Summary of Interim Report April - June 2025
| Group Overview | 2025-04-01 | 2024-04-01 | 2025-01-01 | 2024-01-01 | 2024-01-01 |
| 2025-06-30 | 2024-06-30 | 2025-06-30 | 2024-06-30 | 2024-12-31 | |
| 3 mon | 3 mon | 6 mon | 6 mon | 12 mon | |
| Operating income | 20 592 | 30 322 | 90 586 | 40 380 | 50 054 |
| Earnings after financial items | -8 729 586 | -6 321 701 | -18 627 956 | -14 106 388 | -34 350 238 |
| Balance sheet total | 87 939 144 | 86 640 481 | 87 939 144 | 86 640 481 | 83 279 673 |
| Equity / assets ratio | 85% | 74% | 85% | 74% | 81% |
| Earnings per share | -1,98 | -0,07 | -4,23 | 0,15 | -16,61 |
| Number of shares* | 4 398 704 | 96 994 446 | 4 398 704 | 96 994 446 | 2 068 152 |
| Parent Company Overview | 2025-04-01 | 2024-04-01 | 2025-01-01 | 2024-01-01 | 2024-01-01 |
| 2025-06-30 | 2024-06-30 | 2025-06-30 | 2024-06-30 | 2024-12-31 | |
| 3 mon | 3 mon | 6 mon | 6 mon | 12 mon | |
| Operating income | 20 592 | 30 322 | 90 586 | 40 380 | 50 054 |
| Earnings after financial items | -8 618 743 | -6 158 452 | -18 458 587 | -13 922 442 | -32 409 725 |
| Balance sheet total | 90 551 912 | 87 141 085 | 90 551 912 | 87 141 085 | 85 837 128 |
| Equity / assets ratio | 86% | 74% | 86% | 74% | 82% |
| Earnings per share | -1,96 | -0,06 | -4,20 | -0,14 | -15,67 |
| Number of shares* | 4 398 704 | 96 994 446 | 4 398 704 | 96 994 446 | 2 068 152 |
* In November 2024, a reverse share split was carried out whereby 100 shares were combined into 1 share.
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 April 1 - June 30, 2025, in the amount of SEK 6.7 million.
Employees
The number of employees in the Group at the end of the quarter was 12 full-time employees and 2 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 27.9 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
Over the last quarter, Realheart has been visible in several different forums. In a recently aired public service documentary in Germany and France, Realheart® TAH was showcased, putting the spotlight on artificial hearts as a future treatment option for heart failure patients. Shortly thereafter, our state-of-the-art system was described in a research article in the prestigious journal Artificial Organs. Together with strategic events, including the election of Oskar Mellgren as new chairman of the board, we remain topical while making essential strides forward in the development of Realheart® TAH.
Significant Events During the Second Quarter of the Year
During April, the company received a total of SEK 25.7 million before direct issue costs, which partly stems from payment for shares subscribed for in the directed issue that the board decided on in March 2025 and partly from payment for shares subscribed for through warrents of series TO3.
On April 29, Realheart announces that the company has been granted a patent approval by the Japan Patent Office (JPO) concerning a pressure sensor device for artificial hearts and circulatory support systems such as Realheart® TAH. The patent is a supportive measure to ensure market protection of the company's device on the Japanese market and is valid until 2041.
On May 2, Realheart announces that EIC has Subscribed for 600,000 Shares in the Directed Share Issue Resolved by the Board of Directors of Realheart on 27 April 2025.
At the general meeting in June, two new board members were elected: Mia Tomczak and Oskar Mellgren, who was also elected chairman of the board.
On June 10, Realheart announces that the company's technology is presented and showcased in a public service documentary broadcasted by ARTE TV, targeted at the German and French general public. The documentary features a visit to Realheart and showcases one of the company's preclinical implantation procedures. Additionally, Realheart® TAH is demonstrated in the lab, highlighting its unique adaptive pressure system and the patient-friendly controller that is under development.
On June 17, Realheart announces that the company has been granted patent approval by the United States Patent and Trademark Office (USPTO) concerning the core technology of Realheart® TAH. The same patent has previously been approved in the European Patent Office (EPO). The patent approval confers market protection for the device in the US until 2037.
On June 18, Realheart announces that the company's scientific collaborator at the Royal School of Technology (KTH) has published new results in the scientific journal Artificial Organs, validating the function of Realheart® TAH to produce systemic hemodynamic balance, as well as adaptively adjust the system's cardiac output based on pressure sensor data. The new data are based on simulations from a state-of-the-art semi-virtual system financed through a joint strategic initiative between Vinnova, Formas and the Swedish Energy Agency (Energimyndigheten).
On June 27, Realheart announces that the company is shifting from issuing financial reports once per quarter to semi-annual reporting. The change is made as a strategic decision intended to free up time for the company's management to be dedicated to the development of Realheart® TAH and increase cost efficiency. Consequently, the financial reporting will comprise three reports: one for the first half-year, one for the second half-year/full year, and an annual report.
Significant Events After the End of the Period
On July 7, Realheart announces that the company has received an outstanding payment of approximately SEK 6.8 million from the European Innovation Council (EIC) following the company's directed share issue communicated on May 2, 2025, wherein it was announced that EIC has subscribed 600,000 shares to the subscription price of SEK 11.31 per share.
On August 11, Realheart announces that the company has received its third disbursement from the European Innovation Council (EIC) grant, initially awarded in December 2021. The grant aims to support the development of the artificial heart Realheart® TAH. The payment of EUR 250,000 equals 10% of the total grant sum of EUR 2.5 million.
For more information, please contact:
Ina Laura Perkins, CEO
Phone: +46 (0) 70 406 49 21
E-mail: inalaura.perkins@realheart.se
Certified Adviser: Svensk Kapitalmarknadsgranskning AB, www.skmg.se
About Us
Scandinavian Real Heart AB (publ) is developing the first artificial heart that mimics the shape, function, and blood flow pattern of the human heart. These unique product features provide completely new opportunities to save lives and give patients a good quality of life while waiting for a heart transplant. In the future, artificial hearts may also become an alternative to transplantation for broader groups of patients with severe heart failure. Realheart® TAH (Total Artificial Heart) is now being evaluated in extensive preclinical trials ahead of a first clinical study in patients. The company's shares are traded on Nasdaq Stockholm First North Growth Market. For more information, visit www.realheart.se
This information is information that Scandinavian Real Heart is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-08-28 08:30 CEST.
