“Recently, Kancera announced the strategic decision to focus its business on the clinical development in the field of cardiovascular diseases, initially with the focus on treatment of ST-elevation myocardial infarction (STEMI). The decision was taken based on the extensive analysis conducted and the results from our previous clinical studies and our market access research that shows there is a high unmet medical need and a significant market opportunity for our two candidate drugs KAND567 and KAND145.

By focusing the company’s resources on one therapeutic area, we increase our chances of success. We are convinced a focused strategy is the best way to ensure that Kancera is leveraging its pipeline in the best possible way and building long-term value for both patients and shareholders. In the phase IIa FRACTAL study, KAND567 demonstrated an anti-inflammatory mode-of-action with the potential to protect the heart’s microvascular function and thereby prevent intramyocardial hemorrhage.

There is an emerging awareness that intramyocardial hemorrhage is strongly associated with an increased risk of cardiovascular events such as death and heart failure. Today, there is no available treatment to prevent intramyocardial hemorrhage, which means the medical need is significant and the healthcare system’s willingness to pay for such therapy is considered high.

The next step in the clinical development plan is to conduct a phase IIb study with KAND567 in STEMI, a study we will refer to as FRACTIVE. The FRACTIVE study will be built on the design that proved to be successful in the phase IIa study. We are now working intensively with the preparations for conducting the study, e.g. with defining the study design and establishing the required collaborations with key opinion leaders, investigators, contract research organizations and contract manufacturers and to anchor the study design with regulatory authorities.

In parallel, our business development activities are ongoing to target potential industrial partners and specialist investors with the objective to finance the clinical development towards market approval and commercialization.”

Solna February 21, 2025