Cadrenal Therapeutics Reports Second Quarter 2025 Financial Results, Advances Tecarfarin Clinical Development, and Strengthens Strategic Position in Anticoagulation Market
Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company dedicated to developing next-generation anticoagulation therapies that address significant unmet needs in patient populations with complex medical profiles, announced its financial results for the second quarter ended June 30, 2025, alongside a comprehensive update on the clinical development of its lead drug candidate, tecarfarin, and the company’s broader strategic direction.
The company’s mission centers on improving treatment outcomes for patients for whom current anticoagulation options are inadequate or carry heightened risks. These include individuals with end-stage kidney disease (ESKD), patients supported by left ventricular assist devices (LVADs), and those with other cardiovascular conditions requiring precise and consistent anticoagulation management.
Leadership Perspective on Strategic Goals
Quang X. Pham, Chairman and Chief Executive Officer of Cadrenal Therapeutics, reaffirmed the company’s commitment to advancing the standard of care for high-risk patient groups.
“We continue to advance our goal of developing transformative therapeutics to address the gaps in current anticoagulation therapy for patients with complex needs,” said Pham. “This commitment is reflected in our strategic plan to initiate a clinical trial for tecarfarin in end-stage kidney disease for patients transitioning to dialysis. There is a critical need for safe, effective anticoagulants in this population, and tecarfarin’s orphan drug and fast-track designations for ESKD patients with atrial fibrillation underscore that need. We are very excited to advance this program.”
Pham noted that beyond simply moving tecarfarin through clinical development, the company is building the manufacturing and operational infrastructure necessary to support late-stage trials and eventual commercialization.
“Strong operational execution is fundamental to advancing tecarfarin into late-stage trials,” he added. “By successfully completing the technical transfer of tecarfarin to a U.S. site of a leading global CDMO and manufacturing tecarfarin drug product, we have achieved critical steps in CMC readiness to supply our planned clinical trial and execute our development strategy.”
Key Developments in Q2 2025 and Early Q3 2025
Cadrenal’s update covers progress across clinical development, manufacturing, market analysis, investor engagement, and corporate positioning.
1. Clinical Trial Advancements
In August 2025, Cadrenal announced formal plans to initiate a pivotal clinical trial of tecarfarin in patients with end-stage kidney disease who are transitioning to dialysis, including those with and without atrial fibrillation (AFib). The trial is expected to begin site activation and patient screening later this year.
The choice of this patient group is deliberate and rooted in urgent medical need. Individuals with severe kidney disease face a dramatically elevated risk of thrombotic cardiovascular events such as myocardial infarction and stroke. They also experience a higher incidence of AFib and venous thromboembolism compared with individuals with normal kidney function.
The danger peaks during the transition to dialysis, a period associated with a surge in cardiovascular complications and a marked rise in mortality rates. For this reason, anticoagulation therapy—while essential—must be both effective and precisely managed to avoid bleeding risks and unpredictable drug behavior due to impaired kidney function.
Cadrenal believes tecarfarin could offer a safer, more predictable alternative to existing anticoagulants in this population, backed by its unique metabolism profile that avoids reliance on cytochrome P450 enzymes. The company expects this study will not only support regulatory discussions for ESKD but also open the door to future trials in other high-need cardiovascular populations.
2. Operational Milestones in Manufacturing and CMC Readiness
Manufacturing readiness is a critical element for any late-stage clinical program. In Q2 2025, Cadrenal completed the technical transfer of tecarfarin drug substance production to a U.S.-based facility operated by a leading global contract development and manufacturing organization (CDMO). This move ensures compliance with current good manufacturing practices (cGMP) and positions the company to meet regulatory requirements for both trial and eventual commercial supply.
During the same quarter, Cadrenal successfully produced tecarfarin clinical trial drug product, ensuring sufficient supply for the upcoming ESKD trial. The company also advanced multiple chemistry, manufacturing, and controls (CMC) initiatives to prepare for future scale-up.
3. Market Opportunity Analysis
In parallel with its operational work, Cadrenal undertook detailed market research to identify patient groups where current anticoagulation options leave significant therapeutic gaps. The findings reinforced the company’s belief that tecarfarin is uniquely suited to address needs in populations requiring high anticoagulation predictability, including those with renal impairment, mechanical circulatory support devices, or other complex cardiovascular conditions.
The research also highlighted the limitations of widely used anticoagulants in these populations—such as the variable metabolism of warfarin and renal clearance issues with certain direct oral anticoagulants—further supporting tecarfarin’s differentiation potential.
4. Corporate Visibility and Industry Engagement
Cadrenal maintained an active presence in investor, medical, and industry events during the quarter, using these platforms to highlight its innovation strategy in anticoagulation therapy and strengthen relationships with stakeholders.
Key engagements included:
- BIO International Convention in Boston – Showcasing the company’s pipeline to global biotech and pharmaceutical partners.
- Longwood Healthcare Leaders CEO Conference in Miami – Engaging with executives, investors, and healthcare innovators on growth strategies.
- 18th National Conference on Anticoagulation Therapy in Washington, D.C. – Presenting Cadrenal’s clinical development priorities and gaining feedback from clinicians and researchers specializing in cardiovascular care.
These events reinforced Cadrenal’s strategic positioning and opened doors for potential collaboration opportunities.
5. Strategic Development Collaborations
The company continues to evaluate partnership opportunities to expand tecarfarin’s development into additional indications. These may include patients supported by LVADs—where anticoagulation management is critical to preventing device thrombosis—and other chronic cardiovascular conditions requiring long-term, stable anticoagulation.
6. Index Inclusion and Market Recognition
Effective June 30, 2025, Cadrenal was added to multiple Russell indexes, including the Russell 3000E and Russell Microcap families. These indexes are tracked by a large base of institutional investors and index funds, increasing the company’s visibility in the investment community and potentially broadening its shareholder base.
Second Quarter 2025 Financial Performance
Cadrenal’s Q2 2025 results reflect both ongoing investment in clinical readiness and prudent resource management.
- Research & Development Expenses: $1.1 million, compared to $1.3 million in Q2 2024. The slight decrease reflects the completion of certain preclinical activities offset by increased spending on clinical trial preparations.
- General & Administrative Expenses: $2.7 million, up from $1.2 million in Q2 2024, primarily due to expanded corporate operations, increased investor relations activities, and higher professional service fees.
- Net Loss: $3.7 million, compared to $2.4 million in Q2 2024, reflecting the company’s expanded scope of operations as it advances tecarfarin toward pivotal clinical trials.
Balance Sheet and Liquidity
As of June 30, 2025, Cadrenal reported:
- Cash and Cash Equivalents: $5.6 million, compared to $10.0 million as of December 31, 2024.
- Common Shares Outstanding: Approximately 2.0 million shares.
The company continues to monitor its capital requirements closely and may explore financing options to support ongoing and planned clinical activities.
Cadrenal’s next 12 months are expected to be transformative as the company moves tecarfarin into a critical new phase of clinical testing.
Key upcoming milestones include:
- Initiation of the ESKD Clinical Trial: Beginning site activation and patient screening later in 2025, with the goal of generating pivotal data to support regulatory discussions.
- Expansion of Partnership Discussions: Continuing to explore collaborations that can accelerate tecarfarin’s development in multiple high-need cardiovascular indications.
- Further CMC Advancements: Maintaining momentum in manufacturing readiness to support both the upcoming trial and potential broader commercialization.
- Ongoing Market Development Efforts: Engaging clinicians, payers, and patient advocacy groups to raise awareness of tecarfarin’s potential benefits.
About Tecarfarin
Tecarfarin is an investigational, novel vitamin K antagonist anticoagulant designed to address limitations of current therapies, particularly in patients with complex conditions. Unlike warfarin, tecarfarin is metabolized through esterases rather than the cytochrome P450 system, potentially offering more predictable pharmacokinetics and fewer drug-drug interactions.
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation and fast-track designation to tecarfarin for the prevention of systemic thromboembolism in patients with ESKD and AFib.
About Cadrenal Therapeutics
Cadrenal Therapeutics is focused on developing transformative anticoagulation therapies for patient groups underserved by current treatment options. By advancing tecarfarin through late-stage development and exploring additional indications, the company aims to deliver safer, more predictable anticoagulation solutions that improve clinical outcomes and quality of life.
Forward-Looking Statements:
This press release contains forward-looking statements, including statements regarding the development, regulatory approval, and commercialization of tecarfarin, anticipated clinical trials, and potential market opportunities. These statements are subject to risks and uncertainties that may cause actual results to differ materially. Cadrenal undertakes no obligation to update these statements except as required by law.
