Financial Performance - Cost of revenue for Q4 2025 was $58 thousand, a significant decrease from $1.5 million in Q4 2024, and for the full year 2025, it was $0.7 million compared to $3.3 million in 2024[4] - Research and development expenses for Q4 2025 were $2.2 million, down from $3.4 million in Q4 2024, and for the full year 2025, they totaled $10.6 million compared to $12.2 million in 2024[5] - Selling, general and administrative expenses for Q4 2025 were $1.7 million, a decrease from $4.1 million in Q4 2024, and for the full year 2025, they were $10.6 million compared to $20.0 million in 2024[6] - Net loss for Q4 2025 was $3.3 million, a substantial reduction from a net loss of $57.4 million in Q4 2024, and for the full year 2025, the net loss was $25.1 million compared to $75.0 million in 2024[7] - Cash and cash equivalents as of December 31, 2025, were $17.1 million, down from $20.6 million as of December 31, 2024[8] Clinical Trials and Product Development - The company completed enrollment of the 209-patient FULCRUM-VT pivotal FDA Investigational Device Exemption trial, which is intended to support the premarket approval application for the vCLAS™ System[2] - Preliminary results from the FULCRUM-VT trial demonstrated 97% acute effectiveness with a favorable safety profile using the proprietary ultralow temperature technology[2] Strategic Initiatives - The company closed a private placement with gross proceeds of up to $50 million, with approximately $19 million expected to fund FDA submission activities and ongoing next-generation catheter development[2] - The company appointed Sean Salmon to the Board of Directors, enhancing strategic and governance expertise, and strengthened the executive leadership team with new senior vice presidents[2] - The company is focused on preparing for commercialization of the vCLAS™ technology while continuing to develop next-generation solutions for patients with ventricular tachycardia[3]
Adagio Medical Holdings, Inc.(ADGM) - 2025 Q4 - Annual Results