ANVS — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-15

• Currently we are conducting two clinical studies – a pivotal Phase 3 study in early AD ("Phase 3AD Trial”) (NCT06709014) and an open-label extension ("OLE”) study in PD (NCT07284784), and we plan for a third study in Parkinson’s disease dementia ("PDD”).

• In February of 2025, we initiated the FDA-cleared pivotal Phase 3 AD Trial: a randomized, double-blind, placebo-controlled, multicenter Phase 3 study in 725 early AD patients. The trial investigates buntanetap and consists of two parts: a 6-month treatment period aimed at confirming buntanetap’s sym…

• This pivotal Phase 3 AD Trial will utilize standard clinical outcome measures including Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 ("ADAS-Cog13”) and Alzheimer’s Disease Cooperative Study-InstrumentalActivities of Daily Living Scale ("ADCS-iADL”). Volumetric MRI imaging and certain p…

• In January of 2026, we began an OLE study to evaluate the long-term safety and efficacy of buntanetap in PD patients. The study aims to enroll 500 patients, who will be treated with buntanetap for 36 months or until buntanetap is on the market. The patient population consists of two cohorts: cohort …

• studies and cohort 2 with patients who did not take part in earlier trials but have been receiving deep brain stimulation ("DBS”) for at least 12 months following successful surgery. The OLE PD study represents an important step toward a future NDA submission by helping meet the FDA patient exposure…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• In 2021, we completed two Phase 1/2 clinical studies: one in 14 early AD patients, and one in 54 early PD patients (together, the “AD/PD Trials”). In the AD/PD Trials, early AD patients were defined as those with a Mini Mental State Examination (“MMSE”) score between 19 and 28 and early PD patients …

• All three clinical trials above were double-blind and placebo-controlled. We designed the studies by applying our understanding of the underlying neurodegenerative disease states and measured both target and pathway validation in the spinal fluid of patients to determine whether patients underlying …

• 42-item rating scale designed to assess Parkinson’s disease-related disability and impairment and also evaluate the activities of daily living and motor function.

• Following completion of the AD/PD Trial, we submitted our data to the U.S. Food and Drug Administration (“FDA”) and requested direction to further pursue the development of buntanetap in early PD patients. With the FDA’s guidance, we initiated a Phase 3 study in early PD patients in August 2022 (our…

• Our Phase 3 PD Study was completed on December 4, 2023, and we released the topline PD Study efficacy data on July 2, 2024. The study data showed that in two subgroups, buntanetap improved UPDRS 2, 3, 2+3 and total. It also showed that in the entire intent to treat (“ITT”) population, buntanetap sto…