Summary of Cadrenal Therapeutics Conference Call Company Overview - **Company**: Cadrenal Therapeutics (Ticker: CVKD) - **Focus**: Development of novel anticoagulant drugs to address gaps in anticoagulation therapy, particularly for high-risk patients and orphan indications [2][15] Industry Context - **Market Size**: The global oral anticoagulation market is approximately $38 billion, with the U.S. market accounting for about $20 billion. Cadrenal targets a specific segment worth around $2 billion, focusing on orphan and high-risk indications [3][4] Key Products and Developments Tecarfarin - **Description**: A next-generation vitamin K antagonist designed for chronic use, with orphan drug and fast track designations for end-stage kidney disease (ESKD), atrial fibrillation (AFib), and left ventricular assist devices [4][7] - **Clinical Trials**: Tecarfarin has been studied in 11 clinical trials involving over 1,000 patients. The largest study, EMBRACE AC, showed that tecarfarin provided better or equivalent coagulation control compared to warfarin, with no thrombotic events and a low incidence of bleeding [8][9] - **Unique Features**: Unlike warfarin, tecarfarin is not metabolized by the hepatic cytochrome P450 system, leading to more predictable drug levels and fewer drug-drug interactions. It is also unaffected by poor kidney function, making it suitable for patients with severe kidney disease [6][9] Fornixum - **Description**: An intravenous factor XIa inhibitor acquired by Cadrenal, designed for acute care settings. It is differentiated by its fast-on, fast-off pharmacokinetics, making it suitable for precise control in hospital environments [6][12] - **Development Status**: Fornixum has completed two phase 1 studies and targets complex cardiac surgery as its primary indication [7][14] Market Opportunities - **Target Indications**: Cadrenal is focusing on high-risk areas where current therapies are inadequate, such as ESKD, AFib, and patients with mechanical heart valves [3][4] - **Regulatory Designations**: Tecarfarin has received orphan drug designation, providing seven years of exclusivity post-approval, and fast track designation for ESKD and AFib [7][15] Future Plans - **Clinical Trials**: A phase 2 study for tecarfarin in dialysis patients is planned to begin enrollment in early 2026, followed by a registration study in 2027. An additional phase 2 study for left ventricular assist devices is also targeted for late 2026 [13][14] - **Strategic Goals**: The primary goal for 2026 is to optimize the formulation of Fornixum for complex cardiac surgery applications [14] Conclusion - **Commitment**: Cadrenal Therapeutics aims to improve anticoagulation management standards through its innovative products, tecarfarin and Fornixum, addressing significant market gaps in both chronic and acute care settings [15]

Core Viewpoint - Cadrenal Therapeutics, Inc. is actively engaging with investors through a webcast presentation and one-on-one meetings at the Lytham Partners Fall 2025 Investor Conference, highlighting its focus on innovative anticoagulation therapies [1][2][3]. Company Overview - Cadrenal Therapeutics, Inc. is a biopharmaceutical company dedicated to developing transformative therapeutics aimed at addressing gaps in anticoagulation therapy [4]. - The company's lead investigational product, tecarfarin, is a novel oral Vitamin K antagonist anticoagulant designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation [4]. - Tecarfarin aims to reduce the clinical complexities associated with managing Vitamin K antagonists, particularly in cases where direct-acting oral anticoagulants (DOACs) are inadequate or unproven [4]. Product Designation - Tecarfarin has received Orphan Drug Designation (ODD) and fast-track designation for the prevention of systemic thromboembolism in patients with end-stage kidney disease and atrial fibrillation [5]. - The product also holds ODD for the prevention of thromboembolism and thrombosis in patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs) [5].

Core Viewpoint - Cadrenal Therapeutics, Inc. is actively engaging with investors through a webcast presentation and one-on-one meetings at the Lytham Partners Fall 2025 Investor Conference, highlighting its focus on innovative anticoagulation therapies [1][2][3]. Company Overview - Cadrenal Therapeutics, Inc. is a biopharmaceutical company dedicated to developing transformative therapeutics aimed at addressing gaps in anticoagulation therapy [4]. - The company's lead investigational product, tecarfarin, is a novel oral Vitamin K antagonist anticoagulant designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation [4]. - Tecarfarin aims to reduce the clinical complexities associated with managing Vitamin K antagonists, particularly in cases where direct-acting oral anticoagulants (DOACs) are inadequate or unproven [4]. Product Designation - Tecarfarin has received Orphan Drug Designation (ODD) and fast-track designation for the prevention of systemic thromboembolism in patients with end-stage kidney disease and atrial fibrillation (ESKD+AFib) [5]. - The product also holds ODD for the prevention of thromboembolism and thrombosis in patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs) [5].

Core Insights - Cadrenal Therapeutics, Inc. has acquired the assets of eXIthera Pharmaceuticals, enhancing its pipeline with investigational intravenous and oral Factor XIa inhibitors, targeting the $38 billion global anticoagulation market [1][2][6] Company Overview - Cadrenal Therapeutics is focused on developing transformative therapeutics to address gaps in anticoagulation therapy, with its lead product being tecarfarin, a novel oral Vitamin K antagonist [7][10] Acquisition Details - The acquisition includes eXIthera's lead asset, frunexian, a Phase 2-ready intravenous Factor XIa inhibitor, and EP-7327, an oral Factor XIa inhibitor for major thrombotic conditions [2][6] - eXIthera will receive milestone payments up to $15 million based on future clinical and regulatory milestones, along with royalties on global sales of the acquired assets [6] Strategic Positioning - The acquisition positions Cadrenal as the only company developing both a novel vitamin K antagonist and Factor XIa inhibitors, aiming to fill critical gaps in current antithrombotic treatments [3][4] - Cadrenal plans to conduct trials for tecarfarin in patients with end-stage kidney disease transitioning to dialysis, and is strategically positioned to deliver differentiated therapeutics for cardiovascular thrombotic risk [4][11] Market Potential - The global anticoagulation market is valued at $38 billion, with the newly acquired assets addressing large and underserved segments [1][8]

[Executive Summary & Corporate Update](index=1&type=section&id=Executive%20Summary%20%26%20Corporate%20Update) Cadrenal Therapeutics reported Q2 2025 financial results and a corporate update, emphasizing tecarfarin's strategic clinical development for ESKD patients [Second Quarter 2025 Overview](index=1&type=section&id=Second%20Quarter%202025%20Overview) Cadrenal Therapeutics reported its second quarter 2025 financial results and provided a corporate update, announcing strategic clinical trial plans for tecarfarin in patients with End-Stage Kidney Disease (ESKD) transitioning to dialysis, which can potentially address critical treatment gaps - Cadrenal Therapeutics announced strategic clinical trial plans for tecarfarin in patients with End-Stage Kidney Disease (ESKD) transitioning to dialysis[2](index=2&type=chunk) - Tecarfarin has the potential to address critical treatment gaps in patients with ESKD[2](index=2&type=chunk) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) Chairman & CEO Quang X. Pham emphasized the company's commitment to developing transformative therapeutics for complex anticoagulation needs, highlighted the critical need for safe anticoagulants in ESKD patients, and noted the successful technical transfer and manufacturing of tecarfarin as a key step for clinical trial readiness - The company is committed to developing transformative therapeutics to address gaps in current anticoagulation therapy for patients with complex needs, specifically initiating a clinical trial for tecarfarin in ESKD patients transitioning to dialysis[3](index=3&type=chunk) - Tecarfarin holds Orphan Drug and Fast-Track designations in ESKD patients with Atrial Fibrillation (AFib), underscoring the critical need for this treatment[3](index=3&type=chunk) - Successful technical transfer of tecarfarin to a U.S. CDMO site and manufacturing of drug product achieved critical CMC readiness for planned clinical trials[3](index=3&type=chunk) [Quarterly Highlights and Operational Update](index=1&type=section&id=Quarterly%20Highlights%20and%20Operational%20Update) Cadrenal Therapeutics provided an update on its clinical trial developments, operational achievements, and summarized its financial performance for the quarter [Clinical Trial Developments](index=1&type=section&id=Clinical%20Trial%20Developments) Cadrenal announced plans in August 2025 to initiate a clinical trial for tecarfarin in ESKD patients transitioning to dialysis, including those with and without AFib. Site activation and patient enrollment screening are expected to begin later this year, addressing the urgent need for this high-risk population - Plans announced in August 2025 to initiate a clinical trial for tecarfarin in ESKD patients transitioning to dialysis (with and without AFib)[4](index=4&type=chunk) - Site activation and screening for patient enrollment are planned to begin later in 2025[4](index=4&type=chunk) - ESKD patients, especially during dialysis transition, face high risks of thrombotic cardiovascular events (myocardial infarction, stroke, AFib, VTE) and increased mortality[5](index=5&type=chunk) [Operational Milestones](index=2&type=section&id=Operational%20Milestones) During the quarter, Cadrenal focused on enhancing corporate visibility through conference participation, exploring strategic development collaborations for tecarfarin across various indications, achieving CMC readiness by manufacturing clinical drug product, and conducting market research. The company was also added to multiple Russell indexes - Participated in key investor, medical, and business development conferences (BIO International Convention, Longwood Healthcare Leaders CEO conference, National Conference on Anticoagulation Therapy)[8](index=8&type=chunk) - Continues to explore opportunities for strategic development collaborations to advance tecarfarin for ESKD and AFib, LVADs, and other chronic anticoagulation indications[9](index=9&type=chunk) - Effective June 30, 2025, Cadrenal was added to the Russell 3000E and Russell Microcap indexes[10](index=10&type=chunk) - Achieved CMC readiness by successfully completing technical transfer and manufacturing tecarfarin clinical drug product at a U.S. cGMP-compliant CDMO site[13](index=13&type=chunk) - Market research reinforced tecarfarin's unique positioning to provide clinical benefits in populations with high-need cardiovascular conditions or renal impairment where anticoagulation safety and predictability are crucial[13](index=13&type=chunk) [Financial Highlights (Summary)](index=2&type=section&id=Financial%20Highlights%20%28Summary%29) For Q2 2025, Cadrenal reported a net loss of $3.7 million, an increase from $2.4 million in Q2 2024. Research and development expenses decreased to $1.1 million from $1.3 million, while general and administrative expenses significantly increased to $2.7 million from $1.2 million. Cash and cash equivalents stood at $5.6 million as of June 30, 2025, down from $10.0 million at year-end 2024 Second Quarter 2025 Financial Summary | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (YoY) | | :-------------------------------- | :----------------- | :----------------- | :------------- | | Research and development expenses | $1.1 | $1.3 | $(0.2) | | General and administrative expenses | $2.7 | $1.2 | $1.5 | | Net loss | $(3.7) | $(2.4) | $(1.3) | | Cash and cash equivalents (as of period end) | $5.6 (June 30, 2025) | $10.0 (Dec 31, 2024) | $(4.4) | [Company and Product Information](index=3&type=section&id=Company%20and%20Product%20Information) This section provides an overview of Cadrenal Therapeutics as a biopharmaceutical company and details the key designations and market opportunities for its lead product, tecarfarin [About Cadrenal Therapeutics, Inc.](index=3&type=section&id=About%20Cadrenal%20Therapeutics%2C%20Inc.) Cadrenal Therapeutics is a biopharmaceutical company focused on developing innovative therapies to overcome the limitations of existing anticoagulation treatments. Its primary investigational product, tecarfarin, is a novel oral vitamin K antagonist designed to address unmet needs in preventing blood clots - Cadrenal Therapeutics is a biopharmaceutical company developing transformative therapeutics to address limitations of current anticoagulation therapy[14](index=14&type=chunk) - Tecarfarin is the lead investigational product, a novel oral vitamin K antagonist anticoagulant designed to prevent heart attacks, strokes, and deaths due to blood clots[14](index=14&type=chunk) [Tecarfarin Designations and Market Opportunity](index=3&type=section&id=Tecarfarin%20Designations%20and%20Market%20Opportunity) Tecarfarin has received Orphan Drug Designation and fast-track status for ESKD+AFib, and ODD for patients with implanted mechanical circulatory support devices (including LVADs), highlighting its potential in critical, underserved patient populations. The company is also actively pursuing business development initiatives to expand its cardiovascular therapeutics pipeline - Tecarfarin received Orphan Drug Designation (ODD) and fast-track status for prevention of systemic thromboembolism of cardiac origin in ESKD+AFib patients[15](index=15&type=chunk) - Tecarfarin also received ODD for prevention of thromboembolism and thrombosis in patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs)[15](index=15&type=chunk) - Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics[16](index=16&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) This section presents Cadrenal's detailed balance sheets and statements of operations, reflecting the company's financial position and performance [Balance Sheets](index=4&type=section&id=Balance%20Sheets) The balance sheet as of June 30, 2025, shows a decrease in total assets to $5.98 million from $10.12 million at December 31, 2024, primarily driven by a reduction in cash and cash equivalents. Total liabilities also decreased to $1.68 million from $2.68 million, while the accumulated deficit grew to $(33.24) million Balance Sheet Highlights | Metric | June 30, 2025 | December 31, 2024 | Change | | :-------------------------------- | :-------------- | :---------------- | :------- | | Cash and cash equivalents | $5,570,730 | $10,017,942 | $(4,447,212) | | Total current assets | $5,971,987 | $10,112,797 | $(4,140,810) | | Total assets | $5,978,431 | $10,123,533 | $(4,145,102) | | Total current liabilities | $1,679,518 | $2,683,958 | $(1,004,440) | | Total liabilities | $1,679,518 | $2,683,958 | $(1,004,440) | | Accumulated deficit | $(33,235,450) | $(25,722,783) | $(7,512,667) | | Total stockholders' equity | $4,298,913 | $7,439,575 | $(3,140,662) | [Statements of Operations and Comprehensive Loss](index=5&type=section&id=Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three months ended June 30, 2025, the net loss was $(3.67) million, compared to $(2.39) million in the prior year. General and administrative expenses increased significantly to $2.66 million from $1.21 million, while R&D expenses slightly decreased. For the six months ended June 30, 2025, the net loss was $(7.51) million, up from $(4.06) million in 2024, with both G&A and R&D expenses increasing over the six-month period Statements of Operations Highlights (Three Months Ended June 30) | Metric | 2025 | 2024 | Change | | :------------------------------------------ | :----------- | :----------- | :----------- | | General and administrative expenses | $2,656,392 | $1,212,437 | $1,443,955 | | Research and development expenses | $1,077,498 | $1,253,711 | $(176,213) | | Total operating expenses | $3,734,291 | $2,466,618 | $1,267,673 | | Net loss and comprehensive loss | $(3,667,287) | $(2,392,982) | $(1,274,305) | | Net loss per common share, basic and diluted | $(1.87) | $(2.24) | $0.37 | Statements of Operations Highlights (Six Months Ended June 30) | Metric | 2025 | 2024 | Change | | :------------------------------------------ | :----------- | :----------- | :----------- | | General and administrative expenses | $4,910,970 | $2,338,430 | $2,572,540 | | Research and development expenses | $2,745,379 | $1,882,736 | $862,643 | | Total operating expenses | $7,662,267 | $4,222,233 | $3,440,034 | | Net loss and comprehensive loss | $(7,512,667) | $(4,056,270) | $(3,456,397) | | Net loss per common share, basic and diluted | $(3.95) | $(3.80) | $(0.15) | [Additional Information](index=3&type=section&id=Additional%20Information) This section includes important legal disclaimers regarding forward-looking statements and provides contact information for corporate and media inquiries [Safe Harbor Statement](index=3&type=section&id=Safe%20Harbor%20Statement) This section serves as a standard legal disclaimer, identifying forward-looking statements within the press release, outlining various important factors that could cause actual results to differ materially, and explicitly stating that the company disclaims any obligation to update these statements - Identifies forward-looking statements using terms like "anticipate," "believe," "expect," "plan," and "will"[17](index=17&type=chunk) - Actual results may differ materially due to various important factors, including clinical trial initiation, development strategy execution, CMC readiness, and ability to expand pipeline[17](index=17&type=chunk) - The company disclaims any obligation to update forward-looking statements, except as required by federal securities laws[17](index=17&type=chunk) [Contacts](index=5&type=section&id=Contacts) Provides contact information for corporate and investor relations, and media inquiries, facilitating communication with interested parties - Paul Sagan (LaVoieHealthScience) is the contact for Corporate and Investor Relations[23](index=23&type=chunk) - Andrew Korda (LaVoieHealthScience) is the contact for Media inquiries[23](index=23&type=chunk)

PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) The unaudited financial statements for the period ended June 30, 2025, show decreased cash and total assets, an increased net loss of $7.5 million, and higher cash used in operations [Balance Sheets](index=4&type=section&id=Balance%20Sheets) As of June 30, 2025, total assets decreased to **$6.0 million** from **$10.1 million**, driven by reduced cash, with liabilities and equity also falling Balance Sheet Summary (Unaudited) | Account | June 30, 2025 ($M) | December 31, 2024 ($M) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $5.57M | $10.02M | | Total current assets | $5.97M | $10.11M | | **Total assets** | **$5.98M** | **$10.12M** | | **Liabilities & Equity** | | | | Total current liabilities | $1.68M | $2.68M | | **Total liabilities** | **$1.68M** | **$2.68M** | | Accumulated deficit | $(33.24M) | $(25.72M) | | **Total stockholders' equity** | **$4.30M** | **$7.44M** | [Statements of Operations and Comprehensive Loss](index=5&type=section&id=Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss for the six months ended June 30, 2025, increased to **$7.5 million**, driven by higher operating expenses, particularly General and Administrative costs Operating Results (Unaudited) | Metric | Three Months Ended June 30, 2025 ($M) | Three Months Ended June 30, 2024 ($M) | Six Months Ended June 30, 2025 ($M) | Six Months Ended June 30, 2024 ($M) | | :--- | :--- | :--- | :--- | :--- | | General and administrative expenses | $2.66M | $1.21M | $4.91M | $2.34M | | Research and development expenses | $1.08M | $1.25M | $2.75M | $1.88M | | **Loss from operations** | **$(3.73M)** | **$(2.47M)** | **$(7.66M)** | **$(4.22M)** | | **Net loss** | **$(3.67M)** | **$(2.39M)** | **$(7.51M)** | **$(4.06M)** | | **Net loss per share (basic and diluted)** | **$(1.87)** | **$(2.24)** | **$(3.95)** | **$(3.80)** | [Statements of Cash Flows](index=7&type=section&id=Statements%20of%20Cash%20Flows) Net cash used in operating activities more than doubled to **$7.7 million** for the six months ended June 30, 2025, resulting in a **$4.4 million** net decrease in cash Cash Flow Summary (Unaudited) | Cash Flow Activity | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | $(7,674,557) | $(3,365,624) | | Net cash used in investing activities | $(3,251) | $0 | | Net cash provided by financing activities | $3,230,596 | $298 | | **Net change in cash and cash equivalents** | **$(4,447,212)** | **$(3,365,326)** | | **Cash and cash equivalents – end of period** | **$5,570,730** | **$5,037,174** | [Notes to Financial Statements](index=8&type=section&id=Notes%20to%20Financial%20Statements) Notes highlight tecarfarin development, going concern uncertainty, a **1-for-15 reverse stock split**, and recent ATM equity sales - The company is a biopharmaceutical firm developing **tecarfarin**, a novel oral anticoagulant, for cardiovascular conditions like **end-stage kidney disease with atrial fibrillation (ESKD+AFib)** and for patients with **left ventricular assist devices (LVADs)**[21](index=21&type=chunk)[22](index=22&type=chunk) - The company's cash balance of approximately **$5.0 million** as of August 6, 2025, is expected to fund operations for at least the **next twelve months**[27](index=27&type=chunk) However, **additional funding** is necessary for further late-stage clinical trials, including a **Phase 3 trial** for tecarfarin[28](index=28&type=chunk) - A **1-for-15 reverse stock split** was effected on August 20, 2024[63](index=63&type=chunk) All share and per-share data have been retroactively adjusted to reflect this split[63](index=63&type=chunk) - During the six months ended June 30, 2025, the company sold **186,294 shares** through its **at-the-market (ATM) facility**, generating net proceeds of approximately **$3.2 million**[73](index=73&type=chunk) - Subsequent to the quarter end, from July 1 to July 14, 2025, the company sold an additional **39,741 shares** via its **ATM facility**, raising net proceeds of approximately **$499,000**[90](index=90&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management focuses on tecarfarin for niche cardiovascular conditions; H1 2025 operating expenses increased, requiring additional capital for future clinical trials - The company is pursuing a 'pipeline-in-a-product' approach for **tecarfarin**, targeting niche cardiovascular conditions where DOACs have failed or are unproven, such as in patients with **ESKD and AFib**, or those with **LVADs**[97](index=97&type=chunk)[98](index=98&type=chunk) - On **August 5, 2025**, the company announced plans to initiate a **clinical trial** for tecarfarin in patients with **ESKD transitioning to dialysis**, with enrollment expected to begin later in the year[100](index=100&type=chunk) - As of August 11, 2025, the company had approximately **$5.0 million** in cash and cash equivalents, which is expected to fund operations for at least the **next twelve months**[113](index=113&type=chunk) However, **additional funding** is needed for any further clinical trials, including a **Phase 3 trial** for tecarfarin[113](index=113&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) Total operating expenses increased to **$7.7 million** for the six months ended June 30, 2025, driven by significant increases in G&A and R&D Comparison of Operating Expenses (Six Months Ended June 30) | Expense Category | 2025 ($) | 2024 ($) | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | General and administrative | $4,910,970 | $2,338,430 | $2,572,540 | 110% | | Research and development | $2,745,379 | $1,882,736 | $862,643 | 46% | | **Total operating expenses** | **$7,662,267** | **$4,222,233** | **$3,440,034** | **81.5%** | - The **$2.6 million** increase in G&A expenses for the six-month period was primarily due to a **$1.3 million** rise in public company costs, a **$0.6 million** increase in stock-based compensation, and a **$0.2 million** increase in personnel-related expenses[110](index=110&type=chunk) - The **$0.9 million** increase in R&D expenses for the six-month period was mainly attributed to a **$0.5 million** increase in CMC expenses, a **$0.3 million** increase in personnel costs (severance), and a **$0.1 million** increase in clinical trial preparation costs[111](index=111&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) The company funds operations through equity sales; cash used in operations increased to **$7.7 million** in H1 2025, partially offset by **$3.2 million** from financing Cash Flow Summary (Six Months Ended June 30) | Activity | 2025 ($) | 2024 ($) | | :--- | :--- | :--- | | Cash used in operating activities | $(7,674,557) | $(3,365,624) | | Cash provided by financing activities | $3,230,596 | $298 | | **Net change in cash** | **$(4,447,212)** | **$(3,365,326)** | - Cash used in operating activities for the first six months of 2025 was **$7.7 million**, driven by a net loss of **$7.5 million** (which included **$1.1 million** of non-cash expenses) and a **$1.3 million** use of cash from changes in operating assets and liabilities[113](index=113&type=chunk)[115](index=115&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable as the company qualifies as a smaller reporting company - The company is a **smaller reporting company** and is not required to provide these disclosures[121](index=121&type=chunk) [Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - Based on an evaluation as of June 30, 2025, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were **effective** at the **reasonable assurance level**[123](index=123&type=chunk) - **No changes** in internal control over financial reporting occurred during the quarter ended June 30, 2025, that have **materially affected**, or are reasonably likely to materially affect, internal controls[124](index=124&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - The company is **not currently a party** to any **material legal proceedings**[126](index=126&type=chunk) [Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report - There have been **no material changes** from the risk factors disclosed in the company's Annual Report[127](index=127&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=27&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) On June 29, 2025, the company issued **10,000 shares** of restricted common stock to a consultant, exempt from registration under Section 4(a)(2) - On **June 29, 2025**, the company issued **10,000 shares** of **restricted common stock** to a consultant for services, exempt from registration under **Section 4(a)(2) of the Securities Act**[129](index=129&type=chunk) [Other Information](index=27&type=section&id=Item%205.%20Other%20Information) On May 9, 2025, the CEO and CFO entered into Rule 10b5-1 stock selling plans for up to **50,600** and **33,333 shares**, effective August 2025 - On **May 9, 2025**, the CEO and CFO entered into **Rule 10b5-1 stock selling plans**[135](index=135&type=chunk) - The plans allow for the sale of a maximum of **50,600 shares** by the CEO and **33,333 shares** by the CFO, with the selling period beginning in **August 2025** and ending in **November 2025**[136](index=136&type=chunk) [Exhibits](index=28&type=section&id=Item%206.%20Exhibits) This section provides an index of exhibits filed or furnished as part of the Quarterly Report on Form 10-Q - The report includes an **Exhibit Index** listing all documents filed or furnished with the **Form 10-Q**[137](index=137&type=chunk)

[Corporate Update and Q1 2025 Highlights](index=1&type=section&id=Corporate%20Update%20and%20Q1%202025%20Highlights) Cadrenal strengthened leadership, advanced tecarfarin's clinical development with FDA guidance and Abbott collaboration, and enhanced supply chain security [Leadership and Regulatory Updates](index=1&type=section&id=Leadership%20and%20Regulatory%20Updates) Cadrenal appointed a Chief Medical Officer and gained FDA guidance for its pivotal tecarfarin Phase 3 trial design - Appointed **James J. Ferguson, M.D., FACC, FAHA**, as Chief Medical Officer to lead business development review and the late-stage clinical development of tecarfarin[4](index=4&type=chunk) - Following a Type D meeting in February 2025, the FDA provided additional guidance on the design for a Phase 3 tecarfarin trial and is open to reviewing a final study design[5](index=5&type=chunk) [Strategic Collaborations and Operational Milestones](index=1&type=section&id=Strategic%20Collaborations%20and%20Operational%20Milestones) Cadrenal collaborated with Abbott for the TECH-LVAD trial, secured U.S. tecarfarin manufacturing, and confirmed market potential - Announced a Collaboration Agreement with Abbott in March 2025 to support the pivotal TECH-LVAD trial, with Abbott providing insights, trial design support, and HeartMate 3™ expertise[6](index=6&type=chunk) - Successfully transferred the manufacturing of tecarfarin drug substance (API) from a CDMO in Asia to one in the United States to improve supply chain security[7](index=7&type=chunk) - Market research indicates the LVAD market is projected to nearly **double by 2032**, positioning tecarfarin for significant clinical value[8](index=8&type=chunk) [Corporate Visibility and Development](index=2&type=section&id=Corporate%20Visibility%20and%20Development) Cadrenal enhanced corporate visibility through conference participation and is exploring new pipeline and collaboration opportunities - Participated in key conferences including the J.P. Morgan Healthcare Conference and the BIO CEO and Investor Conference to build corporate visibility[9](index=9&type=chunk) - The company is actively exploring opportunities to add to its clinical pipeline and collaborate with partners to advance tecarfarin development for LVADs and other indications[10](index=10&type=chunk) [First Quarter 2025 Financial Results](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) Cadrenal reported an increased net loss in Q1 2025 due to higher R&D and G&A expenses, with reduced cash reserves [Financial Performance (Statement of Operations)](index=2&type=section&id=Financial%20Performance%20%28Statement%20of%20Operations%29) Cadrenal's Q1 2025 net loss increased to $3.8 million, or ($2.09) per share, driven by higher R&D and G&A expenses Financial Performance Summary | Metric | Q1 2025 (USD) | Q1 2024 (USD) | Change | | :--- | :--- | :--- | :--- | | Research and Development Expenses | $1.7 million | $0.6 million | +183% | | General and Administrative Expenses | $2.3 million | $1.1 million | +109% | | **Net Loss** | **$3.8 million** | **$1.7 million** | **+123.5%** | | Net Loss Per Share | ($2.09) | ($1.56) | Increased Loss | [Financial Position (Balance Sheet)](index=2&type=section&id=Financial%20Position%20%28Balance%20Sheet%29) As of March 31, 2025, Cadrenal's cash decreased to $7.3 million, with total assets at $8.0 million and equity at $6.1 million Financial Position Summary | Metric | March 31, 2025 (USD) | December 31, 2024 (USD) | | :--- | :--- | :--- | | Cash and cash equivalents | $7.3 million | $10.0 million | | Total Assets | $8.0 million | $10.1 million | | Total Liabilities | $1.8 million | $2.7 million | | Total Stockholders' Equity | $6.1 million | $7.4 million | [About Cadrenal Therapeutics, Inc.](index=2&type=section&id=About%20Cadrenal%20Therapeutics%2C%20Inc.) Cadrenal Therapeutics develops cardiovascular treatments, with tecarfarin as its lead product, holding Orphan Drug and Fast Track designations for multiple indications - Cadrenal's lead product is **tecarfarin**, a novel oral vitamin K antagonist anticoagulant designed to address unmet needs in chronic anticoagulation therapy[13](index=13&type=chunk) - The company is pursuing a **'pipeline-in-a-product' approach** with tecarfarin[14](index=14&type=chunk) - Tecarfarin has received **Orphan Drug Designation (ODD)** for patients with LVADs and both **ODD and Fast Track status** for end-stage kidney disease with atrial fibrillation (ESKD+AFib)[14](index=14&type=chunk)

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) For Q1 2025, Cadrenal Therapeutics reported a net loss of $3.8 million, with total assets decreasing to $7.95 million and cash used in operations of $4.6 million [Balance Sheets](index=4&type=section&id=Balance%20Sheets) Total assets decreased from $10.1 million at year-end 2024 to $7.95 million by March 31, 2025, primarily due to reduced cash and equivalents Balance Sheet Summary (Unaudited) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $7,336,072 | $10,017,942 | | Total current assets | $7,944,792 | $10,112,797 | | **Total assets** | **$7,953,262** | **$10,123,533** | | **Liabilities & Equity** | | | | Total current liabilities | $1,840,166 | $2,683,958 | | **Total liabilities** | **$1,840,166** | **$2,683,958** | | **Total stockholders' equity** | **$6,113,096** | **$7,439,575** | [Statements of Operations and Comprehensive Loss](index=5&type=section&id=Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company's net loss for Q1 2025 more than doubled to $3.85 million, driven by significant increases in both G&A and R&D expenses Statements of Operations (Unaudited) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | General and administrative expenses | $2,254,577 | $1,125,993 | | Research and development expenses | $1,667,882 | $629,025 | | Total operating expenses | $3,927,976 | $1,755,615 | | Loss from operations | $(3,927,976) | $(1,755,615) | | **Net loss and comprehensive loss** | **$(3,845,380)** | **$(1,663,288)** | | **Net loss per common share, basic and diluted** | **$(2.09)** | **$(1.56)** | [Statements of Changes in Stockholders' Equity](index=6&type=section&id=Statements%20of%20Changes%20in%20Stockholders'%20Equity) Stockholders' equity decreased to $6.11 million by March 31, 2025, primarily due to the quarterly net loss, partially offset by stock sales and equity compensation - Key changes in stockholders' equity for the three months ended March 31, 2025 include a **net loss of $3,845,380**, proceeds from the sale of common stock of **$1,970,136** (net of costs), and equity-based compensation of **$518,890**[16](index=16&type=chunk) [Statements of Cash Flows](index=7&type=section&id=Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly increased to $4.6 million for the quarter, partially offset by $2.0 million from financing activities Cash Flow Summary (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,648,755) | $(1,836,380) | | Net cash used in investing activities | $(3,251) | $0 | | Net cash provided by financing activities | $1,970,136 | $298 | | **Net change in cash** | **$(2,681,870)** | **$(1,836,082)** | | **Cash and cash equivalents – end of the period** | **$7,336,072** | **$6,566,418** | [Notes to Financial Statements](index=8&type=section&id=Notes%20to%20Financial%20Statements) The notes detail the company's focus on tecarfarin, its liquidity position, and significant financial events including a reverse stock split and ATM sales - The company is a biopharmaceutical firm developing tecarfarin, a novel oral anticoagulant, for cardiovascular conditions with unmet needs, such as patients with LVADs and ESKD+AFib[22](index=22&type=chunk)[23](index=23&type=chunk) - The company has incurred operating losses since inception, with a **net loss of $3.8 million** and an **accumulated deficit of $29.6 million** as of March 31, 2025[26](index=26&type=chunk)[28](index=28&type=chunk) - Cash and cash equivalents of **$7.3 million** are expected to fund operations for at least the next twelve months, but additional funding is required for late-stage clinical trials[29](index=29&type=chunk) - On August 20, 2024, the company effected a **1-for-15 reverse stock split**, with all share and per-share amounts retroactively adjusted[62](index=62&type=chunk) - During Q1 2025, the company sold **102,246 shares** through its ATM facility, raising approximately **$2.0 million** in net proceeds[72](index=72&type=chunk) - From April 1, 2025, through May 7, 2025, the company sold an additional **56,943 shares** via its ATM facility, raising net proceeds of approximately **$876,000**[88](index=88&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses increased operating expenses due to public company costs and R&D, confirming sufficient liquidity for 12 months but noting the need for future trial funding [Company Overview](index=21&type=section&id=Company%20Overview) Cadrenal is developing tecarfarin as a novel oral anticoagulant for specific cardiovascular conditions, leveraging orphan drug and fast-track designations - The company is focused on developing tecarfarin for rare cardiovascular conditions where patients cannot achieve reliable anticoagulation with warfarin and where DOACs have failed or are unproven[95](index=95&type=chunk) - Tecarfarin has received FDA orphan drug designation for patients with implanted mechanical circulatory support devices and both orphan drug and fast-track designations for patients with end-stage kidney disease and atrial fibrillation[96](index=96&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Operating expenses for Q1 2025 increased by $2.2 million (124%) year-over-year, driven by higher G&A and R&D costs Results of Operations Comparison | Expense Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | General and administrative expenses | $2,254,577 | $1,128,584 | +$1,125,993 | | Research and development expenses | $1,667,882 | $629,025 | +$1,038,857 | | **Total operating expenses** | **$3,927,976** | **$1,755,615** | **+$2,172,361** | | **Net loss** | **$(3,845,380)** | **$(1,663,288)** | **+$(2,182,092)** | - The **$1.1 million increase in G&A expenses** was primarily due to a **$0.7 million increase** in public company-related expenses, a **$0.2 million increase** in stock-based compensation, and a **$0.2 million increase** in personnel costs[102](index=102&type=chunk) - The **$1.0 million increase in R&D expenses** was mainly attributed to a **$0.5 million increase** in CMC expenses, **$0.1 million** in clinical trial preparation, **$0.2 million** in stock-based compensation, and **$0.3 million** in personnel-related expenses, including severance[103](index=103&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) The company has funded operations through equity sales and expects current cash to last 12 months, but substantial additional capital is needed for late-stage clinical trials - As of May 8, 2025, the company had approximately **$6.9 million** in cash and cash equivalents[105](index=105&type=chunk) - Management believes current cash is sufficient to fund operations for at least the next twelve months, but additional funding is necessary to conduct further late-stage clinical trials, including a Phase 3 trial for tecarfarin[105](index=105&type=chunk) [Cash Flows](index=24&type=section&id=Cash%20Flows) Cash used in operating activities significantly increased to $4.6 million in Q1 2025, partially offset by $2.0 million from financing activities via the ATM facility - Cash used in operating activities in Q1 2025 was **$4.6 million**, driven by a **$3.3 million** cash-adjusted net loss and a **$1.3 million** use of cash from changes in operating assets and liabilities[107](index=107&type=chunk) - Cash provided by financing activities in Q1 2025 totaled **$2.0 million** from the use of the company's ATM facility[109](index=109&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable as the company is a smaller reporting company - The company is a smaller reporting company and is not required to provide these disclosures[113](index=113&type=chunk) [Item 4. Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting - Based on an evaluation as of March 31, 2025, the CEO and CFO concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[114](index=114&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[115](index=115&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=26&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - The company reports no current material legal proceedings[117](index=117&type=chunk) [Item 1A. Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes from the risk factors previously disclosed in the company's Annual Report on Form 10-K - The company states there have been no material changes from the risk factors described in its Annual Report[118](index=118&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=26&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the quarter, the company issued restricted common stock to a consultant and granted stock options to officers and directors, exempt from registration - On January 8, 2025, the company issued **25,000 shares** of restricted common stock to a consultant for services, exempt from registration under Section 4(a)(2) of the Securities Act[120](index=120&type=chunk) - On January 23, 2025, the company issued stock options to purchase **220,000 shares** to officers and directors under its 2022 Successor Equity Incentive Plan, with an exercise price of **$19.79 per share**[121](index=121&type=chunk) [Item 5. Other Information](index=26&type=section&id=Item%205.%20Other%20Information) No director or officer adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during Q1 2025 - During Q1 2025, no director or officer adopted or terminated a Rule 10b5-1 trading arrangement[126](index=126&type=chunk) [Item 6. Exhibits](index=27&type=section&id=Item%206.%20Exhibits) This section provides an index of the exhibits filed or furnished as part of the Quarterly Report on Form 10-Q

Financial Performance - Cadrenal raised approximately $9.8 million in financing transactions during the year ended December 31, 2024, including $5.1 million through an at-the-market facility and $4.7 million from warrant exercises[9]. - Research and development expenses for the year ended December 31, 2024, were $4.2 million, compared to $4.1 million for the year ended December 31, 2023[14]. - General and administrative expenses for the year ended December 31, 2024, were $6.8 million, compared to $3.5 million for the year ended December 31, 2023[14]. - Cadrenal reported a net loss of $10.7 million for the year ended December 31, 2024, compared to a net loss of $8.4 million for the year ended December 31, 2023[14]. - As of December 31, 2024, Cadrenal's cash and cash equivalents totaled $10.0 million, an increase from $8.4 million as of December 31, 2023[15]. Leadership Changes - The company appointed James J. Ferguson, MD, as Chief Medical Officer and Jeff Cole as Chief Operating Officer to strengthen its leadership team[6]. Clinical Development - A collaboration agreement with Abbott was announced to support the pivotal TECH-LVAD trial for tecarfarin, leveraging insights from recent HeartMate 3 clinical trials[4]. - The FDA provided additional guidance for the design of a future Phase 3 trial of tecarfarin during a Type D meeting held on February 3, 2025[5]. - Cadrenal received FDA Orphan Drug Designation for tecarfarin in April 2024, highlighting its potential impact on rare cardiovascular conditions[11]. - The company is exploring collaborations with potential development partners to advance tecarfarin's pivotal clinical trial for patients with LVAD and other rare cardiovascular conditions[8].

Drug Development and Clinical Trials - Tecarfarin is being developed as a novel oral anticoagulant for patients with rare cardiovascular conditions, addressing unmet needs in anticoagulation therapy[29]. - Tecarfarin has been evaluated in 11 clinical trials involving over 1,000 individuals, with only 1.6% of patients experiencing major bleeding in the Phase 2/3 EMBRACE-AC trial[44]. - The company entered a collaboration agreement with Abbott to support the Phase 3 TECH-LVAD study, which will evaluate tecarfarin's efficacy and safety in LVAD patients[34][36]. - Tecarfarin has been evaluated in 11 human clinical trials involving over 1,000 individuals, including eight Phase 1 trials, two Phase 2 trials, and one Phase 2/3 trial[50]. - In the EMBRACE-AC study, the Time in Therapeutic Range (TTR) for tecarfarin was significantly higher than the TTR in a subset of warfarin-treated patients, with major bleeding events occurring in only 1.6% of tecarfarin subjects compared to 3.6% for warfarin[53]. - The company plans to initiate a pivotal Phase 3 clinical trial for tecarfarin in late 2025 or early 2026, subject to funding, with the potential for a single pivotal trial to be sufficient for NDA filing[55]. - Tecarfarin is proposed as a solution for patients with LVADs, end-stage kidney disease, and other conditions where current anticoagulants are contraindicated[77]. - The clinical program for tecarfarin aims to address the significant thrombosis patient population in need of alternative anticoagulation treatments[78]. - The planned Phase 3 trial will involve approximately 450 HeartMate 3 LVAD patients, with a non-inferiority margin of about 10%[105]. - Tecarfarin has been tested in eleven clinical trials, but there is no guarantee that results from earlier phases will be replicated in the pivotal Phase 3 study[191]. Regulatory and Approval Process - The FDA granted tecarfarin orphan drug designation in 2019 for preventing systemic thromboembolism in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib), with approximately 100,000 to 150,000 ESKD patients also having AFib[39][48]. - The FDA acknowledged that a non-inferiority trial with a primary composite clinical endpoint could be a feasible path forward for tecarfarin's development[37]. - The FDA requires substantial data demonstrating the quality, safety, and efficacy of a new drug before it can be marketed, which typically takes many years[125]. - The FDA may grant orphan drug designation for drugs intended to treat rare diseases, which can provide a seven-year exclusive marketing period and grant funding of up to $500,000 per year for four years[141]. - Accelerated approval pathways exist for drugs that meet serious conditions and fill unmet medical needs, allowing for early approval based on surrogate endpoints[144]. - The FDA's Fast Track designation for tecarfarin does not ensure a faster development or approval process[199]. - Orphan Drug Designation does not guarantee FDA approval or marketing exclusivity, and the company may face competition even with such designation[214]. - Post-approval, tecarfarin will be subject to ongoing regulatory obligations, which may include costly post-marketing trials and compliance requirements[215]. Financial and Business Development - The company is pursuing business development strategies, including licenses and funding partnerships, to support the Phase 3 study of tecarfarin[35]. - The company requires additional capital to fund the Phase 3 clinical trial, as current cash reserves are insufficient[108]. - The company has not generated any revenue from operations to date and expects to continue incurring significant operating losses in connection with the development and sale of its product candidate, tecarfarin[181]. - The company anticipates that its existing cash and cash equivalents will be sufficient to meet its anticipated cash requirements for at least the next twelve months, but will require additional financing for its planned pivotal Phase 3 clinical trial[185]. - The company will need to raise additional capital to fund its development and commercialization efforts for tecarfarin, and failure to do so could delay or curtail product development[184]. - The company faces significant competition from established pharmaceutical companies and generic products, particularly warfarin and DOACs[112]. - Significant investment will be required for the development and commercialization of tecarfarin, with revenues dependent on successful regulatory approval[207]. Market Opportunity and Competition - There are approximately 15,000 patients in the U.S. with LVADs, indicating a significant market opportunity for tecarfarin in this patient group[57]. - Current standard of care with warfarin yields suboptimal anticoagulation levels, leading to excess bleeding complications in LVAD patients[58]. - The company faces substantial competition in the development and commercialization of new drugs, particularly with its product candidate tecarfarin, which aims to prevent heart attacks and strokes[228]. Manufacturing and Supply Chain - Manufacturing will be outsourced to third-party contract pharmaceutical manufacturers, with no long-term supply agreements in place yet[109]. - The company currently lacks long-term supply agreements for tecarfarin, relying on third-party manufacturers for production and distribution[219]. - Any disruption in third-party manufacturing could increase development costs and impact timelines for commercialization[221]. - The company faces uncertainties related to the costs of manufacturing its clinical product and establishing a commercial drug supply[187]. - Contract manufacturers must comply with stringent FDA regulations, and any failure could result in significant delays or sanctions, adversely affecting the company's operations and financial condition[223]. Risks and Challenges - The company has a limited operating history and has not yet demonstrated the ability to successfully run a clinical trial, which poses significant risks to its business model[179]. - The company is subject to risks related to its financial position and need for capital, including the potential inability to secure sufficient funding on acceptable terms[186]. - The company may face delays in clinical trials due to unforeseen safety issues, recruitment challenges, and regulatory compliance, which could increase development costs and delay completion[204]. - Even with successful clinical trials, regulatory approval is not guaranteed, and the company may face ongoing regulatory obligations post-approval[196][200]. - The company may experience supply shortages if contract manufacturers cannot scale production to meet future clinical or commercial demands[226].