Cadrenal Therapeutics, Inc.: Form 10-Q for the period ended Jun 30, 2026

You should read the following management’s discussion and analysis of our financial condition and results of operations in conjunction with our unaudited financial statements and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q and with our audited financial statements and notes thereto for the year ended December 31, 2025, included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 filed on March 31, 2026 ((the “Annual Report”) with the U.S. Securities and Exchange Commission (the “SEC”). This discussion, particularly information with respect to our future results of operations or financial condition, business strategy, plans and objectives for future operations, includes forward-looking statements that involve risks and uncertainties as described under the heading “Special note regarding forward-looking statements” in this Quarterly Report on Form 10-Q. You should review the disclosure under Part 1, Item 1A of the Annual Report for a discussion of important factors that could cause our actual results to differ materially from those anticipated in these forward-looking statements. References in this Quarterly Report on Form 10-Q to “we,” “us,” “our” and similar first-person expressions refer to Cadrenal Therapeutics, Inc. (“Cadrenal”).

Special Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those discussed in the forward-looking statements. The statements contained in this report that are not purely historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “seek,” “should,” “strategy,” “target,” “will,” “would” and similar expressions or variations intended to identify forward-looking statements. These statements are based on the beliefs and assumptions of our management based on information currently available to management. Such forward-looking statements are subject to risks, uncertainties and other important factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified under Part 1, Item 1A of the Annual Report. Furthermore, such forward-looking statements speak only as of the date of this report. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.

Company Overview

Our Product Candidates:

We are late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions. Our pipeline includes CAD-1005, tecarfarin, and frunexian. CAD-1005 is a novel investigational therapeutic in development for the treatment of heparin-induced thrombocytopenia (“HIT”) and Cardiac Surgery-Associated Acute Kidney Injury (“CSA-AKI”). CAD-1005 is designed to selectively inhibit 12-lipoxygenase (“12-LOX”), an enzyme central to platelet immune activation and thrombo-inflammatory signaling in HIT. CAD-1005 is intended to be used alongside existing standards of care and is being developed to address the underlying biological mechanisms that drive disease progression. CAD-1005 has an Orphan Drug Designation (“ODD”) from the U.S Food and Drug Administration (“FDA”) for prophylaxis of thrombosis in patients with HIT, FDA Fast Track designation for the treatment and prevention of HIT, and an orphan designation from the European Medicines Agency for the treatment of platelet-activating factor 4 disorders. Second-generation 12-LOX oral therapeutics (CAD-2000) are also in development for chronic indications.

Tecarfarin is a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease, those with left ventricular assist devices, and potentially those with Kawasaki disease (“KD”), an acute, self-limited, febrile illness that primarily affects children under 5 years old and is the leading cause of acquired heart disease in developed countries.

Tecarfarin has received ODD and Fast Track designation from the FDA for the prevention of systemic thromboembolism of cardiac origin in patients with end-stage renal disease (“ESKD”) and atrial fibrillation (“AFib”). Tecarfarin also received an ODD from the FDA for the prevention of thromboembolism and thrombosis in patients with implanted mechanical circulatory support devices, including left ventricular assist devices (“LVADs”).

On July 8, 2026, we submitted an application for tecarfarin for “Prevention of the Formation of Life-Threatening Blood Clots Inside Coronary Artery Aneurysms in Children with Kawasaki Disease” for a Rare Pediatric Disease Designation (RPDD) with the FDA.

Frunexian is an investigational intravenous Factor XIa inhibitor designed to provide anticoagulation for patients undergoing major cardiac surgery.

However, as discussed in more detail below, we do not currently have the funding to complete clinical trials for any of our product candidates. While we are continuing to advance our product candidates to clinical trial readiness, we do not plan to commence any trials until we have the funding in place to complete the trial. In order to meet our expected capital needs, management is focusing on securing additional funds, which may include the sale of equity, non-dilutive grants, debt financings, a strategic out-licensing and/or a co-development partnership. 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.

We achieved a regulatory milestone after completing our End-of-Phase 2 (“EOP2”) meeting with the FDA and receiving guidance on key elements of a Phase 3 pivotal trial for CAD-1005. The EOP2 meeting with the FDA provided critical guidance on protocol design, study population, dosing, background therapy, exposure, the safety database, and the primary endpoint of new or worsening thrombotic events. After considering FDA feedback on a pivotal registration study (a 120 patient randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to the current standard of care for patients with HIT), we have concluded that we do not currently have sufficient funding to commence or complete such a trial and we do not plan to commence any trials until we have the funding in place to complete such trial and therefore our focus has been on preparing for clinical trial readiness.

Clinical Pipeline Expansion & Updates

Tecarfarin

We continue to leverage tecarfarin’s distinct metabolic pathway. Because it is metabolized via carboxylesterase-1 (CES-1) rather than the cytochrome P450 pathway, it avoids severe drug-drug interactions and genetic variations.

• Kawasaki Disease: We expanded our pipeline to evaluate tecarfarin for giant coronary artery aneurysms (CAAs) caused by Kawasaki Disease. Kawasaki Disease is the leading cause of acquired heart disease in children in developed countries. A critical clinical complication is the development of severe, large coronary artery aneurysms, which create a highly prothrombotic environment due to sluggish, turbulent blood flow and acute platelet activation. This leaves pediatric patients vulnerable to local thrombus formation, myocardial infarction, and sudden cardiac death. There is a critical, unmet medical need for stable, long-term anticoagulation in this vulnerable pediatric population. We are seeking pediatric cardiology networks in the U.S. and Japan to finalize a Phase 3 trial design to evaluate time in therapeutic range (TTR) in this rare pediatric population.

Our RPDD application provides a comprehensive scientific rationale for tecarfarin. In vitro and in vivo studies demonstrate that tecarfarin is a highly selective vitamin K epoxide reductase (VKOR) inhibitor with antithrombotic potency equivalent to warfarin. Unlike standard therapies, tecarfarin is metabolized via the human carboxyl esterase subunit 2 (hCE2) pathway rather than the hepatic cytochrome P450 system. This structural modification significantly reduces the risk of CYP2C9-mediated drug-drug interactions and patient-specific metabolic variability. Epidemiological data in the submission confirm that the estimated domestic prevalence of this condition falls well below the statutory threshold of 200,000 persons.

• Established Indications (ESKD / LVAD): We maintain our foundational focus on patients with ESKD/AFib and LVADs requiring chronic anticoagulation. Our clinical data demonstrates tecarfarin’s favorable stability and anticoagulation control in these complex patient populations compared with traditional vitamin K antagonists.

CAD-1005

If we should be successful in obtaining funding that would allow us to commence and complete the pivotal Phase 3 study evaluating CAD-1005 added to the current standard of care for patients with HIT, we expect that the pivotal Phase 3 study will evaluate CAD-1005 in approximately 120 patients across clinical centers worldwide and is intended to support a projected New Drug Application submission in 2029. The primary endpoint of the Phase 3 study is expected to be the incidence of new or worsening thrombotic events in patients with Serotonin Release Assay (SRA)-confirmed HIT, with at least one planned interim analysis. We believe that CAD-1005 is the only treatment in clinical development that targets the underlying immune drivers of HIT. Our Phase 3 trial protocol will remain subject to additional information and any further comments we may receive from the FDA during their review of the final protocol.

CAD-2000

We are also advancing our preclinical platform asset, CAD-2000, a highly selective, orally bioavailable 12-LOX inhibitor designed to treat chronic cardiorenal inflammatory and thrombotic indications. CAD-2000 serves as a potent oral follow-on companion to our Cardiac Acute Critical Care Franchise, potentially enabling prospective partners to capture extended market share across both acute inpatient settings and chronic outpatient follow-up care.

Cardiac Acute Critical Care (CACC) Franchise

We advanced the mapping for our integrated CACC Franchise. This bundle combines our targeted anticoagulation and renal-protective therapies into a unified bedside protocol. It aims to reduce ICU length of stay and minimize mechanical ventilation days. We are finalizing the regulatory pathway to initiate a multi-center investigator-initiated trial to evaluate health economic outcomes, maximizing the bundle’s attractiveness to potential commercial partners.

Our Strategy

Our updated corporate strategy focuses on advancing our CACC Franchise through early- to mid-stage validation to secure strategic out-licensing, co-development partnerships, or an outright acquisition. We do not intend to independently fund or execute late-stage Phase 3 clinical trials for any of our three product candidates.

This shift in strategy is driven in part by our current capital constraints and historical challenges in securing sufficient capital on acceptable terms to fund the resource-intensive Phase 3 development. As of the date of the filing of this Quarterly Report on Form 10-Q, our existing cash and cash equivalents are insufficient to fund independent Phase 3 clinical trials. If we are unable to secure strategic partnerships, out-licensing agreements, or alternative non-dilutive funding such as grant funding within the next twelve months, we will lack the financial resources to sustain our operations. In such an event, we may be forced to delay, scale back, or eliminate our research and development programs, liquidate asset portfolios, or cease operations entirely. There can be no assurance that any strategic partnership or transaction will be consummated on favorable terms or at all.

For further discussion regarding our liquidity, capital resources, and the management evaluation that led to our substantial doubt about our ability to continue as a going concern, see Note 1—Liquidity to our financial statements included elsewhere in this Quarterly Report on Form 10-Q.

The Cardiac Acute Critical Care (CACC) Franchise

Following a competitor’s recent Phase 3 failure in CSA-AKI, Cadrenal is highlighting the potential of its 12-LOX inhibitor to address a $1 billion+ market opportunity in this critical care space. CAD-1005 is being studied as a "Post-Operative Shield" that uses 12-lipoxygenase (12-LOX) inhibition to target platelet hyperactivation in HIT while simultaneously reducing inflammation-driven injury in patients with CSA-AKI. This dual-mechanism approach is supported by clinical data on CAD-1005 presented last month at the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress in Paris. The late-breaking Phase 2 data for CAD-1005 demonstrated a compelling medical profile, with an absolute reduction in thrombotic events greater than 25% and a favorable safety profile and renal-protective baseline.

Our overarching corporate strategy focuses on building, validating, and positioning our targeted portfolio for strategic out-licensing, portfolio monetization, or commercial co-development partnerships. We recently announced the comprehensive alignment of our clinical portfolio into a Cardiac Acute Critical Care Franchise. Rather than deploying the extensive capital required for late-stage clinical development on an individual basis, our primary objective is to maximize asset value through early- to mid-stage validation, robust regulatory profiling, and portfolio integration. This franchise is built on three strategic pillars:

Recent Developments

PIPE Transaction

On June 30, 2026, we entered into a securities purchase agreement with an investor, pursuant to which we issued and sold, in a private placement priced at-the-market under the rules of the Nasdaq Stock Market (the “PIPE Transaction”), (i) pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to an aggregate of 960,000 shares (the “Pre-Funded Warrant Shares”) of our common stock, par value $0.001 per share (the “Common Stock”), (ii) Series C-1 Common Stock warrants (the “Series C-1 Warrants”) to purchase up to an aggregate of 960,000 shares (the “Series C-1 Warrant Shares”) of Common Stock, and (iii) Series C-2 Common Stock warrants (the “Series C-2 Warrants” and, together with the Series C-1 Warrants, the “Common Warrants”) to purchase up to an aggregate of 960,000 shares (the “Series C-2 Warrant Shares” and, together with the Pre-Funded Warrant Shares and the Series C-1 Warrant Shares, the “PIPE Warrant Shares”) of Common Stock, at a combined purchase price of $3.1249 per Pre-Funded Warrant and accompanying Common Warrants. On July 1, 2026, we received aggregate gross proceeds of approximately $3.0 million, before deducting placement agent fees and other offering expenses.

The Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable immediately, and do not expire until exercised in full. The Series C-1 Warrants and Series C-2 Warrants each have an exercise price of $3.00 per share. The Series C-1 Warrants become exercisable beginning on the effective date of stockholder approval of the issuance of the Series C-1 Warrant Shares (the “Stockholder Approval”) and will expire five years after the later of the effective date of Stockholder Approval or the effective date of a resale registration statement registering for resale all of the Series C-1 Warrant Shares. The Series C-2 Warrants are exercisable immediately upon issuance and expire 24 months after the earliest of the date that (a) the initial registration statement registering for resale all Pre-Funded Warrant Shares and Series C-2 Warrant Shares has been declared effective by the SEC, (b) all of the PIPE Warrant Shares have been sold pursuant to Rule 144 or may be sold pursuant to Rule 144 without the requirement for us to be in compliance with the current public information required under Rule 144 and without volume or manner-of-sale restrictions, (c) following the one year anniversary of the closing of the PIPE Transaction, provided that a holder of PIPE Warrant Shares is not an affiliate of ours, or (d) all of the PIPE Warrant Shares may be sold pursuant to an exemption from registration under Section 4(a)(1) of the Securities Act, without volume or manner-of-sale restrictions (the “Effective Date”). A resale registration statement registering the resale of all of the PIPE Warrant Shares was declared effective by the SEC on July 20, 2026. We intend to seek Stockholder Approval at our 2026 annual meeting of stockholders, currently scheduled for September 24, 2026.

H.C. Wainwright & Co., LLC (“H.C.W.”) served as our exclusive placement agent in connection with the PIPE Transaction. As compensation for H.C.W. serving as our placement agent in connection with the PIPE Transaction, we paid H.C.W. a cash fee equal to 7.0% of the aggregate gross proceeds received and issued to designees of H.C.W unregistered warrants (the “Placement Agent Warrants”) to purchase up to an aggregate of 62,400 shares of Common Stock, equal to 6.5% of the Pre-Funded Warrant Shares sold in the PIPE Transaction. The Placement Agent Warrants have substantially the same terms as the Series C-1 Warrants, except that they are immediately exercisable for a term of five years from the Effective Date and have an exercise price of $3.9063 per share.

April 2026 Warrant Inducement

On March 31, 2026, we entered into a warrant inducement letter agreement (the “Inducement Agreement”) with a holder of warrants to purchase shares of our Common Stock, which warrants were issued in a private placement offering that closed on November 4, 2024 (the “Existing Warrants”). Pursuant to the Inducement Agreement, on April 1, 2026, the holder of the Existing Warrants exercised for cash the Existing Warrants to purchase up to an aggregate of 571,430 shares of Common Stock, at the adjusted exercise price of $4.50 per share (reduced from the initial exercise price of $16.50 per share) and, in consideration for the investor’s exercise of the Existing Warrants, we issued to such investor new unregistered Series B-1 Common Stock purchase warrants (the “Series B-1 Warrants”) to purchase an aggregate of 571,430 shares of Common Stock and new unregistered Series B-2 common stock purchase warrants (the “Series B-2 Warrants” and, together with the Series B-1 Warrants, the “New Warrants”) to purchase an aggregate of 571,430 shares of Common Stock. The New Warrants are immediately exercisable at an exercise price of $4.50 per share. We received aggregate gross proceeds of approximately $2.6 million from the exercise of the Existing Warrants, before deducting placement agent fees and other expenses payable by us. The Series B-1 Warrants and the Series B-2 Warrants are immediately exercisable for a term of five (5) years and eighteen (18) months, respectively, from the date that a resale registration statement registering the resale of the shares of Common Stock issuable upon exercise of the New Warrants (the “Resale Registration Statement”) is declared effective by the SEC. The Resale Registration Statement was declared effective on April 29, 2026.

H.C.W. served as our exclusive placement agent in connection with the transactions consummated pursuant to the Inducement Agreement. As compensation for H.C.W. serving as our placement agent in connection with the offering, we paid H.C.W. a cash fee equal to 7.0% of the aggregate gross proceeds received upon exercise of the Existing Warrants and we issued to designees of H.C.W. warrants to purchase up to 37,143 shares of Common Stock, which warrants have substantially the same terms as the Series B-1 Warrants, except that they have an exercise price of $5.625 per share, which is equal to 125% of the exercise price of the New Warrants.

ATM Facility

During the six months ended June 30, 2026, we sold 189,035 shares of our Common Stock through our at-the-market (ATM) facility with H.C.W. These sales were made at a weighted average price of $7.71 per share, resulting in total gross proceeds of $1,458,088 and net proceeds of $1,382,670. During the three months ended June 30, 2026, we sold 20,345 shares of our Common Stock through our ATM facility with H.C.W. These sales were made at a weighted average price of $4.50 per share resulting in total gross proceeds of $91,553 and net proceeds of $80,104.

Results of Operations

Results of Operations for the Three Months Ended June 30 2026 and 2025

The following table summarizes our results of operations for the three months ended June 30, 2026 and 2025.

General and administrative expenses

General and administrative expenses were $2.6 million for the three months ended June 30, 2026, compared to $2.7 million for the three months ended June 30, 2025, a decrease of approximately $0.02 million, or 1%.

Research and development expenses

Research and development expenses were $0.7 million for the three months ended June 30, 2026, compared to $1.1 million for the three months ended June 30, 2025, a decrease of approximately $0.4 million, or 35%. The decrease was primarily attributable to a $0.7 million decrease in expenses associated with chemistry, manufacturing, and controls (“CMC”) and a $0.2 million decrease in consulting expenses and professional fees. We expect research and development expenses to increase if we commence clinical trials.

Results of Operations for the Six Months Ended June 30, 2026 and 2025

The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025.

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General and administrative expenses

General and administrative expenses for the six months ended June 30, 2026 and 2025 were $4.4 million and $4.9 million, respectively, representing a decrease of approximately $0.5 million, or 11%. The decrease is primarily attributed to a $0.5 million decrease in expenses related to being a public company, a $0.2 million decrease in annual Delaware franchise taxes, and a $0.1 million decrease in consulting expenses. These decreases were offset by $0.3 million increase in personnel-related expenses as a result of our former Chief Financial Officer’s severance agreement entered into in June 2026 and implemented annual pay raises for management in January 2026.

Research and development expenses

Research and development expenses for the six months ended June 30, 2026 and 2025 were $1.5 million and $2.7 million, respectively, representing a decrease of $1.3 million, or 46%. The decrease is primarily attributed to a $1.2 million decrease in expenses associated with CMC, a $0.3 million decrease in stock-based compensation, a $0.2 million decrease in personnel-related expenses, and a $0.1 million decrease in clinical trial preparation costs. These decreases were offset by a $0.5 million increase in consulting expenses.

Interest and dividend income

Interest and dividend income for the six months ended June 30, 2026 and 2025 were $0.1 million and $0.1 million, respectively. This represents the interest and dividend income earned from our investments in money market funds.

Liquidity and Capital Resources

Since inception, we have incurred recurring losses and utilized cash in operations. To date, we have funded our operations from the proceeds of the sale of convertible and promissory notes, our IPO completed in January 2023, our private placement offering completed in July 2023, our warrant inducements completed in November 2024 and April 2026, our private placement offering in June 2026, our registered direct offering and concurrent private placement completed in December 2025, and the sale of Common Stock through our ATM facility with H.C.W.

As of June 30, 2026, we had cash and cash equivalents of $2.4 million, which does not include the net proceeds we received on July 1, 2026 from the PIPE Transaction. For the six months ended June 30, 2026, we reported a net loss of $5.8 million, which included $0.9 million of non-cash expenses, and cash used in operating activities of $5.2 million. We expect to continue to incur operating losses and negative cash flows for the foreseeable future as we advance our clinical and regulatory activities. Based on our current operating plan, we believe that our existing cash resources will not be sufficient to fund our operating and capital requirements for the next 12 months. With our cash position of $4.2 million as of early August 2026, we believe we will be able to fund our operations through the first quarter of 2027; however, the current cash will not be sufficient to advance our product candidates to clinical trial readiness or to commence and complete any clinical trials and no assurances can be provided and our cash runway could differ materially from our expectations based on various factors, many of which are out of our control. 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. These factors raise substantial doubt about our ability to continue as a going concern for at least one year following the issuance of the accompanying financial statements. If we are unable to obtain additional financing, we may be required to delay or reduce the scope of our development programs, implement cost-saving measures, or cease operations entirely. The accompanying financial statements do not include any adjustments that might result from this uncertainty.

Cash Flows

The following table summarizes our cash flows for the period presented:

Operating activities

During the six months ended June 30, 2026, cash used in operating activities was $5.2 million. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $4.8 million in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, used $0.3 million in cash primarily from a $0.3 million decrease in accrued liabilities and a $0.2 million increase in prepaid expenses, partially offset by a $0.2 million increase in accounts payable.

During the six months ended June 30, 2025, cash used in operating activities was $7.7 million. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $6.4 million in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, used $1.3 million in cash primarily from a $0.6 million decrease in accounts payable, a $0.4 million decrease in accrued liabilities, and a $0.3 million increase in prepaid expenses.

Financing activities

During the six months ended June 30, 2026, net cash provided by financing activities totaled $3.6 million primarily consisting of $2.3 net proceeds received from the April 2026 warrant inducement and $1.4 million received upon the sales of Common Stock in our ATM facility.

During the six months ended June 30, 2025, net cash provided by financing activities totaled $3.2 million from the sale of Common Stock of our ATM facility and proceeds from the exercise of stock options.

Critical Accounting Estimates

This discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported expenses incurred during the reporting periods. Significant estimates and assumptions made in the accompanying financial statements include but are not limited to the fair value of financial instruments, the fair value of stock-based awards, deferred tax assets and valuation allowance, income tax uncertainties, and certain accruals. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimated under different assumptions or conditions.

Stock-Based Compensation

We measure our stock-based awards granted to employees, consultants and directors based on the estimated grant-date fair values of the awards and recognize the compensation over the requisite service period. We use the Black-Scholes option-pricing model to estimate the fair value of our stock option awards. Stock-based compensation is recognized using the straight-line method. As the stock compensation expense is based on awards ultimately expected to vest, it is reduced by forfeitures. We account for forfeitures as they occur.

OFF-BALANCE SHEET ARRANGEMENTS

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and Interim Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2026. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. We have adopted and maintain disclosure controls and procedures (as defined Rules 13a-15(e) and 15d-15(e) under the Exchange Act) that are designed to provide reasonable assurance that information required to be disclosed in the reports filed under the Exchange Act, such as this Quarterly Report on Form 10-Q, is collected, recorded, processed, summarized, and reported within the time periods specified in the rules of the SEC. Our disclosure controls and procedures are also designed to ensure that such information is accumulated and communicated to management to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of June 30, 2026, our Chief Executive Officer and Interim Chief Financial Officer concluded that, as of such a date, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

During the quarter ended June 30, 2026, there were no changes in our internal control over financial reporting (as defined in Rules 13a 15(f) and 15d 15(f) of the Exchange Act) that occurred that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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:

• a limited availability of market quotations for our securities;
• reduced liquidity with respect to our securities;
• a determination that our Common Stock is a “penny stock” which will require brokers trading in our ordinary shares to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our ordinary shares;
• a limited amount of news and analyst coverage for our company; and
• a decreased ability to issue additional securities or obtain additional financing in the future.

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:

• Securing strategic out-licensing agreements or clinical co-development partnerships for the Cardiac Acute Critical Care Franchise to unlock upfront milestone payments.
• Pursuing alternative, non-dilutive financing arrangements or structured asset sales of clinical intellectual property portfolios.
• Implementing severe cost-containment measures to defer all non-essential research and development expenditures.

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.