Annovis Bio, Inc.
For the period ended Jun 30, 2025. Filed Aug 12, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 12, 2025
ANVS$0.84+26.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-13.
0001558370-25-007584
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-12.
0001558370-25-011233
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 58 previous paragraphs and 73 current paragraphs.
39 unchanged; 16 reworded; 14 added; 2 removed; 1 previous and 4 current paragraphs rearranged.
Tables are not compared: 15 previous and 16 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (14)
Current report
Research and development expenses for the three months ended June 30, 2025 were $5.2 million, compared to $5.8 million for the three months ended June 30, 2024. The $0.6 million decrease was primarily attributable to $2.5 million of lower contract manufacturing and drug substance costs for clinical supply, offset by $1.9 million in clinical labor and pass-through costs associated with our ongoing Phase 3 AD program.
Current report
General and administrative expenses for the three months ended June 30, 2025 were $1.1 million, compared to $2.0 million for the three months ended June 30, 2024. The $0.9 million decrease was primarily attributable to $0.7 million of lower stock-based compensation expense as well as $0.2 million in reduced corporate legal, printing and public relations fees year over year.
Current report
Other Financing Costs
Current report
There were no other financing costs incurred for the three months ended June 30, 2025, compared to $1.3 million incurred for the three months ended June 30, 2024. The $1.3 million decrease was attributable to the 2024 ELOC financing facility being exhausted prior to the quarter ending June 30, 2025, whereas during the same period during 2024, the facility was active.
Current report
Comparison of the Six Months Ended June 30, 2025 and 2024
Current report
Research and Development Expenses
Current report
Research and development expenses for the six months ended June 30, 2025 were $10.2 million, compared to $12.3 million for the six months ended June 30, 2024. The $2.1 million decrease was attributable to a $6.5 million decrease in costs associated with our completed Phase 3 study in PD patients and Phase 2/3 study in AD patients and a
Current report
$1.1 million decrease in clinical material manufacturing costs, offset by $4.7 million of increased costs for our active Phase 3 AD program as well as $0.8 million of increased clinical support costs.
Current report
General and Administrative Expenses
Current report
General and administrative expenses for the six months ended June 30, 2025 were $2.4 million, compared to $3.3 million for the six months ended June 30, 2024. The $0.9 million decrease was due to a $0.7 million decrease in stock-based compensation expense as well as $0.2 million in reduced employee salary costs.
Current report
Interest Income
Current report
Other Financing Costs
Current report
There were no other financing costs incurred for the six months ended June 30, 2025, compared to $1.3 million incurred for the six months ended June 30, 2024. The $1.3 million decrease was attributable to the 2024 ELOC financing facility being exhausted prior to the six month ending June 30, 2025, whereas during the same period during 2024 the facility was active.
Current report
Change in fair value of warrants was a gain of $0.4 million for the six months ended June 30, 2025, compared to a gain of $10.8 million for the six months ended June 30, 2024. The $10.4 million difference between periods was primarily driven by increased volatility in our stock price during the first half of 2024, as compared to the same period during 2025.
Removed paragraphs (2)
Previous report
Research and development expenses for the three months ended March 31, 2025 were $5.0 million, compared to $6.5 million for the three months ended March 31, 2024. The $1.5 million decrease was attributable to our previous Phase 3 PD and Phase 2/3 AD studies incurring close-out activity during the first quarter 2024 that did not take place in 2025, offset by increased clinical labor, pass-through and API costs incurred during the first quarter of 2025 to support our recently initiated pivotal Phase 3 AD study.
Previous report
General and administrative expenses for the three months ended March 31, 2025 were $1.3 million, compared to $1.3 million for the three months ended March 31, 2024. There were no significant expense differences between each period.
Reworded paragraphs (16)
Previous wording
Our Phase 3 PD Study was completed on December 4, 2023, and we released the topline PD Study efficacy data on July 2, 2024. The study data showed that in two subgroups, buntanetap improved UPDRS 2, 3, 2+3 and total. It also showed that in the entire intent to treat (“ITT”) population, buntanetap stopped the loss of cognition and that in the 12% of patients that already had cognitive issues, buntanetap improved cognition in a dose-dependent, statistically significant way. We expect to discuss the Phase 3 PD data with the FDA during a Type C meeting in June 2025. During that meeting, we plan to propose continued development of buntanetap with an additional, pivotal Phase 3 trial.
Current wording
Our Phase 3 PD Study was completed on December 4, 2023, and we released the topline PD Study efficacy data on July 2, 2024. The study data showed that in two subgroups, buntanetap improved UPDRS 2, 3, 2+3 and total. It also showed that in the entire intent to treat (“ITT”) population, buntanetap stopped the loss of cognition and that in the 12% of patients that already had cognitive issues, buntanetap improved cognition in a dose-dependent, statistically significant way. We asked the FDA for a Type C meeting to discuss the data and the continued development of buntanetap for Lewy Body Dementia. In response, we received a letter from the FDA saying that because Lewy Body Dementia is a challenging disease to treat and because there are no accepted end points, they would like to discuss the two conditions — Dementia with Lewy Bodies and Parkinson’s Disease Dementia — separately and independently. However, the FDA did approve a protocol for an open label study in PD patients, consisting of two cohorts: all patients that previously participated in previous PD studies, as well as patients with deep brain simulation (“DBS”).
Previous wording
The Phase 2/3 AD study was completed on February 13, 2024 and on April 29, 2024, we announced topline efficacy data. The data showed that in early AD patients, buntanetap improved ADAS-Cog11 in a dose-dependent fashion and was statistically significant from placebo and from baseline.
Current wording
Our Phase 2/3 AD study was completed on February 13, 2024 and on April 29, 2024, we announced topline efficacy data. The data showed that in early AD patients, buntanetap improved ADAS-Cog11 in a dose-dependent fashion and was statistically significant from placebo and from baseline.
Previous wording
On October 10, 2024, the Company met with the FDA in an end-of-phase 2 meeting to discuss its Phase 2/3 AD data and to agree on a regulatory path forward. Annovis and the FDA have aligned on a development path for buntanetap towards the filing of New Drug Applications (“NDAs”), one for short-term and one for long-term efficacy. During the end-of-phase 2 meeting for AD, the FDA raised no concerns with the Company’s data on buntanetap’s safety, including impact on liver enzymes, drug interactions, dose selection, pharmacokinetics and population pharmacokinetics. Further, the FDA confirmed that future development can proceed using the new crystal form of buntanetap.
Current wording
On October 10, 2024, we met with the FDA in an end-of-phase 2 meeting to discuss its Phase 2/3 AD data and to agree on a regulatory path forward. Annovis and the FDA have aligned on a development path for buntanetap towards the filing of New Drug Applications (“NDAs”), one for short-term and one for long-term efficacy. During the end-of-phase 2 meeting for AD, the FDA raised no concerns with our data on buntanetap’s safety, including impact on liver enzymes, drug interactions, dose selection, pharmacokinetics and population pharmacokinetics. Further, the FDA confirmed that future development can proceed using the new crystal form of buntanetap.
Previous wording
During February of 2025, we initiated the FDA-cleared pivotal ANVS-25001 trial; a randomized, double-blind, placebo-controlled, multicenter Phase 3 trial in early AD patients. The trial will investigate buntanetap and will consist of two parts: a 6-month treatment period aimed at confirming buntanetap’s symptomatic efficacy, followed by an additional 12 months of treatment to show potential disease-modifying efficacy at 18 months. After the 6-month treatment period has been completed, patients will continue to be blinded for the additional 12 months. If well-designed and well-executed, the symptomatic portion of the trial may be sufficient to support an NDA filing, potentially within one year of the 6-month treatment period initiation.
Current wording
During February of 2025, we initiated the FDA-cleared pivotal ANVS-25001 trial; a randomized, double-blind, placebo-controlled, multicenter Phase 3 trial in early AD patients. The trial investigates buntanetap and consists of two parts: a 6-month treatment period aimed at confirming buntanetap’s symptomatic efficacy, followed by an additional 12 months of treatment to show potential disease-modifying efficacy at 18 months. After the 6-month treatment period has been completed, patients will continue to be blinded for the additional 12 months. If well-designed and well-executed, the symptomatic portion of the trial may be sufficient to support an NDA filing, potentially within one year of the 6-month treatment period initiation. A similar pathway could be available after 18 months, where a second NDA for disease modification may be supportable with a well-designed and well-executed long-term portion of the trial.
Previous wording
We believe that we are the only company developing a drug for AD and PD that is designed to inhibit more than one neurotoxic protein and has a mechanism of action designed to restore nerve cell axonal and synaptic activity. By improving brain function, our goal is to treat memory loss and dementia associated with AD, as well as body and brain function issues associated with PD. Based on pre-clinical and clinical data collected to date, we believe that buntanetap has the potential to be the first drug to interfere with the underlying mechanism of neurodegeneration, potentially enabling buntanetap to be the only drug to improve cognition in AD and motor function in PD. The industry has historically encountered challenges in specifically targeting one neurotoxic protein, be it APP, tau or αSYN, indicating that doing so does not change the underlying course of neurodegeneration. Our ultimate goal is to develop a disease modifying drug (“DMD”) for patients with neurodegeneration by leveraging our clinical and pre-clinical data, which shows inhibition of the most relevant neurotoxic proteins. Studies have found that AD and PD are the most
Current wording
We believe that we are the only company developing a drug for AD and PD that is designed to inhibit more than one neurotoxic protein and has a mechanism of action designed to restore nerve cell axonal and synaptic activity. By improving brain function, our goal is to treat memory loss and dementia associated with AD, as well as body and brain function issues associated with PD. Based on pre-clinical and clinical data collected to date, we believe that buntanetap has the potential to be the first drug to interfere with the underlying mechanism of neurodegeneration,
Previous wording
We have never been profitable and have incurred net losses since inception. Our accumulated deficit at March 31, 2025 was $140.4 million. We expect to incur losses for the foreseeable future, and we expect these losses to increase as we continue our development of, and seek regulatory approvals for, our product candidates. Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability.
Current wording
We have never been profitable and have incurred net losses since inception. Our accumulated deficit at June 30, 2025 was $146.6 million. We expect to incur losses for the foreseeable future, and we expect these losses to increase as we continue our development of, and seek regulatory approvals for, our product candidates. Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability.
Previous wording
We do not have sufficient capital on hand to fund our operations for the next 12 months and will need to raise additional capital to meet our obligations as they become due. We believe that our cash and cash equivalents as of March 31, 2025, will be sufficient to fund our operating expenses and capital expenditure requirements until the fourth quarter of 2025. We will need to raise substantial additional capital to complete the development and commercialization of our product candidates through public or private equity offerings, debt financings, collaboration and licensing arrangements or other financing alternatives. However, there can be no assurance that we will be successful in raising additional capital or that such capital, if available, will be on terms that are acceptable to us. If we are unable to raise sufficient additional capital or defer sufficient operating expenses, we may be compelled to reduce the scope of our operations.
Current wording
We do not have sufficient capital on hand to fund our operations for the next 12 months and will need to raise additional capital to meet our obligations as they become due. We believe that our cash and cash equivalents as of June 30, 2025, will be sufficient to fund our operating expenses and capital expenditure requirements until the first quarter of 2026. We will need to raise substantial additional capital to complete the development and commercialization of our product candidates through public or private equity offerings, debt financings, collaboration and licensing arrangements or other financing alternatives. However, there can be no assurance that we will be successful in raising additional capital or that such capital, if available, will be on terms that are acceptable to us. If we are unable to raise sufficient additional capital or defer sufficient operating expenses, we may be compelled to reduce the scope of, or cease, our operations.
Previous wording
Interest income was $0.2 million for the three months ended March 31, 2025, compared to $0.0 million for the three months ended March 31, 2024. The $0.2 million increase was driven by increased cash and cash equivalent balances, as a result of our public offering with ThinkEquity in February 2025.
Current wording
Interest income was $0.2 million for the three months ended June 30, 2025, compared to $0.0 million for the three months ended June 30, 2024. The $0.2 million increase was driven by increased cash and cash equivalent balances, as a result of our public offering with ThinkEquity, which closed in February 2025.
Previous wording
Change in fair value of warrants was a gain of $0.5 million for the three months ended March 31, 2025, compared to a gain of $6.7 million for the three months ended March 31, 2024. The revaluation between periods was primarily affected by less warrants being outstanding in 2025 and relative changes in our stock price.
Current wording
Change in fair value of warrants was a loss of $0.1 million for the three months ended June 30, 2025, compared to a gain of $4.1 million for the three months ended June 30, 2024. The $4.2 million difference between periods was primarily driven by increased volatility in our stock price during the second quarter of 2024, as compared to the same period during 2025.
Previous wording
Since our inception in 2008, we have devoted most of our cash resources to research and development and general and administrative activities. We have financed our operations primarily with the proceeds from the sale of common stock and warrants. To date, we have not generated any revenue from the sale of products, and we do not anticipate generating any revenue from the sale of products for the foreseeable future. We have incurred losses and generated negative cash flows from operations since inception. As of March 31, 2025, our principal source of liquidity was our cash and cash equivalents, which totaled $22.2 million. We do not believe that our cash on hand will be sufficient to fund our operations for at least twelve months beyond the date of this filing.
Current wording
Since our inception in 2008, we have devoted most of our cash resources to research and development and general and administrative activities. We have financed our operations primarily with the proceeds from the sale of common stock and warrants. To date, we have not generated any revenue from the sale of products, and we do not anticipate generating any revenue from the sale of products for the foreseeable future. We have incurred losses and generated negative cash flows from operations since inception. As of June 30, 2025, our principal source of liquidity was our cash and cash equivalents, which totaled $17.1 million. We do not believe that our cash on hand will be sufficient to fund our operations for at least twelve months beyond the date of this filing.
Previous wording
On February 3, 2025, the Company entered into an Underwriting Agreement with ThinkEquity LLC (“ThinkEquity”), with respect to an underwritten public offering of 5.3 million units of the Company, each unit consisting of one share of its common stock, par value $0.0001 per share and one warrant to purchase one share of the Company Stock (the “ThinkEquity Warrants”). The units were priced at $4.00 per unit and the offering resulted in gross proceeds of $21.0 million, before deducting underwriting discounts, fees and other related expenses. Net proceeds from the transaction totaled $19.3 million. The ThinkEquity Warrants have an exercise price of $5.00 per share, are immediately exercisable and expire five years from their date of issuance. The shares of Common Stock and Warrants were issued separately.
Current wording
On February 3, 2025, the Company entered into an Underwriting Agreement with ThinkEquity LLC (“ThinkEquity”), with respect to an underwritten public offering of 5.3 million units of the Company, each unit consisting of one share of its common stock, par value $0.0001 per share and one warrant to purchase one share of the Company Stock (the “ThinkEquity Warrants”). The units were priced at $4.00 per unit and the offering resulted in gross proceeds of $21.0 million, before deducting underwriting discounts, fees and other related expenses. Net proceeds from the transaction totaled $19.3 million. The ThinkEquity Warrants have an exercise price of $5.00 per share, are immediately exercisable and expire five years from their date of issuance. The shares of Common Stock and Warrants were issued separately. None of the ThinkEquity Warrants were exercised during the three or six month ended June 30, 2025.
Previous wording
During the three months ended March 31, 2025, the Company sold 0.1 million shares of common stock pursuant to the Distribution Agreement for gross proceeds of $0.5 million before commissions.
Current wording
During the three and six months ended June 30, 2025, the Company sold 0.0 million and 0.1 million shares of common stock, respectively, pursuant to the Distribution Agreement for gross proceeds of $0.0 million and $0.5 million, before commissions.
Previous wording
The following table provides a summary of our cash flows for the three months ended March 31, 2025 and 2024:
Current wording
The following table provides a summary of our cash flows for the six months ended June 30, 2025 and 2024:
Previous wording
Cash used in operating activities was $8.1 million for the three months March 31, 2025, compared to $7.0 million for the three months ended March 31, 2024. The $1.1 million increase in cash used in operations was primarily the result of additional cash paid for clinical trial and related expenses, given the planned timing of study costs and related disbursements.
Current wording
Cash used in operating activities was $13.2 million for the six months ended June 30, 2025, compared to $10.4 million for the six months ended June 30, 2024. The $2.8 million increase in cash used in operations was primarily the result of additional cash paid for clinical trials and related expenses, given the planned timing of study costs and related disbursements.
Previous wording
Contingent upon continued achievement of our fundraising requirements, we expect cash used in operating activities to return to elevated levels as 2025 progresses, due to expected operating expenditures associated with continued development of our product candidates. More specifically, we expect elevated operating cash burn as a result of costs associated with completing our Phase 3 trial for AD.
Current wording
Contingent upon continued achievement of our fundraising requirements, we expect cash used in operating activities to remain at elevated levels as 2025 progresses, due to expected operating expenditures associated with continued development of our product candidates. More specifically, we expect elevated operating cash burn as a result of costs associated with completing our active Phase 3 trial for AD.
Previous wording
Cash provided by financing activities was $19.8 million and primarily consisted of the proceeds from our registered offering with ThinkEquity, as well as proceeds from our ATM facility with OpCo. Cash provided by financing activities for the three months ended March 31, 2024, was $4.4 million and consisted of proceeds from our March 2024 Registered Direct Offerings and exercises of our Canaccord Warrants.
Current wording
Cash provided by financing activities for the six months ended June 30, 2025 was $19.8 million and primarily consisted of the $19.3 million of proceeds from our registered offering with ThinkEquity, as well as $0.5 million of proceeds from our ATM facility with OpCo. Cash provided by financing activities for the six months ended June 30, 2024, was $8.7 million and consisted of $4.0 million of proceeds from our March 2024 Registered Direct Offerings, $4.2 million of proceeds from our 2024 ELOC facility and $0.5 million of proceeds from warrant exercises.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
potentially enabling buntanetap to be the only drug to improve cognition in AD and motor function in PD. The industry has historically encountered challenges in specifically targeting one neurotoxic protein, be it APP, tau or αSYN, indicating that doing so does not change the underlying course of neurodegeneration. Our ultimate goal is to develop a disease modifying drug (“DMD”) for patients with neurodegeneration by leveraging our clinical and pre-clinical data, which shows inhibition of the most relevant neurotoxic proteins. Studies have found that AD and PD are the most common neurodegenerative diseases in the U.S., and accordingly these diseases present two unmet needs of the aging population and two potentially large U.S. markets, if a DMD is developed and approved.
Current report — wording carried from elsewhere
The following table summarizes the results of our operations for the six months ended June 30, 2025 and 2024:
Current report — wording carried from elsewhere
Interest income was $0.4 million for the six months ended June 30, 2025, compared to $0.1 million for the six months ended June 30, 2024. The $0.3 million increase was driven by increased cash and cash equivalent balances, as a result of our public offering with ThinkEquity, which closed in February 2025.
Current report — wording carried from elsewhere
Change in Fair Value of Warrants
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
common neurodegenerative diseases in the U.S., and accordingly these diseases present two unmet needs of the aging population and two potentially large U.S. markets, if a DMD is developed and approved.