Interim Report H1 2026

Revenue and Result
Scandinavian Real Heart AB is currently engaged in research and development and currently has no sales of its own products. Research and development costs incurred for Realheart® TAH were capitalized during the period January 1 - June 30, 2026, in the amount of SEK 17.5 million.

Employees
The number of employees in the Group at the end of the quarter was 18 full-time employees and 1 hourly employees.

Transactions With Related Parties
No significant transactions with related parties have taken place during the period.

Significant Risks and Uncertainties
Realheart’s focus is on getting through the preclinical phase (hemolysis, GLP studies in animals and endurance tests) to be able to start clinical studies. This means that the Company must finalize the version of both the controller and the heart pump to be included in these tests. Realheart must also hold parallel discussions with the Notified Body in the EU and with the FDA in the US to ensure the fastest and safest route for the product to market.

The Company is continuously working on measures to minimize delays. Furthermore, the continued product development requires that the Company can secure funding in both the short and long term. The board is continuously working on different scenarios to ensure the Company’s future operations.

Financial Position
At the end of the period, the Group’s cash and cash equivalents amounted to SEK 40.0 million. At present, the Group does not generate its own positive cash flow and is thus dependent on external financing. In order to solve the longer-term financing needs, the Board of Directors is continuously evaluating options for further capitalization of the Company.

CEO Comment
At the beginning of 2026, we identified three operational priorities for the year: increasing our production rate, advancing our in vivo program toward longer-term support, and demonstrating long-term system reliability. These priorities support our path toward future clinical studies. Following the end of the reporting period, the Board of Directors adopted a new strategic goal: for Realheart to be ready for a first-in-human implantation of Realheart® TAH in February 2028. This milestone provides a clear framework for our development activities and reflects the substantial progress made across multiple critical areas of the program. We believe this represents an ambitious yet achievable target and an important step toward bringing our technology closer to patients.

Significant Events During the First Half of the Year
On January 13, Realheart announces that the subscription period in the previously resolved rights issue has commenced. The issue is carried out with the aim of strengthening the Company’s financial position and enabling continued development and commercialization of Realheart® TAH.

On January 28, Realheart announces the outcome of the Rights Issue, showing that 2,502,531 shares were subscribed for with subscription rights, corresponding to approximately 50 percent of the Rights Issue. In addition, the Company has received subscription applications for 295,402 shares, corresponding to approximately 6 percent of the Rights Issue, for subscription without subscription rights. A total of 2,797,933 shares were subscribed for with subscription rights and subscription applications, corresponding to approximately 56 percent of the Rights Issue. This means that guarantee commitments of 701,160 shares, corresponding to approximately 14 percent of the Rights Issue, will be utilized. A total of 3,499,093 shares were thus subscribed, corresponding to approximately 70 percent of the Rights Issue. Through the Rights Issue, the Company will receive approximately SEK 49 million before issue costs.

On February 11, Realheart announces that the Company has been granted patent approval by the European Patent Office (EPO). The patent concerns both the core technology of Realheart® TAH, pertaining to the structure and function of the total artificial heart, and the integrated feedback mechanism that regulates the device’s cardiac output. The recent approval grants a unitary patent protecting the technology in 17 EU countries, including Realheart’s key markets, France and Germany, and its home market, Sweden, through 2041.

On March 4, Realheart announces that the Company has been granted a patent approval in India. The patent covers a control method and system configuration for artificial heart products, such as Realheart® TAH, featuring integrated feedback mechanisms for real-time regulation of cardiac output. The approval grants patent protection in India until March 2041.

On April 9, Realheart announces that the Company’s artificial heart technology, its founder and inventor Dr. Azad Najar, and long-standing clinical research collaborator Professor Göran Dellgren are featured in the new SVT documentary series Victorias Hjärta, premiering on April 9, 2026. The series provides a rare behind-the-scenes look at Swedish cardiac care, the existential realities of heart disease, and the medical advances that save lives every day.

On April 21, Realheart announces that a new in vitro study, published in the peer-reviewed journal Artificial Organs, demonstrates that the Realheart® TAH causes approximately half the level of hemolysis – the mechanical destruction of red blood cells – compared with the only FDA-approved artificial heart device currently in wide clinical use. The differences across all primary endpoints were statistically significant (p < 0.05). In summary, Realheart® TAH causes significantly less harm to red blood cells than the market-approved alternative.

Significant Events After the End of the Period
On August 20, Realheart announces that the Company’s Board of Directors has adopted a new strategic goal: that the Company shall be ready for the first-in-human implantation of the Realheart® Total Artificial Heart in February 2028. The Company’s communicated 2026 objectives remain important milestones on the path toward first-in-human implantation readiness.