8-K

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 (Dateof earliest event reported): February 12, 2026

ANNOVIS BIO, INC.

(Exact Name of Registrant as Specified in Charter)

Delaware	001-39202	26-2540421
(State or Other Jurisdiction<br><br> <br>of Incorporation)	(Commission<br><br> <br>File Number)	(I.R.S. Employer<br><br> <br>Identification No.)

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101Lindenwood Drive**, Suite 225** Malvern , PA

19355

(Address of Principal Executive Offices, andZip Code)

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(484) 875-3192

Registrant’s Telephone Number, IncludingArea Code

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NotApplicable

(Former Name or Former Address, if Changed SinceLast 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)
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¨	Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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¨	Pre-commencement communication pursuant to Rule 13e-4(c) under<br>the Exchange Act (17 CFR 240.13e-4(c))
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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. ¨

Item 7.01	Regulation FD Disclosure.

On February 12, 2026, Annovis Bio, Inc. issued the press release furnished herewith as Exhibit 99.1.

ITEM 9.01	Financial Statements and Exhibits
Exhibit Number	Description
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99.1	Press Release
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: February 12, 2026	By:	/s/ Maria Maccecchini
		Name:	Maria Maccecchini
		Title:	President and Chief Executive Officer

Exhibit 99.1

Annovis Secures DSMB Approval to Advance Pivotal Phase 3 Trial ofBuntanetap in Alzheimer’s Disease

Malvern, PA, Feb. 12 -- 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 that an independent Data and Safety Monitoring Board (DSMB) has issued a positive recommendation regarding the safety of buntanetap at 6 months, supporting the continuation of the ongoing pivotal Phase 3 AD clinical trial without modification.

The DSMB is responsible for periodically reviewing accumulated safety data and providing independent recommendations on the conduct and progression of the study. During the open session, Annovis presented an overview of the trial status, including enrollment progress, adverse events, and study timelines. In the closed session, attended exclusively by DSMB voting members to ensure full objectivity and by an unblinded reporting statistician, unmasked safety data were reviewed.

Following a comprehensive evaluation, the DSMB concluded that no safety concerns were identified and recommended that the clinical trial continue as planned, without changes. Moreover, the 6-month safety data in Alzheimer’s patients were consistent with those observed in Parkinson’s patients at the same time point. Subsequent safety evaluations are planned at 12 and 18 months.

“We are pleased to receive this positive recommendation from the DSMB,” said Maria Maccecchini, Ph.D., President, and CEO of Annovis. “This response reinforces our confidence in the safety profile of buntanetap and allows the clinical program to proceed without interruption. Importantly, due to the alignment of safety outcomes across the Alzheimer’s and Parkinson’s studies, the FDA indicated it may consider accepting combined safety data in a future NDA submission.”

The pivotal Phase 3 AD clinical trial of buntanetap (NCT06709014) is currently recruiting patients across the United States and is now 40% complete. The first symptomatic efficacy readout is anticipated in early 2027, followed by a disease-modifying readout expected in early 2028.

AboutAnnovis

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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.

InvestorAlerts

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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-LookingStatements

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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.

ContactInformation:

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Annovis Bio Inc.

101 Lindenwood Drive

Suite 225

Malvern, PA 19355

www.annovisbio.com

InvestorContact:

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Alexander Morin, Ph.D.

Director, Strategic Communications

Annovis Bio

ir@annovisbio.com‍