Financial Performance - Cadrenal reported a net loss of $2.7 million for Q3 2025, compared to a net loss of $2.4 million for Q3 2024[5]. - The total operating expenses for Q3 2025 were $2.7 million, compared to $2.5 million in Q3 2024[13]. - The accumulated deficit as of September 30, 2025, was $35.9 million, compared to $25.7 million at the end of 2024[11]. - The weighted average number of common shares used in computing net loss per common share for Q3 2025 was approximately 2.04 million[13]. Expenses - Research and development expenses for Q3 2025 were $0.7 million, a decrease from $0.8 million in Q3 2024, while general and administrative expenses increased to $2.0 million from $1.7 million in the same period[5]. Cash Position - As of September 30, 2025, Cadrenal had cash and cash equivalents of $3.9 million, down from $10.0 million at the end of 2024[6]. Product Development - The company completed the manufacturing of tecarfarin drug product in accordance with current good manufacturing practices (cGMP) and is advancing clinical development[4]. - Cadrenal expanded its portfolio by acquiring assets from eXIthera Pharmaceuticals, including the Phase 2-ready IV Factor XIa inhibitor, frunexian[4]. - Cadrenal is in discussions with key partners to advance the development strategy for tecarfarin, targeting significant anticoagulation challenges[3]. Strategic Goals - The company aims to reshape standards of care in anticoagulation by targeting underserved patient populations with its novel therapeutics[7].

Core Insights - Cadrenal Therapeutics, Inc. is focused on developing innovative anticoagulants, tecarfarin and frunexian, to address existing gaps in anticoagulation therapy [3][6] - The company reported a net loss of $2.7 million for Q3 2025, an increase from a net loss of $2.4 million in Q3 2024 [4] - As of September 30, 2025, Cadrenal had cash and cash equivalents of $3.9 million and approximately 2.1 million shares outstanding [5] Financial Highlights - Research and development expenses for Q3 2025 were $0.7 million, down from $0.8 million in Q3 2024 [4] - General and administrative expenses increased to $2.0 million in Q3 2025 from $1.7 million in Q3 2024 [4] - The total operating expenses for Q3 2025 were $2.7 million, compared to $2.5 million in Q3 2024 [12] Clinical Development Updates - The company has progressed the clinical development of tecarfarin, completing its manufacturing in accordance with current good manufacturing practices (cGMP) [8] - Ongoing activities include a single-site U.S. Phase 2 study of tecarfarin in LVAD patients and discussions for a potential multi-site Phase 2 study in dialysis patients [8] - Cadrenal expanded its portfolio by acquiring assets from eXIthera Pharmaceuticals, including frunexian, a Phase 2-ready IV Factor XIa inhibitor [8]

Product Development - Cadrenal's lead product candidate, tecarfarin, is designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation [96]. - Tecarfarin has been evaluated in 11 human clinical trials involving over 1,000 individuals, with only 1.6% of subjects experiencing major bleeding in the largest trial, EMBRACE-AC [101]. - The company is evaluating opportunities for additional Phase 2 trials for tecarfarin, potentially advancing clinical trials in 2026 for specific patient groups [102]. - Cadrenal's focus on orphan cardiovascular conditions aims to provide more reliable anticoagulation for patients who cannot achieve optimal results with warfarin or DOACs [99]. Financial Performance - The company reported total operating expenses of $2.73 million for the three months ended September 30, 2025, an increase of 11% compared to $2.46 million in the same period of 2024 [112]. - General and administrative expenses rose to $2.04 million in Q3 2025, up 22% from $1.67 million in Q3 2024, primarily due to increased public company expenses and stock-based compensation [113]. - Research and development expenses for the nine months ended September 30, 2025, were $3.4 million, an increase of $0.7 million or 29% compared to $2.7 million in 2024 [119]. - General and administrative expenses increased to $7.0 million for the nine months ended September 30, 2025, up $3.0 million or 73% from $4.0 million in 2024 [118]. - Total operating expenses for the nine months ended September 30, 2025, were $10.4 million, a 56% increase from $6.7 million in 2024 [117]. - The net loss for the nine months ended September 30, 2025, was $10.2 million, compared to a net loss of $6.5 million in 2024, representing a 46% increase [122]. - Cash used in operating activities for the nine months ended September 30, 2025, was $10.0 million, compared to $5.6 million in 2024 [123]. - Cash and cash equivalents at the end of the period were $3.9 million as of September 30, 2025, down from $4.4 million at the end of 2024 [123]. - Interest and dividend income for the nine months ended September 30, 2025, was $0.1 million, a decrease of 9% from $0.2 million in 2024 [120]. - The company incurred $1.6 million of non-cash expenses as part of the net loss for the nine months ended September 30, 2025 [122]. Strategic Initiatives - Cadrenal acquired assets from eXIthera Pharmaceuticals, including the IV Factor XIa inhibitor frunexian, enhancing its pipeline in the $38 billion global anticoagulation market [106]. - The acquisition includes milestone payments of up to $15 million and royalties of 2% on annual net sales of products covered by valid patents [104][105]. - The company sold 236,728 shares through its at-the-market facility at an average price of $16.96 per share, generating approximately $4.02 million in gross proceeds [108]. - From October 1 to November 10, 2025, Cadrenal sold an additional 16,091 shares at an average price of $14.16, resulting in gross proceeds of approximately $227,772 [109]. - The company plans to seek additional capital through strategic partnerships, equity offerings, and/or debt financings to meet anticipated funding needs [122]. - The company anticipates an increase in research and development expenses when clinical trials commence [119].

Group 1 - The core valuation of CVKD is based on a probability adjusted DCF model, estimating a share value of $30.00 [1] - The model incorporates potential future revenues from tecarfarin in specific medical applications, including LVADs, ESKD+AFib, and mechanical heart valves [1] - The valuation is highly contingent on the continued clinical success of tecarfarin, with adjustments expected based on future clinical results [1]

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 (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 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 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)