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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): August 12, 2025
ANNOVIS BIO, INC.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 001-39202 | 26-2540421 |
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
101
Lindenwood Drive, Suite 225
Malvern, PA
19355
(Address of Principal Executive Offices, and Zip Code)
(484) 875-3192
Registrant’s Telephone Number, Including Area Code
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Stock, par value $0.0001 per share | ANVS | New York Stock Exchange |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company x
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. x On August 12, 2025, Annovis Bio, Inc. issued a press release announcing its financial results for the second quarter ended June 30, 2025 and providing a corporate update. A copy of the press release is furnished herewith as Exhibit 99.1.
Item 2.02 Results of Operations and Financial Condition.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. |
Description | |
| 99.1 | Press Release Dated August 12, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ANNOVIS BIO, INC. | ||
| Date: August 12, 2025 | By: | /s/ Maria Maccecchini |
| Name: Maria Maccecchini | ||
| Title: President and Chief Executive Officer | ||
Exhibit 99.1
Annovis Provides Corporate Updates and Reports Second Quarter 2025 Financial Results
Malvern, Pa., August 12, 2025 – Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today provided corporate updates and second quarter 2025 financial results.
“In the past quarter, our efforts were centered on driving enrollment for the pivotal Phase 3 trial in early AD, which now includes 76 secured clinical sites across the U.S. and over 400 patients screened to date,” said Maria Maccecchini, Ph.D., President and CEO of Annovis. “At the same time, we reached other notable milestones, including presenting our latest scientific findings at AAIC 2025 with the largest attendance ever from Annovis team and strengthening our global intellectual property protection by completing the transfer of all patent families to crystal buntanetap. As we move forward, our focus stays firmly on completing enrollment as planned to produce strong and trustworthy results, while also advancing our Parkinson’s program, with more updates coming as we progress.”
Clinical highlights
| · | Annovis’ pivotal Phase 3 study in early AD (NCT06709014) is advancing rapidly, with 76 U.S. sites secured and 46 currently enrolling patients. The remaining sites are expected to begin enrollment shortly. | |
| · | The pivotal Phase 3 trial has attracted strong participation, with 38 patients already receiving buntanetap or placebo and nearly 200 more in screening – a number that continues to grow each day – with screen failure rate being as expected at 50%. |
Business highlights
| · | In April, Annovis welcomed Hui Liu as Director of Biostatistics, who is responsible for maintaining statistical integrity of the data generated by the Company’s clinical trials. | |
| · | In June, Annovis hosted a webcast to provide updates on its Phase 3 trial, engaging directly with the audience through a live Q&A session. The recording is available in the Video Library on the Company’s website. | |
| · | In July, senior members of Annovis attended AAIC 2025 in Toronto, presenting four scientific posters highlighting advancements in the Alzheimer’s Phase 3 study and the pharmacokinetic profile of its lead drug candidate, buntanetap. All posters are available in the Media Library on the Company’s website. |
| · | In August, Annovis announced the successful transfer of all patent families to crystal buntanetap, achieving comprehensive global IP coverage for both the original and new forms of the Company’s drug candidate. |
Financial results
| · | Annovis’ cash and cash equivalents totaled $17.1 million as of June 30, 2025, compared to $10.6 million as of December 31, 2024. The Company had 19.5 million shares of common stock outstanding as of June 30, 2025. | |
| · | Research and development expenses for the three months ending June 30, 2025, were $5.2 million compared to $5.8 million for the three months ending June 30, 2024. | |
| · | General and administrative expenses for the three months ending June 30, 2025, were $1.1 million compared to $2.0 million for the three months ending June 30, 2024. | |
| · | Annovis reported a $0.32 basic and diluted net loss per common share for the three months ending June 30, 2025, compared to a $0.44 basic and diluted net loss per common share for the three months ending June 30, 2024. |
About Annovis
Headquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as AD and PD. The Company is committed to developing innovative therapies that improve patient outcomes and quality of life. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X.
Investor Alerts
Interested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for email alerts at https://www.annovisbio.com/email-alerts.
Forward-Looking Statements
This press release contains forward-looking statements under the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended. Actual results may differ due to various risks and uncertainties, including those outlined in the Company’s SEC filings under “Risk Factors” in its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update forward-looking statements except as required by law.
Contact Information:
Annovis Bio Inc.
101 Lindenwood Drive
Suite 225
Malvern, PA 19355
www.annovisbio.com
Investor Contact:
Alexander Morin, Ph.D.
Director, Strategic Communications
Annovis Bio
ir@annovisbio.com
(Tables to follow)
ANNOVIS BIO, INC.
Balance Sheets
(Unaudited)
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 17,130,286 | $ | 10,551,916 | ||||
| Prepaid expenses and other current assets | 4,324,285 | 3,373,717 | ||||||
| Total assets | $ | 21,454,571 | $ | 13,925,633 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 974,311 | $ | 2,305,974 | ||||
| Accrued expenses | 1,830,813 | 1,575,013 | ||||||
| Total current liabilities | 2,805,124 | 3,880,987 | ||||||
| Non-current liabilities: | ||||||||
| Warrant liability | 319,000 | 737,000 | ||||||
| Total liabilities | 3,124,124 | 4,617,987 | ||||||
| Commitments and contingencies | ||||||||
| 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, 19,486,231 and 14,141,521 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively | 1,948 | 1,414 | ||||||
| Additional paid-in capital | 164,935,088 | 144,155,694 | ||||||
| Accumulated deficit | (146,606,589 | ) | (134,849,462 | ) | ||||
| Total stockholders’ equity | 18,330,447 | 9,307,646 | ||||||
| Total liabilities and stockholders’ equity | $ | 21,454,571 | $ | 13,925,633 | ||||
ANNOVIS BIO, INC.
Statements of Operations
(Unaudited)
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 5,161,921 | $ | 5,785,217 | $ | 10,173,438 | $ | 12,307,308 | ||||||||
| General and administrative | 1,109,532 | 1,977,421 | 2,380,696 | 3,265,137 | ||||||||||||
| Total operating expenses | 6,271,453 | 7,762,638 | 12,554,134 | 15,572,445 | ||||||||||||
| Operating loss | (6,271,453 | ) | (7,762,638 | ) | (12,554,134 | ) | (15,572,445 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 191,395 | 25,978 | 379,007 | 70,146 | ||||||||||||
| Other financing costs | — | (1,346,060 | ) | — | (1,346,060 | ) | ||||||||||
| Change in fair value of warrants | (140,000 | ) | 4,062,308 | 418,000 | 10,761,000 | |||||||||||
| Total other income, net | 51,395 | 2,742,226 | 797,007 | 9,485,086 | ||||||||||||
| Net loss | $ | (6,220,058 | ) | $ | (5,020,412 | ) | $ | (11,757,127 | ) | $ | (6,087,359 | ) | ||||
| Net loss per share | ||||||||||||||||
| Basic | $ | (0.32 | ) | $ | (0.44 | ) | $ | (0.64 | ) | $ | (0.56 | ) | ||||
| Diluted | $ | (0.32 | ) | $ | (0.44 | ) | $ | (0.64 | ) | $ | (1.52 | ) | ||||
| Weighted-average number of common shares used in computing net loss per share | ||||||||||||||||
| Basic | 19,486,231 | 11,307,759 | 18,464,877 | 10,966,412 | ||||||||||||
| Diluted | 19,486,231 | 11,307,759 | 18,464,877 | 11,066,265 | ||||||||||||