Isofol Medical AB (publ) reported data from the AGENT study that formed the basis for its assessment that it was not justified to continue the study. Isofol will continue to collect and review data related to, among other areas, subgroups and gene expression, in order to identify possible commercial value. Data has so far failed to show any concrete results of value, which means severely limited commercial potential.

The AGENT study will be terminated in accordance with applicable ethical considerations and regulatory requirements, which will occur during the autumn. Parallel to this, Isofol's Board of Directors will evaluate possible courses of action to secure the greatest possible value for Isofol's shareholders. The information in this press release is intended for investors.

On August 3, 2022 Isofol presented top-line results showing that the AGENT study met neither its primary endpoint nor its key secondary endpoints. On August 31, 2022 the company announced that based on available data([1]), it was not justified to continue conducting the AGENT study further. Now, Isofol is able to present data from the AGENT study that formed the basis for this assessment and that indicate a severely limited clinical and commercial value for Isofol: -- The Palalue[2] for the primary endpoint of objective response rate (ORR) was approximately 0.85 and the study arms displayed no difference in outcome.

Data for this endpoint is deemed to be final. -- Progression-free survival (PFS) was approximately 12.8 months for the arfolitixorin arm and 11.6 months for the control arm, with a P-value of 0.76. Data for this endpoint is not final but it is not deemed to change significantly moving forward.

-- Analysis of overall survival (OS), one of the AGENT study's safety endpoints, showed a preliminary indication of a non-significant detrimental trend for the experimental arm of the study compared with the control arm. -- There was no difference between the study arms with regards to key safety data. -- No significant differences between the study arms in any subgroups have been identified so far.