Core Insights - Cadrenal Therapeutics is advancing its late-stage development of tecarfarin, a new vitamin K antagonist aimed at providing safer anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions [1][9][11] Recent Highlights - In early September, Cadrenal leadership engaged with the U.S. FDA regarding the Phase 3 clinical trial protocol for tecarfarin in LVAD patients and continues these discussions [2] - The company is progressing collaboration discussions with Abbott for a pivotal clinical trial involving the Abbott LVAD HeartMate 3, the only LVAD available in the U.S. [2] Corporate Developments - Cadrenal joined the Corporate Council of the Anticoagulation Forum in October 2024, aiming to collaborate with 15,000 healthcare professionals to improve outcomes for patients on anticoagulants [3] - The company completed operational readiness activities with its CDMO to supply active pharmaceutical ingredients and clinical trial materials in compliance with cGMP [4] Financial Updates - On October 24, 2024, Cadrenal raised approximately $5.1 million through its at-the-market facility, followed by the exercise of warrants generating about $4.7 million on November 1, 2024 [5] - Recent financing transactions totaling $9.8 million increased the cash balance to approximately $11.3 million, providing additional working capital for advancing tecarfarin towards a pivotal Phase 3 trial [5][6] Clinical Development - Tecarfarin is the only anticoagulant in development for patients with implanted cardiac devices and is designed to address challenges associated with warfarin, potentially offering a safer and more effective chronic anticoagulant option [9][12] - The drug is expected to improve outcomes and reduce major events for warfarin-dependent patients, with Phase 2/3 trials indicating enhanced stability and time in therapeutic range [12]

Core Viewpoint - Cadrenal Therapeutics, Inc. has entered into a definitive agreement for the immediate exercise of certain outstanding warrants, allowing the purchase of up to 285,715 shares of common stock at a reduced exercise price of $16.50 per share, down from the original price of $26.25 per share [1][3]. Group 1: Financial Details - The gross proceeds from the exercise of the warrants are expected to be approximately $4.7 million, prior to deducting placement agent fees and estimated offering expenses [4]. - The new Series A-1 and Series A-2 warrants will allow the purchase of the same number of shares at the reduced price and will be immediately exercisable upon issuance [3]. Group 2: Use of Proceeds - The net proceeds from the offering will be used for the pivotal Phase 3 trial and partnering activities related to the development of tecarfarin [4]. Group 3: Company Overview - Cadrenal Therapeutics is focused on developing tecarfarin, a novel oral and reversible anticoagulant designed for patients with rare medical conditions, particularly those with implanted cardiac devices [7]. - Tecarfarin is expected to have fewer adverse events compared to warfarin, the commonly used anticoagulant, and has received orphan drug designation for specific patient groups [7].

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 ...

Analysis features the growing need to evolve anticoagulation therapy beyond warfarin to avoid gastrointestinal bleeding, a significant and common complication for left ventricular assist device (LVAD) patients resulting in expensive hospitalizations Tecarfarin, a novel vitamin K antagonist (VKA), uses a different metabolic pathway than warfarin, the most commonly used anticoagulant for LVAD patients, and may offer more stable and effective anticoagulation PONTE VEDRA, Fla., Aug. 20, 2024 /PRNewswire/ -- Cad ...

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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-41596 CADRENAL THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) | --- | --- | |------------------------------------ ...