PONTE VEDRA, Fla., Jan. 31, 2024 /PRNewswire/ -- Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a novel Vitamin K Antagonist (VKA) for unmet needs in anticoagulation (blood thinning) therapy, cited today a recent peer-reviewed article in the Journal of the American College of Cardiology (JACC) titled, "When Direct Oral Anticoagulants Should Not Be Standard Treatment" by Antoine Bejjani, MD, et.al. The article examines the numerous medical conditions where dir ...

PONTE VEDRA, Fla., Jan. 24, 2024 /PRNewswire/ -- Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes and deaths due to blood clots in patients with certain conditions, announced today that Douglas Losordo, M.D., Chief Medical Officer of Cadrenal, will participate in a fireside chat moderated by Joe Pantginis, Ph.D., Managing Director of Research at H.C. ...

Drug Development - Tecarfarin is a late-stage novel oral anticoagulant designed to prevent thromboembolic events in patients with ESKD and AFib, with FDA orphan drug and Fast Track designations[152][154]. - The company plans to submit its Phase 3 trial design to the FDA in the second half of 2024, contingent upon sufficient funding[153]. - Tecarfarin has been evaluated in 11 human clinical trials involving over 1,003 individuals, including eight Phase 1 trials, two Phase 2 trials, and one Phase 2/3 trial[158]. - The company is exploring tecarfarin's use in other settings, including patients with LVADs and autoimmune conditions like APS[156]. - The company anticipates potential regulatory discussions with the FDA regarding other indications for tecarfarin[153]. - Tecarfarin has been evaluated in 11 clinical trials with over 1,003 individuals, showing a major bleeding rate of only 1.6% in the largest trial, EMBRACE-AC, which included 607 patients[179]. - The FDA designated the investigation of tecarfarin as a Fast Track development program on January 13, 2023, to expedite its review for patients with ESKD and AFib[215]. - The company aims to provide a safer alternative to warfarin for patients with ESKD and AFib, as current therapies pose significant risks for this population[182]. - The company has two issued U.S. patents for tecarfarin, expected to seek extensions beyond the current expiration in 2024[213]. Financial Performance - Research and development expenses for the nine months ended September 30, 2023, were $3,720,222, a significant increase of $3,443,740 compared to $276,482 for the same period in 2022[194]. - The net loss for the three months ended September 30, 2023, was $1,036,451, compared to a net loss of $1,026,114 for the same period in 2022[190]. - Total operating expenses for the three months ended September 30, 2023, were $1,142,596, up from $972,791 in the same period of 2022[190]. - Interest and dividend income for the nine months ended September 30, 2023, was $129,321, derived from investments in money market funds[195]. - The company recorded a $740,139 loss on the extinguishment of debt during the nine months ended September 30, 2023, related to convertible notes and promissory notes settled with the IPO[198]. - General and administrative expenses for the nine months ended September 30, 2023, were $2,647,407, compared to $1,348,670 for the same period in 2022, reflecting a 96% increase[222]. - Total operating expenses for the nine months ended September 30, 2023, were $6,369,012, significantly higher than $1,625,658 for the same period in 2022[222]. - Net loss for the nine months ended September 30, 2023, was $7,213,026, compared to a net loss of $1,704,902 for the same period in 2022[222]. - Cash used in operating activities for the nine months ended September 30, 2023, was $(2,835,878), compared to $(914,554) for the same period in 2022[226]. - Cash provided by financing activities for the nine months ended September 30, 2023, was $11,915,991, compared to $1,019,914 for the same period in 2022[226]. Stock and Financing Activities - The company completed its IPO on January 24, 2023, raising gross proceeds of $7 million from the sale of 1,400,000 shares at $5.00 per share[166]. - In July 2023, the company sold 1,300,000 shares and issued Pre-Funded Warrants and Common Warrants, with a combined purchase price of $1.75 per share[167]. - The company sold 1,300,000 shares of common stock in a private placement at a combined purchase price of $1.75 per share[217]. - As of September 30, 2023, the company had 1,175,000 stock options outstanding with a weighted average exercise price of $0.86[173]. Market Context - Total Medicare spending for patients with end-stage kidney disease (ESKD) reached $51 billion in 2019, accounting for approximately 7% of Medicare paid claims costs[183]. - Approximately 150,000 ESKD patients also have atrial fibrillation (AFib), which nearly doubles the anticipated mortality and increases stroke risk by about five-fold in these patients[183]. Insurance and Risk Management - The company has a directors and officers liability insurance policy to cover potential claims against its officers and directors[164]. - The company experienced a significant increase in personnel-related expenses, contributing to the rise in general and administrative expenses[222].

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, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | | | Name of each exchange on which | | --- | --- | --- | | Title of each class | Trading symbol(s) | registered | | Common Stock, par value $0.001 per share | CVKD | The Nasdaq Stock Market, LLC | | ...

Item 1. Legal Proceedings 24 FORM 10-Q For the quarterly period ended March 31, 2023 For the transition period from to | --- | --- | |--------------------------------------------------|-----------------------| | Delaware | 88-0860746 | | (State or other jurisdiction of | (I.R.S. Employer | | incorporation or organization) | Identification No.) | | 822 A1A North, Suite 306 | | | Ponte Vedra, Florida | 32082 | | (Address of principal executive offices) | (Zip Code) | | --- | --- | --- | |--------------------- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 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) | Delaware | 88-0860746 | | --- | --- | | (Stat ...