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
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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or Congress or stayed or withdrawn by the new Administration,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
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