Scandinavian Real Heart (HEART) Q1 2025 earnings summary

Executive summary

• Realheart® TAH, a total artificial heart mimicking human physiology, advanced preclinical studies and received FDA HUD designation, enabling expedited US regulatory pathways.

• SEK 30.2 million raised through directed share issues and warrants, strengthening financial position for clinical trial preparations.

• Patent granted in Japan for a biocompatible pressure sensor, supporting market protection and future integration in advanced medical systems.

• Focus remains on progressing to first-in-human clinical trials and expanding product inclusivity for broader patient groups.

Financial highlights

• Operating income for Q1 2025 was SEK 69,994, unchanged year-over-year; net loss widened to SEK -9.9 million from SEK -7.8 million in Q1 2024.

• Cash and cash equivalents at period end were SEK 11.5 million, down from SEK 23.7 million at year-end 2024.

• Equity/assets ratio stood at 81% for the group.

• No product sales; SEK 7 million in R&D costs capitalized during the quarter.

Outlook and guidance

• Continued focus on completing preclinical studies and securing regulatory approvals to initiate clinical trials.

• Ongoing evaluation of further capitalization options to support long-term development and operations.