ALTO-207 TRD Phase 2b Study Off And Running Now

Research evidence excerpt

ALTO-207 TRD Phase 2b Study Off And Running Now

Pipeline Updates

ANRO initiated the Phase 2b ALTO-207 study which was consistent with prior timing guidance

(1H26). Management anticipates potential top-line results in the treatment-resistant depression

(TRD) study in 2H27 (no change). They also reiterated timing to start the Phase 3 ALTO-207 TRD

study in early-2027. What’s new? ANRO initiated a review on site-level metrics and eligibility

review for the Phase 2b ALTO-100 bipolar depression (BPD) study and the Phase 2b ALTO-300

MDD study. After implementing a new eligibility review process in the studies, approximately

11% and 13% of patients were screened out of the ALTO-100 and ALTO-300 studies. The

downstream effect is timing for readouts in both studies will be pushed out. Results from the

Phase 2b ALTO-100 BPD study are now anticipated in mid-2027 (prior 2H26), while the Phase 2b

ALTO 300 MDD top-line results are now expected in 1H27 (prior mid-2026). Management

already incorporated the enrollment adjustments to the Phase 2b ALTO-207 2H27 readout

guidance. Although the delays are disappointing, it’s encouraging to see that PK testing

demonstrates high compliance among participants (97% of samples at expected drug

concentration levels).

Model Updates

Following the 1Q26 update, we are making the following adjustments to our ANRO

estimates. First, we are introducing FY34 estimates to our ANRO model. Second, although R&D

spend exceeded $20M in 1Q26, we are adjusting our R&D expense trajectory. Management

reiterated cash runway guidance which extends through 2029. We assume cash burn of ~$22M

per quarter for the remainder of the FY26 period which represents a stepdown from the

reported level in 1Q26. The net of these changes yields a new $24 target on ANRO shares