Investors

Building momentum across
myeloid blood cancers

Clinical development gathered momentum during the second quarter of 2026, broadening the positioning of vididencel in acute myeloid leukemia (AML) and expanding into chronic myeloid leukemia (CML). For the remainder of the year, Mendus anticipates further clinical catalysts validating the clinical and commercial potential of vididencel across these myeloid blood cancers.

Following successful Phase 2 proof-of-concept in AML patients with measurable residual disease (MRD) in the ADVANCE II trial, our strategy is to apply the principle of durable immune-mediated disease control across AML and CML. The CADENCE Phase 2b trial in AML reached the first 20-patients enrollment milestone, allowing for an initial evaluation of vididencel in combination with oral azacitidine following high-intensity chemotherapy, irrespective of MRD status. Building on this progress, we have continued preparations for the DIVA trial, in which vididencel will be combined with venetoclax and azacitidine (Ven+Aza) to treat newly diagnosed AML patients deemed unfit for intensive chemotherapy. The DIVA trial is expected to start in the second half of 2026 and, together with the ongoing CADENCE trial, will position vididencel broadly as a first-line post-remission immunotherapy in AML.

In CML, vididencel may help patients to safely discontinue tyrosine kinase inhibitor (TKI) treatment to establish functional cure, or ‘treatment-free remission’ (TFR). Today, the possibility of TFR is limited to patients who achieve deep and sustained molecular responses to TKI therapy over several years, leaving patients with suboptimal responses dependent on lifelong treatment. The VITAL-CML trial will evaluate whether vididencel can stimulate immune-mediated disease control and enable chronic-phase CML patients with suboptimal TKI responses to become eligible for TFR. Recruitment of the first safety and tolerability stage of the trial was completed in July, supporting an initial read out in the second half of 2026.

Beyond TFR eligibility, a second major obstacle to successful TFR is the high relapse rate following discontinuation of TKI treatment. During an initial TFR attempt, approximately half of patients experience disease relapse within 6 to 12 months and must restart daily TKI therapy. Failure rates are even higher in subsequent TFR attempts. To address this unmet need, Mendus entered a collaboration with the South Australian Health and Medical Research Institute (SAHMRI), a leading Australian medical research institute, to support
the Phase 2a VITAL-TFR2 trial. Subject to positive safety data from the first stage of the VITAL-CML trial, VITAL-TFR2 is expected to start in Q4 2026 and will evaluate whether vididencel can improve the likelihood of durable TFR in patients with a previous failed TFR attempt.

At the Association for Cancer Immunotherapy (CIMT) meeting, we presented supportive preclinical data in CML, confirming that vididencel can be combined with a broad range of TKIs, including new allosteric (”STAMP”) inhibitors such as asciminib.

We also presented additional positive data from the Phase 1b ALISON trial in high-grade serous ovarian cancer at the American Society for Clinical Oncology meeting (ASCO), demonstrating tumor-directed immune responses associated with improved survival. Five participants of the trial remained progression-free at long-term follow-up, including two beyond 3.5 years. These findings further support the safety and feasibility of vididencel in ovarian cancer, potentially creating opportunities for collaborations based on combination therapies in this indication.

To support our clinical development strategy, we have assembled a clinical advisory board with renowned international experts in the field of myeloid blood cancers. We are encouraged that the US investment bank Lucid Capital Markets initiated coverage of the Mendus share, increasing our visibility to US investors.

We enter the second half of 2026 with several ongoing and planned clinical trials expected to generate important value inflection points in both AML and CML. The growing visibility of our programs among the international clinical community and institutional investors further supports awareness of the opportunities ahead.

Erik Manting, Ph.D.
Chief Executive Officer

*Published on August 20th 2026