Core Insights - Cadrenal Therapeutics, Inc. has been awarded the 2024 "Anticoagulation Therapy Company of the Year" by Pharma Tech Outlook for its innovative development of tecarfarin, a new vitamin K antagonist anticoagulant aimed at patients with implanted cardiac devices and rare cardiovascular conditions [1][3] Company Overview - Cadrenal Therapeutics is a late-stage biopharmaceutical company focused on developing tecarfarin to provide safer and superior chronic anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions [4] - The company aims to address significant unmet needs in anticoagulation therapy, particularly for patients with left ventricular assist devices (LVADs) and those with end-stage kidney disease (ESKD) [4] Product Development - Tecarfarin is designed to overcome challenges associated with warfarin therapy, including drug-drug interactions and the need for frequent dosing adjustments [2][4] - The unique metabolic pathway of tecarfarin is less affected by drug interactions and kidney impairment, allowing for a stable, once-daily dosing regimen [2][4] - The product has received orphan drug and fast-track designations, positioning it to fill gaps in chronic anticoagulation treatment options for specific patient populations [3][4] Market Positioning - The company is advancing a pivotal trial for tecarfarin and is pursuing clinical and commercial partnerships, with plans to study its application in mechanical heart valve patients facing anticoagulation difficulties [4]

Core Insights - Cadrenal Therapeutics is developing tecarfarin, a new vitamin K antagonist (VKA) anticoagulant, aimed at providing safer chronic anticoagulation for patients with implanted cardiac devices, particularly those with left ventricular assist devices (LVADs) [1][4] - A presentation at the EACTS Mechanical Circulatory Support Summit highlighted tecarfarin's historical data and a proposed clinical trial protocol to evaluate its effectiveness compared to warfarin in patients using the Abbott HeartMate3 LVAD [1][2] Company Overview - Cadrenal Therapeutics is a late-stage biopharmaceutical company focused on tecarfarin, which is expected to result in fewer adverse events compared to warfarin, including strokes, heart attacks, and bleeding [4] - The company has received orphan drug designation for advanced heart failure patients with LVADs and fast-track status for end-stage kidney disease patients with atrial fibrillation [4] Clinical Trial Insights - The proposed TECH-LVAD trial aims to study tecarfarin's potential to reduce bleeding events associated with the use of the HM3 LVAD in advanced heart failure patients [3] - Historical data presented indicated an inverse relationship between bleeding rates and time in therapeutic range (TTR) for HM3 patients, suggesting tecarfarin may improve TTR [2][3] Future Plans - Cadrenal is actively engaging with the FDA and Abbott to advance the tecarfarin study in LVAD patients, with plans for investigator outreach and patient recruitment [3] - The company is also exploring pivotal clinical trials and potential partnerships to further develop tecarfarin for patients with mechanical heart valves facing anticoagulation challenges [4]

Financial Performance - The net loss for the three months ended September 30, 2024, was $2,407,829, compared to a net loss of $1,036,451 for the same period in 2023[109]. - The net loss for the nine months ended September 30, 2024, was $6,464,099, which included $656,987 of non-cash expenses[117]. - Cash used in operating activities totaled $5,566,844 for the nine months ended September 30, 2024, compared to $2,835,878 in the same period of 2023[118]. - Cash flows from operating activities showed a net loss adjusted for non-cash items using $5,807,112 in cash for the nine months ended September 30, 2024[119]. Research and Development - Tecarfarin is being developed as a new Vitamin K Antagonist (VKA) chronic anticoagulant to prevent heart attacks, strokes, and deaths due to thrombosis in patients with implanted cardiac devices or rare cardiovascular conditions[90]. - Tecarfarin has been evaluated in eleven clinical trials involving over 1,000 individuals, with only 1.6% of patients experiencing major bleeding in the largest trial[95]. - The average time in the therapeutic range for patients using warfarin was only 56%, significantly below the target of 70%, indicating a need for improved anticoagulation options[99]. - The company expects to require additional funding to complete its planned Phase 3 clinical trial and submit its New Drug Application[117]. Expenses - The company reported a 222% increase in research and development expenses, totaling $784,646 for the three months ended September 30, 2024, compared to $243,948 for the same period in 2023[107]. - General and administrative expenses rose by 87% to $1,674,905 for the three months ended September 30, 2024, up from $898,051 in the prior year[106]. - General and administrative expenses increased by $1,365,929, or 52%, to $4,013,336 for the nine months ended September 30, 2024, compared to $2,647,407 for the same period in 2023[112]. - Research and development expenses decreased to $2,667,382 for the nine months ended September 30, 2024, down from $3,720,222 in the prior year, primarily due to a $3.0 million expense in 2023 related to stock issuance[113]. Financing Activities - The company generated gross proceeds of $7,000,000 from its initial public offering (IPO) on January 24, 2023, selling 93,333 shares at $75.00 per share[100]. - In a private placement on July 12, 2023, the company raised approximately $7.5 million by selling 86,667 shares and warrants[101]. - The company sold 154,144 shares through its at-the-market (ATM) facility, generating gross proceeds of $1,635,777 during the quarter ended September 30, 2024[103]. - Net cash provided by financing activities was $1,528,244 for the nine months ended September 30, 2024, significantly lower than $11,915,991 in the prior year due to the completion of the IPO[122]. - The company utilized its ATM facility, generating proceeds of $1,527,946 during the nine months ended September 30, 2024[121]. Cash Position - As of November 7, 2024, the company had cash and cash equivalents of approximately $11.3 million, expected to fund operations for at least the next twelve months[117]. - The company recorded a $740,139 loss on extinguishment of debt during the nine months ended September 30, 2023, with no such activity in 2024[116].

Financial Results - Cadrenal Therapeutics, Inc. reported financial results for the fiscal quarter ended September 30, 2024[4]. - The company issued a press release on November 7, 2024, detailing its financial performance[4]. Regulatory Information - The report is not deemed "filed" under the Securities Exchange Act of 1934, ensuring it is not subject to certain liabilities[5]. - The company is classified as an emerging growth company under the Securities Act of 1933[4]. - The press release is attached as Exhibit 99.1 to the Current Report on Form 8-K[6]. - The financial statements and exhibits are furnished with the Current Report on Form 8-K[6]. - The report was signed by Quang Pham, Chairman and CEO of Cadrenal Therapeutics, Inc.[7]. Company Information - The company is headquartered in Ponte Vedra, Florida[2]. - The trading symbol for the company's common stock is CVKD on the Nasdaq Capital Market[3]. - The company has not elected to use the extended transition period for new financial accounting standards[4].

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 ...

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]