Last close As at 05/08/2026
SEK6.71
▲ −0.16 (−2.33%)
Market capitalisation
SEK435m
Research: Healthcare
The Human Research Ethics Committee (HREC) has provided the green light to commence enrolment for Mendus’s AMLM22-CADENCE trial from April 2024. This Phase II trial in collaboration with the Australasian Leukaemia and Lymphoma Group, a clinical trial research group focused on haematological cancers, will evaluate lead cancer vaccine vididencel, in combination with standard of care oral azacitidine (Onureg) as a maintenance treatment for acute myeloid leukaemia (AML). A pivotal global registrational trial is planned from H225 with safety data from the AMLM22-CADENCE trial to be used for in the registration dossier. We view the latest update as a positive indicator that this programme is progressing as planned and believe that the launch of AMLM22-CADENCE will represent a key milestone.
Written by
Mendus |
Regulatory green light for CADENCE trial |
Clinical update |
Pharma and biotech |
28 March 2024 |
Share price performance
Business description
Analysts
Mendus is a research client of Edison Investment Research Limited |
||||||||||||||||||||||||||||||||||||||
The Human Research Ethics Committee (HREC) has provided the green light to commence enrolment for Mendus’s AMLM22-CADENCE trial from April 2024. This Phase II trial in collaboration with the Australasian Leukaemia and Lymphoma Group, a clinical trial research group focused on haematological cancers, will evaluate lead cancer vaccine vididencel, in combination with standard of care oral azacitidine (Onureg) as a maintenance treatment for acute myeloid leukaemia (AML). A pivotal global registrational trial is planned from H225 with safety data from the AMLM22-CADENCE trial to be used for in the registration dossier. We view the latest update as a positive indicator that this programme is progressing as planned and believe that the launch of AMLM22-CADENCE will represent a key milestone.
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.
As per the announcement, the approval from the HREC enables patient enrolment for the Phase II AMLM22-CADENCE trial to commence from April 2024. This is an encouraging sign that Mendus’s plans are progressing as the anticipated AMLM22-CADENCE (expected n=140) trial will be a randomised, multi-centre clinical trial consisting of two stages and will involve AML patients in complete remission following high-intensity chemotherapy. The first stage (18–24 months) will assess the safety of vididencel in combination with Onureg, compared to Onureg alone, in 40 patients. The second stage (24–36 months) will assess the efficacy of the combination in a further 100 patients. Per the study protocol, vididencel will be administered as four biweekly intradermal injections, after which three booster injections will be administered up to six months after the start of treatment.
Mendus will also continue to prepare for a separate global registrational trial for vididencel in the AML maintenance setting, focusing on trial protocol development and backed by the large-scale good manufacturing practice batches of vididencel through its agreement with NorthX Biologics (a company specialised in the manufacturing of cell and gene therapies). Management has had encouraging discussions with the FDA and Mendus intends to launch this registrational programme from H225. Given that AML is a highly aggressive type of blood cancer with limited therapeutic options in the maintenance setting, we believe there is a sizeable opportunity for Mendus in this space.
For a more detailed overview of the encouraging clinical data obtained to date for vididencel in AML, along with the company’s other active programmes, please refer to our previous update note.
|
|
Research: Financials
Alpha Bank (Alpha) reported €611m in net profit, a 66% jump from FY22, as the bank benefited from an elevated interest rate environment with little impact from deposit migration and strong cost control. Alpha delivered a normalised return on tangible equity (RoTE) of 12.9% in FY23, beating its own upgraded target of >11.5%. The increased profitability coupled with a robust capital position (fully loaded common equity tier 1 (FL CET1) of 14.3%) have enabled a proposed dividend of €0.05 a share, subject to regulatory approval.