Scandinavian Real Heart (HEART) Q4 2024 earnings summary

Executive summary

• Achieved key milestones in preclinical safety studies for RealheartⓇ TAH, with improved survival times in animal models, advancing toward FDA clinical study requirements.

• Received FDA Humanitarian Use Device (HUD) status for RealheartⓇ TAH, enabling potential fast-track regulatory pathways and initial market access for patients with advanced biventricular heart failure.

• Initiated collaborations with leading transplant surgeons and secured new patents, strengthening clinical and intellectual property positions.

Financial highlights

• Operating income for Q4 2024 was SEK 5,024, with full-year income at SEK 50,054, mainly from research grants; no product sales yet.

• Net loss for Q4 2024 was SEK -10.3 million; full-year net loss was SEK -34.4 million, reflecting ongoing R&D investments.

• Cash and cash equivalents at year-end were SEK 23.7 million; the company remains dependent on external financing.

• Equity/assets ratio remained strong at 81% for the group at year-end.

• Share reverse split (1:100) completed in November 2024, reducing the number of shares outstanding.

Outlook and guidance

• Focus remains on completing preclinical studies and securing regulatory approvals to initiate clinical trials.

• Ongoing efforts to secure both short- and long-term funding to support continued product development and operations.

• Plans to apply for Humanitarian Device Exemption (HDE) to enable limited market introduction in the US.