be accelerated so that it will be declared effective at 4:00 p.m., Eastern Time, on October 25, 2019 or as soon thereafter as may
be practicable.
The undersigned respectfully requests that
it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, McDermott Will & Emery
LLP, by calling Gary Emmanuel at (212) 547-5541. The Company hereby authorizes Mr. Emmanuel to orally modify or withdraw this request
for acceleration.
Very truly yours,
AKARI THERAPEUTICS, PLC
By:
/s/ Clive Richardson
Name:
Clive Richardson
Title:
Chief Executive Officer and Chief Operating Officer
2019-09-06 - CORRESP - Akari Therapeutics Plc
CORRESP
1
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Akari Therapeutics, PLC
75/76 Wimpole Street
London W1G 9RT
United Kingdom
September 6, 2019
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Akari Therapeutics, PLC
Registration Statement on Form F-1
File No. 333-233048
VIA EDGAR
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities
Act of 1933, as amended, Akari Therapeutics, PLC (the “Registrant”) hereby respectfully requests that the effectiveness
of the Registration Statement on Form F-1 (File No. 333-233048) of the Registrant (the “Registration Statement”)
be accelerated so that it will be declared effective at 4:30 p.m., Eastern Time, on September 6, 2019 or as soon thereafter as
may be practicable.
The undersigned respectfully requests that
it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, McDermott Will & Emery
LLP, by calling Gary Emmanuel at (212) 547-5541. The Company hereby authorizes Mr. Emmanuel to orally modify or withdraw this request
for acceleration.
Very truly yours,
AKARI THERAPEUTICS, PLC
By:
/s/ Dov Elefant
Name: Dov Elefant
Title: Chief Financial Officer
2019-08-12 - UPLOAD - Akari Therapeutics Plc
August 12, 2019
Clive Richardson
Interim Chief Executive Officer
Akari Therapeutics, Plc
75/76 Wimpole Street
London W1G 9RT
United Kingdom
Re:Akari Therapeutics, Plc
Registration Statement on Form F-1
Filed August 6, 2019
File No. 333-233048
Dear Mr. Richardson:
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: Gary Emmanuel, Esq.
2019-02-27 - CORRESP - Akari Therapeutics Plc
CORRESP
1
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Akari Therapeutics, PLC
75/76 Wimpole Street
London W1G 9RT
United Kingdom
February 27, 2019
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Akari Therapeutics, PLC
Registration Statement on Form F-1
File No. 333-227752
VIA EDGAR
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, Akari Therapeutics, PLC (the “Registrant”)
hereby respectfully requests that the effectiveness of the Registration Statement on Form F-1 (File No. 333-227752) of the Registrant
(the “Registration Statement”) be accelerated so that it will be declared effective at 9:30 a.m., Eastern
Time, on March 4, 2019 or as soon thereafter as may be practicable.
The Registrant hereby confirms that it is
aware of its responsibilities under the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended,
as they relate to the proposed offering of the securities specified in the Registration Statement. The Registrant hereby acknowledges
that:
· should the Securities and Exchange Commission (the “Commission”) or the 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 the 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
filing; 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 undersigned respectfully requests that
it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, McDermott Will & Emery
LLP, by calling Heidi Steele at (312) 984-3624. The Company hereby authorizes Ms. Steele to orally modify or withdraw this request
for acceleration.
Very truly yours,
AKARI THERAPEUTICS, PLC
By:
/s/ Dov Elefant
Name: Dov Elefant
Title: Chief Financial Officer
2019-02-11 - CORRESP - Akari Therapeutics Plc
CORRESP
1
filename1.htm
mwe.com
Heidi Steele
Attorney at Law
hsteele@mwe.com
+1 312 984 3624
February 11, 2019
Via EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re: Akari Therapeutics Plc
Registration Statement on Form F-1
Filed October 9, 2018
File No. 333-227752
Ladies and Gentlemen:
On behalf of Akari
Therapeutic plc (“Akari” or the “Company”), set forth below is our response to the comment
received from the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange
Commission (the “Commission”) by letter dated December 19, 2018, with respect to the above-referenced Registration
Statement on Form F-1 (the “Registration Statement”). Set forth below in bold is the Staff’s comment,
followed immediately by the Company’s response.
General
1. We refer to parts A and C.4 of your response to prior comment 1 and note that your registration
of 5 million ADS represents approximately 67% of your ADS currently outstanding and held by non-affiliates. Given the size of the
offering, we cannot agree that this transaction can be made on a secondary basis in reliance on Rule 415(a)(1)(i). Accordingly,
please revise the Form S-1 to indicate that the offering will be made at a fixed price or advise.
Response:
A. Background
The Company respectfully
submits that the transaction set forth in the Registration Statement relates to the offering of common stock solely by or on behalf
of a person other than the registrant, a subsidiary of the registrant or a person of which the registrant is a subsidiary, as discussed
in greater detail below and, therefore, is eligible to be made on a continuous or delayed basis under Rule 415(a)(1)(i).
United States Securities and Exchange Commission
Page 2
As
noted in the Registration Statement, as of September 25, 2018, the Company had 1,525,693,415 ordinary shares outstanding, with
743,347,813 of those ordinary shares held by non-affiliates. Aspire Capital, LLC (“Aspire”) is an institutional
investor that invests in a wide range of companies and industries emphasizing life sciences, energy and technology companies. Prior
to entering into a securities purchase agreement (the “Purchase
Agreement”) with the Company on September 26, 2018, Aspire did not own any securities of the Company and was not affiliated
with the Company or any of its officers, directors, or any greater than 5% holder of the Company’s outstanding shares. Aspire
acquired 30,000,000 of the Company’s ordinary shares as a commitment fee for entering into the Purchase Agreement and purchased
an additional 25,000,000 ordinary shares. These 55,000,000 shares (the “Initial Shares”) are
included in the 500,000,000 ordinary shares represented by 5,000,000 American Depositary Shares (each American Depositary Share,
an “ADS”), with each ADS representing 100 of the Company’s ordinary shares, that are the subject of the
Registration Statement. The transaction between Aspire and the Company is akin to an equity line transaction. The transaction is
not comparable to any other type of transaction; for example, it does not involve a convertible security and, as such, it does
not include a variable conversion price.
B. The
Registration Statement is Appropriate Under Rule 415(a)(1)(i))
Rule 415(a)(1)(i) of
the Securities Act of 1933 (the “Securities Act”), provides that securities may be registered for an offering
to be made on a continuous or delayed basis in the future, provided that the registration statement pertains only to securities
which are to be offered or sold solely by or on behalf of a person or persons other than the registrant, a subsidiary of the registrant
or a person of which the registrant is a subsidiary. As stated in the Registration Statement, the securities are being registered
for resale or other disposition by the selling stockholder, Aspire. Proceeds from the sale of any securities are solely for the
account of Aspire, although the Company may receive proceeds of up to $20 million from the sale of ADSs to Aspire pursuant to the
terms of the Purchase Agreement. With regard to the Staff’s comment, we note our discussion of Securities Act Rules Compliance
and Disclosure Interpretation (“C&DI”) 612.09 in our prior response to comments. C&DI 612.09 indicates
that the issue of whether an offering is by or on behalf of the issuer involves an analysis of six factors. As discussed in our
prior response to comments, and for the reasons discussed below, we respectfully submit that the proposed registration is eligible
to be made on a continuous or delayed basis under Rule 415(a)(1)(i).
Of
the 500,000,000 ordinary shares, represented by ADSs, being registered pursuant to the Registration Statement, the Initial
Shares were issued in connection with Aspire’s entry into the Purchase
Agreement and the remaining shares, represented by ADSs, may be sold to Aspire, and subsequently resold under the Registration
Statement. In this regard, we believe it is important to note that Securities Act Sections C&DI 139.13 sets forth the Staff’s
view as to when an offering of securities by a selling stockholder may be characterized as an indirect primary offering. Specifically,
a company must meet the following conditions:
United States Securities and Exchange Commission
Page 3
· it must “complete” the private
transaction of all of the securities it is registering for “resale” prior to the filing of the registration statement;
· the “resale” registration
statement must be on the form that the company is eligible to use for a primary offering, in the Company’s case a Form F-1;
and
· the investor(s) must be identified as
underwriter(s) in the prospectus, as well as selling stockholder(s).
C&DI
139.13 provides that no minimum holding period is required where the Company has “completed the private transaction of all
of the securities it is registering” through an equity line transaction and the investor is at market risk at the time of
filing of the resale registration statement. We respectfully submit that the Company meets the requirements set forth above such
that the offering set forth in the Registration Statement is properly characterized as an indirect primary offering. As in all
equity line transactions, Aspire has accepted the market risk of its investment from the date of entering into the Purchase Agreement,
including market risk related to the Initial Shares and the ADSs
that the Company may choose, in its sole discretion, to put to Aspire pursuant to the terms of that agreement.
The
terms of sale of ADSs to be registered under the Registration Statement were finalized through a privately negotiated transaction
completed at arm’s length prior to the filing of the Registration Statement. Although Aspire is required by the Staff to
include disclosure that it is “underwriter” with regard to its resales under the Registration Statement, we respectfully
note that the transaction has characteristics significantly more closely associated with a traditional investment transaction than
with an underwritten offering. Specifically, in a typical underwriting, the underwriter and the issuer agree on a price at which
the securities will be sold to the public and the underwriter receives a portion of the proceeds of such sale as compensation for
its selling efforts and for bearing market risk. Pursuant to the Purchase Agreement, Aspire will purchase any ADSs, put to it by
the Company at a slight discount to the market price of the ADSs. However, Aspire is required to take the securities put to it
by the Company under the Purchase Agreement and there is no agreement or arrangement regarding the price at which Aspire will resell
such ADSs to the public pursuant to the Registration Statement. Additionally, Aspire is prohibited from engaging in or effecting,
directly or indirectly, any (i) “short sale” of the Company’s securities or
(ii) hedging transaction, which establishes a net short position with respect to the Company’s securities.
As such, unlike a traditional underwriter, Aspire is taking investment risk with regard to the securities it will acquire under
the Purchase Agreement and there is no certainty that it will receive a premium on the resale of any ADSs it purchases pursuant
to the Purchase Agreement. Indeed, Aspire is at risk that it may incur a loss on the resale of those ADSs.
We
understand that the Staff has raised concerns generally that provisions of equity line transactions could have a “toxic”
effect on existing shareholders. As set forth in the following
bullets, the sales process under the Purchase Agreement differs meaningfully from typical equity line transactions and these differences
should allay any potential concerns that the Staff should have with respect to sales under the Purchase Agreement.
United States Securities and Exchange Commission
Page 4
· Unlike most equity line transactions,
the Purchase Agreement prohibits Aspire from engaging in any direct or indirect short selling or hedging of the Company’s
securities, which provides a fundamental economic incentive to Aspire to avoid selling into the market if it would cause downward
pressure on the market price for the ADSs and discourage the investor from exerting downward pricing pressure on the ADSs.
· As described in the Registration Statement,
the Purchase Agreement permits the Company, in its sole discretion, to put ADSs to Aspire at a price tied directly to the market
price of the ADSs which protects the Company against volatile trading prices in the ADSs. When the Company gives notice to Aspire
of a put, the Company is able to either know the exact price at which such ADSs will be purchased by Aspire (in the case of a “Regular
Purchase”) or establish a minimum purchase price (in the case of a VWAP Purchase).
· Unlike most equity line financings, the
Purchase Agreement allows that the sales price can be determined prior to the sale commitment which could limit the amount of dilution
to existing shareholders as a result of the sale by setting objective parameters regarding when the Company can put ADSs to Aspire.
While most equity line transactions permit “forward pricing” (i.e., calculation of the purchase price with reference
to market prices after the seller gives notice of a put to the purchaser) and thereby expose the Company to potential unanticipated
share dilution and market manipulation, the Purchase Agreement calculates the price with reference to market prices on or before
the purchase date. For Regular Purchases, the put notice may be delivered after the close of the Nasdaq Stock Market on the purchase
date. While the “VWAP Purchase Notice” must be delivered by the close of business on the business day immediately preceding
the purchase date, the Company is able to set a minimum purchase price in the notice to protect it against unexpected decreases
in the market price of its ADSs. By including provisions that allow the Company to know or set the minimum purchase price for each
put prior to such transaction, and prohibiting Aspire from engaging in any short or hedging transactions with regard to those ADSs,
the Purchase Agreement requires that Aspire assume investment risk with respect to the purchased ADSs and aligns Aspire’s
economic interests with those of the non-affiliated shareholders.
Due to these factors
and the other factors discussed in this letter, the Company respectfully submits that the resale registration transaction registered
in the Registration Statement should not be re-characterized as a primary offering.
Aspire
is not an affiliate of the Company or a broker-dealer or an affiliate of a broker-dealer. The only relationship between Aspire
and the Company is the relationship established through the Purchase Agreement. Aspire has agreed to acquire the Company’s
ADSs for investment purposes as a principal, not as an agent, and is at market risk for the Initial Shares ADSs
purchased as part of its investment. Aspire will retain all proceeds from the sale of the Initial Shares and the ADSs
pursuant to the Registration Statement and, in contrast to the economic terms of an underwritten offering, the proceeds of sale
by the Company to Aspire are not dependent on the price at which Aspire ultimately sells the securities pursuant
to the Registration Statement. In addition, Aspire has not, and will not, receive a commission or any other remuneration from the
Company if and when the additional ADSs are sold to Aspire under the Purchase Agreement. Aspire will be responsible for paying
any broker-dealer fees or underwriting discounts or commissions directly to any broker-dealers it engages to assist in selling
any ADSs, as applicable.
United States Securities and Exchange Commission
Page 5
The
nature of the parties to this transaction, the lack of any prior relationship between them and the structure of the Purchase Agreement
support the conclusion that Aspire is not acting as a mere conduit for the Company in selling ADSs. Aspire is an institutional
investor that had no relationship with the Company and owned no shares or ADSs
of the Company prior to entering into the Purchase Agreement on September 26, 2018. Aspire is not in the business of underwriting
securities and is not a registered broker-dealer. Aspire and its principals have a long history of entering into equity line transactions
that are similar to the transaction it has entered into with the Company. The Company entered into the Purchase Agreement with
Aspire on an arm’s length basis on terms that obligate Aspire to purchase the Company’s ADSs as principal at prices
determined by formulas tied to the market. Aspire was irrevocably bound to purchase the Company’s securities upon the execution
of the Purchase Agreement. For the reasons discussed above the Company believes that this transaction is eligible to be made on
a continuous or delayed basis pursuant to Rule 415(a)(1)(i) because Aspire is not an affiliate of the Company, would not be considered
one even if it held all shares and ADSs registered for resale, is not acting on behalf of the Company or any of its affiliates,
and is not a broker-dealer or in the business of acting as one.
C. The
Registration Statement is Appropriate Under Rule 415(a)(1)(i) Despite the Number of Ordinary Shares and ADSs Registered for Resale
As noted above, as
of September 25, 2018, the Company had 1,525,693,413 ordinary shares outstanding, with 743,347,813 of those ordinary shares held
by non-affiliates. Aspire seeks to have the Company register 500,000,000 ordinary shares, as represented by ADSs and the Initial
Shares, pursuant to the Registration Statement, constituting approximately 32.8% of the total outstanding shares and 67.2% of the
ordinary shares held by non-affiliates (which includes shares represented by ADSs). In the context of convertible securities that
have the potential for a significant, but undefined, dilutive effect on existing stockholders, the Staff has expressed concerns
that a registered resale transaction involving more than one-third of the issuer’s outstanding shares (which includes shares
represented by ADSs) held by non-affiliates may constitute a primary offering on behalf of the issuer. Importantly, that Staff
position is limited to resales of securities underlying convertible securities, which present significant policy issues that are
not present in the transaction being registered in the Registration Statement, which relates only to the resale of non-convertible
ADSs.
As noted above, prior
to entering into the Purchase Agreement, Aspire had no affiliation, agreements or understandings with the Company, its officers,
directors or affiliates. Were the Company to issue all 500,000,000 ordinary shares that it has the contractual right to issue to
Aspire under the Purchase Agreement and if Aspi
2018-12-20 - UPLOAD - Akari Therapeutics Plc
December 19, 2018
Clive Richardson
Interim Chief Executive Officer
Akari Therapeutics Plc
75/76 Wimpole Street
London W1G 9RT
United Kingdom
Re:Akari Therapeutics Plc
Registration Statement on Form F-1
Response dated December 6, 2018
File No. 333-227752
Dear Mr. Richardson:
We have reviewed your December 6, 2018 response to our comment letter and have the
following comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies 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 this comment, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our October 25, 2018 letter.
Form F-1 Filed October 9, 2018
General
1.We refer to parts A and C.4 of your response to prior comment 1 and note that your
registration of 5 million ADS represents approximately 67% of your ADS currently
outstanding and held by non-affiliates. Given the size of the offering, we cannot agree
that this transaction can be made on a secondary basis in reliance on Rule 415(a)(1)(i).
Accordingly, please revise the Form S-1 to indicate that the offering will be made at a
fixed price or advise.
FirstName LastNameClive Richardson
Comapany NameAkari Therapeutics Plc
December 19, 2018 Page 2
FirstName LastName
Clive Richardson
Akari Therapeutics Plc
December 19, 2018
Page 2
You may contact Jeffrey Gabor at 202-551-2544 or Joe McCann at 202-551-6262 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Heidi Steele, Esq.
2018-12-06 - CORRESP - Akari Therapeutics Plc
CORRESP
1
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Heidi Steele
Attorney at Law
hsteele@mwe.com
+1 312 984 3624
December 6, 2018
Via EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re: Akari Therapeutics Plc
Registration Statement on Form F-1
Filed October 9, 2018
File No. 333-227752
Ladies and Gentlemen:
On behalf of Akari Therapeutic plc (“Akari”
or the “Company”), set forth below are responses to the comments received from the staff of the Division of
Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”)
by letter dated October 25, 2018, with respect to the above-referenced Registration Statement on Form F-1 (the “Registration
Statement”).
Set forth below in bold is the Staff’s
comment, followed immediately by the Company’s response.
General
1. Given the nature
of the offering and size of the transaction relative to the number of outstanding shares held by non-affiliates, please advise
us of your basis for determining that the transaction is appropriately characterized as a transaction that is eligible to be made
on a shelf basis under Rule 415(a)(1)(i).
Response:
The Company respectfully submits that the
transaction set forth in the Registration Statement relates to the offering of securities solely by or on behalf of a person or
persons other than the registrant, a subsidiary of the registrant or a person of which the registrant is a subsidiary, as discussed
in greater detail below, and therefore, is eligible to be made on a continuous or delayed basis under Rule 415(a)(1)(i) promulgated
under the Securities Act of 1933 (the “Securities Act”).
United States Securities and Exchange Commission
Page 2
A. Background
On September 26, 2018, the Company entered
into a Purchase Agreement with Aspire Capital Fund, LLC, an Illinois limited liability company (“Aspire Capital”),
which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed
to purchase up to an aggregate of $19.5 million of Company ADSs representing ordinary shares over the approximately 30-month term
of the Purchase Agreement. In consideration for entering into the Purchase Agreement, concurrently with the execution of the Purchase
Agreement, the Company issued to Aspire Capital 30,000,000 ordinary shares that are exchangeable for 300,000 ADSs as a commitment
fee (the “Commitment Shares”) and sold to Aspire Capital 25,000,000 ordinary shares that are exchangeable for
250,000 ADSs for $0.02 per share (equivalent to $2.00 per ADS). Concurrently with entering into the Purchase Agreement, the Company
also entered into a registration rights agreement with Aspire Capital (the “Registration Rights Agreement”),
in which the Company agreed to file the Registration Statement to register under the Securities Act the sale of the ADSs that have
been and may be issued to Aspire Capital under the Purchase Agreement.
As of October 8, 2018, there were 1,525,693,413
ordinary shares outstanding (743,347,813 ordinary shares held by non-affiliates), represented by 15,256,934 ADSs, excluding the
5,000,000 ADSs representing 500,000,000 ordinary shares offered that have been issued or may be issuable to Aspire Capital pursuant
to the Purchase Agreement. If all of such 5,000,000 ADSs subject to the Registration Statement were issued and outstanding, such
shares would represent 24.7% of the total ADSs outstanding or 40.2% of the non-affiliate ADSs currently outstanding. The number
of ADSs representing ordinary shares ultimately offered for sale by Aspire Capital is dependent upon the number of ADSs purchased
by Aspire Capital under the Purchase Agreement.
Aspire Capital is an institutional investor
that invests in a wide range of companies and industries, with an emphasis on life sciences, energy and technology companies. Prior
to entering into the Purchase Agreement, Aspire Capital did not own any securities of the Company and was not affiliated with the
Company or any of its officers, directors or any other greater than 5% holder of the Company’s outstanding ordinary shares
(including outstanding ADSs representing ordinary shares).
B. Staff
Guidance
Rule 415(a)(1)(i) of the Securities Act
provides that securities may be registered for an offering to be made on a continuous or delayed basis in the future, provided,
that the registration statement pertains only to securities which are to be offered or sold solely by or on behalf of a person
or persons other than the registrant, a subsidiary of the registrant or a person of which the registrant is a subsidiary. As stated
in the Registration Statement, the securities are being registered for resale or other disposition by the selling stockholder,
Aspire Capital. Proceeds from the sale of any securities are solely for the account of Aspire Capital, although the Company has
received approximately $0.5 million from the selling stockholder for the sale of 25,000,000 ordinary shares to the selling stockholder
upon signing the Purchase Agreement. The selling stockholder will receive all of the proceeds from the sale of the ADSs offered
for sale by it under the Registration Statement. The Company will not receive proceeds from the sale of the ADSs by the selling
stockholder. However, the Company may receive up to an additional $19.5 million in proceeds from the sale of Company ADSs to the
selling stockholder under the Purchase Agreement.
United States Securities and Exchange Commission
Page 3
With regard to the Staff’s comment,
we note Securities Act Rules Compliance and Disclosure Interpretation (“C&DI”) 612.09, which indicates that
the issue of whether an offering styled as a secondary offering is really by or on behalf of the issuer involves an analysis of
facts beyond the entity that will receive the proceeds of the sale of securities that are being registered. Specifically, C&DI
612.09 states that consideration should be given to the following factors:
· How long the selling stockholders have held the shares;
· The circumstances under which they received them;
· Their relationship to the issuer;
· The amount of shares involved;
· Whether the sellers are in the business of underwriting securities;
and
· Whether under all the circumstances it appears that the seller is
acting as a conduit for the issuer.
As detailed below, we have considered the
above factors and respectfully submit that the proposed registration is eligible to be made on a continuous or delayed basis in
the future under Rule 415(a)(1)(i) of the Securities Act.
C. Analysis
of the Six Factors Described in C&DI 612.09
1. How
long the selling stockholders have held the shares.
The securities being registered for resale
pursuant to the Registration Statement include: (a) 30,000,000 ordinary shares the Company will issue (as Commitment Shares) that
are exchangeable for 300,000 ADSs and (b) 25,000,000 ordinary shares that are exchangeable for 250,000 ADSs for $0.02 per share
(equivalent to $2.00 per ADS) that the Company sold to Aspire Capital in consideration for entering into the Purchase Agreement.
In this regard, we believe it is important to note that C&DI 139.13 provides that no minimum holding period is required, and
the Commission will permit a company to register the resale of the underlying securities prior to exercise of a put right, where
the Company has “completed the private transaction of all of the securities it is registering” through an equity line
transaction and the investor is at market risk at the time of filing of the resale registration statement. As in all equity line
transactions, Aspire Capital has accepted the market risk of its investment from the date of entering into the Purchase Agreement,
including market risk related to the shares currently held and those that the Company may choose, in its sole discretion, to put
to Aspire Capital pursuant to the terms of the Purchase Agreement.
United States Securities and Exchange Commission
Page 4
2. The
circumstances under which the selling stockholders received the shares.
Aspire Capital will receive the shares offered
in the Registration Statement pursuant to the privately negotiated transaction between the Company and Aspire Capital completed
at arm’s length prior to the filing of the Registration Statement. Although Aspire Capital is required by the Staff to include
disclosure that it is an “underwriter” with regard to its resales under the Registration Statement, we respectfully
note that the transaction has characteristics more closely associated with a traditional investment transaction than with an underwritten
offering. Specifically, in a typical underwriting, the underwriter and the issuer agree on a price at which the securities will
be sold to the public and the underwriter receives a portion of the proceeds of such sale as compensation for its selling efforts
and for bearing market risk. Pursuant to the Purchase Agreement, however, Aspire Capital will purchase any shares put to it by
the Company at a slight discount to the market price for the shares. Aspire Capital is required to take the securities put to it
by the Company under the Purchase Agreement and there is no agreement or arrangement regarding the price at which Aspire Capital
will resell such shares to the public pursuant to the Registration Statement. Additionally, Aspire Capital is prohibited from engaging
in or effecting, directly or indirectly, any (i) “short sale” of the Company’s ADSs or of the ordinary shares
represented by the ADSs or (ii) hedging of the Company’s ADSs or of the ordinary shares represented by the ADSs. As such,
unlike a traditional underwriter, Aspire Capital is taking investment risk with regard to the securities it will acquire under
the Purchase Agreement and there is no certainty that it will receive a premium on the resale of any shares it purchases pursuant
to the Purchase Agreement. Aspire Capital is at risk that it may incur a loss on the resale of those shares.
3. The
selling stockholders’ relationship to the issuer.
Aspire Capital is not an affiliate of the
Company or a broker-dealer or an affiliate of a broker-dealer. The only relationship between Aspire Capital and the Company is
the relationship established through the Purchase Agreement and the transactions contemplated thereby, and any other separate transactions
that the Company and Aspire Capital may enter into from time to time. Under the Purchase Agreement, Aspire Capital has agreed to
acquire the Company’s securities for investment purposes as a principal, not as an agent, and is at market risk for all shares
purchased as part of its investment. Aspire Capital will retain all proceeds from the sale of shares pursuant to the Registration
Statement and, in contrast to the economic terms of an underwritten offering, the proceeds of the sale by the Company to Aspire
Capital are not dependent on the price at which Aspire Capital ultimately sells the shares pursuant to the Registration Statement.
In addition, Aspire Capital has not and
will not receive a commission or any other remuneration from the Company if and when the additional shares are sold to Aspire Capital
under the Purchase Agreement. Aspire Capital will be responsible for paying any broker-dealer fees or underwriting discounts or
commissions directly to any broker-dealers it engages to assist in selling any ADSs, as applicable. Aspire Capital will retain
all proceeds from the resale of shares pursuant to the Registration Statement and the Company will not obtain any direct or indirect
benefit from any amounts received from those sales.
United States Securities and Exchange Commission
Page 5
The Company also notes that even if Aspire
Capital were an affiliate of the Company, pursuant to C&DI 212.15 the Staff has acknowledged that “aside from parents
and subsidiaries, affiliates of issuers are not necessarily treated as being the alter egos of the issuers. Under appropriate circumstances,
affiliates may make offerings which are deemed to be genuine secondaries.” For the reasons set forth above, the Company submits
that Aspire Capital’s relationship to the Company as an investor that assumes market risk with respect to the ADSs representing
ordinary shares it acquires under the Purchase Agreement is appropriate for resale under Rule 415(a)(1)(i).
4. The
amount of shares involved.
As of October 8, 2018, there were 1,525,693,413
ordinary shares outstanding (743,347,813 ordinary shares held by non-affiliates), represented by 15,256,934 ADSs, excluding the
5,000,000 ADSs representing 500,000,000 ordinary shares offered that have been issued or may be issuable to Aspire Capital pursuant
to the Purchase Agreement. If all of such 5,000,000 ADSs offered hereby were issued and outstanding as of the date hereof, such
shares would represent 24.7% of the total ADSs outstanding or 40.2% of the non-affiliate ADSs outstanding as of the date hereof.
The number of ADSs representing ordinary shares ultimately offered for sale by Aspire Capital is entirely dependent upon the number
of ADSs purchased by Aspire Capital under the Purchase Agreement.
Aspire Capital is an institutional investor
that invests in a wide range of companies and industries, with an emphasis on life sciences, energy and technology companies. Prior
to entering into the Purchase Agreement, Aspire Capital did not own any securities of the Company and was not affiliated with the
Company or any of its officers, directors or any other greater than 5% holder of the Company’s outstanding ordinary shares
(including ADSs representing ordinary shares).
5. Whether
the sellers are in the business of underwriting securities.
Aspire Capital is not in the business of
underwriting securities and is not a registered broker-dealer. In fact, Aspire Capital and its principals have a long history of
entering into equity line transactions that are fundamentally similar to the transaction it has entered into with the Company and
a long history of maintaining ownership interest in the companies with which it engages in those transactions.
6. Whether
under all the circumstances it appears that the seller is acting as a conduit for the issuer.
Aspire Capital is an investor in the Company
and has agreed to incur the economic risk for its investment over the term of the Purchase Agreement. In contrast, an underwriter
typically desires to sell shares before it even acquires them to eliminate market risk, among other reasons. The Company also notes
that the Purchase Agreement does not contain any provisions requiring Aspire Capital to place the ADSs with other investors or
to otherwise distribute the ADSs or ordinary shares in any way, nor are there other arrangements or understandings between the
Company and Aspire Capital to do so.
United States Securities and Exchange Commission
Page 6
D. Additional
Support
C&DI 139.13 sets forth the Staff’s
view as to when a private equity line financing will qualify for resale registration despite the fact that the Staff considers
such transactions to be “indirect primary offerings”. Specifically, a company must meet the following conditions:
· the company must have “completed” the private transaction
of all of the securities it is registering for “resale” prior to the filing of the registration statement;
· the “resale” registration statement must be on the form
that the company is eligible to use for a primary offering (in this instance, Form F-1); and
· in the prospectus, the investor(s) must be
2018-10-25 - UPLOAD - Akari Therapeutics Plc
October 25, 2018
Clive Richardson
Interim Chief Executive Officer
Akari Therapeutics Plc
75/76 Wimpole Street
London W1G 9RT
United Kingdom
Re:Akari Therapeutics Plc
Registration Statement on Form F-1
Filed October 9, 2018
File No. 333-227752
Dear Mr. Richardson:
We have limited our review of your registration statement to those issues we have
addressed in our comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies 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 this comment, we may have additional comments.
Form F-1 Filed October 9, 2018
General
1.Given the nature of the offering and size of the transaction relative to the number of
outstanding shares held by non-affiliates, please advise us of your basis for determining
that the transaction is appropriately characterized as a transaction that is eligible to be
made on a shelf basis under Rule 415(a)(1)(i).
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 LastNameClive Richardson
Comapany NameAkari Therapeutics Plc
October 25, 2018 Page 2
FirstName LastName
Clive Richardson
Akari Therapeutics Plc
October 25, 2018
Page 2
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
You may contact Jeffrey Gabor at 202-551-2544 or Joe McCann at 202-551-6262 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Heidi Steele, Esq.
2018-02-23 - CORRESP - Akari Therapeutics Plc
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Akari Therapeutics, PLC
75/76 Wimpole Street
London W1G 9RT
United Kingdom
February 22, 2018
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Akari Therapeutics, PLC
Registration Statement on Form F-3
File No. 333-220052
VIA EDGAR
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities
Act of 1933, as amended, Akari Therapeutics, PLC (the “Registrant”) hereby respectfully requests that the effectiveness
of the Registration Statement on Form F-3 (File No. 333-220052) of the Registrant (the “Registration Statement”)
be accelerated so that it will be declared effective at 4:00 p.m., Eastern Time, on February 23, 2018 or as soon thereafter as
may be practicable.
The Registrant hereby confirms that it is
aware of its responsibilities under the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended,
as they relate to the proposed offering of the securities specified in the Registration Statement. The Registrant hereby acknowledges
that:
· should the Securities and Exchange Commission (the “Commission”) or the 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 the 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
filing; 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 undersigned respectfully requests that
it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, McDermott Will & Emery
LLP, by calling Gary Emmanuel at (917) 297-4545. The Company hereby authorizes Mr. Emmanuel to orally modify or withdraw this request
for acceleration.
Please also provide a copy of the Commission’s
order declaring the Registration Statement effective to Mr. Emmanuel via email to gemmanuel@mwe.com or facsimile to (212) 547-5444
and via mail at 340 Madison Avenue, New York, NY 10173.
Very truly yours,
AKARI THERAPEUTICS, PLC
By:
/s/ David Horn Solomon
Name: David Horn Solomon
Title: Chief Executive Officer
cc: Gary Emmanuel (McDermott Will & Emery LLP)
2017-08-24 - UPLOAD - Akari Therapeutics Plc
August 24, 2017 Ray Prudo Interim Chief Executive Officer Akari Therapeutics, Plc 75/76 Wimpole Street London W1G 9RT United Kingdom Akari Therapeutics, Plc Registration Statement on Form F-3 Filed August 18, 2017 File No. 333-220052Re: Dear Dr. Prudo: 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. Division of Corporation Finance Office of Healthcare & Insurance cc: Gary Emmanuel, Esq.
2015-10-28 - CORRESP - Akari Therapeutics Plc
CORRESP
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AKARI
THERAPEUTICS, PLC
24 West 40th Street
New York, NY 10018
October 28, 2015
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E., Mail Stop 4720
Washington, D.C. 20549
Attention:
Suzanne Hayes
Scott Foley
Re:
Akari Therapeutics, Plc
Registration Statement on Form S-3
Filed on October 16, 2015
File No. 333-207443
Ladies and Gentleman:
Pursuant to Rule 461 of the Rules and Regulations
promulgated under the Securities Act of 1933, as amended, Akari Therapeutics, Plc (the “Company”) hereby requests that
the effectiveness of the above-captioned Registration Statement on Form S-3 be accelerated to Friday, October 30, 2015, at 10:00
a.m., EST, or as soon as thereafter practicable.
Please note that the Company acknowledges the following:
· should the U.S. Securities and Exchange Commission (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.
Securities and Exchange Commission
October 28, 2015
Page 2
Any questions regarding
this request should be addressed to Jeffrey P. Schultz, Esq., at Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., Chrysler
Center, 666 Third Avenue, New York, New York 10017, telephone (212) 935-3000.
Thank you very much.
Very truly yours,
AKARI THERAPEUTICS, PLC
/s/ Gur Roshwalb
Gur Roshwalb, M.D.
Chief Executive Officer
cc: Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
Kenneth R. Koch, Esq.
Jeffrey P. Schultz, Esq.
2015-10-27 - UPLOAD - Akari Therapeutics Plc
Mail Stop 4720 October 26, 2015 Via E -mail Gur Roshwalb, M.D. Chief Executive Officer Akari Therapeutics, Plc 24 West 40th Street New York, NY 10018 Re: Akari Therapeutics, Plc Registration Statement on Form S-3 Filed October 16, 2015 File No. 333-207443 Dear Dr. Roshwalb : 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 wit h 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 th e 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. Gur Roshwalb, M.D. Akari Therapeutics, Plc October 26, 2015 Page 2 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 registered securities . Please contact Scot Foley at (202) 551 -3383 or me at (202) 551 -3675 with any questions. Sincerely, /s/ Suzanne Hayes Suzanne Hayes Assistant Director cc: Kenneth R. Koch, Esq. Jeffrey P. Schultz, Esq. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo P.C. Chrysler Center, 666 Third Avenue New York, NY 10017
2013-01-31 - CORRESP - Akari Therapeutics Plc
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Morria Biopharmaceuticals Plc
London Office
53 Davies street
Mayfair
London W1K 5JH
Tel: +44 (0)207 152 6341
Fax: +44 (0) 207 152 6342
Email: info@morria.com
Registered Address
Thames House
Portsmouth Road
Esher
Surrey
KT10 9AD
January 31, 2013
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Rose Zukin, Esq.
Re:
Morria Biopharmaceuticals PLC
Registration Statement on Form F-1
Filed December 3, 2012,
as amended on December 27, 2012 and January 22, 2013
File No. 333-185247
Dear Ms. Zukin:
With respect to the
above-referenced Registration Statement on Form F-1 (the “Registration Statement”), and pursuant to Rule 461 of Regulation
C promulgated under the Securities Act of 1933, as amended, the undersigned hereby respectfully requests, on behalf of Morria Biopharmaceuticals
PLC (the “Company”), that the Securities and Exchange Commission (the “Commission”) accelerate the effective
date of the Registration Statement to Friday, February 1, 2013 at 11:00 a.m., or as soon as practicable thereafter.
In connection with
the foregoing request, the Company acknowledges the following:
· 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.
The cooperation of
the staff in meeting the timetable described above is very much appreciated. Please call Jeffrey P. Schultz of Mintz, Levin, Cohn,
Ferris, Glovsky and Popeo, P.C., counsel to the Company, at (212) 692-6732 with any comments or questions regarding the Registration
Statement.
Very truly yours,
/s/ Dov Elefant
Dov Elefant
Chief Financial Officer
Cc:
Mark Cohen, Executive Chairman
Jeffrey Schultz, Esq. 7994721v.1
2013-01-09 - UPLOAD - Akari Therapeutics Plc
January 8 , 2013 Via E -mail Dr. Yuval Cohen President Morria Biopharmaceuticals PLC 53 Davies Street London W1K 5JH United Kingdom Re: Morria Biopharmaceuticals PLC Amendment No. 1 to Registration Statement on Form F-1 Filed December 27, 2012 File No. 333-185247 Dear D r. Cohen: We have reviewed your amended registration statement and response letter 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 . Where 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. Amendment No. 1 to Registration Statement on Form F -1 1. Please update your Compensation information to provide executive compensation disclosure for the 2012 fiscal year. Please refer to Item 4 of Form F -1 and Item 6 o f Form 20 -F for guidance. Exhibit 5.1 2. Please refer to your response to comment 2 regarding assumptions or qualifications that appear to be neither necessary nor appropriate. It appears that the revised legal opinion continues to include assumptions conc erning facts that are readily ascertainable. For example, refer to the assumption relating to whether the resolutions of the board of directors have not been amended or rescinded contained in section 2.4; and that no members ’ or creditors ’ voluntary windi ng up resolution has been passed and no petition Dr. Yuval Cohen Morria Biopharmaceuticals PLC January 8, 2013 Page 2 has been presented and no order has been made for the administration, winding up or dissolution of the Company and no receiver, administrative receiver, administrator or similar officer has been appointed in relation to the Company or any of its assets in section 2.17. We also note that there are assumptions, the purpose of which is unclear, such as the assumption that no shares or securities in the Company are listed on any recognized investment exchange in the United Kingdom (as defined in section 285 of the Financial Services and Markets Act 2000) , or the assumption stating that the Company’s place of central management and control is not in the UK, the Channel Islands or the Isle of Man for the purposes o f the City Code on Takeovers & Mergers . Please have counsel revise its opinion to remove all assumptions or qualifications that are inconsistent with the staff’s views contained in Section II.B.3 of Staff Legal Bulletin No. 19 (Oct. 14, 2011) or unneces sary to the substance of the opinion rendered. To the extent counsel wishes to retain the assumptions contained in the opinion, please provide us with supplemental support justifying their inclusion. Please also provide us with a blackline version showin g the revisions made to the opinion. 3. In response to prior comment 3, you have assumed that the definition of non -assessable in relation to the securities means that the holders will be under no obligation to contribute to the liabilities of the company solely in their capacity as holders of such securities. Please expand the definition of non -assessable in the opinion to address whether holders will have any obligation to make any payments or contributions to the registrant or its creditors solely by re ason of the purchasers’ ownership of the securities. For guidance, please refer to Section II.B.1.b. and c. of Staff Legal Bulletin No. 19. 4. Please refer to your response to comment 4. As noted in Section II.B.3.d of Staff Legal Bulletin No. 19, the sta ff does not accept any limitation on the reliance of the purchasers of the securities in this offering. The following statements are impermissible limitations on reliance and should be removed from the legal opinion. “This Opinion is given solely to you for the purpose of the filing of a registration statement on Form F -1. It may not be used or relied upon for any other purpose or by any other person.” “Our total (and where appropriate, aggregate) liability to the ad dressee in accordance with the provision of this letter and the opinions contained herein is limited to a maximum of £3,000,000.” We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that th e 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. Dr. Yuval Cohen Morria Biopharmaceuticals PLC January 8, 2013 Page 3 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 t he 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 delega ted 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. 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 p roposed 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 of the registration statement. You may contact Rose Zukin at (202) 551 -3239, Jennifer Riegel at (202) 551 -3575, or me at (202) 551 -3710 with any questions. Sincerely, /s/ Jennifer Riegel for Jeffrey P. Riedler Assistant Director cc: Jeffrey P. Schultz, Esq. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. 666 Third Avenue New York, NY 10017
2012-12-18 - UPLOAD - Akari Therapeutics Plc
December 18 , 2012 Via E -mail Dr. Yuval Cohen President Morria Biopharmaceuticals PLC 53 Davies Street, London United KingdomW1K 5JH Re: Morria Biopharmaceuticals PLC Registration Statement on Form F-1 Filed December 3, 2012 File No. 333-185247 Dear Dr. Cohen: We have limited our review of your registration statement to those issues we have addressed in our 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 . Where 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. Registration Statement on Form F -1 Exhibit 5.1 1. In Section 1 of the legal opinion filed as Exhibit 5.1, you list the documents examined by counsel (the “Documents”). You state on page 2 of the legal opinion that you have relied upon the Documents listed without independent investigation of the matters provided for in such Documents for the purpose of providing the opinions expressed in Exhibit 5.1. In addition, you have reviewed the drafts of Documents 1.3 to 1.5 (th e “Transaction Documents”) and not the final executed versions of the Transaction Documents. Further, in Documents 1.6 and 1.7, you refer to specific minutes and resolutions that counsel has reviewed. The language of the legal opinion implies that counse l reviewed only the documents listed in Section 1. Please remove language in the opinions implying that counsel’s Dr. Yuval Cohen Morria Biopharmaceuticals PLC December 18, 2012 Page 2 review was limited to only a specific set of documents. We will not object to counsel including a list of documents it reviewed provided tha t the language does not state or imply that these were the only documents reviewed by counsel. Counsel must review all documents necessary in order to render its opinion regarding the legality of the shares. 2. We note that the opinion contain s a lengthy li st of assumptions or qualifications that appear to be neither necessary nor appropriate. While certain assumptions are appropriate, such as that the documents reviewed or relied upon in giving the opinion are authentic and complete , or that the signatures on documents are genuine, other assumptions cover matters that appear to be essential to rendering the opinion given. Others are either overly broad , concern facts that are readily ascertainable or gratuitous insofar as the purpose of the provision is di fficult to ascertain. For example, refer to certain assumptions relating to whether the final form Transaction Documents are in the same form as those circulated to counsel in draft form; that the resolutions of the board of directors were duly passed at properly convened meetings of duly appointed directors of the Company at which a quorum was present throughout, have not been amended or rescinded; that as of the date of the opinion, the Company has not passed a voluntary winding up resolution, etc . We a lso note that there are assumptions, the purpose of which is unclear, such as the assumption that none of the parties who are party to the Transaction Documents, or who have received any prospectuses in relation to the Company, or any documents related to any matters relating to the Transaction Documents are resident in or were in the United Kingdom at the time they entered into or received any such documents. Please have counsel revise its opinion to remove all assumptions or qualifications that are inconsistent with the staff’s views contained in Section II.B.3 of Staff Legal Bulletin No. 19 (Oct. 14, 2011) or unnecessary to the substance of the opinion rendered. To the extent counsel wishes to retain the assumptions contained in the opinion , please provide us with supplemental support justifying their inclusion. Please also provide us with a blackline version showing the revisions made to the opinion. 3. Please note that Commission rules require an opinion of counsel with respect to whether the secur ities being registered will be, when sold, non -assessable. Please revise the legal opinion to opine as to whether the ordinary shares that are the subject of the registration statement will be non -assessable when sold. Please refer to Section II.B.1.a of Staff Legal Bulletin No. 19 for guidance. 4. The legal opinion includes the sentence, “This opinion is given to the addresses for the sole benefit of the addresses and for the purpose of the Transaction Documents. . . . This opinion may not be delivered to nor relied upon by any other person or for any other purpose and is not to be quoted or referred to in any document or filed with any person, except in any case with our prior written consent.” Please note that these sentences are impermissible limitation s on reliance , since all purchasers in the offering are entitled to rely on the opinion of counsel. Please remove these statements from the legal opinion. For guidance, please refer to Section II.B.3.d of Staff Legal Bulletin No. 19. Dr. Yuval Cohen Morria Biopharmaceuticals PLC December 18, 2012 Page 3 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. 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 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 revie w any amendment prior to the requested effective date of the registration statement. You may contact Rose Zukin at (202) 551 -3239, Jennifer Riegel at (202) 551 -3575, or me at (202) 551 -3710 with any questions. Sincerely, /s/ Jennifer Riegel for Jeffrey P. Riedler Assistant Director cc: Jeffrey P. Schultz, Esq. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. 666 Third Avenue New York, NY 10017
2012-11-30 - UPLOAD - Akari Therapeutics Plc
November 29, 2012 Via E -mail Dr. Yuval Cohen President Morria Biopharmaceuticals PLC 53 Davies Street London W1K 5JH United Kingdom Re: Morria Biopharmaceuticals PLC Registration Statement on Form 20 -F Filed August 31 , 2012 File No. 000 -54749 Dear Dr. Cohen: We have completed our review of your filing. We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or the filing and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. 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 Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Jeffrey P. Riedler Jeffrey P. Riedler Assistant Di rector cc: Jeffrey Schultz, Esq. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. 666 Third Avenue New York, NY 10017
2012-11-14 - UPLOAD - Akari Therapeutics Plc
November 14 , 2012 Via E -mail Dr. Yuval Cohen President Morria Biopharmaceuticals PLC 53 Davies Street London W1K 5JH United Kingdom Re: Morria Biopharmaceuticals PLC Amendment No. 2 to Registration Statement on Form 20 -F Filed October 29 , 2012 File No. 000 -54749 Dear Dr. Cohen: We have reviewed your amended registration statement and we have the following additional comment s. Please respond to this letter within ten business days by amending your filing, by providing the requested information, or by advising us when you wil l provide the requested response. 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 the next amendment to your registration statement and the information you provide in response to th ese comment s, we may have additional comments. Interim Consolidated Financial Statements (Unaudited) General 1. Please re -number the pages to the unaudited interim financial statements so they do not duplicate the same page numbers in the audited financial statements. 2. It appears that the column headings on pages F -4 and F -6 label on ly 2011 as unaudited. Please label all three columns as unaudited or label the entire financial statement as unaudited. Notes to Consolidated Financial Statements General 3. Please label the header to all pages of the interim notes as unaudited. Dr. Yuval Cohen Morria Biopharmaceuticals PLC November 14 , 2012 Page 2 Note 3 . Unaudited Interim Consolidated Financial Statements, page F -9 4. Please revise to include a statement in the notes to the financial statements disclosing that the interim financial statements reflect all adjustments, which are, in the opinion of managemen t, necessary to a fair statement of the results for the interim periods presented as required by Rule 10 -01(b)(8) of Regulation S -X. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includ es the information the Securities Exchange Act of 1934 and all applicable Exchange 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 adequac y of the disclosures they have made. In responding to our comments, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or ch anges to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person und er the federal securities laws of the United States. You may contact Ja mes Peklenk at (202) 551 -3661 or Donald Abbott at (202) 551 -3608 if you have questions regarding comments on the financial statements and related matters. Please contact Scot Foley at (2020) 551 -3383, Jennifer Riegel at (202) 551 -3575 or me at (202) 551-3715 with any other questions. Sincerely, /s/ Jennifer Riegel for Jeffrey Riedler Assistant Director cc: Jeffrey Schultz, Esq. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. 666 Third Avenue New York, NY 10017
2012-10-11 - UPLOAD - Akari Therapeutics Plc
October 1 0, 2012 Via E -mail Dr. Yuval Cohen President Morria Biopharmaceuticals PLC 53 Davies Street London W1K 5JH United Kingdom Re: Morria Biopharmaceuticals PLC Amendment No. 1 to Registration Statement on Form 20 -F Filed September 27 , 2012 File No. 000 -54749 Dear Dr. Cohen: We have reviewed your amended registration statement and your correspondence dated September 27, 2012 and we have the following additional comment. Please respond to this letter by amending your registration statement as requested . Please respond to this letter within ten busines s days by amending your filing , or by advising us when you wil l provide the requested response. If you do not believe our comment applies 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 filing and the information you provide in response to this comment , we may have additional comments. General 1. With your next amendment, please p rovide updated interim consolidated financial statements and related financial information as required by Item 8.A.5 of Form 20 -F. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includ es the information the Securities Exchange Act of 1934 and all applicable Exchange 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 adequac y of the disclosures they have made. Dr. Yuval Cohen Morria Biopharmaceuticals PLC October 1 0, 2012 Page 2 In responding to our comments, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or ch anges to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person und er the federal securities laws of the United States. You may contact James Peklenk at (202) 551 -3661 or Donald Abbott at (202) 551 -3608 if you have questions regarding comments on the financial statements and related matters. Please contact Scot Foley at (2020) 551 -3383, Jennifer Riegel at (202) 551 -3575 or me at (202) 551-3715 with any other questions. Sincerely, /s/ Jennifer Riegel for Jeffrey Riedler Assistant Director cc: Jeffrey Schultz, Esq. Mintz, Levin, Cohn, Ferris, Glo vsky and Popeo, P.C. 666 Third Avenue New York, NY 10017
2012-09-21 - UPLOAD - Akari Therapeutics Plc
September 20, 2012 Dr. Yuval Cohen President Morria Biopharmaceuticals PLC 53 Davies Street London W1K 5JH United Kingdom Re: Morria Biopharmaceuticals PLC Registration Statement on Form 20 -F Filed August 31, 2012 File No. 000 -54749 Dear Dr. Cohen: We have reviewed your registration statement and your correspondence dated August 31, 2012 and we 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 no t 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. Item 6. Directors , Senior Management and Employees B. Compensation Employment and Consulting Agreements, page 83 1. We note your response to our prior comment 9. Please expand your disclosure to note that the Executive Service Agreement between Dr. Bondi and the Company w as written in accordance with English Law, and despite certain terms in the agreement, was intended to be an independent contractor /relationship and not an employment agreement. In addition, please disclose that you intend to amend the Executive Service A greement to reflect your independent contractor relationship and provide the material terms of that relationship. Dr. Yuval Cohen Morria Biopharmaceuticals PLC September 20, 2012 Page 2 Item 19, Exhibits, page 126 2. We note your response to prior comment 14. Please be advised that if you intend to redact any portion of a mate rial agreement, you are required to apply for confidential treatment pursuant to Staff Legal Bulletin No.1. Please advise us whether you intend to submit a confidential treatment application or, alternatively, please amend your registration statement to i nclude the complete schedules with this exhibit. 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 Se curities 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 t he 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 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. Please refer to Rules 460 and 461 regarding requests for acceleration. We will consider a written request for accele ration 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 of the registration statement. Dr. Yuval Cohen Morria Biopharmaceuticals PLC September 20, 2012 Page 3 You may contact Ja mes Peklenk at (202) 551 -3661 or Donald Abbott at (202) 551 -3608 if you have questions regarding comments on the financial statements and related matters. Please contact Scot Foley at (2020) 551 -3383, Jennifer Riegel at (202) 551 -3575 or me at (202) 551-3715 with any other questions. Sincerely, /s/ Jennifer Riegel for Jeffrey Riedler Assistant Director cc: Jeffrey Schultz, Esq. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. 666 Third Avenue New York, NY 10017
2012-08-31 - CORRESP - Akari Therapeutics Plc
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Jeffrey Schultz | 212 692
6732 | jschultz@mintz.com
Chrysler Center
666 Third Avenue
New York, NY 10017
212-935-3000
212-983-3115 fax
www.mintz.com
August 31, 2012
Via EDGAR and by Federal Express
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Morria Biopharmaceuticals PLC
Registration Statement on Form 20-F
Originally Filed on August 8, 2012
File No. 000-54749
Ladies and Gentleman:
On
behalf of Morria Biopharmaceuticals PLC (the “Company”), we hereby file with
the Securities and Exchange Commission (the “Commission”) Amendment No. 2 to the Company’s Registration
Statement on Form 20-FR12G (the “Amendment”), as initially filed with the Commission on June 28, 2012 and as
amended by Amendment No. 1 on August 8, 2012 and subsequently withdrawn on August 24, 2012. We are also delivering five clean and
marked complete courtesy copies of the Amendment to the attention of Scot Foley, Esq.
Set forth below are
the Company’s responses to the Commission’s comments provided by a letter (the “Comment Letter”)
dated August 21, 2012, from the staff at the Commission (the “Staff”). The Company’s responses are numbered
to correspond to the comments, as set forth in the Comment Letter, which, for convenience, we have incorporated into this response
letter.
Item 3. Key Information
D. Risk Factors, page 5
“We will require additional
capital to fund our operations, and if we are unable to obtain such capital, we will be unable to successfully develop and commercialize
our product candidates,” page 6
1. We note your response to prior comment 7. It is unclear from your disclosure how you believe you
can execute your operating plan for the fiscal year, which you estimate to cost $1.7 million, without additional funding when the
balance of your cash and investment securities is currently $280,000. Please clarify and/or revise this disclosure both here and
on page 45.
Response: We have revised
the disclosure on pages 6 and 45 of the Amendment in response to the Staff’s comment.
“Our product candidates are
still in the early stages of development and remain subject to clinical testing and regulatory approval…,” page 10
Mintz, Levin, Cohn, Ferris, Glovsky and
Popeo, P.C.
Boston
| Washington | New York | Stamford | Los Angeles | Palo Alto | San Diego | London
Mintz,
Levin,
Cohn,
Ferris,
Glovsky
and
Popeo,
P.C.
Securities
and
Exchange
Commission
August
31,
2012
Page
2
2. We note your response to prior comment 9. Based on your disclosure on pages 41 and 51, please expand
your disclosure in this risk factor to disclose that the clinical trials you have performed to date for MRX-6 were not conducted
in the United States, were not compliant with either ICH or FDA regulations, and that you are required to complete a new clinical
trial that will be acceptable to the FDA in order to advance this product candidate’s development.
Response: We have expanded the disclosure in this risk
factor to provide that MRX-6 is currently being conducted as an academic study, which is neither FDA- nor ICH-compliant, and that
the Company is required to execute another clinical trial that will be either FDA compliant or ICH-compliant (and, thus, FDA-compliant),
in order to advance this product candidate’s development. Please see page 10 of the Amendment.
“U.S. investors may not be able
to enforce their civil liabilities against our company or our directors, controlling persons and officers,” page 35
3. Please consider including discussion of the availability of a treaty or reciprocity between the U.S. and the United Kingdom.
Response: We have revised the disclosure in response
to the Staff’s comment. Please see page 35 of the Amendment.
Item 4. Information on the Company
B. Business Overview
Product Candidates, page 41
4. We note your response to prior comment 20. Please include both in this discussion and in your related
disclosure on page 50 a brief description of the ICH and the reasons why clinical trials conducted according to its rules are acceptable
to the FDA. Please also disclose the circumstances in which foreign clinical trials can be used to support an IND, including if:
(a) they are performed in accordance with good clinical practice, including review and approval by an independent ethics committee
and informed consent from subjects, and (b) the FDA is able to validate the data from the study through an onsite inspection, if
necessary.
Response: We
have revised the disclosure on page 50 of the Amendment as set forth below to briefly describe the ICH and the reasons why clinical
trials conducted subject to its guidelines are acceptable to the FDA and to describe that foreign clinical trials can be used to
support an IND, including if they are performed in accordance with good clinical practice, including review and approval by an
independent ethics committee and informed consent from subjects, and the FDA is able to validate the data from the study through
an onsite inspection, if necessary.
Mintz,
Levin,
Cohn,
Ferris,
Glovsky
and
Popeo,
P.C.
Securities
and
Exchange
Commission
August
31,
2012
Page
3
Beginning in 1990, the FDA and corresponding
regulatory agencies of the EU and Japan commenced discussions to develop harmonized standards for preclinical and clinical studies
and the format and content of applications for new drug approvals through a process known as the International Conference on Harmonisation
of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Data from multinational studies adhering to
ICH- Good Clinical Practice (GCP) are now generally acceptable to the FDA and regulators in Australia, Canada, the EU, Japan and
Latin American countries and the World Health Organization (WHO). GCP is a
standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a
way that provides assurance that the data are credible and accurate and that the rights, safety, and well-being of trial subjects
are protected. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects
are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial
data are credible. GCP includes review and approval (or provision of a
favorable opinion) by an independent ethics committee, or IEC, before initiating a study, continuing review of an ongoing
study by an IEC, and obtaining and documenting the freely given informed consent of the subject (or a subject's legally authorized
representative, if the subject is unable to provide informed consent) before initiating a study. The FDA enforces these GCP guidelines
through periodic onsite inspections of trial sponsors, principal investigators, CRO trial sites, laboratories, and any entity having
to do with the completion of the study protocol and processing of data.
The MRX-4 clinical trial was a non-IND
foreign study performed in accordance with ICH GCP standards, including review and approval by an independent ethics committee
and the obtaining of the informed consent from its subjects in compliance with the requirements in the FDA’s regulations.
Moreover, the FDA is able to validate the data from the study through onsite inspection of the clinical site, if necessary.
Scientific Background to Inflammation
and Our Product Candidates, page 45
5. We note your response to prior comment 22. You state that the role of PLA2 in inflammatory diseases
has been “universally” accepted in the scientific community. Please provide the factual basis for this assertion, particularly
in light of your next sentence claiming that this role has become “increasingly better understood” since the 1980s,
which calls into question the universality of its acceptance.
Response: We have revised the disclosure
in response to the Staff’s comment and included references to certain scholarly articles and textbooks on the subject. Please
see page 45 of the Amendment.
6. You state that your principal shareholder’s work in this field has been “generally”
accepted by his peers. To the extent that you are aware of any dissents in the scientific community relating to his conclusions,
please describe them here and note, if applicable, where these dissents have been published.
Response: We have revised the disclosure
in response to the Staff’s comment to reflect that Professor Yedgar’s work has been “widely” accepted by
his peers, as evidenced by the publication of his work in this area in various peer-reviewed publications cited in the Amendment.
Please see page 45 of the Amendment.
Mintz,
Levin,
Cohn,
Ferris,
Glovsky
and
Popeo,
P.C.
Securities
and
Exchange
Commission
August
31,
2012
Page
4
7. If your principal shareholder or any of your other affiliates were engaged in any of the clinical
programs using PLA2 indicators that were launched in the 1990s, please revise your disclosure to state this.
Response: Neither the Company’s
principal shareholder nor any of its other affiliates were engaged in any of the clinical programs using PLA2 indicators that were
launched in the 1990s. Accordingly, we have not revised the disclosure.
Item 6. Directors, Senior
Management and Employees
B. Compensation
Employment
and Consulting Agreements, page 83
8. Please expand your discussion of your agreements with Prof. Saul Yedgar to disclose that you also
entered into a director agreement on February 21, 2005, which is filed as Exhibit 4.13.
Response: We have revised the disclosure
to include a description of the director agreement with Professor Yedgar dated February 21, 2005. Please see pages 82 and 84 of
the Amendment.
9. You disclose that you entered into a consulting agreement with Dr. Joseph Bondi effective June
1, 2007. Based on the agreement filed as Exhibit 4.19, it appears that this was an employment agreement. Please revise your filing
for this inconsistency. Alternatively, please provide us with an analysis that supports your conclusion that this was a consulting
agreement rather than an employment agreement.
Response: Dr.
Bondi is an independent contractor who provides consulting services to ot
2012-08-22 - UPLOAD - Akari Therapeutics Plc
August 21, 2012 Via E -mail Dr. Yuval Cohen President Morria Biopharmaceuticals PLC 53 Davies Street London W1K 5JH United Kingdom Re: Morria Biopharmaceuticals PLC Amendment No. 1 to Registration Statement on Form 20 -F Filed August 8, 2012 File No. 000 -54749 Dear Dr. Cohen: We have reviewed your amended registration statement and your correspondence dated August 8, 2012 and we have the following additional 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 further amending your registration statement and providing the requested information. If you do not believe our comm ents apply to your facts and circumstances or do not believe another amendment is appropriate, please tell us why in your response. After reviewing any further amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Item 3. Key Information D. Risk Factors “We will require additional capital to fund our operations, and if we are unable to obtain such capital, we will be unable to successfully develop and commercialize o ur product candidates,” page 6 1. We note your response to prior comment 7. It is unclear from your disclosure how you believe you can execute your operating plan for the fiscal year, which you estimate to cost $1.7 million, without additional funding when the balance of your cash and investment securities is currently $280,000. Please clarify and/or revise this disclosure both here and on page 45. Dr. Yuval Cohen Morria Biopharmaceuticals PLC August 21, 2012 Page 2 “Our product candidates are still in the early stages of development and remain subject to clinical testing and regulatory approval . . .,” page 10 2. We note your response to prior comment 9. Based on your disclosure on pages 41 and 51, please expand your disclosure in this risk factor to disclose that the clinical trials you have performed to date for MRX -6 were not conducted in the United States, were not compliant with either ICH or FDA regulations, and that you are required to complete a new clinical trial that will be acceptable to the FDA in order to advance this product candidate’s development. “U.S. inve stors may not be able to enforce their civil liabilities against our company or our directors, controlling persons and officers,” page 35 3. Please consider including discussion of the availability of a treaty or reciprocity between the U.S. and the United K ingdom. Item 4. Information on the Company B. Business Overview Product Candidates, page 41 4. We note your response to prior comment 20. Please include both in this discussion and in your related disclosure on page 50 a brief description of the ICH and the reasons why clinical trials conducted according to its rules are acceptable to the FDA. Pleas e also disclose the circumstances in which foreign clinical trials can be used to support an IND, including if: (a) they are performed in accordance with good clinical practice, including review and approval by an independent ethics committee and informed consent from subjects, and (b) the FDA is able to validate the data from the study through an onsite inspection, if necessary. Scientific Background to Inflammation and Our Product Candidates, page 45 5. We note your response to prior comment 22. You sta te that the role of PLA2 in inflammatory diseases has been “universally” accepted in the scientific community. Please provide the factual basis for this assertion, particularly in light of your next sentence claiming that this role has become “increasingly better understood” since the 1980s, which calls into question the universality of its acceptance. 6. You state that your principal shareholder’s work in this field has been “generally” accepted by his peers. To the extent that you are aware of any dissents in the scientific community relating to his conclusions, please describe them here and note, if applicable, where these dissents have been published. Dr. Yuval Cohen Morria Biopharmaceuticals PLC August 21, 2012 Page 3 7. If your principal shareholder or any of your other affiliates were engaged in any of the clinical progr ams using PLA2 indicators that were launched in the 1990s, please revise your disclosure to state this. Item 6. Directors, Senior Management and Employees B. Compensation Employment and Consulting Agreements, page 83 8. Please expand your discussion of your agreements with Prof. Saul Yedgar to disclose that you also entered into a director agreement on February 21, 2005, which is filed as Exhibit 4.13. 9. You disclose that you entered into a consulting agreement with Dr. Joseph Bondi effective June 1, 2007. Based on the agreement filed as Exhibit 4.19, it appears that this was an employment agreement. Please revise your filing for this inconsistency. Alternatively, please provide us with an analysis that supports your conclusion that this was a consulting agreement rather than an employment agreement. Item 7. Major Shareholders and Related Party Transactions B. Related Party Transactions, page 89 10. We ha ve reviewed your response to prior comment 32. Based on your disclosure on pages 102 -104, it appears that your agreements with Yissum are related party agreements. Please expand your disclosure in this section to provide a brief summary of the related party transactions with Yissum. Alternatively, please provide us with an analysis that supports your conclusion your agreements with Yissum are not related party transactions. Item 10. Additional Information E. Taxation Information reporting and backu p withholding, page 111 11. Please include a discussion of the requirements of the Hiring Incentives to Restore Employment Act of 2010. Dr. Yuval Cohen Morria Biopharmaceuticals PLC August 21, 2012 Page 4 Item 11. Quantitative and Qualitative Disclosures About Risk D. American Depositary Shares, page 114 12. Please update this section as follows: Make clear the timelines for notices of meetings and shareholder voting and make clear whether shareholders or the depositary has the option of voting electronically or by mail; We note your disclosure under “Fees and Charges, p age 118” that ADS holders may be charged for “other regulatory requirements.” Please make clear, here or elsewhere, the requirements being referenced, particularly as distinguished from the taxes, fees, and expenses already specified here or elsewhere. Supplementally, tell us whether ordinary shareholders are also subject to such expenses; and Your discussion of pre -released ADSs should make clear whether the depositary may pre-release amounts above the 30% threshold and why. Item 19. Exhibits, page 126 13. Please revise your exhibit index for Exhibit 4.18 to reference May 25, 2011 rather than February 21, 2005. 14. We have reviewed your response to prior comment 36. The current version of the security agreement filed as Exhibit 4.30 does not contain complete schedules to the agreement. Please file a complete copy of the executed version of the security agreement currently filed as Exhibit 4.30. 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 r esponsible 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 Commission from taking any action with respect to the filing; Dr. Yuval Cohen Morria Biopharmaceuticals PLC August 21, 2012 Page 5 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. 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 Exchan ge 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 of the registration statement. You may contact James Peklenk at (202) 551 -3661 or at Donald Abbott at (202) 551 - 3608 if you have questions regarding comments on the financial statements and related matters. Please contact Scot Foley at (202 ) 551 -3383, Jennifer Riegel at (202) 551 -3575 or me at (202) 551-3715 with any other questions. Sincerely, /s/ Jennifer Riegel for Jeffrey Riedler Assistant Director cc: Jeffrey Schultz, Esq. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. 666 Third Avenue New York, NY 10017
2012-08-08 - CORRESP - Akari Therapeutics Plc
CORRESP
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filename1.htm
Jeffrey Schultz | 212 692
6732 | jschultz@mintz.com
Chrysler Center
666 Third Avenue
New York, NY 10017
212-935-3000
212-983-3115 fax
www.mintz.com
August 8, 2012
Via EDGAR and by Federal Express
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Mail Stop 3561
Washington, D.C. 20549
Re: Morria Biopharmaceuticals PLC
Registration Statement on Form 20-FR12G/A
Filed June 28, 2012
File No. 000-54749
Ladies and Gentleman:
On
behalf of Morria Biopharmaceuticals PLC (the “Company”), we hereby file with
the Securities and Exchange Commission (the “Commission”) Amendment No. 1 to the Company’s Registration
Statement on Form 20-FR12G (the “Amendment”), as originally filed with the Commission on June 28, 2012. We are
also delivering five clean and marked complete courtesy copies of the Amendment to the attention of Jeffrey Riedler, Esq. Assistant
Director of the Commission.
Set forth below are
the Company’s responses to the Commission’s comments provided by a letter (the “Comment Letter”)
dated July 25, 2012, from the staff at the Commission (the “Staff”). The Company’s responses are numbered
to correspond to the comments, as set forth in the Comment Letter, which, for convenience, we have incorporated into this response
letter. All references to page numbers are to the marked draft of Amendment No. 1.
General
1. Pursuant to section 12(g)(1) of the Exchange Act, your registration statement will become effective
by operation of law on August 27, 2012 at which time you will be required to begin filing all of the reports mandated by Section
12(g) of the Securities Exchange Act of 1934. If the review process has not been completed before that date you should consider
withdrawing the registration statement prior to August 27, 2012 to prevent it from becoming effective and refiling it at such time
as you are able to respond to any remaining issues or comments.
Response: We note the Staff’s comment and will
withdraw the registration statement, and subsequently re-file it, if all comments have not been resolved prior to August 27, 2012.
Mintz, Levin, Cohn, Ferris, Glovsky and
Popeo, P.C.
Boston
| Washington | New York | Stamford | Los Angeles | Palo Alto | San Diego | London
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
Securities and Exchange Commission
August 8, 2012
Page 2
2. Please be advised that your registration statement is concurrently being reviewed by the Office of International Corporate
Finance. You will receive comments generated by that Office, if any, at a later date.
Response: We note the Staff’s comment and will
await further comments, if any, from the Office of International Corporate Finance.
3. Since you appear to qualify as an “emerging growth company,” as defined in the Jumpstart
Our Business Startups Act, please disclose on your prospectus cover page that you are an emerging growth company, and revise your
prospectus to:
· Describe how and when a company may lose emerging growth company status;
· Briefly describe the exemption from Section 404(b) of the Sarbanes-Oxley Act of 2002 and update
your risk factor on page 33 for this exemption; and
· State your election under Section 107(b) of the JOBS Act:
o If you have elected to opt out of the extended transition period for complying with new or revised
accounting standards pursuant to Section 107(b), include a statement that the election is irrevocable; or
o If you have elected to use the extended transition period for complying with
new or revised accounting standards under Section 102(b)(1), provide a risk factor explaining that this election allows you to
delay the adoption of new or revised accounting standards that have different effective dates for public and private companies
until those standards apply to private companies. Please state in your risk factor 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
critical accounting policy disclosures.
Response: We have revised the cover page of Amendment
No.1 to reflect that the Company qualifies as an “emerging growth company,” as defined in the Jumpstart Our Business
Startups Act (the “JOBS Act”) and have revised Amendment No. 1 to respond to the Staff’s comment. Please
see the cover page and pages 33 and 70 of Amendment No. 1.
Item 3. Key Information
A. Selected Financial Data, page 4
4. The identification of some columns of selected financial data as “unaudited” may give
an investor the impression that the other columns have been audited. We believe your disclosure in the introductory paragraphs
of this section is sufficient to highlight to investors which selected financial data have been derived from audited or unaudited
financial statements. Please revise your disclosure to remove any label identifying a column as unaudited.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
Securities and Exchange Commission
August 8, 2012
Page 3
Response: In response to the Staff’s comment, we
have revised the disclosure to remove any labels identifying a column as unaudited. Please see pages 4 and 5 of Amendment No. 1.
D. Risk Factors, page 5
5. Please expand your disclosure in this section to add a risk factor that addresses the risks resulting
from the fact that the report of your independent registered public accounting firm on your financial statements states that your
recurring operating losses, negative cash flows and dependence on additional financial support raise substantial doubt about your
ability to continue as a going concern. Please include in this risk factor the fact that the auditor’s going concern opinion
may have a detrimental effect on your ability to obtain additional funding.
Response: In response to the Staff’s
comment, we have added a risk factor on page 7 of Amendment No. 1 advising that the auditor’s going concern opinion may have
a detrimental effect on the Company’s ability to obtain additional funding.
“We anticipate that we will
incur losses for the foreseeable future and we may never achieve or sustain profitability.” Page 6
6. Please state in this risk factor that your total accumulated deficit as of the end of 2011 was
$12,621,000.
Response: We have revised the risk factor at issue and
included the disclosure requested by the Staff. Please see page 6 of Amendment No. 1.
“We will require additional capital to fund our
operations, and if we are unable to obtain such capital, we will be unable to successfully develop and commercialize our product
candidates,” Page 6
7. Please expand your risk factor to
· Include an estimate of your operating expenses, including your research and development costs, for fiscal year 2012;
· Disclose the amount of your existing cash and investment securities;
· Disclose the amount of all compensation that you anticipate deferring; and
· Disclose the material elements of your current contemplated plan for your fiscal year ended December 31, 2012.
Response: We have revised the risk factor at issue and
included the disclosure requested by the Staff. Please see page 6 of Amendment No. 1.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
Securities and Exchange Commission
August 8, 2012
Page 4
“If we default on our convertible notes, we may
lose all of our assets and intellectual property,” page 8
8. Please expand this risk factor to disclose:
· The list of events of default as defined in your Securities Purchase Agreement dated April 3, 2012;
and
· That you are required to repay your convertible notes by January 4, 2013, the aggregate amount
that you expect to be due as of that date, and that you do not currently have sufficient cash available to repay them.
Response: In response to the Staff’s
comment, we have revised the disclosure to include a list of events of default, the repayment date and amount of the convertible
notes, and that the Company does not currently have sufficient cash available to repay them. Please see page 8 of Amendment No.
1.
“Our product candidates are
still in the early stages of development and remain subject to clinical testing and regulatory approval…” page 10
9. Please expand this risk factor to disclose when you intend to file your IND application for your
two product candidates in clinical trials.
Response: In response to the Staff’s
comment, we have expanded the disclosure in this risk factor to state when the Company intends to file its IND applications for
the two product candidates in clinical trials. Please see page 10 of Amendment No. 1.
“We have not conducted any
absorption, distribution, metabolism and excretion (ADME) studies with respect to our clinical and pre-clinical product candidates.”
page 15
10. In this risk factor, please include the reason you have yet to perform ADME studies and whether
or not you intend to conduct such studies in the future.
Response: In response to the Staff’s
comment, we have expanded the disclosure in this risk factor to include the reason why the Company has not yet performed ADME studies
and that the Company does intend to conduct such studies prior to final submission to the FDA for drug approval. Please see page
15 of Amendment No. 1.
“If our competitors are better
able to develop and market products than any products that we and/or any potential future collaborators may develop . . .,”
page 21
11. Please include in this risk factor the names of the companies that you believe will be your principal
competitors and those products that you believe will compete with yours at such time as yours enter the marketplace.
Response: In response to the Staff’s
comment, we have revised the risk factor to include the name of Anthera Pharmaceuticals, Inc. as a competitor of which the Company
is aware and that it has a PLA2 inhibitor currently in Phase 3 clinical trial. Please see page 21 of Amendment No. 1.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
Securities and Exchange Commission
August 8, 2012
Page 5
“We depend on third-party suppliers
for key raw materials used in our manufacturing processes…” page 22
12. Please include in this risk factor the names of the third-party suppliers you are dependent upon.
Response: In response to the Staff’s
comment, we have revised the disclosure in this risk factor to include the names of the third-party suppliers that the Company
uses. Please see page 22 of Amendment No. 1.
“Use of third-party manufacturers
may increase the risk that we will not have adequate supplies of our product candidates or products.” page 24
13. You disclose that your present or future manufacturing partners may not be able to comply with
FDA-mandated current Good Manufacturing Practice regulations or other FDA regulatory requirements. To the extent you are aware
that one or more of your current manufacturing partners do not comply with FDA-mandated current Good Manufacturing Practice regulations
or other FDA regulatory requirements, please disclose this fact as well as the names of each manufacturing partner that does not
comply.
Response: All of the Company’s
manufacturing partners are compliant with current Good Manufacturing Practice regulations, and we have revised the disclosure on
page 24 of Amendment No. 1 in response to the Staff’s comment to reflect this fact.
“We rely on third parties to
conduct our clinical trials, and those third parties may not perform satisfactorily…,” page 25
14. Please include in this risk factor the names of the material contract research organizations that
have performed your clinical trials to date.
Response: We have revised the risk
factor at issue to include the name of the material contract research organization that performs the Company’s clinical trials.
Please see page 25 of Amendment No. 1.
“If we do not establish strategic
collaborations, we may have to alter our development plans.” page 25
15. This risk factor is substantially similar to the second one on page 22. Please merge them into
a single risk factor in order to avoid repetition in your disclosure.
Response: In response to the Staff’s
comment, we have merged the two risk factors at issue into a single risk factor. Please see page 22 of Amendment No. 1.
“We will incur increased costs
and demands upon management as a result of complying with the laws and regulations affecting public companies…,” page
33
16. Please estimate the costs you will incur as a result of complying with public company laws and
regulations over the next fiscal year and on an annual basis thereafter.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
Securities and Exchange Commission
August 8, 2012
Page 6
Response: In response to the Staff’s
comment, we have included disclosure regarding the estimate of costs that the Company will incur as a result of complying with
public company laws and regulations over the next fiscal year and on an annual basis thereafter. Please see page 33 of Amendment
No. 1.
Item 4. Information on the Company
A. History and Development of the Company
April 2012 Private Placement of Senior
Secured Convertible Notes and Warrants, page 38
17. In your “Description of Notes” on page 40 please provide the definition of “material
adverse event” in your Securities Purchase Agreement.
Response: In response to the Staff’s
comment, we have provided the definition of “material adverse effect” (“material adverse event” was a typographical
error). Please see page 40 of Amendment No. 1.
18. In your description of the Registration Rights Agreement on page 40, please disclose the actual
date rather than referring to the “Self Filing Effective Date” and describe the payments you will be required to make
to your investors if this registration statement is not filed and/or declared effective on a timely basis.
Response: We respectfully refer
the Staff to page 38 of Amendment No. 1, where “Self Filing Effective Date” has already been defined. We have, however,
in response to the Staff’s comment, amended the disclosure to describe the payments the Company will have to make to its
investors if this registration statement is not filed and/or declared effective on a timely basis. Please see page 40 of Amendment
No. 1.
B. Business Overview
Product Candidates, page 41
19. Please state here, as well as in your discussion of your clinical pipeline on page 49 and your
Overview on page 68, that the clinical trials your two major product candidates have undergone were performed in Israel and South
Africa, and not in the United States.
Response: In response to the Staff’s
comment, we have revised the disclosures at issue to state that the clinical trials are being conducted in Israel and South Africa.
Please see pages 49 and 68 of Amendment No. 1.
20. Please state here and wherever else applicable in your registration statement whether or not you
believe your clinical trials have complied with the rules for such trials set forth by the FDA. If they have not, please specify
how your clinical trials have differed from those rules.
Response: We have added disclosure
in response to the Staff’s comment regarding the Company’s compliance with rules set forth by the FDA regarding the
conduct of clinical trials. Please see pages 41, 51 and 52 of Amendment No. 1.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
Securities and Exchange Commission
August 8, 2012
Page 7
Steroids and Currently Available
Alternatives, page 42
21. In your table on page 44, please indicate in the row describing your product candidates that your
studies to date have not advanced beyond Phase 2.
Response: We have revised the table
on page 44 of Amendment No. 1 in response to the Staff’s comment to indicate that the studies are currently in Phase 2 clinical
trials.
Scientific Background to Inflammation
and Our Product Candidates, page 45
22. In this disc
2012-07-25 - UPLOAD - Akari Therapeutics Plc
July 2 5, 2012 Via E -mail Dr. Yuval Cohen President Morria Biopharmaceuticals PLC 53 Davies Street London W1K 5JH United Kingdom Re: Morria Biopharmaceuticals PLC Registration Statement on Form 20 -FR12G Filed June 28, 2012 File No. 000 -54749 Dear Dr. Cohen : We have reviewed your filing 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 within ten business days by amending your filing, by providing the requested information, or by advising us when you will provide the requested response. 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 filing and the information you provide in response to these comments, we may have additional comments. General 1. Pursuant to section 12(g)(1) of the Exchange Act, your registration statement will become effective by operation of law on August 27, 2012 at which time you will be required to begin filing all of the reports mandated by Section 12(g) of the Securities Exch ange Act of 1934. If the review process has not been completed before that date you should consider withdrawing the registration statement prior to August 27, 2012 to prevent it from becoming effective and refiling it at such time as you are able to respo nd to any remaining issues or comments. 2. Please be advised that your registration statement is concurrently being reviewed by the Office of International Corporate Finance. You will receive comments generated by that Office, if any, at a later date. Dr. Yuval Cohen Morria Biopharmaceuticals PLC July 2 5, 2012 Page 2 3. Since you appear to qualify as an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, please disclose on your prospectus cover page that you are an emerging growth company, and revise your prospectus to: Describe how and when a company may lose emerging growth company status; Briefly describe the exemption from Section 404(b) of the Sarbanes -Oxley Act of 2002 and update your risk factor on page 33 for this exemption ; and State your election under Section 107(b) of the JOBS Act: o If you have elected to opt out of the extended transition period for complying with new or revised accounting standards pursuant to Section 107(b), include a statement that the election is irrevocable; or o If you have elected to use the extended tran sition period for complying with new or revised accounting standards under Section 102(b)(1), provide a risk factor explaining that this election allows you to delay the adoption of new or revised accounting standards that have different effective dates fo r public and private companies until those standards apply to private companies. Please state in your risk factor that, as a result of this election, your financial statements may not be comparable to companies that comply with public company effective da tes. Include a similar statement in your critical accounting policy disclosures. Item 3. Key Information A. Selected Financial Data, page 4 4. The identification of some columns of selected financial data as “unaudited” may give a n investor the impressio n that the other columns have been audited. We believe your disclosure in the introductory paragraphs of this section is sufficient to highlight to investors which selected financial data have been derived from audited or unaudited financial statements. Please revise your disclosure to remove any label identifying a column as unaudited. D. Risk Factors , page 5 5. Please expand your disclosure in this section to add a risk factor that addresses the risks resulting from the fact that the report of your indep endent registered public accounting firm on your financial statements states that your recurring operating losses, negative cash flows and dependence on additional financial support raise substantial doubt about your ability to continue as a going concern. Please include in this risk factor the fact that the auditor’s going concern opinion may have a detrimental effect on your ability to obtain additional funding. Dr. Yuval Cohen Morria Biopharmaceuticals PLC July 2 5, 2012 Page 3 “We anticipate that we will incur losses for the foreseeable future and we may never achiev e or sustain profitability,” page 6 6. Please state in this risk factor that your total accumulated deficit as of the end of 2011 was $12,621,000. “We will require additional capital to fund our operations, and if we are unable to obtain such capital, we will be unable to successfully develop and commercialize our product candidates,” page 6 7. Please expand your risk factor to include an estimate of your operating expenses, including your research and development costs, for fiscal year 2012 ; disclose the amount of your existing cash and investment securities; disclose the amount of all compensation that you anticipate deferring; and disclose the material elements of your current contemplated plan for your fiscal year ended December 31, 2012. “If we default on our convertible notes, we may lose all of our assets and intellectual property,” page 8 8. Please expand this risk factor to disclose the list of events of default as defined in your Securities Purchase Agreement dated April 3, 2012; and that yo u are required to repay your convertible notes by January 4, 2013 , the aggregate amount that you expect to be due as of that date, and that you do not currently have sufficient cash available to repay them . “Our product candidates are still in the early stages of development and remain subject to clinical testing and regulatory approval…” page 10 9. Please expand this risk factor to disclose when you intend to file your IND application for your two product candi dates in clinical trials. “We have not conducted any absorption, distribution, metabolism and excretion (ADME) studies with respect to our clinical and pre -clinical product candidates,” page 15 10. In this risk factor, please include the reason you have yet to perform ADME studies and whether or not you intend to conduct such studies in the future. Dr. Yuval Cohen Morria Biopharmaceuticals PLC July 2 5, 2012 Page 4 “If our competitors are better able to develop and market products than any products that we and/or an y potential future collaborators may develop . . .,” page 21 11. Please include in this risk factor the names of the companies that you believe will be your principal competitors and those products that you believe will compete with yours at such time as your s enter the marketplace. “We depend on third -party suppliers for key raw materials used in our manufacturing processes . . .,” page 22 12. Please include in this risk factor the names of the third -party suppliers you are dependent upon. “Use of third -party manufacturers may increase the risk that we will not have adequate supplies of our product candidates or products .” page 24 13. You disclose that your present or future manufacturing partners may not be able to comply with FDA -mandated current Good Man ufacturing Practice regulations or other FDA regulatory requirements . To the extent you are aware that one or more of your current manufacturing partners do not comply with FDA -mandated current Good Manufacturing Practice regulations or other FDA regulatory r equirements , please disclose this fact as well as the names of each manufacturing partner that does not comply. “We rely on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily . . .,” page 25 14. Please incl ude in this risk factor the names of the material contract research organizations that have performed your clinical trials to date. “If we do not establish strategic collaborations, we may have to alter our development plans,” page 25 15. This risk factor i s substantially similar to the second one on page 22. Please merge them into a single risk factor in order to avoid repetition in your disclosure. “We will incur increased costs and demands upon management as a result of complying with the laws and regulations affecting public companies . . .,” page 33 16. Please estimate the costs you will incur as a result of complying with public company laws and regulations over the next fiscal year and on an annual basis thereafter. Dr. Yuval Cohen Morria Biopharmaceuticals PLC July 2 5, 2012 Page 5 Item 4. Information on the Company A. History and Development of the Company April 2012 Private Placement of Senior Secured Convertible Notes and Warrants, page 38 17. In your “Description of Notes” on page 40 please provide the definition of “material adverse event” in your Securities Purchase Agreement. 18. In your description of the Registration Rights Agreement on page 40, please disclose the actual date rather than re ferring to the “Self Filing Effective Date” and describe the payments you will be required to make to your investors if this registration statement is not filed and/or declared effective on a timely basis. B. Business Overview Product Candidates, page 41 19. Please state here, as well as in your discussion of your clinical pipeline on page 49 and your Overview on page 68, that the clinical trials your two major product candidates have undergone were performed in Israel and South Africa, and not in the Unit ed States. 20. Please state here and wherever else applicable in your registration statement whether or not you believe your clinical trials have complied with the rules for such trials set forth by the FDA. If they have not, please specify how your clinica l trials have differed from those rules. Steroids and Currently Available Alternatives, page 42 21. In your table on page 44, please indicate in the row describing your product candidates that your studies to date have not advanced beyond Phase 2 . Scientific Background to Inflammation and Our Product Candidates, page 45 22. In this discussion, please address whether the research performed by your principal shareholder into the field of lipid conjugates has produced conclusive evidence into their anti-inflammatory properties. If there is any controversy in the greater scientific community as to this assertion, you should note this here and discuss any possible ramifications, particularly how this uncertainty could impact the development of your product c andidates. If appropriate, you should amend your disclosure wherever you discuss this research and its implications, including the risk factor on pages 10 -11. Dr. Yuval Cohen Morria Biopharmaceuticals PLC July 2 5, 2012 Page 6 Research and Development, page 45 23. Please include in this discussion the amounts you have s pent on R&D over the last three fiscal years as well as an estimate of your R&D expenses for fiscal year 2012. 24. We note that you disclose the focus of your development plan for fiscal 2012, provided that you raise additional capital. Given your disclosur e on page 6 that you believe that your existing cash and investment securities will be sufficient to support your current contemplated operating plan until December 31, 2012 , please expand your disclosure to disclose the focus of your development plan for fiscal 2012 if you do not raise additional capital. Development of our Clinical Pipeline for our Product Candidates, page 49 25. For each of the trials discussed, please disclose any side effects observed with your product candidates and, where available, p lease disclose whether the results are statistically significant and provide all p -values that you have available. Intellectual Property, page 52 26. Please indicate the product candidates to which each of your material U.S. and non -U.S. patents relate. Manufacturing, Marketing and Sales of our Drugs, page 55 27. Please disclose the names of your third -party manufacturer(s) here and in the risk factor on page 23. Please also disclose here the material terms of your contractual relationships with them, if any. If you are substantially dependent on an agreement with a third -party for the manufacture of your product candidates, please file this agreement as an exhibit to your registration statement. Alternatively, please provide us with an analysis that supports your determination that you are not substantially depen dent on an agreement with a third -party manufacturer. Item 5. Operating and Financial Review and Prospects Stock -based Compensation and Fair Value of Ordinary Shares, page 70 28. With respect to your common stock valuation s, please expand your disclosures to provide the following information relating to your issuances of equity instruments during the past three fiscal years : A discussion of the significant objective and subjective factors, assumptions, and methodologies used in determining fair value of the shares underlying the options, warrants and deferred shares issued; Dr. Yuval Cohen Morria Biopharmaceuticals PLC July 2 5, 2012 Page 7 Include in your discussion how management determined fair value based on the share price used in equity financing rounds; and Identify the recent equity transactions used to determine fair value. C. Research and Development, Patents and Licenses, etc., page 74 29. Please provide disclosure to quantify the amount of costs, both internal and external, incurred during each period presented and incurred to date on each of your major research and development projects. Please reconcile these amounts to the research and development expense reported on your st atements of operations. To the extent that you cannot attribute costs to a project, please explain why management does not maintain and evaluate those costs by project. F. Tabular Disclosure of Contractual Obligations, page 75 30. Please expand your disclo sure to include the obligation to pay Yissum $70,000 per year, described in Note 7 to the financial statements, in the table. Also, expand your disclosure here to discuss all future potential royalties, milestones and other fees reasonably likely to be pa id relating to this agreement. Item 6. Directors, Senior Management and Employees B. Compensation Other Director Compensation, page 82 31. Please file copies of the agreements you disclose in this section and your agreements with Prof. Saul Yedgar and Dr. Joseph Bondi that you disclose in the section below. See 4(b)(i) and (ii) of the Instructions as to Exhibits. Item 7. Major Shareholders and Related Party Transactions B. Related Party Transactions 32. We note that you state “See also “Material C ontracts.” Please expand your disclosure to provide a brief summary of the related party transactions referenced later in the filing. [ Dr. Yuval Cohen Morria Biopharmaceuticals PLC July 2 5, 2012 Page 8 Item 9. The Offer and Listing C. Markets, page 91 33. You state elsewhere in your registration statement that you intend to apply to list your common shares on the NYSE Amex. You should therefore include this information in this section, pursuant to Form 20 -F. Item 10. Additional Information A. Share Capital, page 91 34. In your description of your outstanding convertible notes, you refer to them as “debentures.” As the term debenture typically refers to unsecured debt, and these notes are secured by your assets, it is not appropriate to use this term to describe the notes . Please amend your disclosure accordingly. C. Material Contracts, page 102 35. It does not appear that your sub -license agreement dated February 1, 2005, or your amendment dated April 4, 2012, have been filed as exhibits to your registration statement. Pl ease file these contracts, as they are material to your operations. Item 19. Exhibits, page 126 36. Please file complete and executed copies of the agreemen