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Annovis Reports Peer-Reviewed Publication Highlighting Pharmacokinetics of Novel Crystal Buntanetap

Key Takeaway: Annovis Bio has published a peer-reviewed article detailing the pharmacokinetics of a new crystal form of buntanetap. This new dihydrate form demonstrates greater stability and maintains the pharmacokinetic profile of the original form. The findings support its use in ongoing Phase 3 clinical trials for Alzheimer's disease, with key readouts expected in 2026 and 2027.

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POSITIVE FACTORS

  • New crystal form of buntanetap shows greater stability.
  • Publication validates the use of crystal buntanetap in clinical trials.
  • Maintains pharmacokinetic profile essential for therapeutic efficacy.
  • Extends intellectual property protection into the 2040s.

Full Press Release Details

MALVERN, Pa., Sept. 16, 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 the publication of a new article in a peer-reviewed journalBiomolecules, which describes the pharmacokinetic (PK) profile of a new crystal form of buntanetap and compares it to the old form across several studies including mice, dogs, and humans.
The original anhydrous form of buntanetap has been used in all preclinical and clinical studies to date. Recently, the Annovis team identified a new dihydrate crystal, which incorporates two moles of water in its structure and offers greater stability. This publication examines how the new crystal form behaves in the body following oral administration, focusing on absorption and clearance. The findings confirm that crystal buntanetap preserves the PK profile and metabolism of the original form, which are essential for the drug’s therapeutic efficacy.
“We have highlighted the new form of buntanetap in prior presentations, but this open-access publication presents the data in full to a broader audience. It not only validates the use of crystal buntanetap in clinical trials but also reinforces the consistency and reliability of our lead asset,” said Alexander Morin, Ph.D., Director of Strategic Communications. “PK is central to understanding how a drug works, and we remain committed to rigorous analysis of buntanetap to ensure the most beneficial outcomes for patients.”
The new crystal buntanetap is currently being used in the pivotal Phase 3 clinical trial (NCT06709014) in patients with early AD, which is actively enrolling participants across the U.S. The study is designed to deliver two key readouts: symptomatic (Fall 2026) and disease-modifying (Fall 2027). Moreover, this new form extends the intellectual property protection of the Company’s lead compound into the 2040s, covering its mechanism of action, therapeutic use, and combination with other drugs.
The publication can be accessed online via theLINKor found in thePublications libraryon Annovis’ website.
About AnnovisHeadquartered 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, visitwww.annovisbio.comand follow us onLinkedIn,YouTube, andX.
Investor AlertsInterested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for email alerts athttps://www.annovisbio.com/email-alerts.
Forward-Looking StatementsThis 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 DriveSuite 225Malvern, PA 19355www.annovisbio.com

Investor Contact:Alexander Morin, Ph.D.Director, Strategic CommunicationsAnnovis Bioir@annovisbio.com

Frequently Asked Questions

What is the new crystal form of buntanetap?

The new crystal form of buntanetap is a dihydrate that offers greater stability.

What does the new publication confirm?

The publication confirms that the new crystal form preserves the pharmacokinetic profile of the original form.

When are the key readouts for the Phase 3 trial expected?

Key readouts for the Phase 3 trial are expected in Fall 2026 and Fall 2027.

How does the new form affect intellectual property?

The new form extends the intellectual property protection of buntanetap into the 2040s.

Last updated: Sep 16, 2025