New CEO Pending, Catalysts Imminent

Research evidence excerpt

New CEO Pending, Catalysts Imminent

2 readout is expected in

2Q26, representing a key near-term catalyst. Interim blinded data from earlier cohorts have already

demonstrated dose-dependent immunogenicity and increasing responder rates with repeat dosing,

supporting continued development.

ACI-24.060’s design may offer meaningful differentiation versus earlier and competing Aβ vaccine

approaches, which have historically faced challenges linked to full-length Abeta sequences and

T-cell activation risk. By leveraging a small, conformationally constrained antigen design, the

program aims to drive a targeted antibody response while avoiding these liabilities, positioning it

competitively within the evolving AD landscape.

However, potential delays with ABATE trial are highly likely: From a trial perspective, Takeda’s

funding fully covers the study through the initial 36-patient AD4 cohort, with further support

available for expansion up to 112 patients. While recruitment to the initial cohort is expected to be

relatively straightforward (c.12 months), an expansion is likely required to build a sufficiently robust

dataset. Takeda retains significant influence over any expansion decision, although such a step

would be viewed as a prudent derisking measure ahead of Phase 3, however would be a source

of delay. Under this scenario, following initial treatment and evaluation (lasting approximately

12–18 months and extending through c.4Q28E), an expansion phase would add a further c.12

months of recruitment (2Q29-4Q29E), followed by an additional 12-month treatment and readout

period extending into c.2Q30E-4Q30E. As a result, Phase 3 initiation could be pushed to c.2031E

(vs. 2029 in a no-expansion scenario), with study completion in 2033E, followed by regulatory