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Research: Healthcare
Mendus has reported a positive first-stage readout from its Phase Ib VITAL-CML trial, following review by the data safety monitoring board (DSMB). The DSMB concluded that vididencel in combination with ongoing tyrosine kinase inhibitor (TKI) treatment raised no safety or tolerability concerns in the first eight patients, all of whom completed four vididencel doses. This result supports continued enrolment in VITAL-CML, which has now recruited 12 out of a planned 24 participants, and keeps the programme on track for additional readouts in Q426 and initial top-line data from all 24 patients in mid-2027. Importantly, the positive safety assessment also enables Mendus to initiate the distinct Phase IIa VITAL-TFR2 study, planned for Q426, in patients who previously failed a treatment-free remission (TFR) attempt. We view the outcome as encouraging for the pace of Mendus’s expanded chronic myeloid leukaemia (CML) strategy, with the next key steps being further VITAL-CML data and launch of VITAL-TFR2 in Q426.
| Year end | Revenue (SEKm) | PBT (SEKm) | EPS (SEK) | DPS (SEK) | P/E (x) | Yield (%) |
|---|---|---|---|---|---|---|
| 12/24 | 5.0 | (128.4) | (2.64) | 0.00 | N/A | N/A |
| 12/25 | 7.9 | (113.3) | (2.17) | 0.00 | N/A | N/A |
| 12/26e | 15.0 | (89.9) | (1.44) | 0.00 | N/A | N/A |
| 12/27e | 94.8 | (16.1) | (0.26) | 0.00 | N/A | N/A |
The latest readout represents a key safety milestone, rather than an efficacy result, for vididencel in this new patient population. VITAL-CML is designed first to establish safety and tolerability in chronic phase CML patients with suboptimal responses to TKIs, before assessing whether vididencel can deepen molecular remissions through immune-mediated disease control. The initial eight-patient cohort has therefore met its immediate objective, with no safety or tolerability concerns identified by the DSMB after four doses. In our view, this removes an important execution hurdle and supports continued development in this setting.
The clinical rationale remains centred on TFR. TKIs have transformed CML outcomes, with survival now similar to the general population, but many patients remain dependent on long-term treatment. Mendus estimates that fewer than 25% achieve durable TFR because of relapse after treatment discontinuation. VITAL-CML targets patients who are currently ineligible for TFR because molecular responses remain suboptimal despite ongoing TKI therapy. The aim is to strengthen immune control of residual disease and potentially deepen responses enough for treatment discontinuation. The trial has recruited 12 of 24 planned patients, with additional readouts expected in Q426 and initial top-line data from the full cohort in mid-2027.
The positive safety assessment also enables the second CML development path. VITAL-TFR2 is scheduled to start in Q426 and will assess whether vididencel can improve durable TFR in patients who previously relapsed after stopping TKIs. We see progression of both studies as encouraging for Mendus's expanded clinical strategy. In AML, the same principle of immune control over residual disease underpins the CADENCE and DIVA trials, which remain central to broadening vididencel's value proposition across myeloid malignancies. For a more detailed discussion, we direct readers to our prior update note.
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Research: Financials
Halyk Bank reported a 16.1% y-o-y decline in net income to KZT212.8bn in Q226, implying an annualised return on average equity of 23.5% in Q226 compared with 32.2% in Q225. The lower net profit was due to the combination of a lower net interest margin (NIM) of 6.7% (vs 7.1% in Q225), resulting from the new minimum reserve requirements gradually introduced from Q325, a fall in net fee and commission (F&C) income, the net insurance result and net foreign exchange gains. That said, management reiterated its FY26 return on equity (ROE) guidance of c 29% (implying a substantial step-up in profitability in H226), as it expects Halyk to benefit from multiple positive factors, including continued robust loan book growth, a reduction in the base rate, strong results from its fx dealing business, rebounding net F&C income, as well as the reversal of some negative effects in the insurance business. Halyk’s extraordinary general meeting (EGM) on 20 August approved the payment of a dividend of KZT28.09 per share, which brings the total payout from 2025 earnings to KZT58.19 (up c 15% y-o-y), implying a c 60% payout ratio and a yield of 15.4% based on the last closing price.