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​

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 SEPTEMBER 30, 2025

OR

​ | ​
☐ | 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 November 12, 2025 was: 26,502,889

​

​

​

​

Table of Contents

ANNOVIS BIO, INC.

QUARTERLY REPORT ON FORM 10-Q

FOR THE QUARTER ENDED JUNE 30, 2025

​

PART I – FINANCIAL INFORMATION |  | Page
|  | ​ |
​ | ​ | ​ | ​
Item 1. | Financial Statements | ​ | 3
​ | ​ | ​ | ​
| Balance Sheets as of September 30, 2025 (Unaudited) and December 31, 2024 | ​ | 3
​ | ​ | ​ | ​
| Statements of Operations (Unaudited) for the Three and Nine Months Ended September 30, 2025 and 2024 | ​ | 4
​ | ​ | ​ | ​
| Statements of Changes in Stockholders’ Equity (Deficit) (Unaudited) for the Three and Nine Months Ended September 30, 2025 and 2024 | ​ | 5
​ | ​ | ​ | ​
| Statements of Cash Flows (Unaudited) for the Nine Months Ended September 30, 2025 and 2024 | ​ | 6
​ | ​ | ​ | ​
| Notes to Financial Statements (Unaudited) | ​ | 7
​ | ​ | ​ | ​
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | ​ | 21
​ | ​ | ​ | ​
Item 3. | Quantitative and Qualitative Disclosure About Market Risk | ​ | 29
​ | ​ | ​ | ​
Item 4. | Controls and Procedures | ​ | 29
​ | ​ | ​ | ​
​ | ​ | ​ | ​
PART II – OTHER INFORMATION | ​ | ​
​ | ​ | ​ | ​
​ | ​ | ​ | ​
Item 1. | Legal Proceedings | ​ | 30
​ | ​ | ​ | ​
Item 1A. | Risk Factors | ​ | 30
​ | ​ | ​ | ​
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | ​ | 30
​ | ​ | ​ | ​
Item 3. | Defaults Upon Senior Securities | ​ | 30
​ | ​ | ​ | ​
Item 4. | Mine Safety Disclosures | ​ | 30
​ | ​ | ​ | ​
Item 5. | Other Information | ​ | 30
​ | ​ | ​ | ​
Item 6. | Exhibits | ​ | 31
​ | ​ | ​ | ​
| Signatures | ​ | 32

​

​

​

2

Table of Contents

PART I

FINANCIAL INFORMATION

Item 1. Financial Statements

Annovis Bio, Inc.

Balance Sheets

​

​ | ​ | ​ | ​ | ​ | ​ | ​
​ |  | September 30, | ​ | ​
​ |  | 2025 |  | December 31,
​ | ​ | (Unaudited) | ​ | 2024
​ | ​ | ​ | ​ | ​ | ​ | ​
Assets |  | ​ |  |  | ​ |
Current assets: |  | ​ |  |  | ​ |
Cash and cash equivalents | ​ | $ | 15,286,399 | ​ | $ | 10,551,916
Prepaid expenses and other current assets | ​ |  | 1,902,562 | ​ |  | 3,373,717
Total assets | ​ | $ | 17,188,961 | ​ | $ | 13,925,633
Liabilities and stockholders’ equity | ​ |  |  | ​ |  |
Current liabilities: | ​ |  |  | ​ |  |
Accounts payable | ​ | $ | 2,112,026 | ​ | $ | 2,305,974
Accrued expenses | ​ |  | 1,621,771 | ​ |  | 1,575,013
Total current liabilities | ​ |  | 3,733,797 | ​ |  | 3,880,987
Non-current liabilities: | ​ | ​ | ​ | ​ | ​ | ​
Warrant liability | ​ | ​ | 299,000 | ​ | ​ | 737,000
Total liabilities | ​ |  | 4,032,797 | ​ |  | 4,617,987
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, 20,187,904 and 14,141,521 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively | ​ |  | 2,019 | ​ |  | 1,414
Additional paid-in capital | ​ |  | 167,023,392 | ​ |  | 144,155,694
Accumulated deficit | ​ |  | (153,869,247) | ​ |  | (134,849,462)
Total stockholders’ equity | ​ |  | 13,156,164 | ​ |  | 9,307,646
Total liabilities and stockholders’ equity | ​ | $ | 17,188,961 | ​ | $ | 13,925,633

​

See accompanying notes to financial statements.

​

3

Table of Contents

Annovis Bio, Inc.

Statements of Operations

(Unaudited)

​

​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ |  | Three Months Ended | ​ | Nine Months Ended
​ | ​ | September 30, | ​ | September 30,
​ | ​ | 2025 |  | 2024 |  | 2025 |  | 2024
Operating expenses: | ​ | ​ |  |  | ​ |  | ​ | ​ |  |  | ​ |
Research and development | ​ | $ | 6,291,171 | ​ | $ | 2,689,561 | ​ | $ | 16,464,609 | ​ | $ | 14,996,868
General and administrative | ​ |  | 1,143,804 | ​ |  | 1,698,050 | ​ |  | 3,524,500 | ​ |  | 4,963,188
Total operating expenses | ​ |  | 7,434,975 | ​ |  | 4,387,611 | ​ |  | 19,989,109 | ​ |  | 19,960,056
Operating loss | ​ | ​ | (7,434,975) | ​ | ​ | (4,387,611) | ​ | ​ | (19,989,109) | ​ | ​ | (19,960,056)
Other income (expense): | ​ |  |  | ​ |  |  | ​ |  |  | ​ |  |
Interest income | ​ |  | 152,317 | ​ |  | 135,430 | ​ |  | 531,324 | ​ |  | 205,576
Other financing costs (Note 7) | ​ | ​ | — | ​ | ​ | (524,068) | ​ | ​ | — | ​ | ​ | (1,870,128)
Change in fair value of warrants (Note 7) | ​ | ​ | 20,000 | ​ | ​ | (7,862,108) | ​ | ​ | 438,000 | ​ | ​ | 2,898,892
Total other income (expense), net | ​ |  | 172,317 | ​ |  | (8,250,746) | ​ |  | 969,324 | ​ |  | 1,234,340
Net loss | ​ | $ | (7,262,658) | ​ | $ | (12,638,357) | ​ | $ | (19,019,785) | ​ | $ | (18,725,716)
Net loss per share (Note 9) | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Basic | ​ | $ | (0.37) | ​ | $ | (0.97) | ​ | $ | (1.01) | ​ | $ | (1.64)
Diluted | ​ | $ | (0.37) | ​ | $ | (0.97) | ​ | $ | (1.01) | ​ | $ | (1.89)
Weighted-average number of common shares used in computing net loss per share | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Basic | ​ | ​ | 19,685,071 | ​ | ​ | 12,975,808 | ​ | ​ | 18,876,078 | ​ | ​ | 11,394,729
Diluted | ​ |  | 19,685,071 | ​ |  | 12,975,808 | ​ |  | 18,876,078 | ​ |  | 11,461,298

​

See accompanying notes to financial statements.

​

​

4

Table of Contents

Annovis Bio, Inc.

Statements of Changes in Stockholders’ Equity (Deficit)

(Unaudited)

​

​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | Additional | ​ | Total | ​ | Total
​ | ​ | Common Stock | ​ | Paid-in | ​ | Accumulated | ​ | Stockholders' Equity
​ |  | Shares |  | Amount |  | Capital |  | Deficit |  | (Deficit)
Three and Nine Months Ended September 30, 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
Stock-based compensation expense | ​ | — | ​ |  | — | ​ | ​ | 496,618 | ​ | ​ | — | ​ | ​ | 496,618
Net loss | ​ | — | ​ |  | — | ​ |  | — | ​ |  | (6,220,058) | ​ |  | (6,220,058)
Balance, June 30, 2025 | ​ | 19,486,231 | ​ | ​ | 1,948 | ​ | ​ | 164,935,088 | ​ | ​ | (146,606,589) | ​ | ​ | 18,330,447
Issuance of common stock, pursuant to Equity Distribution Agreement, net of issuance costs |  | 701,673 | ​ |  | 71 | ​ | ​ | 1,643,657 | ​ | ​ | — | ​ | ​ | 1,643,728
Stock-based compensation expense | ​ | — | ​ | ​ | — | ​ | ​ | 444,647 | ​ | ​ | — | ​ | ​ | 444,647
Net loss |  | — | ​ |  | — | ​ | ​ | — | ​ | ​ | (7,262,658) | ​ | ​ | (7,262,658)
Balance, September 30, 2025 |  | 20,187,904 | ​ | $ | 2,019 | ​ | $ | 167,023,392 | ​ | $ | (153,869,247) | ​ | $ | 13,156,164
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Three and Nine Months Ended September 30, 2024 | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Balance, December 31, 2023 |  | 10,519,933 | ​ | $ | 1,052 | ​ | $ | 102,507,189 | ​ | $ | (110,259,087) | ​ | $ | (7,750,846)
Exercise of common stock warrants, inclusive of warrant reduction |  | 60,000 | ​ |  | 6 | ​ |  | 1,223,994 | ​ |  | — | ​ |  | 1,224,000
Issuance of common stock, net of issuance costs | ​ | 431,366 | ​ |  | 43 | ​ | ​ | 3,874,957 | ​ | ​ | — | ​ | ​ | 3,875,000
Stock-based compensation expense | ​ | — | ​ | ​ | — | ​ | ​ | 364,765 | ​ | ​ | — | ​ | ​ | 364,765
Net loss |  | — | ​ |  | — | ​ |  | — | ​ |  | (1,066,947) | ​ |  | (1,066,947)
Balance, March 31, 2024 |  | 11,011,299 | ​ | ​ | 1,101 | ​ | ​ | 107,970,905 | ​ | ​ | (111,326,034) | ​ | ​ | (3,354,028)
Issuance of common stock under ELOC, net of issuance costs | ​ | 710,181 | ​ |  | 71 | ​ | ​ | 5,026,973 | ​ | ​ | — | ​ | ​ | 5,027,044
Stock-based compensation expense | ​ | — | ​ | ​ | — | ​ | ​ | 1,596,512 | ​ | ​ | — | ​ | ​ | 1,596,512
Net loss | ​ | — | ​ |  | — | ​ |  | — | ​ |  | (5,020,412) | ​ |  | (5,020,412)
Balance, June 30, 2024 | ​ | 11,721,480 | ​ | ​ | 1,172 | ​ | ​ | 114,594,390 | ​ | ​ | (116,346,446) | ​ | ​ | (1,750,884)
Exercise of common stock warrants, inclusive of warrant reduction | ​ | 831,667 | ​ |  | 83 | ​ | ​ | 16,118,028 | ​ | ​ | — | ​ | ​ | 16,118,111
Issuance of common stock, net of issuance costs | ​ | 510,181 | ​ | ​ | 51 | ​ | ​ | 4,941,699 | ​ | ​ | — | ​ | ​ | 4,941,750
Cashless exercise of stock options | ​ | 220,339 | ​ | ​ | 22 | ​ | ​ | (22) | ​ | ​ | — | ​ | ​ | —
Stock-based compensation expense | ​ | — | ​ | ​ | — | ​ | ​ | 393,080 | ​ | ​ | — | ​ | ​ | 393,080
Net loss | ​ | — | ​ |  | — | ​ | ​ | — | ​ | ​ | (12,638,357) | ​ | ​ | (12,638,357)
Balance, September 30, 2024 | ​ | 13,283,667 | ​ | $ | 1,328 | ​ | $ | 136,047,175 | ​ | $ | (128,984,803) | ​ | $ | 7,063,700

​

See accompanying notes to financial statements.

​

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Annovis Bio, Inc.

Statements of Cash Flows

(Unaudited)

​

​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | Nine Months Ended September 30,
​ | ​ | 2025 | ​ | 2024
Cash flows from operating activities: | ​ | ​ |  |  | ​ |
Net loss | ​ | $ | (19,019,785) | ​ | $ | (18,725,716)
Adjustments to reconcile net loss to net cash used in operating activities: | ​ |  | ​ | ​ |  | ​
Stock-based compensation expense | ​ |  | 1,441,152 | ​ |  | 2,354,357
Change in fair value of warrants | ​ | ​ | (438,000) | ​ | ​ | (2,898,892)
Non-cash other financing costs | ​ | ​ | — | ​ | ​ | 1,820,129
Changes in operating assets and liabilities: | ​ |  | ​ | ​ |  | ​
Prepaid expenses and other current assets | ​ |  | 1,471,155 | ​ |  | 2,728,598
Accounts payable | ​ |  | (193,948) | ​ |  | 2,806,577
Accrued expenses | ​ |  | 46,758 | ​ |  | (1,694,311)
Net cash used in operating activities | ​ |  | (16,692,668) | ​ |  | (13,609,258)
Cash flows from financing activities: | ​ |  |  | ​ |  |
Proceeds from issuance of common stock, net | ​ | ​ | 21,427,151 | ​ | ​ | 12,466,165
Proceeds from exercise of warrants | ​ | ​ | — | ​ | ​ | 8,025,003
Net cash provided by financing activities | ​ |  | 21,427,151 | ​ |  | 20,491,168
Net increase in cash and cash equivalents | ​ |  | 4,734,483 | ​ |  | 6,881,910
Cash and cash equivalents, beginning of period | ​ |  | 10,551,916 | ​ |  | 5,754,720
Cash and cash equivalents, end of period | ​ | $ | 15,286,399 | ​ | $ | 12,636,630
Supplemental disclosure of cash flow information: | ​ | ​ | ​ | ​ | ​ | ​
Other adjustments to value of warrants related to exercises | ​ | $ | — | ​ | $ | 9,317,108
Cash paid for financing costs | ​ | $ | — | ​ | $ | 50,000

​

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.

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 no t 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 September 30, 2025, the Company had cash and cash equivalents of $15.3 million and an accumulated deficit of $153.9 million. The Company’s net loss was $19.0 million and $18.7 million for the nine months ended September 30, 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 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 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 September 30, 2025, its results of operations for the three and nine months ended September 30, 2025 and 2024 and its cash flows for the nine months ended September 30, 2025 and 2024. These interim results of operations are not necessarily indicative of the results to be expected for a full year or any future period. The accompanying financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”) and the rules and regulations of the SEC. Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). Certain information and note disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to such rules and regulations relating to interim financial statements.

(b) Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires Management to make estimates and assumptions that affect the reported amounts of assets and liabilities, including disclosure of contingent assets and liabilities, at the date of the financial statements, and the reported amounts of 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.

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(e) Issuance Costs Associated with Equity Issuances

Issuance costs incurred in connection with the Company’s equity issuances, which primarily consist of direct incremental legal, printing, listing and accounting fees, are offset against proceeds received in the issuances and charged to additional paid-in capital in the period the equity issuance is completed. Issuance costs related to the Equity Line of Credit (“ELOC”) Purchase Agreement are expensed as incurred as prescribed by ASC 815.

(f) Derivative Liability

The Company evaluates all features contained in financing agreements to determine if there are any embedded derivatives that require separate accounting from the underlying agreement under ASC 815 – Derivatives and Hedging. An embedded derivative that requires separation is accounted for as a separate liability or asset from the host agreement. The separated embedded derivative is accounted for at fair market value, with changes in fair value recognized in the statements of operations within the other financing costs line item. The Company determined that certain features under the ELOC Purchase Agreement (See Note 7 — Stockholders’ Equity) collectively qualified as an embedded derivative. The derivative was accounted for separately from the underlying ELOC Purchase Agreement and is accounted for at fair value.

(g) Common Stock Warrants

On October 31, 2023, the Company completed an underwritten offering whereby the Company sold (i) 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.

(h) Fair Value of Financial Instruments

The fair value of the Company’s assets and liabilities, which qualify as financial instruments under FASB ASC Topic 820, “Fair Value Measurements,” equals or approximates the carrying amounts represented in the balance sheets, primarily due to their short-term nature, except for the aforementioned warrant liabilities (see Note 3 — Fair Value Measurements).

(i) Research and Development

Research and development costs are either expensed as incurred, or recorded separately as a prepaid asset where expense is recognized when the service is performed. These costs are primarily comprised of personnel-related expenses and external research and development expenses incurred under arrangements with third parties, such as contract research organizations and consultants. At the end of each reporting period, the Company compares the payments made to each service provider to the estimated progress towards completion of the related project. Factors that the Company considers in preparing these estimates include the number of patients enrolled in studies, project milestones achieved, and other relevant criteria related to the efforts of its vendors. These estimates will be subject to change as additional information becomes available. Depending on the timing of payments to vendors and estimated services provided, the Company will record net prepaid expenses or accrued expenses related to these costs. Prepaid clinical expenses represent valid future economic benefits based on the Company’s contracts with its vendors and are realized in the ordinary course of business.

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(j) Stock-Based Compensation

The Company accounts for its stock-based compensation awards in accordance with FASB ASC Topic 718, Compensation—Stock Compensation (“ASC 718”). The Company has issued stock-based compensation awards, primarily in the form of stock options. ASC 718 requires all stock-based payments, including grants of stock options, to be recognized in the financial statements based on their grant date fair values. The Company uses the Black-Scholes option-pricing model to determine the fair value of stock options granted. The Company recognizes forfeitures as they occur.

Expense related to stock-based compensation awards granted with service-based vesting conditions is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which is generally the vesting term. Stock options have a contractual term of 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 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.

(k) Income Taxes

The Company provides for income taxes using the asset and liability approach. Deferred tax assets and liabilities are recorded based on the differences between the financial statement and tax bases of assets and liabilities and the tax rates in effect when these differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. As of September 30, 2025 and December 31, 2024, the Company had a full valuation allowance against its deferred tax assets.

The Company is subject to the provisions of ASC 740, Income Taxes, which prescribes a more likely-than-not threshold for the financial statement recognition of uncertain tax positions. ASC 740 clarifies the accounting for income taxes by prescribing a minimum recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. There are currently no open federal or

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state tax audits. The Company has not recorded any liability for uncertain tax positions at September 30, 2025 or December 31, 2024.

(l) Recent Accounting Pronouncements

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which improves income tax disclosures by requiring: (1) consistent categories and greater disaggregation of information in the rate reconciliation, and (2) income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. ASU 2023-09 is effective for annual periods beginning after December 15, 2024. Early adoption is permitted. The ASU indicates that all entities will apply the guidance prospectively with an option for retroactive application to each period presented in the financial statements. The Company is evaluating the impact this ASU on its future financial statements and disclosures.

In November 2024, the FASB issued ASU 2024-03, Income Statement — Reporting Comprehensive Income — Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”), which requires public entities, at annual and interim reporting periods, to disclose in a tabular format additional information about specific expense categories in the notes to the financial statements. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027, with early adoption permitted. The Company is evaluating the impacts of this ASU on its future financial statements and disclosures.

(3) Fair Value Measurements

The Company measures certain assets and liabilities at fair value in accordance with ASC 820, Fair Value Measurements and Disclosures. ASC 820 defines fair value as the price that would be received to sell an asset or paid to transfer a liability (the exit price) in an orderly transaction between market participants at the measurement date. The guidance in ASC 820 outlines a valuation framework and creates a fair value hierarchy that serves to increase the consistency and comparability of fair value measurements and the related disclosures. In determining fair value, the Company maximizes the use of quoted prices and observable inputs. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from independent sources. The fair value hierarchy is broken down into three levels based on the source of inputs as follows:

​

Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities.

Level 2—Valuations based on observable inputs and quoted prices in active markets for similar assets and liabilities.

Level 3—Valuations based on unobservable inputs and models that are supported by little or no market activity.

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The following table provides the carrying value and fair value of certain financial assets and liabilities of the Company measured at fair value on a recurring basis as of September 30, 2025 and December 31, 2024:

​

​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ |  | ​ | ​ |  | Fair Value Measurement at
​ | ​ | ​ | ​ | ​ | September 30, 2025
​ | ​ | Carrying Value | ​ | Level 1 | ​ | Level 2 | ​ | Level 3
Assets: | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Cash equivalents | ​ | $ | 507,743 | ​ | $ | 507,743 | ​ | $ | — | ​ | $ | —
Total assets measured and recorded at fair value | ​ | $ | 507,743 | ​ | $ | 507,743 | ​ | $ | — | ​ | $ | —
Liabilities: | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Warrant liability | ​ | $ | 299,000 | ​ | $ | — | ​ | $ | — | ​ | $ | 299,000
Total liabilities measured and recorded at fair value | ​ | $ | 299,000 | ​ | $ | — | ​ | $ | — | ​ | $ | 299,000

​

​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ |  | ​ | ​ |  | 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 or nine months ended September 30, 2025 and 2024.

(a) Canaccord Warrants

The common stock warrants issued in connection with the Company’s equity raise in November 2023 (“Canaccord Warrants”) were classified as liabilities at the time of issuance due to certain cash settlement adjustment features that are outside of the Company’s control or not deemed to be indexed to the Company’s stock. The Canaccord Warrant liability is remeasured each reporting period with the change in fair value recorded to other income (expense) in the statements of operations until the warrants are exercised, expired, reclassified, or otherwise settled. From their date of issuance until the period ended September 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 September 30, 2024, the fair value of the Canaccord Warrants was estimated using a Black-Scholes option-pricing model.

The estimated fair value of the Canaccord Warrants is determined using Level 3 inputs. Inherent in a Black-Scholes option-pricing model are assumptions related to expected stock-price volatility, expected life, risk-free interest rate and other inputs. The Company estimates the volatility of its warrants based on implied volatility from the Company’s traded warrants. The risk-free interest rate is based on the market yield of U.S. Treasuries over a term commensurate with the remaining term to expiration. Any changes in these assumptions can change the associated valuation significantly.

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The following tables provide quantitative information regarding the Level 3 classified Canaccord Warrants as of their respective measurement dates:

​

​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ |  | ​ | ​ | September 30, 2025 |  | ​ | December 31, 2024 | ​
Exercise price | ​ | ​ | ​ | $ | 9.00 | ​ | ​ | $ | 9.00 | ​
Closing stock price | ​ | ​ | ​ | $ | 2.07 | ​ | ​ | $ | 5.03 | ​
Number of warrants | ​ | ​ | ​ |  | 308,333 | ​ | ​ |  | 308,333 | ​
Volatility | ​ | ​ | ​ |  | 118 | % | ​ |  | 80 | %
Term (time to expiration in years) | ​ | ​ | ​ |  | 3.09 | ​ | ​ |  | 3.84 | ​
Risk-free rate | ​ | ​ | ​ |  | 3.7 | % | ​ |  | 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:

​

​ | ​ | ​ | ​ | ​ | ​ | ​
​ |  | September 30, | ​ | December 31,
​ | ​ | 2025 | ​ | 2024
Prepaid clinical expenses | ​ | $ | 1,500,169 | ​ | $ | 2,998,811
Prepaid other | ​ | ​ | 348,451 | ​ | ​ | 346,313
Prepaid insurance | ​ | ​ | 46,447 | ​ | ​ | 21,098
Security deposits | ​ |  | 7,495 | ​ |  | 7,495
Total prepaid expenses and other current assets | ​ | $ | 1,902,562 | ​ | $ | 3,373,717

​

​

(5) Accrued Expenses

Accrued expenses consisted of the following:

​

​ | ​ | ​ | ​ | ​ | ​ | ​
​ |  | September 30, | ​ | December 31,
​ | ​ | 2025 | ​ | 2024
Accrued clinical expenses | ​ | $ | 699,808 | ​ | $ | 948,695
Payroll and related benefits | ​ | ​ | 706,650 | ​ | ​ | 364,717
Accrued professional and other | ​ |  | 215,313 | ​ |  | 261,601
Total accrued expenses | ​ | $ | 1,621,771 | ​ | $ | 1,575,013

​

​

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(6) Commitments and Contingencies

(a) Research and Development

The Company has entered into contracts with contract research organizations (“CROs”) and contract manufacturers (“CMOs”) related to the Company’s clinical trials. These contracts generally require upfront payments, milestone payments, and pass through cost reimbursements, to be made. While the contracts are generally cancellable with (written) notice, the Company is obligated to make payments for services rendered through the termination date of the project with any applicable CRO/CMO.

(b) Leases

The Company maintains one short-term lease associated with occupying its corporate headquarters. Total rental expense was $24,181 and $24,344 for the three months ended September 30, 2025 and 2024 and $81,763 and $82,457 for the nine months ended September 30, 2025 and 2024.

(c) Employment Agreements

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 $1.4 million at September 30, 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 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.

Liquidation

Subject to the rights of holders of all classes of stock outstanding having rights that are senior to or equivalent to holders of common stock as to liquidation, upon the liquidation, dissolution or winding up of the Company, the assets of the Company will be distributed to the holders of common stock.

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Voting

The holders of common stock are entitled to one 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 was no preferred stock issued or outstanding as of September 30, 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 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 or nine months ended September 30, 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.

​

(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 $6.8 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 or nine months ended September 30, 2025. During the three and nine months ended September 30, 2024, 0.0 million and 0.1 million Canaccord Warrants were exercised, respectively.

​

The following is a roll-forward of the Common Stock Warrant Liability from December 31, 2024 to September 30, 2025:

​ | ​ | ​
Warrant liability at December 31, 2024 | $ | 737,000
Change in fair value of warrant liability | ​ | (558,000)
Warrant liability at March 31, 2025 | ​ | 179,000
Change in fair value of warrant liability |  | 140,000
Warrant liability at June 30, 2025 | ​ | 319,000
Change in fair value of warrant liability | ​ | (20,000)
Warrant liability at September 30, 2025 | $ | 299,000

​

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(f) IPO Warrants

In conjunction with the closing of the Company’s Initial Public Offering (“IPO”), the Company granted its underwriters 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. As of September 30, 2025 and December 31, 2024, 0 and 2,400 of the IPO Warrants were outstanding, respectively. No IPO Warrants were exercised during the three or nine months ended September 30, 2025 or 2024.

(g) Warrant Summary

As of September 30, 2025, the Company had the following common stock warrants outstanding:

​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ |  | ​ |  | Outstanding |  | ​ |  |  |  | Outstanding |  | Exercise |  | ​
​ | ​ | ​ | ​ | December 31, | ​ | ​ | ​ | Exercised or | ​ | September 30, | ​ | 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 and nine month months ended September 30, 2025, the Company sold 0.7 million and 0.8 million shares of common stock, respectively, pursuant to the Distribution Agreement for gross proceeds of $1.7 million and $2.2 million, before commissions.

​

(i) ELOC Purchase Agreement

On April 25, 2024, the Company entered into an ELOC Purchase Agreement with an ELOC Purchaser, whereby the Company could offer and sell, from time to time at its sole discretion, and whereby the ELOC Purchaser committed to purchase, up to 2.0 million shares of shares of the Company’s common stock. Due to certain pricing and settlement provisions, the ELOC Purchase Agreement qualified as a standby equity purchase agreement and included an embedded put option and embedded forward option. The Company therefore accounted for the ELOC Purchase Agreement as a derivative measured at fair value, with changes in the fair value recognized in the statements of operations within other financing costs. The Company initially recognized a derivative liability related to the purchased put option at inception of the ELOC Purchase Agreement. During the three and nine months ended September 30, 2024, the Company recognized $0.5 million related to changes in derivative liability. There were no similar expenses during the three or nine months ended September 30, 2025 as the ELOC had been fully exhausted.

Upon execution of the ELOC Purchase Agreement, the Company agreed to issue to the ELOC Purchaser 33,937 shares of Common Stock as commitment shares (the “Commitment Shares”). The Company expensed the difference between the discounted purchase price of the settled forward and the fair value of shares on the date of settlement, as well as legal costs incurred in connection with the ELOC Purchase Agreement, as noncash financing issuance costs. During the three and nine months ended September 30, 2024, the Company recognized $0.8 million related to these items. There were no similar expenses during the three or nine months ended September 30, 2025 as the ELOC had been fully exhausted.

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(j) March 2024 Registered Direct Offerings

On March 15, 2024 and March 21, 2024, the Company entered into two 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 1.0 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 September 30, 2025, 0.2 million shares were available for future grants under the Plan.

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

​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | Three Months Ended | ​ | Nine Months Ended
​ | ​ | September 30, | ​ | September 30,
​ |  | 2025 |  | 2024 | ​ | 2025 |  | 2024
General and administrative | ​ | $ | 232,852 | ​ | $ | 203,785 | ​ | $ | 770,185 | ​ | $ | 1,437,305
Research and development | ​ |  | 211,795 | ​ | ​ | 189,295 | ​ |  | 670,967 | ​ | ​ | 917,052
​ | ​ | $ | 444,647 | ​ | $ | 393,080 | ​ | $ | 1,441,152 | ​ | $ | 2,354,357

​

Stock Options to Purchase Common Stock

The following table summarizes stock option activity:

​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ |  | ​ |  | ​ | ​ |  | Weighted |  | ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | Average | ​ | ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | Remaining | ​ | Aggregate
​ | ​ | ​ | ​ | Weighted | ​ | Contractual | ​ | Intrinsic
​ | ​ | Number of | ​ | Average | ​ | Life | ​ | Value
​ | ​ | Options | ​ | Exercise Price | ​ | (Years) | ​ | (Thousands)
Options outstanding at December 31, 2024 |  | 2,336,020 | ​ | $ | 11.39 | ​ | 7.3 | ​ | $ 1,298
Options granted | ​ | 220,000 | ​ | $ | 2.09 | ​ | — | ​ | —
Options expired | ​ | (92,562) | ​ | $ | 10.12 | ​ | — | ​ | —
Options outstanding at September 30, 2025 |  | 2,463,458 | ​ | $ | 10.61 | ​ | 7.0 |  | $ 245
Options exercisable at September 30, 2025 | ​ | 1,994,267 | ​ | $ | 12.08 | ​ | 6.6 |  | $ 238

​

The weighted-average grant date fair value of stock options granted was $1.80 and $1.76, respectively, during the three and nine months ended September 30, 2025. The weighted-average grant date fair value of stock options granted was $4.47 and $5.04, respectively, during the three and nine months ended September 30, 2024.

During the three and nine months ended September 30, 2025, the Company granted 0 and 25,000 shares of restricted stock, respectively. The weighted-average grant date fair value of the restricted stock issued by the Company during the nine months ended September 30, 2025 was $4.89 per share.

​

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(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 | ​ | Nine Months Ended | ​
​ | ​ | September 30, | ​ | September 30, | ​
​ |  | 2025 |  | 2024 |  | 2025 |  | 2024 | ​
Net loss per share – Basic: |  | ​ | ​ |  | ​ |  | ​ | ​ |  |  | ​ |  | ​
Numerator | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Net loss | ​ | $ | (7,262,658) | ​ | $ | (12,638,357) | ​ | $ | (19,019,785) | ​ | $ | (18,725,716) | ​
Denominator | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ |  | ​ | ​
Weighted-average common shares outstanding, basic | ​ | ​ | 19,685,071 | ​ | ​ | 12,975,808 | ​ | ​ | 18,876,078 | ​ | ​ | 11,394,729 | ​
Basic net loss per common share | ​ | $ | (0.37) | ​ | $ | (0.97) | ​ | $ | (1.01) | ​ | $ | (1.64) | ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Net loss per share – Diluted: | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Numerator | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Net loss | ​ | $ | (7,262,658) | ​ | $ | (12,638,357) | ​ | $ | (19,019,785) | ​ | $ | (18,725,716) | ​
Less: gain from change in fair value applicable to dilutive liability-classified warrants | ​ | ​ | — | ​ | ​ | — | ​ | ​ | — | ​ | ​ | (2,898,892) | ​
Numerator for diluted net loss per share | ​ | $ | (7,262,658) | ​ | $ | (12,638,357) | ​ | $ | (19,019,785) | ​ | $ | (21,624,608) | ​
Denominator | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Denominator for basic net loss per share | ​ | ​ | 19,685,071 | ​ | ​ | 12,975,808 | ​ | ​ | 18,876,078 | ​ | ​ | 11,394,729 | ​
Plus: incremental shares underlying “in the money” liability-classified warrants outstanding | ​ | ​ | — | ​ | ​ | — | ​ | ​ | — | ​ | ​ | 66,569 | ​
Denominator for diluted net loss per share | ​ | ​ | 19,685,071 | ​ | ​ | 12,975,808 | ​ | ​ | 18,876,078 | ​ | ​ | 11,461,298 | ​
Diluted net loss per common share | ​ | $ | (0.37) | ​ | $ | (0.97) | ​ | $ | (1.01) | ​ | $ | (1.89) | ​

​

Potentially dilutive securities, whose effect would have been antidilutive, were excluded from the computation of diluted earnings per share for each of the three and nine months ended September 30, 2025 and 2024. Total antidilutive securities that were excluded from the computation of diluted weighted-average shares outstanding were as follows:

​

​ | ​ | ​ | ​ | ​
​ | ​ | September 30,
​ |  | 2025 |  | 2024
Stock options | ​ | 2,463,458 | ​ | 1,877,751
ELOC shares remaining | ​ | — | ​ | 817,491
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 and nine months ended September 30, 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 and nine months ended September 30, 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

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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 September 30, 2025, and December 31, 2024, 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.

​

(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 | ​ | Nine Months Ended
​ | ​ | September 30, | ​ | September 30,
​ |  | 2025 |  | 2024 | ​ | 2025 |  | 2024
Program expenses related to clinical-stage product candidates1 | ​ | $ | (4,799,800) | ​ | $ | (1,078,604) | ​ | $ | (11,595,094) | ​ | $ | (8,858,608)
Program expenses related to preclinical and discovery programs | ​ | ​ | (119,507) | ​ | ​ | (200,759) | ​ | ​ | (333,746) | ​ | ​ | (661,572)
Program expenses related to clinical manufacturing candidates | ​ | ​ | (679,713) | ​ | ​ | (862,378) | ​ | ​ | (2,196,348) | ​ | ​ | (3,487,187)
Personnel-related expenses (including stock-based compensation) | ​ | ​ | (1,218,491) | ​ | ​ | (1,125,522) | ​ | ​ | (4,113,009) | ​ | ​ | (4,666,720)
General and administrative professional and consultant fees | ​ | ​ | (468,749) | ​ | ​ | (491,027) | ​ | ​ | (1,206,263) | ​ | ​ | (1,250,575)
Other segment items2 | ​ | ​ | (148,715) | ​ | ​ | (629,321) | ​ | ​ | (544,649) | ​ | ​ | (1,035,394)
Interest income | ​ | ​ | 152,317 | ​ | ​ | 135,430 | ​ | ​ | 531,324 | ​ | ​ | 205,576
Other non-cash income (expense) items3 | ​ | ​ | 20,000 | ​ | ​ | (8,386,176) | ​ | ​ | 438,000 | ​ | ​ | 1,028,764
Net Loss | ​ | $ | (7,262,658) | ​ | $ | (12,638,357) | ​ | $ | (19,019,785) | ​ | $ | (18,725,716)

​

1 For the three months ended September 30, 2025 $4.1 million of this expense relates to our AD 6 month trial and $0.7 million of this expense relates to our PD Open Label Extension study. The remaining $0.1 million reflects clinical costs not specifically associated with either study.

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

3 Other non-cash income (expense) items includes financing costs from our ELOC and change in fair value of our liability classified warrants.

​

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(12) Subsequent Events

Subsequent to September 30, 2025, the Company sold 0.6 million shares of its common stock pursuant to the ATM through October 9, 2025 for net proceeds of $1.5 million.

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). The net proceeds to the Company from the Offering were $5.5 million.

On October 26, 2025, Annovis Bio, Inc. 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 will be issued. The offering price of each Share is $2.05 per share. The net proceeds to the Company from the Offering were $3.1 million.

​

​

​

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

Cautionary Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements, within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” “will,” or “would,” and or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report on Form 10-Q, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain.

The forward-looking statements in this Quarterly Report on Form 10-Q include, among other things, statements about:

| ● | our cash and cash equivalents balance, runway and needs, as well as financing plans;

| ● | our business strategies;

| ● | the timing of regulatory submissions;

| ● | our ability to obtain and maintain regulatory approval of our existing product candidates and any other product candidates we may develop and the labeling under any approval we may obtain;

| ● | risks relating to the timing and costs of clinical trials and the timing and costs of other expenses;

| ● | risks related to market acceptance of products;

| ● | risks associated with our reliance on third-party organizations;

| ● | our competitive position;

| ● | assumptions regarding the size of the available market, product pricing and timing of commercialization of our product candidates;

| ● | our intellectual property position and our ability to maintain and protect our intellectual property rights;

| ● | our results of operations, financial condition, liquidity, prospects and growth strategies;

| ● | the industry in which we operate; and

| ● | the trends that may affect the industry or us.

You should refer to Part I, Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2024 for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Those factors are updated, as applicable, in “Factors that May Affect Future Results” below. As a result of the risks, uncertainties and assumptions described above and elsewhere, we cannot assure you that the forward-looking statements in this Quarterly Report on Form 10-Q will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the

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significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all.

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, or events and circumstances reflected in the forward-looking statements will be achieved or occur. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this report to conform these statements to new information, actual results or changes in our expectations, except as required by law.

The following Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with: (i) the interim financial statements and related notes thereto which are included in this Quarterly Report on Form 10-Q; and (ii) our annual financial statements for the 2024 fiscal year, which are included in our Annual Report on Form 10-K for the year ended December 31, 2024.

Company Overview

We are a late-stage clinical drug platform company addressing neurodegeneration, such as Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”). We are developing our lead product candidate, buntanetap, which is designed to address AD, PD, and potentially other chronic neurodegenerative diseases. Buntanetap is a synthetically produced small molecule, orally administered, brain penetrant compound. In several studies, buntanetap was observed to inhibit the synthesis of neurotoxic proteins — APP/Aβ (“APP”), tau/phospho- tau (“tau”) and α-Synuclein (“αSYN”) — that are some of the main causes of neurodegeneration. High levels of neurotoxic proteins lead to reduced axonal transport, which is responsible for the communication between and within nerve cells. When that communication is compromised, the immune system is activated and attacks the nerve cells, eventually killing them. We have observed in our completed clinical studies in AD and PD patients and pre-clinical studies in mice and rats that buntanetap lowered neurotoxic protein levels leading to improved axonal transport, reduced inflammation, lower nerve cell death and improved affected functions.

​

In 2021, we completed two Phase 1/2 clinical studies: one in 14 early AD patients, and one in 54 early PD patients (together, the “AD/PD Trials”). In the AD/PD Trials, early AD patients were defined as those with a Mini Mental State Examination (“MMSE”) score between 19 and 28 and early PD patients as those patients at Hoehn & Yahr stages 1, 2 or 3. MMSE is a brief screening instrument used to assess cognitive function, with total scores ranging from 0 to 30 and a lower score indicating greater disease severity, while the Hoehn & Yahr scale is a medical assessment used to measure staging of the functional disability associated with PD where a higher stage indicates greater disease severity. In collaboration with the Alzheimer’s Disease Cooperative Study (“ADCS”), we also conducted a trial in 16 early AD patients (the “ADCS Trial”). In the ADCS Trial, early AD patients were defined as those patients with an MMSE score between 19 and 28. At the completion of the ADCS Trial, the data showed that buntanetap acts as a translational inhibitor in humans just like in animals, and we further observed that there was statistical improvement in cognition in early AD patients, just like in the AD/PD Trials.

​

All three clinical trials above were double-blind and placebo-controlled. We designed the studies by applying our understanding of the underlying neurodegenerative disease states and measured both target and pathway validation in the spinal fluid of patients to determine whether patients underlying disease condition improved following treatment. In addition to meeting their primary endpoints of safety and tolerability and secondary endpoint of pharmacokinetics (“PK”) of buntanetap, our AD/PD Trials also met exploratory endpoints of measures of biomarkers and improvements in cognition in AD patients, as well as function in PD patients. We believe that the AD/PD Trial represents the first double-blind, placebo-controlled study that showed improvements in AD patients, as measured by Alzheimer’s Disease Assessment Scale-Cognitive Subscale (“ADAS-Cog”) and in PD patients, as measured by Unified Parkinson’s Disease Rating Scale (“MDS-UPDRS” or “UPDRS”). ADAS-Cog is an assessment scale that measures cognitive functions and non-cognitive functions such as mood and behavior. More specifically, ADAS-Cog 11 is the cognitive assessment scale used to measure areas commonly seen to decline in AD patients. It consists of 11 specific tasks such as word recall, comprehension, object-naming, etc., in order to produce a scale measurement. UPDRS Part II and III are composed of a

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42-item rating scale designed to assess Parkinson’s disease-related disability and impairment and also evaluate the activities of daily living and motor function.

​

Following completion of the AD/PD Trial, we submitted our data to the U.S. Food and Drug Administration (“FDA”) and requested direction to further pursue the development of buntanetap in early PD patients. With the FDA’s guidance, we initiated a Phase 3 study in early PD patients in August 2022 (our “Phase 3 PD Study”). In the Phase 3 PD Study, early PD patients were defined as those at Hoehn & Yahr stages 1, 2 or 3 and OFF times of less than two hours per day. OFF time refers to periods when PD motor and/or non-motor symptoms occur between medication doses. We also submitted a proposed protocol for the treatment of moderate AD to the FDA, and after receiving permission to proceed, we initiated a Phase 2/3 study in mild to moderate AD patients in February 2023 (our “Phase 2/3 AD Study”). In the Phase 2/3 AD Study, mild to moderate AD patients were defined as those with an MMSE score between 14 and 24. Our Phase 3 PD Study and Phase 2/3 AD Study each had built in interim analyses.

​

Our Phase 3 PD Study was completed on December 4, 2023, and we released the topline PD Study efficacy data on July 2, 2024. The study data showed that in two subgroups, buntanetap improved UPDRS 2, 3, 2+3 and total. It also showed that in the entire intent to treat (“ITT”) population, buntanetap stopped the loss of cognition and that in the 12% of patients that already had cognitive issues, buntanetap improved cognition in a dose-dependent, statistically significant way. We asked the FDA for a Type C meeting to discuss the data and the continued development of buntanetap for Lewy Body Dementia. In response, we received a letter from the FDA saying that because Lewy Body Dementia is a challenging disease to treat and because there are no accepted end points, they would like to discuss the two conditions — Dementia with Lewy Bodies and Parkinson’s Disease Dementia — separately and independently. However, the FDA did approve a protocol for an open label study in PD patients, consisting of two cohorts: all patients that previously participated in previous PD studies, as well as patients with deep brain simulation (“DBS”).

​

Our Phase 2/3 AD study was completed on February 13, 2024 and on April 29, 2024, we announced topline efficacy data. The data showed that in early AD patients, buntanetap improved ADAS-Cog11 in a dose-dependent fashion and was statistically significant from placebo and from baseline.

​

On October 10, 2024, we met with the FDA in an end-of-phase 2 meeting to discuss its Phase 2/3 AD data and to agree on a regulatory path forward. Annovis and the FDA have aligned on a development path for buntanetap towards the filing of New Drug Applications (“NDAs”), one for short-term and one for long-term efficacy. During the end-of-phase 2 meeting for AD, the FDA raised no concerns with our data on buntanetap’s safety, including impact on liver enzymes, drug interactions, dose selection, pharmacokinetics and population pharmacokinetics. Further, the FDA confirmed that future development can proceed using the new crystal form of buntanetap.

During February of 2025, we initiated the FDA-cleared pivotal ANVS-25001 trial; a randomized, double-blind, placebo-controlled, multicenter Phase 3 trial in early AD patients. The trial investigates buntanetap and consists of two parts: a 6-month treatment period aimed at confirming buntanetap’s symptomatic efficacy, followed by an additional 12 months of treatment to show potential disease-modifying efficacy at 18 months. After the 6-month treatment period has been completed, patients will continue to be blinded for the additional 12 months. If well-designed and well-executed, the symptomatic portion of the trial may be sufficient to support an NDA filing, potentially within one year of the 6-month treatment period initiation. A similar pathway could be available after 18 months, where a second NDA for disease modification may be supportable with a well-designed and well-executed long-term portion of the trial.

The pivotal Phase 3 AD trial will utilize standard clinical outcome measures for Alzheimer’s disease including ADAS-Cog13 (cognition) and ADCS-iADL (daily living activities). Volumetric MRI imaging and certain plasma biomarkers will also be assessed, including p-tau217 ratios, leveraging recent biomarker assay advances in AD to better diagnose Alzheimer’s patients and disease progression.

We believe that we are the only company developing a drug for AD and PD that is designed to inhibit more than one neurotoxic protein and has a mechanism of action designed to restore nerve cell axonal and synaptic activity. By improving brain function, our goal is to treat memory loss and dementia associated with AD, as well as body and brain function issues associated with PD. Based on pre-clinical and clinical data collected to date, we believe that buntanetap has the potential to be the first drug to interfere with the underlying mechanism of neurodegeneration,

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potentially enabling buntanetap to be the only drug to improve cognition in AD and motor function in PD. The industry has historically encountered challenges in specifically targeting one neurotoxic protein, be it APP, tau or αSYN, indicating that doing so does not change the underlying course of neurodegeneration. Our ultimate goal is to develop a disease modifying drug (“DMD”) for patients with neurodegeneration by leveraging our clinical and pre-clinical data, which shows inhibition of the most relevant neurotoxic proteins. Studies have found that AD and PD are the most common neurodegenerative diseases in the U.S., and accordingly these diseases present two unmet needs of the aging population and two potentially large U.S. markets, if a DMD is developed and approved.

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Funding Requirements

We have never been profitable and have incurred net losses since inception. Our accumulated deficit at September 30, 2025 was $153.9 million. We expect to incur losses for the foreseeable future, and we expect these losses to increase as we continue our development of, and seek regulatory approvals for, our product candidates. Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability.

We do not have sufficient capital on hand to fund our operations for the next 12 months and will need to raise additional capital to meet our obligations as they become due. We believe that our cash and cash equivalents, will be sufficient to fund our operating expenses and capital expenditure requirements until the third quarter of 2026. We will need to raise substantial additional capital to complete the development and commercialization of our product candidates through public or private equity offerings, debt financings, collaboration and licensing arrangements or other financing alternatives. However, there can be no assurance that we will be successful in raising additional capital or that such capital, if available, will be on terms that are acceptable to us. If we are unable to raise sufficient additional capital or defer sufficient operating expenses, we may be compelled to reduce the scope of, or cease, our operations.

In order to fund operations and additional clinical trials, we plan to finance our cash needs through public or private equity offerings, debt financings, collaboration and licensing arrangements or other financing alternatives. We do not currently have committed external sources of funds. Additional equity or debt financing or collaboration and licensing arrangements may not be available on acceptable terms, if at all.

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Results of Operations

Comparison of the Three Months Ended September 30, 2025 and 2024

The following table summarizes the results of our operations for the three months ended September 30, 2025 and 2024:

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​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | Three Months Ended | ​ | ​ | ​
​ | ​ | September 30, | ​ | ​ | ​
​ |  | 2025 |  | 2024 | ​ | Change
​ | ​ | (in thousands) | ​ | ​ | ​
Operating expenses: | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Research and development | ​ | $ | 6,291 |  | $ | 2,690 | ​ | $ | 3,601
General and administrative | ​ | ​ | 1,144 | ​ | ​ | 1,698 | ​ | ​ | (554)
Total operating expense | ​ | ​ | 7,435 | ​ | ​ | 4,388 | ​ | ​ | 3,047
Other income (expense): | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Interest income | ​ | ​ | 152 | ​ | ​ | 135 | ​ | ​ | 17
Other financing costs | ​ | ​ | — | ​ | ​ | (524) | ​ | ​ | 524
Change in fair value of warrants | ​ | ​ | 20 | ​ | ​ | (7,862) | ​ | ​ | 7,882
Total other income (expense), net | ​ | ​ | 172 | ​ | ​ | (8,251) | ​ | ​ | 8,423
Net loss | ​ | $ | (7,263) | ​ | $ | (12,639) | ​ | $ | 5,376

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Research and Development Expenses

Research and development expenses for the three months ended September 30, 2025 were $6.3 million, compared to $2.7 million for the three months ended September 30, 2024. The $3.6 million increase was primarily attributable to $3.5 million of additional costs associated with our AD 6 month trial patients. Of the $6.3 million for the three months ended September 30, 2025 $4.1 million of this expense relates to our AD 6 month trial and $0.7 million of this expense relates to our PD Open Label Extension study. The remaining $1.5 million reflects clinical costs not specifically associated with either study.

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General and Administrative Expenses

General and administrative expenses for the three months ended September 30, 2025 were $1.1 million, compared to $1.7 million for the three months ended September 30, 2024. The $0.6 million decrease was primarily attributable to $0.4 million of increased stock listing & transfer fees, driven by the Canaccord Warrants, which occurred in Q3 2024, discussed in footnote 3(a).

Interest Income

Interest income was $0.2 million for the three months ended September 30, 2025, compared to $0.1 million for the three months ended September 30, 2024. The $0.1 million increase was driven by increased cash and cash equivalent balances, as a result of our public offering with ThinkEquity, which closed in February 2025.

Other Financing Costs

There were no other financing costs incurred for the three months ended September 30, 2025, compared to $0.5 million incurred for the three months ended September 30, 2024. The $0.5 million decrease was attributable to the 2024 ELOC financing facility being exhausted prior to the quarter ending September 30, 2025, whereas during the same period during 2024, the facility was active.

Change in Fair Value of Warrants

Change in fair value of warrants was a loss of $0.0 million for the three months ended September 30, 2025, compared to a gain of $7.9 million for the three months ended September 30, 2024. The $7.9 million difference between periods was primarily driven by increased volatility in our stock price during the third quarter of 2024, as compared to the same period during 2025.

Comparison of the Nine Months Ended September 30, 2025 and 2024

The following table summarizes the results of our operations for the nine months ended September 30, 2025 and 2024:

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​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | Nine Months Ended | ​ | ​ | ​
​ | ​ | September 30, | ​ | ​ | ​
​ |  | 2025 |  | 2024 | ​ | Change
​ | ​ | (in thousands) | ​ | ​ | ​
Operating expenses: | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Research and development | ​ | $ | 16,465 |  | $ | 14,997 | ​ | $ | 1,468
General and administrative | ​ | ​ | 3,524 | ​ | ​ | 4,963 | ​ | ​ | (1,439)
Total operating expense | ​ | ​ | 19,989 | ​ | ​ | 19,960 | ​ | ​ | 29
Other income (expense): | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Interest income | ​ | ​ | 531 | ​ | ​ | 206 | ​ | ​ | 325
Other financing costs | ​ | ​ | — | ​ | ​ | (1,870) | ​ | ​ | 1,870
Change in fair value of warrants | ​ | ​ | 438 | ​ | ​ | 2,899 | ​ | ​ | (2,461)
Total other income, net | ​ | ​ | 969 | ​ | ​ | 1,235 | ​ | ​ | (266)
Net loss | ​ | $ | (19,020) | ​ | $ | (18,725) | ​ | $ | (295)

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Research and Development Expenses

Research and development expenses for the nine months ended September 30, 2025 were $16.5 million, compared to $15.0 million for the nine months ended September 30, 2024. The $1.5 million increase was primarily attributable to a $1.9 million increase in costs associated with our AD 6 month trial patients and a $1.4 million increase in bioanalytical work. These increases are partially offset by a $1.3 million decrease in clinical material manufacturing costs, which resulted from a large supply of product being released for use in the Phase 3 studies during 2024.

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General and Administrative Expenses

General and administrative expenses for the nine months ended September 30, 2025 were $3.5 million, compared to $5.0 million for the nine months ended September 30, 2024. The $1.5 million decrease was due to a $0.7 million decrease in stock-based compensation expense as well as $0.5 million in reduced stock listing and transfer fees.

Interest Income

Interest income was $0.5 million for the nine months ended September 30, 2025, compared to $0.2 million for the nine months ended September 30, 2024. The $0.3 million increase was driven by increased cash and cash equivalent balances, as a result of our public offering with ThinkEquity, which closed in February 2025.

Other Financing Costs

There were no other financing costs incurred for the nine months ended September 30, 2025, compared to $1.9 million incurred for the nine months ended September 30, 2024. The $1.9 million decrease was attributable to the 2024 ELOC financing facility being exhausted prior to the nine month ended September 30, 2025, whereas during the same period during 2024 the facility was active.

Change in Fair Value of Warrants

Change in fair value of warrants was a gain of $0.4 million for the nine months ended September 30, 2025, compared to a gain of $2.9 million for the nine months ended September 30, 2024. The $2.5 million difference between periods was primarily driven by increased volatility in our stock price during the first half of 2024, as compared to the same period during 2025.

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 September 30, 2025, our principal source of liquidity was our cash and cash equivalents, which totaled $15.3 million. We do not believe that our cash on hand will be sufficient to fund our operations for at least twelve months beyond the date of this filing.

February 2025 ThinkEquity Underwritten Offering

On February 3, 2025, the Company entered into an Underwriting Agreement with ThinkEquity LLC (“ThinkEquity”), with respect to an underwritten public offering of 5.3 million units of the Company, each unit consisting of one share of its common stock, par value $0.0001 per share and one warrant to purchase one share of the Company Stock (the “ThinkEquity Warrants”). The units were priced at $4.00 per unit and the offering resulted in gross proceeds of $21.0 million, before deducting underwriting discounts, fees and other related expenses. Net proceeds from the transaction totaled $19.3 million. The ThinkEquity Warrants have an exercise price of $5.00 per share, are immediately exercisable and expire five years from their date of issuance. The shares of Common Stock and Warrants were issued separately. None of the ThinkEquity Warrants were exercised during the three or nine month ended September 30, 2025.

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December 2024 ATM

On December 11, 2024, the Company entered into an Equity Distribution Agreement (“Distribution Agreement”) with Oppenheimer & Co. Inc., (“OpCo”) relating to the sale of shares of the Company’s common stock. In accordance with the terms of the Distribution Agreement, The Company may offer and sell shares of its common stock having an aggregate offering price of up to $50.0 million from time to time through or to OpCo, acting as agent or principal.

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During the three and nine months ended September 30, 2025, the Company sold 0.7 million and 0.8 million shares of common stock, respectively, pursuant to the Distribution Agreement for gross proceeds of $1.7 million and $2.2 million, before commissions.

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Cash Flows

The following table provides a summary of our cash flows for the nine months ended September 30, 2025 and 2024:

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​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | Nine Months Ended
​ | ​ | September 30,
​ |  | 2025 |  | 2024
​ | ​ | (in thousands)
Total net cash provided by (used in): |  | ​ |  |  | ​ |
Operating activities | ​ | $ | (16,693) | ​ | $ | (13,609)
Financing activities | ​ |  | 21,427 | ​ |  | 20,491
Net increase in cash and cash equivalents | ​ | $ | 4,734 | ​ | $ | 6,882

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Operating Activities

Cash used in operating activities was $16.7 million for the nine months ended September 30, 2025, compared to $13.6 million for the nine months ended September 30, 2024. The $3.1 million increase in cash used in operations was primarily the result of additional cash paid for clinical trials and related expenses, given the planned timing of study costs and related disbursements.

Contingent upon continued achievement of our fundraising requirements, we expect cash used in operating activities to remain at elevated levels as 2025 progresses, due to expected operating expenditures associated with continued development of our product candidates. More specifically, we expect elevated operating cash burn as a result of costs associated with completing our active Phase 3 trial for AD.

Financing Activitie s

Cash provided by financing activities for the nine months ended September 30, 2025 was $21.4 million and primarily consisted of the $19.3 million of proceeds from our registered offering with ThinkEquity, as well as $2.2 million of proceeds from our ATM facility with OpCo. Cash provided by financing activities for the nine months ended September 30, 2024, was $20.5 million and consisted of $8.0 million from warrant exercises, a combined $3.9 million received from our March registered direct offerings and $8.6 million of proceeds from share issuances under our ELOC Purchase Agreement.

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Contractual Obligations and Other Commitments

This item is not required for smaller reporting companies.

Factors that May Affect Future Results

You should refer to Part I, Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2024 for a discussion of important factors that may affect our future results.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements, as defined by applicable SEC regulations.

Critical Accounting Policies and Significant Judgments and Estimates

The preparation of financial statements in conformity with GAAP requires us to use judgment in making certain estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses in our financial statements and accompanying notes. Critical accounting policies are those that are most important to the portrayal of our financial condition and results of operations and require difficult, subjective and complex judgments by Management in order to make estimates about the effect of matters that are inherently uncertain. During the three-month period ended September 30, 2025, there were no significant changes to our critical accounting policies from those described in our annual financial statements for the 2024 fiscal year, which we included in our Annual Report on Form 10-K for the year ended December 31, 2024.

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Item 3. Quantitative and Qualitative Disclosure About Market Risk

This item is not required for smaller reporting companies.

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Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Our Management, with the participation of our principal executive officer and principal financial officer, have evaluated the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of September 30, 2025. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and Management necessarily applies its judgment in evaluating the cost benefit relationship of possible controls and procedures. Based on such evaluation, our principal executive officer and principal financial officer have concluded that as of September 30, 2025, our disclosure controls and procedures were effective to ensure that the information required to be disclosed in our reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and that information required to be disclosed in the reports that we file or submit under the Exchange Act is accumulated and communicated to our Management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure.

Changes in Internal Control Over Financial Reporting

There was no change in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(f) and 15d-15(f) of the Exchange Act that occurred during the period covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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PART II

OTHER INFORMATION

Item 1. Legal Proceedings

From time to time, we may become subject to litigation and claims arising in the ordinary course of business. We are not currently a party to any legal proceedings that we believe could have a material adverse effect on our business, operating results or financial condition and are not aware of any pending or threatened legal proceedings against us.

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Item 1A. Risk Factors

Risk factors that may affect our business and financial results are discussed within Item 1A “Risk Factors” of our annual report on Form 10-K filed with the SEC on March 21, 2025 (“2024 Form 10-K”). There have been no material changes to the disclosures relating to this item from those set forth in our 2024 Form 10-K.

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

None.

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Item 3. Defaults upon Senior Securities

None.

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Item 4. Mine Safety Disclosures

Not applicable.

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Item 5. Other Information

During the three months ended September 30, 2025, none of our directors or "officers," as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934, adopted or terminated a Rule 10b5-1 trading plan or arrangement or a non-Rule 10b5-1 trading plan or arrangement, as defined in Item 408(c) of Regulation S-K.

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Item 6. Exhibits

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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.)
​ | ​ | ​
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.
31.2* | ​ | Certification of Principal Financial 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.

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| ​ |
101.INS* | ​ | XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
​ | ​ | ​
101.SCH* | ​ | Inline XBRL Taxonomy Extension Schema Document
​ | ​ | ​
101.CAL* | ​ | Inline XBRL Taxonomy Extension Calculation Linkbase Document
​ | ​ | ​
101.DEF* | ​ | Inline XBRL Taxonomy Extension Definition Linkbase Document
​ | ​ | ​
101.LAB* | ​ | Inline XBRL Taxonomy Extension Labels Linkbase Document
​ | ​ | ​
101.PRE* | ​ | Inline XBRL Taxonomy Extension Presentation Linkbase Document
​ | ​ | ​
104* | ​ | Cover Page Interactive Data File – the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

*Filed herewith

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SIGNATURES

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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

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Annovis Bio, Inc.

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Signature |  | Title |  | Date
/s/ Maria Maccecchini | ​ | President and Chief Executive Officer (Principal | ​ | November 12, 2025
Maria Maccecchini | ​ | Executive Officer) | ​ | ​
​ | ​ | ​ | ​ | ​
/s/ Mark Guerin |  | Chief Financial Officer (Principal Financial |  | November 12, 2025
Mark Guerin | ​ | Officer) | ​ | ​

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