Last close As at 05/08/2026
SEK6.71
▲ −0.16 (−2.33%)
Market capitalisation
SEK435m
Research: Healthcare
Mendus is forging ahead with vididencel, its primary clinical asset, aiming to address a market niche: the acute myeloid leukaemia (AML) maintenance setting. The company is gearing up to launch the Phase II CADENCE combination trial assessing its lead cancer vaccine candidate, vididencel, in combination with oral azacitidine (Onureg), the only approved AML maintenance drug, to prevent relapse after remission for AML patients. This study is being conducted in collaboration with the Australasian Leukaemia and Lymphoma Group, leveraging Mendus’s local expertise and clinical trial network. During a recent business update, management indicated that the company has received positive feedback from the FDA regarding late-stage development. Mendus expects to commence a global registrational trial in H225, with manufacturing to be guided through the alliance with NorthX Biologics and large-scale Good Manufacturing Practice (GMP) batches expected from mid-2025. The CADENCE trial is on track to start recruiting patients in April 2024.
Written by
Mendus |
Stars align for CADENCE combination trial |
Company update |
Pharma and biotech |
13 March 2024 |
Share price performance
Business description
Analysts
Mendus is a research client of Edison Investment Research Limited |
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Mendus is forging ahead with vididencel, its primary clinical asset, aiming to address a market niche: the acute myeloid leukaemia (AML) maintenance setting. The company is gearing up to launch the Phase II CADENCE combination trial assessing its lead cancer vaccine candidate, vididencel, in combination with oral azacitidine (Onureg), the only approved AML maintenance drug, to prevent relapse after remission for AML patients. This study is being conducted in collaboration with the Australasian Leukaemia and Lymphoma Group, leveraging Mendus’s local expertise and clinical trial network. During a recent business update, management indicated that the company has received positive feedback from the FDA regarding late-stage development. Mendus expects to commence a global registrational trial in H225, with manufacturing to be guided through the alliance with NorthX Biologics and large-scale Good Manufacturing Practice (GMP) batches expected from mid-2025. The CADENCE trial is on track to start recruiting patients in April 2024.
Year |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/22 |
3.4 |
(138.8) |
(0.70) |
0.0 |
N/A |
N/A |
12/23 |
29.6 |
(101.6) |
(0.22) |
0.0 |
N/A |
N/A |
12/24e |
0.0 |
(122.0) |
(0.14) |
0.0 |
N/A |
N/A |
12/25e |
0.0 |
(125.9) |
(0.15) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
AML is a highly aggressive form of blood cancer that has a notably low five-year survival rate of c 30% and where relapse after remission represents a high risk. Mendus is focused on the development of vididencel, an off-the-shelf cellular maintenance immunotherapy in AML, an indication where alternative immunotherapy strategies (such as checkpoint inhibitors) have not found success.
In December 2023, Mendus presented positive data for ADVANCE II (vididencel as a monotherapy), showing durable responses with sustained survival benefit, even after one year of treatment. Mendus is now ready to launch the CADENCE trial, exploring potential synergy with the current standard of care, Onureg. CADENCE will be an adaptive, randomised, multi-centre Phase II clinical trial consisting of two stages, aiming to recruit a total of 140 patients. The first stage (18–24 months) will involve 40 patients and will assess the safety of vididencel in combination with Onureg, compared to Onureg alone. The second stage (24–36 months) will involve a further 100 patients, aiming to evaluate the efficacy of the combination. While Mendus has sufficient inventory of vididencel for the CADENCE combination trial, the company has a manufacturing alliance with NorthX Biologics, a company specialised in cell and gene therapies, for the vididencel production needs in late-stage clinical development and for potential commercialisation. As per the latest update, the alliance with NorthX Biologics is progressing as anticipated, with the production facility installed and the tech transfer for large-scale GMP for vididencel ongoing.
In parallel with CADENCE, Mendus is planning a separate global registrational trial for the pivotal stages of development. The company has had encouraging discussions with the FDA on the potential design, and manufacturing arrangements, for Phase III, and management aims to commence this programme from H225.
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Research: TMT
Following receipt of the £58.8m second tranche from the Samsung litigation on 24 January, Nanoco plans to return £30m to shareholders via a tender offer (c 38.5% of outstanding shares), alongside a £3m share buyback. After completing this £33m return and repaying c £5m outstanding debt, Nanoco expects to have c £23m cash to accelerate commercial production of nanomaterials at scale. With its validated technology, robust pipeline and strong financial position, we believe the group is positioned to drive long-term shareholder value creation. With Nanoco only valued marginally higher than the second tranche proceeds, we believe the market is undervaluing the group’s several commercial opportunities and intellectual property (IP) despite recent progress.