Form 8-K

8-K — Annovis Bio, Inc.

Accession: 0001104659-26-097091

Filed: 2026-08-14

Period: 2026-08-14

CIK: 0001477845

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — tm2623272d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2623272d1_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): August 14, 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 ¨

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. ¨

Item 2.02

Results of Operations and Financial Condition.

On August 14, 2026, Annovis Bio, Inc. (the “Registrant”)

issued a press release reporting earnings for the quarter ended June 30, 2026. A copy of the press release is furnished as Exhibit 99

hereto and incorporated herein by reference.

Item 9.01

Financial Statements and Exhibits

Exhibit Number

Description

Press Release Dated August 14, 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: August 14, 2026

By:

/s/ Maria Maccecchini

Name: Maria Maccecchini

Title: President and Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2623272d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Annovis Provides Corporate Updates

and Second Quarter 2026 Financial Results

· Pivotal Phase 3 Alzheimer’s disease (AD) trial is fully enrolled with a total number of 850 patients, exceeding original projections.

· Parkinson’s disease (PD) open-label extension (OLE) study has enrolled 266 patients with full enrollment projected in Q4 2026.

· Annovis will host a corporate update webinar on Wednesday, September 2, 2026, at 4:00 pm EDT.

Malvern, PA, August 14, 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 provided

business updates and reported financial results for the second quarter ended June 30, 2026.

“Our company witnessed major clinical strides during the second

quarter,” said Maria Maccecchini, Ph.D., President and CEO of Annovis. “We reached an important milestone – full enrollment

of our pivotal Phase 3 study in early AD – having recruited 850 patients. This number tells us how urgently patients and families

need new options and underscores their faith in our approach to treating AD. We also plan to continue the ongoing study with an open-label

extension (OLE) so AD patients can continue buntanetap treatment after finishing the trial. With topline data on track for early 2027,

our team has already begun preparing for regulatory submission so that we are ready to move once the results are in hand.”

Clinical highlights

Alzheimer’s disease – pivotal Phase 3 trial

· Enrollment: The trial is fully enrolled with 850 patients, exceeding the original target enrollment number of 760 patients.

· Patients: The pivotal Phase 3 AD trial includes patients diagnosed with early AD (MMSE 20-28) who are also positive for plasma

pTau217 biomarker, confirming the presence of amyloid and tau pathology in the brain.

· Study design: The study measures cognition (ADAS-Cog13) and function (ADCS-iADL) as co-primary endpoints, supported by volumetric

MRI, pTau217, and other biomarkers to evaluate changes in disease pathology. The study is designed to test both symptomatic (6 months)

and disease-modifying (18 months) effects of buntanetap.

· Timeline: The Company plans a database lock for the 6-month analysis in Q1 2027, with the top-line symptomatic data readout

anticipated in the same quarter. The disease-modifying data readout is expected a year later.

Alzheimer’s disease – OLE study

· Start: The AD OLE study is expected to initiate in October 2026.

· Aim and patients: The AD OLE study will allow patients who are currently in the pivotal Phase 3 trial to receive buntanetap

after completing their 18-month treatment period. Patients from both arms – buntanetap and placebo – will be allowed to join.

The initiation of the AD OLE is timed to coincide with the first patient finishing their 18-month treatment, ensuring seamless transition

into the extension study. The AD OLE will also be open to participants from Annovis’ prior AD clinical trials.

Parkinson’s disease – OLE study

· Enrollment: The study has so far enrolled 266 patients toward its estimated enrollment goal of 500. It accepts participants

who were in prior Annovis’ clinical trials as well as new patients who have deep brain stimulation (DBS).

· Site activation: 26 clinical sites have been activated across the US.

· Study design: The PD OLE study is designed to evaluate buntanetap's safety and long-term efficacy over the period of 36 months,

supported by NeuroRPM, a real-time digital biomarker that measures core PD symptoms, and a skin biopsy test for alpha-synuclein pathology.

Corporate highlights

· Management: Annovis promoted Cheng Fang, Ph.D., to Chief Scientific Officer (CSO), where she will oversee the clinical execution

and scientific advancement of buntanetap as the Company approaches key regulatory milestones.

Upcoming milestones

· Corporate

webinar: Annovis will host a corporate update webinar on Wednesday, September 2,

2026, at 4:00 pm EDT. To participate, please register using the following link: Annovis

Webinar - Corporate Update

· Questions:

Participants are encouraged to submit questions in advance to ir@annovisbio.com

Financial results

· Annovis’ cash and cash equivalents totaled $18.7 million as of June 30, 2026, compared to $19.5 million as of December 31,

2025. Annovis had 42.6 million shares of common stock outstanding as of June 30, 2026.

· Research and development expenses for the three months ended June 30, 2026, were $12.0 million compared to $5.2 million for the

three months ended June 30, 2025.

· General and administrative expenses for the three months ended June 30, 2026, were $2.4 million compared to $1.1 million for

the three months ended June 30, 2025.

· Annovis reported a $0.40 basic and diluted net loss per common share for the three months ended June 30, 2026, compared to a

$0.32 basic and diluted net loss per common share for the three months ended June 30, 2025.

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. 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

(Tables to follow)

ANNOVIS BIO, INC.

Balance Sheets

June 30,

2026

December 31,

(Unaudited)

2025

Assets

Current assets:

Cash and cash equivalents

$ 18,728,945

$ 19,532,338

Prepaid expenses and other current assets

3,308,146

1,549,287

Total assets

$ 22,037,091

$ 21,081,625

Liabilities and stockholders’ equity

Current liabilities:

Accounts payable

$ 3,327,138

$ 2,590,516

Accrued expenses

3,031,572

1,044,859

Total current liabilities

6,358,710

3,635,375

Non-current liabilities:

Warrant liability

19,933,000

595,000

Total liabilities

26,291,710

4,230,375

Commitments and contingencies (Note 6)

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, 42,606,152 and 27,199,139 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively

4,260

2,719

Additional paid-in capital

191,871,978

180,552,190

Accumulated deficit

(196,130,857 )

(163,703,659 )

Total stockholders’ equity

(4,254,619 )

16,851,250

Total liabilities and stockholders’ equity

$ 22,037,091

$ 21,081,625

ANNOVIS BIO, INC.

Statement of Operations

(Unaudited)

Three Months Ended

Six Months Ended

June 30,

2026

2025

2026

2025

Operating expenses:

Research and development

$ 12,007,300

$ 5,161,921

$ 28,727,663

$ 10,173,438

General and administrative

2,370,412

1,109,532

3,662,232

2,380,696

Total operating expenses

14,377,712

6,271,453

32,389,895

12,554,134

Operating loss

(14,377,712 )

(6,271,453 )

(32,389,895 )

(12,554,134 )

Other income:

Interest income

160,233

191,395

298,033

379,007

Other financing costs (Note 7)

(1,589,336 )

—

(1,589,336 )

—

Change in fair value of warrants (Note 7)

986,000

(140,000 )

1,254,000

418,000

Total other income, net

(443,103 )

51,395

(37,303 )

797,007

Net loss

$ (14,820,815 )

$ (6,220,058 )

$ (32,427,198 )

$ (11,757,127 )

Net loss per share (Note 9)

Basic

$ (0.40 )

$ (0.32 )

$ (0.99 )

$ (0.64 )

Diluted

$ (0.40 )

$ (0.32 )

$ (0.99 )

$ (0.64 )

Weighted-average number of common shares used in computing net loss per share

Basic

37,518,778

19,486,231

32,710,046

18,464,877

Diluted

37,518,778

19,486,231

32,710,046

18,464,877

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