Annovis Bio, Inc. (ANVS) Bundle
Annovis Bio, Inc. (ANVS) is a micro-cap biotech with a market capitalization of around $55.1 million as of late 2025, but does its unique approach to neurodegeneration justify the risk? This clinical-stage company is pioneering a disease-modifying therapy, buntanetap, which uniquely targets multiple neurotoxic proteins simultaneously, a strategy that sets it apart from single-target treatments in the Alzheimer's and Parkinson's space.
You need to understand the science behind a drug that just saw its pivotal Phase 3 Alzheimer's trial reach 25% completion with all 84 U.S. sites fully activated, plus how a Q3 2025 net loss of $7.3 million maps to their cash runway, so let's break down the history, the mechanism, and the financial reality of this high-stakes biotech.
Annovis Bio, Inc. (ANVS) History
Given Company's Founding Timeline
Year established
Annovis Bio, Inc. was originally incorporated as QR Pharma, Inc. on May 20, 2008.
Original location
The company was first established in Berwyn, Pennsylvania, USA. They later moved their principal executive offices to the nearby Malvern, PA area as the company grew and began its public phase.
Founding team members
The company's foundation was laid by Maria L. Maccecchini, Ph.D., who is the Founder, President, and Chief Executive Officer. Dr. Maccecchini's vision, rooted in over 30 years of neuroscience and drug development expertise, shaped the initial direction toward neurodegenerative diseases.
Initial capital/funding
Early funding for the company came primarily from private placements and founder investment to support initial research. The first major external capital infusion was the Initial Public Offering (IPO) in January 2020, which raised gross proceeds of $12,000,000.
Given Company's Evolution Milestones
| Year | Key Event | Significance |
|---|---|---|
| 2008 | Company Founded (as QR Pharma, Inc.) | Established the core mission to research and develop treatments for neurodegenerative diseases. |
| 2019 | Name Change to Annovis Bio, Inc. | Reflected a broader strategic scope and rebranding in preparation for seeking public capital. |
| 2020 | Initial Public Offering (IPO) on NYSE American | Secured $12,000,000 in gross proceeds, providing the necessary capital to significantly advance clinical development. |
| 2021 | $50 Million Follow-on Public Offering | Raised $50,000,000 in gross proceeds, fueling the planned Phase 3 clinical trial for their lead compound, buntanetap. |
| 2025 | Pivotal Phase 3 AD Trial Initiation | Began the key Phase 3 clinical trial for buntanetap in early Alzheimer's disease, targeting 760 participants. |
Given Company's Transformative Moments
The company's trajectory has been defined by key financial and clinical leaps, moving from a private venture to a late-stage clinical company. The 2020 IPO was the first big step, but the 2021 follow-on offering was a true game-changer, injecting $50,000,000 in gross proceeds. That capital was critical for scaling up their clinical program, especially the pivotal trials.
The focus on buntanetap, a drug designed to inhibit multiple neurotoxic proteins simultaneously, is their core strategic differentiator. This approach is what positions them uniquely in the Alzheimer's disease (AD) and Parkinson's disease (PD) space. To be fair, this is a high-risk, high-reward bet, but the potential is massive if the science holds up. You can read more about their philosophical approach here: Mission Statement, Vision, & Core Values of Annovis Bio, Inc. (ANVS).
In 2025, the company made defintely clear moves to solidify its position: they raised another $21,000,000 in gross proceeds from a February public offering, and by November 2025, they had all 84 sites fully activated for the Phase 3 AD study. Here's the quick math on their burn: Research and Development expenses were $5.0 million in Q1 2025 and $5.2 million in Q2 2025, showing a consistent, heavy investment into those critical trials. This is why cash management is paramount; their cash and cash equivalents were $17.1 million as of June 30, 2025.
- Secured IP: Successfully transferred all patent families to the crystal form of buntanetap in August 2025, strengthening global protection.
- Pivotal Trial Focus: Enrollment for the 760-patient Phase 3 AD trial is the near-term priority, with results expected to be transformative, for better or worse.
- Financial Discipline: Despite a Q3 2025 net loss per share of ($0.37), the company operates with zero debt, which is a rare, strong position for a clinical-stage biotech.
Annovis Bio, Inc. (ANVS) Ownership Structure
The ownership structure of Annovis Bio, Inc. is characteristic of a clinical-stage biotechnology company, with a significant portion of shares held by the public and a strong, concentrated stake held by company insiders.
This distribution means that while institutional investors provide a layer of professional oversight, the strategic direction is defintely still heavily influenced by the conviction of the executive team and directors.
Given Company's Current Status
Annovis Bio, Inc. is a publicly traded, late-stage clinical drug platform company. It is listed on the New York Stock Exchange (NYSE) under the ticker symbol ANVS.
As a clinical-stage firm, its business model is currently focused on research and development (R&D) rather than commercial revenue, which is typical for a biotech advancing its lead candidate, Buntanetap, through pivotal Phase 3 trials for neurodegenerative diseases.
The company reported cash and cash equivalents of $15.3 million as of September 30, 2025, following recent capital raises, which management expects will fund operations into the third quarter of 2026.
Given Company's Ownership Breakdown
Understanding who owns the stock is crucial for assessing governance and potential selling pressure. As of November 2025, the ownership structure shows a moderate institutional presence but a higher-than-average insider stake for a company of its size, with a market capitalization around $51.97 million.
| Shareholder Type | Ownership, % | Notes |
|---|---|---|
| Public Float (Retail) | 70.55% | Represents the majority of shares available for trading. |
| Institutional Investors | 14.59% | Includes firms like Vanguard Group Inc and BlackRock, Inc., holding over 1.9 million shares. |
| Insiders (Executives & Directors) | 14.86% | A high concentration, indicating management's strong vested interest. |
You can see the insiders' conviction in recent activity, like the October 2025 purchase by Director Michael Hoffman, who acquired 975,610 shares, increasing his direct ownership by 65.92%.
Given Company's Leadership
The company is steered by a small, focused executive team with deep scientific and financial expertise, which is essential for a high-risk, high-reward biotech venture.
The leadership team is responsible for guiding the pivotal Phase 3 Alzheimer's study and managing the burn rate-R&D expenses hit $6.3 million in Q3 2025 alone.
- Maria Maccecchini, Ph.D.: Founder, President, and Chief Executive Officer (CEO). Her scientific background and long-term commitment drive the drug platform strategy.
- Mark Guerin: Chief Financial Officer (CFO). Appointed to strengthen the financial strategy as the company moves toward potential data readouts and commercial planning.
- Mark White: Chief Business Officer (CBO). Focuses on global pharmaceutical marketing and business development, critical for future commercialization efforts.
For a detailed breakdown of the company's core principles that guide this team, you should review their Mission Statement, Vision, & Core Values of Annovis Bio, Inc. (ANVS).
Annovis Bio, Inc. (ANVS) Mission and Values
Annovis Bio, Inc.'s core purpose transcends standard biotech goals; it is fundamentally about ending the fear and despair associated with neurodegenerative diseases by halting nerve cell death. This mission defines their cultural DNA, prioritizing scientific rigor and patient impact over everything else.
Annovis Bio, Inc.'s Core Purpose
The company's mission and values are rooted in a clear, patient-centric mandate: to pioneer scientifically proven therapies for devastating conditions like Alzheimer's disease (AD) and Parkinson's disease (PD). The whole organization is focused on advancing its lead drug candidate, buntanetap, through late-stage clinical trials. For example, the pivotal Phase 3 study for early AD is designed to enroll an estimated 760 participants across the U.S.
Official mission statement
The formal mission is a powerful statement about changing the narrative for millions of affected families. It's not just about a drug; it's about a future where resilience, not despair, is the response to these diagnoses. The goal is simple, but defintely not easy: halt the death of nerve cells.
- Halt the death of nerve cells.
- Present new hope for millions of patients and their families.
- Deliver a potentially life-changing treatment to patients as soon as possible.
Vision statement
The vision is to normalize brain function by stopping the toxic cascade-the process where damaged nerve cells produce neurotoxic proteins-which is the root cause of neurodegeneration (the gradual breakdown and loss of neuron function). This is a disease-modifying approach, not just a symptomatic one.
The company's long-term aspiration, or vision, is to develop innovative therapies that improve patient outcomes and quality of life, moving toward a future where neurodegenerative diseases are met with scientifically proven treatments. Mission Statement, Vision, & Core Values of Annovis Bio, Inc. (ANVS).
- Address neurodegeneration in diseases like AD and PD.
- Develop innovative therapies that improve patient outcomes and quality of life.
- Meet neurodegenerative challenges with resilience and scientifically proven therapies.
This commitment requires serious capital. The company reported a net loss of $7.3 million for the third quarter of 2025, with R&D expenses for the first nine months of 2025 totaling over $16.4 million, showing their deep financial dedication to this vision.
Annovis Bio, Inc. slogan/tagline
While Annovis Bio, Inc. doesn't use a short, punchy tagline in its corporate communications, its operational philosophy is clearly: 'Stopping the Toxic Cascade in Neurodegeneration.' This phrase captures their unique mechanism of action (MOA)-inhibiting the translation of multiple neurotoxic proteins-which is the entire basis of their platform.
To be fair, in a clinical-stage biotech, the science is the slogan.
Annovis Bio, Inc. (ANVS) How It Works
Annovis Bio, Inc. operates as a late-stage clinical drug platform company, meaning its core work is the research and development of a single, small-molecule drug candidate, buntanetap, to treat neurodegenerative diseases like Alzheimer's and Parkinson's. The company does not currently generate revenue from product sales; it creates value by advancing its drug through pivotal clinical trials and securing intellectual property, aiming for eventual regulatory approval and commercialization. The company's revenue for the trailing twelve months ending June 30, 2025, was $0.00, reflecting its clinical-stage status.
Annovis Bio, Inc.'s Product/Service Portfolio
The company's value proposition centers on its lead compound, buntanetap, a translational inhibitor that targets the toxic cascade common across multiple neurodegenerative disorders. The drug is an orally available small molecule, a significant feature in a market dominated by injectable or infusible biologics. The pipeline also includes other candidates leveraging the same platform technology.
| Product/Service | Target Market | Key Features |
|---|---|---|
| Buntanetap (ANVS401) | Early Alzheimer's Disease (AD) & Parkinson's Disease (PD) | Oral small molecule; inhibits multiple neurotoxic proteins (APP, tau, $\alpha$SYN, TDP-43); pivotal Phase 3 trial underway for AD, aiming for symptomatic and disease-modifying effects. |
| ANVS405 | Acute Neurodegeneration (e.g., acute brain injuries) | Same mechanism of action as buntanetap; granted a U.S. patent in January 2025 for treatment and prevention methods of acute brain and nerve injuries. |
| ANVS301 | Alzheimer's Disease (AD) | Pipeline product targeting AD; intended to leverage the company's platform approach to neurodegeneration. |
Annovis Bio, Inc.'s Operational Framework
The operational framework is lean, focusing almost entirely on outsourcing and managing the complex, expensive clinical trial process. The company's primary activity is translating its unique scientific platform into clinical data that supports a New Drug Application (NDA) with the FDA. Here's the quick math on their burn rate: Research and Development (R&D) expenses for Q3 2025 were $6.3 million, significantly outpacing the General and Administrative (G&A) expenses of $1.1 million for the same period.
- Drug Development and Trial Management: Manages the pivotal Phase 3 AD trial, which has 84 clinical sites fully activated across the U.S. and is targeting an estimated 760 participants.
- Funding and Capital Management: Finances operations through capital raises, as product revenue is currently $0.00. Cash and cash equivalents totaled $15.3 million as of September 30, 2025, which is projected to fund operations into Q3 2026.
- Data Generation: Collects and analyzes biomarker data from trials, such as the October 2025 data showing reductions in neuroinflammation markers like IL-5, IL-6, and NFL, which are key to proving the drug's disease-modifying potential.
The whole business model hinges on successful trial execution. If onboarding takes 14+ days, churn risk rises. For more details on the capital structure, you should be Exploring Annovis Bio, Inc. (ANVS) Investor Profile: Who's Buying and Why?
Annovis Bio, Inc.'s Strategic Advantages
The company's market success hinges on its ability to differentiate its lead candidate, buntanetap, from other Alzheimer's and Parkinson's treatments, which often target only a single neurotoxic protein. This multi-target approach is their defintely biggest differentiator.
- Multi-Target Mechanism of Action: Buntanetap inhibits the translation of multiple neurotoxic proteins simultaneously (amyloid-beta, tau, alpha-synuclein, TDP-43), addressing the multifactorial nature of neurodegeneration.
- Proprietary IP and Drug Form: Intellectual property for the drug is secured through 2046, following the transfer of patents to a new, more stable crystalline form of buntanetap.
- Oral Administration: As an oral small molecule, buntanetap offers a competitive advantage over large-molecule antibody therapies (like aducanumab or lecanemab) that require intravenous infusion, simplifying patient access and administration.
- Disease-Modifying Potential: Clinical data from October 2025 showed reductions in key biomarkers of neuroinflammation and neurodegeneration, suggesting the drug may fundamentally alter the course of the disease, not just treat symptoms.
Annovis Bio, Inc. (ANVS) How It Makes Money
Annovis Bio, Inc. is a pre-revenue, clinical-stage biopharmaceutical company, meaning it currently generates virtually zero income from selling its lead drug candidate, buntanetap, or any other product. The company's financial engine is entirely focused on burning capital to fund research and development (R&D) and is sustained almost exclusively by raising money through equity financing, which is the sale of stock to investors.
Its core business model is a high-risk, high-reward bet: spend millions now to develop a drug for neurodegenerative diseases like Alzheimer's and Parkinson's, with the goal of generating billions in revenue only if the drug achieves regulatory approval years down the line.
Annovis Bio, Inc.'s Revenue Breakdown
To be clear, Annovis Bio's revenue is not from its core business. The total revenue reported is minimal and comes from non-core activities like interest earned on cash holdings. For the three months ended September 30, 2025, the company reported total other income, net, of just $172,317.
| Revenue Stream | % of Total | Growth Trend |
|---|---|---|
| Product Sales (Buntanetap) | 0% | Stable (at zero) |
| Non-Product Revenue (Interest/Other) | 100% | Stable/Slightly Increasing |
The growth in this small revenue stream is generally tied to rising interest rates on cash reserves and the increasing size of the company's cash position due to recent stock offerings.
Business Economics
The economics of a clinical-stage biotech like Annovis Bio are simple but brutal: cash burn is the only constant. The entire value proposition hinges on the success of its Phase 3 clinical trials, not current sales. This is why traditional metrics like Price-to-Earnings (P/E) are meaningless here.
- Primary Cost Driver: Research and Development (R&D) expenses are the single largest outflow, totaling $6.3 million in the third quarter of 2025, which represents a significant increase from $2.7 million in the same quarter last year as the pivotal Phase 3 Alzheimer's study ramps up.
- Funding Mechanism (Dilution): The company funds its operations by issuing new stock (equity financing). This is critical because it leads to shareholder dilution-your slice of the company pie shrinks with every new offering. For example, the shares outstanding jumped to 20.2 million as of September 30, 2025.
- Valuation Reality: You don't value Annovis Bio based on current earnings; you use a probability-adjusted Discounted Cash Flow (DCF) model. This means forecasting billions in potential future drug sales, then discounting that back to today's value, and finally multiplying that by the estimated chance (or probability of success) that the FDA will actually approve buntanetap.
The company's survival depends on its ability to keep raising capital until it hits a major clinical milestone. Breaking Down Annovis Bio, Inc. (ANVS) Financial Health: Key Insights for Investors is a good place to see how this reliance on external funding plays out in the balance sheet.
Annovis Bio, Inc.'s Financial Performance
As of November 2025, the financial performance is measured by its cash position and its burn rate, not profitability. The company is not profitable and is not expected to be for several years.
- Net Loss: For the nine months ended September 30, 2025, the company reported a net loss of $19.02 million, reflecting the heavy investment in clinical trials. The net loss for the third quarter of 2025 alone was $7.26 million, or $0.37 per diluted share.
- Cash Runway: Annovis Bio's cash and cash equivalents totaled $15.3 million as of September 30, 2025. They improved their liquidity immediately after the quarter close with two October 2025 registered direct offerings, raising an additional $6.0 million and $3.4 million in gross proceeds.
- Accumulated Deficit: The company's accumulated deficit-the total of all historical losses-hit a staggering $153.9 million as of September 30, 2025. That's a lot of money spent to get to this stage.
- Expense Trend: While R&D expenses are climbing, General and Administrative (G&A) expenses actually decreased to $1.1 million in Q3 2025 from $1.7 million a year prior, suggesting some cost discipline outside of the core scientific mission.
The key action for you, the investor, is to track the cash balance and the clinical data readouts, defintely not the revenue line.
Annovis Bio, Inc. (ANVS) Market Position & Future Outlook
Annovis Bio, Inc. (ANVS) is a high-risk, high-reward clinical-stage biotechnology company whose future hinges entirely on the success of its lead drug candidate, Buntanetap (ANVS401), in late-stage trials. The company currently holds a 0% market share in the neurodegenerative drug space, as it generates no product revenue, but its multi-modal mechanism positions it to potentially disrupt the Alzheimer's disease (AD) and Parkinson's disease (PD) markets if its Phase 3 data is positive. Exploring Annovis Bio, Inc. (ANVS) Investor Profile: Who's Buying and Why?
The company is currently focused on executing its pivotal Phase 3 study for early AD, which reached 25% completion as of November 2025, with all 84 clinical sites fully activated across the U.S. This is a critical inflection point.
Competitive Landscape
The neurodegenerative market is bifurcated between established, low-cost symptomatic treatments and new, high-cost disease-modifying therapies (DMTs). Annovis Bio's Buntanetap, an oral small molecule, is aiming for the DMT segment but with a novel mechanism that targets multiple neurotoxic proteins, unlike the current amyloid-focused monoclonal antibodies.
Here's how Annovis Bio stands against key players in the Alzheimer's market, which is projected to be worth $6.41 billion in 2025.
| Company | Market Share, % | Key Advantage |
|---|---|---|
| Annovis Bio | 0% | Oral, multi-modal mechanism; targets AD, PD, and acute injuries. |
| Generic Donepezil (e.g., Aricept) | ~67.7% | Established, low-cost, symptomatic relief; first-line standard of care. |
| Eisai/Biogen (Leqembi) | ~7.9% | First-mover FDA-approved disease-modifying antibody (anti-amyloid). |
Opportunities & Challenges
The core opportunity is Buntanetap's unique mechanism of action (MOA). It's designed to inhibit the synthesis of neurotoxic proteins, which could offer a more comprehensive treatment for both AD and PD than single-target therapies. Still, the company is a clinical-stage biotech, so the risks are defintely high.
| Opportunities | Risks |
|---|---|
| Disease-Modifying Potential: Biomarker data shows Buntanetap reducing neuroinflammation and neurodegeneration markers. | Clinical Trial Failure: Any negative Phase 3 data readout (symptomatic data expected late 2026) could lead to a catastrophic loss of value. |
| Broad Pipeline Application: Drug is being developed for Alzheimer's, Parkinson's, and acute brain/nerve injuries (ANVS405). | Capital and Dilution Risk: Company is pre-revenue, relying on financing. Cash reserves of $15.3 million (Q3 2025) fund operations only through Q3 2026. |
| Strong IP Protection: New crystal form of Buntanetap secures global intellectual property until 2046, extending its commercial runway. | Market Volatility: The stock exhibits high volatility, with a beta around 3.71, making it highly sensitive to news. |
Industry Position
Annovis Bio is a micro-cap player in a global market dominated by large pharmaceutical companies like Eli Lilly and Biogen. Its market capitalization is approximately $55.1 million as of November 2025, which is tiny compared to its competitors. The company's standing is purely speculative, built on the promise of its platform. It's a binary bet.
- Novel MOA: Buntanetap's multi-target approach is a key differentiator against the current anti-amyloid monoclonal antibodies, which face safety and logistical hurdles (infusion, required MRI monitoring).
- Oral Dosing Advantage: As an oral small molecule, Buntanetap would offer a significant logistical and cost advantage over the currently approved intravenous (IV) DMTs like Leqembi.
- High Analyst Confidence: Despite the risks, analysts maintain a median price target of $13.50, suggesting a potential upside of over 485% from recent trading levels, reflecting belief in the Phase 3 outcome.
The next step for you is to monitor the Phase 3 trial progress, specifically looking for any updates on the 6-month symptomatic data readout expected in the second half of 2026.

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