Annovis Bio Granted U.S. Patent Covering New Crystalline Form of Buntanetap
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Annovis Bio (NYSE: ANVS) received a U.S. patent covering the new crystalline Form B of its investigational therapy buntanetap.
Granted November 3, 2026, U.S. Patent No. 12,780,831 protects Form B through June 21, 2044, covering the solid form, pharmaceutical compositions and preparation methods. Form B is used in the ongoing pivotal Phase 3 early Alzheimer’s trial and open-label Parkinson’s extension study.
Enrollment in the Alzheimer’s trial is complete. Annovis expects symptomatic top-line data in Q1 2027 and a disease-modifying readout in Q1 2028, following six-month and 18-month analyses, respectively. The company has begun preparing New Drug Application submissions to follow each readout.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointU.S. Patent No. 12,780,831 protects buntanetap Form B, compositions and preparation methods through June 21, 2044.
- Moderate pointPivotal Phase 3 Alzheimer’s trial enrollment is complete.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Symptomatic top-line data are expected in Q1 2027; disease-modifying data are expected in Q1 2028.
- Minor pointNew Drug Application preparations have begun for submissions planned to follow each readout.
- Minor pointFDA clearance in July 2024 permitted transition to Form B in future clinical trials.
- Minor pointForm B versus Form A comparisons across mice, dogs and humans showed comparable drug-exposure profiles.
Negative
- None.
Details
News Market Reaction – ANVS
On Nov 12, the day this news came out, ANVS closed 0.71% below the previous close. Argus tracked a peak move of +9.9% during that session. Our momentum scanner recorded 5 alerts for this stock that day.
Data tracked by StockTitan Argus for the Nov 12 session.
Key Figures
- Patent protection through
- June 21, 2044
- Form B patent
- Patent claims
- 11 claims
- Directed at the new crystalline form of buntanetap
- Form B purity
- 99.9%
- HPLC analysis
- Trial dose
- 30 mg once daily
- Pivotal early Alzheimer’s disease trial
- Symptomatic analysis
- 6 months
- Pre-specified trial readout
- Disease-modifying analysis
- 18 months
- Pre-specified trial readout
- Symptomatic top-line readout
- Q1 2027
- Company expectation
- Disease-modifying readout
- Q1 2028
- Company expectation
Key Terms
x-ray powder diffraction technical
high-performance liquid chromatography technical
dihydrate technical
pharmacokinetic medical
new drug application regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
- U.S. Patent No. 12,780,831 covers posiphen (buntanetap) D-tartrate Form B, a highly crystalline dihydrate, together with pharmaceutical compositions and methods of preparation, providing protection through 2044
- Form B is used in the Company’s ongoing pivotal Phase 3 trial in early Alzheimer’s disease and in the open-label extension Parkinson’s study
- Issued patent strengthens the Company’s intellectual property position ahead of the top-line data readout from its fully enrolled pivotal Phase 3 Alzheimer’s trial
MALVERN, Pa., Nov. 12, 2026 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a Phase 3 clinical-stage biotechnology company developing the investigational oral therapy, buntanetap, for neurodegenerative diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 12,780,831, titled “Solid Forms of Posiphen D-Tartrate.”
The patent contains eleven claims directed at the new crystalline form of buntanetap, designated Form B. The claims cover the Form B solid form, as characterized by its X-ray powder diffraction pattern and crystal unit cell, and at high purity levels – greater than
“Securing composition of matter protection for the new crystal form of buntanetap is an important milestone for Annovis,” said Maria Maccecchini, Ph.D., Founder, President and CEO of Annovis. “This patent covers the form of buntanetap (Form B) that we have moved into our clinical program, and it strengthens our position as we approach the readout of our pivotal Phase 3 Alzheimer’s study and prepare for regulatory submissions that will follow.”
The patent provides Annovis with protection of buntanetap Form B through June 21, 2044.
About the New Crystalline Form
As described in the patent, Form B is a highly crystalline dihydrate, while the previously used Form A is a semi-crystalline anhydrate. The two forms do not readily interconvert and have distinct crystalline phases. Form B was characterized as a robust and stable dihydrate: it does not lose water or change form when dried under vacuum, and it shows no change in form or crystallinity after milling. An HPLC analysis reported
The pharmacokinetic comparison of Form B with Form A across mice, dogs and humans revealed comparable profiles for both forms in plasma, brain, and cerebrospinal fluid. The results were submitted to the FDA and have been published in a peer-reviewed manuscript in Biomolecules journal.
Background
- In June 2024, Annovis announced the filing of a composition of matter patent application for new solid forms of buntanetap.
- In July 2024, the Company announced that the U.S. Food and Drug Administration (FDA) cleared the transition to the new crystalline form in future clinical trials, after reviewing bridge studies comparing Form A with Form B, together with data on the Company’s new large-scale manufacturing process for that form.
- On November 3, 2026, Annovis was granted U.S. Patent No. 12,780,831 which covers the new crystalline form of buntanetap (Form B) that is used in the Company’s ongoing clinical trials.
Clinical Development Update
Annovis has completed enrollment in its pivotal Phase 3 trial (NCT06709014) evaluating once-daily oral buntanetap (Form B, 30 mg) in patients with early AD who are positive for the plasma biomarker pTau217. The trial is designed with two pre-specified readouts: a 6-month analysis of symptomatic effects and an 18-month analysis of disease-modifying effects. The Company expects the symptomatic top-line data readout in Q1 2027 and the disease-modifying readout in Q1 2028. Annovis has begun preparation for New Drug Application (NDA) submissions that will follow each readout.
About Annovis
Headquartered in Malvern, Pennsylvania, Annovis Bio, Inc. (NYSE: ANVS) is a Phase 3 clinical-stage biotechnology company developing treatments for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD). The Company's lead drug candidate, buntanetap (formerly posiphen), is an investigational once-daily oral therapy that inhibits the translation of multiple neurotoxic proteins, including APP and amyloid beta, tau, alpha-synuclein, and TDP-43, through a specific RNA-targeting mechanism. By addressing the underlying causes of neurodegeneration, Annovis aims to halt disease progression and improve cognitive and motor functions in patients. 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
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What does Annovis Bio’s buntanetap patent cover, and when does protection expire?
U.S. Patent No. 12,780,831 covers buntanetap Form B, pharmaceutical compositions containing it and methods of preparation, with protection through June 21, 2044. The patent contains eleven claims and was granted on November 3, 2026.
When does Annovis Bio expect results from its pivotal Phase 3 Alzheimer’s trial?
Annovis expects symptomatic top-line data in Q1 2027 and a disease-modifying readout in Q1 2028. These correspond to the trial’s pre-specified six-month and 18-month analyses, respectively. Enrollment is complete.
Which patients and dose are included in Annovis Bio’s pivotal Phase 3 Alzheimer’s trial?
The trial evaluates once-daily oral buntanetap Form B, 30 mg, in patients with early Alzheimer’s disease who test positive for the plasma biomarker pTau217. Its trial identifier is NCT06709014.