Adagio Medical Holdings (ADGM) Q3 2025 earnings summary

Executive summary

• Completed enrollment in pivotal FULCRUM-VT IDE clinical trial for vCLAS Cryoablation System in October 2025; FDA Breakthrough Device Designation received in April 2025.

• Achieved strong preliminary results in the FULCRUM-VT trial, with 97% acute effectiveness and favorable safety profile.

• Closed a private placement for up to $50 million, with $19 million upfront to fund FDA submission and next-gen catheter development.

• Strengthened leadership with the appointment of a new CFO to support growth strategy.

• Focused on developing and commercializing ULTC technology for ventricular tachycardia; paused commercial activity in Europe during 2025.

Financial highlights

• Revenue for Q3 2025 was $132,000, up from $53,000 in Q3 2024; revenue was nil for the nine months ended September 30, 2025, due to inventory buyback and pause in European commercial activity.

• Net loss for Q3 2025 was $10.1 million, compared to $4.6 million in Q3 2024; net loss for the nine months ended September 30, 2025, was $21.8 million.

• Cash and cash equivalents were $4.7 million as of September 30, 2025, down from $20.6 million at December 31, 2024.

• Operating cash outflows were $14.9 million for the nine months ended September 30, 2025.

• Research and development expenses were $2.8 million for Q3 2025 and $8.4 million for the nine months ended September 30, 2025.

Outlook and guidance

• Proceeds from the recent financing are expected to fund FDA submission activities, ongoing product development, and operations for at least 12 months from report issuance.

• Management anticipates further gross proceeds if warrants from the private placement are exercised.

• Plans to submit FULCRUM-VT trial results for FDA approval in the first half of 2026.

• Additional capital may be required for future development, clinical, and commercialization activities.