Form 8-K

8-K — Annovis Bio, Inc.

Accession: 0001104659-26-062451

Filed: 2026-05-15

Period: 2026-05-15

CIK: 0001477845

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — tm2614822d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2614822d1_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): May 15, 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 May 15, 2026, Annovis Bio, Inc. (the “Registrant”) issued

a press release reporting earnings for the quarter ended March 31, 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

99.1

Press Release Dated May 15, 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: May 15, 2026

By:

/s/ Maria Maccecchini

Name:

Maria Maccecchini

Title:

President and Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2614822d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Annovis

Provides Corporate Updates and Reports First Quarter 2026 Financial Results

· Phase 3 AD trial: 85% of patients enrolled; full enrollment on track in summer 2026

· PD open-label extension (OLE) study: 40% of patients enrolled; full enrollment on track in fourth quarter 2026

· New Drug Application (NDA) for buntanetap as a symptomatic treatment for AD is expected in early 2027 and as a potential disease-modifying

treatment in early 2028

Malvern, PA, May 15, 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 first quarter ended March 31, 2026.

"We saw strong momentum across both our AD and PD programs in

the first quarter," said Maria Maccecchini, Ph.D., President and CEO of Annovis. “Our Phase 3 AD clinical trial achieved significant

enrollment growth, keeping us firmly on track to complete randomization of patients in summer 2026 and deliver first top-line results

in early 2027. Simultaneously, we launched a PD OLE study and have been encouraged by the robust interest from both returning and new

patients. This year is pivotal: we expect to generate substantive clinical data across both indications that will anchor our regulatory

path toward an NDA submission for buntanetap."

Clinical highlights

Alzheimer’s disease – pivotal Phase 3 trial (NCT06709014)

· Enrollment: 85% of patients enrolled.

· Screening: On May 15, 2026, Annovis closed enrollment to new participants after reaching a sufficient number of patients in

screening to meet the trial's enrollment goal.

· Safety: Annovis received a positive recommendation from the Data and Safety Monitoring Board (DSMB) regarding the drug’s

safety at 6 months, supporting seamless continuation of the study.

· Study design: The pivotal Phase 3 AD trial is recruiting early AD patients positive for pTau217 plasma biomarker. The study

is designed to evaluate buntanetap's symptomatic effect at 6 months and its potential disease-modifying effect at 18 months.

Parkinson’s disease – OLE study (NCT07284784)

· Enrollment: 40% of patients enrolled.

· Skin biomarker: The PD OLE study is implementing a biomarker test measuring levels of phosphorylated alpha-synuclein and nerve

cell fiber density via skin biopsy.

· Digital biomarker: Annovis entered into a partnership with NeuroRPM to integrate an AI-powered digital biomarker, enabling

continuous, real-world assessment of motor functions in response to buntanetap.

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

in participants from prior Annovis’ trials as well as in new patients who had deep brain stimulation (DBS) surgery.

Corporate highlights

· Publications

o Annovis

published a byline article in The Scientist, tracing the 170-year scientific

history of buntanetap, from the origins of its predecessor compound to its mechanism of action

and key events that shaped the drug’s clinical development.

o Annovis

announced a peer-reviewed publication of the Phase 2/3 AD clinical trial results in Nature

NPJ Dementia, available open access, demonstrating a dose-dependent cognitive

improvement and biomarker reductions in patients treated with buntanetap.

· Presentations

o Cheng Fang, Ph.D., SVP, R&D, presented two posters at the AD/PD2026 conference, highlighting clinical data which support buntanetap's

treatment effect in PD with a particular focus on cognition and biomarker findings as well as an update on the ongoing pivotal Phase 3

AD trial.

o Maria

Maccecchini, Ph.D., President and CEO, presented at Fierce Biotech Week 2026 in Boston, delivering

a talk titled "The Multi-Protein Reality of Alzheimer's Disease: What the Science

Has Known for Decades and What the Field Has Yet to Accept," making the scientific

case for targeting multiple neurotoxic proteins in AD and presenting buntanetap's clinical

evidence of cognitive and biomarker improvements.

· Patents

o Annovis secured a U.S. patent, covering prevention and treatment of neurological injuries arising from brain infections through the

administration of buntanetap or related compounds.

Upcoming milestones

· Phase 3 AD study: Annovis expects to reach full enrollment in summer 2026. The symptomatic data readout is anticipated approximately

6 months after the last patient is dosed. The disease-modifying data readout is anticipated 18 months after the last patient is dosed.

· PD OLE study: Annovis expects to complete enrollment for the PD OLE study in the fourth quarter of 2026.

· NDA pathway: Based on the Phase 3 AD study outcomes, Annovis plans to engage with the FDA regarding a regulatory NDA submission

for buntanetap as a symptomatic treatment for AD in early 2027 and as a disease-modifying treatment in early 2028.

Financial results

· Annovis’ cash and cash equivalents totaled $14.2 million as of March 31, 2026, compared to $19.5 million as of December 31,

2025. This excludes gross proceeds from its recent $10.0 million registered direct offering on April 10, 2026. Annovis had 28.5 million

shares of common stock outstanding as of March 31, 2026.

· Research and development expenses for the three months ended March 31, 2026, were $16.7 million compared to $5.0 million for the three

months ended March 31, 2025.

· General and administrative expenses for the three months ended March 31, 2026, were $1.3 million compared to $1.3 million for the

three months ended March 31, 2025.

· Annovis reported a $0.63 basic and diluted net loss per common share for the three months ended March 31, 2026, compared to a $0.32

basic and diluted net loss per common share for the three months ended March 31, 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 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

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

March 31,

2026

December 31,

(Unaudited)

2025

Assets

Current assets:

Cash and cash equivalents

$ 14,219,081

$ 19,532,338

Prepaid expenses and other current assets

2,024,622

1,549,287

Total assets

$ 16,243,703

$ 21,081,625

Liabilities and stockholders’ equity

Current liabilities:

Accounts payable

$ 5,275,668

$ 2,590,516

Accrued expenses

7,514,977

1,044,859

Total current liabilities

12,790,645

3,635,375

Non-current liabilities:

Warrant liability

327,000

595,000

Total liabilities

13,117,645

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, 28,537,302 and 27,199,139 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively

2,854

2,719

Additional paid-in capital

184,433,245

180,552,190

Accumulated deficit

(181,310,041 )

(163,703,659 )

Total stockholders’ equity

3,126,058

16,851,250

Total liabilities and stockholders’ equity

$ 16,243,703

$ 21,081,625

ANNOVIS BIO, INC.

Statements of Operations

Three Months Ended

March 31,

2026

2025

Operating expenses:

Research and development

$ 16,720,362

$ 5,011,517

General and administrative

1,291,820

1,271,164

Total operating expenses

18,012,182

6,282,681

Operating loss

(18,012,182 )

(6,282,681 )

Other income:

Interest income

137,800

187,612

Change in fair value of warrants (Note 7)

268,000

558,000

Total other income, net

405,800

745,612

Net loss

$ (17,606,382 )

$ (5,537,069 )

Net loss per share (Note 9)

Basic

$ (0.63 )

$ (0.32 )

Diluted

$ (0.63 )

$ (0.32 )

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

Basic

27,847,884

17,431,234

Diluted

27,847,884

17,431,234

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