ANVS 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-14

• To date, we have concluded 11 clinical studies – in healthy volunteers to assess safety, food effect, pharmacokinetics ("PK”), distribution, etc., and in AD and PD patients to assess safety and efficacy. Currently we are conducting two clinical studies – a pivotal Phase 3 study in early AD ("Phase 3…

• In February 2023, we initiated a Phase 2/3 trial in mild to moderate AD patients (our “Phase 2/3 AD Study”), who were defined as those with a Mini Mental State Examination (“MMSE”) score from 14 to 24. Our Phase 2/3 AD Study was completed on February 13, 2024, and on April 29, 2024, we announced the…

• On October 10, 2024, we met with the FDA in an end-of-phase 2 meeting to discuss our Phase 2/3 AD data and to agree on a regulatory path forward. Annovis and the FDA have aligned on a development path for buntanetap towards the filing of two New Drug Applications (“NDA”) – one for short-term symptom…

• modifying efficacy. During the end-of-phase 2 meeting for AD, the FDA raised no concerns with our data on buntanetap’s safety, including impact on liver enzymes, drug interactions, dose selection, PK, and population PK. Further, the FDA confirmed that future development can proceed using the new cry…

• In February 2025, we initiated the FDA-cleared pivotal Phase 3 AD Study: a randomized, double-blind, placebo-controlled, multicenter Phase 3 trial in early AD patients with the MMSE score from 20 to 28. Patients are also screened for plasma p-tau217 biomarker, indicating amyloid and tau pathology in…

相对上期删除的文字 · 来源: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…

相对上期新增的文字 · 来源:10-Q · 2026-08-14

• During the three months ended June 30, 2026, two of our directors or "officers," as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934, terminated a Rule 10b5-1 trading plan or arrangement or a non-Rule 10b5-1 trading plan or arrangement, as defined in Item 408(c) of Regulation S-K. …

相对上期删除的文字 · 来源:10-Q · 2026-05-15

• During the three months ended March 31, 2026, none of our directors or "officers," as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934, adopted or terminated a Rule 10b5-1 trading plan or arrangement or a non-Rule 10b5-1 trading plan or arrangement, as defined in Item 408(c) of Reg…