Core Viewpoint - Cadrenal Therapeutics has successfully raised approximately $5.1 million through its at-the-market facility to support the development of tecarfarin, a new vitamin K antagonist aimed at improving chronic anticoagulation for patients with specific cardiovascular conditions [1][2]. Financial Summary - The company sold 391,243 shares of common stock at a weighted average price of $13.15 per share [1]. - As of October 23, 2024, Cadrenal has 1,496,771 shares of common stock outstanding and a cash balance of approximately $7.4 million [1]. Company Overview - Cadrenal Therapeutics is a late-stage biopharmaceutical company focused on developing tecarfarin, which is designed to provide safer chronic anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions [3]. - Tecarfarin is expected to result in fewer adverse events compared to warfarin, the commonly used anticoagulant, which has significant side effects and drug interactions [3]. - The drug has received orphan drug designation for advanced heart failure patients with implanted left ventricular assist devices (LVADs) and both orphan drug and fast-track status for end-stage kidney disease patients with atrial fibrillation [3]. - The company is planning pivotal clinical trials and is pursuing clinical and commercial partnerships, including studying tecarfarin in patients with mechanical heart valves [3].

Core Insights - Cadrenal Therapeutics has joined the Corporate Council of the Anticoagulation Forum, emphasizing its commitment to innovation and improved patient outcomes in anticoagulation therapy [1][2]. Company Overview - Cadrenal Therapeutics is a late-stage biopharmaceutical company focused on developing tecarfarin, a new vitamin K antagonist aimed at providing safer chronic anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions [3]. - Tecarfarin is expected to result in fewer adverse events compared to warfarin, the commonly used anticoagulant, which has significant side effects and requires frequent dosing adjustments [3]. - The company has received orphan drug designation for advanced heart failure patients with implanted left ventricular assist devices (LVADs) and both orphan drug and fast-track status for end-stage kidney disease patients with atrial fibrillation [3]. - Cadrenal is planning pivotal clinical trials and is pursuing clinical and commercial partnerships, including studying tecarfarin in patients with mechanical heart valves facing anticoagulation challenges [3]. Industry Context - The Anticoagulation Forum is the largest professional organization for anticoagulation specialists, with over 15,000 members across 3,000 healthcare institutions, dedicated to enhancing the safety and quality of care for over 1 million patients annually [4]. - The forum aims to advance chronic anticoagulation care globally through education, research sharing, and advocacy initiatives [2][4].

PONTE VEDRA, Fla., Aug. 22, 2024 /PRNewswire/ -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage, next-generation Vitamin K Antagonist (VKA) oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices and those with rare cardiovascular conditions, announced today that it will be engaging with the U.S. Food and Drug Administration (FDA) in earl ...

Core Insights - The article emphasizes the need for evolving anticoagulation therapy beyond warfarin to mitigate gastrointestinal bleeding in LVAD patients, which leads to costly hospitalizations [1][2] - Tecarfarin, a novel vitamin K antagonist, is highlighted as a potential alternative to warfarin, offering more stable and effective anticoagulation [1][3] Company Overview - Cadrenal Therapeutics, Inc. is developing tecarfarin, a late-stage oral and reversible anticoagulant aimed at preventing heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices [1][7] - Tecarfarin is the only oral anticoagulant in development for patients with implanted cardiac devices and is designed to overcome challenges associated with warfarin [3][4] Clinical Findings - A recent study published in the Journal of Cardiac Failure evaluated the relationship between time in therapeutic range (TTR) and clinical outcomes in LVAD patients, finding a median TTR of 56% and a 47% reduction in bleeding risk for patients with TTR above the median [2] - The study indicates that lower TTRs correlate with a threefold increase in sub-therapeutic INRs compared to supra-therapeutic INRs, with no clear link between higher INRs and bleeding events [2] Tecarfarin's Advantages - Tecarfarin is metabolized differently than warfarin, using carboxyl esterase instead of the cytochrome P450 system, which may reduce drug-drug interactions and provide stable anticoagulation, especially in patients with renal dysfunction [3][4] - In a Phase II study, patients switched from warfarin to tecarfarin achieved a mean interpolated TTR of 71.4% within three weeks, with minimal time spent in extreme INR ranges [3] Regulatory Status - Tecarfarin has received Orphan Drug Designation from the FDA for the prevention of thromboembolism in patients with implanted mechanical circulatory support devices, including LVADs [6][7] - The company is in discussions with Abbott regarding a pivotal study of tecarfarin in patients with recently implanted LVADs [5]

PONTE VEDRA, Fla., Aug. 14, 2024 /PRNewswire/ -- Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage, next-generation Vitamin K Antagonist (VKA) oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices and those with rare cardiovascular conditions, will participate in the following upcoming conferences that will be available to investors by we ...

[Form 8-K Current Report](index=1&type=section&id=Form%208-K%20Current%20Report) [Item 2.02 Results of Operations and Financial Condition](index=1&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) Cadrenal Therapeutics, Inc. announced Q2 2024 financial results via a press release, furnished but not filed with the SEC, limiting legal liability - The company issued a press release on August 7, 2024, which included financial information for the fiscal quarter ended June 30, 2024[2](index=2&type=chunk) - The information in the press release (Exhibit 99.1) is not considered "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, which limits certain legal liabilities[3](index=3&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=2&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section details exhibits furnished with the Form 8-K, including the August 7, 2024 press release and interactive data file Exhibits Furnished with the Report | Exhibit Number | Description | | :--- | :--- | | 99.1 | Press Release, issued by Cadrenal Therapeutics, Inc. on August 7, 2024 | | 104 | Cover Page Interactive Data File (embedded within the inline XBRL document) | [Signatures](index=3&type=section&id=SIGNATURES) The Form 8-K was officially signed by Quang Pham, Chairman and CEO of Cadrenal Therapeutics, Inc., on August 8, 2024 - The Form 8-K was signed and authorized by Quang Pham, Chairman and Chief Executive Officer, on August 8, 2024[5](index=5&type=chunk)[6](index=6&type=chunk)

PONTE VEDRA, Fla., Aug. 7, 2024 /PRNewswire/ -- Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage, next-generation Vitamin K Antagonist (VKA) oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices and those with rare cardiovascular conditions, today provided a corporate update coinciding with the filing of its Quarterly Report on Form 10-Q ...

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the company's unaudited financial statements, management's discussion and analysis, and related financial disclosures [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited H1 2024 financials report a **$4.1 million net loss**, increased operating expenses, and **$5.0 million cash**, raising going concern doubts [Balance Sheets](index=4&type=section&id=Balance%20Sheets) Balance sheets show decreased cash and total assets, increased liabilities and accumulated deficit by June 30, 2024 Balance Sheet Summary (as of June 30, 2024 vs. December 31, 2023) | Metric | June 30, 2024 (Unaudited) | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $5,037,174 | $8,402,500 | | Total current assets | $5,443,504 | $8,492,173 | | Total assets | $5,457,171 | $8,519,250 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $1,464,917 | $826,875 | | Total liabilities | $1,464,917 | $826,875 | | Accumulated deficit | $(19,127,685) | $(15,071,415) | | Total stockholders' equity | $3,992,254 | $7,692,375 | [Statements of Operations and Comprehensive Loss](index=5&type=section&id=Statements%20of%20Operations%20and%20Comprehensive%20Loss) Operating results show increased G&A expenses, fluctuating R&D costs, and significant net losses for Q2 and H1 2024 Operating Results Summary (Unaudited) | Metric | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | General & administrative expenses | $1,212,437 | $784,623 | $2,338,430 | $1,749,356 | | Research & development expenses | $1,253,711 | $240,957 | $1,882,736 | $3,476,274 | | Loss from operations | $(2,466,618) | $(1,026,177) | $(4,222,233) | $(5,226,416) | | Net loss | $(2,392,982) | $(1,003,001) | $(4,056,270) | $(6,176,575) | | Net loss per share (basic & diluted) | $(0.15) | $(0.09) | $(0.25) | $(0.55) | [Statements of Changes in Stockholders' Equity](index=6&type=section&id=Statements%20of%20Changes%20in%20Stockholders'%20Equity) Stockholders' equity decreased in H1 2024 due to net loss, partially offset by equity compensation and warrant exercises - For the six months ended June 30, 2024, total stockholders' equity decreased from **$7.7 million** to **$4.0 million**, primarily due to a net loss of **$4.1 million** This was partially offset by equity-based compensation of **$355,851** and the issuance of **2,985,715** common shares from the exercise of pre-funded warrants[7](index=7&type=chunk) [Statements of Cash Flows](index=7&type=section&id=Statements%20of%20Cash%20Flows) Cash flow statements show significant cash used in operating activities and a substantial net decrease in cash for H1 2024 Cash Flow Summary for the Six Months Ended June 30 (Unaudited) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(3,365,624) | $(2,208,102) | | Net cash provided by financing activities | $298 | $5,408,575 | | Net change in cash | $(3,365,326) | $3,197,220 | | Cash and cash equivalents – end of period | $5,037,174 | $3,229,806 | [Notes to Financial Statements](index=8&type=section&id=Notes%20to%20Financial%20Statements) Notes detail drug development, going concern risks, recent financing, and post-quarter equity plan amendments - The company is developing tecarfarin, an oral anticoagulant with orphan drug and fast-track designations from the FDA for specific cardiovascular conditions[10](index=10&type=chunk) - The company has incurred significant operating losses and negative cash flows since inception, leading to substantial doubt about its ability to continue as a going concern for at least one year Management plans to raise additional funds, but there is no assurance of success[13](index=13&type=chunk)[14](index=14&type=chunk)[15](index=15&type=chunk) - In January 2023, the company completed its IPO, raising net proceeds of **$5.4 million** In July 2023, it raised an additional **$7.5 million** in gross proceeds through a private placement[52](index=52&type=chunk)[53](index=53&type=chunk)[54](index=54&type=chunk) - Subsequent to the quarter end, on July 29, 2024, stockholders approved an amendment to the 2022 Equity Incentive Plan, increasing the available shares by **2,000,000** to **4,604,550**[67](index=67&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses increased operating expenses (R&D, G&A) and critical liquidity, with **$5.0 million cash** insufficient for twelve months, reinforcing going concern uncertainty [Company Overview](index=22&type=section&id=Company%20Overview) The company focuses on developing tecarfarin, an oral anticoagulant with FDA orphan drug and fast-track designations for rare cardiovascular conditions - The company is focused on developing tecarfarin, a new-generation oral anticoagulant designed for patients with rare cardiovascular conditions requiring lifelong anticoagulation Tecarfarin has received orphan drug and fast-track designations from the FDA[71](index=71&type=chunk) - Tecarfarin is designed to use a different metabolic pathway than warfarin, potentially reducing drug-drug interactions and being more suitable for patients with impaired kidney function[71](index=71&type=chunk)[73](index=73&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Operating results show increased G&A expenses from personnel and public company costs, and surging R&D expenses driven by CMC activities - General and administrative expenses increased by **55%** to **$1.2 million** for Q2 2024 compared to Q2 2023, driven by increased personnel-related expenses from hiring a Chief Operating Officer, higher public company costs, and professional fees[80](index=80&type=chunk) - Research and development expenses surged by **420%** to **$1.3 million** for Q2 2024 compared to Q2 2023, primarily due to a **$671,300** increase in chemistry, manufacturing, and controls (CMC) activities[83](index=83&type=chunk) - For the six months ended June 30, 2024, R&D expenses decreased to **$1.9 million** from **$3.5 million** in the prior year period The 2023 period included a one-time **$3.0 million** non-cash expense for stock issued pursuant to an asset purchase agreement[86](index=86&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is critical with **$5.0 million** cash, insufficient for twelve months, necessitating additional funding to address going concern uncertainty - As of June 30, 2024, the company had cash and cash equivalents of approximately **$5.0 million** and no debt The cash balance decreased to approximately **$4.2 million** by August 7, 2024[91](index=91&type=chunk) - The company projects that its current cash is not sufficient to fund operations for the next twelve months, raising substantial doubt about its ability to continue as a going concern It intends to raise additional funds through partnering, equity, or debt financings[91](index=91&type=chunk) Cash Flow Summary for Six Months Ended June 30 | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Cash used in operating activities | $(3,365,624) | $(2,208,102) | | Cash provided by financing activities | $298 | $5,408,575 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Cadrenal Therapeutics is not required to provide the information for this item - The company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide the information required under this item[101](index=101&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective at a reasonable assurance level as of June 30, 2024 There were no material changes in internal control over financial reporting during the quarter - Based on an evaluation as of June 30, 2024, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[102](index=102&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended June 30, 2024, that have materially affected, or are reasonably likely to materially affect, internal controls[103](index=103&type=chunk) [PART II. OTHER INFORMATION](index=28&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, key risk factors, equity sales, defaults, mine safety, other information, and exhibits [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently subject to any material legal proceedings - The company is not currently subject to any material legal proceedings[103](index=103&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) The company faces going concern risk (insufficient funds) and Nasdaq delisting risk (**$1.00** minimum bid price), despite an extension and approved reverse stock split - The company's financial statements include a going concern qualification, as existing cash is not sufficient to meet anticipated cash requirements for the next twelve months, raising substantial doubt about its ability to continue operations[105](index=105&type=chunk) - The company is not in compliance with Nasdaq's minimum bid price rule of **$1.00** per share and received an extension until September 3, 2024, to regain compliance Failure to do so could result in delisting[107](index=107&type=chunk) - Shareholders approved a potential reverse stock split to address the Nasdaq compliance issue, but there is no guarantee it will be effective or that it won't adversely affect the stock's liquidity[108](index=108&type=chunk)[111](index=111&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=31&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company states that it did not sell any unregistered equity securities during the quarter ended June 30, 2024, other than what has been previously disclosed in SEC filings - No unregistered sales of equity securities occurred during the quarter ended June 30, 2024, other than as previously disclosed[112](index=112&type=chunk) [Item 3. Defaults Upon Senior Securities](index=31&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company - Not applicable[112](index=112&type=chunk) [Item 4. Mine Safety Disclosures](index=31&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[113](index=113&type=chunk) [Item 5. Other Information](index=31&type=section&id=Item%205.%20Other%20Information) During the second quarter of 2024, no director or officer of the company adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement - During the three months ended June 30, 2024, no director or officer adopted or terminated a 'Rule 10b5-1 trading arrangement' or 'non-Rule 10b5-1 trading arrangement'[113](index=113&type=chunk) [Item 6. Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section provides an index of the exhibits filed with the Quarterly Report on Form 10-Q, which includes corporate governance documents, officer certifications required by the Sarbanes-Oxley Act, and interactive data files (XBRL) - The report includes several exhibits, such as CEO and CFO certifications pursuant to Sarbanes-Oxley Sections 302 and 906, and Inline XBRL files for financial data[115](index=115&type=chunk)

Core Insights - Cadrenal Therapeutics is developing tecarfarin, a new-generation Vitamin K Antagonist (VKA) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices and rare cardiovascular conditions [1][5] - The company is in discussions with Abbott regarding a pivotal study of tecarfarin in patients with recently implanted Left Ventricular Assist Devices (LVADs), which require lifelong anticoagulation [1] - Tecarfarin received FDA Orphan Drug Designation in April 2024 for preventing blood clots and strokes in patients with implanted mechanical circulatory support devices like LVADs [2] Company Overview - Cadrenal Therapeutics focuses on unmet needs in anticoagulation therapy, specifically targeting patients with implanted cardiac devices and those with rare cardiovascular conditions [5] - Tecarfarin has been evaluated in eleven clinical trials involving over 1,000 individuals, demonstrating good tolerability in both healthy adults and patients with chronic kidney disease [5] - The drug is designed to utilize a different metabolic pathway than warfarin, the most commonly prescribed VKA [5] Collaboration and Clinical Insights - Abbott has initiated a collaborative effort with Cadrenal for the trial, which is deemed important for LVAD patients [4] - Prior studies indicate that tecarfarin may improve anticoagulation quality, particularly in patients on multiple medications and those with impaired renal function, common in LVAD patients [4][5] - A secondary analysis of the ARIES-HM3 study by Abbott suggests that maintaining high-quality anticoagulation can enhance outcomes for HeartMate 3 LVAD patients [3]

Company Overview - Cadrenal Therapeutics, Inc. is a biopharmaceutical company focused on developing tecarfarin, a late-stage, new-generation Vitamin K Antagonist (VKA) oral and reversible anticoagulant designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions [5]. Product Development - Tecarfarin is being developed for unmet needs in anticoagulation therapy and has received orphan drug designation from the FDA for preventing thrombosis and thromboembolism in patients with implanted mechanical circulatory support devices, including left ventricular assist devices (LVAD) [3]. - The drug also has orphan drug and fast-track designations from the FDA for preventing systemic thromboembolism of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib) [3]. - Tecarfarin has been evaluated in eleven human clinical trials involving more than 1,000 individuals, demonstrating general tolerability in both healthy adults and patients with chronic kidney disease [3]. Upcoming Events - Cadrenal will present at the Emerging Growth Conference on Thursday, July 18, 2024, at 4:15 pm ET, with a webcast link available on the investor relations page of the company's website [1]. - Management will also host one-on-one investor meetings after the conference, with interested parties encouraged to contact the company's investor relations team [2].