ANVS 10-Q
Annovis Bio, Inc. (ANVS)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
COMMISSION FILE NUMBER
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of | (I.R.S. Employer |
(Address of registrant’s principal executive offices)
(
Registrant’s telephone number, including area code
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class |
| Trading Symbol |
| Name of Each Exchange on Which Registered |
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ | |
☒ | Smaller reporting company | |||
Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
The number of outstanding shares of the registrant’s common stock as of August 8, 2025 was:
ANNOVIS BIO, INC.
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTER ENDED JUNE 30, 2025
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PART I
FINANCIAL INFORMATION
Item 1. Financial Statements
Annovis Bio, Inc.
Balance Sheets
| June 30, | |||||
| 2025 |
| December 31, | |||
(Unaudited) | 2024 | |||||
Assets |
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Current assets: |
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Cash and cash equivalents | $ | | $ | | ||
Prepaid expenses and other current assets |
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Total assets | $ | | $ | | ||
Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable | $ | | $ | | ||
Accrued expenses |
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Total current liabilities |
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Non-current liabilities: | ||||||
Warrant liability | | | ||||
Total liabilities |
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Commitments and contingencies (Note 6) |
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Stockholders’ equity: |
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Preferred stock - $ | ||||||
Common stock - $ |
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Additional paid-in capital |
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Accumulated deficit |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity | $ | | $ | | ||
See accompanying notes to financial statements.
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Annovis Bio, Inc.
Statements of Operations
(Unaudited)
| Three Months Ended | Six Months Ended | ||||||||||
June 30, | June 30, | |||||||||||
2025 |
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Operating expenses: |
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Research and development | $ | | $ | | $ | | $ | | ||||
General and administrative |
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Total operating expenses |
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Operating loss | ( | ( | ( | ( | ||||||||
Other income (expense): |
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Interest income |
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Other financing costs (Note 7) | — | ( | — | ( | ||||||||
Change in fair value of warrants (Note 7) | ( | | | | ||||||||
Total other income, net |
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Net loss | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Net loss per share (Note 9) | ||||||||||||
Basic | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Diluted | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Weighted-average number of common shares used in computing net loss per share | ||||||||||||
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Diluted |
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See accompanying notes to financial statements.
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Annovis Bio, Inc.
Statements of Changes in Stockholders’ Equity (Deficit)
(Unaudited)
Additional | Total | Total | ||||||||||||
Common Stock | Paid-in | Accumulated | Stockholders' Equity | |||||||||||
| Shares |
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| Capital |
| Deficit |
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Three and Six Months Ended June 30, 2025 | ||||||||||||||
Balance, December 31, 2024 |
| | $ | | $ | | $ | ( | $ | | ||||
Issuance of common stock, pursuant to Equity Distribution Agreement, net of issuance costs |
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Issuance of common stock and warrants under registered direct offering, net of issuance costs | | | | — | | |||||||||
Stock-based compensation expense | — | — | | — | | |||||||||
Net loss | — | — | — | ( | ( | |||||||||
Balance, March 31, 2025 | | $ | | $ | | $ | ( | $ | | |||||
Stock-based compensation expense | — |
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Net loss | — |
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Balance, June 30, 2025 | | $ | | $ | | $ | ( | $ | | |||||
Three and Six Months Ended June 30, 2024 | ||||||||||||||
Balance, December 31, 2023 |
| | $ | | $ | | $ | ( | $ | ( | ||||
Exercise of common stock warrants, inclusive of warrant reduction |
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Issuance of common stock, net of issuance costs | |
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Stock-based compensation expense | — | — | | — | | |||||||||
Net loss |
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Balance, March 31, 2024 |
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Issuance of common stock under ELOC, net of issuance costs | |
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Stock-based compensation expense | — | — | | — | | |||||||||
Net loss | — |
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Balance, June 30, 2024 | | $ | | $ | | $ | ( | $ | ( | |||||
See accompanying notes to financial statements.
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Annovis Bio, Inc.
Statements of Cash Flows
(Unaudited)
Six Months Ended June 30, | ||||||
2025 | 2024 | |||||
Cash flows from operating activities: |
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Net loss | $ | ( | $ | ( | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Stock-based compensation expense |
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Change in fair value of warrants | ( | ( | ||||
Non-cash other financing costs | — | | ||||
Changes in operating assets and liabilities: |
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Prepaid expenses and other current assets |
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Accounts payable |
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Accrued expenses |
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Net cash used in operating activities |
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Cash flows from financing activities: |
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Proceeds from issuance of common stock, net | | | ||||
Proceeds from exercise of warrants | — | | ||||
Net cash provided by financing activities |
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Net increase (decrease) in cash and cash equivalents |
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Cash and cash equivalents, beginning of period |
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Cash and cash equivalents, end of period | $ | | $ | | ||
Supplemental disclosure of cash flow information: | ||||||
Reduction in value of warrants related to exercises | $ | — | $ | | ||
Cash paid for financing costs | $ | — | $ | | ||
See accompanying notes to financial statements.
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(1) Nature of Business, Going Concern and Management’s Plan
Annovis Bio, Inc. (the “Company” or “Annovis”) was incorporated on April 29, 2008, under the laws of the State of Delaware. Annovis is a late-stage clinical drug platform company addressing neurodegeneration, such as Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”). The toxic cascade in neurodegeneration begins with high levels of neurotoxic proteins, which lead to impaired axonal transport, inflammation, death of nerve cells and loss of cognition and motor function. The Company’s lead product candidate, buntanetap, is a small molecule administered orally that is designed to attack neurodegeneration by entering the brain and inhibiting the translation of multiple neurotoxic proteins, thereby impeding the toxic cascade. High levels of neurotoxic proteins lead to reduced axonal transport, which is responsible for the communication between and within nerve cells. When that communication is compromised, the immune system is activated and attacks the nerve cells, eventually killing them. The Company has shown in its clinical studies in AD and PD patients as well as in pre-clinical studies in mice and rats that buntanetap lowered neurotoxic protein levels, leading to improved axonal transport, reduced inflammation, lower nerve cell death and improved affected functions.
Going Concern
Since its founding, the Company has been engaged in organizational activities, including raising capital, as well as research and development activities. The Company has
The Company has a history of incurring net losses and anticipates incurring additional losses until such time, if ever, that it can generate significant revenue from its product candidates currently in development. The Company’s primary source of capital has historically been the issuance of common stock and warrants to purchase common stock.
Since the Company’s inception, the Company has incurred losses and negative cash flows from operations. At June 30, 2025, the Company had cash and cash equivalents of $
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The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary, should the Company be unable to continue as a going concern.
(2) Summary of Significant Accounting Policies
(a) Basis of Presentation of Interim Unaudited Financial Statements
The accompanying interim financial statements of Annovis Bio, Inc. should be read in conjunction with the audited financial statements and notes thereto included in the Company’s 2024 Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 21, 2025. The interim financial statements included herein are unaudited. In the opinion of Management, these statements include all adjustments, consisting of normal, recurring adjustments, necessary for a fair presentation of the financial position of Annovis at June 30, 2025, its results of operations for the three and six months ended June 30, 2025 and 2024 and its cash flows for the six months ended June 30, 2025 and 2024. These interim results of operations are not necessarily indicative of the results to be expected for a full year or any future period. The accompanying financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”) and the rules and regulations of the SEC. Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). Certain information and note disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to such rules and regulations relating to interim financial statements.
(b) Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires Management to make estimates and assumptions that affect the reported amounts of assets and liabilities, including disclosure of contingent assets and liabilities, at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the financial statements, actual results may materially vary from these estimates.
Significant items subject to such estimates and assumptions include the accounting and fair value of equity instruments, common stock warrant liabilities, derivative liabilities, as well as accounting for research and development contracts, including clinical trial accruals. Future events and their effects cannot be predicted with certainty; accordingly, accounting estimates require the exercise of judgment. Accounting estimates used in the preparation of these financial statements change as new events occur, as more experience is acquired, as additional information is obtained and as the operating environment changes.
(c) Basic and Diluted Net Loss per Share
Basic net loss per share is determined using the weighted average number of shares of common stock outstanding during each period. Diluted net loss per share includes the effect, if any, from the potential exercise or conversion of securities, such as warrants and stock options, which would result in the issuance of incremental shares of common stock. The computation of diluted net loss per shares does not include the conversion of securities that would have an anti-dilutive effect.
(d) Cash and Cash Equivalents
The Company considers all highly-liquid investments with original maturities of three months or less to be cash equivalents. The Company has cash balances at financial institutions which throughout the year regularly exceed the federally insured limit of $
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(e) Issuance Costs Associated with Equity Issuances
Issuance costs incurred in connection with the Company’s equity issuances, which primarily consist of direct incremental legal, printing, listing and accounting fees, are offset against proceeds received in the issuances and charged to additional paid-in capital in the period the equity issuance is completed. Issuance costs related to the Equity Line of Credit (“ELOC”) Purchase Agreement are expensed as incurred as prescribed by ASC 815.
(f) Derivative Liability
The Company evaluates all features contained in financing agreements to determine if there are any embedded derivatives that require separate accounting from the underlying agreement under ASC 815 – Derivatives and Hedging. An embedded derivative that requires separation is accounted for as a separate liability or asset from the host agreement. The separated embedded derivative is accounted for at fair market value, with changes in fair value recognized in the statements of operations within the other financing costs line item. The Company determined that certain features under the ELOC Purchase Agreement (See Note 7 — Stockholders’ (Deficit) Equity) collectively qualified as an embedded derivative. The derivative was accounted for separately from the underlying ELOC Purchase Agreement and is accounted for at fair value.
(g) Common Stock Warrants
On October 31, 2023, the Company completed an underwritten offering whereby the Company sold (i)
(h) Fair Value of Financial Instruments
The fair value of the Company’s assets and liabilities, which qualify as financial instruments under FASB ASC Topic 820, “Fair Value Measurements,” equals or approximates the carrying amounts represented in the balance sheets, primarily due to their short-term nature, except for the aforementioned warrant liabilities (see Note 3 — Fair Value Measurements).
(i) Research and Development
Research and development costs are either expensed as incurred, or recorded separately as a prepaid asset where expense is recognized when the service is performed. These costs are primarily comprised of personnel-related expenses and external research and development expenses incurred under arrangements with third parties, such as contract research organizations and consultants. At the end of each reporting period, the Company compares the payments made to each service provider to the estimated progress towards completion of the related project. Factors that the Company considers in preparing these estimates include the number of patients enrolled in studies, project milestones achieved, and other relevant criteria related to the efforts of its vendors. These estimates will be subject to change as additional information becomes available. Depending on the timing of payments to vendors and estimated services provided, the Company will record net prepaid expenses or accrued expenses related to these costs. Prepaid clinical expenses represent valid future economic benefits based on the Company’s contracts with its vendors and are realized in the ordinary course of business.
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(j) Stock-Based Compensation
The Company accounts for its stock-based compensation awards in accordance with FASB ASC Topic 718, Compensation—Stock Compensation (“ASC 718”). The Company has issued stock-based compensation awards, primarily in the form of stock options. ASC 718 requires all stock-based payments, including grants of stock options, to be recognized in the financial statements based on their grant date fair values. The Company uses the Black-Scholes option-pricing model to determine the fair value of stock options granted. The Company recognizes forfeitures as they occur.
Expense related to stock-based compensation awards granted with service-based vesting conditions is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which is generally the vesting term. Stock options have a contractual term of
Estimating the fair value of stock options requires the input of subjective assumptions, including the expected term of the stock option, stock price volatility, the risk-free interest rate, and expected dividends. The assumptions used in the Company’s Black-Scholes option-pricing model represent Management’s best estimates and involve a number of variables, uncertainties, assumptions, and the application of Management’s judgment, as they are inherently subjective. If any assumptions change, the Company’s stock-based compensation expense could be materially different in the future.
The assumptions used in the Company’s Black-Scholes option-pricing model for stock options are as follows:
Expected Term. As Annovis does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate expected term, the expected term of employee stock options subject to service-based vesting conditions is determined using the “simplified” method, as prescribed in SEC’s Staff Accounting Bulletin No. 107, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the stock option.
Expected Volatility. The expected volatility is based on historical volatilities of Annovis and similar entities within the Company’s industry for periods commensurate with the assumed expected term.
Risk-Free Interest Rate. The risk-free interest rate is based on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected term.
Expected Dividends. The expected dividend yield is
(k) Income Taxes
The Company provides for income taxes using the asset and liability approach. Deferred tax assets and liabilities are recorded based on the differences between the financial statement and tax bases of assets and liabilities and the tax rates in effect when these differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. As of June 30, 2025 and December 31, 2024, the Company had a full valuation allowance against its deferred tax assets.
The Company is subject to the provisions of ASC 740, Income Taxes, which prescribes a more likely-than-not threshold for the financial statement recognition of uncertain tax positions. ASC 740 clarifies the accounting for income taxes by prescribing a minimum recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. There are currently no open federal or
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state tax audits. The Company has not recorded any liability for uncertain tax positions at June 30, 2025 or December 31, 2024.
(l) Recent Accounting Pronouncements
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which improves income tax disclosures by requiring: (1) consistent categories and greater disaggregation of information in the rate reconciliation, and (2) income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. ASU 2023-09 is effective for annual periods beginning after December 15, 2024. Early adoption is permitted. The ASU indicates that all entities will apply the guidance prospectively with an option for retroactive application to each period presented in the financial statements. The Company has not determined the impact ASU 2023-09 may have on the Company’s financial statement disclosures but is not expecting material impacts.
In November 2024, the FASB issued ASU 2024-03, Income Statement — Reporting Comprehensive Income — Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”), which requires public entities, at annual and interim reporting periods, to disclose in a tabular format additional information about specific expense categories in the notes to the financial statements. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027, with early adoption permitted. The Company is evaluating the impacts of this ASU on its future financial statements and disclosures.
(3) Fair Value Measurements
The Company measures certain assets and liabilities at fair value in accordance with ASC 820, Fair Value Measurements and Disclosures. ASC 820 defines fair value as the price that would be received to sell an asset or paid to transfer a liability (the exit price) in an orderly transaction between market participants at the measurement date. The guidance in ASC 820 outlines a valuation framework and creates a fair value hierarchy that serves to increase the consistency and comparability of fair value measurements and the related disclosures. In determining fair value, the Company maximizes the use of quoted prices and observable inputs. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from independent sources. The fair value hierarchy is broken down into three levels based on the source of inputs as follows:
Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities.
Level 2—Valuations based on observable inputs and quoted prices in active markets for similar assets and liabilities.
Level 3—Valuations based on unobservable inputs and models that are supported by little or no market activity.
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The following table provides the carrying value and fair value of certain financial assets and liabilities of the Company measured at fair value on a recurring basis as of June 30, 2025 and December 31, 2024:
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| Fair Value Measurement at | ||||||||||
June 30, 2025 | ||||||||||||
Carrying Value | Level 1 | Level 2 | Level 3 | |||||||||
Assets: | ||||||||||||
Cash equivalents | $ | | $ | | $ | — | $ | — | ||||
Total assets measured and recorded at fair value | $ | | $ | | $ | — | $ | — | ||||
Liabilities: | ||||||||||||
Warrant liability | $ | | $ | — | $ | — | $ | | ||||
Total liabilities measured and recorded at fair value | $ | | $ | — | $ | — | $ | | ||||
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| Fair Value Measurement at | ||||||||||
December 31, 2024 | ||||||||||||
Carrying Value | Level 1 | Level 2 | Level 3 | |||||||||
Assets: | ||||||||||||
Cash equivalents | $ | | $ | | $ | — | $ | — | ||||
Total assets measured and recorded at fair value | $ | | $ | | $ | — | $ | — | ||||
Liabilities: | ||||||||||||
Warrant liability | $ | | $ | — | $ | — | $ | | ||||
Total liabilities measured and recorded at fair value | $ | | $ | — | $ | — | $ | | ||||
The Company did not transfer any financial instruments into or out of Level 3 classification, during the three or six months ended June 30, 2025 and 2024.
(a) Canaccord Warrants
The common stock warrants issued in connection with the Company’s equity raise in November 2023 (“Canaccord Warrants”) were classified as liabilities at the time of issuance due to certain cash settlement adjustment features that are outside of the Company’s control or not deemed to be indexed to the Company’s stock. The Canaccord Warrant liability is remeasured each reporting period with the change in fair value recorded to other income (expense) in the statements of operations until the warrants are exercised, expired, reclassified, or otherwise settled. From their date of issuance until the period ended June 30, 2024, the fair value of the Canaccord Warrants were estimated using a Monte Carlo simulation model, given the performance conditions outlined further below. However, during the period ended September 30, 2024, the Company determined that certain performance conditions could not be met and that going forward, their use as inputs for determining fair value was no longer appropriate. As such, after the period ended June 30, 2024, the fair value of the Canaccord Warrants was estimated using a Black-Scholes option-pricing model.
The estimated fair value of the Canaccord Warrants is determined using Level 3 inputs. Inherent in a Black-Scholes option-pricing model are assumptions related to expected stock-price volatility, expected life, risk-free interest rate and other inputs. The Company estimates the volatility of its warrants based on implied volatility from the Company’s traded warrants. The risk-free interest rate is based on the market yield of U.S. Treasuries over a term commensurate with the remaining term to expiration. Any changes in these assumptions can change the associated valuation significantly.
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The following tables provide quantitative information regarding the Level 3 classified Canaccord Warrants as of their respective measurement dates:
| June 30, 2025 |
| December 31, 2024 | |||||||
Exercise price | $ | | $ | | ||||||
Closing stock price | $ | | $ | | ||||||
Number of warrants |
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Volatility |
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Term (time to expiration in years) |
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Risk-free rate |
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The Canaccord Warrants have an exercise price of $
| ● | the Company’s public announcement of Positive Topline Data (as defined in the Warrant Agreement) from its Phase 3 study in patients with Parkinson’s Disease; and |
| ● | the date on which (a) the closing price of the Company’s common stock on the principal exchange or trading facility on which it is then traded has equaled or exceeded $ |
During the quarter ended September 30, 2024, the Company released topline data from its Phase 3 study in patients with Parkinson’s Disease. It was determined that based on the data, both criteria above required for redemption of the Canaccord Warrants were not met.
The common stock warrants are exercisable immediately and will expire on November 2, 2028,
(4) Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following:
| June 30, | December 31, | ||||
2025 | 2024 | |||||
Prepaid clinical expenses | $ | | $ | | ||
Prepaid other | | | ||||
Prepaid insurance | | | ||||
Security deposits |
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Total prepaid expenses and other current assets | $ | | $ | | ||
(5) Accrued Expenses
Accrued expenses consisted of the following:
| June 30, | December 31, | ||||
2025 | 2024 | |||||
Accrued clinical expenses | $ | | $ | | ||
Payroll and related benefits | | | ||||
Accrued professional and other |
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Total accrued expenses | $ | | $ | | ||
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(6) Commitments and Contingencies
(a) Research and Development
The Company has entered into contracts with contract research organizations (“CROs”) and contract manufacturers (“CMOs”) related to the Company’s clinical trials. These contracts generally require upfront payments, milestone payments, and pass through cost reimbursements, to be made. While the contracts are generally cancellable with (written) notice, the Company is obligated to make payments for services rendered through the termination date of the project with any applicable CRO/CMO.
(b) Leases
The Company maintains
(c) Employment Agreements
The Company has an agreement with its Chief Executive Officer that provides for severance payments to the employee upon termination of the agreement by the Company for any reason other than for cause, death, or disability or by the employee for good reason. The maximum aggregate severance payments under the agreement were estimated to be $
(d) Litigation
The Company is subject, from time to time, to claims by third parties under various legal disputes. The defense of such claims, or any adverse outcome relating to any such claims, could have a material adverse effect on the Company’s liquidity, financial condition and cash flows.
(7) Stockholders’ Equity
(a) Overview
The Company’s Amended and Restated Certificate of Incorporation was adopted on January 31, 2020, in conjunction with the closing of the Company’s initial public offering (the “IPO”) and amended on June 15, 2023 to increase the authorized number of shares. Currently, there are
(b) Common Stock
Dividends
Subject to the rights of holders of all classes of Company stock outstanding having rights that are senior to or equivalent to holders of common stock, the holders of the common stock are entitled to receive dividends when and as declared by the Board.
Liquidation
Subject to the rights of holders of all classes of stock outstanding having rights that are senior to or equivalent to holders of common stock as to liquidation, upon the liquidation, dissolution or winding up of the Company, the assets of the Company will be distributed to the holders of common stock.
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Voting
The holders of common stock are entitled to
(c) Preferred Stock
Preferred stock may be issued from time to time by the Board in one or more series. There was
(d) February 2025 ThinkEquity Underwritten Offering and Warrant Issuance
On February 3, 2025, the Company entered into an Underwriting Agreement with ThinkEquity LLC (“ThinkEquity”), with respect to an underwritten public offering of
The Company evaluated the appropriate balance sheet classification for the ThinkEquity warrants and determined equity classified was appropriate, as the warrants do not contain a required cash settlement adjustment feature with respect to a transaction outside of the Company’s control or not deemed to be indexed to the Company’s stock.
(e) November 2023 Canaccord Equity Offering and Warrant Issuance
On October 31, 2023, the Company entered into an underwritten offering with a Canaccord Genuity LLC whereby the Company sold (i)
The following is a roll-forward of the Common Stock Warrant Liability from December 31, 2024 to June 30, 2025:
Warrant liability at December 31, 2024 | $ | |
Change in fair value of warrant liability | ( | |
Warrant liability at March 31, 2025 | | |
Change in fair value of warrant liability |
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Warrant liability at June 30, 2025 | $ | |
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(f) IPO Warrants
In conjunction with the closing of the Company’s Initial Public Offering (“IPO”), the Company granted its underwriters
(g) Warrant Summary
As of June 30, 2025, the Company had the following common stock warrants outstanding:
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| Outstanding |
| Exercise |
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December 31, | Exercised or | June 30, | price per | Expiration | |||||||||||
Classification | 2024 | Granted | Expired | 2025 | share | date | |||||||||
ThinkEquity warrants | Equity | | | — | | $ | | February 4, 2030 | |||||||
Canaccord warrants |
| Liability |
| |
| — |
| — |
| | | November 2, 2028 | |||
IPO warrants |
| Equity |
| |
| — |
| ( |
| | $ | | January 29, 2025 | ||
(h) December 2024 ATM
On December 11, 2024, the Company entered into an Equity Distribution Agreement (“Distribution Agreement”) with Oppenheimer & Co. Inc., (“OpCo”) relating to the sale of shares of the Company’s common stock. In accordance with the terms of the Distribution Agreement, The Company may offer and sell shares of its common stock having an aggregate offering price of up to $
During the three and six month months ended June 30, 2025, the Company sold
(i) ELOC Purchase Agreement
On April 25, 2024, the Company entered into an ELOC Purchase Agreement with an ELOC Purchaser, whereby the Company could offer and sell, from time to time at its sole discretion, and whereby the ELOC Purchaser committed to purchase, up to
Upon execution of the ELOC Purchase Agreement, the Company agreed to issue to the ELOC Purchaser
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(j) March 2024 Registered Direct Offerings
On March 15, 2024 and March 21, 2024, the Company entered into
(8) Stock-Based Compensation
The Company’s 2019 Equity Incentive Plan (the “2019 Plan”) became effective on January 31, 2020, succeeding the Company’s previous equity incentive plan.
Effective June 1, 2021, the 2019 Plan was amended to increase the number of shares authorized to be issued from
Stock-based compensation expense reflected in the statement of operations was as follows:
Three Months Ended | Six Months Ended | |||||||||||
June 30, | June 30, | |||||||||||
| 2025 |
| 2024 | 2025 |
| 2024 | ||||||
General and administrative | $ | | $ | | $ | | $ | | ||||
Research and development |
| | |
| | | ||||||
$ | | $ | | $ | | $ | | |||||
Stock Options to Purchase Common Stock
The following table summarizes stock option activity:
|
|
| Weighted |
| |||||
Average | |||||||||
Remaining | Aggregate | ||||||||
Weighted | Contractual | Intrinsic | |||||||
Number of | Average | Life | Value | ||||||
Options | Exercise Price | (Years) | (Thousands) | ||||||
Options outstanding at December 31, 2024 |
| | $ | | $ | ||||
Options granted | | $ | | — | — | ||||
Options expired | ( | $ | | — | — | ||||
Options outstanding at June 30, 2025 |
| | $ | |
| $ | |||
Options exercisable at June 30, 2025 | | $ | |
| $ | ||||
The weighted-average grant date fair value of stock options granted was $
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During the three and six months ended June 30, 2025, the Company granted
(9) Net Loss Per Share
The Company analyzes the potential dilutive effect of stock options and warrants under the treasury stock method (as applicable), during periods of income, or during periods in which income is recognized related to changes in fair value of its liability-classified securities.
The following table sets forth the computation of basic and diluted net loss per common share:
| Three Months Ended | Six Months Ended | |||||||||||
June 30, | June 30, | ||||||||||||
| 2025 |
| 2024 |
| 2025 |
| 2024 | ||||||
Net loss per share – Basic: |
|
|
|
|
|
| |||||||
Numerator | |||||||||||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||
Denominator |
|
|
|
|
|
|
| ||||||
Weighted-average common shares outstanding, basic |
| |
| |
| | | ||||||
Basic net loss per common share | $ | ( | $ | ( | $ | ( | $ | ( | |||||
Net loss per share – Diluted: | |||||||||||||
Numerator | |||||||||||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||
Less: gain from change in fair value applicable to dilutive liability-classified warrants |
| — |
| — |
| — |
| ( | |||||
Numerator for diluted net loss per share | $ | ( | $ | ( | $ | ( | $ | ( | |||||
Denominator | |||||||||||||
Denominator for basic net loss per share | | | | | |||||||||
Plus: incremental shares underlying “in the money” liability-classified warrants outstanding | — | — | — | | |||||||||
Denominator for diluted net loss per share | | | | | |||||||||
Diluted net loss per common share | $ | ( | $ | ( | $ | ( | $ | ( | |||||
Potentially dilutive securities, whose effect would have been antidilutive, were excluded from the computation of diluted earnings per share for each of the three and six months ended June 30, 2025 and 2024. Total antidilutive securities that were excluded from the computation of diluted weighted-average shares outstanding were as follows:
June 30, | ||||
| 2025 |
| 2024 | |
Stock options | | | ||
ELOC shares remaining | — | | ||
Warrants | | | ||
Restricted stock |
| | — | |
(10) Income Taxes
The Company’s income tax benefit (expense) was $
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Net operating loss and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code as well as similar state provisions. The Company has completed financings since its inception which may have resulted in a change in control as defined by Sections 382 and 383 of the Internal Revenue Code or could result in a change in control in the future.
As of June 30, 2025, and December 31, 2024, the Company had not recorded any liability for uncertain tax positions, accrued interest or penalties thereon, and
(11) Segment Information
The Company is a clinical-stage biopharmaceutical company and has not generated any revenue since commencing significant operations in 2008. The Company’s operations are organized and reported as a single reportable segment, which includes all activities related to the discovery, development, and commercialization of our lead product candidate, buntanetap, which is designed to address AD, PD, and potentially other chronic neurodegenerative diseases. This presentation is consistent with how the Company’s chief operating decision maker (“CODM”), its Chief Executive Officer, assesses the performance of the Company and makes operating decisions. The accounting policies of the segment are the same as those described in the summary of significant accounting policies (see Note 2). The CODM assesses performance and decides how to allocate resources based on net loss as reported on the statements of operations. The CODM uses net loss to monitor actual operating results, assess cash runway, and benchmark against the Company’s competitors. The measure of segment assets is reported on the balance sheets as total assets. The Company’s assets are held in the United States.
When evaluating the Company’s financial performance, the CODM regularly reviews the following expense categories that comprise net loss. The table below sets forth the Company’s segment information as reviewed by the CODM:
Three Months Ended | Six Months Ended | ||||||||||
June 30, | June 30, | ||||||||||
2025 |
| 2024 | 2025 |
| 2024 | ||||||
Program expenses related to clinical-stage product candidates | $ | ( | $ | ( | $ | ( | $ | ( | |||
Program expenses related to preclinical and discovery programs | ( | ( | ( | ( | |||||||
Personnel-related expenses (including stock-based compensation) | ( | ( | ( | ( | |||||||
General and administrative professional and consultant fees | ( | ( | ( | ( | |||||||
Other segment items¹ | ( | ( | ( | ( | |||||||
Interest income | | | | | |||||||
Other non-cash income (expense) items² | ( | | | | |||||||
Net Loss | $ | ( | $ | ( | $ | ( | $ | ( | |||
¹ Other segment items included in net loss include insurance expenses, rent expense, information technology expenses, listing/printing fees, warrant commissions and other miscellaneous expenses.
² Other non-cash income (expense) items includes financing costs from our ELOC and change in fair value of our liability classified warrants.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Cautionary Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements, within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” “will,” or “would,” and or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report on Form 10-Q, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain.
The forward-looking statements in this Quarterly Report on Form 10-Q include, among other things, statements about:
| ● | our cash and cash equivalents balance, runway and needs, as well as financing plans; |
| ● | our business strategies; |
| ● | the timing of regulatory submissions; |
| ● | our ability to obtain and maintain regulatory approval of our existing product candidates and any other product candidates we may develop and the labeling under any approval we may obtain; |
| ● | risks relating to the timing and costs of clinical trials and the timing and costs of other expenses; |
| ● | risks related to market acceptance of products; |
| ● | risks associated with our reliance on third-party organizations; |
| ● | our competitive position; |
| ● | assumptions regarding the size of the available market, product pricing and timing of commercialization of our product candidates; |
| ● | our intellectual property position and our ability to maintain and protect our intellectual property rights; |
| ● | our results of operations, financial condition, liquidity, prospects and growth strategies; |
| ● | the industry in which we operate; and |
| ● | the trends that may affect the industry or us. |
You should refer to Part I, Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2024 for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Those factors are updated, as applicable, in “Factors that May Affect Future Results” below. As a result of the risks, uncertainties and assumptions described above and elsewhere, we cannot assure you that the forward-looking statements in this Quarterly Report on Form 10-Q will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the
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significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all.
You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, or events and circumstances reflected in the forward-looking statements will be achieved or occur. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this report to conform these statements to new information, actual results or changes in our expectations, except as required by law.
The following Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with: (i) the interim financial statements and related notes thereto which are included in this Quarterly Report on Form 10-Q; and (ii) our annual financial statements for the 2024 fiscal year, which are included in our Annual Report on Form 10-K for the year ended December 31, 2024.
Company Overview
We are a late-stage clinical drug platform company addressing neurodegeneration, such as Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”). We are developing our lead product candidate, buntanetap, which is designed to address AD, PD, and potentially other chronic neurodegenerative diseases. Buntanetap is a synthetically produced small molecule, orally administered, brain penetrant compound. In several studies, buntanetap was observed to inhibit the synthesis of neurotoxic proteins — APP/Aβ (“APP”), tau/phospho- tau (“tau”) and α-Synuclein (“αSYN”) — that are some of the main causes of neurodegeneration. High levels of neurotoxic proteins lead to reduced axonal transport, which is responsible for the communication between and within nerve cells. When that communication is compromised, the immune system is activated and attacks the nerve cells, eventually killing them. We have observed in our completed clinical studies in AD and PD patients and pre-clinical studies in mice and rats that buntanetap lowered neurotoxic protein levels leading to improved axonal transport, reduced inflammation, lower nerve cell death and improved affected functions.
In 2021, we completed two Phase 1/2 clinical studies: one in 14 early AD patients, and one in 54 early PD patients (together, the “AD/PD Trials”). In the AD/PD Trials, early AD patients were defined as those with a Mini Mental State Examination (“MMSE”) score between 19 and 28 and early PD patients as those patients at Hoehn & Yahr stages 1, 2 or 3. MMSE is a brief screening instrument used to assess cognitive function, with total scores ranging from 0 to 30 and a lower score indicating greater disease severity, while the Hoehn & Yahr scale is a medical assessment used to measure staging of the functional disability associated with PD where a higher stage indicates greater disease severity. In collaboration with the Alzheimer’s Disease Cooperative Study (“ADCS”), we also conducted a trial in 16 early AD patients (the “ADCS Trial”). In the ADCS Trial, early AD patients were defined as those patients with an MMSE score between 19 and 28. At the completion of the ADCS Trial, the data showed that buntanetap acts as a translational inhibitor in humans just like in animals, and we further observed that there was statistical improvement in cognition in early AD patients, just like in the AD/PD Trials.
All three clinical trials above were double-blind and placebo-controlled. We designed the studies by applying our understanding of the underlying neurodegenerative disease states and measured both target and pathway validation in the spinal fluid of patients to determine whether patients underlying disease condition improved following treatment. In addition to meeting their primary endpoints of safety and tolerability and secondary endpoint of pharmacokinetics (“PK”) of buntanetap, our AD/PD Trials also met exploratory endpoints of measures of biomarkers and improvements in cognition in AD patients, as well as function in PD patients. We believe that the AD/PD Trial represents the first double-blind, placebo-controlled study that showed improvements in AD patients, as measured by Alzheimer’s Disease Assessment Scale-Cognitive Subscale (“ADAS-Cog”) and in PD patients, as measured by Unified Parkinson’s Disease Rating Scale (“MDS-UPDRS” or “UPDRS”). ADAS-Cog is an assessment scale that measures cognitive functions and non-cognitive functions such as mood and behavior. More specifically, ADAS-Cog 11 is the cognitive assessment scale used to measure areas commonly seen to decline in AD patients. It consists of 11 specific tasks such as word recall, comprehension, object-naming, etc., in order to produce a scale measurement. UPDRS Part II and III are composed of a
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42-item rating scale designed to assess Parkinson’s disease-related disability and impairment and also evaluate the activities of daily living and motor function.
Following completion of the AD/PD Trial, we submitted our data to the U.S. Food and Drug Administration (“FDA”) and requested direction to further pursue the development of buntanetap in early PD patients. With the FDA’s guidance, we initiated a Phase 3 study in early PD patients in August 2022 (our “Phase 3 PD Study”). In the Phase 3 PD Study, early PD patients were defined as those at Hoehn & Yahr stages 1, 2 or 3 and OFF times of less than two hours per day. OFF time refers to periods when PD motor and/or non-motor symptoms occur between medication doses. We also submitted a proposed protocol for the treatment of moderate AD to the FDA, and after receiving permission to proceed, we initiated a Phase 2/3 study in mild to moderate AD patients in February 2023 (our “Phase 2/3 AD Study”). In the Phase 2/3 AD Study, mild to moderate AD patients were defined as those with an MMSE score between 14 and 24. Our Phase 3 PD Study and Phase 2/3 AD Study each had built in interim analyses.
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”).
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.
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.
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.
The pivotal Phase 3 AD trial will utilize standard clinical outcome measures for Alzheimer’s disease including ADAS-Cog13 (cognition) and ADCS-iADL (daily living activities). Volumetric MRI imaging and certain plasma biomarkers will also be assessed, including p-tau217 ratios, leveraging recent biomarker assay advances in AD to better diagnose Alzheimer’s patients and disease progression.
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,
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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.
Funding Requirements
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.
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.
In order to fund operations and additional clinical trials, we plan to finance our cash needs through public or private equity offerings, debt financings, collaboration and licensing arrangements or other financing alternatives. We do not currently have committed external sources of funds. Additional equity or debt financing or collaboration and licensing arrangements may not be available on acceptable terms, if at all.
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Results of Operations
Comparison of the Three Months Ended June 30, 2025 and 2024
The following table summarizes the results of our operations for the three months ended June 30, 2025 and 2024:
Three Months Ended | |||||||||
June 30, | |||||||||
| 2025 |
| 2024 | Change | |||||
(in thousands) | |||||||||
Operating expenses: | |||||||||
Research and development | $ | 5,162 |
| $ | 5,785 | $ | (623) | ||
General and administrative | 1,110 | 1,977 | (867) | ||||||
Total operating expense | 6,272 | 7,762 | (1,490) | ||||||
Other income (expense): | |||||||||
Interest income | 191 | 26 | 165 | ||||||
Other financing costs | — | (1,346) | 1,346 | ||||||
Change in fair value of warrants | (140) | 4,062 | (4,202) | ||||||
Total other income (expense), net | 51 | 2,742 | (2,691) | ||||||
Net loss | $ | (6,221) | $ | (5,020) | $ | (1,201) | |||
Research and Development Expenses
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.
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General and Administrative Expenses
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.
Interest Income
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.
Other Financing Costs
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.
Change in Fair Value of Warrants
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.
Comparison of the Six Months Ended June 30, 2025 and 2024
The following table summarizes the results of our operations for the six months ended June 30, 2025 and 2024:
Six Months Ended | |||||||||
June 30, | |||||||||
| 2025 |
| 2024 | Change | |||||
(in thousands) | |||||||||
Operating expenses: | |||||||||
Research and development | $ | 10,173 |
| $ | 12,307 | $ | (2,134) | ||
General and administrative | 2,381 | 3,265 | (884) | ||||||
Total operating expense | 12,554 | 15,572 | (3,018) | ||||||
Other income (expense): | |||||||||
Interest income | 379 | 70 | 309 | ||||||
Other financing costs | — | (1,346) | 1,346 | ||||||
Change in fair value of warrants | 418 | 10,761 | (10,343) | ||||||
Total other income, net | 797 | 9,485 | (8,688) | ||||||
Net loss | $ | (11,757) | $ | (6,087) | $ | (5,670) | |||
Research and Development Expenses
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
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$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.
General and Administrative Expenses
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.
Interest Income
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.
Other Financing Costs
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.
Change in Fair Value of Warrants
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.
Liquidity and Capital Resources
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.
February 2025 ThinkEquity Underwritten Offering
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.
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December 2024 ATM
On December 11, 2024, the Company entered into an Equity Distribution Agreement (“Distribution Agreement”) with Oppenheimer & Co. Inc., (“OpCo”) relating to the sale of shares of the Company’s common stock. In accordance with the terms of the Distribution Agreement, The Company may offer and sell shares of its common stock having an aggregate offering price of up to $50.0 million from time to time through or to OpCo, acting as agent or principal.
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.
Cash Flows
The following table provides a summary of our cash flows for the six months ended June 30, 2025 and 2024:
Six Months Ended | ||||||
June 30, | ||||||
| 2025 |
| 2024 | |||
(in thousands) | ||||||
Total net cash provided by (used in): |
|
|
|
| ||
Operating activities | $ | (13,205) | $ | (10,408) | ||
Financing activities |
| 19,783 |
| 8,651 | ||
Net increase (decrease) in cash and cash equivalents | $ | 6,578 | $ | (1,757) | ||
Operating Activities
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.
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.
Financing Activities
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.
Contractual Obligations and Other Commitments
This item is not required for smaller reporting companies.
Factors that May Affect Future Results
You should refer to Part I, Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2024 for a discussion of important factors that may affect our future results.
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Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements, as defined by applicable SEC regulations.
Critical Accounting Policies and Significant Judgments and Estimates
The preparation of financial statements in conformity with GAAP requires us to use judgment in making certain estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses in our financial statements and accompanying notes. Critical accounting policies are those that are most important to the portrayal of our financial condition and results of operations and require difficult, subjective and complex judgments by Management in order to make estimates about the effect of matters that are inherently uncertain. During the three-month period ended June 30, 2025, there were no significant changes to our critical accounting policies from those described in our annual financial statements for the 2024 fiscal year, which we included in our Annual Report on Form 10-K for the year ended December 31, 2024.
Item 3. Quantitative and Qualitative Disclosure About Market Risk
This item is not required for smaller reporting companies.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our Management, with the participation of our principal executive officer and principal financial officer, have evaluated the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of June 30, 2025. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and Management necessarily applies its judgment in evaluating the cost benefit relationship of possible controls and procedures. Based on such evaluation, our principal executive officer and principal financial officer have concluded that as of June 30, 2025, our disclosure controls and procedures were effective to ensure that the information required to be disclosed in our reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and that information required to be disclosed in the reports that we file or submit under the Exchange Act is accumulated and communicated to our Management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
There was no change in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(f) and 15d-15(f) of the Exchange Act that occurred during the period covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II
OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may become subject to litigation and claims arising in the ordinary course of business. We are not currently a party to any legal proceedings that we believe could have a material adverse effect on our business, operating results or financial condition and are not aware of any pending or threatened legal proceedings against us.
Item 1A. Risk Factors
Risk factors that may affect our business and financial results are discussed within Item 1A “Risk Factors” of our annual report on Form 10-K filed with the SEC on March 21, 2025 (“2024 Form 10-K”). There have been no material changes to the disclosures relating to this item from those set forth in our 2024 Form 10-K.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
During the three months ended June 30, 2025, none of our directors or "officers," as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934,
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Item 6. Exhibits
Exhibit |
| Description of Exhibit |
| ||
3.1 | ||
| ||
3.2 | ||
31.1* | ||
| ||
31.2* | ||
32.1* |
101.INS* | XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. | |
101.SCH* | Inline XBRL Taxonomy Extension Schema Document | |
101.CAL* | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |
101.DEF* | Inline XBRL Taxonomy Extension Definition Linkbase Document | |
101.LAB* | Inline XBRL Taxonomy Extension Labels Linkbase Document | |
101.PRE* | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |
104* | Cover Page Interactive Data File – the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. |
*Filed herewith
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Annovis Bio, Inc.
Signature |
| Title |
| Date |
|
|
| ||
/s/ Maria Maccecchini | President and Chief Executive Officer (Principal | August 12, 2025 | ||
Maria Maccecchini | Executive Officer) | |||
/s/ Andrew Walsh | Vice President Finance (Principal Financial | August 12, 2025 | ||
Andrew Walsh | Officer) |
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