tecarfarin (ATI-5923) / Cadrenal Therapeutics - LARVOL DELTA

Cadrenal Therapeutics to Present at Inaugural Centri Capital Conference at Nasdaq (Businesswire) - "Cadrenal Therapeutics, Inc...today announced that Chairman and CEO Quang X. Pham will present at the inaugural Centri Capital Conference, to be held at Nasdaq in New York City on April 22, 2025....Mr. Pham will deliver a company overview and provide updates on the development of tecarfarin, Cadrenal’s lead asset, addressing unmet needs in anticoagulation therapy."

Pipeline update • Atrial Fibrillation • Cardiovascular

Cadrenal Therapeutics Announces Collaboration Agreement with Abbott in Support of Pivotal Study of Tecarfarin in Patients with HeartMate 3 LVAD (Businesswire) - "Cadrenal Therapeutics...announced the signing of a Collaboration Agreement with Abbott...to support Cadrenal’s pivotal TECarfarin Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices (TECH-LVAD) trial....Under the terms of the Collaboration and Data Sharing Agreement, Abbott will support Cadrenal on the planning and execution of the TECH-LVAD trial to evaluate the efficacy and safety of tecarfarin in patients with LVADs. Under the Agreement, Abbott will share insights from recent HeartMate 3 trials and will support Cadrenal with: trial design, site identification, trial awareness, and HeartMate 3 expertise."

Commercial • New P3 trial • Cardiovascular

Cadrenal Therapeutics Announces Chief Medical Officer Transition to Advance Clinical Development of Tecarfarin (Businesswire) - "Cadrenal Therapeutics, Inc...today announced a leadership transition appointing James J. Ferguson, MD, FACC, FAHA, as its new Chief Medical Officer, effective immediately. Dr. Ferguson is a distinguished medical expert with over 25 years of leadership in the cardiovascular field and deep expertise in clinical development. Dr. Ferguson will lead the late-stage clinical development of tecarfarin to include the pivotal trial in LVAD patients and other indications in rare cardiovascular conditions requiring life-long anticoagulation therapy as well as other business development opportunities to build the Company’s pipeline."

Commercial • Cardiovascular

CADRENAL THERAPEUTICS HIGHLIGHTS PRESENTATION AT EUROPEAN ASSOCIATION FOR CARDIO-THORACIC SURGERY (EACTS) MEDICAL CONGRESS (PRNewswire) - "Cadrenal Therapeutics, Inc...today highlighted a key opinion leader presentation at the November 2024 European Association for Cardio-thoracic Surgery (EACTS) Mechanical Circulatory Support Summit that featured tecarfarin historical data and Cadrenal's proposed clinical trial protocol to evaluate tecarfarin versus warfarin in patients with the Abbott HeartMate3 (HM3) left ventricular assist device (LVAD)....In the presentation Dr. Mehra highlighted data from past trials demonstrating the inverse relationship between bleeding rates and time in therapeutic range (TTR) for HM3 patients, and evidence from prior studies indicating tecarfarin's potential ability to improve TTR. He included data from a trial in end-stage kidney disease (ESKD) patients showing that ESKD does not alter tecarfarin exposure while warfarin exposure is increased, explaining that this is one of the critical differentiators for tecarfarin because many LVAD patients have kidney impairment."

Clinical • Atrial Fibrillation • Cardiovascular

CADRENAL THERAPEUTICS PROVIDES THIRD-QUARTER CORPORATE UPDATE (PRNewswire) - "Recent financing transactions totaling $9.8 million increased its cash balance to approximately $11.3 million and strengthened its balance sheet. The net proceeds provide Cadrenal with additional working capital as it advances tecarfarin toward a pivotal Phase 3 trial."

Commercial • Atrial Fibrillation • Cardiovascular

Cadrenal Therapeutics Announces Exercise of Warrants for $4.7 Million Gross Proceeds (PRNewswire) - "Cadrenal Therapeutics, Inc...today announced the entry into a definitive agreement for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 285,715 shares of common stock of the originally issued in July 2023, having an exercise price of $26.25 per share, at a reduced exercise price of $16.50 per share....The gross proceeds to the Company from the exercise of the warrants are expected to be approximately $4.7 million, prior to deducting placement agent fees and estimated offering expenses. The Company intends to use the net proceeds from the offering for its pivotal Phase 3 trial and partnering activities."

Financing • Atrial Fibrillation • Cardiovascular

Cadrenal Therapeutics Raises $5.1 Million via At-The-Market Facility (PRNewswire) - "Cadrenal Therapeutics, Inc...today announced that is has raised gross proceeds of approximately $5.1 million through its at-the-market (ATM) facility, selling an aggregate of 391,243 shares of common stock at a weighted average price of $13.15 per share....'The net proceeds provide us with added working capital as we continue developing tecarfarin, prepare for our pivotal Phase 3 trial...'"

Financing • Atrial Fibrillation • Cardiovascular

Safety and Tolerability of Tecarfarin (ATI-5923) in Healthy Chinese Volunteers: Multiple Oral Dose-Escalation Phase I Trial. (PubMed, Am J Cardiovasc Drugs) - P1 | "Tecarfarin was well-tolerated by Chinese volunteers. Dose titration was needed for tecarfarin doses larger than 20 mg to keep the INR in the target range."

Journal • P1 data

EMERGING ANTICOAGULANTS FOR THE THROMBOPROPHYLAXIS OF ATRIAL FIBRILLATION IN PATIENTS WITH CHRONIC KIDNEY DISEASE. (WSMRF 2022) - "Summary of Results The four anticoagulants we found matching our inclusion criteria includes Betrixaban, Fondaparinux, Tecafarin and Ichorcumab. Tecarfarin has most of the benefits associated with warfarin but with less drug-drug interaction and a decrease kidney dependent metabolism...Conclusions Our review suggests there are multiple novel anticoagulants that may diversify the current EHRA and AHA recommendations for patients with concomitant Afib and ESRD. Although these therapies have demonstrated non-inferiority to warfarin, higher level trials are needed to further establish their therapeutic index and efficacy in the context of Afib and ESRD."

Clinical • Atrial Fibrillation • Cardiovascular • Chronic Kidney Disease • Nephrology • Pediatrics • Renal Disease

An Ascending, Multiple-Dose, Safety and Tolerability Study of Tecarfarin in Healthy Chinese Volunteers (clinicaltrials.gov) - P1; N=40; Enrolling by invitation; Sponsor: Lee's Pharmaceutical Limited

Clinical • New P1 trial

A Study to Evaluate the Safety and Tolerability of Tecarfarin in Healthy Chinese Volunteers (clinicaltrials.gov) - P1; N=40; Completed; Sponsor: Lee's Pharmaceutical Limited; Active, not recruiting ➔ Completed

Clinical • Trial completion • F2

A Study to Evaluate the Safety and Tolerability of Tecarfarin in Healthy Chinese Volunteers (clinicaltrials.gov) - P1; N=40; Active, not recruiting; Sponsor: Lee's Pharmaceutical Limited; Recruiting ➔ Active, not recruiting; Trial completion date: Dec 2018 ➔ Oct 2019; Trial primary completion date: Nov 2018 ➔ Jul 2019

Clinical • Enrollment closed • Trial completion date • Trial primary completion date