Summary and Analysis of Key Points

Company Overview

• Cadrenal is developing tecarfarin, a novel oral and reversible anticoagulant (blood thinner), to address unmet needs in anticoagulation therapy.
• Tecarfarin is being targeted for rare cardiovascular conditions where patients are unable to achieve reliable chronic anticoagulation with warfarin, and where direct-acting oral anticoagulants (DOACs) have either failed or their efficacy and safety remain unproven.
• These conditions include patients with mechanical heart valves, left ventricular assist devices (LVADs), and end-stage kidney disease (ESKD) with atrial fibrillation (AFib).
• Tecarfarin has received orphan drug and fast-track designations from the FDA for certain indications.
• Tecarfarin has been evaluated in 11 clinical trials involving over 1,000 individuals, and has generally been well-tolerated in both healthy subjects and patients with chronic kidney disease.

Financial Performance

• For the three months ended March 31, 2025, Cadrenal reported a net loss of $3.8 million, compared to a net loss of $1.7 million in the same period of 2024.
• The increase in net loss was primarily driven by higher general and administrative expenses (up $1.1 million) and research and development expenses (up $1.0 million).
• The increase in general and administrative expenses was due to higher public company-related costs, stock-based compensation, and personnel-related expenses.
• The increase in research and development expenses was due to higher chemistry, manufacturing, and controls (CMC) costs, clinical trial preparation costs, stock-based compensation, and personnel-related expenses.
• Interest and dividend income remained relatively flat at around $0.1 million in both periods.

Liquidity and Capital Resources

• As of May 8, 2025, Cadrenal had cash and cash equivalents of approximately $6.9 million, which is expected to be sufficient to fund operations for at least the next 12 months.
• However, the company will require additional funding to conduct any further late-stage clinical trials, including a potential Phase 3 trial for tecarfarin.
• During the three months ended March 31, 2025, Cadrenal raised $2.0 million in net proceeds from the sale of common stock through its at-the-market (ATM) facility.
• Cash used in operating activities was $4.6 million for the three months ended March 31, 2025, compared to $1.8 million in the same period of 2024, reflecting the increase in operating expenses.

Outlook and Risks

• Cadrenal’s focus on developing tecarfarin for rare cardiovascular conditions where there is an unmet need for reliable anticoagulation therapy appears to be a promising strategy.
• However, the company will need to secure additional funding to advance tecarfarin through late-stage clinical trials and potential regulatory approval, which could be a significant challenge.
• The competitive landscape, with the rise of DOACs, has also made the original broad-label development plan for tecarfarin more challenging.
• Cadrenal’s success will depend on its ability to demonstrate the safety and efficacy of tecarfarin in its targeted patient populations, navigate the regulatory process, and secure the necessary funding to support its development efforts.

Overall, Cadrenal’s financial performance in the first quarter of 2025 reflects the company’s increased investment in the development of tecarfarin, as it focuses on addressing unmet needs in anticoagulation therapy. While the company has made progress, it will need to continue to carefully manage its resources and seek additional funding to advance its lead candidate through the clinical and regulatory process.