Mendus Q1 on Friday: Patient recruitment to start for the CADENCE trial

Mendus will release its Q1 report on Friday, May 17 at 08:00 CEST. According to the recent business update, the company is starting patient recruitment for the Phase II CADENCE trial in acute myeloid leukemia (AML) in Q2'24. In April, Mendus also announced the exercise of TO3 warrants that extend the company's cash runway until Q3'25. In our view, the company should have the necessary building blocks to achieve a data readout from the CADENCE trial as well as to finalize readiness for a pivotal-stage trial in AML by H2'25.

Q1 provided a business update and extension of cash runway

Mendus provided a business update in Q1. The company announced plans to start patient recruitment for the CADENCE trial (formally AMLM22-CADENCE) during Q2’24 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. The first phase of the trial will enroll 40 patients, half of whom will receive vididencel + standard-of-care and half of whom will receive only standard-of-care. An additional 100 patients will be enrolled in the second phase. Mendus plans to report data from these two phases in mid-2025 and late 2026, respectively. The company is also building readiness for a pivotal-stage trial, including upscaling manufacturing of vididencel in partnership with NorthX. We believe these targets 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 the recent 69 MSEK exercise of TO3 warrants.

In terms of finances, we expect EBIT of -28.6 MSEK up 3.4% vs Q1’23 (-29.6 MSEK). We expect a smaller loss compared to Q1’23 due to lower employee costs (30 employees at year-end vs 33 at the end of Q1’23).

In 2024 focus is on the launch of CADENCE trial and readout of the ALISON trial for ovarian cancer

If successful, vididencel could build long-lasting immunity against cancer and help prolong disease-free and overall survival. This target in 2024 is mainly driven by the CADENCE trial. Current preparations for the pivotal stage readiness could mean starting a registrational trial in late 2025 or early 2026 although this estimation includes major uncertainties. We also expect a data readout of the Phase I ALISON trial exploring vididencel for ovarian cancer during 2024. In our long-term estimates we expect vididencel to launch for AML in 2029 with further launches to follow in 2030 and 2031. For details, see our recent Initiation of Coverage report.