“Recently Kancera announced its strategic decision to focus on cardiovascular diseases. Short term, this decision means that the company’s resources will be focused on ST-elevation myocardial infarction (STEMI) and build on the previous positive phase IIa-results in the FRACTAL-study. In this clinical phase IIa study, it was demonstrated that KAND567’s anti-inflammatory mode of action has the potential to reduce intramyocardial hemorrhage following primary percutaneous coronary intervention (PCI). There is an emerging awareness that intramyocardial hemorrhage is strongly associated with an increased risk of mortality and heart failure. Today, there is no treatment available to prevent intramyocardial hemorrhage so the medical need for an effective drug is high. We therefore believe that there are good opportunities to position an upcoming product as part of the standard-of-care for high-risk STEMI patients undergoing primary PCI.

After the FRACTAL top-line results were presented, Kancera has conducted extensive market access research and development concerning the product positioning of our candidate drugs KAND567 and KAND145 in STEMI. Based on the preliminary positioning we have developed a high-level development plan up until market approval.

Our development activities have also included primary market access research, through interviews with regulatory experts that verify that our clinical development plan is in line with the anticipated regulatory requirements for market approvals and with US payers that suggest that there is a high willingness to pay, if the effect we expect to deliver based on the FRACTAL-study can be demonstrated in a phase III study.

Based on the market access research conducted, we assess that an annual turnover >USD 1 billion at peak sales is achievable in the US alone. Considering the potential of this project we believe that there is a significant upside in keeping the commercial rights in selected markets. We are therefore evaluating the opportunities for developing and commercializing our drugs by ourselves in selected markets, such as in the US, in combination with out-licensing of rights to partners in other key markets.”

Solna November 15, 2024