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SEK435m
Research: Healthcare
Mendus has announced a collaboration with Institut Bergonié, an established comprehensive cancer centre in France, to test ilixadencel in soft tissue sarcomas (STS) as part of an ongoing Phase I/II basket trial (REGOMUNE). The trial is a multi-centre, prospective open-label study assessing the combination of regorafenib (a tyrosine kinase inhibitor) and avelumab (an immune checkpoint inhibitor) in various solid tumours. Ilixadencel will be evaluated along with a combination in one of the treatment arms and the trial will involve up to 43 STS patients. The trial is sponsored by Institut Bergonié and Mendus will supply ilixadencel to the STS cohort (regorafenib and avelumab will be supplied by Bayer and Merck KGaA, respectively). Management expects trial preparations for the ilixadencel arm to be completed in H224, with the first patient data expected in H126. We anticipate that trial readouts will influence the clinical path forward.
Written by
Mendus |
Collaboration unveils path forward for ilixadencel |
Clinical update |
Pharma and biotech |
24 July 2024 |
Share price performance
Business description
Analysts
Mendus is a research client of Edison Investment Research Limited |
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Mendus has announced a collaboration with Institut Bergonié, an established comprehensive cancer centre in France, to test ilixadencel in soft tissue sarcomas (STS) as part of an ongoing Phase I/II basket trial (REGOMUNE). The trial is a multi-centre, prospective open-label study assessing the combination of regorafenib (a tyrosine kinase inhibitor) and avelumab (an immune checkpoint inhibitor) in various solid tumours. Ilixadencel will be evaluated along with a combination in one of the treatment arms and the trial will involve up to 43 STS patients. The trial is sponsored by Institut Bergonié and Mendus will supply ilixadencel to the STS cohort (regorafenib and avelumab will be supplied by Bayer and Merck KGaA, respectively). Management expects trial preparations for the ilixadencel arm to be completed in H224, with the first patient data expected in H126. We anticipate that trial readouts will influence the clinical path forward.
Year |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/22 |
3.4 |
(138.8) |
(14.0) |
0.0 |
N/A |
N/A |
12/23 |
29.6 |
(101.6) |
(4.4) |
0.0 |
N/A |
N/A |
12/24e |
3.1 |
(124.6) |
(2.6) |
0.0 |
N/A |
N/A |
12/25e |
0.0 |
(125.7) |
(2.4) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments. EPS adjusted for the 20:1 share consolidation undertaken in June 2024.
Ilixadencel is an immune primer comprising pro-inflammatory allogenic dendritic cells, which, when injected into a tumour, generates an immune response by recruiting and activating the patient’s dendritic cells, alongside natural killer cells and T-cells. Pre-clinical data suggest that combining ilixadencel with other treatments could enhance clinical utility, with proof-of-concept established with tyrosine kinase inhibitors and immune checkpoint inhibitors. At the start of 2024, management communicated that its strategy for ilixadencel will focus on the broad indication of STS, a group of tumours that appear challenging to manage with current immunotherapy approaches. We note that the FDA has previously granted ilixadencel Fast Track and Orphan Drug designations in this indication.
The collaboration with Institut Bergonié makes strategic sense as it will allow Mendus to evaluate the potential benefit of ilixadencel as part of a combination treatment approach in STS patients, while avoiding the capital commitments normally required for a self-sponsored study. Patient recruitment for the REGOMUNE trial (currently in the Phase I dose escalation phase) is ongoing and is based across seven cancer hospitals in France. This will be followed by the Phase II portion, which will comprise 17 independent cohorts (aiming to enrol 747 patients in total) focused on various advanced or metastatic tumours. We understand that ilixadencel will be tested in one of these cohorts (c 43 patients), which will include patients with STS.
Given that the study is investigator-sponsored (by the Institut Bergonié), we note that Mendus will likely have limited control over the trial pace and timelines. Nonetheless, management anticipates preparatory activities for the ilixadencel arm to be complete within H224, with first patient data expected in H126. We expect the trial results to help determine a clearer clinical development path for ilixadencel.
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Research: TMT
Centaur’s new mantra is ‘Build, Improve, Grow’ and this underpins its four-year management plan, BIG27, first unveiled in April. At its heart, BIG27 is predicated on leveraging Centaur’s strong brands addressing the marketing and legal sectors. The focus is on building ‘strategically valuable’ revenues in premium content, training and advisory and events, increasing the group’s subscription and recurring revenue. Implementing the plan will suppress EBITDA margins in the short term but should accelerate revenue growth within BIG27’s timescale, building towards management’s medium-term revenue aspiration of £60m. We withdrew forecasts on April’s (abandoned) potential bid and now reinstate them, with the costs of BIG27 factored in.