Isofol Medical AB (publ) announced that, having received access to additional data, the company does not consider it justified to continue conducting the AGENT study. Review of study data will continue until the company can compile the final study report which is estimated to take place during the fourth quarter of 2022. On August 3, 2022, Isofol presented top line results showing that the AGENT study did not meet its primary or key secondary endpoints.

Isofol has subsequently taken several operational measures and received additional data from the study. The status of the company and the AGENT study is as follows: Based on further analysis of AGENT study data Isofol's assessment is that the conclusions related to the endpoints objective response rate (ORR) and progression-free survival (PFS) that were presented in connection with top line results on August 3 will not change. Further analysis has also shown a preliminary indication of a non-significant detrimental trend in the endpoint of overall survival (OS) for the experimental arm of the study compared with the control arm.

This was one of the safety goals of the AGENT study. However, the analysis indicates that both arms of the AGENT study performed well for all-comer patients with non-operable metastatic colorectal cancer (mCRC), irrespective of mutational status, in relation to today's standard of care. The company will continue to further analyze the study data as it becomes available in order to compile a final study report.

This report will consist of, among other things, analysis of subgroups and gene expression as well as additional safety data. The ambition remains to present detailed study data at a scientific congress or in a scientific publication during 2023. Therefore, Isofol's overall assessment is that it is no longer justified to continue conducting the AGENT study.

Patients who are still being treated in the experimental arm of the study will therefore be offered the opportunity to switch to standard of care and follow-up of patients will thereby be terminated. Several measures have been implemented to use financial resources in an appropriate and cost-effective way in order to protect the company's financial standing. In light of this, Isofol's board of directors has decided to evaluate possible courses of action for the company's future in order to maximize its value.

  Isofol intends to keep the stock market informed regarding the AGENT study's results and the company's future on a continual basis, and expects to be able to provide a new status update in the beginning of the fourth quarter of 2022.