Cadrenal Therapeutics(US:CVKD)2025-11-10 11:21Product Development - Cadrenal's lead product candidate, tecarfarin, is designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation [96]. - Tecarfarin has been evaluated in 11 human clinical trials involving over 1,000 individuals, with only 1.6% of subjects experiencing major bleeding in the largest trial, EMBRACE-AC [101]. - The company is evaluating opportunities for additional Phase 2 trials for tecarfarin, potentially advancing clinical trials in 2026 for specific patient groups [102]. - Cadrenal's focus on orphan cardiovascular conditions aims to provide more reliable anticoagulation for patients who cannot achieve optimal results with warfarin or DOACs [99]. Financial Performance - The company reported total operating expenses of $2.73 million for the three months ended September 30, 2025, an increase of 11% compared to $2.46 million in the same period of 2024 [112]. - General and administrative expenses rose to $2.04 million in Q3 2025, up 22% from $1.67 million in Q3 2024, primarily due to increased public company expenses and stock-based compensation [113]. - Research and development expenses for the nine months ended September 30, 2025, were $3.4 million, an increase of $0.7 million or 29% compared to $2.7 million in 2024 [119]. - General and administrative expenses increased to $7.0 million for the nine months ended September 30, 2025, up $3.0 million or 73% from $4.0 million in 2024 [118]. - Total operating expenses for the nine months ended September 30, 2025, were $10.4 million, a 56% increase from $6.7 million in 2024 [117]. - The net loss for the nine months ended September 30, 2025, was $10.2 million, compared to a net loss of $6.5 million in 2024, representing a 46% increase [122]. - Cash used in operating activities for the nine months ended September 30, 2025, was $10.0 million, compared to $5.6 million in 2024 [123]. - Cash and cash equivalents at the end of the period were $3.9 million as of September 30, 2025, down from $4.4 million at the end of 2024 [123]. - Interest and dividend income for the nine months ended September 30, 2025, was $0.1 million, a decrease of 9% from $0.2 million in 2024 [120]. - The company incurred $1.6 million of non-cash expenses as part of the net loss for the nine months ended September 30, 2025 [122]. Strategic Initiatives - Cadrenal acquired assets from eXIthera Pharmaceuticals, including the IV Factor XIa inhibitor frunexian, enhancing its pipeline in the $38 billion global anticoagulation market [106]. - The acquisition includes milestone payments of up to $15 million and royalties of 2% on annual net sales of products covered by valid patents [104][105]. - The company sold 236,728 shares through its at-the-market facility at an average price of $16.96 per share, generating approximately $4.02 million in gross proceeds [108]. - From October 1 to November 10, 2025, Cadrenal sold an additional 16,091 shares at an average price of $14.16, resulting in gross proceeds of approximately $227,772 [109]. - The company plans to seek additional capital through strategic partnerships, equity offerings, and/or debt financings to meet anticipated funding needs [122]. - The company anticipates an increase in research and development expenses when clinical trials commence [119].