SEC Comment Letter 0000000000-24-013495 to Clene Inc. (CLNN)
Clene Inc.
Date: Dec. 6, 2024 · CIK: 0001822791 · Accession: 0000000000-24-013495
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 001-39834
Letter
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
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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