Mendus AB (publ) Interim Report January – June 2023

“In the second quarter of 2023, Mendus’ main objectives were focused on driving the evolution of our pipeline and securing the related financing. The progress made in the previous quarters, including the positive survival data of the ADVANCE II trial, improvements of our production processes and adjusting our strategy to the rapidly evolving cancer therapy landscape, provided the basis for a next financing round, which we announced last June. The directed placement and rights issue totaling approximately SEK 317M will support the ongoing ADVANCE II and ALISON vididencel trials, the start of a combination trial with vididencel in AML maintenance and the start of a new clinical trial with ilixadencel in soft tissue sarcomas. The new financing will furthermore be used for the development of our preclinical NK cell program and the recently announced manufacturing alliance with NorthX Biologics.

Mendus is committed to changing the course of cancer treatment by positioning our product candidates where they can have the biggest impact on survival, combined with a benign safety profile. This is particularly relevant for cancer maintenance therapy, which aims to extend disease-free survival following initial treatment. Our lead program vididencel is currently studied in the ADVANCE II monotherapy Phase 2 trial as a maintenance therapy for acute myeloid leukemia (AML). Following the positive survival data reported at the end of 2022, we prepare for a next read-out of the ADVANCE II trial in the fourth quarter of 2023. In the meantime, we carry out the in-depth analysis of the study samples collected as part of the trial. These immunomonitoring data provide useful insights in the interaction between vididencel and the immune system. Immunological analyses of patient samples before and after vididencel treatment support vididencel’s mode of action as an immunotherapy which boosts antitumor responses against residual disease and were presented at the CIMT and EHA conferences during the second quarter.

Based on the monotherapy efficacy data and excellent safety profile reported in the ADVANCE II trial, combined with supportive preclinical data, an obvious next step is to combine vididencel with oral azacitidine, currently the only approved drug for AML maintenance. This new combination trial is expected to start before the year-end of 2023. The trial with oral azacitidine will be important to study this combination in the clinical setting and as a step-up towards pivotal-stage development. In parallel, Mendus will set up the large-scale manufacturing of vididencel required for late-stage clinical development and commercialization. For this, Mendus has closed a manufacturing alliance with NorthX Biologics, a leading Swedish contract development and manufacturing organization for cell and gene therapies. This alliance will provide stability for our manufacturing plans and bring additional resources and competence. NorthX Biologics will be a significant partner going forward.