
PART I. FINANCIAL INFORMATION Item 1. Financial Statements (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 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 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 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 $518,89016 Statements of Cash Flows 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 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+AFib2223 - 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, 20252628 - 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 trials29 - On August 20, 2024, the company effected a 1-for-15 reverse stock split, with all share and per-share amounts retroactively adjusted62 - During Q1 2025, the company sold 102,246 shares through its ATM facility, raising approximately $2.0 million in net proceeds72 - 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 $876,00088 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 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 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 unproven95 - 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 fibrillation96 Results of Operations 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 costs102 - 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 severance103 Liquidity and Capital Resources 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 equivalents105 - 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 tecarfarin105 Cash Flows 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 liabilities107 - Cash provided by financing activities in Q1 2025 totaled $2.0 million from the use of the company's ATM facility109 Item 3. Quantitative and Qualitative Disclosures About Market Risk 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 disclosures113 Item 4. Controls and Procedures 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 level114 - 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 controls115 PART II. OTHER INFORMATION Item 1. Legal Proceedings The company is not currently subject to any material legal proceedings - The company reports no current material legal proceedings117 Item 1A. Risk Factors 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 Report118 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 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 Act120 - 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 share121 Item 5. Other Information 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 arrangement126 Item 6. Exhibits This section provides an index of the exhibits filed or furnished as part of the Quarterly Report on Form 10-Q