Last close As at 05/08/2026
SEK6.71
▲ −0.16 (−2.33%)
Market capitalisation
SEK435m
Research: Healthcare
Mendus wrapped up FY23 with a clinical pipeline update. Management is maintaining its plans to explore ilixadencel in soft tissue sarcomas (STS), with the Phase II trial due to start in H124 and the MERECA trial (ilixadencel) in metastatic renal cell carcinoma (mRCC) no longer being pursued. The MERECA long-term follow-up has confirmed findings from the initial study (no significant survival difference between the monotherapy and combination arms). Our valuation remains unchanged as our estimates did not include considerations for mRCC. Mendus has announced the completion of patient enrolment in the Phase I ALISON trial in ovarian cancer (OC) for its lead asset vididencel, with survival data expected in H224. Management also reiterated the recently presented positive data from the ADVANCE II trial and confirmed plans for the combination trial with Onureg (oral azacitidine) for acute myeloid leukaemia (AML), with patient enrolment due to start in early 2024.
Written by
Mendus |
Poised for an active 2024 |
Pipeline update |
Pharma and biotech |
2 January 2024 |
Share price performance
Business description
Analysts
Mendus is a research client of Edison Investment Research Limited |
||||||||||||||||||||||||||||||||||||||
Mendus wrapped up FY23 with a clinical pipeline update. Management is maintaining its plans to explore ilixadencel in soft tissue sarcomas (STS), with the Phase II trial due to start in H124 and the MERECA trial (ilixadencel) in metastatic renal cell carcinoma (mRCC) no longer being pursued. The MERECA long-term follow-up has confirmed findings from the initial study (no significant survival difference between the monotherapy and combination arms). Our valuation remains unchanged as our estimates did not include considerations for mRCC. Mendus has announced the completion of patient enrolment in the Phase I ALISON trial in ovarian cancer (OC) for its lead asset vididencel, with survival data expected in H224. Management also reiterated the recently presented positive data from the ADVANCE II trial and confirmed plans for the combination trial with Onureg (oral azacitidine) for acute myeloid leukaemia (AML), with patient enrolment due to start in early 2024.
Year |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/21 |
0.0 |
(133.4) |
(0.73) |
0.0 |
N/A |
N/A |
12/22 |
3.4 |
(138.8) |
(0.70) |
0.0 |
N/A |
N/A |
12/23e |
0.8 |
(97.2) |
(0.18) |
0.0 |
N/A |
N/A |
12/24e |
0.0 |
(124.5) |
(0.14) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Mendus ended 2023 with a pipeline update, covering clinical programmes for its two lead assets. Long-term follow-up data from the MERECA trial (evaluating ilixadencel in mRCC) has confirmed previously reported observations, indicating there is no significant survival benefit with ilixadencel plus standard-of-care sunitinib versus sunitinib alone. Management has concluded that the data do not support continued development in mRCC. However, the company will continue to evaluate ilixadencel for treating STS and the Phase II proof-of-concept study is expected to begin in H124. We note that the FDA has previously granted ilixadencel Fast Track and Orphan Drug designations in this indication. Our model assumes gastrointestinal stromal tumours as a specific indication within STS, based on Mendus’s initial data. If also displayed in other sarcomas, efficacy should add upside potential to our valuation.
Mendus’s lead asset, vididencel, is a cell-based cancer vaccine being developed as a potential maintenance therapy in AML and OC. The Phase I ALISON trial is now fully recruited (n=17) and readouts are expected throughout 2024, including a survival analysis in H224. Prior readouts have demonstrated early signs of immune responses against tumour antigens implicated in OC, as well as a desirable safety profile. Vididencel is also being assessed in preventing relapse after remission for AML patients. Encouraging survival data were recently presented at the American Society of Hematology 2023 meeting, suggesting a potentially competitive profile over Onureg, the current standard of care. All eyes are now on the CADENCE combination trial (n=140), a two-stage, adaptive, randomised, multi-centre Phase II study to investigate the combination of vididencel with Onureg, versus Onureg alone. The trial is expected to take place across 2024 and 2025 and we see the results as a significant inflection point for Mendus.
|
|
Research: Healthcare
IRLAB Therapeutics has announced a new loan facility of up to SEK55m with Formue Nord to support its development programmes. Provided the facility is fully drawn down, we estimate it will extend IRLAB’s cash runway through Q324, past key inflection points (top-line results from the pirepemat Phase IIb trial and the results from the end of Phase II meeting with the FDA, both expected in H124). Considering the market environment, we view the transaction as practical as it provides increased liquidity with limited potential dilution. The first tranche (SEK30m) is paid out on signing the agreement and the second (SEK25m) can be drawn down at IRLAB’s discretion between 22 May and 22 August 2024, provided the company’s market cap exceeds SEK550m (c 40% premium over the current SEK389m market cap). The facility is due for repayment on 22 May 2025 and SEK10m of the loan can be converted to equity. We will update our estimates for this new funding but anticipate no material changes to our valuation.