Cardio Diagnostics Holdings, Inc.

ITEM 1A. RISK FACTORS

There have been no material changes to the risk factors previously described in Item 1A of Part I of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 except as set forth below. These risk factors, collectively, describe some of the assumptions, risks, uncertainties and other factors that could adversely affect our business or that could otherwise result in changes that differ materially from our expectations. We may disclose changes to such risk factors or disclose additional risk factors from time to time in our future filings with the SEC, including as set forth below. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition or future results.

There can be no assurance that we will be able to comply with the continued listing standards of Nasdaq.

Our Common Stock is listed on The Nasdaq Capital Market (Nasdaq). In order to maintain that listing, we must satisfy minimum financial and other requirements. On July 22, 2026, the SEC adopted a final rule implementing a proposed revision to Nasdaqs requirements for continued listing on Nasdaq. The rule would require Nasdaq-listed companies to maintain at least $5 million in market value of listed securities (MVLS), with an immediate suspension and delisting framework if the requirement is not met for 30 consecutive business days. On July 29, 2026, the SEC temporarily stayed the July 22 order after receiving multiple notices of intention to petition review of the delegated action from parties that would likely be impacted by the new rule. The stay will remain in effect until further order of the SEC. However, at such time as this MVLS rule goes into effect, if it does, the new listing standard could have serious implications for our status as a Nasdaq-listed company. If finally adopted, then if our MVLS fails to meet the $5 million threshold for 30 consecutive business days, our securities will be subject to immediate suspension and delisting from Nasdaq, without any cure or compliance period as is typically granted to issuers that fail to maintain compliance with other continued listing standards. In its current form, the July 22, 2026 rule provides that a Nasdaq Hearings Panel may reverse a delisting decision where it determines the delisting determination was in error, or grant an exception for a period not to exceed 180 days from the delisting determination for the company to demonstrate that it meets all requirements for initial listing. Those initial listing standards are, for the most part, more rigorous than the standards to maintain continued listing on Nasdaq. It seems likely that some version of the July 22, 2026 rule will be adopted.

The price of our Common Stock has been on a downward trend for at least the last six months. On August 6, 2026, our Common Stock closed at $1.66, and with a total of 2,959,469 shares outstanding, the MVLS on that date was $4,912,719. As such, if the new MVLS listing standard were currently in effect, our securities could be in danger of failing to meet the continued listing standard of $5 million in MVLS at some point in the foreseeable future. Were that to occur, our stock would immediately be delisted from Nasdaq and would begin trading on the OTC market. It is unlikely that we could meet the initial listing requirements to regain access to Nasdaq within the 180 day period provided in the new rule, as originally adopted on July 22, 2026. Accordingly, if our securities are delisted from Nasdaq, either for failing to meet the new MVLS standard, if finally adopted, or if we fail to meet any other listing standard required for continued listing on the Nasdaq Capital Market, investors should expect that the OTC market will be the trading market for our securities for the foreseeable future. Trading in the OTC market involves significant risks, including, among others, low liquidity, wide bid-ask spreads and a lack of reliable financial transparency. In the event our securities are delisted from Nasdaq and move to the OTC market, investors should expect volatile stock prices and the possibility that they may find it difficult to sell their shares for the price they would like to receive, if at all.