Annovis Achieves Significant Milestones and Sustains Strong Progress in Phase 3 Alzheimer’s Program

Rhea-AI Summary

Annovis (NYSE: ANVS) reported that all 84 Phase 3 sites for its pivotal early Alzheimer's trial are fully activated and enrolling across the U.S., with the first participants having completed the 6-month treatment milestone.

The study is now 25% complete toward a total enrollment target of 760 patients with biomarker-confirmed amyloid pathology. A symptomatic 6-month readout is on track for H2 2026, followed by an 18-month disease‑modifying assessment; participants completing 6 months continue blinded treatment for 12 more months.

Positive

• 84 clinical sites fully activated and enrolling
• Study is 25% complete
• First cohort reached the 6-month treatment milestone
• 760-patient enrollment target with amyloid confirmation
• 6-month symptomatic readout targeted for H2 2026

Negative

• None.

Insights

Clinical Development Strategist

All 84 U.S. Phase 3 sites are active; study 25% complete with first 6‑month cohort reached, keeping a 6‑month readout on track for H2 2026.

Annovis has activated all 84 trial sites and reports the study is 25% complete, with the earliest participants completing the 6‑month treatment window. The trial's dual design separates a symptomatic 6‑month readout from an 18‑month disease‑modifying evaluation, and participants continue blinded treatment after month six.

The business mechanism is clear: operational execution speeds the timing of actionable clinical data and preserves trial integrity by retaining blinded treatment into the longer assessment. Key dependencies include sustained enrollment, site performance, and data quality; any delays or site dropouts would push timelines. Watch the announced 6‑month symptomatic readout scheduled for H2 2026, interim enrollment percentages versus target, and retention rates over the next 6–18 months as concrete milestones that will materially affect development value.

All 84 clinical sites across the U.S. are fully activated, enrolling, and treating patients

The first group of participants reached the 6-month treatment milestone

The study is now 25% complete, keeping Annovis on track for data readout

MALVERN, Pa., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced that all 84 sites for its pivotal Phase 3 study in early AD are now fully activated and enrolling participants, with the majority already treating patients across the U.S. This milestone is complemented by another achievement: the first group of patients has completed the 6-month treatment period, keeping the Company on track to deliver symptomatic data in the second half of 2026.

“Our Phase 3 trial is now 25% complete, with all sites open, and our earliest enrollees having reached the 6-month treatment milestone," said Maria Maccecchini, Ph.D., President and CEO of Annovis. “These achievements keep us on schedule for our first 6-month readout in 2026 and underscore the continued momentum toward bringing buntanetap to patients who urgently need a safe and effective treatment.”

The pivotal Phase 3 study (NCT06709014) aims to enroll a total of 760 patients with early AD and biomarker-confirmed amyloid pathology. The trial employs a dual design: a 6-month readout evaluating the symptomatic efficacy of buntanetap, Annovis' lead drug candidate, followed by an 18-month readout focused on a potential disease-modifying response. Participants who have completed the initial 6-month period seamlessly continue blinded treatment for additional 12 months toward the study completion.

"The pace of enrollment and patient progression through the protocol demonstrates strong execution across all aspects of this pivotal trial," said Melissa Gaines, Senior Vice President of Clinical Operations at Annovis. "This momentum reflects the dedication of our entire team, the excellence of our site partners, and the remarkable engagement of patients and caregivers who recognize the potential impact of our treatment."

More information about the clinical trial and site locations can be found on our website or at ClinicalTrials.gov.

About Annovis
Headquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD). The Company is committed to developing innovative therapies that improve patient outcomes and quality of life. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X.

Investor Alerts
Interested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for email alerts at https://www.annovisbio.com/email-alerts.

Forward-Looking Statements
This press release contains forward-looking statements under the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended. Actual results may differ due to various risks and uncertainties, including those outlined in the Company’s SEC filings under “Risk Factors” in its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update forward-looking statements except as required by law.

Contact Information:
Annovis Bio Inc.
101 Lindenwood Drive
Suite 225
Malvern, PA 19355
www.annovisbio.com

Investor Contact:
Alexander Morin, Ph.D.
Director, Strategic Communications
Annovis Bio
ir@annovisbio.com

FAQ

How many sites are active in Annovis' Phase 3 trial (ANVS) as of Nov 6, 2025?

All 84 clinical sites are fully activated and enrolling across the U.S.

What proportion of Annovis' Phase 3 early AD study (ANVS) is complete on Nov 6, 2025?

The trial is reported as 25% complete toward full enrollment.

When is Annovis expecting the first 6-month symptomatic readout for buntanetap (ANVS)?

The company is on track for a 6-month readout in the second half of 2026.

How many patients will Annovis enroll in its pivotal Phase 3 early AD study (ANVS)?

The trial aims to enroll 760 patients with biomarker-confirmed amyloid pathology.

What is the Phase 3 design and timeline for buntanetap (ANVS)?

A dual design: a 6-month symptomatic assessment followed by an 18-month disease‑modifying readout; 6‑month completers remain blinded for 12 more months.