“We view the top line results from the FRACTAL study as very positive and that this exploratory study is a success for Kancera. We have met the primary objective, meaning that we have demonstrated that KAND567 is safe and tolerable at the expected dose level for treatment of high-risk STEMI patients undergoing acute percutaneous coronary intervention. It’s very encouraging that we now in two consecutive trials in very vulnerable patients, COVID and STEMI, have shown that our candidate drug is safe. We have also repeated our achievement from the previous phase IIa study in COVID patients – to demonstrate target engagement of the fractalkine axis in human.

Equally important, we have met the objective to identify signals of heart-protective effects. The two most convincing signals are a reduction of left ventricular thrombosis and reduced intramyocardial hemorrhage. This is certainly encouraging considering that the effect comes on top of an intensive clinical treatment with anticoagulants and platelet inhibitors. It is worth pointing out that intramyocardial hemorrhage is an independent marker for MACE (major adverse cardiovascular event), which is a commonly used endpoint in pivotal studies. Based on our discussions with cardiologists we are convinced that these signals of effect are of high clinical relevance as these markers are strongly correlated with reduced risk of severe complications such as reperfusion injury, systemic embolism and heart failure.

In addition to this, all other cardiac function and integrity markers were numerically in favor of KAND567, including infarction size. Recognizing that this was an explorative study, not powered to be statistically significant, we are encouraged that all results point in the right direction.

We therefore view the study outcome as successful and clearly argues for progressing this program to pivotal studies. We will now intensify our efforts to seek a partner for the continued development of KAND567 in cardiovascular diseases.”

Solna, December 20, 2023