Mendus — CADENCE trial enrols first patient

Mendus (OMX: IMMU)

Last close As at 21/02/2025

SEK8.14

0.04 (0.49%)

Market capitalisation

SEK408m

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Research: Healthcare

Mendus — CADENCE trial enrols first patient

Mendus has announced that the first patient has been enrolled in the CADENCE trial, sponsored by the Australasian Leukaemia and Lymphoma Group (ALLG). This is a multi-centre, randomised, controlled Phase II study evaluating vididencel in combination with oral azacitidine, versus oral azacitidine alone, as a potential maintenance treatment for acute myeloid leukaemia (AML). We note that the first patient enrolment is slightly later than previously guided, however, since the trial is being run by the ALLG, Mendus has limited control. Importantly, management has communicated that it is not reliant on CADENCE for the pivotal stages of development, but it will use the safety data to support its regulatory dossier for the programme. In parallel to CADENCE, the AML programme is on track to be pivotal-stage ready from H225.

Jyoti Prakash

Written by

Jyoti Prakash, CFA

Analyst, Healthcare

Healthcare

Clinical update

21 February 2025

Price SEK8.14
Market cap SEK408m

Net cash at 31 December 2024 (excluding lease liabilities)

SEK101.1m

Shares in issue

50.4m
Free float 25.0%
Code IMMU
Primary exchange OMX
Secondary exchange N/A
Price Performance

Business description

Mendus is a clinical-stage immunoncology (IO) company based in Sweden and the Netherlands. The company specialises in allogeneic dendritic cell biology and currently has two lead, cell-based, off-the-shelf therapies for haematological and solid tumours.

Analysts

Jyoti Prakash, CFA
+44 (0)20 3077 5700
Arron Aatkar, PhD
+44 (0)20 3077 5700

Mendus is a research client of Edison Investment Research Limited

Note: PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments. EPS is adjusted for 20:1 share consolidation (June 2024).

Year end Revenue (SEKm) PBT (SEKm) EPS (SEK) DPS (SEK) P/E (x) Yield (%)
12/23 29.6 (101.6) (4.39) 0.00 N/A N/A
12/24 5.0 (128.4) (2.64) 0.00 N/A N/A
12/25e 0.0 (125.6) (2.49) 0.00 N/A N/A
12/26e 864.7 777.4 15.44 0.00 0.5 N/A

According to the announcement, Mendus has enrolled the first patient in the AMLM22-CADENCE trial, an encouraging sign that the company’s lead programme is making headway, in our view. Following the encouraging data from the preceding ADVANCE II trial (discussed in detail in our December 2024 outlook note), CADENCE is evaluating vididencel in combination with oral azacitidine, the current standard-of-care and only drug approved for AML maintenance. The CADENCE trial will be conducted in two parts, the first of which will assess safety in 40 patients, and the second of which will assess efficacy in 100 patients. It includes both measurable residual disease-positive (MRD+) and MRD negative (MRD-) patients in first complete remission after induction chemotherapy. Participants are randomised to receive either oral azacitidine alone, or oral azacitidine in combination with vididencel (administered as four biweekly intradermal injections, followed by three booster injections up to six months after starting treatment).

The priority for Mendus remains preparations for the global registrational trial, which will aim to include 100–120 sites across the EU, the US and the Australasian region, testing vididencel in combination with oral azacitidine in MRD+ patients, targeting 150–200 participants in total. Trial preparations have been endorsed by the EMA and FDA, and the company’s manufacturing alliance with NorthX Biologics is on track to support pivotal-stage readiness from H225. We expect this will be followed by the launch of the registrational trial in early 2026.

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