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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): May 9, 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 May 13, 2025, Annovis Bio, Inc. issued a press release announcing its financial results for the first quarter ended March 31, 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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Appointment of Principal Financial Officer
On May 9, 2025, the Board of Directors appointed Andrew Walsh, the Company’s current Vice President of Finance, as the Company’s Principal Financial Officer. Mr. Walsh, age 36, has served as the Company's Vice President of Finance since December 2023. He holds a Bachelor's degree in Accounting from Drexel University, summa cum laude.
Mr. Walsh is entitled to an annual base salary of $264,000 and is eligible for an annual incentive cash bonus with a target payout of 25% of his annual base salary.
There is no arrangement or understanding between Mr. Walsh and any other person pursuant to which Mr. Walsh has been appointed as Principal Financial Officer, and there is no family relationship between Mr. Walsh and any of the Company’s directors or executive officers. Mr. Walsh has no interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. |
Description | |
| 99.1 | Press Release Dated May 13, 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: May 13, 2025 | By: |
/s/ Maria Maccecchini |
| Name: Maria Maccecchini | ||
| Title: President and Chief Executive Officer | ||
Exhibit 99.1
Annovis Provides Corporate Updates and Reports First Quarter 2025 Financial Results
Malvern, Pa., May 13, 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 first quarter 2025 financial results.
The first quarter was largely dedicated to the initiation of a pivotal Phase 3 clinical trial in early AD, with the first participants entering the study on February 5, 2025. The trial is currently in the process of activating clinical sites across the U.S. and enrolling patients with the goal of treating an estimated 760 participants with either buntanetap or placebo. This dual 6/18-month pivotal Phase 3 study will evaluate the symptomatic benefits of buntanetap during the first 6 months and its potential disease-modifying effects over the subsequent 12 months. In addition, the first quarter was marked by active conference participation from Annovis senior management.
“We are advancing as planned with our pivotal Phase 3 Alzheimer’s study, making steady progress every day,” said Melissa Gaines, SVP, Clinical Operations. “Our team is grateful to all collaborators for helping make this process efficient and to our community for their ongoing support. We look forward to providing continued updates on the current trial and other initiatives we have planned for this year.”
“In these times of great uncertainty, we are choosing resilience and discipline, putting one foot in front of the other as we stay focused on advancing the Phase 3 AD study,” added Maria Maccecchini, Ph.D., Founder and CEO of Annovis. “Our mission remains clear: to deliver a potentially life-changing treatment to patients as soon as possible.”
Business highlights
| · | In January, Annovis was granted a U.S. patent covering methods for the treatment and prevention of acute brain and nerve injuries using buntanetap. |
| · | In February, Annovis participated in Oppenheimer’s 35th Annual Healthcare Life Sciences Conference, which brought together leading innovators and investors in the healthcare sector. |
| · | In February and March, Annovis’ management team participated in several key scientific conferences focused on neurodegenerative diseases. At AD/PDTM 2025 in Vienna, Annovis gave two presentations, showcasing findings from its Phase 3 PD trial and data on buntanetap in ApoE4 carriers from its Phase 2/3 AD study. The Company also participated in a forum on the development of alpha-synuclein treatments. Additionally, at Alzheimer’s Partnering Summit and at the 13th Annual Alzheimer’s & Parkinson’s Drug Development Summit, Dr. Maccecchini presented and contributed to discussions on clinical advancements in AD and PD and on approaches to targeting alpha-synuclein. |
Financial results
| · | Annovis’ cash and cash equivalents totaled $22.2 million as of March 31, 2025, compared to $10.6 million as of March 31, 2024. The Company had 19.5 million shares of common stock outstanding as of March 31, 2025. |
| · | Research and development expenses for the three months ended March 31, 2025, were $5.0 million compared to $6.5 million for the three months ended March 31, 2024. |
| · | General and administrative expenses for the three months ended March 31, 2025, were $1.3 million compared to $1.3 million for the three months ended March 31, 2024. |
| · | Annovis reported a $0.32 basic and $0.32 diluted net loss per common share for the three months ended March 31, 2025, compared to a $0.10 basic and $0.72 diluted net loss per common share for the three months ended March 31, 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)
| March 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 22,236,175 | $ | 10,551,916 | ||||
| Prepaid expenses and other current assets | 4,501,078 | 3,373,717 | ||||||
| Total assets | $ | 26,737,253 | $ | 13,925,633 | ||||
| Liabilities and stockholders’ equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,370,189 | $ | 2,305,974 | ||||
| Accrued expenses | 1,134,177 | 1,575,013 | ||||||
| Total current liabilities | 2,504,366 | 3,880,987 | ||||||
| Non-current liabilities: | ||||||||
| Warrant liability | 179,000 | 737,000 | ||||||
| Total liabilities | 2,683,366 | 4,617,987 | ||||||
| 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, 19,486,231 and 14,141,521 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively | 1,948 | 1,414 | ||||||
| Additional paid-in capital | 164,438,470 | 144,155,694 | ||||||
| Accumulated deficit | (140,386,531 | ) | (134,849,462 | ) | ||||
| Total stockholders’ equity | 24,053,887 | 9,307,646 | ||||||
| Total liabilities and stockholders’ equity | $ | 26,737,253 | $ | 13,925,633 | ||||
ANNOVIS BIO, INC.
Statements of Operations
(Unaudited)
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 5,011,517 | $ | 6,514,920 | ||||
| General and administrative | 1,271,164 | 1,294,887 | ||||||
| Total operating expenses | 6,282,681 | 7,809,807 | ||||||
| Operating loss | (6,282,681 | ) | (7,809,807 | ) | ||||
| Other income: | ||||||||
| Interest income | 187,612 | 44,168 | ||||||
| Change in fair value of warrants (Note 7) | 558,000 | 6,698,692 | ||||||
| Total other income, net | 745,612 | 6,742,860 | ||||||
| Net loss | $ | (5,537,069 | ) | $ | (1,066,947 | ) | ||
| Net loss per share (Note 9) | ||||||||
| Basic | $ | (0.32 | ) | $ | (0.10 | ) | ||
| Diluted | $ | (0.32 | ) | $ | (0.72 | ) | ||
| Weighted-average number of common shares used in computing net loss per share | ||||||||
| Basic | 17,431,234 | 10,625,065 | ||||||
| Diluted | 17,431,234 | 10,824,771 | ||||||