Form 8-K

8-K — Annovis Bio, Inc.

Accession: 0001104659-26-082341

Filed: 2026-07-10

Period: 2026-07-07

CIK: 0001477845

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — tm2620172d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2620172d1_ex99-1.htm)

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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

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

Item 8.01

Other Events.

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

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2620172d1_ex99-1.htm · Sequence: 2

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

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