Kancera AB (Kancera) has previously reported the initial top line results from the FRACTAL study and Kancera presents the statistical analyses that confirm that: the primary objective was met, by showing that KAND567 was safe and well tolerated in high-risk ST-elevation myocardial infarction patients., the secondary objective was met, by demonstrating signals of cardio-protective effects. these signals of cardio-protective effect are clinically relevant as they are markers for commonly used efficacy endpoints in myocardial infarction pivotal studies. In December 2023, Kancera reported the initial top line results From the FRACTAL study, an exploratory phase IIa, randomized, two-armed parallel-group, placebo-controlled, double-blind, multi-centre trial of KAND567 in high-risk ST- elevation myocardial infARction (STEMI) patients undergoing percutaneous coronary intervention.

Kancera reported that both the primary objective, to demonstrate safety and tolerability, and the secondary objective, to demonstrate signals of cardio-protective benefits, were met. The top line results were based on the primary analysis report from the Newcastle University, Kancera's collaboration partner in the study. Since then, Kancera has received the complete study database, validated the results and conducted additional statistical analyses.

Kancera presents the results of the statistical analyses, including analyses on sub-group level of the previously reported top line results. Primary endpoints confirm a favorable safety profile in STEMI patients. In total, 71 patients were recruited to the study and included in the evaluation of the primary endpoints.

GAD5-SD (%), Late gadolinium-enhanced MRI was used at Day 90 to compare infarction size in patients administered placebo or KAND567 using a thresholding of 5 standard deviations above the mean signal intensity from normal myocardium. Signals of effects are markers for efficacy endpoints commonly used in pivotal studies. Kancera has in previous clinical studies demonstrated safety and tolerability and pharmacological engagement of the fractalkine axis in severely inflamed patients.

The FRACTAL study has now confirmed these results in high-risk STEMI patients. With demonstrated pharmacological effect, i.e. proof-of-mechanism in human, and a confirmed favorable safety profile, Kancera has reached an important development milestone, which overall contributes to a reduced risk and increased the probability of success going forward towards market approval. Further, Kancera believes that the signals of cardio-protective results demonstrated, increase the probability that KAND567 will meet future product registration efficacy endpoints, as the FRACTAL results are fully aligned with well-established integrated parts of "Major Adverse Cardiovascular Events (MACE)"3, which commonly defines endpoints in pivotal studies: Reduced IM hemorrhage is strongly associated with, and an independent marker of, a lower risk of heart failure.

Reduced LV thrombosis is strongly associated with a lower risk of systemic embolism, including stroke. As described above, this is typically measured through follow up of Major Adverse Cardiovascular events (MACE). Kancera's preliminary primary efficacy endpoint in a combined phase IIb/III pivotal study is a composite of cardiovascular death, heart failure, non-fatal MI or stroke, measured as relative risk reduction and absolute risk reduction compared to placebo.