Annovis Bio, Inc.
For the period ended Mar 31, 2025. Filed May 13, 2025.
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Mar 31, 2025 · Filed May 13, 2025
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Notes to Financial Statements (Unaudited)
(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 hasnot generated substantial revenues and has not yet achieved profitable operations, nor has it ever generated positive cash flows from operations. There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. The Company is subject to those risks associated with any clinical stage pharmaceutical company that has substantial expenditures for research and development. There can be no assurance that the Company’s research and development projects will be successful, that products developed will obtain necessary regulatory approval, or that any approved product will become commercially viable. In addition, the Company operates in an environment of rapid technological change and is largely dependent on the services of its employees and consultants. Further, the Company’s future operations are dependent on the success of its efforts to raise additional capital.
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 March 31, 2025, the Company had cash and cash equivalents of$22.2 million and an accumulated deficit of$140.4 million. The Company’s net loss was$5.5 million and$1.1 million for the three months ended March 31, 2025 and 2024, respectively. In addition, the Company’s operating loss was$6.3 million and$7.8 million for the three months ended March 31, 2025 and 2024, respectively. The Company follows the provisions of Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 205-40, Presentation of Financial Statements-Going Concern, or ASC 205-40, which requires Management to assess the Company’s ability to continue as a going concern for one year after the date its financial statements are issued. The Company expects that its existing balance of cash and cash equivalents as of March 31, 2025 is not sufficient to fund operations for the period through one year after the date of this filing and therefore, Management has concluded that substantial doubt exists about the Company’s ability to continue as a going concern. Management’s plans to mitigate this risk include raising additional capital through equity financings, debt or other potential alternatives. Management’s plans may also include the deferral of certain operating expenses unless and until additional capital is received. However, there can be no assurance that the Company will be successful in raising additional capital or that such capital, if available, will be on terms that are acceptable to the Company, or that the Company will be successful in deferring certain operating expenses. As such, Management has concluded that such plans do not alleviate the aforementioned substantial doubt. If the Company is unable to raise sufficient additional capital or defer sufficient operating expenses, the Company may be compelled to reduce the scope of its operations.
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 March 31, 2025, its results of operations for the three months ended March 31, 2025 and 2024 and its cash flows for the three months ended March 31, 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 $250,000. Any loss incurred or a lack of access to such funds, could have a significant adverse effect on the Company’s financial condition, results of operations and cash flows.
(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.
(f) Common Stock Warrants
On October 31, 2023, the Company completed an underwritten offering whereby the Company sold (i)1,250,000 shares of common stock and (ii) warrants to purchase an aggregate of 1,250,000 shares of common stock at an exercise price of $9.00 per share (“Canaccord Warrants”). The Canaccord Warrants are liability classified as they contain 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 warrant liabilities are recorded at fair value regardless of the timing of the redemption feature, the redemption price, or the likelihood of redemption. These warrants are subject to re-measurement at each balance sheet date and any change in fair value is recognized as a component of change in fair value of warrant liability in the statements of operations. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise, expiration, or other settlement of the warrants. The warrants are classified as Level 3 liabilities.
(g) 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).
(h) 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.
(i) 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 10 years. Expense for stock-based compensation awards with performance-based vesting conditions is only recognized when the performance-based vesting condition is deemed probable to occur. Expense related to stock-based compensation awards are recorded in
research and development expense or general and administrative expense based on the underlying function of the individual that was granted the stock-based compensation award.
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 0% because Annovis has not historically paid, and does not expect for the foreseeable future to pay, a dividend on its common stock.
(j) 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 March 31, 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 state tax audits. The Company has not recorded any liability for uncertain tax positions at March 31, 2025 or December 31, 2024.
(k) 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 still 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.
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 March 31, 2025 and December 31, 2024:
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · · Fair Value Measurement at | ||||||||||||
| · · · · · March 31, 2025 | ||||||||||||
| · · Carrying Value · · Level 1 · · Level 2 · · Level 3 | ||||||||||||
| Assets: | | | | | | | | | | | | |
| Cash equivalents | | $496,216 | | $496,216 | | $— | | $— | ||||
| Total assets measured and recorded at fair value | | $496,216 | | $496,216 | | $— | | $— | ||||
| Liabilities: | | | | | | | | | | | | |
| Warrant liability | | $179,000 | | $— | | $— | | $179,000 | ||||
| Total liabilities measured and recorded at fair value | | $179,000 | | $— | | $— | | $179,000 | ||||
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · · Fair Value Measurement at | ||||||||||||
| · · · · · December 31, 2024 | ||||||||||||
| · · Carrying Value · · Level 1 · · Level 2 · · Level 3 | ||||||||||||
| Assets: | | | | | | | | | | | | |
| Cash equivalents | | $491,006 | | $491,006 | | $— | | $— | ||||
| Total assets measured and recorded at fair value | | $491,006 | | $491,006 | | $— | | $— | ||||
| Liabilities: | | | | | | | | | | | | |
| Warrant liability | | $737,000 | | $— | | $— | | $737,000 | ||||
| Total liabilities measured and recorded at fair value | | $737,000 | | $— | | $— | | $737,000 | ||||
The Company did not transfer any financial instruments into or out of Level 3 classification, during the three months ended March 31, 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.
The following tables provide quantitative information regarding the Level 3 classified Canaccord Warrants as of their respective measurement dates:
| · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| · · · March 31, 2025 · · December 31, 2024 · | ||||||||
| Exercise price | | | | $9.00 | | | $9.00 | |
| Closing stock price | | | | $1.50 | | | $5.03 | |
| Number of warrants | | | | 308,333 | | | 308,333 | |
| Volatility | | | | 105% | | 80% | ||
| Term (time to expiration in years) | | | | 3.59 | | | 3.84 | |
| Risk-free rate | | | | 3.9% | | 4.3% | ||
The Canaccord Warrants have an exercise price of $9.00 per unit, and were redeemable at the Company’s option, in whole or in part, at a redemption price equal to $0.001 per Warrant upon 30 days’ prior written notice, at any time after:
| ● | 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 $14.25 and (b) the average daily trading value (“ADTV”) of the Company’s common stock is equal to or exceeds $2,000,000, for two consecutive Trading Days. |
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, five years from the date of issuance. See Note 7 – Stockholders’ Equity for additional background.
(4) Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · March 31, · · December 31, | ||||||
| · · 2025 · · 2024 | ||||||
| Prepaid clinical expenses | | $4,091,504 | | $2,998,811 | ||
| Prepaid other | | | 321,526 | | | 346,313 |
| Prepaid insurance | | | 80,553 | | | 21,098 |
| Security deposits | | 7,495 | | 7,495 | ||
| Total prepaid expenses and other current assets | | $4,501,078 | | $3,373,717 | ||
(5) Accrued Expenses
Accrued expenses consisted of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · March 31, · · December 31, | ||||||
| · · 2025 · · 2024 | ||||||
| Accrued clinical expenses | | $615,120 | | $948,695 | ||
| Payroll and related benefits | | | 289,677 | | | 364,717 |
| Accrued professional and other | | 229,380 | | 261,601 | ||
| Total accrued expenses | | $1,134,177 | | $1,575,013 | ||
(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 maintainsone short-term lease associated with occupying its corporate headquarters. Total rental expense was $32,737 and $33,875 for the three months ended March 31, 2025 and 2024.
(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 $1.2 million at March 31, 2025.
(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 aretwo classes of stock authorized which are designated, respectively, common stock and preferred stock. The total number of shares which the Company is authorized to issue is 72,000,000, each with apar value of $0.0001 per share. Of these shares,70,000,000 is designated as common stock and 2,000,000 is preferred stock.
(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.
Voting
The holders of common stock are entitled toone vote for each share of common stock held. There is no cumulative voting.
(c) Preferred Stock
Preferred stock may be issued from time to time by the Board in one or more series. There wasno preferred stock issued or outstanding as of March 31, 2025 or December 31, 2024.
(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 5.3 million units of the Company, each unit consisting ofone share of its common stock, par value $0.0001 per share andone warrant to purchaseone 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.
The Company evaluated the appropriate balance sheet classification for the ThinkEquity warrants during the three months ended March 31, 2025. The ThinkEquity warrants areequity classified as they 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)1.3 million shares of common stock and (ii) warrants (“Canaccord Warrants”) to purchase an aggregate of 1.3 million shares of common stock at an exercise price of $9.00 per share. The warrants are exercisable immediately on the date of issuance and will expire five years after the date of issuance. The Company received $6.83 million in net cash proceeds after deducting underwriter discount and fees, as well as other third-party costs. The Canaccord Warrants are liability classified as they contain 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 following is a roll-forward of the Common Stock Warrant Liability from December 31, 2024 to March 31, 2025:
| · · | |
|---|---|
| Warrant liability at December 31, 2024 | $737,000 |
| Change in fair value of warrant liabilities | (558,000) |
| Warrant liability at March 31, 2025 | $179,000 |
(f) IPO Warrants
In conjunction with the closing of the Company’s Initial Public Offering (“IPO”), the Company granted its underwriters 0.1 million warrants to purchase shares of Company common stock (“IPO Warrants”) at an exercise price of $7.50 per share, which was 125% of the IPO price. The IPO Warrants have afive-year term and were exercisable as of January 29, 2021 and have been classified by the Company as a component of stockholders’ equity. As of March 31, 2025 and December 31, 2024,0 and 2,400 of the IPO Warrants were outstanding, respectively. No IPO Warrants were exercised during the three months ended March 31, 2025 or 2024.
(g) Warrant Summary
As of March 31, 2025, the Company had the following common stock warrants outstanding:
| | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Outstanding · · Outstanding · Exercise · | |||||||||||||||
| · · · · December 31, · · · · Exercised or · · March 31, · · price per · · Expiration | |||||||||||||||
| · · Classification · · 2024 · · Granted · · Expired · · 2025 · · share · · date | |||||||||||||||
| ThinkEquity warrants | | Equity | | — | | 5,250,000 | | — | | 5,250,000 | | $5.00 | | February 4, 2030 | |
| Canaccord warrants | Liability | 308,333 | — | — | 308,333 | | | 9.00 | | November 2, 2028 | |||||
| IPO warrants | Equity | 2,400 | — | (2,400) | — | | $7.50 | | 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 $50.0 million from time to time through or to OpCo, acting as agent or principal.
During the three months ended March 31, 2025, the Company sold 0.1 million shares of common stock pursuant to the Distribution Agreement for gross proceeds of $0.5 million before commissions.
(i) March 2024 Registered Direct Offerings
On March 15, 2024 and March 21, 2024, the Company entered intotwo separate securities purchase agreements with the same institutional investor. When aggregating the results of both purchase agreements, the Company issued 0.4 million shares for combined net proceeds of $3.9 million.
(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. No new options may be issued under the previous plan, although shares subject to grants which are cancelled or forfeited will again be available under the 2019 Plan.
Effective June 1, 2021, the 2019 Plan was amended to increase the number of shares authorized to be issued from 1,000,000 to 2,000,000. Effective June 12, 2024, the 2019 Plan was amended to increase the number of shares authorized from 2,000,000 to 3,000,000. As of March 31, 2025,329,299 shares were available for future grants.
Stock-based compensation expense was as follows:
| · · · · · · | |||||
|---|---|---|---|---|---|
| · · Three Months Ended | |||||
| · · March 31, | |||||
| · 2025 · 2024 | |||||
| General and administrative | | $266,937 | | $235,740 | |
| Research and development | | 232,950 | | | 129,025 |
| | | $499,887 | | $364,765 | |
During the three months ended March 31, 2025, the Company didnot grant any new stock option awards.
During the three months ended March 31, 2025, the Company granted 25,000 shares of restricted stock to a consultant. The weighted-average grant date fair value of the restricted stock issued by the Company during the three months ended March 31, 2025 was $4.89 per share.
There wereno stock options exercised during the three months ended March 31, 2025.
There wereno stock options that expired during the three months ended March 31, 2025.
As of March 31, 2025, there were 2,361,020 equity awards outstanding, of which 1,915,358 were vested and exercisable. As of December 31, 2024, there were 2,336,020 options outstanding, of which 1,824,122 were vested and exercisable.
(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 · | |||||||
| · · March 31, · | |||||||
| · 2025 · 2024 · | |||||||
| Net loss per share – Basic: · · · · | |||||||
| Numerator | | | | | | | |
| Net loss | | $(5,537,069) | | $(1,066,947) | | ||
| Denominator | | | | | | | |
| Weighted-average common shares outstanding, basic | | | 17,431,234 | | | 10,625,065 | |
| Basic net loss per common share | | $(0.32) | | $(0.10) | | ||
| | | | | | | | |
| Net loss per share – Diluted: | | | | | | | |
| Numerator | | | | | | | |
| Net loss | | $(5,537,069) | | $(1,066,947) | | ||
| Less: gain from change in fair value applicable to dilutive liability-classified warrants | | | — | | | (6,698,692) | |
| Numerator for diluted net loss per share | | $(5,537,069) | | $(7,765,639) | | ||
| Denominator | | | | | | | |
| Denominator for basic net loss per share | | | 17,431,234 | | | 10,625,065 | |
| Plus: incremental shares underlying “in the money” liability-classified warrants outstanding | | | — | | | 199,706 | |
| Denominator for diluted net loss per share | | | 17,431,234 | | | 10,824,771 | |
| Diluted net loss per common share | | $(0.32) | | $(0.72) | | ||
Potentially dilutive securities, whose effect would have been antidilutive, were excluded from the computation of diluted earnings per share for each of the three months ended March 31, 2025 and 2024. Total antidilutive securities that were excluded from the computation of diluted weighted-average shares outstanding were as follows:
| | | | | |
|---|---|---|---|---|
| · · March 31, | ||||
| · 2025 · 2024 | ||||
| Stock options | | 2,336,020 | | 1,954,774 |
| Warrants | | 5,558,333 | | 2,400 |
| Restricted stock | 25,000 | | — | |
(10) Income Taxes
The Company’s income tax benefit (expense) was $0 for the three months ended March 31, 2025 and 2024. The Company has recorded a valuation allowance to reduce its net deferred tax asset to an amount that is more likely than not to be realized in future years. Accordingly, the benefit of the net operating loss (“NOL”) that would have been recognized in the three months ended March 31, 2025 and 2024 was offset by changes in the valuation allowance.
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 March 31, 2025, and December 31, 2024, the Company had not recorded any liability for uncertain tax positions, accrued interest or penalties thereon, andno amounts have been recognized in the Company’s statements of operations.
(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 | ||||
| | March 31, | ||||
| · 2025 · 2024 | |||||
| Program expenses related to clinical-stage product candidates | $(4,217,214) | | $(5,912,029) | ||
| Program expenses related to preclinical and discovery programs | | (30,600) | | | (108,338) |
| Personnel-related expenses (including stock-based compensation) | | (1,397,874) | | | (1,194,687) |
| General and administrative professional and consultant fees | | (444,865) | | | (369,353) |
| Other segment items¹ | | (192,128) | | | (225,400) |
| Interest income | | 187,612 | | | 44,168 |
| Other non-cash income items² | | 558,000 | | | 6,698,692 |
| Net Loss | $(5,537,069) | | $(1,066,947) | ||
¹ Other segment items included in net loss include insurance expenses, information technology expenses, listing/printing fees, warrant commissions and other miscellaneous expenses.
² Other non-cash income items includes the change in fair value of our liability classified warrants.
(12) Subsequent Events
None.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.