Cadrenal Therapeutics(US:CVKD)2023-11-08 16:00Drug 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].