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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): July 7,
2026
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.
On July 7, 2026, Annovis Bio, Inc.
(the “Company”) issued a press release announcing that full enrollment of its pivotal Phase 3 trial (NCT06709014) evaluating
buntanetap in patients with early AD has been reached. The trial enrolled 850 patients with pTau217-confirmed AD pathology across 83
clinical sites in the US. A copy of the press release is filed as Exhibit 99.1 hereto and is incorporated herein by reference.
| Item 9.01 |
Financial Statements and Exhibits |
| Exhibit Number |
Description |
| |
|
| 99.1 |
Press Release Dated July 7, 2026 |
| 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: July 9, 2026 |
|
| |
By: |
/s/
Maria Maccecchini |
| |
Name: Maria Maccecchini |
| |
Title: President and Chief Executive Officer |
Exhibit 99.1
Annovis Reaches Full Enrollment
in Pivotal Phase 3 Trial of Buntanetap for Early Alzheimer’s Disease
Pivotal Phase 3 trial enrolls 850 patients, exceeding
original projections
Study completion on track: symptomatic data readout
- Q1 2027, disease-modifying data readout - Q1 2028
Company positions for two NDA submissions following
each readout
Malvern, PA, July 7, 2026
-- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a Phase 3 clinical-stage biotechnology company
developing the investigational oral therapy, buntanetap, for neurodegenerative diseases such as Alzheimer’s disease (AD) and Parkinson’s
disease (PD), today announced full enrollment of its pivotal Phase 3 trial (NCT06709014) evaluating buntanetap in patients with early
AD. The trial enrolled 850 patients with pTau217-confirmed AD pathology across 83 clinical sites in the US.
“Reaching this level of enrollment, well above our
original goal, reflects the trust patients and families living with this disease have placed in our work, and that is not something we
take for granted,” said Maria Maccecchini, Ph.D., Founder, President and CEO of Annovis. “I am deeply grateful to the entire
Annovis team for their professionalism and passion in conducting this study according to the highest standards.”
The pivotal Phase 3 AD study is a randomized, placebo-controlled,
double-blind dual clinical trial designed with two pre-specified readouts: a 6-month analysis of symptomatic effects and an 18-month analysis
of disease-modifying effects of daily oral buntanetap (30mg). The trial has recruited patients diagnosed with early AD (MMSE 20-28) who
are positive for blood biomarker pTau217, which indicates Alzheimer's pathology in the brain. The primary endpoints will assess changes
in cognition (ADAS-Cog13) and function (ADCS-iADL). This dual design will produce two distinct data readouts, each intended to support
a separate regulatory submission for a New Drug Application (NDA).
Next Milestones
With the last patient expected to complete the 6-month
treatment period in January 2027, followed by data cleaning and analysis, Annovis anticipates the following near-term milestones:
| | · | Q1 2027: 6-month symptomatic top-line data readout |
| | · | Q1 2028: 18-month disease-modifying top-line data readout |
| | · | Regulatory submissions: The Company has already begun preparations for NDA submissions to the U.S. Food
and Drug Administration (FDA), building on guidance received during prior FDA interactions, to position Annovis for submission shortly
after each respective readout |
“That level of enthusiasm from the patient community
underscores how urgently a new treatment for Alzheimer's is needed, and how eager people affected by the disease are to help advance it
toward the finish line,” said Cheng Fang, Ph.D., CSO at Annovis. “High enrollment also strengthens the statistical power of
our dataset. Combined with the FDA-aligned protocol, we are executing this trial according to regulatory requirements as we approach this
important moment for our company and the Alzheimer's community.”
“This time last year, our trial had 50
patients enrolled; today, the number stands at 850. We want to thank every patient, caregiver, and investigator who made this
progress possible,” said Sarah MacCallum, VP, Clinical Operations at Annovis. “Seamless execution across so many
clinical sites and consistent follow-up with every patient throughout this rigorous enrollment process – all required great
effort from every party involved, and we are thankful to everyone who helped us reach this milestone.”
About Annovis
Headquartered in Malvern, Pennsylvania, Annovis Bio, Inc.
(NYSE: ANVS) is a Phase 3 clinical-stage biotechnology company developing treatments for neurodegenerative diseases such as Alzheimer's
disease (AD) and Parkinson's disease (PD). The Company's lead drug candidate, buntanetap (formerly posiphen), is an investigational once-daily
oral therapy that inhibits the translation of multiple neurotoxic proteins, including APP and amyloid beta, tau, alpha-synuclein, and
TDP-43, through a specific RNA-targeting mechanism of action. By addressing the underlying causes of neurodegeneration, Annovis aims to
halt disease progression and improve cognitive and motor functions in patients. 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
