Annovis Bio, Inc._MARCH 31, 2026

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q


☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2026


☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

COMMISSION FILE NUMBER 001-39202

Annovis Bio, Inc.

(Exact name of registrant as specified in its charter)

Delaware		26-2540421
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

101 Lindenwood Drive, Suite 225

Malvern, PA 19355

(Address of registrant’s principal executive offices)

(484) 875-3192

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
Common Stock, par value $0.0001 per share		ANVS		New York Stock Exchange

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. ☒ Yes ☐ No.

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). ☒ Yes ☐ No.

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	☐

Non-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). ☐ Yes ☒ No.

The number of outstanding shares of the registrant’s common stock as of May 15, 2026 was: 34,646,868

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PART I

FINANCIAL INFORMATION

Item 1. Financial Statements

Annovis Bio, Inc.

Balance Sheets


		March 31,
		2026			December 31,
		(Unaudited)			2025

Assets
Current assets:
Cash and cash equivalents		$	14,219,081		$	19,532,338
Prepaid expenses and other current assets			2,024,622			1,549,287
Total assets		$	16,243,703		$	21,081,625
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable		$	5,275,668		$	2,590,516
Accrued expenses			7,514,977			1,044,859
Total current liabilities			12,790,645			3,635,375
Non-current liabilities:
Warrant liability			327,000			595,000
Total liabilities			13,117,645			4,230,375
Commitments and contingencies (Note 6)
Stockholders’ equity:
Preferred stock - $0.0001 par value, 2,000,000 shares authorized and 0 shares issued and outstanding			—			—
Common stock - $0.0001 par value, 70,000,000 shares authorized, 28,537,302 and 27,199,139 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively			2,854			2,719
Additional paid-in capital			184,433,245			180,552,190
Accumulated deficit			(181,310,041)			(163,703,659)
Total stockholders’ equity			3,126,058			16,851,250
Total liabilities and stockholders’ equity		$	16,243,703		$	21,081,625

See accompanying notes to financial statements.

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Annovis Bio, Inc.

Statements of Operations

(Unaudited)


		Three Months Ended
		March 31,
		2026			2025
Operating expenses:
Research and development		$	16,720,362		$	5,011,517
General and administrative			1,291,820			1,271,164
Total operating expenses			18,012,182			6,282,681
Operating loss			(18,012,182)			(6,282,681)
Other income:
Interest income			137,800			187,612
Change in fair value of warrants (Note 7)			268,000			558,000
Total other income, net			405,800			745,612
Net loss		$	(17,606,382)		$	(5,537,069)
Net loss per share (Note 9)
Basic		$	(0.63)		$	(0.32)
Diluted		$	(0.63)		$	(0.32)
Weighted-average number of common shares used in computing net loss per share
Basic			27,847,884			17,431,234
Diluted			27,847,884			17,431,234

See accompanying notes to financial statements.

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Annovis Bio, Inc.

Statements of Changes in Stockholders’ Equity

(Unaudited)



							Additional			Total
		Common Stock					Paid-in			Accumulated			Total
		Shares		Amount			Capital			Deficit			Stockholders' Equity
Three Months Ended March 31, 2026
Balance, December 31, 2025		27,199,139		$	2,719		$	180,552,190		$	(163,703,659)		$	16,851,250
Issuance of common stock, pursuant to Equity Distribution Agreement, net of issuance costs		1,338,163			135			3,698,232			—			3,698,367
Stock-based compensation expense		—			—			182,823			—			182,823
Net loss		—			—			—			(17,606,382)			(17,606,382)
Balance, March 31, 2026		28,537,302		$	2,854		$	184,433,245		$	(181,310,041)		$	3,126,058

Three Months Ended March 31, 2025
Balance, December 31, 2024		14,141,521		$	1,414		$	144,155,694		$	(134,849,462)		$	9,307,646
Issuance of common stock, pursuant to Equity Distribution Agreement, net of issuance costs		94,710			9			502,925			—			502,934
Issuance of common stock and warrants under registered direct offering, net of issuance costs		5,250,000			525			19,279,964			—			19,280,489
Stock-based compensation expense		—			—			499,887			—			499,887
Net loss		—			—			—			(5,537,069)			(5,537,069)
Balance, March 31, 2025		19,486,231		$	1,948		$	164,438,470		$	(140,386,531)		$	24,053,887

See accompanying notes to financial statements.

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Annovis Bio, Inc.

Statements of Cash Flows

(Unaudited)


	Three Months Ended March 31,
	2026		2025
Cash flows from operating activities:
Net loss	$	(17,606,382)	$	(5,537,069)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense		182,823		499,887
Change in fair value of warrants		(268,000)		(558,000)
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		(475,335)		(1,127,361)
Accounts payable		2,685,152		(935,785)
Accrued expenses		6,470,118		(440,836)
Net cash used in operating activities		(9,011,624)		(8,099,164)
Cash flows from financing activities:
Proceeds from issuance of common stock, and warrants, net		3,698,367		19,783,423
Net cash provided by financing activities		3,698,367		19,783,423
Net (decrease) increase in cash and cash equivalents		(5,313,257)		11,684,259
Cash and cash equivalents, beginning of period		19,532,338		10,551,916
Cash and cash equivalents, end of period	$	14,219,081	$	22,236,175

See accompanying notes to financial statements.

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Annovis Bio, Inc.

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. The Company has treated more than 1,300 patients and is conducting the last clinical study before filing for marketing approval.

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 not 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, 2026, the Company had cash and cash equivalents of $14.2 million and an accumulated deficit of $181.3 million. The Company’s net loss was $17.6 million and $5.5 million for the three months ended March 31, 2026 and 2025, respectively. In addition, the Company’s operating loss was $18.0 million and $6.3 million for the three months ended March 31, 2026 and 2025, 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, 2026, 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, or cease, its operations.

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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 2025 Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2026. 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, 2026, its results of operations for the three months ended March 31, 2026 and 2025, and its cash flows for the three months ended March 31, 2026 and 2025. 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 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, 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.

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.

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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.

(f) Liability Classified Common Stock Warrants

On October 31, 2023, the Company completed an underwritten offering whereby the Company sold (i) 1.3 million shares of common stock and (ii) warrants to purchase an aggregate of 1.3 million 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 (“CROs”) 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

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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 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 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, 2026 and December 31, 2025, 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, 2026 or December 31, 2025.

(k) Recent Accounting Pronouncements

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.

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(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, 2026 and December 31, 2025:


				Fair Value Measurement at
				March 31, 2026
		Carrying Value		Level 1		Level 2		Level 3
Assets:
Cash equivalents		$	12,552,683	$	12,552,683	$	—	$	—
Total assets measured and recorded at fair value		$	12,552,683	$	12,552,683	$	—	$	—
Liabilities:
Warrant liability		$	327,000	$	—	$	—	$	327,000
Total liabilities measured and recorded at fair value		$	327,000	$	—	$	—	$	327,000


				Fair Value Measurement at
				December 31, 2025
		Carrying Value		Level 1		Level 2		Level 3
Assets:
Cash equivalents		$	19,184,883	$	19,184,883	$	—	$	—
Total assets measured and recorded at fair value		$	19,184,883	$	19,184,883	$	—	$	—
Liabilities:
Warrant liability		$	595,000	$	—	$	—	$	595,000
Total liabilities measured and recorded at fair value		$	595,000	$	—	$	—	$	595,000

The Company did not transfer any financial instruments into or out of Level 3 classification, during the three months ended March 31, 2026 and 2025.

(a) Canaccord Warrants

The common stock warrants issued in connection with the Company’s equity raise in October 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

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the statements of operations until the warrants are exercised, expired, reclassified, or otherwise settled. The fair value of the Canaccord Warrants is 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, 2026			December 31, 2025
Exercise price		$	9.00		$	9.00
Closing stock price		$	2.23		$	3.46
Number of warrants			308,333			308,333
Volatility			128	%		123	%
Term (time to expiration in years)			2.59			2.84
Risk-free rate			3.8	%		3.5	%

The Canaccord Warrants have an exercise price of $9.00 per unit.

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,
		2026		2025
Prepaid clinical expenses		$	1,375,479	$	1,204,720
Prepaid other			552,065		321,009
Prepaid insurance			89,583		16,063
Security deposits			7,495		7,495
Total prepaid expenses and other current assets		$	2,024,622	$	1,549,287

(5) Accrued Expenses

Accrued expenses consisted of the following:


		March 31,		December 31,
		2026		2025
Accrued clinical expenses		$	6,608,326	$	283,944
Payroll and related benefits			734,337		426,202
Accrued professional and other			172,314		334,713
Total accrued expenses		$	7,514,977	$	1,044,859

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(6) Commitments and Contingencies

(a) Research and Development

The Company has entered into contracts with 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 one short-term lease associated with occupying its corporate headquarters. Total rental expense was $25,886 and $32,737 for the three months ended March 31, 2026 and 2025.

The Company has agreements with its executive officers that provide 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, 2026.

In March 2026, the Company entered into a separation agreement with its Chief Financial Officer and incurred $0.1 million of severance expense, which was recorded to General and administrative expenses in the Company’s Statement of operations for the three months ended March 31, 2026.

(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.

For both the three months ended March 31, 2026 and March 31, 2025, the Company did not have any pending legal actions deemed to be material.

(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 two 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 72.0 million, each with a par value of $0.0001 per share. Of these shares, 70.0 million is designated as common stock and 2.0 million 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.

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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 to one vote for each share of common stock held. There is no cumulative voting.

Preferred stock may be issued from time to time by the Board in one or more series. There was no preferred stock issued or outstanding as of March 31, 2026 or December 31, 2025.

(d) October 2025 Registered Direct Offerings and Warrant Issuances

On October 10, 2025, the Company entered into a Securities Purchase Agreement, with the purchasers signatory thereto pursuant to which the Company agreed to issue and sell, in a registered direct offering an aggregate of 3,150,000 shares (the "Shares”) of the Company’s common stock, $0.0001 par value per share and pre-funded warrants to purchase up to an aggregate of 850,000 shares of Common Stock (the "Pre-Funded Warrants”). The Shares and the Pre-Funded Warrants are collectively referred to herein as the "Securities.” The offering price of each Share is $1.50 per share. The offering price of each Pre-Funded Warrant is $1.4999 (equal to the offering price per Share, minus $0.0001, the exercise price of each Pre-Funded Warrant). In addition, in connection with this offering, the Company granted to a placement agent, warrants to purchase a total 200,000 shares of Common Stock (the "October 14, 2025 Placement Agent Warrants”) that have an exercise price per share equal to $2.20 and a term of 5 years from the date of issuance.

The October 14, 2025 Placement Agent Warrants were issued for services performed by the placement agent and were treated as offering costs. The aggregate fair value was determined to be approximately $0.2 million using the Black-Scholes pricing model with the following assumptions: 122.5% volatility, risk free interest rate of 3.6%, an expected life of 2.5 years, and no dividend. The aggregate fair market value was recorded as an offset to gross proceeds of the Offering and an increase to additional paid-in capital. The net proceeds to the Company from the Offering were $5.5 million, net of offering costs of $0.5 million. The Company issued 850,000 shares of common stock upon the exercise of the pre-funded warrants during the year ended December 31, 2025. As of March 31, 2026, no pre-funded warrants remained outstanding.

The Company evaluated the appropriate balance sheet classification for the Pre-Funded Warrants and the October 14, 2025 Placement Agent Warrants and determined equity classification 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.

On October 26, 2025, the Company entered into (i) a Securities Purchase Agreement, with the purchasers signatory thereto pursuant to which the Company agreed to issue and sell, in a registered direct offering an aggregate of 597,561 shares of the Company’s common stock, $0.0001 par value per share and (ii) Stock Subscription Agreements (the "Subscription Agreements”) with two members of the Board of Directors of the Company pursuant to which they agree to purchase an aggregate of 1,073,171 shares of Common Stock. An aggregate number of 1,670,732 shares of Common Stock was issued. The offering price of each share was $2.05 per share. In addition, in connection with this offering, the Company granted to a placement agent, warrants to purchase a total 83,357 shares of Common Stock (the "October 26, 2025 Placement Agent Warrants”) that have an exercise price per share equal to $2.56 and a term of 5 years from the date of issuance. The October 26, 2025 Placement Agent Warrants were issued for services performed by the placement agent and were treated as offering costs. The aggregate fair value was determined to be approximately $0.1 million using the Black-Scholes pricing model with the following assumptions: 122.5% volatility, risk free interest rate of 3.6%, an expected life of 2.5 years and no dividend. The aggregate fair market value was recorded as an offset to

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gross proceeds of the Offering and an increase to additional paid-in capital. The net proceeds to the Company from the Offering were $3.1 million, net of offering costs of $0.1 million.

The Company evaluated the appropriate balance sheet classification for the October 26, 2025 Placement Agent Warrants and determined equity classification 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) 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 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. No ThinkEquity Warrants were exercised during the three months ended March 31, 2026 and 2025.

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.

(f) October 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 $6.8 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. No Canaccord Warrants were exercised during the three months ended March 31, 2026 and 2025.

The following is a roll-forward of the Common Stock Warrant Liability from December 31, 2025 to March 31, 2026:


Warrant liability at December 31, 2025	$	595,000
Change in fair value of warrant liability		(268,000)
Warrant liability at March 31, 2026	$	327,000

(g) IPO Warrants

In conjunction with the closing of the Company’s 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 a five-year term and were exercisable as of January 29, 2021 and have been classified by the Company as a component of stockholders’ equity. The IPO warrants expired on January 29, 2025 and none of the IPO Warrants had been exercised.

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(h)Warrant Summary

As of March 31, 2026, the Company had the following common stock warrants outstanding:


		Outstanding				Outstanding	Exercise
	Issued	December 31,			Exercised or	March 31,	price per		Expiration
Issuance (Classification)	date	2025		Granted	Expired	2026	share		date

ThinkEquity Warrants (Equity)	February 3, 2025	5,250,000		—	—	5,250,000	$	5.00	February 4, 2030
Canaccord Warrants (Liability)	November 2, 2023	308,333		—	—	308,333	$	9.00	November 2, 2028
Placement Agent Warrants (Equity)	October 14, 2025	200,000		—	—	200,000	$	2.20	October 10, 2030
Placement Agent Warrants (Equity)	October 28, 2025	83,537		—	—	83,537	$	2.56	October 20, 2030

(i) 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, 2026, the Company sold 1.3 million shares of common stock pursuant to the Distribution Agreement for gross proceeds of $3.8 million, before commissions. The Company had issuance costs of $0.1 million during the three months ended March 31, 2026. 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.

(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 1.0 million to 2.0 million. Effective June 12, 2024, the 2019 Plan was amended to increase the number of shares authorized from 2.0 million to 3.0 million. As of March 31, 2026, 0.4 million shares were available for future grants under the Plan.

The 2019 Plan provides for grants to employees, members of the Board of Directors, consultants and advisors to the Company, in the form of stock options, stock awards and other equity-based awards. The amount and terms of grants are determined by the Board of Directors, except when they are below previously approved thresholds allowing the Company’s Chief Executive Officer to grant awards on a discretionary basis. The Company’s stock options generally carry a maximum term of 10 years after date of grant and are exercisable in cash, or as otherwise determined by the Board of Directors.

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Stock-based compensation expense reflected in the statement of operations was as follows:


	Three Months Ended
	March 31,
	2026		2025
General and administrative	$	87,351	$	266,937
Research and development		95,472		232,950
	$	182,823	$	499,887

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 exercisable at December 31, 2025		2,394,503		$	10.79		6.9		$	777
Options granted		30,000		$	2.28					-
Options exercised		—		$	-					-
Options forfeited / canceled		(187,084)		$	2.34					18
Options outstanding at March 31, 2026		2,237,419		$	11.38		6.2		$	255
Options exercisable at March 31, 2026		2,086,776		$	11.80		6.0		$	248

The weighted-average grant date fair value of stock options granted was $2.62 during the three months ended March 31, 2026. During the three months ended March 31, 2025, the Company did not grant any new stock option awards.

During the three months ended March 31, 2025, the Company granted 25,000 shares of restricted stock. 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.

(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.

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The following table sets forth the computation of basic and diluted net loss per common share:


			Three Months Ended
			March 31,
			2026			2025
Net loss per share – Basic:
Numerator
Net loss			$	(17,606,382)		$	(5,537,069)
Denominator
Weighted-average common shares outstanding, basic				27,847,884			17,431,234
Basic net loss per common share			$	(0.63)		$	(0.32)

Net loss per share – Diluted:
Numerator
Net loss			$	(17,606,382)		$	(5,537,069)
Numerator for diluted net loss per share			$	(17,606,382)		$	(5,537,069)
Denominator
Denominator for basic net loss per share				27,847,884			17,431,234
Denominator for diluted net loss per share				27,847,884			17,431,234
Diluted net loss per common share			$	(0.63)		$	(0.32)

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, 2026 and 2025. Total antidilutive securities that were excluded from the computation of diluted weighted-average shares outstanding were as follows:


		March 31,
		2026		2025
Stock options		2,237,419		2,336,020
Warrants		5,841,870		5,558,333
Restricted stock		—		25,000

(10) Income Taxes

The Company’s income tax benefit (expense) was $0 for the three months ended March 31, 2026 and 2025. 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, 2026 and 2025 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, 2026, and December 31, 2025, the Company had not recorded any liability for uncertain tax positions, accrued interest or penalties thereon, and no amounts have been recognized in the Company’s statements of operations.

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(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,
		2026			2025
Program expenses related to clinical-stage product candidates		$	(15,580,338)		$	(4,217,214)
Program expenses related to preclinical and discovery programs			(196,994)			(30,600)
Program expenses related to clinical manufacturing candidates			(270,830)			-
Personnel-related expenses (including stock-based compensation)			(1,272,579)			(1,397,874)
General and administrative professional and consultant fees			(490,577)			(444,865)
Other segment items¹			(200,864)			(192,128)
Interest income			137,800			187,612
Other non-cash income (expense) items²			268,000			558,000
Net Loss		$	(17,606,382)		$	(5,537,069)

¹Other segment items included in net loss include insurance expenses, rent expense, information technology expenses, listing/printing fees, warrant commissions and other miscellaneous expenses.

²Other non-cash income (expense) items include the change in fair value of our liability classified warrants.

(12) Subsequent Events

Subsequent to March 31, 2026, the Company sold 0.8 million shares of its common stock pursuant to the ATM through May 13, 2026 for net proceeds of $1.8 million.

On April 9, 2026, the Company entered into an Underwriting Agreement with Canaccord Genuity LLC, acting as representative of the underwriters 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 “Canaccord 2026 Warrants”). The units were priced at $1.90 per unit and the offering resulted in gross proceeds of $10.0 million, before deducting underwriting discounts, fees and other related expenses. Net proceeds from the transaction totaled $9.3 million. The Canaccord 2026 Warrants have an exercise price of $2.50 per share, are exercisable after six months from their issuance date, and expire five and one half years from their date of issuance.

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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;

●

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;

●

our business strategies;

●

risks relating to the timing and costs of clinical trials and the timing and costs of other organizational 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, 2025 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.

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Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the 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 2025 fiscal year, which are included in our Annual Report on Form 10-K for the year ended December 31, 2025.

Company Overview

We are a late-stage clinical 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”), α-Synuclein (“αSYN”) and TDP43 — 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.

Currently we are conducting two clinical studies – a pivotal Phase 3 study in early AD ("Phase 3AD Trial”) (NCT06709014) and an open-label extension ("OLE”) study in PD (NCT07284784), and we plan for a third study in Parkinson’s disease dementia ("PDD”).

In February of 2025, we initiated the FDA-cleared pivotal Phase 3 AD Trial: a randomized, double-blind, placebo-controlled, multicenter Phase 3 study in 725 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 an additional 12 months. If well-designed and well-executed, the symptomatic portion of the trial may be sufficient to support a New Drug Application ("NDA”) filing, potentially within one year of the 6-month treatment period completion. 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 Phase 3 AD Trial is currently enrolling patients, with screening expected to conclude on May 15, 2026, and full enrollment anticipated two months thereafter.

This pivotal Phase 3 AD Trial will utilize standard clinical outcome measures including Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 ("ADAS-Cog13”) and Alzheimer’s Disease Cooperative Study-InstrumentalActivities of Daily Living Scale ("ADCS-iADL”). Volumetric MRI imaging and certain plasma biomarkers will also be assessed, including p-tau217 levels and inflammatory markers, leveraging recent biomarker assay advances in AD to better diagnose Alzheimer’s patients and disease progression.

In January of 2026, we began an OLE study to evaluate the long-term safety and efficacy of buntanetap in PD patients. The study aims to enroll 500 patients, who will be treated with buntanetap for 36 months or until buntanetap is on the market. The patient population consists of two cohorts: cohort 1with invited participants from prior clinical

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studies and cohort 2 with patients who did not take part in earlier trials but have been receiving deep brain stimulation ("DBS”) for at least 12 months following successful surgery. The OLE PD study represents an important step toward a future NDA submission by helping meet the FDA patient exposure requirements.

In 2025, we further discussed a study in PDD with the FDA. After showing that the amyloid-positive PD population with the Mini Mental State Examination ("MMSE”) score above 20 responds exceptionally well to our drug, buntanetap, we received approval to proceed. We are refining the proposed protocol for the PDD program and will initiate the study contingent on additional funding.

To date, we have concluded 12 clinical studies, in healthy volunteers to assess safety, food effect, pharmacokinetics ("PK”), distribution, etc., and in AD and PD patients to assess safety and efficacy. The most important clinical studies are described below:

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 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 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 Trials represent the first double-blind, placebo-controlled study that showed improvements in AD patients, as measured by 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 42-item rating scale designed to assess PD-related disability and impairment and also evaluate the activities of daily living and motor function.

Following completion of the AD/PD Trials, we submitted our data to the 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 Part II, III, II+III 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

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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 endpoints, they would like to discuss the two conditions — dementia with Lewy bodies and PDD — separately and independently. However, the FDA did approve a protocol for an OLE study in PD patients, consisting of two cohorts: cohort 1 with invited participants from prior clinical studies and cohort 2 with patients who did not take part in earlier trials but have been receiving DBS for at least 12 months following successful surgery.

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 two 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, PK, and population PK. Further, the FDA confirmed that future development can proceed using the new crystal form of buntanetap.

We believe that we are the only company developing a drug for AD and PD that is designed to inhibit more than one neurotoxic protein and has a mechanism of action designed to restore nerve cell axonal and synaptic activity. By improving brain function, our goal is to treat memory loss and dementia associated with AD as well as body and brain function issues associated with PD. Based on pre-clinical and clinical data collected to date, we believe that buntanetap has the potential to be the first drug to interfere with the underlying mechanism of neurodegeneration, potentially enabling buntanetap to be the only drug to improve cognition in AD and motor function in PD. The industry has historically encountered challenges in specifically targeting one neurotoxic protein, be it APP, tau or αSYN, indicating that doing so does not change the underlying course of neurodegeneration. Our ultimate goal is to develop a disease-modifying drug (“DMD”) for patients with neurodegeneration by leveraging our clinical and pre-clinical data, which show 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.

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Future Capital Requirements

We have never been profitable and have incurred net losses since inception. Our accumulated deficit at March 31, 2026 was $181.3 million. We do not have sufficient capital on hand to fund our operations for the next 12 months and will need to raise additional capital to meet our obligations as they become due. We believe that our cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements until the fourth 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. Accordingly, we have concluded that substantial doubt exists with respect to our ability to continue as a going concern within one year after the date that these financial statements are issued.

We expect to incur losses for the foreseeable future. We also expect these losses to further increase, as we ramp up our clinical development programs and begin activities for commercial launch readiness. We may also encounter unforeseen expenses, difficulties, complications, delays and other currently unknown factors that could adversely affect our business.

Our future funding requirements, both near and long-term, will depend on many factors, including, but not limited to:

●

the initiation, progress, timing, costs and results of preclinical studies and clinical trials, including patient enrollment in such trials, for buntanetap or any other future product candidates;

●

the clinical development plans we establish for buntanetap and any other future product candidates, including any modifications to clinical development plans based on feedback that we may receive from regulatory authorities;

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the number and characteristics of product candidates that we discover or in-license and develop;

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the outcome, timing and cost of regulatory meetings and reviews by the FDA and comparable foreign regulatory authorities, including the potential for the FDA or comparable foreign regulatory authorities to require that we perform more studies than those that we currently expect;

●

the requirements of regulatory authorities in any additional jurisdictions in which we may seek approval for buntanetap and any future product candidates and our anticipated timing for seeking approval in such jurisdictions;

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the costs of filing, prosecuting, defending and enforcing any patent claims and maintaining and enforcing other intellectual property and proprietary rights;

●

the effects of competing technological and market developments;

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the costs associated with hiring additional personnel and consultants as our business grows, including additional executive officers and clinical development, regulatory, CMC, quality and commercial personnel;

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the costs and timing of the implementation of commercial-scale manufacturing activities, if any product candidate is approved, including as a result of inflation, any supply chain issues or component shortages;

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the costs and timing of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval;

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our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products;

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the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements; and

●

the costs associated with any products or technologies that we may in-license or acquire.

A change in the outcome of any of these or other variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. Furthermore, our operating plans may change in the future, and we will continue to require additional capital to meet operational needs and capital requirements associated with such operating plans. If we raise additional funds by issuing equity securities, our stockholders may experience dilution. Any future debt financing into which we enter may impose upon us additional covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our common stock, make certain investments or engage in certain merger, consolidation or asset sale transactions. Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders.

Adequate funding may not be available to us on acceptable terms, or at all. Our potential inability to raise capital when needed could have a negative impact on our financial condition and our ability to pursue our business strategies. If we are unable to raise additional funds as required, we may need to delay, reduce, or terminate some or all development programs and clinical trials. We may also be required to sell or license our rights to product candidates in certain territories or indications that we would otherwise prefer to develop and commercialize ourselves. If we are required to enter into collaborations and other arrangements to address our liquidity needs, we may have to give up certain rights that limit our ability to develop and commercialize our product candidates or may have other terms that are not favorable to us or our stockholders, which could materially and adversely affect our business and financial prospects. See the section of our 2025 Annual Report on Form 10-K titled “Risk Factors” for additional risks associated with our substantial capital requirements.

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Results of Operations

Comparison of the Three Months Ended March 31, 2026 and 2025

The following table summarizes the results of our operations for the three months ended March 31, 2026 and 2025:


	Three Months Ended
	March 31,
	2026		2025		Change

	(in thousands)
Operating expenses:
Research and development	$	16,720	$	5,012	$	11,708
General and administrative		1,292		1,271		21
Total operating expense		18,012		6,283		11,729
Other income (expense):
Interest income		138		188		(50)
Change in fair value of warrants		268		558		(290)
Total other income, net		406		746		(340)
Net loss	$	(17,606)	$	(5,537)	$	(12,069)

Research and Development Expenses

Research and development expenses for the three months ended March 31, 2026 were $16.7 million, compared to $5.0 million for the three months ended March 31, 2025. The $11.7 million increase was primarily attributable to an increase of $11.9 million for costs associated with our AD 6 month trial patients, an increase of $2.2 million for costs associated with our PD OLE trial, and a decrease of $2.4 million in clinical costs not specifically associated with either study.

General and Administrative Expenses

General and administrative expenses for the three months ended March 31, 2026 were $1.3 million, compared to $1.3 million for the three months ended March 31, 2025. For the three months ended March 31, 2026, General and administrative expenses were increased primarily due to $0.1 million of severance expense related to the Company entering into a separation agreement with its Chief Financial Officer. These costs were offset by a decrease of $0.1 million related to legal fees for corporate and intellectual property matters and employee recruitment costs incurred.

Interest Income

Interest income was $0.1 million for the three months ended March 31, 2026, compared to $0.2 million for the three months ended March 31, 2025. The $0.1 million decrease was driven by lower cash and cash equivalent balances at March 31, 2026 as compared to March 31, 2025, as the March 31, 2025 balance reflected additional funds as a result of our public offering with ThinkEquity, which closed in February 2025. Cash balances have declined since March 31, 2025 due to cash payments to fund our studies.

Change in Fair Value of Warrants

Change in fair value of warrants was a gain of $0.3 million for the three months ended March 31, 2026, compared to a gain of $0.6 million for the three months ended March 31, 2025. The $0.3 million difference between periods was primarily driven by greater volatility in our stock price during the first quarter of 2025, as compared to the same period during 2026.

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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 March 31, 2026, our principal source of liquidity was our cash and cash equivalents, which totaled $14.2 million. We do not believe that our cash on hand will be sufficient to fund our operations for at least twelve months beyond the date of this filing.

April 2026 Canaccord Underwritten Offering

On April 9, 2026, the Company entered into an Underwriting Agreement with Canaccord Genuity LLC (“Canaccord”), 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 “Canaccord 2026 Warrants”). The units were priced at $1.90 per unit and the offering resulted in gross proceeds of $10.0 million, before deducting underwriting discounts, fees and other related expenses. Net proceeds from the transaction totaled $9.3 million. The Canaccord 2026 Warrants have an exercise price of $2.50 per share, are exercisable after six months from their issuance date, and expire five and one half years from their date of issuance.

October 2025 Registered Direct Offerings and Warrant Issuances

On October 26, 2025, the Company entered into (i) a Securities Purchase Agreement, with the purchasers signatory thereto pursuant to which the Company agreed to issue and sell, in a registered direct offering an aggregate of 597,561 shares of the Company’s common stock, $0.0001 par value per share and (ii) Stock Subscription Agreements (the "Subscription Agreements”) with two members of the Board of Directors of the Company pursuant to which they agree to purchase an aggregate of 1,073,171 shares of Common Stock. An aggregate number of 1,670,732 shares of Common Stock was issued. The offering price of each share was $2.05 per share. In addition, in connection with this offering, the Company granted to a placement agent, warrants to purchase a total 83,357 shares of Common Stock (the "October 26, 2025 Placement Agent Warrants”) that have an exercise price per share equal to $2.56 and a term of 5 years from the date of issuance. The aggregate fair market value was recorded as an offset to gross proceeds of the Offering and an increase to additional paid-in capital. The net proceeds to the Company from the Offering were $3.1 million.

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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 common 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. None of the ThinkEquity Warrants were exercised as of March 31, 2026.

December 2024 ATM

During the three months ended March 31, 2026, the Company sold 1.3 million shares of common stock pursuant to the Distribution Agreement for gross proceeds of $3.8 million, before commissions. During the year-ended December 31, 2025, the Company sold 2.1 million shares of common stock pursuant to the Distribution Agreement for gross proceeds of $6.8 million before commissions.

Cash Flows

The following table provides a summary of our cash flows for the three months ended March 31, 2026 and 2025:


	Three Months Ended
	March 31,
	2026		2025

	(in thousands)
Total net cash provided by (used in):
Operating activities	$	(9,012)	$	(8,099)
Financing activities		3,698		19,783
Net increase (decrease) in cash and cash equivalents	$	(5,314)	$	11,684

Operating Activities

Cash used in operating activities was $9.0 million for the three months ended March 31, 2026, compared to $8.1 million for the three months ended March 31, 2025 The $0.9 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 2026 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 AD Trial.

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31.1*		Certification of Principal Executive Officer pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1**		Certifications of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.


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

** Furnished herewith

PART I – FINANCIAL INFORMATION		Page


Item 1.	Financial Statements	3

	Balance Sheets as of March 31, 2026 (Unaudited) and December 31, 2025	3

	Statements of Operations (Unaudited) for the Three Months Ended March 31, 2026 and 2025	4

	Statements of Changes in Stockholders’ Equity (Unaudited) for the Three Months Ended March 31, 2026 and 2025	5

	Statements of Cash Flows (Unaudited) for the Three Months Ended March 31, 2026 and 2025	6

	Notes to Financial Statements (Unaudited)	7

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	20

Item 3.	Quantitative and Qualitative Disclosure About Market Risk	29

Item 4.	Controls and Procedures	30


PART II – OTHER INFORMATION


Item 1.	Legal Proceedings	31

Item 1A.	Risk Factors	31

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	31

Item 3.	Defaults Upon Senior Securities	31

Item 4.	Mine Safety Disclosures	31

Item 5.	Other Information	31

Item 6.	Exhibits	32

	Signatures	34

Exhibit Number		Description of Exhibit

3.1		Amended and Restated Certificate of Incorporation of the Registrant. (Incorporated by reference to Exhibit 3.1 to Form 8-K filed February 6, 2020.)

3.2		Amended and Restated Bylaws of the Registrant. (Incorporated by reference to Exhibit 3.2 to Form 8-K filed February 6, 2020.)

3.3		Certificate of Amendment to the Amended and Restated Certificate of Incorporation of the Registrant. (Incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed June 16, 2023.)

4.1		Specimen Certificate evidencing shares of the Registrant’s common stock. (Incorporated by reference to Exhibit 4.1 to Amendment No. 3 to the Registration Statement on Form S-1 filed September 20, 2019.)

4.2		Form of Warrant Agreement (Incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on November 1, 2023.)

4.3		Form of Warrant (Incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed on February 5, 2025)

4.4		Warrant Agency Agreement (Incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K filed on February 5, 2025)

10.1+		Second Amended and Restated Employment Agreement dated as of March 24, 2020 between the Registrant and Maria Maccecchini (Incorporated by reference to Exhibit 10.1 to Form 10-K filed March 25, 2020.)

10.2+		Annovis Bio, Inc. 2018 Equity Incentive Plan. (Incorporated by reference to Exhibit 4.3 to the Registration Statement on Form S-8 filed February 14, 2020.)

10.3+		Amendment to Annovis Bio, Inc. 2019 Equity Incentive Plan (Incorporate by reference to form DEF 14A filed April 29, 2024.)

10.4		Registration Rights Agreement dated as of December 19, 2014 among the Registrant and the signatories thereto. (Incorporated by reference to Exhibit 10.5 to Amendment No. 1 to Form S-1 filed August 8, 2019.)

10.5+		Form of Non-Qualified Stock Option Award Agreement for the Annovis Bio, Inc. 2019 Equity Incentive Plan. (Incorporated by reference to Exhibit 10.6 to the Annual Report on Form 10-K filed on March 31, 2023)

10.6		Distribution Agreement, dated December 11, 2024, by and between Annovis Bio, Inc. and Oppenheimer & Co. Inc. (Incorporated by reference to Exhibit 1.1 to the Current Report on Form 8-K filed December 12, 2024)

10.7		Underwriting Agreement, dated February 3, 2025, by and between Annovis Bio, Inc. and ThinkEquity LLC (Incorporated by reference to Exhibit 1.1 to the Current Report filed on February 5, 2025)

19.1		Insider Trading Policy (Incorporated by reference to Exhibit 19.1 to the Annual Report on Form 10-K filed on March 21, 2025).

Signature	Title	Date

/s/ Maria Maccecchini	President and Chief Executive Officer (Principal	May 15, 2026
Maria Maccecchini	Executive and Principal Financial Officer)