Cadrenal Therapeutics(CVKD) - 2025 Q2 - Quarterly Results

Executive Summary & Corporate Update Cadrenal Therapeutics reported Q2 2025 financial results and a corporate update, emphasizing tecarfarin's strategic clinical development for ESKD patients Second Quarter 2025 Overview 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] - Tecarfarin has the potential to address critical treatment gaps in patients with ESKD[2] CEO Commentary 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] - Tecarfarin holds Orphan Drug and Fast-Track designations in ESKD patients with Atrial Fibrillation (AFib), underscoring the critical need for this treatment[3] - 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] Quarterly Highlights and Operational Update Cadrenal Therapeutics provided an update on its clinical trial developments, operational achievements, and summarized its financial performance for the quarter Clinical Trial Developments 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] - Site activation and screening for patient enrollment are planned to begin later in 2025[4] - ESKD patients, especially during dialysis transition, face high risks of thrombotic cardiovascular events (myocardial infarction, stroke, AFib, VTE) and increased mortality[5] Operational Milestones 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] - Continues to explore opportunities for strategic development collaborations to advance tecarfarin for ESKD and AFib, LVADs, and other chronic anticoagulation indications[9] - Effective June 30, 2025, Cadrenal was added to the Russell 3000E and Russell Microcap indexes[10] - Achieved CMC readiness by successfully completing technical transfer and manufacturing tecarfarin clinical drug product at a U.S. cGMP-compliant CDMO site[13] - 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] Financial Highlights (Summary) 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 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. 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] - 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] Tecarfarin Designations and Market Opportunity 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] - 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] - Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics[16] Financial Statements This section presents Cadrenal's detailed balance sheets and statements of operations, reflecting the company's financial position and performance Balance Sheets 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 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 This section includes important legal disclaimers regarding forward-looking statements and provides contact information for corporate and media inquiries Safe Harbor Statement 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] - 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] - The company disclaims any obligation to update forward-looking statements, except as required by federal securities laws[17] 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] - Andrew Korda (LaVoieHealthScience) is the contact for Media inquiries[23]