ALTITUDE-AD Phase II On Track with Top-Line Readout Expected Late 2026
ALTITUDE-AD execution remains on track; participants transitioning into the 12-month open-label extension with a high conversion rate. The study is well-powered (≈542 subjects) to detect a statistically significant difference after 18 months on the primary endpoint (iADRS) and will report key secondary endpoints (CDR-SB), ARIA rates and biomarkers.
Dose Strategy and Target Engagement
ALTITUDE-AD is evaluating two active doses (35 mg/kg and 50 mg/kg) that bracket the exposure range shown to achieve pharmacodynamic target engagement in INTERCEPT-AD Phase I, enabling assessment of dose-related efficacy and safety.
Enhanced Brain Delivery (EBD) Program Progress & Imminent Candidate Licenses
EBD preclinical work is positive; company intends to exercise option to license two JCR Pharma-developed compounds in Q2 2026 and expects an IND filing targeted for mid-2027. EBD aims to enable improved brain penetration, broader distribution and patient-friendly subcutaneous dosing.
Substantial Brain Exposure Improvements in Preclinical Studies
In preclinical primate studies, EBD candidates demonstrated approximately 14–40x higher brain exposure vs. non-carrier constructs, with improved distribution across multiple brain regions — a key rationale for pursuing oligomer-targeted cargo via carrier technology.
Strong KOL and Physician Interest
KOL feedback and clinician interactions show significant interest and anticipation for sabirnetug due to its oligomer-targeted mechanism and potential for differentiation from approved anti-amyloid agents.
Operational Screening Efficiency Improvement with Plasma Biomarker
Using plasma p-tau217 as a screening step reduced negative amyloid PET scans from ~60% to under 20%, improving screening efficiency by more than two-thirds and shortening enrollment time (completed enrollment in ~10 months).
Balance Sheet Strengthened by Private Placement
Cash and marketable securities totaled $128.4 million as of March 31, 2026. A private placement in March grossed $35.75 million to support the EBD program and increased the quarter-over-quarter cash balance.
Controlled Operating Spend Leading to Lower Opex in Q1
Q1 2026 R&D expenses were $16.5 million (lower YoY driven by reduced manufacturing/material and CRO costs) and G&A was $4.7 million (lower legal, accounting, consulting, insurance), demonstrating operational cost control while advancing programs.