Annovis Bio, Inc.
For the period ended Sep 30, 2025. Filed Nov 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.
Sep 30, 2025 · Filed Nov 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 2025-06-30; filed 2025-08-12.
0001558370-25-011233
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001104659-25-110393
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 73 previous paragraphs and 72 current paragraphs.
52 unchanged; 16 reworded; 4 added; 5 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 16 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 (4)
Current report
Research and development expenses for the three months ended September 30, 2025 were $6.3 million, compared to $2.7 million for the three months ended September 30, 2024. The $3.6 million increase was primarily attributable to $3.5 million of additional costs associated with our AD 6 month trial patients. Of the $6.3 million for the three months ended September 30, 2025 $4.1 million of this expense relates to our AD 6 month trial and $0.7 million of this expense relates to our PD Open Label Extension study. The remaining $1.5 million reflects clinical costs not specifically associated with either study.
Current report
General and administrative expenses for the three months ended September 30, 2025 were $1.1 million, compared to $1.7 million for the three months ended September 30, 2024. The $0.6 million decrease was primarily attributable to $0.4 million of increased stock listing & transfer fees, driven by the Canaccord Warrants, which occurred in Q3 2024, discussed in footnote 3(a).
Current report
Comparison of the Nine Months Ended September 30, 2025 and 2024
Current report
Research and development expenses for the nine months ended September 30, 2025 were $16.5 million, compared to $15.0 million for the nine months ended September 30, 2024. The $1.5 million increase was primarily attributable to a $1.9 million increase in costs associated with our AD 6 month trial patients and a $1.4 million increase in bioanalytical work. These increases are partially offset by a $1.3 million decrease in clinical material manufacturing costs, which resulted from a large supply of product being released for use in the Phase 3 studies during 2024.
Removed paragraphs (5)
Previous 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.
Previous 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.
Previous report
Comparison of the Six Months Ended June 30, 2025 and 2024
Previous 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
Previous 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.
Reworded paragraphs (16)
Previous 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.
Current wording
We have never been profitable and have incurred net losses since inception. Our accumulated deficit at September 30, 2025 was $153.9 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 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.
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, will be sufficient to fund our operating expenses and capital expenditure requirements until the third 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 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.
Current wording
Interest income was $0.2 million for the three months ended September 30, 2025, compared to $0.1 million for the three months ended September 30, 2024. The $0.1 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
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 wording
There were no other financing costs incurred for the three months ended September 30, 2025, compared to $0.5 million incurred for the three months ended September 30, 2024. The $0.5 million decrease was attributable to the 2024 ELOC financing facility being exhausted prior to the quarter ending September 30, 2025, whereas during the same period during 2024, the facility was active.
Previous 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.
Current wording
Change in fair value of warrants was a loss of $0.0 million for the three months ended September 30, 2025, compared to a gain of $7.9 million for the three months ended September 30, 2024. The $7.9 million difference between periods was primarily driven by increased volatility in our stock price during the third quarter of 2024, as compared to the same period during 2025.
Previous wording
The following table summarizes the results of our operations for the six months ended June 30, 2025 and 2024:
Current wording
The following table summarizes the results of our operations for the nine months ended September 30, 2025 and 2024:
Previous wording
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 wording
General and administrative expenses for the nine months ended September 30, 2025 were $3.5 million, compared to $5.0 million for the nine months ended September 30, 2024. The $1.5 million decrease was due to a $0.7 million decrease in stock-based compensation expense as well as $0.5 million in reduced stock listing and transfer fees.
Previous wording
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 wording
Interest income was $0.5 million for the nine months ended September 30, 2025, compared to $0.2 million for the nine months ended September 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.
Previous wording
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 wording
There were no other financing costs incurred for the nine months ended September 30, 2025, compared to $1.9 million incurred for the nine months ended September 30, 2024. The $1.9 million decrease was attributable to the 2024 ELOC financing facility being exhausted prior to the nine month ended September 30, 2025, whereas during the same period during 2024 the facility was active.
Previous wording
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.
Current wording
Change in fair value of warrants was a gain of $0.4 million for the nine months ended September 30, 2025, compared to a gain of $2.9 million for the nine months ended September 30, 2024. The $2.5 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.
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 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.
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 September 30, 2025, our principal source of liquidity was our cash and cash equivalents, which totaled $15.3 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. None of the ThinkEquity Warrants were exercised during the three or six month ended June 30, 2025.
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 nine month ended September 30, 2025.
Previous 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.
Current wording
During the three and nine months ended September 30, 2025, the Company sold 0.7 million and 0.8 million shares of common stock, respectively, pursuant to the Distribution Agreement for gross proceeds of $1.7 million and $2.2 million, before commissions.
Previous wording
The following table provides a summary of our cash flows for the six months ended June 30, 2025 and 2024:
Current wording
The following table provides a summary of our cash flows for the nine months ended September 30, 2025 and 2024:
Previous 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.
Current wording
Cash used in operating activities was $16.7 million for the nine months ended September 30, 2025, compared to $13.6 million for the nine months ended September 30, 2024. The $3.1 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
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.
Current wording
Cash provided by financing activities for the nine months ended September 30, 2025 was $21.4 million and primarily consisted of the $19.3 million of proceeds from our registered offering with ThinkEquity, as well as $2.2 million of proceeds from our ATM facility with OpCo. Cash provided by financing activities for the nine months ended September 30, 2024, was $20.5 million and consisted of $8.0 million from warrant exercises, a combined $3.9 million received from our March registered direct offerings and $8.6 million of proceeds from share issuances under our ELOC Purchase Agreement.