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Clene Inc.
Response Received
1 company response(s)
High - file number match
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Clene Inc.
Response Received
1 company response(s)
High - file number match
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Clene Inc.
Response Received
1 company response(s)
High - file number match
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Clene Inc.
Awaiting Response
0 company response(s)
High
Clene Inc.
Response Received
1 company response(s)
High - file number match
↓
Company responded
2025-01-02
Clene Inc.
References: December 6, 2024
Summary
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Clene Inc.
Response Received
1 company response(s)
High - file number match
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Clene Inc.
Response Received
2 company response(s)
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Company responded
2023-09-29
Clene Inc.
References: September 27, 2023
Summary
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Clene Inc.
Awaiting Response
0 company response(s)
Medium
Clene Inc.
Response Received
1 company response(s)
High - file number match
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Clene Inc.
Response Received
1 company response(s)
High - file number match
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Clene Inc.
Response Received
3 company response(s)
High - file number match
↓
Company responded
2021-03-29
Clene Inc.
References: March 1, 2021
Summary
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Company responded
2021-04-07
Clene Inc.
References: April 5, 2021
Summary
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Clene Inc.
Awaiting Response
0 company response(s)
High
Clene Inc.
Response Received
4 company response(s)
High - file number match
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Company responded
2020-10-19
Clene Inc.
References: October 9, 2019
Summary
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Company responded
2020-11-18
Clene Inc.
References: November
4, 2020
Summary
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Company responded
2020-12-07
Clene Inc.
References: December
1, 2020
Summary
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Clene Inc.
Awaiting Response
0 company response(s)
High
Clene Inc.
Awaiting Response
0 company response(s)
High
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-10 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2025-09-09 | SEC Comment Letter | Clene Inc. | DE | 333-290075 | Read Filing View |
| 2025-04-23 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2025-03-27 | SEC Comment Letter | Clene Inc. | DE | 333-286058 | Read Filing View |
| 2025-01-31 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2025-01-30 | SEC Comment Letter | Clene Inc. | DE | 333-284479 | Read Filing View |
| 2025-01-16 | SEC Comment Letter | Clene Inc. | DE | 001-39834 | Read Filing View |
| 2025-01-02 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2024-12-06 | SEC Comment Letter | Clene Inc. | DE | 001-39834 | Read Filing View |
| 2024-11-20 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2024-11-19 | SEC Comment Letter | Clene Inc. | DE | 333-283204 | Read Filing View |
| 2023-10-04 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2023-09-29 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2023-09-27 | SEC Comment Letter | Clene Inc. | DE | N/A | Read Filing View |
| 2023-02-13 | SEC Comment Letter | Clene Inc. | DE | N/A | Read Filing View |
| 2022-04-22 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2022-04-18 | SEC Comment Letter | Clene Inc. | DE | N/A | Read Filing View |
| 2021-07-30 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2021-07-28 | SEC Comment Letter | Clene Inc. | DE | N/A | Read Filing View |
| 2021-04-16 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2021-04-07 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2021-04-05 | SEC Comment Letter | Clene Inc. | DE | N/A | Read Filing View |
| 2021-03-29 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2021-03-01 | SEC Comment Letter | Clene Inc. | DE | N/A | Read Filing View |
| 2020-12-16 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2020-12-07 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2020-12-01 | SEC Comment Letter | Clene Inc. | DE | N/A | Read Filing View |
| 2020-11-18 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2020-11-05 | SEC Comment Letter | Clene Inc. | DE | N/A | Read Filing View |
| 2020-10-19 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2020-10-13 | SEC Comment Letter | Clene Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-09 | SEC Comment Letter | Clene Inc. | DE | 333-290075 | Read Filing View |
| 2025-03-27 | SEC Comment Letter | Clene Inc. | DE | 333-286058 | Read Filing View |
| 2025-01-30 | SEC Comment Letter | Clene Inc. | DE | 333-284479 | Read Filing View |
| 2025-01-16 | SEC Comment Letter | Clene Inc. | DE | 001-39834 | Read Filing View |
| 2024-12-06 | SEC Comment Letter | Clene Inc. | DE | 001-39834 | Read Filing View |
| 2024-11-19 | SEC Comment Letter | Clene Inc. | DE | 333-283204 | Read Filing View |
| 2023-09-27 | SEC Comment Letter | Clene Inc. | DE | N/A | Read Filing View |
| 2023-02-13 | SEC Comment Letter | Clene Inc. | DE | N/A | Read Filing View |
| 2022-04-18 | SEC Comment Letter | Clene Inc. | DE | N/A | Read Filing View |
| 2021-07-28 | SEC Comment Letter | Clene Inc. | DE | N/A | Read Filing View |
| 2021-04-05 | SEC Comment Letter | Clene Inc. | DE | N/A | Read Filing View |
| 2021-03-01 | SEC Comment Letter | Clene Inc. | DE | N/A | Read Filing View |
| 2020-12-01 | SEC Comment Letter | Clene Inc. | DE | N/A | Read Filing View |
| 2020-11-05 | SEC Comment Letter | Clene Inc. | DE | N/A | Read Filing View |
| 2020-10-13 | SEC Comment Letter | Clene Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-10 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2025-04-23 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2025-01-31 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2025-01-02 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2024-11-20 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2023-10-04 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2023-09-29 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2022-04-22 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2021-07-30 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2021-04-16 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2021-04-07 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2021-03-29 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2020-12-16 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2020-12-07 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2020-11-18 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
| 2020-10-19 | Company Response | Clene Inc. | DE | N/A | Read Filing View |
2025-09-10 - CORRESP - Clene Inc.
CORRESP 1 filename1.htm clnn20250910_corresp.htm Clene Inc. 6550 South Millrock Drive, Suite G50 Salt Lake City, Utah 84121 VIA EDGAR September 10, 2025 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Chris Edwards Re: Clene Inc. Acceleration Request for Registration Statement on Form S-3 File No. 333-290075 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Clene Inc. (the “Company”) hereby requests acceleration of the effective date of the above referenced registration statement (the “Registration Statement”) to 4:00 p.m., Eastern Time, on September 12, 2025, or as soon thereafter as practicable. Please contact Tom McAleavey of Holland & Knight, special counsel to the Company, by email at tom.mcaleavey@hklaw.com or by phone at (407) 244-5108 if you have any other questions or concerns regarding this matter. [Signature Page Follows] Sincerely, /s/ Robert Etherington Name: Robert Etherington Title: President and Chief Executive Officer
2025-09-09 - UPLOAD - Clene Inc. File: 333-290075
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 9, 2025 Robert Etherington President and Chief Executive Officer Clene Inc. 6550 South Millrock Drive, Suite G50 Salt Lake City, Utah 84121 Re: Clene Inc. Registration Statement on Form S-3 Filed September 5, 2025 File No. 333-290075 Dear Robert Etherington: 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 Chris Edwards at 202-551-6761 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Tom McAleavey </TEXT> </DOCUMENT>
2025-04-23 - CORRESP - Clene Inc.
CORRESP 1 filename1.htm clnn20250423_corresp.htm Clene Inc. 6550 South Millrock Drive, Suite G50 Salt Lake City, Utah 84121 VIA EDGAR April 23, 2025 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Lauren Hamill Re: Clene Inc. Acceleration Request for Registration Statement on Form S-3 File No. 333-286058 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Clene Inc. (the “Company”) hereby requests acceleration of the effective date of the above referenced registration statement (the “Registration Statement”) to 4:00 p.m., Eastern Time, on April 25, 2025, or as soon thereafter as practicable. Please contact Tom McAleavey of Holland & Knight, special counsel to the Company, by email at tom.mcaleavey@hklaw.com or by phone at (407) 244-5108 if you have any other questions or concerns regarding this matter. [Signature Page Follows] Sincerely, /s/ Robert Etherington Name: Robert Etherington Title: President and Chief Executive Officer
2025-03-27 - UPLOAD - Clene Inc. File: 333-286058
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 27, 2025 Robert Etherington Chief Executive Officer Clene Inc. 6550 South Millrock Drive, Suite G50 Salt Lake City, UT 84121 Re: Clene Inc. Registration Statement on Form S-3 Filed March 24, 2025 File No. 333-286058 Dear Robert Etherington: 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 Lauren Hamill at 303-844-1008 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Tom McAleavey </TEXT> </DOCUMENT>
2025-01-31 - CORRESP - Clene Inc.
CORRESP 1 filename1.htm clnn20250130_corresp.htm Clene Inc. 6550 South Millrock Drive, Suite G50 Salt Lake City, Utah 84121 VIA EDGAR January 30, 2025 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Tyler Howes Re: Clene Inc. Acceleration Request for Registration Statement on Form S-3 File No. 333-284479 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Clene Inc. (the “Company”) hereby requests acceleration of the effective date of the above referenced registration statement (the “Registration Statement”) to 4:00 p.m., Eastern Time, on February 3, 2025, or as soon thereafter as practicable. Please contact Tom McAleavey of Holland & Knight, special counsel to the Company, by email at tom.mcaleavey@hklaw.com or by phone at (407) 244-5108 if you have any other questions or concerns regarding this matter. [Signature Page Follows] Sincerely, /s/ Robert Etherington Name: Robert Etherington Title: President and Chief Executive Officer
2025-01-30 - UPLOAD - Clene Inc. File: 333-284479
January 30, 2025
Robert Etherington
Chief Executive Officer
Clene Inc.
6550 South Millrock Drive, Suite G50
Salt Lake City, UT 84121
Re:Clene Inc.
Registration Statement on Form S-3
Filed January 24, 2025
File No. 333-284479
Dear Robert Etherington:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tyler Howes at 202-551-3370 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Tom McAleavey, Esq,
2025-01-16 - UPLOAD - Clene Inc. File: 001-39834
January 16, 2025
Morgan R. Brown
Chief Financial Officer
Clene Inc.
6550 South Millrock Drive, Suite G50
Salt Lake City, UT 84121
Re:Clene Inc.
Form 10-K for the fiscal year ended December 31, 2023
Filed March 13, 2024
File No. 001-39834
Dear Morgan R. Brown:
We have completed our review of your filing. We remind you that the company and
its management are responsible for the accuracy and adequacy of their disclosures,
notwithstanding any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2025-01-02 - CORRESP - Clene Inc.
CORRESP
1
filename1.htm
clnn20250102_corresp.htm
January 2, 2025
VIA EDGAR & ELECTRONIC MAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention: Jenn Do and Kevin Vaughn
Re: Clene Inc.
Form 10-K for the fiscal year ended December 31, 2023
Filed March 13, 2024
File No. 001-39834
Ladies and Gentlemen:
This letter sets forth the response of Clene Inc. (the “Company”) to the comments of the Staff (the “Staff”) of the Securities and Exchange Commission set forth in your letter, dated December 6, 2024, with respect to the Company’s Annual Report on Form 10-K, filed on March 13, 2024 (the “Form 10-K”).
For your convenience, the Staff’s comment is reprinted in bold below, followed by the Company’s response thereto.
Form 10-K for the fiscal year ended December 31, 2023
Management's Discussion and Analysis of Financial Condition and Results of Operations, page 85
Results of Operations, page 89
General
1.
We note the tabular presentation of research and development expense on page 90. Please revise your future filings to address the following:
●
Based on the disclosures provided immediately following the table, it appears that you may track certain of your direct research and development expenses for CNM-Au8 by indication. If so, revise the table to separately quantify expenses for each indication that was pursued during those periods. If you are not able to quantify any expenses by indication, disclose that fact.
●
Given the significance of the Unallocated line item to consolidated research and development, please further break out these aggregated expenses by nature, i.e., amounts attributed to research, manufacturing, equipment, materials, rent, utilities, depreciation, etc.
U.S. Securities and Exchange Commission
Divisions of Corporation Finance
Office of Life Sciences
January 2, 2025
Page 2
●
Please revise the table or accompanying disclosure to quantify amounts received as reimbursements during the period from any grants.
●
Revise your pipeline table graphics on pages 8 and 87 to clearly identify which product candidates are referenced (e.g., CNM-Au8 and CNM-ZnAg) so that it easily corelates to the tabular breakdown on page 90.
RESPONSE:
The Company acknowledges the Staff’s comment and advises the Staff that in future filings, the Company will revise its disclosure to include the Staff’s comments above by separately quantifying expenses for each indication that was pursued during the applicable periods, further breaking out aggregate expenses by nature, quantifying amounts received as reimbursements during the period from any grants, and revising the pipeline table graphics to clearly identify which product candidates are referenced.
The Company believes the foregoing fairly responds to the Staff’s comment in its letter dated December 6, 2024, and is prepared to provide the Staff with additional information. Thank you in advance for your assistance in this matter. If you have any questions or additional comments, please do not hesitate to contact Tom McAleavey at (407) 244-5108.
Sincerely,
/s/ Morgan Brown
Name: Morgan Brown
Title: Chief Financial Officer
cc: Tom McAleavey, Esq., Holland & Knight LLP
2024-12-06 - UPLOAD - Clene Inc. File: 001-39834
December 6, 2024
Morgan R. Brown
Chief Financial Officer
Clene Inc.
6550 South Millrock Drive, Suite G50
Salt Lake City, UT 84121
Re:Clene Inc.
Form 10-K for the fiscal year ended December 31, 2023
Filed March 13, 2024
File No. 001-39834
Dear Morgan R. Brown:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comment.
Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe
the comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this letter, we may have additional comments.
Form 10-K for the fiscal year ended December 31, 2023
Management's Discussion and Analysis of Financial Condition and Results of Operations,
page 85
Results of Operations, page 89
We note the tabular presentation of research and development expense on page 90.
Please revise your future filings to address the following:
•Based on the disclosures provided immediately following the table, it appears that
you may track certain of your direct research and development expenses for
CNM-Au8 by indication. If so, revise the table to separately quantify expenses for
each indication that was pursued during those periods. If you are not able to
quantify any expenses by indication, disclose that fact.
•Given the significance of the Unallocated line item to consolidated research and
development, please further break out these aggregated expenses by nature, i.e.,
amounts attributed to research, manufacturing, equipment, materials, rent,
utilities, depreciation, etc.1.
December 6, 2024
Page 2
•Please revise the table or accompanying disclosure to quantify amounts received
as reimbursements during the period from any grants.
•Revise your pipeline table graphics on pages 8 and 87 to clearly identify which
product candidates are referenced (e.g., CNM-Au8 and CNM-ZnAg) so that it
easily corelates to the tabular breakdown on page 90.
In closing, we remind you that the company and its management are responsible for
the accuracy and adequacy of their disclosures, notwithstanding any review, comments,
action or absence of action by the staff.
Please contact Jenn Do at 202-551-3743 or Kevin Vaughn at 202-551-3494 with any
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2024-11-20 - CORRESP - Clene Inc.
CORRESP 1 filename1.htm clnn20241120_corresp.htm Clene Inc. 6550 South Millrock Drive, Suite G50 Salt Lake City, Utah 84121 VIA EDGAR November 20, 2024 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Lauren Hamill Re: Clene Inc. Acceleration Request for Registration Statement on Form S-3 File No. 333-283204 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Clene Inc. (the “Company”) hereby requests acceleration of the effective date of the above referenced registration statement (the “Registration Statement”) to 4:00 p.m., Eastern Time, on November 22, 2024, or as soon thereafter as practicable. Please contact Tom McAleavey of Holland & Knight, special counsel to the Company, by email at tom.mcaleavey@hklaw.com or by phone at (407) 244-5108 if you have any other questions or concerns regarding this matter. [Signature Page Follows] Sincerely, /s/ Robert Etherington Name: Robert Etherington Title: President and Chief Executive Officer
2024-11-19 - UPLOAD - Clene Inc. File: 333-283204
November 19, 2024
Robert Etherington
Chief Executive Officer
Clene Inc.
6550 South Millrock Drive, Suite G50
Salt Lake City, UT 84121
Re:Clene Inc.
Registration Statement on Form S-3
Filed November 13, 2024
File No. 333-283204
Dear Robert Etherington:
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 Lauren Hamill at 303-844-1008 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Tom McAleavey
2023-10-04 - CORRESP - Clene Inc.
CORRESP 1 filename1.htm clnn20231004_corresp.htm Clene Inc. 6550 South Millrock Drive, Suite G50 Salt Lake City, Utah 84121 VIA EDGAR October 4, 2023 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Lauren Hamill and Laura Crotty Re: Clene Inc. Acceleration Request for Registration Statement on Form S-3 File No. 333-274651 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Clene Inc. (the “Company”) hereby requests acceleration of the effective date of the above referenced registration statement (the “Registration Statement”) to 4:00 p.m., Eastern Time, on October 6, 2023, or as soon thereafter as practicable. Please contact Tom McAleavey of Holland & Knight, special counsel to the Company, by email at tom.mcaleavey@hklaw.com or by phone at (407) 244-5108 if you have any other questions or concerns regarding this matter. [Signature Page Follows] Sincerely, /s/ Robert Etherington Name: Robert Etherington Title: President and Chief Executive Officer
2023-09-29 - CORRESP - Clene Inc.
CORRESP
1
filename1.htm
clnn20230928_corresp.htm
Clene Inc.
6550 South Millrock Drive, Suite G50
Salt Lake City, Utah 84121
September 29, 2023
VIA EDGAR & ELECTRONIC MAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention: Lauren Hamill and Laura Crotty
Re: Clene Inc.
Registration Statement on Form S-3
Filed September 22, 2023
File No. 333-274651
Ladies and Gentlemen:
This letter sets forth the response of Clene Inc. (the “Company”) to the comments of the Staff (the “Staff”) of the Securities and Exchange Commission set forth in your letter, dated September 27, 2023, with respect to the Company’s Registration Statement on Form S-3, filed on September 22, 2023 (the “Form S-3”).
Concurrent with the submission of this letter, we are filing an amendment to the Form S-3 in response to the Staff’s comments. For your convenience, the Staff’s comment is reprinted in bold below, followed by the Company’s response thereto.
Registration Statement on Form S-3 filed September 22, 2023
General
1.
In relation to the 3,000,000 shares of common stock underlying a warrant issued as part of an amendment to a loan and security agreement between you and Avenue Venture Opportunities Fund, L.P. (the "Warrant"), please tell us your basis for registering the offering of these shares on a primary basis. In this regard, we note that the Warrant was issued pursuant to Section 4(a)(2) of the Securities Act and Rule 506(b) of Regulation D promulgated thereunder and is exercisable within one year. Please consider the rationale set out in Securities Act Sections C&DI Questions 139.08, 239.15, and 103.04.
RESPONSE:
The Company is not seeking to register the primary issuance of shares; rather, the Company is seeking to register the resale of shares of common stock issuable upon the exercise of the Warrant. The Company has revised the disclosure in the Form S-3 in this respect.
The Company believes the foregoing fairly responds to the Staff’s comment in its letter dated September 27, 2023, and is prepared to provide the Staff with additional information. Thank you in advance for your assistance in this matter. If you have any questions or additional comments, please do not hesitate to contact Tom McAleavey at (407) 244-5108.
Sincerely,
/s/ Morgan Brown
Name: Morgan Brown
Title: Chief Financial Officer
cc: Tom McAleavey, Esq., Holland & Knight LLP
2023-09-27 - UPLOAD - Clene Inc.
United States securities and exchange commission logo
September 27, 2023
Morgan Brown
Chief Financial Officer
Clene Inc.
6550 South Millrock Drive, Suite G50
Salt Lake City, UT 84121
Re:Clene Inc.
Registration Statement on Form S-3
Filed September 22, 2023
File No. 333-274651
Dear Morgan Brown:
We have limited our review of your registration statement to those issues we have
addressed in our comment. In our comment 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 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.
Registration Statement on Form S-3 filed September 22, 2023
General
1.In relation to the 3,000,000 shares of common stock underlying a warrant issued as part of
an amendment to a loan and security agreement between you and Avenue Venture
Opportunities Fund, L.P. (the "Warrant"), please tell us your basis for registering the
offering of these shares on a primary basis. In this regard, we note that the Warrant was
issued pursuant to Section 4(a)(2) of the Securities Act and Rule 506(b) of Regulation D
promulgated thereunder and is exercisable within one year. Please consider the rationale
set out in Securities Act Sections C&DI Questions 139.08, 239.15, and 103.04.
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
FirstName LastNameMorgan Brown
Comapany NameClene Inc.
September 27, 2023 Page 2
FirstName LastName
Morgan Brown
Clene Inc.
September 27, 2023
Page 2
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.
You may contact Lauren Hamill at 303-844-1008 or Laura Crotty at 202-551-7614 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Tom McAleavey
2023-02-13 - UPLOAD - Clene Inc.
United States securities and exchange commission logo
February 13, 2023
David J. Matlin
61 Cedar Pt. Lane
Sag Harbor, NY 11963
Re:Clene Inc.
Schedule 13D filed by David J. Matlin
Filed February 6, 2023
File No. 005-91949
Dear David J. Matlin:
We have reviewed the above-captioned filing, and have the following comments.
Please respond to this letter by amending the filing or by providing the requested
information. If a belief exists that our comments do not apply to your facts and circumstances or
that an amendment is inappropriate, please advise us why in a response letter.
After reviewing any amendment to the filing and any information provided in response
to these comments, we may have additional comments.
Schedule 13D filed February 6, 2023
General
1.We note the date of the event reported as requiring the filing of the Schedule 13D was
November 2, 2022. Rule 13d-1(a) of Regulation 13D-G requires the filing of a Schedule
13D within 10 days after the acquisition of more than five percent of a class of equity
securities specified in Rule 13d-1(i). Based on the November 2, 2022 event date, the
Schedule 13D submitted on February 6, 2023 was not timely filed. Please advise us why
the Schedule 13D was not filed within the required 10 days after the acquisition.
2.We note footnote number two to the cover page explains that the percentage of beneficial
ownership reported as being owned is based upon 73,820,010 shares of the issuer’s
common stock outstanding. Under Rule 13d-3(d)(1), "a person is deemed to be the
beneficial owner of a security....if that person has the right to acquire beneficial ownership
of such security [ ] within sixty days..." and "[a]ny securities not outstanding which are
subject to such options...shall be deemed to be outstanding for the purpose of computing
the percentage of outstanding securities of the class...." Accordingly, please revise the
disclosure to clarify, if true, that the amount of beneficial ownership was calculated in part
based on the amount outstanding as determined under Rule 13d-3(d)(1).
FirstName LastNameDavid J. Matlin
Comapany Name61 Cedar Pt. Lane
February 13, 2023 Page 2
FirstName LastName
David J. Matlin
61 Cedar Pt. Lane
February 13, 2023
Page 2
3.In response to Item 5(c) to Schedule 13D, the disclosure reads in part: "[e]xcept as
described in this Schedule 13D...." Item 5(c) of Schedule 13D requires a description of
"any transactions in the class of securities reported on that were effected during the past
sixty days....." The disclosure offered in reply to this requirement suggests transactions
have occurred within the specified sixty day period and have been disclosed in the
Schedule 13D. Please revise to remove the implication that reportable transactions did in
fact occur, or alternatively, disclose exactly which transactions did occur within the period
specified under Item 5(c) of Schedule 13D.
We remind you that the filing persons are responsible for the accuracy and adequacy of
their disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please direct any questions to Michael Killoy (202) 551-7576 or Nicholas Panos at (202)
551-3266.
Sincerely,
Division of Corporation Finance
Office of Mergers & Acquisitions
cc: Kevin Shuler, Esq.
2022-04-22 - CORRESP - Clene Inc.
CORRESP
1
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Clene
Inc.
6550
South Millrock Drive, Suite G50
Salt
Lake City, Utah 84121
VIA
EDGAR
April
22, 2022
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Daniel Crawford
Re:
Clene
Inc.
Acceleration
Request for Registration Statement on Form S-3
File
No. 333-264299
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Clene Inc. (the “Company”)
hereby requests acceleration of the effective date of the above referenced registration statement (the “Registration Statement”)
to 4:00 p.m., Eastern Time, on April 26, 2022, or as soon thereafter as practicable.
Please
contact Tom McAleavey of Holland & Knight, special counsel to the Company, by email at tom.mcaleavey@hklaw.com or by phone at (407)
244-5108 if you have any other questions or concerns regarding this matter.
[Signature
Page Follows]
Sincerely,
/s/ Robert Etherington
Name:
Robert
Etherington
Title:
President
and Chief Executive Officer
Signature
Page to Acceleration Request Letter
2022-04-18 - UPLOAD - Clene Inc.
United States securities and exchange commission logo
April 18, 2022
Robert Etherington
President and Chief Executive Officer
Clene Inc.
6550 South Millrock Drive, Suite G50
Salt Lake City, Utah 84121
Re:Clene Inc.
Registration Statement on Form S-3
Filed April 14, 2022
File No. 333-264299
Dear Mr. Etherington:
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: Tom McAleavey
2021-07-30 - CORRESP - Clene Inc.
CORRESP
1
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Clene Inc.
6550 South Millrock Drive, Suite G50
Salt Lake City, Utah 84121
VIA EDGAR
July 30, 2021
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention: Deanna Virginio
Re:
Clene Inc.
Registration Statement on Form S-1
File No. 333-258098
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933,
as amended, Clene Inc. (the “Company”) hereby requests acceleration of the effective date of the above referenced Registration
Statement to 4:00 p.m., Eastern Time, on August 2, 2021, or as soon thereafter as practicable.
Please contact Tom McAleavey of Holland & Knight,
special counsel to the Company, by email at tom.mcaleavey@hklaw.com or by phone at (407) 244-5108 if you have any other questions or concerns
regarding this matter.
Sincerely,
/s/ Robert Etherington
Name: Robert Etherington
Title: President, Chief Executive Officer and Director
2021-07-28 - UPLOAD - Clene Inc.
United States securities and exchange commission logo
July 28, 2021
Robert Etherington
President and Chief Executive Officer
Clene Inc.
6550 South Millrock Drive, Suite G50
Salt Lake City, UT 84121
Re:Clene Inc.
Registration Statement on Form S-1
Filed July 22, 2021
File No. 333-258098
Dear Mr. Etherington:
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 Deanna Virginio at 202-551-4530 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Tom McAleavey, Esq.
2021-04-16 - CORRESP - Clene Inc.
CORRESP
1
filename1.htm
Clene Inc.
6550 South Millrock Drive, Suite G50
Salt Lake City, Utah 84121
VIA EDGAR
April 16, 2021
Securities and Exchange Commission
Division of Corporation Finance
Office of Energy & Transportation
100 F Street, N.E.
Washington, D.C. 20549
Attention: Abby Adams / Celeste Murphy
Re:
Clene Inc.
Registration Statement on Form S-1
File No. 333-253173
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act
of 1933, as amended, Clene Inc. (the “Company”) hereby requests acceleration of the effective date of the above referenced
Registration Statement to 4:00 p.m., Eastern Time, on April 19, 2021, or as soon thereafter as practicable, or at such other time as the
Company or its outside counsel, Kirkland & Ellis, request by telephone that such Registration Statement be declared effective.
Please contact Ben James, of Kirkland & Ellis,
special counsel to the Company, by email at ben.james@kirkland.com or by phone at +852 3761 3412, as soon as the Registration Statement
has been declared effective, or if you have any other questions or concerns regarding this matter.
Sincerely,
/s/ Robert Etherington
Name: Robert Etherington
Title: President, Chief Executive Officer and Director
2021-04-07 - CORRESP - Clene Inc.
CORRESP
1
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26th Floor, Gloucester
Tower
The Landmark
15 Queen’s
Road Central
Hong Kong
Telephone: +852-3761-3300
Facsimile: +852-3761-3301
Ben James
+852-3761-3412
ben.james@kirkland.com
VIA EDGAR
April 7, 2021
U.S. Securities & Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, D.C. 20549
Attn: Abby Adams / Celeste Murphy
Re:
Clene Inc.
Registration Statement on Form S-1
File No. 333-253173
Dear Ms. Adams and Ms. Murphy:
On behalf of Clene Inc.
(the “Company”), we hereby transmit the Company’s response to the comment letter received from the staff (the
“Staff”) of the U.S. Securities and Exchange Commission (the “Commission”), dated April 5, 2021,
regarding the Company’s Registration Statement on Form S-1 (the “Registration Statement”) filed on February 17,
2021, and subsequently amended on March 29, 2021.
For the Staff’s convenience,
we have repeated below the Staff’s comments in bold, and have followed each comment with the Company’s response.
Registration Statement on Form S-1
Security Ownership of Certain Beneficial Owners
and Management, page 137
1. We note the revised disclosure in response to comment 1, and reissue the comment. Please identify the
individual members of the board of managers that exercise voting and dispositive power over the General Resonance, LLC, shares or tell
us why you do not believe they do not have beneficial ownership over the shares. We note General Resonance is a 26.8% shareholder offering
all of their almost 16 million shares in this resale registration statement, and that your director Mr. Wilcox co-founded General Resonance.
Tell us whether he is a member of the board of managers.
PARTNERS: Pierre-Luc Arsenault3 |
Manas Chandrashekar6 | Lai Yi Chau | Justin M. Dolling6 | David Patrick Eich1,5,6 |Liu Gan2 |
David G. Harrington8 | Karen K.Y. Ho | Damian C. Jacobs6 | Guang Li3 | Mengyu Lu3 |
Neil E.M. McDonald | Kelly Naphtali | Ram Narayan3 | Amy Y.M. Ngan8 | Nicholas A. Norris6 |
Paul S. Quinn | Michael D. Rackham6 | Fergus A. Saurin6 | Richard C.C. Sharpe |
Jesse D. Sheley# | Li Chien Wong | Jacqueline B.N. Zheng3,6
REGISTERED FOREIGN LAWYERS:
Gautam Agarwal6 | Michelle Cheh7 | Daniel Dusek3 | James A. Hill6 | Ju Huang3 |
Benjamin W. James4 | Cori A. Lable2 | Wei Yang Lim6 | Xiaoxi Lin3 | Yazhe Liu3 |
Daniel A. Margulies6 | Bo Peng9 | Mi Tang3 | Wenchen Tang3 | Liyong Xing3 | Jiayuan Yu3 |
David Zhang3
ADMITTED IN: 1 State of Illinois (U.S.A.);
2 Commonwealth of Massachusetts (U.S.A.); 3 State of New York (U.S.A.); 4 State of Texas (U.S.A.);
5 State of Wisconsin (U.S.A.); 6 England and Wales; 7 Victoria (Australia); 8 New South Wales (Australia);
9 State of Georgia (U.S.A.); # non-resident
Bay Area Beijing Boston Chicago Dallas Houston London Los Angeles Munich New York Paris Shanghai Washington, D.C.
U.S. Securities & Exchange Commission
April 7, 2021
Page 2
The Company wishes to advise the Staff that the board of managers
of General Resonance, LLC (“General Resonance”) has nine members, and any decision to exercise voting or dispositive
power over the shares of the Company held by General Resonance would require a majority of the members of the board of managers. Thus,
no individual member, including Mr. Wilcox who sits on the board of managers, has voting or dispositive power over such shares.
The Company believes its view is consistent with the Staff’s
position in the Southland Corp. No-Action Letter (August 10, 1987). In this No-Action Letter, the Staff concurred in the view that no
individual should be deemed the beneficial owner of shares of common stock held by certain employee benefit plans of The Southland Corporation
solely by virtue of the fact that such individual was a trustee of any such plan or a director of the company. Five trustees, who could
only act by majority vote, administered each plan; no trustee could act individually to vote or sell shares held by the plans. The Company
also believes the “rule of three,” as articulated by Romeo & Dye in The Section 16 Treatise and Reporting Guide, 4th Edition,
in its analysis of beneficial ownership under Section 13(d) of the Securities Exchange Act of 1934, based on the Southland Corp. No-Action
Letter, likewise supports its view. As this rule is stated therein, where voting and investment decisions regarding an entity’s
portfolio securities are made by three or more individuals, and a voting or investment decision requires the approval of a majority of
those individuals, none of the individuals would be deemed a beneficial owner of the entity’s portfolio securities.
* * * * *
We thank the Staff for
its review of the foregoing and the Registration Statement. If you have further comments, please feel free to contact me at ben.james@kirkland.com
or by telephone at +852-3761-3412, or David Zhang at david.zhang@kirkland.com, or by telephone at +852-3761-3318.
Sincerely,
/s/Benjamin W. James
cc:
Rob Etherington, Chief Executive Officer
Ted Jeong, Chief Financial Officer
2021-04-05 - UPLOAD - Clene Inc.
United States securities and exchange commission logo
April 5, 2021
Ted Jeong
Chief Financial Officer
Clene Inc.
6550 South Millrock Drive, Suite G50
Salt Lake City, Utah 84121
Re:Clene Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed March 29, 2021
File No. 333-253173
Dear Mr. Jeong:
We have reviewed your amended registration statement 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 our comment, we may have additional comments.
Amendment No. 1 to Registration Statement on Form S-1
Security Ownership of Certain Beneficial Owners and Management, page 138
1.We note the revised disclosure in response to comment 1, and reissue the comment.
Please identify the individual members of the board of managers that exercise voting and
dispositive power over the General Resonance, LLC, shares or tell us why you do not
believe they do not have beneficial ownership over the shares. We note General
Resonance is a 26.8% shareholder offering all of their almost 16 million shares in this
resale registration statement, and that your director Mr. Wilcox co-founded General
Resonance. Tell us whether he is a member of the board of managers.
FirstName LastNameTed Jeong
Comapany NameClene Inc.
April 5, 2021 Page 2
FirstName LastName
Ted Jeong
Clene Inc.
April 5, 2021
Page 2
Please contact Abby Adams at (202) 551-6902 or Celeste Murphy at (202) 551-3257 with
any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Ben James
2021-03-29 - CORRESP - Clene Inc.
CORRESP
1
filename1.htm
26th Floor,
Gloucester Tower
The Landmark
15 Queen’s
Road Central
Hong Kong
Telephone:
+852 3761 3300
Facsimile:
+852 3761 3301
www.kirkland.com
Ben James
+852 3761 3412
ben.james@kirkland.com
VIA EDGAR
March 26, 2021
U.S. Securities & Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, D.C. 20549
Attn: Abby Adams / Celeste Murphy
Re:
Clene Inc.
Registration Statement on Form S-1
Filed February 17, 2021
File No. 333-253173
Dear Ms. Adams and Ms. Murphy:
On behalf of Clene
Inc. (the “Company”), we hereby transmit the Company’s response to the comment letter received from the
staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”), dated
March 1, 2021, regarding the Company’s Registration Statement on Form S-1 (the “Registration Statement”)
filed on February 17, 2021.
For the Staff’s
convenience, we have repeated below the Staff’s comments in bold, and have followed each comment with the Company’s
response. Disclosure changes made in response to the Staff’s comments have been made in the Revised Registration Statement
on Form S-1 (the “Revised Registration Statement”), which is being filed with the Commission contemporaneously
with the submission of this letter.
Registration Statement on Form S-1
Security Ownership of Certain Beneficial
Owners and Management, page 137
1. Please identify the natural person or persons who directly or indirectly exercise sole or shared voting and/or dispositive power with respect
to the common stock held by the entities identified in the table. Refer to Item 403 of Regulation S-K.
In response to the Staff’s comments, the Company
has revised the disclosure on pages 138 and 139 of the Revised Registration Statement to provide the requested disclosure.
PARTNERS:
Pierre-Luc Arsenault3 | Manas Chandrashekar6 | Lai Yi Chau |
Justin M. Dolling6 | David Patrick Eich1,5,6 | Liu Gan2 |
David G. Harrington8 | Karen K.Y. Ho | Damian C. Jacobs6 |
Guang Li3 | Mengyu Lu3 | Neil E.M. McDonald | Kelly Naphtali |
Ram Narayan3 | Amy Y.M. Ngan8 | Nicholas A. Norris6 | Paul S. Quinn |
Michael D. Rackham6 | Fergus A. Saurin6 | Richard C.C. Sharpe |
Jesse D. Sheley# | Li Chien Wong | Jacqueline B.N. Zheng3,6
REGISTERED
FOREIGN LAWYERS: Gautam Agarwal6 | Michelle Cheh7 | Daniel Dusek3 | James A. Hill6 |
Ju Huang3 | Benjamin W. James4 | Cori A. Lable2 | Wei Yang Lim6 |
Xiaoxi Lin3 | Yazhe Liu3 | Daniel A. Margulies6 | Bo Peng9 | Mi Tang3 |
Wenchen Tang3 | Liyong Xing3 | Jiayuan Yu3 | David Zhang3
ADMITTED
IN: 1 State of Illinois (U.S.A.); 2 Commonwealth of Massachusetts (U.S.A.);
3 State of New York (U.S.A.); 4 State of Texas (U.S.A.); 5 State of Wisconsin (U.S.A.);
6 England and Wales; 7 Victoria (Australia); 8 New South Wales (Australia);
9 State of Georgia (U.S.A.); # non-resident
Bay Area Beijing Boston Chicago Dallas Houston London Los Angeles Munich New York Paris Shanghai Washington, D.C.
U.S. Securities & Exchange Commission
March 26, 2021
Page 2
General
2. Revise to include audited financial statements for
the fiscal year ended December 31, 2020. For guidance,
refer to the Division of Corporation Finance's Financial Reporting Manual 1220.3.
In responses to the Staff’s
comments, the Company has updated the Revised Registration Statement to include the financial statements for the fiscal year ended
December 31, 2020, and made appropriate revisions throughout.
* * * * *
We thank the Staff
for its review of the foregoing and the Registration Statement. If you have further comments, please feel free to contact me at
ben.james@kirkland.com or by telephone at +852-3761-3412, or David Zhang at david.zhang@kirkland.com, or by telephone at +852-3761-3318.
Sincerely,
/s/Benjamin W. James
cc: Rob
Etherington, Chief Executive Officer
Ted Jeong, Chief Financial
Officer
2021-03-01 - UPLOAD - Clene Inc.
United States securities and exchange commission logo
March 1, 2021
Ted Jeong
Chief Financial Officer
Clene Inc.
6550 South Millrock Drive, Suite G50
Salt Lake City, Utah 84121
Re:Clene Inc.
Registration Statement on Form S-1
Filed February 17, 2021
File No. 333-253173
Dear Mr. Jeong:
We have limited our review of your registration statement to those issues we have
addressed in our comments. Please respond to this letter by amending your registration
statement and providing the requested information. If you do not believe our comments apply to
your facts and circumstances or do not believe an amendment is appropriate, please tell us why
in your response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-1
Security Ownership of Certain Beneficial Owners and Management, page 137
1.Please identify the natural person or persons who directly or indirectly exercise sole or
shared voting and/or dispositive power with respect to the common stock held by the
entities identified in the table. Refer to Item 403 of Regulation S-K.
General
2.Revise to include audited financial statements for the fiscal year ended December 31,
2020. For guidance, refer to the Division of Corporation Finance's Financial Reporting
Manual 1220.3.
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 LastNameTed Jeong
Comapany NameClene Inc.
March 1, 2021 Page 2
FirstName LastName
Ted Jeong
Clene Inc.
March 1, 2021
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.
Please contact Abby Adams at (202) 551-6902 or Celeste Murphy at (202) 551-3257 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Ben James
2020-12-16 - CORRESP - Clene Inc.
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Chelsea Worldwide Inc.
11 Marshall Road,
Suite 1L, Wappingers Falls,
New York, New York 12590
VIA EDGAR
December 16, 2020
U.S. Securities & Exchange Commission
Division of Corporation Finance
Office of Finance
100 F Street, NE
Washington, D.C. 20549
Re:
Chelsea Worldwide Inc.
Registration Statement on Form S-4 (File No. 333-248703)
Dear Ms. Schwartz:
Pursuant to Rule 461 promulgated under
the Securities Act of 1933, as amended, Chelsea Worldwide Inc. hereby requests acceleration of the effectiveness of the above referenced
Registration Statement so that it will become effective at 2:00 P.M. Eastern Time on December 18, 2020, or as soon as thereafter
practicable.
Very truly yours,
/s/ Jason Ma
Name: Jason Ma
Title: Chief Executive Officer
2020-12-07 - CORRESP - Clene Inc.
CORRESP
1
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Giovanni
Caruso
Partner
345 Park Avenue
New York, NY 10154
Direct 212.407.4866
Main 212.407.4000
Fax 212.937.3943
gcaruso@loeb.com
Via Edgar
December 7, 2020
Division of Corporation Finance
Office of Life Sciences
U.S. Securities & Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Re:
Chelsea Worldwide Inc.
Amendment No. 4 to Registration Statement on Form S-4
Filed November 18, 2020
File No. 333-248703
Dear SEC Officers:
On behalf of our client,
Chelsea Worldwide Inc. (the “Company”), we hereby provide a response to the comments issued in a letter dated December
1, 2020 (the “Staff’s Letter”) regarding the Registration Statement on Form S-4 (the “Registration Statement”).
Contemporaneously, we are filing the amended Registration Statement via Edgar (the “Amended Registration Statement”).
In order to facilitate
the review by the Commission’s staff (the “Staff”) of the Amended Registration Statement, we have responded,
on behalf of the Company, to the comments set forth in the Staff’s Letter on a point-by-point basis. The numbered paragraphs
set forth below respond to the Staff’s comments and correspond to the numbered paragraph in the Staff’s Letter.
Amendment No.4 to Registration Statement on Form S-4,
Filed November 18, 2020
Q: Will holders of TOTA Ordinary Shares, TOTA Rights or
TOTA Warrants be subject to U.S. federal income tax..., page iii
1.
We note your revised disclosure on pages xiii, 54 and 105 in response to our prior comment number 5. Please revise the first sentence of the answer on page xiii to state clearly, as you do on page 54, that the "Business Combination is likely to be a taxable event for U.S. Holders of TOTA Ordinary Shares, TOTA Warrants, and TOTA Rights" and to indicate, if true, that this treatment is based on a belief that Tottenham likely was a PFIC for the fiscal year ended December 31, 2019 and/or likely will be a PFIC for the fiscal year ended December 31, 2020. For the benefit of the Clene holders, consider adding a separate Q&A regarding Tottenham's PFIC status and the potential impact of making timely and effective elections for the first year they acquire the securities in the Business Combination.
Response: The disclosure
on pages xii and xiii of the Amended Registration Statement has been revised in accordance with the Staff’s comment. In addition,
since Clene holders will acquire an interest in the Company, a Delaware corporation, instead of Tottenham, Tottenham’s PFIC
status will not impact Clene holders.
December 7, 2020
Page | 2
Summary of the Proxy Statement/Consent Solicitation Statement/Prospectus,
page 1
2.
We note your response to our prior comment number 5 and your statement on page 85: “Taking into account that 54.25 million shares of Chelsea Worldwide Stock will be issued by Tottenham to Clene’s shareholders and management, the aggregate equity value for Clene could be as high as $805.61 million.” Please revise to explain how you calculated the $805.61 aggregate equity value for Clene.
Response: The disclosure
on page 85 of the Amended Registration Statement has been revised in accordance with the Staff’s comment.
Certain U.S. Federal Income Tax Consequences
to U.S. Holders of Tottenham Securities of Exercising Redemption Rights, page 109
3.
With reference to our prior comment number 6, we note that your disclosure on pages 109-110 and xii-xiii indicates that the tax treatment is subject to the passive foreign investment company (“ PFIC”) rules of the Code. Please revise these discussions to clarify the impact of your belief that Tottenham likely was a PFIC for the fiscal year ended December 31, 2019 and likely will be a PFIC for the fiscal year ended December 31, 2020.
Response: The disclosure
on pages 109 and 110 of the Amended Registration Statement has been revised in accordance with the Staff’s comment.
Business of Clene, page 107
4.
We note your response to our prior comment number 7. In the pipeline table on page 117, please visually differentiate the representation of the Harvard (MGH) EAP from the arrows for your trials or otherwise provide sufficient context so that the status of this candidate is clarified.
Response: The disclosure
on page 117 of the Amended Registration Statement has been revised in accordance with the Staff’s comment.
5.
We note your response to our prior comment number 8. Please revise pages 122-124 to provide a brief explanation of how p-values are used to measure statistical significance and how statistical significance relates to FDA approval.
Response: The disclosure
on page 122 of the Amended Registration Statement has been revised in accordance with the Staff’s comment.
Please call me at 212-407-4866
if you would like additional information with respect to any of the foregoing.
Thank you.
Sincerely,
/s/ Giovanni Caruso
Giovanni Caruso
Partner
2020-12-01 - UPLOAD - Clene Inc.
United States securities and exchange commission logo
December 1, 2020
Jason Ma
President
Chelsea Worldwide Inc.
11 Marshall Road, Suite 1L
Wappingers Falls, New York 12590
Re:Chelsea Worldwide Inc.
Amendment No. 4 to Registration Statement on Form S-4
Filed November 18, 2020
File No. 333-248703
Dear Mr. Ma:
We have reviewed your amended registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is 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. Unless we note
otherwise, our references to prior comments are to comments in our November 4, 2020 letter.
Amendment No. 4 to Registration Statement on Form S-4, Filed November 18, 2020
Q: Will holders of TOTA Ordinary Shares, TOTA Rights or TOTA Warrants be subject to U.S.
federal income tax..., page iii
1.We note your revised disclosure on pages xiii, 54 and 105 in response to our prior
comment number 5. Please revise the first sentence of the answer on page xiii to state
clearly, as you do on page 54, that the "Business Combination is likely to be a taxable
event for U.S. Holders of TOTA Ordinary Shares, TOTA Warrants, and TOTA Rights"
and to indicate, if true, that this treatment is based on a belief that Tottenham likely was a
PFIC for the fiscal year ended December 31, 2019 and/or likely will be a PFIC for the
fiscal year ended December 31, 2020. For the benefit of the Clene holders, consider
adding a separate Q&A regarding Tottenham's PFIC status and the potential impact of
FirstName LastNameJason Ma
Comapany NameChelsea Worldwide Inc.
December 1, 2020 Page 2
FirstName LastName
Jason Ma
Chelsea Worldwide Inc.
December 1, 2020
Page 2
making timely and effective elections for the first year they acquire the securities in the
Business Combination.
Summary of the Proxy Statement/Consent Solicitation Statement/Prospectus, page 1
2.We note your response to our prior comment number 5 and your statement on page 85:
“Taking into account that 54.25 million shares of Chelsea Worldwide Stock will be issued
by Tottenham to Clene’s shareholders and management, the aggregate equity value for
Clene could be as high as $805.61 million.” Please revise to explain how you calculated
the $805.61 aggregate equity value for Clene.
Certain U.S. Federal Income Tax Consequences to U.S. Holders of Tottenham Securities of
Exercising Redemption Rights,, page 109
3.With reference to our prior comment number 6, we note that your disclosure on pages
109-110 and xii-xiii indicates that the tax treatment is subject to the passive foreign
investment company (“ PFIC”) rules of the Code. Please revise these discussions to
clarify the impact of your belief that Tottenham likely was a PFIC for the fiscal year
ended December 31, 2019 and likely will be a PFIC for the fiscal year ended December
31, 2020.
Business of Clene, page 114
4.We note your response to our prior comment number 7. In the pipeline table on page 117,
please visually differentiate the representation of the Harvard (MGH) EAP from the
arrows for your trials or otherwise provide sufficient context so that the status of this
candidate is clarified.
5.We note your response to our prior comment number 8. Please revise pages 122-124 to
provide a brief explanation of how p-values are used to measure statistical significance
and how statistical significance relates to FDA approval.
You may contact Tracey McKoy at 202-551-3772 or Terence O'Brien at 202-551-3355 if
you have questions regarding comments on the financial statements and related matters. Please
contact Margaret Schwartz at 202-551-7153 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Giovanni Caruso
2020-11-18 - CORRESP - Clene Inc.
CORRESP
1
filename1.htm
Giovanni
Caruso
Partner
345 Park Avenue
New York, NY 10154
Direct 212.407.4866
Main 212.407.4000
Fax 212.937.3943
gcaruso@loeb.com
Via Edgar
November 18, 2020
Division of Corporation Finance
Office of Life Sciences
U.S. Securities & Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Re:
Chelsea Worldwide Inc.
Amendment No. 3 to Registration Statement on Form S-4
File No. 333-248703
Dear SEC Officers:
On behalf of our client,
Chelsea Worldwide Inc. (the “Company”), we hereby provide a response to the comments issued in a letter dated November
4, 2020 (the “Staff’s Letter”) regarding the Registration Statement on Form S-4 (the “Registration Statement”).
Contemporaneously, we are filing the amended Registration Statement via Edgar (the “Amended Registration Statement”).
In order to facilitate
the review by the Commission’s staff (the “Staff”) of the Amended Registration Statement, we have responded,
on behalf of the Company, to the comments set forth in the Staff’s Letter on a point-by-point basis. The numbered paragraphs
set forth below respond to the Staff’s comments and correspond to the numbered paragraph in the Staff’s Letter.
Amended Registration Statement on Form S-4, Filed October
20, 2020
Summary of the Proxy Statement/Consent Solicitation Statement/Prospectus,
page 1
1. We note your response to our
prior comment number 4. Please revise page 2 to briefly describe the Clene common and
preferred stock exchange mechanics and state that the basis for the 0.1320 conversion
ratio cited is an estimate based on the date of the execution of the Merger Agreement,
as you state on page 184. Additionally, please revise page 184 to clarify whether you
are referring to the shares to be held in escrow to satisfy any indemnity obligation
or the earn-out shares in the following reference on page 184: “the 5% to be held
in escrow and subject to earn-out.”
Response: The
disclosure on pages 3 and 194 of the Amended Registration Statement has been revised in accordance with the Staff’s comment.
November 18, 2020
Page | 2
Proposal No. 1 The Reincorporation
Merger Proposal, page 61
2. We note your response to our prior comment number 11. Please revise to identify the “certain
claims” referenced on page 66. We note that your proposed charter on page B-8 appears to state that all federal securities
law claims must be brought in federal court.
Response: The
disclosure on page 68 of the Amended Registration Statement has been revised in accordance with the Staff’s comment.
3. We note your response to our prior comment number 12; however, it is unclear why you have not
addressed the portion of our comment relating to Rule 14a-4(a)(3) of Regulation 14A. Accordingly, we reissue this portion of the
comment. Revise, and update your proxy card, to identify clearly and impartially each separate matter intended to be acted upon.
Response: In
response the Staff’s comment, the Company has broken down the various proposed amendment to the charter documents as
separate proposals in the proxy statement and on the proxy card. The disclosure on pages 64 to 71 of the Amended Registration
Statement has been revised in accordance with the Staff’s comment.
4. We note your response to our prior comment number 15. The Q&A on the Merger Agreement closing
conditions on page xii cross references the “Summary of the Proxy Statement/Consent Solicitation Statement/Prospectus —
The Business Combination and the Merger Agreement” but the Summary does not discuss closing conditions. Therefore, please
revise this Q&A on page xii to include a brief description of these closing conditions or, alternatively, revise the cross
reference to instead refer to the discussion of the closing conditions on pages 69-70.
Response: The disclosure
on page xii of the Amended Registration Statement has been revised in accordance with the Staff’s comment.
5. We note your response to our prior comment number 17. Please include discussion of the quantitative
basis for determining Clene’s fair market value was at least 80% of Tottenham’s net assets as quantitative factors
are necessary to understand fair market value. In this regard, we note the following disclosure contained in Tottenham’s IPO prospectus:
“The fair market value of the target will be determined by our board of directors based upon one or more standards generally
accepted by the financial community (such as actual and potential sales, earnings, cash flow and/or book value).”
Response: The disclosure
from page 82 and pages 84 to 86 of the Amended Registration Statement has been revised in accordance with the Staff’s comment.
Material U.S. Federal Income Tax
Consequences of the Business Combination, page 94
6. We note your revisions in response to prior comment 18. In light of the fact that Proposals
1 and 2 are conditioned upon each other, please revise the disclosure on page 96 and elsewhere, as applicable, to discuss and clarify
the material tax consequences of the “Business Combination” to U.S. Holders of Tottenham Securities, or advise. With
reference to Staff Legal Bulletin No. 19, please also note that it is inappropriate to assume any legal conclusion underlying counsel’s
opinion and consider the guidance concerning opinions subject to uncertainty. In this regard, and without limitation, revise the
two tax Q&As on pages xii and xiii to clarify the tax consequences and any uncertainties concerning redemption and the Business
Combination. Similarly, revise the header to the risk factor heading on page 53 concerning what the tax consequences “may
be”. Also revise page 94 to clarify that this section of the prospectus/proxy constitutes the opinion of Loeb & Loeb LLP
and remove the reference to the disclosure as a “general discussion”.
Response: The disclosure
on pages xii, xiii, 54, 101, 103 and 104 of the Amended Registration Statement has been revised in accordance with the Staff’s
comment.
November 18, 2020
Page | 3
Business of Clene, page 107
7. We refer to prior comment 20 and note your response concerning presentation of the expanded
access program for ALS as a Phase 2 program. With reference to your discussion on page 139 concerning Phase 2 trials, we note that
a Phase 2 trial typically includes an assessment of efficacy. Given that your disclosure concerning the expanded access program
for ALS lacks any mention of efficacy, it does not appear appropriate to depict this program as a Phase 2 study in the pipeline
table. Please revise your presentation accordingly.
Response: The chart on
page 117 of the Amended Registration Statement has been revised to change the applicable column heading from “Phase 2”
to “Phase 2 or EAP” in accordance with the Staff’s comment.
8. We note your response to our prior comment number 22. Please revise pages 115-116 to provide
a brief explanation of the disclosed p-values and how p-values are used to measure statistical significance.
Response: The disclosure
on pages 122 to 124 of the Amended Registration Statement has been revised in accordance with the Staff’s comment.
9. We note your revised disclosure in response to prior comment number 23. Please revise your disclosure
concerning the peer-reviewed publication by Robinson to disclose, if true, that Clene Nanomedicine, Inc. funded it and that Clene
employees were involved in both the study and publication. In addition, provide additional information regarding the number and
type of subjects and p-values for the reported results, including support for the statement that CNM-Au8 “demonstrated a
statistically significant recovery of remyelinated axons in therapeutically treated animals.”.
Response: The disclosure
on page 128 of the Amended Registration Statement has been revised in accordance with the Staff’s comment.
10. We note your response to prior comment number 24. Please revise your disclosure on page 122
to include all material information concerning the MSOAC data/Goldman study so that investors can understand and assess the “anticipated
decline” and understand how this data may help to suggest a clinical effect for CNM -Au8. For example, in connection with
your statement about the expected long-term decline in LCLA, SDMT, 9HPT and T25FW, disclose the duration that patients were studied
for the Goldman study.
Response: The disclosure
on page 130 of the Amended Registration Statement has been revised in accordance with the Staff’s comment.
November 18, 2020
Page | 4
Security Ownership of Certain Beneficial
Owners and Management Prior to the Business Combination, page 208
11. We note your response to our prior comment number 42. Please revise page 209 to provide the
beneficial ownership disclosure of Clene in accordance with the requirements of Item 403 of Regulation S-K. For instance, list
the beneficial ownership of individual directors and nominees, named executive officers and directors and executive officers as
a group as well as the beneficial owners of more than five percent of any class of Clene’s voting securities.
Response: The disclosure
on pages 220 to 222 of the Amended Registration Statement has been revised in accordance with the Staff’s comment.
Security Ownership of the Combined
Company after the Business Combination, page 210
12. We note your response to our prior comment number 44. Please revise Annex A or the exhibit index
to include a list briefly identifying the contents of all omitted schedules for your Merger Agreement, specifically the disclosure
schedules. Please also describe the schedules or similar attachments omitted from Exhibit 10.14 in the Exhibit Index.
Response: The disclosure
on page Annex A-58 and Exhibit 10.14 of the Amended Registration Statement has been revised in accordance with the Staff’s
comment.
13. With reference to page 201 and Rule 438, please provide signatures or consents for all applicable
directors.
Response: Exhibit 99.1
to 99.8 of the Amended Registration Statement has been added in accordance with the Staff’s comment.
14. We note the removal of Polar Asset Management Partners Inc. from Tottenham’s beneficial
ownership table. We also note that this table is as of June 30, 2020. If this removal is to reflect events subsequent to June 30,
2020, then please update the table to reflect a more recent date or advise.
Response: The disclosure
on page 218 of the Amended Registration Statement has been revised in accordance with the Staff’s comment.
General
15. We note your response to our prior comment number 45. Please revise your proxy card to indicate
that the approval of certain proposals is conditioned upon the approval of other proposals. Refer to Rule 14a-4(a)(3) of Regulation
14A.
Response: The form of
preliminary proxy card has been revised in accordance with the Staff’s comment.
16. Given the transactions, please tell us why Tottenham should not be identified as a co- registrant
and subject to the signature requirements of Form S-4.
Response: Neither the
Company nor Tottenham believes that Tottenham should be considered as a co-registrant. Rule 100 under the Rules and Regulations
Promulgated under the Securities Act of 1933, as amended, defines a registrant as “the issuer of securities for which a
registration statement is filed.” In the case of the Amended Registration Statement, only the securities of the Company
are being registered. The securities of the Company are the only securities being issued in the transaction, and Tottenham will
cease to exist at the closing of the transaction (all its outstanding securities having been converted to Company securities).
Based on the foregoing, the Company and Tottenham believe that it is clear that Tottenham is not a co-registrant.
In order to insure that this
is clear to investor, instead of filing a duplicate Form S-4 on Tottenham’s edgar filer page, Tottenham will file a proxy
statement with a cross reference back to the Amended Registration Statement.
November 18, 2020
Page | 5
Please call me at 212-407-4866
if you would like additional information with respect to any of the foregoing. Thank you.
Sincerely,
/s/ Giovanni Caruso
Giovanni Caruso
Partner
2020-11-05 - UPLOAD - Clene Inc.
United States securities and exchange commission logo
November 4, 2020
Jason Ma
President
Chelsea Worldwide Inc.
11 Marshall Road, Suite 1L
Wappingers Falls, New York 12590
Re:Chelsea Worldwide Inc.
Amendment No. 3 to Registration Statement on Form S-4
Filed October 20, 2020
File No. 333-248703
Dear Mr. Ma:
We have reviewed your amended registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is 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. Unless we note
otherwise, our references to prior comments are to comments in our October 9, 2020 letter.
Amended Registration Statement on Form S-4, Filed October 20, 2020
Summary of the Proxy Statement/Consent Solicitation Statement/Prospectus, page 1
1.We note your response to our prior comment number 4. Please revise page 2 to briefly
describe the Clene common and preferred stock exchange mechanics and state that the
basis for the 0.1320 conversion ratio cited is an estimate based on the date of the
execution of the Merger Agreement, as you state on page 184. Additionally, please
revise page 184 to clarify whether you are referring to the shares to be held in escrow to
satisfy any indemnity obligation or the earn-out shares in the following reference on page
184: "the 5% to be held in escrow and subject to earn-out."
FirstName LastNameJason Ma
Comapany NameChelsea Worldwide Inc.
November 4, 2020 Page 2
FirstName LastName
Jason Ma
Chelsea Worldwide Inc.
November 4, 2020
Page 2
Proposal No. 1 The Reincorporation Merger Proposal, page 61
2.We note your response to our prior comment number 11. Please revise to identify the
“certain claims” referenced on page 66. We note that your proposed charter on page B-8
appears to state that all federal securities law claims must be brought in federal court.
3.We note your response to our prior comment number 12; however, it is unclear why you
have not addressed the portion of our comment relating to Rule 14a-4(a)(3) of Regulation
14A. Accordingly, we reissue this portion of the comment. Revise, and update your
proxy card, to identify clearly and impartially each separate matter intended to be acted
upon.
4.We note your response to our prior comment number 15. The Q&A on the Merger
Agreement closing conditions on page xii cross references the “Summary of the Proxy
Statement/Consent Solicitation Statement/Prospectus — The Business Combination and
the Merger Agreement" but the Summary does not discuss closing conditions. Therefore,
please revise this Q&A on page xii to include a brief description of these closing
conditions or, alternatively, revise the cross reference to instead refer to the discussion of
the closing conditions on pages 69-70.
5.We note your response to our prior comment number 17. Please include discussion of the
quantitative basis for determining Clene’s fair market value was at least 80% of
Tottenham’s net assets as quantitative factors are necessary to understand fair market
value. In this regard, we note the following disclosure contained in Tottenham's IPO
prospectus: "The fair market value of the target will be determined by our board of
directors based upon one or more standards generally accepted by the financial
community (such as actual and potential sales, earnings, cash flow and/or book value)."
Material U.S. Federal Income Tax Consequences of the Business Combination, page 94
6.We note your revisions in response to prior comment 18. In light of the fact that
Proposals 1 and 2 are conditioned upon each other, please revise the disclosure on page 96
and elsewhere, as applicable, to discuss and clarify the material tax consequences of the
"Business Combination" to U.S. Holders of Tottenham Securities, or advise. With
reference to Staff Legal Bulletin No. 19, please also note that it is inappropriate to assume
any legal conclusion underlying counsel's opinion and consider the guidance concerning
opinions subject to uncertainty. In this regard, and without limitation, revise the two tax
Q&As on pages xii and xiii to clarify the tax consequences and any uncertainties
concerning redemption and the Business Combination. Similarly, revise the header to the
risk factor heading on page 53 concerning what the tax consequences "may be". Also
revise page 94 to clarify that this section of the prospectus/proxy constitutes the opinion of
Loeb & Loeb LLP and remove the reference to the disclosure as a "general discussion".
FirstName LastNameJason Ma
Comapany NameChelsea Worldwide Inc.
November 4, 2020 Page 3
FirstName LastName
Jason Ma
Chelsea Worldwide Inc.
November 4, 2020
Page 3
Business of Clene, page 107
7.We refer to prior comment 20 and note your response concerning presentation of the
expanded access program for ALS as a Phase 2 program. With reference to your
discussion on page 139 concerning Phase 2 trials, we note that a Phase 2 trial typically
includes an assessment of efficacy. Given that your disclosure concerning the expanded
access program for ALS lacks any mention of efficacy, it does not appear appropriate
to depict this program as a Phase 2 study in the pipeline table. Please revise your
presentation accordingly.
8.We note your response to our prior comment number 22. Please revise pages 115-116 to
provide a brief explanation of the disclosed p-values and how p-values are used to
measure statistical significance.
9.We note your revised disclosure in response to prior comment number 23. Please revise
your disclosure concerning the peer-reviewed publication by Robinson to disclose, if true,
that Clene Nanomedicine, Inc. funded it and that Clene employees were involved in both
the study and publication. In addition, provide additional information regarding the
number and type of subjects and p-values for the reported results, including support for
the statement that CNM-Au8 “demonstrated a statistically significant recovery of
remyelinated axons in therapeutically treated animals.”
10.We note your response to prior comment number 24. Please revise your disclosure on
page 122 to include all material information concerning the MSOAC data/Goldman study
so that investors can understand and assess the "anticipated decline" and understand how
this data may help to suggest a clinical effect for CNM -Au8. For example, in connection
with your statement about the expected long-term decline in LCLA, SDMT, 9HPT and
T25FW, disclose the duration that patients were studied for the Goldman study.
Security Ownership of Certain Beneficial Owners and Management Prior to the Business
Combination, page 208
11.We note your response to our prior comment number 42. Please revise page 209 to
provide the beneficial ownership disclosure of Clene in accordance with the requirements
of Item 403 of Regulation S-K. For instance, list the beneficial ownership of individual
directors and nominees, named executive officers and directors and executive officers as a
group as well as the beneficial owners of more than five percent of any class of Clene’s
voting securities.
Security Ownership of the Combined Company after the Business Combination, page 210
12.We note your response to our prior comment number 44. Please revise Annex A or the
exhibit index to include a list briefly identifying the contents of all omitted schedules for
your Merger Agreement, specifically the disclosure schedules. Please also describe the
schedules or similar attachments omitted from Exhibit 10.14 in the Exhibit Index.
FirstName LastNameJason Ma
Comapany NameChelsea Worldwide Inc.
November 4, 2020 Page 4
FirstName LastName
Jason Ma
Chelsea Worldwide Inc.
November 4, 2020
Page 4
13.With reference to page 201 and Rule 438, please provide signatures or consents for all
applicable directors.
14.We note the removal of Polar Asset Management Partners Inc. from Tottenham’s
beneficial ownership table. We also note that this table is as of June 30, 2020. If this
removal is to reflect events subsequent to June 30, 2020, then please update the table to
reflect a more recent date or advise.
General
15.We note your response to our prior comment number 45. Please revise your proxy card to
indicate that the approval of certain proposals is conditioned upon the approval of other
proposals. Refer to Rule 14a-4(a)(3) of Regulation 14A.
16.Given the transactions, please tell us why Tottenham should not be identified as a co-
registrant and subject to the signature requirements of Form S-4.
You may contact Tracey McKoy at 202-551-3772 or Terence O'Brien at 202-551-3355 if
you have questions regarding comments on the financial statements and related matters. Please
contact Margaret Schwartz at 202-551-7153 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Giovanni Caruso
2020-10-19 - CORRESP - Clene Inc.
CORRESP
1
filename1.htm
Giovanni
Caruso
Partner
345
Park Avenue
New York, NY 10154
Direct 212.407.4866
Main 212.407.4000
Fax 212.937.3943
gcaruso@loeb.com
Via
Edgar
October
19, 2020
Division
of Corporation Finance
Office
of Trade & Services
U.S. Securities & Exchange Commission
100
F Street, NE
Washington,
D.C. 20549
Re:
Chelsea
Worldwide Inc.
Registration
Statement on Form S-4
Filed
September 10, 2020
File
No. 333-248703
Dear
SEC Officers:
On
behalf of our client, Chelsea Worldwide Inc. (the “Company”), we hereby provide a response to the comments issued
in a letter dated October 9, 2019 (the “Staff’s Letter”) regarding the Registration Statement on Form S-4 (the
“Registration Statement”). Contemporaneously, we are filing the amended Registration Statement via Edgar (the “Amended
Registration Statement”).
In
order to facilitate the review by the Commission’s staff (the “Staff”) of the Amended Registration Statement,
we have responded, on behalf of the Company, to the comments set forth in the Staff’s Letter on a point-by-point basis.
The numbered paragraphs set forth below respond to the Staff’s comments and correspond to the numbered paragraph in the
Staff’s Letter.
Registration
Statement on Form S-4, filed September 10, 2020
Cover
Page
1. Please
amend to register the PubCo Common Stock subject to the earn-out arrangements, or advise.
Response:
The disclosure on the Cover Page of the Amended Registration Statement has been revised in accordance with the Staff’s
comment.
2. Please
revise the disclosure in the final Q&A on page vii to identify, and if applicable,
quantify all incentives and compensation to the Sponsor for consummating the merger.
Response:
The disclosure on page vii of the Amended Registration Statement has been revised in accordance with the Staff’s comment.
October 19, 2020
Page | 2
Summary
of the Proxy Statement/Consent Solicitation Statement/Prospectus, page 1
3. Please
revise the disclosure to describe the voting power of Clene’s common stock and
preferred stock.
Response:
The disclosure on page 2 of the Amended Registration Statement has been revised in accordance with the Staff’s comment.
4. Please
provide additional quantitative detail on page 3 concerning the breakdown of the amounts
of TOTA Ordinary Shares, TOTA Warrants and TOTA Rights outstanding and that will exist
in the form of PubCo Common Stock and PubCo Warrants upon consummation of the Business
Combination, and the amount of Clene common and preferred stock outstanding. Include
a description of the Clene common and preferred stock exchange mechanics, which first
appear in the notes to the pro forma financials on page 175. Ensure that the revised
disclosure allows an investor to understand the underlying share amounts for the percentages
shown in the graphic on page 5.
Response:
The disclosure on pages 2 and 3 of the Amended Registration Statement has been revised in accordance with the Staff’s
comment.
5. We
note your references to Clene’s product candidates as “first-in-class”
on page 2 and throughout the registration statement. This term suggests that Clene’s
product candidates are effective and likely to be approved. Accordingly, please revise
to balance these statements and provide context concerning the development and regulatory
status of your product candidates and uncertainties concerning approval and whether it
will be first in class in the future. Alternatively, please revise to delete these references
throughout your registration statement.
Response: The disclosure
on pages 2, 107, 125, 126, and 151 of the Amended Registration Statement has been revised in accordance with the Staff’s
comment.
6. Please
reconcile the statement on page 7 that requests for redemption may be withdrawn “at
any time up to two business days immediately preceding the Extraordinary General Meeting”
with the statement on page 58 that requests for redemption may be withdrawn “at
any time up to the business day immediately preceding the consummation of the proposed
Business Combination.”
Response: The disclosure
on pages 7 and 59 of the Amended Registration Statement has been revised in accordance with the Staff’s comment.
7. Please
disclose on page 7 and elsewhere that the Business Combination requires consent of the
holders of a majority of shares of each of Series B, Series C and Series D preferred
stock, including the Series D lead investor, which is currently only mentioned in the
“Questions and Answers about the Business Combination, the Extraordinary General
Meeting and the Consent Solicitation” section. Also, revise to identify the Lead
Investor.
Response:
The disclosure on pages 8 and 86 of the Amended Registration Statement has been revised in accordance with the Staff’s
comment.
October 19, 2020
Page | 3
8. You
state that Tottenham’s initial shareholders have agreed to vote in favor of the
Reincorporation Merger Proposal and the Acquisition Merger Proposal, and intend to vote
for the other Proposals but there is no agreement in place with respect to voting on
the other Proposals. Please state the type of agreement entered into with the initial
shareholders and file such exhibit pursuant to Item 601 of Regulation S-K.
Response:
The disclosure on page 7 of the Amended Registration Statement has been revised in accordance with the Staff’s comment.
The related letter agreements are filed as Exhibit 10.1 to Amended Registration Statement.
Comparative
Per Share Information, page 13
9. Please
remove the dollar sign in note 6 to improve clarity of the nature of the exchange ratio.
Response:
The disclosure on page 15 of the Amended Registration Statement has been revised in accordance with the Staff’s comment.
Risk
Factors
Risks
Relating to PubCo, page 52
10. Please
include risk factor disclosure detailing the risks involved with the provisions of your
proposed charter noted on pages 61-62, including, for instance, having a classified board,
prohibiting shareholders from calling special meetings and requiring more than a majority
vote for certain actions.
Response:
The disclosure on page 53 of the Amended Registration Statement has been revised in accordance with the Staff’s comment.
Proposal
No. 1 The Reincorporation Merger Proposal, page 60
11. Please
revise your disclosure on page 62 to reflect the provisions in the proposed charter included
as Annex B. In this regard, the disclosure on page 62 implies that the requirements of
the Securities Act and Exchange Act apply to claims arising under the Securities Act
and the Exchange Act. However, in Annex B it appears that claims arising under the Securities
Act and the Exchange Act must be brought in a US federal court, even though Section 22
of the Securities Act creates concurrent jurisdiction for federal and state courts over
all claims arising under the Securities Act.
Response: The
disclosure on page 66 of the Amended Registration Statement has been revised in accordance with the Staff’s
comment.
12. Please
revise the disclosure to provide an explanation of any material differences between the
rights of Tottenham’s shareholders and the rights of PubCo’s shareholders.
Also refer to Rule 14a-4(a)(3) and identify clearly and impartially each separate matter
intended to be acted upon. For instance, and without limitation, we note that the reincorporated
PubCo entity has a classified board of directors which is not the case for Tottenham.
For additional guidance, please refer to the interpretations available at: https://www.sec.gov/divisions/corpfin/guidance/exchange-act-rule-14a-
4a3.htm.
Response: The disclosure
on pages 62-66 of the Amended Registration Statement has been revised in accordance with the Staff’s comment.
October 19, 2020
Page | 4
Proposal
No. 2 The Acquisition Merger Proposal, page 63
13. Please
revise the disclosure to briefly describe the non-solicitation requirements of Section
7.3 of the Merger Agreement.
Response: The disclosure
on page 68 of the Amended Registration Statement has been revised in accordance with the Staff’s comment.
14. In
your discussions of the Tottenham earn-out shares, please reconcile the reference to
the Sponsor receiving earn-out shares and the initial shareholders receiving earn-out
shares. See for example pages 63 (which references Milestone 1 Sponsor Earn-out Shares)
and 176, referencing the Sponsor, and pages 4 and Annex A-15, referencing the initial
shareholders. In general, please be sure to distinguish between the initial shareholders
and the Sponsor where appropriate.
Response:
The disclosure throughout the Amended Registration Statement has been revised in accordance with the Staff’s comment.
15. Please
revise the disclosure on page 65 and elsewhere as appropriate to briefly describe the
COVID-19 implications reflected in the Merger Agreement. Please also disclose that the
closing conditions under the Merger Agreement include requirements that (i) Tottenham
remain listed on Nasdaq and not have received any written notice from Nasdaq that it
has failed, or would reasonably be expected to fail, to meet the Nasdaq listing requirements
and (ii) the additional listing application for the closing payment shares issued to
Clene’s stockholders is approved by Nasdaq.
Response: The disclosure
on pages 69 and 70 of the Amended Registration Statement has been revised in accordance with the Staff’s comment.
16. Please
revise the disclosure to provide more detail about the lock-up agreements and registration
rights agreements. For instance, with respect to the lock-up agreements, please include
the time limit from page 206, state the number of shares the lockup agreements are expected
to cover and provide a brief overview of the exceptions. With respect to the registration
rights agreements, include the number of shares covered by the registration rights.
Response: The disclosure
on pages 6, 71, 72, and 214 of the Amended Registration Statement has been revised in accordance with the Staff’s comment.
17. Please
revise the disclosure to explain whether Clene’s collective fair market value satisfies
the 80% test.
Response:
The disclosure on pages 10, 49 and 73 of the Amended Registration Statement has been revised in accordance with the Staff’s
comment.
October 19, 2020
Page | 5
Material
U.S. Federal Income Tax Consequences of the Business Combination, page 87
18. Please
file a tax opinion as an exhibit to the filing or provide us your analysis why the tax
consequences are not material to an investor and therefore no tax opinion is required
to be filed. Refer to Item 601(b)(8) of Regulation S-K and Section III.A.2 of Staff Legal
Bulletin 19. Also revise, as applicable, to discuss whether there is uncertainty concerning
U.S. federal income tax consequences stemming from uncertainty regarding whether the
Reincorporation Merger will qualify as a reorganization.
Response:
The disclosure on pages xiii, 53, 54, 94, 96, and 104 of the Amended
Registration Statement has been revised in accordance with the Staff’s comment. The tax opinion has been added to the Amended
Registration Statement as Exhibit 8.1 in accordance with the Staff’s comment.
Business
of Clene, page 100
19. On
page 102 you state “A Phase 1 First-In-Human study demonstrated the safety and
tolerability of CNM-Au8 in healthy human volunteers.” You also state on page 11,
with respect to your Phase 1 trial of CNM-Au8, “All doses used in this study were
determined to be safe and well-tolerated” and on page 121: “Administration
of the dietary supplement was therefore found to be safe and well-tolerated over the
7-day dosing period.” Please revise these and all similar statements throughout
your prospectus that state or imply that your product candidates are safe or effective
as these determinations are solely within the authority of the FDA and comparable regulatory
bodies.
Response: The disclosure
on pages 109, 118 and 1
2020-10-13 - UPLOAD - Clene Inc.
United States securities and exchange commission logo
October 9, 2020
Jason Ma
President
Chelsea Worldwide Inc.
11 Marshall Road, Suite 1L
Wappingers Falls, New York 12590
Re:Chelsea Worldwide Inc.
Registration Statement on Form S-4
Filed September 10, 2020
File No. 333-248703
Dear Mr. Ma:
We have reviewed your registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-4, filed September 10, 2020
Cover Page
1.Please amend to register the PubCo Common Stock subject to the earn-out arrangements,
or advise.
2.Please revise the disclosure in the final Q&A on page vii to identify, and if applicable,
quantify all incentives and compensation to the Sponsor for consummating the merger.
Summary of the Proxy Statement/Consent Solicitation Statement/Prospectus, page 1
3.Please revise the disclosure to describe the voting power of Clene’s common stock and
preferred stock.
4.Please provide additional quantitative detail on page 3 concerning the breakdown of the
FirstName LastNameJason Ma
Comapany NameChelsea Worldwide Inc.
October 9, 2020 Page 2
FirstName LastNameJason Ma
Chelsea Worldwide Inc.
October 9, 2020
Page 2
amounts of TOTA Ordinary Shares, TOTA Warrants and TOTA Rights outstanding and
that will exist in the form of PubCo Common Stock and PubCo Warrants upon
consummation of the Business Combination, and the amount of Clene common and
preferred stock outstanding. Include a description of the Clene common and preferred
stock exchange mechanics, which first appear in the notes to the pro forma financials on
page 175. Ensure that the revised disclosure allows an investor to understand the
underlying share amounts for the percentages shown in the graphic on page 5.
5.We note your references to Clene’s product candidates as “first-in-class” on page 2 and
throughout the registration statement. This term suggests that Clene's product candidates
are effective and likely to be approved. Accordingly, please revise to balance these
statements and provide context concerning the development and regulatory status of
your product candidates and uncertainties concerning approval and whether it will be first
in class in the future. Alternatively, please revise to delete these references throughout
your registration statement.
6.Please reconcile the statement on page 7 that requests for redemption may be withdrawn
“at any time up to two business days immediately preceding the Extraordinary General
Meeting” with the statement on page 58 that requests for redemption may be withdrawn
“at any time up to the business day immediately preceding the consummation of the
proposed Business Combination.”
7.Please disclose on page 7 and elsewhere that the Business Combination requires consent
of the holders of a majority of shares of each of Series B, Series C and Series D preferred
stock, including the Series D lead investor, which is currently only mentioned in the
"Questions and Answers about the Business Combination, the Extraordinary General
Meeting and the Consent Solicitation" section. Also, revise to identify the Lead Investor.
8.You state that Tottenham’s initial shareholders have agreed to vote in favor of the
Reincorporation Merger Proposal and the Acquisition Merger Proposal, and intend to vote
for the other Proposals but there is no agreement in place with respect to voting on the
other Proposals. Please state the type of agreement entered into with the initial
shareholders and file such exhibit pursuant to Item 601 of Regulation S-K.
Comparative Per Share Information, page 13
9.Please remove the dollar sign in note 6 to improve clarity of the nature of the exchange
ratio.
Risk Factors
Risks Relating to PubCo, page 52
10.Please include risk factor disclosure detailing the risks involved with the provisions of
your proposed charter noted on pages 61-62, including, for instance, having a classified
board, prohibiting shareholders from calling special meetings and requiring more than a
majority vote for certain actions.
FirstName LastNameJason Ma
Comapany NameChelsea Worldwide Inc.
October 9, 2020 Page 3
FirstName LastNameJason Ma
Chelsea Worldwide Inc.
October 9, 2020
Page 3
Proposal No. 1 The Reincorporation Merger Proposal, page 60
11.Please revise your disclosure on page 62 to reflect the provisions in the proposed
charter included as Annex B. In this regard, the disclosure on page 62 implies that the
requirements of the Securities Act and Exchange Act apply to claims arising under the
Securities Act and the Exchange Act. However, in Annex B it appears that claims arising
under the Securities Act and the Exchange Act must be brought in a US federal court,
even though Section 22 of the Securities Act creates concurrent jurisdiction for federal
and state courts over all claims arising under the Securities Act.
12.Please revise the disclosure to provide an explanation of any material differences between
the rights of Tottenham’s shareholders and the rights of PubCo’s shareholders. Also refer
to Rule 14a-4(a)(3) and identify clearly and impartially each separate matter intended to
be acted upon. For instance, and without limitation, we note that the reincorporated
PubCo entity has a classified board of directors which is not the case for Tottenham. For
additional guidance, please refer to the interpretations
available at: https://www.sec.gov/divisions/corpfin/guidance/exchange-act-rule-14a-
4a3.htm.
Proposal No. 2 The Acquisition Merger Proposal, page 63
13.Please revise the disclosure to briefly describe the non-solicitation requirements of Section
7.3 of the Merger Agreement.
14.In your discussions of the Tottenham earn-out shares, please reconcile the reference to the
Sponsor receiving earn-out shares and the initial shareholders receiving earn-out shares.
See for example pages 63 (which references Milestone 1 Sponsor Earn-out Shares) and
176, referencing the Sponsor, and pages 4 and Annex A-15, referencing the initial
shareholders. In general, please be sure to distinguish between the initial shareholders and
the Sponsor where appropriate.
15.Please revise the disclosure on page 65 and elsewhere as appropriate to briefly describe
the COVID-19 implications reflected in the Merger Agreement. Please also disclose that
the closing conditions under the Merger Agreement include requirements that (i)
Tottenham remain listed on Nasdaq and not have received any written notice from Nasdaq
that it has failed, or would reasonably be expected to fail, to meet the Nasdaq listing
requirements and (ii) the additional listing application for the closing payment shares
issued to Clene’s stockholders is approved by Nasdaq.
16.Please revise the disclosure to provide more detail about the lock-up agreements and
registration rights agreements. For instance, with respect to the lock-up agreements, please
include the time limit from page 206, state the number of shares the lockup agreements
are expected to cover and provide a brief overview of the exceptions. With respect to the
registration rights agreements, include the number of shares covered by the registration
rights.
FirstName LastNameJason Ma
Comapany NameChelsea Worldwide Inc.
October 9, 2020 Page 4
FirstName LastNameJason Ma
Chelsea Worldwide Inc.
October 9, 2020
Page 4
17.Please revise the disclosure to explain whether Clene’s collective fair market value
satisfies the 80% test.
Material U.S. Federal Income Tax Consequences of the Business Combination, page 87
18.Please file a tax opinion as an exhibit to the filing or provide us your analysis why the tax
consequences are not material to an investor and therefore no tax opinion is required to be
filed. Refer to Item 601(b)(8) of Regulation S-K and Section III.A.2 of Staff Legal
Bulletin 19. Also revise, as applicable, to discuss whether there is uncertainty
concerning U.S. federal income tax consequences stemming from uncertainty regarding
whether the Reincorporation Merger will qualify as a reorganization.
Business of Clene, page 100
19.On page 102 you state “A Phase 1 First-In-Human study demonstrated the safety and
tolerability of CNM-Au8 in healthy human volunteers.” You also state on page 11, with
respect to your Phase 1 trial of CNM-Au8, “All doses used in this study were determined
to be safe and well-tolerated” and on page 121: “Administration of the dietary supplement
was therefore found to be safe and well-tolerated over the 7-day dosing period.” Please
revise these and all similar statements throughout your prospectus that state or imply that
your product candidates are safe or effective as these determinations are solely within the
authority of the FDA and comparable regulatory bodies.
20.Please shorten the length of the arrows for the clinical studies that are not yet completed in
the pipeline table on page 103. For instance, each of the Phase 2 arrows for CNM-AU8
needs to be shortened, as well as the arrow for CNM-PtAu7 given disclosure on page 123
indicates this is in the research stage, and the arrow for CNM-AgZn17 given the
disclosure on page 123 indicates this is still ongoing preclinical trials. Please tell us why
you feel it is appropriate to include the Expanded Access Program in the table, and how
you determined the arrow should show the Expanded Access Program as a Phase 2 study.
Please also clarify the disclosure regarding whether the COVID-19 clinical studies have
begun, and if they have not begun please clarify this in the pipeline table.
21.In the discussion of market potential on page 106, please revise to provide support for the
statement that receipt of regulatory approval “would result in significant commercial sales
potentially exceeding billions of dollars annually.” Include, as applicable, a discussion of
the number of people affected by the diseases targeted by Clene’s product candidates that
are in clinical trials and the importance of any limiting factors, such as adequate coverage
and reimbursement rates from governmental healthcare programs and commercial payors.
22.Please provide p-values for the graphics in Figure 4 on page 108 and Figure 5 on page
109. We note that Figures 4E and 4F and Figures 5C and 5D have asterisks that, based on
the asterisk in Figure 6, indicate p-values were meant to be included. Please provide a
brief explanation of the disclosed p-values and how p-values are used to measure
statistical significance. Please also increase the size of the graphics in Figure 5 on page
109 so they are legible.
FirstName LastNameJason Ma
Comapany NameChelsea Worldwide Inc.
October 9, 2020 Page 5
FirstName LastNameJason Ma
Chelsea Worldwide Inc.
October 9, 2020
Page 5
23.Please further describe the in vivo studies for MS mentioned at the top of page 113.
24.On page 114 you state “Once again, these data demonstrated consistent, clinically relevant
improvements in LCLA, SDMT, 9HPT, and T25FW in the population as a whole.” Please
revise the disclosure to explain why you believe this data is significant given it includes
participants taking the placebo and such participants are improving without taking the
medication. Please also explain the meaning of low contrast letter acuity (“LCLA”).
25.Please revise the disclosure to state the amount of the fee Clene will pay in connection
with the Healey-ALS Platform Trial, mentioned on page 120, to the extent material, and
file the agreement with the Sean M. Healey & AMG Center for ALS at Massachusetts
General Hospital pursuant to Item 601(b)(10) of Regulation S-K or tell us why you
believe it is not required to be filed.
26.Please revise page 120 to briefly explain what an Expanded Access Program is and why it
is significant, including the requirements for achieving this designation and its impact on
Clene’s clinical development.
27.Please provide additional detail in support of the statement on page 121 that “[i]n
nonclinical studies, CNM-ZnAg demonstrated significant anti-viral activity against three
different viral pathogens…and numerous bacterial, fungal and parasitic pathogens.”
Please also provide the number of participants in the seven-day human tolerability study
for CNM-ZnAg mentioned on page 121.
28.In the description of the industrial food processing facility study, please revise to clarify
whether any of the employees continued to work after treatment initiation. Please also
explain why you believe symptoms decreased rapidly and showed a marked improvement
in global impression of change for those that reported symptoms, given it appears that less
than 50% ever reported feeling any better. Given this is an uncontrolled study, please
discuss, if known, how long it takes for symptoms to resolve or for a person infected with
COVID-19 to test negative.
29.On page 124 you mention certain collaborations with Johns Hopkins University,
Cambridge University, Northwestern University, the George Washington University and
the University of Edinburgh. Please revise to describe these arrangements and tell us why
you did not file any agreements concerning these arrangements as exhibits pursuant to
Item 601(b)(10) of Regulation S-K.
30.Please file the license and exclusive supply agreement with 4Life Research LLC as an
exhibit pursuant to Item 601(b)(10) of Regulation S-K. We note, in that respect, that you
state you have not licensed your technology or CSN therapeutics to any other parties other
than 4Life, and that 4Life is a related party. Please revise the disclosure on page 126 to
describe the term of the agreement, the number of years from the first commercial sale
that royalties are payable and the termination grounds.
31.Please specify the product candidates or technologies to which your patents relate and the
expiration dates on page 127.
FirstName LastNameJason Ma
Comapany NameChelsea Worldwide Inc.
October 9, 2020 Page 6
FirstName LastNameJason Ma
Chelsea Worldwide Inc.
October 9, 2020
Page 6
32.Please tell us why you believe that the lease for your Maryland facility is not required to
be filed as an exhibit pursuant to Item 601(b)(10)(ii)(D) of Regulation S-K.
Management’s Discussion and Analysis of Financial Condition and Results of Operations of
Clene, page 142
33.Please expand your disclosure in the Business of Clene section to disclose more
information regarding the material terms of the grants mentioned on page 143, such as any
conditions on funding, obligations under the grants, and the intellectual property rights of
each party. Please file as exhibits any material written agreements with the entity that
awarded grants pursuant to Item 601(b)(10) of Regulation S-K or tell us why such
agreements are not required to be filed.
34.Please revise your COVID-19 disclosure to specifically state any material impacts
COVID-19 has had on your business. You state there have not been any material impacts
but on page 116 imply you were forced to pause you REPAIR-PD trial, and on page 151
you disclose that you took out a PPP loan under the CARES Act.
Tottenham’s Business, page 158
35.We note your disclosure on page 139 concerning the lack of litigation involving Clene.
Please revise to also include compliance and legal proceedings disclosure concerning
Tottenham.
Notes to Unaudited Pro Forma Condensed Combined Financial Information, page 175
36.Please revise the two instances of “$0.1320” on page 175 to remove the dollar signs to
improve clarity.
37.Please provide a calculation of the estimated Exchange Ratio of 0.