What Annovis Bio does

Annovis Bio, Inc. (NYSE: ANVS) is a Phase 3 clinical-stage biotechnology company founded in 2008 by Dr. Maria Maccecchini and headquartered in Malvern, Pennsylvania. The company is developing buntanetap (formerly Posiphen/ANVS401), an orally administered small molecule that inhibits translation of multiple neurotoxic aggregating proteins—including APP/amyloid-beta, tau, alpha-synuclein, and TDP-43—through an RNA-targeting mechanism involving Iron Regulatory Protein 1 (IRP1). The in-licensed compound (from the NIH National Institute on Aging in 2009) is being evaluated in two pivotal-stage programs: a 760-patient Phase 3 trial in early Alzheimer's disease across 83 U.S. sites (65% enrolled as of March 2026) and a 500-patient, 36-month open-label Phase 3 extension in Parkinson's disease across 25 U.S. sites launched in January 2026.

The company is pre-revenue and does not yet commercialize any product. Its operating model is funded almost entirely through repeated dilutive public equity offerings, with approximately $112 million raised since IPO in January 2020—including $25 million in October 2025 and $25 million across April–May 2026—to extend the cash runway through approximately Q2 2027. FY2025 financials show R&D expense of $25.2 million, a net loss of $28.9 million ($1.40 per share), and $19.5 million in cash and equivalents. Future revenue, if buntanetap receives FDA approval, would come from commercial drug sales, with pricing and distribution models not yet established.

Annovis serves patients with early-stage Alzheimer's disease (ages 55–85, MMSE 21–28, plasma pTau217 positive) and Parkinson's disease (ages 40–85, H&Y 1–3), with planned indication expansion into Parkinson's disease dementia (FDA Type C meeting January 2026) and broader neurodegeneration. Clinical operations are supported by 83 Alzheimer's and 25 Parkinson's trial sites including academic centers (UCLA, Duke, Rush, UC Davis), and the Parkinson's program integrates NeuroRPM's FDA-cleared AI wearable biomarker platform as a partnered technology layer. The company maintains a small management team (~10–15 members) and a Scientific Advisory Board that includes National Academy members and former directors of the Cleveland Clinic Lou Ruvo Center.

Name

Annovis Bio

Legal name

Annovis Bio, Inc.

Website

https://annovisbio.com

Company type

Public

Founded year

2008

Operating status

Operating

Headcount range

1–10 employees

Short description

Annovis Bio is a Phase 3 clinical-stage biotechnology company developing buntanetap, an oral small molecule that targets multiple neurotoxic proteins, for patients with early Alzheimer's disease and Parkinson's disease.

Ownership category

akta.pro rank

Product category

Neurodegenerative Disease Therapeutics

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Medicinal Chemicals & Botanical Products (2833)

akta.pro primary industry

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)

akta.pro secondary industry

Immunology & Inflammation Pharmaceuticals (HLAIAAAD)

Keywords

• Neurodegenerative disease therapeutics
• Alzheimer's disease treatment
• Parkinson's disease treatment
• RNA-targeting small molecule
• Clinical-stage biotechnology

Headquarters

HQ city

Berwyn

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2C

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Drug Development and Commercialization: Annovis Bio is a pre-revenue clinical-stage biotechnology company. The company raises capital through public offerings of equity to fund clinical development of buntanetap for Alzheimer's and Parkinson's diseases. If buntanetap receives FDA approval, future revenue would come from commercial drug sales.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels8 records

Core offering

Annovis Bio is developing buntanetap, an investigational once-daily oral small molecule that targets multiple neurotoxic aggregating proteins (APP, amyloid-beta, tau, alpha-synuclein, TDP-43) through an RNA-targeting translational inhibition mechanism that strengthens binding of mRNAs to Iron Regulatory Protein 1 (IRP1). The drug is in Phase 3 clinical trials for both early Alzheimer's disease and Parkinson's disease, with the company pursuing FDA approval for disease-modifying treatment of neurodegeneration.

Product overview

Annovis Bio is a Phase 3 clinical-stage biotechnology company developing buntanetap (formerly Posiphen, ANVS401) as its lead investigational once-daily oral therapy for neurodegenerative diseases, targeting multiple neurotoxic proteins including APP/amyloid-beta, tau, alpha-synuclein, and TDP-43 through a unique RNA-targeting translational inhibition mechanism. The company also has two additional pipeline compounds — ANVS405 and ANVS301 — in earlier stages of development targeting neurodegenerative diseases. In its clinical operations, Annovis Bio has partnered with NeuroRPM to deploy an FDA-cleared AI-powered wearable digital biomarker platform in its ongoing open-label Phase 3 Parkinson's disease study (ANVS-25002), enabling continuous passive monitoring of motor symptoms.

Differentiator

Problem solved

Functional benefit

Products and services

• Buntanetap (formerly Posiphen, ANVS401) Investigational once-daily oral small molecule that works as a translational inhibitor targeting multiple neurotoxic aggregating proteins (APP, amyloid-beta, tau, alpha-synuclein, TDP-43) through an RNA-targeting mechanism that strengthens binding of mRNAs to Iron Regulatory Protein 1 (IRP1). Designed to halt neurodegeneration in Alzheimer's disease and Parkinson's disease by restoring nerve cell function and communication. Phase 2/3 data showed 3.3 point improvement in ADAS-Cog11 at 30mg dose vs 0.26 for placebo (p<0.001).
• ANVS405 Pipeline drug candidate targeting neurodegenerative diseases, listed alongside buntanetap in Annovis Bio's development pipeline. Earlier-stage compound with limited public detail available.
• ANVS301 Pipeline drug candidate targeting neurodegenerative diseases, listed alongside buntanetap and ANVS405 in Annovis Bio's development pipeline. Earlier-stage compound with limited public detail available.

Quantifiable outcome

• Phase 2/3 Alzheimer's study: 3.3 point improvement in ADAS-Cog11 at 30mg dose vs 0.26 for placebo (p<0.001)
• +5 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature5 records

Partnerships

One partnership is on record.

• NeuroRPMcoreTechnology or Integration · 19 March 2026Annovis partnered with NeuroRPM to deploy an FDA-cleared AI-powered digital biomarker platform in its ongoing open-label Phase 3 Parkinson's disease study (ANVS-25002). The wearable technology using Apple Watch monitors primary PD symptoms—bradykinesia, tremor, and dyskinesia—in real-world settings, generating digital biomarker data to complement clinical assessments. The partnership aims to provide objective, AI-enabled measurement of disease progression throughout the 36-month trial enrolling 500 patients across 25 U.S. sites.

Scale indicators13 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Sage Therapeutics: Sage Therapeutics is a CNS-focused biotechnology company that developed Zurzuvae (zuranolone) for postpartum depression. It is comparable to Annovis in CNS specialty pharmaceutical focus, small molecule development, and clinical-to-commercial stage transition experience.
• Cognition Therapeutics: Cognition Therapeutics is a clinical-stage biotech developing CT1812 for Alzheimer's disease and dementia with Lewy bodies. It is a direct peer given similar size, indication focus on neurodegenerative proteinopathies, and small molecule oral therapy modality.
• Denali Therapeutics: Denali Therapeutics develops therapeutics for neurodegenerative diseases including Parkinson's (LRRK2 inhibitors) and Alzheimer's, with a focus on neurodegeneration biology. It is comparable in indication focus though larger and broader in pipeline.
• Athira Pharma: Athira Pharma was a clinical-stage biotech developing small molecule therapies (fosgonimeton) targeting HGF/MET for Alzheimer's disease and other neurodegenerative disorders. It is a direct peer in indication and clinical-stage status.
• Prothena Corporation: Prothena is a clinical-stage biotech developing therapies targeting misfolded proteins (tau, alpha-synuclein, amyloid) in neurodegenerative diseases including Parkinson's and Alzheimer's. It is directly comparable to Annovis in mechanism focus on aggregating neurotoxic proteins.
• Cassava Sciences: Cassava Sciences is a late-stage clinical biotech developing simufilam for Alzheimer's disease. It is the closest direct peer to Annovis Bio in terms of company size, indication focus (early AD), small molecule approach, and pre-revenue clinical-stage status.

Emerging players

• Acadia Pharmaceuticals: Acadia Pharmaceuticals is a CNS specialty pharma commercializing drugs for Parkinson's disease psychosis (Nuplazid) and Rett syndrome (Daybue). It represents an emerging CNS commercial-stage peer that has navigated the same patient population Annovis targets in PD.

Broad incumbents

• Biogen: Biogen is a large established biotech with deep Alzheimer's franchise including Leqembi (lecanemab) co-developed with Eisai. As the leading AD player, it represents the dominant incumbent competing for the same patient population Annovis targets.
• Eisai: Eisai co-developed Leqembi (lecanemab) with Biogen and has been a long-standing leader in dementia therapeutics. It is a broad incumbent peer with deep AD commercial and clinical capabilities relevant to buntanetap's target market.
• Eli Lilly: Eli Lilly developed Kisunla (donanemab), an FDA-approved anti-amyloid antibody for early Alzheimer's. As a global pharma incumbent with massive AD commercial infrastructure, it is the primary competitive benchmark for any new AD therapeutic.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/qrpharma
• YouTubeyoutube.com/@AnnovisBio
• LinkedInlinkedin.com/company/annovis-bio-inc
• Facebookfacebook.com/qrpharma

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

Funding overview

Funding rounds17 records

Investors7 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Annovis Bio