Currency in SEK
Last close As at 25/03/2023
SEK1.28
▲ −0.01 (−0.78%)
Market capitalisation
SEK258m
Mendus has announced it will receive a final payment of €1.69m (SEK18m) as part of the Horizon 2020-funded AML-VACCiN project. This EU-funded initiative has provided Mendus with a total of €6.0m since 2020, specifically to aid the development of its dendritic cell-based vaccine, DCP-001 as acute myeloid leukaemia (AML) maintenance therapy. Important median relapse-free survival (RFS) and overall survival (OS) data from the Phase II ADVANCE II trial of DCP-001 in this setting are expected in Q422, and management notes the study has been directly funded by AML-VACCiN grants. We continue to see this data readout as a major near-term catalyst for Mendus, as it will begin to clarify DCP-001’s place in the AML maintenance therapy landscape. Our estimates are unchanged and we will adjust them when the AML-VACCiN funds hit the company’s books. Our valuation of Mendus is unchanged at SEK1.87bn or SEK9.35 per share.
Mendus |
Final EU grant payment of €1.69m expected |
Funding update |
Pharma and biotech |
12 October 2022 |
Share price performance Business description
Analysts
Mendus is a research client of Edison Investment Research Limited |
Mendus has announced it will receive a final payment of €1.69m (SEK18m) as part of the Horizon 2020-funded AML-VACCiN project. This EU-funded initiative has provided Mendus with a total of €6.0m since 2020, specifically to aid the development of its dendritic cell-based vaccine, DCP-001 as acute myeloid leukaemia (AML) maintenance therapy. Important median relapse-free survival (RFS) and overall survival (OS) data from the Phase II ADVANCE II trial of DCP-001 in this setting are expected in Q422, and management notes the study has been directly funded by AML-VACCiN grants. We continue to see this data readout as a major near-term catalyst for Mendus, as it will begin to clarify DCP-001’s place in the AML maintenance therapy landscape. Our estimates are unchanged and we will adjust them when the AML-VACCiN funds hit the company’s books. Our valuation of Mendus is unchanged at SEK1.87bn or SEK9.35 per share.
Year end |
Revenue (SEKm) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/20 |
0.0 |
(89.2) |
(1.17) |
0.0 |
N/A |
N/A |
12/21 |
0.0 |
(133.4) |
(0.73) |
0.0 |
N/A |
N/A |
12/22e |
1.9 |
(126.0) |
(0.63) |
0.0 |
N/A |
N/A |
12/23e |
0.0 |
(128.9) |
(0.65) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
As a reminder, interim results from the Phase II ADVANCE II trial (NCT03697707) in AML maintenance therapy demonstrated that seven out of 20 patients treated with DCP-001 had shown a measurable residual disease (MRD) response (classified as completed MRD conversion or more than 10x reduction) over the 32-week study period. Five patients converted from MRD+ to MRD- and two patients demonstrated at least a 10-fold reduction in MRD. At median follow-up (14.3 months), the study had not reached median RFS or median OS. However, management did report an estimated six-month RFS and OS of 83.7% and 97.0%, respectively.
Currently, oral azacitidine (Onureg, Bristol Myers Squibb) is the only therapeutic approved for AML maintenance. As the ADVANCE II study had not yet reached median RFS and median OS at 14.3 months, we believe this suggests a potentially significant improvement over Onureg (median RFS 7.1 months, median OS 14.6 months). However, we note these are preliminary data and care must be taken when making comparisons between clinical trials. In our view, median RFS and median OS, which we expect to be reported in Q422, represent a significant near-term catalyst for Mendus.
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Research: Healthcare
Incannex has announced the completion of a pre-investigational new drug (IND) meeting with the US FDA for its proprietary inhaled drug product IHL-216A for the treatment of concussion and traumatic brain injury (TBI), following submission of the data package in August 2022. According to the company, the FDA has provided detailed feedback and guidance on the most efficient clinical trial development plan to effect successful commercialisation, in particular related to the complexities and specific requirements of developing an inhaled drug. As the next step, Incannex is preparing a follow-up request seeking additional information on the FDA’s recommendations. We see the current development as a positive step towards clinical development for IHL-216A. Our valuation remains unchanged at US$714.7m or US$11.74 per ADR, but we note the upside potential on successful clinical transition.
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