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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): March 21, 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 March 21, 2025, Annovis Bio, Inc. issued a press release announcing its financial results for the fourth quarter and the fiscal year ended December 31, 2024 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 March 21, 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: March 21, 2025 | By: |
/s/ Maria Maccecchini |
| Name: Maria Maccecchini | ||
| Title: President and Chief Executive Officer | ||
Exhibit 99.1
Annovis Provides Corporate Updates and Reports Fourth Quarter and Fiscal Year 2024 Financial Results
Malvern, Pa., Mar. 21, 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 fourth quarter/full year 2024 financial results.
In 2024, Annovis made significant progress by advancing the buntanetap program, successfully completing two clinical trials—Phase 2/3 AD and Phase 3 PD. Both studies yielded promising results, reinforcing buntanetap’s ability to improve cognition in AD and PD patients, as well as motor function in PD patients. Building on this success, the FDA cleared Annovis to proceed with a pivotal Phase 3 trial in early AD, which was launched at the start of 2025. The Company also participated in multiple scientific and investor conferences, announced new publications in peer-reviewed journals, expanded its patent portfolio, and added accomplished professionals to its growing team.
“The last year was filled with extraordinary achievements for our company, and we are pleased with our continued momentum into 2025,” said Maria Maccecchini, Ph.D., Founder and CEO of Annovis. “We are deeply grateful to everyone who has supported and believed in our mission. As we move ahead, our focus remains on generating robust data for buntanetap and advancing its path to the patients who need it most.”
Clinical progress
| · | In October 2024, the FDA granted clearance to proceed with a pivotal Phase 3 study for early AD, based on Phase 2/3 clinical data demonstrating symptomatic improvement in the subgroup of early AD patients. |
| · | In February 2025, Annovis launched the pivotal Phase 3 AD study, which includes a 6-month data readout focused on buntanetap’s symptomatic effects followed by an additional 12-month assessment to evaluate its potential disease-modifying response. The symptomatic data is anticipated in mid-2026, followed by the disease-modifying data in mid-2027, with both expected to support their respective New Drug Applications (NDAs). |
Business highlights
| · | In October 2024, Annovis appointed Matthew Peterson, Ph.D., as Senior Clinical Scientist. In this role, Dr. Peterson ensures the medical, ethical, and scientific integrity of Annovis’ clinical trials, overseeing their initiation, execution, reporting, and successful completion. |
| · | In October and November 2024, Annovis’ leadership participated in key scientific conferences in the neurodegenerative disease space. At the 7th Clinical Trials on Alzheimer’s Disease (CTAD) conference, Annovis presented two posters highlighting findings from its Phase 2/3 AD trial and related biomarker data. Additionally, Annovis was invited to speak at the NIA/NINDS Workshop on Dementia with Lewy Bodies (DLB), where it presented buntanetap’s distinctive mechanism of action and its potential as a treatment for DLB. |
| · | In December 2024, Annovis hosted a year-end webcast, where management addressed key questions from shareholders and provided updates on the Company’s clinical progress and upcoming milestones. |
Financial results
| · | Fourth quarter – Research and development expenses for the three months ended December 31, 2024, were $5.0 million compared to $8.9 million for the three months ended December 31, 2023. General and administrative expenses for the three months ended December 31, 2024, were $1.7 million compared to $1.5 million for the three months ended December 31, 2023. Annovis reported a $0.43 basic and diluted net loss per common share for the three months ended December 31, 2024, compared to a $2.24 basic and diluted net loss per common share for the three months ended December 31, 2023. |
| · | Full year – Research and development expenses for the year ended December 31, 2024, were $20.0 million compared to $38.8 million for the year ended December 31, 2023. General and administrative expenses for the year ended December 31, 2024, were $6.7 million compared to $6.2 million for the year ended December 31, 2023. Annovis reported a $2.02 basic and $2.31 diluted net loss per common share for the year ended December 31, 2024, compared to a $6.23 basic and diluted net loss per common share for the year ended December 31, 2023. |
| · | Annovis’ cash and cash equivalents totaled $10.6 million as of December 31, 2024, compared to $5.8 million as of December 31, 2023. The Company estimates that its current cash and cash equivalents, which also include proceeds from its recent $21.0 million stock offering with ThinkEquity, will enable it to fund its operations into the fourth quarter of 2025. The Company had 14.1 million shares of common stock outstanding as of December 31, 2024 and 19.5 million shares of common stock outstanding after the offering with ThinkEquity. |
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)
| As of December 31, | ||||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 10,551,916 | $ | 5,754,720 | ||||
| Prepaid expenses and other current assets | 3,373,717 | 4,453,544 | ||||||
| Total assets | $ | 13,925,633 | $ | 10,208,264 | ||||
| Liabilities and stockholders’ equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,305,974 | $ | 1,292,837 | ||||
| Accrued expenses | 1,575,013 | 2,986,273 | ||||||
| Total current liabilities | 3,880,987 | 4,279,110 | ||||||
| Non-current liabilities: | ||||||||
| Warrant liability | 737,000 | 13,680,000 | ||||||
| Total liabilities | 4,617,987 | 17,959,110 | ||||||
| Commitments and contingencies (Note 6) | ||||||||
| Stockholders’ equity (deficit) : | ||||||||
| 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 and 14,141,521 and 10,519,933 shares issued and outstanding at December 31, 2024 and December 31, 2023, respectively | 1,414 | 1,052 | ||||||
| Additional paid-in capital | 144,155,694 | 102,507,189 | ||||||
| Accumulated deficit | (134,849,462 | ) | (110,259,087 | ) | ||||
| Total stockholders’ equity (deficit) | 9,307,646 | (7,750,846 | ) | |||||
| Total liabilities and stockholders’ equity (deficit) | $ | 13,925,633 | $ | 10,208,264 | ||||
ANNOVIS BIO, INC.
Statements of Operations
(Unaudited)
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 4,998,578 | $ | 8,904,730 | $ | 19,995,447 | $ | 38,790,603 | ||||||||
| General and administrative | 1,736,293 | 1,537,094 | 6,699,481 | 6,244,408 | ||||||||||||
| Total operating expenses | 6,734,871 | 10,441,824 | 26,694,928 | 45,035,011 | ||||||||||||
| Operating loss | (6,734,871 | ) | (10,441,824 | ) | (26,694,928 | ) | (45,035,011 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 126,273 | 66,130 | 331,849 | 667,898 | ||||||||||||
| Other financing costs | 16,939 | — | (1,853,189 | ) | — | |||||||||||
| Change in fair value of warrants | 727,000 | (11,837,200 | ) | 3,625,893 | (11,837,200 | ) | ||||||||||
| Total other income (expense), net | 870,212 | (11,771,070 | ) | 2,104,553 | (11,169,302 | ) | ||||||||||
| Net loss | $ | (5,864,659 | ) | $ | (22,212,894 | ) | $ | (24,590,375 | ) | $ | (56,204,313 | ) | ||||
| Net loss per share | ||||||||||||||||
| Basic | $ | (0.43 | ) | $ | (2.24 | ) | $ | (2.02 | ) | $ | (6.23 | ) | ||||
| Diluted | $ | (0.43 | ) | $ | (2.24 | ) | $ | (2.31 | ) | $ | (6.23 | ) | ||||
| Weighted-average number of common shares used in computing net loss per share | ||||||||||||||||
| Basic | 13,794,519 | 9,903,564 | 12,182,475 | 9,023,138 | ||||||||||||
| Diluted | 13,794,519 | 9,903,564 | 12,235,444 | 9,023,138 | ||||||||||||