Phase II ALTITUDE-AD Progress and Enrollment
Completed enrollment ~1 year ago for the 18-month ALTITUDE-AD Phase II study; participant transition into the 12-month open-label extension (OLE) started November 2025 is smooth with a high rollover/conversion rate and retention metrics in line with other major AD trials.
Positive Phase Ib Biomarker Signals for Sabirnetug
INTERCEPT-AD Phase Ib data showed positive effects on CSF biomarkers after 3 doses (notably reductions in pTau181 and neurogranin), supporting target engagement of sabirnetug and providing rationale for continued Phase II evaluation.
Enhanced Brain Delivery (EBD) Preclinical Results
EBD candidates (sabirnetug + JCR carrier) demonstrated 14- to 40-fold higher brain exposure in nonhuman primates versus native antibody controls at 24 hours post dose, exceeding the program's target product profile and giving multiple viable IND candidate options.
Favorable Hematology and Stability in NHP Studies
Nonhuman primate hematology at 24 hours post subcutaneous dosing showed no observed changes in red blood cell count, hematocrit, hemoglobin or reticulocyte counts, indicating low anemia signal early in preclinical testing; stability supportive of subcutaneous dosing with low-volume devices.
Focused Financing to Support EBD
Closed a private placement on March 16, 2026 grossing $35.75 million before expenses to primarily support the EBD program and working capital, which investors viewed as validation of the EBD strategy.
Cash Position and Cost Management
Ended 2025 with $116.9 million in cash and marketable securities; management expects these funds to support current clinical and operational activities into early 2027. General & administrative expenses decreased to $18.9 million in 2025 driven by lower recruiting, insurance and consulting costs.
Near-Term Milestones and Regulatory Pathway
Plan to read out ALTITUDE-AD efficacy and safety data late 2026 and target an IND filing for an EBD clinical candidate by mid-2027; management indicated interactions with FDA and a base-case expectation that one additional Phase III could support a BLA if Phase II is positive.