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SEK435m
Research: Healthcare
Mendus recently presented positive data from two ongoing clinical studies, ADVANCE II and ALISON, at the EHA and ESMO conferences, respectively. While the Phase I ALISON trial, evaluating lead asset vididencel in ovarian cancer, met its primary endpoint of generating sufficient vaccine-induced responses (VIR), further analysis of ADVANCE II data (studying vididencel as a maintenance therapy in AML) confirmed the drug’s potential in generating a broader immune response through both T-cell and B-cell activation (vs selected T-cell action seen in antigen and neo-antigen-based approaches). This may be indicative of better clinical AML maintenance outcomes. We expect the next catalyst to be the Phase II CADENCE trial (patient enrolment to commence imminently), evaluating vididencel in combination with azacitidine (Onureg) in AML patients. Mendus is also planning a global registrational trial for vididencel, for which preparatory activities are expected to complete by H225.
Written by
Mendus |
Recent clinical data highlight vididencel’s potential |
Clinical update |
Pharma and biotech |
21 June 2024 |
Share price performance
Business description
Analysts
Mendus is a research client of Edison Investment Research Limited |
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Mendus recently presented positive data from two ongoing clinical studies, ADVANCE II and ALISON, at the EHA and ESMO conferences, respectively. While the Phase I ALISON trial, evaluating lead asset vididencel in ovarian cancer, met its primary endpoint of generating sufficient vaccine-induced responses (VIR), further analysis of ADVANCE II data (studying vididencel as a maintenance therapy in AML) confirmed the drug’s potential in generating a broader immune response through both T-cell and B-cell activation (vs selected T-cell action seen in antigen and neo-antigen-based approaches). This may be indicative of better clinical AML maintenance outcomes. We expect the next catalyst to be the Phase II CADENCE trial (patient enrolment to commence imminently), evaluating vididencel in combination with azacitidine (Onureg) in AML patients. Mendus is also planning a global registrational trial for vididencel, for which preparatory activities are expected to complete by H225.
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.
While the poster presented at the European Hematology Association (EHA) conference reaffirmed previously communicated (in December 2023) ADVANCE II efficacy data, one of the key takeaways was vididencel’s ability to generate a broad immune response, by activating both T cells and antibody producing B cells. We believe this differentiates this (a whole cell-based vaccine) from antigen-based treatments, with their selective T-cell targeting of antigens. The poster noted that 85% of the patients in the trial (17 of 20) showed at least one T-cell VIR against the common tumour antigens (WT1, PRAME and RHAMM) following treatment with vididencel, and nine of 20 patients had at least two VIRs (termed confirmed T cell responses), associated with significantly improved overall survival (OS) rates. Moreover, vididencel treatment increased B cell levels across all responder subgroups, which was also associated with higher OS rates. While these data relate to a small patient population, we believe they are indicative of a potential longer-term clinical benefit in AML with vididencel.
Management also announced presentation of updated clinical data from the Phase I ALISON trial at the European Society for Medical Oncology (ESMO). The study evaluated vididencel as a maintenance treatment in ovarian cancer. All 17 patients have now completed the treatment and 10 of the 15 evaluated patients showed a VIR against typical ovarian cancer-related tumour antigens, meeting the primary objective of the study. At week 22, 10 patients had stable disease and long-term follow-up is ongoing. Full data from the study are expected in Q424.
We expect investor focus to now be on the Phase II CADENCE trial (n=140), being undertaken in collaboration with the Australasian Leukaemia and Lymphoma Group, which received Human Research Ethics Committee approval in March 2024 and will initially enrol 40 patients across nine trial sites in Australia.
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Research: Consumer
Games Workshop Group’s FY24 trading update provided a nice surprise on the revenue side, broadly equally split between core and licensing, and an even nicer surprise for PBT, suggesting an improvement in gross margin. We have upgraded our FY24 estimates to be consistent with the indicated figures and marginally increase our estimates for FY25, which reverts to a 52-week period accounting period.