Cadrenal Therapeutics, Inc.

Investing in our securities involves a high degree of risk. Please refer to Part I, Item 1A, “Risk Factors,” contained in our Annual Report for a description of certain significant risks and uncertainties to which our business, financial condition and results of operations are subject. Except as set forth below, there have been no material changes from these risk factors as of the date of filing of this Quarterly Report on Form 10-Q.

Our financial statements have been prepared assuming that we will continue as a going concern.

We had an accumulated deficit of approximately $44.8 million as of June 30, 2026 and a net loss of approximately $5.8 million for the six months ended June 30, 2026. We expect to incur significant expenses and continued losses from operations for the foreseeable future. We believe that our existing cash and cash equivalents will not be sufficient to meet our anticipated cash requirements for the next twelve months. We will require additional financing as we continue to execute our business strategy, including additional funds to advance our product candidates to clinical trial readiness or to commence any clinical trials. Our unaudited financial statements for the six months ended June 30, 2026 were prepared under the assumption that we will continue as a going concern; however, we have incurred significant losses from operations to date and we expect our expenses to increase in connection with the advancement of our product candidates to clinical trials readiness. These factors raise substantial doubt about our ability to continue as a going concern for one year after the financial statements are issued. Our unaudited financial statements for the quarter ended June 30, 2026 contain an explanatory paragraph with respect to this uncertainty. In addition, in connection with the filing of our Annual Report, our independent registered public accounting firm issued a report that included an explanatory paragraph with respect to this uncertainty. Our liquidity may be negatively impacted as a result of research and development cost increases in addition to general economic and industry factors. In order to meet our expected capital needs, management is focusing on securing additional funds, which may include strategic partnerships, out-licensing agreements, non-dilutive grant funding, sales under our ATM facility with H.C.W., equity offerings, debt financings, or a combination thereof. However, there can be no assurance that we will be able to complete partnering transactions or financings on terms acceptable to us or at all or that we will be awarded any grant funding. The various ways that we could raise capital carry potential risks. Any additional financing will likely involve the issuance of our equity securities, which will have a dilutive effect on our stockholders. Any debt financing, if available, may involve restrictive covenants that may impact our ability to conduct our business. If we raise funds through partnering, such as collaborations and licensing arrangements, we might be required to relinquish significant rights to our technologies or grant licenses on terms that are not favorable to us. If we do not succeed in raising additional funds on acceptable terms or at all, we may be unable to advance our product candidates to clinical trial readiness or to complete any clinical trials. As such, we cannot conclude that such plans will be effectively implemented within one year after the date that the financial statements included in this Quarterly Report on Form 10Q are filed with the SEC and there is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt about our ability to continue as a going concern.

We cannot be assured that we will be able to maintain our listing on the Nasdaq Capital Market.

Our securities are listed on The Nasdaq Capital Market, a national securities exchange. We cannot be assured that we will continue to comply with the rules, regulations or requirements governing the listing of our Common Stock on Nasdaq Capital Market Stock Market LLC (“Nasdaq”) or that our securities will continue to be listed on Nasdaq Capital Market in the future. If Nasdaq should determine at any time that we fail to meet Nasdaq requirements, we may be subject to a delisting action by Nasdaq.

As reported in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 our stockholders’ equity of $1.8 million as of March 31, 2026 was below the minimum stockholders’ equity requirement of at least $2,500,000 for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(1) (the “Stockholders’ Equity Requirement”). We believe that we have regained compliance with the Stockholders’ Equity Requirement as a result of our receipt of net proceeds of $2.3 million from the exercise of the Existing Warrants in connection with the Warrant Inducement consummated on April 1, 2026. As of the date of the filing of this Quarterly Report on Form 10-Q, Nasdaq has not issued a deficiency letter related to our compliance with the Stockholders’ Equity Requirement. Nasdaq will continue to monitor our ongoing compliance with the Stockholders’ Equity Requirement, and if at the time of our next periodic report we do not evidence compliance, we may be subject to delisting.

On July 22, 2026, the SEC approved Nasdaq’s recently proposed rule changes to (i) adopt NASDAQ Listing Rule 5550(a)(6) to require issuers listed on the Nasdaq Capital Market to maintain a minimum Market Value of Listed Securities (as defined in Nasdaq Listing Rule 5005(a)(23)) (“MVLS”) of at least $5 million for a period of thirty (30) consecutive business days, and (ii) amend Rule 5810 to suspend trading and immediately delist from Nasdaq securities of issuers that do not satisfy the proposed new requirements, and Rule 5815 to set forth the procedures for requesting a hearing before a Hearings Panel and the scope of the Panel’s discretion. MVLS is generally calculated by multiplying the consolidated closing bid price by the number of shares of listed securities outstanding and, where a company has more than one class or series of equity security listed on Nasdaq, the values are aggregated. Under the new rule, if a company’s MVLS remains below $5 million for 30 consecutive business days, Nasdaq will issue a Staff Delisting Determination and immediately suspend trading of the company’s securities.

Unlike many other Nasdaq continued listing standards, the new MVLS requirement does not provide a compliance or cure period before a Staff Delisting Determination is issued. Additionally, a request for a hearing before the Hearings Panel does not automatically stay the suspension of trading. While the Hearings Panel may reverse a Staff Delisting Determination if it concludes that Nasdaq made an error, or in limited circumstances grant an exception of up to 180 calendar days for a company to demonstrate compliance with Nasdaq’s initial listing standards — which are generally more stringent than the continued listing standards — there can be no assurance that any such relief would be granted. A company may further appeal an adverse Hearings Panel decision to the Nasdaq Listing and Hearing Review Council; however, the company’s securities would generally trade in the over-the-counter market during the pendency of any such appeal.

However, on July 29, 2026, Nasdaq’s new continued listing requirement requiring companies to maintain at least $5 million in MVLS was automatically stayed. For now, Nasdaq’s new $5 million MVLS continued listing requirement is not effective. The SEC must decide whether to review the approval and, if it does, whether to affirm, modify, reverse, set aside, or remand the matter for further proceedings. The SEC may also decline review. During that process, the stay remains in place, and there is no prescribed timeline for the SEC to reach a decision. Because filing a petition for SEC review is generally a prerequisite to seeking judicial review, the matter could ultimately proceed to a federal court of appeals. If that occurs, the listing requirement could remain stayed during the pendency of the litigation, potentially delaying implementation for a significant period of time.

There can be no assurance that our MVLS will remain at or above the $5 million threshold for periods long enough to comply with the new standard. Our MVLS may be adversely affected by factors outside of our control, including general market conditions, macroeconomic uncertainty, sector-specific developments, investor sentiment, and volatility in the trading price of our Common Stock. Because the rule is triggered by 30 consecutive business days below the threshold, even a sustained but temporary decline in our stock price could result in non-compliance and the immediate suspension and delisting of our Common Stock.

If Nasdaq delists our securities from trading on its exchange at some future date, we would take actions to restore our compliance with The Nasdaq Capital Market’s listing requirements, but we can provide no assurance that any such action taken by us would allow our Common Stock to become listed again, stabilize the market price or improve the liquidity of our Common Stock, prevent our Common Stock from dropping below The Nasdaq Capital Market, minimum bid price requirement or prevent future non-compliance with The Nasdaq Capital Market’s listing requirements. In the event of a delisting, we could face significant material adverse consequences, including:

Our shift to a partnership and out-licensing strategy may not be successful, and we may be unable to advance our pipeline candidates or continue operations if we do not secure additional funding or strategic transactions.

In response to liquidity constraints, management has formally pivoted its operational strategy from independent late-stage clinical development to advancing an out-licensing, portfolio monetization, and corporate partnership model, rather than independently funding late-stage clinical development of our lead assets as we lack the financial resources to independently fund Phase 3 clinical progression for our pipeline candidates. Management’s plans to mitigate these conditions are centered on:

The corporate pivot to a partnership model represents management’s primary strategy to alleviate liquidity pressures. However, the consummation of strategic transactions or partnerships is inherently uncertain and subject to third-party negotiations beyond our control. There can be no assurance that we will be able to identify suitable partners, negotiate acceptable terms, obtain non-dilutive financing or complete any strategic transaction on a timely basis or at all. Even if we enter into a partnership, license or co-development arrangement, our collaborators may not allocate sufficient resources to our programs, may prioritize other programs over ours or may fail to perform as expected. If we are unable to monetize our assets or obtain additional funding, we may be required to delay, scale back or discontinue development programs, liquidate intellectual property or other assets, or cease operations entirely.

The terms of our recent PIPE Transaction may limit our ability to raise additional capital, and failure to satisfy our registration obligations could require us to make payments that would reduce the cash available to fund our operations.

In connection with the PIPE Transaction, we agreed to certain restrictions on issuing Common Stock or common stock equivalents and filing new registration statements for a period following the applicable effective date, subject to limited exceptions. We also agreed not to enter into variable-rate transactions for a period of one year following the applicable effective date, subject to a limited exception permitting sales under our at-the-market facility beginning 60 days after such effective date.

Because we expect to require substantial additional capital, these restrictions could limit our ability to raise capital on favorable terms, or at all, during the restricted periods. In addition, under the registration rights agreement entered into in connection with the private placement, we are required to file and maintain a resale registration statement covering certain warrant shares and may be required to pay liquidated damages if we fail to satisfy specified filing, effectiveness or availability requirements. Any such payments would reduce the cash available to fund our operations and could further adversely affect our liquidity.

The issuance and resale of shares of Common Stock underlying outstanding warrants may result in substantial dilution and could adversely affect the market price of our Common Stock.

In connection with the PIPE Transaction, we issued Pre-Funded Warrants, Series C-1 Warrants and Series C-2 Warrants to purchase a significant number of shares of our Common Stock, and we also issued Placement Agent Warrants. A resale registration statement registering the resale of all of the shares of Common Stock issuable upon exercise of such warrants was declared effective by the SEC on July 20, 2026. The issuance of shares of Common Stock upon exercise of these warrants would dilute existing stockholders. Sales of substantial amounts of our Common Stock in the public market, or the perception that such sales may occur, could adversely affect the market price of our Common Stock. The existence of a significant number of outstanding warrants may also make it more difficult for us to raise additional capital on favorable terms.

The Series C-1 Warrants will not become exercisable unless and until we obtain Stockholder Approval, which we may not obtain.

The Series C-1 Warrants issued in the PIPE Transaction will become exercisable only upon the effective date of Stockholder Approval of the issuance of the shares of Common Stock issuable upon exercise of the Series C-1 Warrants. We cannot assure you that we will obtain the required Stockholder Approval. If Stockholder Approval is not obtained, the Series C-1 Warrants will not become exercisable, the shares underlying the Series C-1 Warrants may not be issued, and we may not receive any proceeds from the cash exercise of those warrants. We may also be required to call one or more additional stockholder meetings to seek approval, which could result in additional costs and delays. Any of these outcomes could adversely affect our liquidity, our ability to fund our operations and the value of the Series C-1 Warrants.