Annovis Bio, Inc. (ANVS): Business Model Canvas [Dec-2025 Updated]

You're looking at a classic, high-stakes biotech play right now, and Annovis Bio, Inc. is squarely in the hot seat as it pushes Buntanetap through pivotal Phase 3 trials for Alzheimer's. Honestly, the model is all about runway: they burned through $6.3 million on Research and Development in Q3 2025, leaving them with $15.3 million in cash as of September 30, 2025, though they did pull in $9.4 million from an October offering to help manage the burn. This isn't about product sales yet; it's about de-risking a potential disease-modifying treatment with strong Intellectual Property secured until 2046. Here's the quick math: every day in that trial counts. Dive into the full Business Model Canvas below to see exactly how Annovis Bio, Inc. is structuring its operations to hit that next critical data readout.

Annovis Bio, Inc. (ANVS) - Canvas Business Model: Key Partnerships

You're looking at how Annovis Bio, Inc. gets its critical operational and financial muscle through external relationships. It's all about execution speed and capital access when you're pre-revenue, so these partnerships are key.

Contract Research Organizations (CROs) for large-scale trial execution

The execution of the pivotal Phase 3 study in early Alzheimer's disease relies heavily on a network of external clinical partners, which typically involves CROs managing the logistics across multiple sites.

The scale of this operational partnership is evidenced by the activation of 84 U.S. clinical sites for the Phase 3 study as of November 6, 2025.

Network of 84 U.S. clinical sites for Phase 3 AD enrollment

The physical network for patient recruitment and treatment is substantial, designed to hit the enrollment target of 760 patients with biomarker-confirmed amyloid pathology.

By November 6, 2025, all 84 of these U.S. sites were reported as fully activated and enrolling participants.

The first cohort of participants had already completed the 6-month treatment milestone in that same period.

Academic and medical key opinion leaders (KOLs) for scientific validation

Scientific validation comes through presenting data and engaging with the community, often led by internal experts who represent the company's scientific standing.

Key scientific validation points were scheduled for presentation at the 18th Clinical Trials on Alzheimer's Disease (CTAD) conference in December 2025, with presentations given by President and CEO Maria Maccecchini, Ph.D., and Cheng Fang, Ph.D., Senior VP, Research & Development.

The company also presented at the AD/PD™ 2025 conference in April 2025.

• Scientific presentations at CTAD 2025 covered the double 6/18-month Phase 3 study.
• Data on buntanetap for APOE4 carriers was presented at AD/PD™ 2025.

Investment banks for continuous equity financing and capital raises

Securing non-dilutive capital is crucial, and Annovis Bio, Inc. has actively used registered direct offerings to bolster its cash position.

In October 2025, the company executed two registered direct offerings, raising a combined gross proceeds of $9.4 million.

One offering secured $6 million through the sale of 4,000,000 shares at $1.50 per share, with H.C. Wainwright & Co. acting as the exclusive placement agent.

The second offering raised $3.4 million.

Following these raises, cash and cash equivalents totaled $15.3 million as of September 30, 2025, funding operations to the third quarter of 2026.

Annovis Bio, Inc. (ANVS) - Canvas Business Model: Key Activities

You're looking at the core engine driving Annovis Bio, Inc. right now-the essential things the company must do well to move Buntanetap toward a potential market launch. It's all about clinical execution and keeping the lights on through financing.

Executing the pivotal Phase 3 AD trial with 760 estimated participants

The primary activity centers on the pivotal Phase 3 clinical trial for early Alzheimer's disease (AD), designated NCT06709014. This study is designed with a dual readout structure to assess both immediate and long-term drug effects. The trial aims to enroll a total of 760 patients confirmed with early AD and amyloid pathology. 84 clinical sites across the U.S. are fully activated to support this enrollment. As of early November 2025, the trial reached 25% completion, with the earliest enrollees having completed the initial 6-month treatment milestone. The symptomatic efficacy data readout is targeted for the second half of 2026.

Here's a snapshot of the clinical activity and associated costs:

Research and Development (R&D) for Buntanetap and pipeline expansion

Research and Development activity is heavily weighted toward supporting the ongoing Phase 3 trial and presenting supporting data. You see this reflected directly in the quarterly spending figures. The company is also actively exploring pipeline expansion based on Buntanetap's mechanism of action, including combination therapies.

The R&D expenditure shows the intensity of the current clinical phase:

• Research and development expenses for the three months ending March 31, 2025 (Q1 2025) were $5.0 million.
• Research and development expenses for the three months ending June 30, 2025 (Q2 2025) were $5.2 million.
• Research and development expense rose to $6.3 million for the three months ending September 30, 2025 (Q3 2025).

Also, Annovis Bio presented data at the Alzheimer's Association International Conference (AAIC) 2025 and is scheduled to present at the Clinical Trials on Alzheimer's Disease (CTAD) conference in December 2025, focusing on biomarker data supporting Buntanetap's potential disease-modifying activity.

Protecting and maintaining Intellectual Property (IP) globally

Securing the intellectual property for Buntanetap is a critical, non-clinical activity. As of August 2025, Annovis Bio completed the transfer of all patent families to cover both the original semi-crystalline and the new crystalline forms of the drug candidate. This comprehensive protection is set to extend through 2046. The portfolio includes protection for composition of matter and mechanism of action.

The IP portfolio strength is quantified as follows:

• Total patent families covering both forms: 13.
• Global coverage secured for both forms.
• A U.S. patent for treatment and prevention of acute brain or nerve injuries using buntanetap was issued on January 2, 2025.

Raising capital through equity offerings to extend cash runway

Since Annovis Bio is generating no revenue and is funding its pivotal trial entirely through external financing, capital raising is a constant key activity. The company executed several financing events in 2025 to manage its cash burn and extend its operational window past the critical 6-month AD trial data readout.

Financing activity and resulting cash position:

Also, Annovis Bio has an Equity Distribution Agreement in place that allows for raising up to $50 million in common stock, which serves as a potential future lifeline. The share count increased materially, moving from approximately 14.14 million at the end of 2024 to 20.2 million as of September 30, 2025, due to these offerings. The net cash used in operating activities for the nine months ending September 30, 2025, surged 23% to $16.7 million.

Annovis Bio, Inc. (ANVS) - Canvas Business Model: Key Resources

You're looking at the core assets Annovis Bio, Inc. (ANVS) relies on to drive its value proposition in the neurodegenerative space. These aren't just ideas; they are tangible, protected, and quantified resources as of late 2025.

The primary asset is the lead drug candidate, Buntanetap, which is characterized as a small oral molecule. The Company has successfully transitioned to a new crystalline form of this molecule, a dihydrate crystal, which offers better solid-state stability while maintaining the same pharmacokinetic (PK) profile and metabolism as the original compound. This new form is what is currently being used in the pivotal Phase 3 Alzheimer's disease trial.

Intellectual Property (IP) protection is a critical barrier to entry, and Annovis Bio, Inc. has significantly fortified this. The Company announced the successful transfer of all patents to cover this new crystal form, securing comprehensive global intellectual property protection that extends until 2046. This robust IP portfolio covers the composition of matter, mechanism of action, and applications for buntanetap across both the original and new crystalline forms, represented by a total of 13 patent families.

Financially, the Company's immediate operational runway is supported by its cash position. Here's the quick math on the balance sheet as of the third quarter close:

Clinical validation is perhaps the most valuable non-financial resource. Data from the ongoing Phase 2/3 Alzheimer's disease trial (NCT05686044) provides evidence of Buntanetap's potential as a disease-modifying therapy beyond just symptomatic relief. Mild AD patients in the prior Phase 2/3 study had already demonstrated significant cognitive improvement. More recently, October 2025 biomarker results from the Phase 2/3 study showed profound effects in patients with mild and moderate stages of the disease who had positive pTau217 plasma levels.

These biomarker results specifically demonstrated that Buntanetap attenuated key markers of neuroinflammation and neurodegeneration compared to placebo. The reductions observed included:

• Inflammatory markers: IL-5, IL-6, S100A12, IFN-γ, and IGF1R.
• Neurodegeneration marker: Decreased levels of NFL (a protein fragment released from damaged neurons), indicating improved cellular integrity.

The Phase 3 trial itself is a resource, with 84 clinical sites across the U.S. fully activated and enrolling patients, keeping the Company on track for symptomatic data readouts in the second half of 2026.

Annovis Bio, Inc. (ANVS) - Canvas Business Model: Value Propositions

You're looking at the core reasons why Annovis Bio, Inc.'s buntanetap stands out in the neurodegenerative space. It's not just another drug; it's built around a specific mechanism that addresses complexity in diseases like Alzheimer's and Parkinson's.

Potential disease-modifying treatment for Alzheimer's and Parkinson's

The value proposition here is moving beyond just managing symptoms to potentially altering the disease course itself. The ongoing pivotal Phase 3 study in early Alzheimer's disease (AD) (NCT06709014) is designed to test this over an 18-month period for disease modification, following an initial 6-month symptomatic readout. As of November 2025, all 84 clinical sites across the U.S. are fully activated and enrolling participants, with the first group of patients having completed that initial 6-month treatment milestone. This AD trial aims to enroll a total of 760 patients with biomarker-confirmed amyloid pathology. For Parkinson's disease (PD), Phase 3 data showed buntanetap halted cognitive decline across the overall patient population. Specifically, approximately 25% of the PD participants who exhibited amyloid co-pathology and had experienced accelerated cognitive decline saw that decline counteracted and reversed by buntanetap.

Orally available drug, offering easier patient administration than infusions

Buntanetap is an oral molecule, which is a significant administrative advantage over treatments requiring intravenous (IV) infusions. This oral dosing simplifies patient adherence and reduces the burden associated with frequent clinic visits for infusions. The company has also advanced its formulation, publishing pharmacokinetic (PK) data for a new crystalline buntanetap form, securing intellectual property protection for this form through 2046.

Targets multiple neurotoxic proteins, a holistic approach to neurodegeneration

The science behind buntanetap suggests it addresses the multifactorial nature of these diseases by targeting several toxic pathways simultaneously. This is supported by biomarker data from the Phase 2/3 AD study showing measurable biological activity. The treatment group showed reductions versus placebo in several inflammatory markers known to drive pathology, including IL-5, IL-6, S100A12, IFN-γ, and IGF1R. Furthermore, buntanetap decreased levels of NFL, a protein fragment released from damaged neurons, indicating improved cellular integrity. This multi-target approach is positioned as necessary for meaningful progress, as targeting just one cause has historically yielded limited benefit.

Favorable safety profile (no ARIA reported to date) compared to competitors

The safety profile has been a consistent point of emphasis. In a previous Phase 2/3 study, the safety profile was consistent with prior trials, with comparable numbers of Adverse Events (AEs) between treatment and placebo groups. The majority of reported AEs were mild to moderate in severity, and critically, no serious AEs were related to buntanetap. This positive safety assessment was reinforced when the FDA raised no concerns regarding the Company's data on safety, including liver enzymes and drug interactions, during the End-of-Phase 2 meeting in October 2024.

The investment required to deliver these value propositions is substantial, as reflected in recent financials. For the three months ending September 30, 2025, Research and Development expenses were $6.3 million, up from $2.7 million in the same quarter of 2024, driven by the Phase 3 activity. The company reported cash and cash equivalents of $15.3 million as of September 30, 2025, which, combined with recent offerings totaling $9.4 million ($6.0 million and $3.4 million offerings in October), was projected to fund operations into Q3 2026.

You can see the commitment in the Q3 2025 R&D spend of $6.3 million, which is more than double the $2.7 million spent in Q3 2024. Finance: draft 13-week cash view by Friday.

Annovis Bio, Inc. (ANVS) - Canvas Business Model: Customer Relationships

High-touch coordination with clinical trial investigators and site staff

• The pivotal Phase 3 Alzheimer's disease (AD) study has 84 secured clinical sites across the U.S. fully activated and enrolling/treating patients as of November 2025.
• The Phase 3 AD trial is designed to enroll a total of 760 patients.
• As of August 12, 2025, 76 U.S. sites were secured for the AD trial, with 46 currently enrolling.
• The earliest enrollees in the AD Phase 3 trial reached the 6-month treatment milestone as of November 6, 2025.
• The AD Phase 3 study was reported as 25% complete as of November 6, 2025.
• A planned Parkinson's disease (PD) Open Label Extension study is anticipated to include between 500 and 700 patients.
• Previous PD studies involved a 4,500 patient study.
• The AD Phase 2/3 study previously involved 350 patients.

Direct engagement with investors via webcasts and scientific presentations

Annovis Bio, Inc. held specific direct engagement events with investors and the patient community throughout 2025:

Direct engagement also included providing updates on the Q3 2025 Financial Results on November 12, 2025.

Regulatory relationship management with the U.S. FDA

The relationship management with the U.S. FDA has been characterized by formal meetings and protocol alignment:

• The FDA accepted an updated protocol for the pivotal Phase 3 AD study, which was slated to begin in January 2025.
• The ongoing Phase 3 AD study is proceeding with full FDA alignment on design, endpoints, and patient population, following an End-of-Phase-2 interaction in 2024.
• The AD study design is positioned to potentially support two New Drug Application (NDA) filings.
• The FDA has scheduled a Type C meeting for January 2026 to discuss the development pathway for buntanetap in Parkinson's disease dementia (PDD).

Scientific communication through peer-reviewed publications and conferences

Annovis Bio, Inc. presented scientific data at major neurology conferences in 2025:

• Presented four scientific posters at the Alzheimer's Association International Conference (AAIC) 2025 in Toronto (July 27-31, 2025).
• Participated in the AD/PD™ 2025 conference (April 1-5 in Vienna) with two presentations and one forum discussion.
• Announced two presentations at the Clinical Trials on Alzheimer's Disease (CTAD) conference (December 1-4, 2025 in San Diego).
• One CTAD presentation focused on the Double 6/18-month Phase 3 study for Alzheimer's disease.

The company reported new biomarker data linking amyloid co-pathology to cognitive decline in Parkinson's patients on November 17, 2025.

Annovis Bio, Inc. (ANVS) - Canvas Business Model: Channels

You're looking at how Annovis Bio, Inc. gets its data, its story, and eventually, its drug, to the right people. Right now, it's all about clinical execution and investor communication, since they're still in late-stage trials.

U.S. clinical trial network for patient recruitment and drug delivery

The primary channel for Annovis Bio, Inc. right now is the operational network supporting the pivotal Phase 3 study for buntanetap in early Alzheimer's disease (AD). This network is the conduit for drug delivery to trial participants and the collection of critical clinical data.

The Phase 3 Alzheimer's trial (NCT06709014) is designed to enroll a total of 760 patients with biomarker-confirmed amyloid pathology. As of November 6, 2025, all 84 sites across the U.S. are fully activated and enrolling participants. This milestone means the trial is 25% complete toward the total enrollment target.

Here's a snapshot of the trial structure and progress as of late 2025:

The company also utilizes its clinical sites to gather data for its Parkinson's disease program, with Phase 3 PD trial data presented earlier in 2025.

Scientific and medical conferences (e.g., CTAD, AAIC) for data dissemination

Annovis Bio, Inc. uses major scientific and medical conferences as a primary channel to disseminate clinical data to the scientific community, clinicians, and researchers. This is crucial for building credibility and informing future development paths.

Key conference engagements in 2025 included:

• Attended AAIC 2025 in Toronto (July 27-31, 2025).
• Presented four scientific posters at AAIC 2025.
• Presented at AD/PD™ 2025 in Vienna (April 1-5).
• Announced two presentations at CTAD 2025 in San Diego (December 1-4, 2025).

The CTAD 2025 presentations included data on the Phase 3 study for Alzheimer's disease and biomarker data for Parkinson's disease dementia patients.

Investor Relations (IR) channels for public disclosures and financing

For financial disclosures and capital raising, Annovis Bio, Inc. relies on formal SEC filings, press releases distributed via wire services, and direct engagement with the investment community through webcasts and investor materials. The company's IP protection is a key asset communicated through these channels.

Financial and corporate data points as of late 2025:

The company directs investors to its website, www.AnnovisBio.com, and social channels like LinkedIn, X, and YouTube for updates. Email alerts are available at https://www.annovisbio.com/email-alerts.

Specialty pharmacies and distributors (future commercial channel)

As Annovis Bio, Inc. remains in late-stage clinical development, the formal channel for drug distribution via specialty pharmacies and distributors is not yet active. This channel is contingent upon successful completion of the Phase 3 trials and subsequent New Drug Application (NDA) submission and approval. The symptomatic readout is targeted for H2 2026, which would precede commercial launch planning.

Annovis Bio, Inc. (ANVS) - Canvas Business Model: Customer Segments

You're looking at the core groups Annovis Bio, Inc. (ANVS) targets with buntanetap, which is a critical view before we even touch on how they plan to make money. Honestly, for a late-stage biotech, the customer segments are laser-focused on the clinical and financial gatekeepers.

Patients with early Alzheimer's Disease (AD) and biomarker-confirmed pathology

This segment represents the primary indication for the pivotal Phase 3 trial. The patient pool is substantial, though Annovis Bio, Inc. is specifically targeting the early stage, which is where their biomarker data suggests the greatest impact. The company's Phase 3 AD clinical trial is fully activated across 84 U.S. clinical sites as of late 2025. This focus is on patients whose pathology can be confirmed, likely including those with the ApoE4 carrier status mentioned in prior studies.

Here are some relevant population statistics for context:

• Americans currently living with Alzheimer's Disease: 6.9M
• Projected Americans to be diagnosed with Alzheimer's by 2060: 2X the current number
• Historical success rate for developing new Alzheimer's treatments: 2%

Patients with Parkinson's Disease (PD), especially those with cognitive decline

This segment is important because Annovis Bio, Inc. is demonstrating that PD cognitive decline often overlaps with AD pathology. The data suggests a strong response in PD patients who also have this co-pathology. The company is also preparing for a Type C meeting with the FDA in January 2026 to discuss the development pathway for Parkinson's disease dementia (PDD), a serious complication within this group.

The scope of this patient group and its complication is significant:

Neurologists and specialists treating neurodegenerative disorders

These are the prescribers and key opinion leaders (KOLs) who validate the clinical data and ultimately recommend the therapy. Their segment is reached through scientific presentations, such as those at the CTAD 2025 conference, where Annovis Bio, Inc. presented on both its AD and PD programs. The company is focused on convincing this group that buntanetap offers a disease-modifying potential by reducing neuroinflammation and neurodegeneration markers like pTau217, total tau, and brain-derived tau.

Engagement points for this segment include:

• Presentations at CTAD 2025 conference (December 1-4, 2025)
• Discussions on novel therapeutic and biomarker strategies for PD and related disorders
• Data supporting reductions in neuroinflammation and neurodegeneration markers

Institutional investors and biotech-focused venture capital firms

This group provides the necessary capital to fund the late-stage clinical trials and operations. You need to keep them informed on cash runway and R&D spend. As of September 30, 2025, Annovis Bio, Inc. reported cash and cash equivalents of $15.3M, which, along with recent offerings, was stated to fund operations through Q3 2026. Research and development expenses for Q3 2025 were $6.3M. The company had 20.2M shares of common stock outstanding as of that date.

The institutional landscape as of late 2025 shows active management:

The basic and diluted net loss per common share for the three months ending September 30, 2025, was $0.37. Finance: draft 13-week cash view by Friday.

Annovis Bio, Inc. (ANVS) - Canvas Business Model: Cost Structure

You're looking at the core spending that fuels Annovis Bio, Inc.'s late-stage development, which is heavily weighted toward clinical execution and securing the future of buntanetap. For a clinical-stage biotech, the cost structure is almost entirely operational burn, centered on the drug trials.

The most significant cost driver is Research and Development (R&D), which reflects the intensive work of advancing the pivotal Phase 3 Alzheimer's disease trial. For the three months ended September 30, 2025, Annovis Bio, Inc. reported R&D expenses of $6.3 million. This figure is up significantly from $2.7 million in the same period in 2024, showing the ramp-up in trial activity.

General and Administrative (G&A) expenses are the next major component, covering overhead, executive salaries, and corporate functions. In Q3 2025, G&A expenses totaled $1.1 million, a decrease from $1.7 million reported in Q3 2024. This reduction in administrative spend, while R&D surged, suggests a focus on operational efficiency to preserve cash.

Here's a quick look at the key quarterly expense categories for Annovis Bio, Inc. for the third quarter of 2025:

Clinical trial expenses are embedded within the R&D figure, but the scale of the operation gives you a sense of the magnitude of these costs. You should know that the pivotal Phase 3 Alzheimer's disease trial has reached full activation across 84 U.S. sites as of late 2025. These sites drive costs related to site activation, patient recruitment, drug administration, and ongoing patient monitoring, all critical for generating reliable data.

Protecting the intellectual property (IP) is a non-negotiable, albeit less visible, cost. Annovis Bio, Inc. has been actively managing this, having completed the transfer of all patent families for the new crystalline form of buntanetap. This action secures global IP protection through the year 2046. These costs include:

• Patent maintenance fees for international filings.
• Legal fees associated with IP prosecution and defense.
• Costs related to the transfer and formalization of the new crystalline form patents.

The company's cash position as of September 30, 2025, stood at $15.3 million, which, following October financing activities, management indicated was sufficient to fund operations into the third quarter of 2026. The burn rate implied by the Q3 operating expenses, coupled with other non-cash items, dictates the runway you need to track closely.

Finance: draft 13-week cash view by Friday.

Annovis Bio, Inc. (ANVS) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Annovis Bio, Inc. (ANVS) as of late 2025. Since the company is deep in clinical development, the revenue profile is entirely focused on non-product sources right now, with the big money sitting in the future, contingent on regulatory success.

Current revenue is $0.00 from product sales, which is absolutely typical for a clinical-stage firm like Annovis Bio, Inc. They are not selling any commercialized drugs yet; all resources are directed toward advancing buntanetap through its pivotal trials.

The primary current cash inflow comes from financing activities, essentially selling ownership stakes to fund the expensive clinical work. You can see the recent capital raises below:

The combined gross proceeds from the October 2025 offerings totaled $9.4 million. Remember, these are gross figures; placement agent fees and expenses will reduce the net cash received. As of September 30, 2025, the cash balance was $15.3 million, which incorporated these October funds. Honestly, this cash runway is what keeps the lights on until the next data readout.

Future revenue streams are entirely potential, tied to the success of buntanetap in the clinic. These are the non-dilutive possibilities that analysts watch closely:

• Future potential milestone payments from any in-licensing or collaboration agreements that Annovis Bio, Inc. might secure.
• Royalties or product sales revenue following potential regulatory approval (NDA submission) for buntanetap in Alzheimer's disease (AD) or Parkinson's disease (PD).
• Potential payments related to the new crystalline form of buntanetap patents secured through 2046.

The near-term focus is on the pivotal Phase 3 AD trial, which is aiming for symptomatic data in the second half of 2026, the final step before an NDA submission. That readout is the trigger for any serious discussions about milestone payments or future commercialization revenue sharing.

To be fair, the specific dollar amounts for future milestone payments or royalty percentages are not public information at this stage; they are locked away in potential future agreements. What this estimate hides is the risk that these future streams never materialize if the drug fails to meet its primary endpoints.

Finance: draft 13-week cash view by Friday.