Mendus Q2'24 earnings preview: Patient recruitment started for CADENCE trial

Mendus will release its Q2 results on Friday, August 23, at 08:00 am CEST. The live Q2 presentation and business update can be viewed here. Patient enrollment has started for the all-important Phase II CADENCE trial for acute myeloid leukemia (AML) during Q2’24. During the quarter, the company also published research on immune activation by vididencel in the ALISON (vididencel for ovarian cancer) and ADVANCE II (vididencel for AML) trials. Mendus also announced plans to bring ilixadencel back into clinical development for soft tissue sarcomas. With the funding secured, the company should have the necessary building blocks to achieve a data readout of the CADENCE trial as well as to finalize building readiness for a pivotal-stage trial for AML by H2’25.

Q2 news were on vididencel’s anti-tumor effects and a new trial with ilixadencel

During the second quarter, Mendus announced research results on the ability of vididencel to induce anti-tumor immune responses. We have previously commented on the results of the ADVANCE II trial here and the ALISON trial here. In aggregate, these results provide further evidence of vididencel's ability to induce anti-tumor immune responses. These responses have correlated positively with clinical benefits. However, we caution that further research is needed to confirm that vididencel is the sole cause of the observed benefits. During the second quarter, Mendus also announced that its second asset, ilixadencel, will return to the clinic. Ilixadencel will be evaluated in a new trial in collaboration with the French cancer center Institut Bergonié. The trial will combine ilixadencel with the anticancer drugs regorafenib and avelumab in soft tissue sarcomas.

Mendus’ leading clinical development is the CADENCE trial (formally AMLM22-CADENCE) which started enrolling patients in Q2'24. The trial is being conducted in collaboration with the Australasian Leukaemia and Lymphoma Group (ALLG). CADENCE combines Mendus' lead asset, vididencel, with the standard of care oral azacitidine for AML maintenance therapy. Mendus plans to report data in mid-2025. The company is also building readiness for pivotal trials, including upscaling manufacturing of vididencel in partnership with NorthX. We believe these goals are achievable with the financing already in place. Mendus' cash runway is until Q3'25, strengthened by a 317 MSEK financing round in summer 2023 and a recent exercise of warrants.

On the financial side, we expect an EBIT of -30.1 MSEK (Q2'23: -27.7 MSEK). We expect a slightly higher loss compared to Q2'23 due to R&D costs.

In H2'24, focus on start of CADENCE trial and readout of ALISON trial

If successful, vididencel could build long-lasting immunity against cancer and help extend disease-free and overall survival. In 2024 this target is mainly driven by the CADENCE trial. Current preparations for pivotal readiness could mean that a registration trial could start in late 2025-early 2026, although this estimate is subject to significant uncertainty. We also expect to see data from the Phase I ALISON trial in 2024. In our long-term estimates, we expect vididencel for AML to be launched in 2029, with further launches to follow in 2030 and 2031. For more detailed information, see our recent Initiation of coverage report.