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UPLOAD Filing

Cardio Diagnostics Holdings, Inc.
Date: April 24, 2025 · CIK: 0001870144 · Accession: 0000000000-25-004361

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File numbers found in text: 001-41097

Date
April 24, 2025
Author
Division of
Form
UPLOAD
Company
Cardio Diagnostics Holdings, Inc.

Letter

Re: Cardio Diagnostics Holdings, Inc. Form 10-K for the Fiscal Year Ended December 31, 2024 File No. 001-41097 Dear Elisa Luqman:

April 24, 2025

Elisa Luqman Chief Financial Officer Cardio Diagnostics Holdings, Inc. 311 West Superior Street Suite 444 Chicago, IL 60654

We have limited our review of your filing to the financial statements and related disclosures and have the following comments.

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 a 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, 2024 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations Recent Regulatory Developments, page 59

1. We note your disclosure that beginning on May 6, 2025, unless overturned by a court or Congress or stayed or withdrawn by the new Administration, implementation of the FDA final rule on laboratory developed tests will "substantially increase costs and regulatory burdens" for many clinical laboratories. Please revise your disclosure in future filings to describe the potential material unfavorable impact that implementation of this new law is reasonably likely to have on your net sales or revenues or income from continuing operations. Refer to Item 303(b)(2)(ii) of Regulation S-K. General and Administrative Expenses, page 61

2. We note your general and administrative expenses represent over 80% of net loss for 2024 and 2023. Please revise your future filings to disaggregate your general and April 24, 2025 Page 2

administrative expenses to provide investors with a quantified understanding of significant underlying components that are material to your operations. Your current disclosures only provide explanation of the year-over-year change and the nature and drivers of current year activity are unclear. Further, enhance your disclosures to clarify the impact of material changes on future operating trends. Refer to Item 303(b)(2) of Regulation S-K. Contractual Obligations, page 64

3. We note that it appears you are contractually obligated under your exclusive license agreement with the University of Iowa Research Foundation ("UIRF"), entered into on May 2, 2017 and amended on September 2, 2022, to pay each of: (i) 2% of annual net sales, and (ii) 15% of non-royalty fees to UIRF if the Company enters into one or more sublicensing agreements. Please revise your future contractual obligation disclosures to include a discussion of your license agreements to disclose all material payment terms including quantification of any amounts the Company has paid under such agreements to date, as well as term and termination provisions. Item 9A. Controls and Procedures, page 67

4. We note your annual report does not include a report of management s assessment regarding internal control over financial reporting ("ICFR") due to a transition period established by rules of the Securities and Exchange Commission for newly public companies. Since you were required to file or filed an annual report for the prior year, it appears you are required to report on your management s assessment of ICFR. Please confirm that you will revise your future filings to provide management's conclusion regarding the effectiveness of your internal control over financial reporting. Refer to Item 308(a) of Regulation S-K. Item 8. Financial Statements and Supplemental Data Note 3 - Summary of Significant Accounting Policies, page F-7

5. Please confirm that you will provide the segment disclosures required by ASC 280- 10-50, as amended by ASU 2023-07, in your future filings. Refer to ASC 280-10-50- 20 for single reportable segment entity requirements. 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 Bonnie Baynes at 202-551-4924 or Angela Connell at 202-551-3426 with any questions.

Sincerely,
Division of
Corporation Finance
Office of Life
Sciences

Show Raw Text
<DOCUMENT>
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<TEXT>
 April 24, 2025

Elisa Luqman
Chief Financial Officer
Cardio Diagnostics Holdings, Inc.
311 West Superior Street Suite 444
Chicago, IL 60654

 Re: Cardio Diagnostics Holdings, Inc.
 Form 10-K for the Fiscal Year Ended December 31, 2024
 File No. 001-41097
Dear Elisa Luqman:

 We have limited our review of your filing to the financial statements
and related
disclosures and have the following comments.

 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 a
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, 2024
Item 7. Management's Discussion and Analysis of Financial Condition and Results
of
Operations
Recent Regulatory Developments, page 59

1. We note your disclosure that beginning on May 6, 2025, unless overturned
by a court
 or Congress or stayed or withdrawn by the new Administration,
implementation of the
 FDA final rule on laboratory developed tests will "substantially
increase costs and
 regulatory burdens" for many clinical laboratories. Please revise your
disclosure in
 future filings to describe the potential material unfavorable impact
that
 implementation of this new law is reasonably likely to have on your net
sales or
 revenues or income from continuing operations. Refer to Item
303(b)(2)(ii) of
 Regulation S-K.
General and Administrative Expenses, page 61

2. We note your general and administrative expenses represent over 80% of
net loss for
 2024 and 2023. Please revise your future filings to disaggregate your
general and
 April 24, 2025
Page 2

 administrative expenses to provide investors with a quantified
understanding of
 significant underlying components that are material to your operations.
Your current
 disclosures only provide explanation of the year-over-year change and
the nature and
 drivers of current year activity are unclear. Further, enhance your
disclosures to
 clarify the impact of material changes on future operating trends. Refer
to Item
 303(b)(2) of Regulation S-K.
Contractual Obligations, page 64

3. We note that it appears you are contractually obligated under your
exclusive license
 agreement with the University of Iowa Research Foundation ("UIRF"),
entered into
 on May 2, 2017 and amended on September 2, 2022, to pay each of: (i) 2%
of annual
 net sales, and (ii) 15% of non-royalty fees to UIRF if the Company
enters into one or
 more sublicensing agreements. Please revise your future contractual
obligation
 disclosures to include a discussion of your license agreements to
disclose all material
 payment terms including quantification of any amounts the Company has
paid under
 such agreements to date, as well as term and termination provisions.
Item 9A. Controls and Procedures, page 67

4. We note your annual report does not include a report of management s
assessment
 regarding internal control over financial reporting ("ICFR") due to a
transition period
 established by rules of the Securities and Exchange Commission for newly
public
 companies. Since you were required to file or filed an annual report for
the prior year,
 it appears you are required to report on your management s assessment
of ICFR.
 Please confirm that you will revise your future filings to provide
management's
 conclusion regarding the effectiveness of your internal control over
financial
 reporting. Refer to Item 308(a) of Regulation S-K.
Item 8. Financial Statements and Supplemental Data
Note 3 - Summary of Significant Accounting Policies, page F-7

5. Please confirm that you will provide the segment disclosures required by
ASC 280-
 10-50, as amended by ASU 2023-07, in your future filings. Refer to ASC
280-10-50-
 20 for single reportable segment entity requirements.
 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 Bonnie Baynes at 202-551-4924 or Angela Connell at
202-551-3426
with any questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Life
Sciences
</TEXT>
</DOCUMENT>