“The first quarter was a busy period for the Kancera team as we continued our preparations for the FRACTIVE study, a planned phase IIb study in ST-elevation myocardial infarction (STEMI). We also signed a letter of intent agreement with the US biotech company Recardio Inc. with the goal to out-license our candidate drugs KAND567 and KAND145. Both of these activities are anchored by our strategic decision to focus the company’s development on cardiovascular diseases.

Our new strategic focus that we announced in the fourth quarter 2024 was based on extensive analysis, including market access research supporting our preliminary product positioning in STEMI. Based on our research we are optimistic that we can meet the expected regulatory requirements from both the FDA and the EMA and that payers will pay for our treatment. All together, we see that there is significant market potential given the promising data from our previous clinical studies. We see an opportunity for our candidate drugs to become first-in-class and a totally new treatment option of acute myocardial infarction in high-risk patients.

The treatment aims to prevent hyperinflammation and intramyocardial hemorrhage in connection with percutaneous coronary intervention (PCI), which is standard-of-care for these patients, and ultimately reduce the risk of death and heart failure. The treatment of heart failure is a significant burden to healthcare systems globally. Hence, if we can reduce the risk of heart failure post PCI, we can contribute to a significant reduction of treatment costs for the global health care systems.

With our strategic focus on cardiovascular diseases, signing the letter of intent with Recardio makes business and scientific sense. Both Kancera and Recardio have late clinical-stage programs targeting acute myocardial infarction and joining our programs and capabilities, we have the potential to create a leading specialty care company in the field of cardiovascular diseases to the benefit of patients and that US and European investors will find attractive. With this joint pipeline and equity story, we are together in a better position to build the financial options needed to advance our programs into the next clinical phase.

Together with Recardio we have had investor meetings with potential US investors aiming to secure financing of the combined business’ long term business plan. This business plan includes the planned FRACTIVE study and Recardio’s planned phase III study with dutogliptin in acute myocardial infarction.

During the first quarter Kancera has also announced its intention to change the name of the company to Novakand Pharma, a change that is in line with the company’s decision to not conduct R&D in the field of cancer and focus on cardiovascular diseases. Subject to a decision at the Annual General Meeting, we plan to implement the new company name in September.

During the second quarter, Kancera also reported the last patient had completed the last visit in the ongoing phase Ib/IIa KANDOVA study evaluating KAND567 in ovarian cancer. In total, 18 patients were recruited to the study, of which 15 patients are fully evaluable, and the top-line results are expected to be presented in the third quarter 2025.

The start of 2025 has certainly been busy, preparing for the planned FRACTIVE study and the extensive work with Recardio to secure financing of the joint business plan and the planned clinical studies. The general macro environment implies that the targeted capital raise may take time, but we are convinced that a transaction with Recardio enables creating a leading specialty care company in the field of cardiovascular diseases, of value to both patients and shareholders.”

Solna May 23, 2025