Annovis DSMB backs Phase 3 Alzheimer’s trial safety

Annovis Bio reported that an independent Data and Safety Monitoring Board completed a planned 6‑month safety review of its pivotal Phase 3 Alzheimer’s disease trial of buntanetap and recommended the study continue without changes.

Filing Impact

(High)

Filing Sentiment

(Neutral)

Form Type

8-K

Rhea-AI Filing Summary

Annovis Bio reported that an independent Data and Safety Monitoring Board completed a planned 6‑month safety review of its pivotal Phase 3 Alzheimer’s disease trial of buntanetap and recommended the study continue without changes. The DSMB found no safety concerns, and 6‑month safety data in Alzheimer’s patients were consistent with those previously observed in Parkinson’s patients.

The Phase 3 Alzheimer’s trial is recruiting across the United States and is about 40% complete. The first symptomatic efficacy results are expected in early 2027, followed by a disease‑modifying readout in early 2028. The company also noted that, given the aligned safety outcomes across Alzheimer’s and Parkinson’s studies, the FDA indicated it may consider accepting combined safety data in a future NDA submission.

Positive

DSMB clears pivotal Phase 3 Alzheimer’s trial to continue without changes, reporting no safety concerns for buntanetap at 6 months and supporting ongoing development.
Regulatory dialogue suggests potential use of combined safety data, as the FDA indicated it may consider accepting Alzheimer’s and Parkinson’s safety results together in a future NDA submission.

Negative

None.

Insights

Positive DSMB safety review supports continued Phase 3 development of buntanetap in Alzheimer’s disease.

The independent DSMB reviewed 6‑month, unblinded safety data from the pivotal Phase 3 Alzheimer’s trial of buntanetap and found no safety concerns. It recommended the study continue as planned, without protocol changes, indicating the current dosing and design have been acceptable so far.

Safety data in Alzheimer’s patients were described as consistent with those seen in Parkinson’s patients at the same 6‑month point. The trial is about 40% enrolled in the United States, with the first symptomatic efficacy readout anticipated in early 2027 and a disease‑modifying readout expected in early 2028, so outcomes remain several years away.

The company also stated that, due to the alignment of safety outcomes across Alzheimer’s and Parkinson’s studies, the FDA indicated it may consider accepting combined safety data in a future NDA. While this does not guarantee approval, it points to a potentially more efficient safety package if future efficacy results are supportive.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Annovis Bio (ANVS) announce about its Phase 3 Alzheimer’s trial?

Annovis Bio announced an independent DSMB completed a 6‑month safety review of its pivotal Phase 3 Alzheimer’s trial of buntanetap and found no safety concerns. The board recommended the trial continue as planned, without any protocol modifications, supporting ongoing late‑stage development.

What is the role of the DSMB in Annovis Bio’s buntanetap trial?

The DSMB periodically reviews accumulated safety data from the buntanetap Alzheimer’s Phase 3 trial and issues independent recommendations. In this 6‑month review, it examined unblinded safety information and concluded the drug’s safety profile was acceptable, allowing the study to proceed without changes to its conduct.

How far along is Annovis Bio’s Phase 3 Alzheimer’s study of buntanetap?

The pivotal Phase 3 Alzheimer’s trial of buntanetap is recruiting patients across the United States and is described as 40% complete. This reflects trial progress but still leaves substantial enrollment and follow‑up ahead before the planned symptomatic and disease‑modifying efficacy readouts.

When are efficacy results expected from Annovis Bio’s buntanetap Alzheimer’s trial?

Annovis Bio expects the first symptomatic efficacy readout from its pivotal Phase 3 Alzheimer’s trial in early 2027. A separate disease‑modifying efficacy readout is anticipated in early 2028, providing two key future assessments of buntanetap’s clinical benefit in Alzheimer’s disease.

How do buntanetap safety results compare between Alzheimer’s and Parkinson’s patients?

The company reported that 6‑month safety data in Alzheimer’s patients were consistent with those seen in Parkinson’s patients at the same time point. This alignment across indications underpins the statement that the FDA may consider accepting combined safety data in a future NDA submission.

What did Annovis Bio say about potential FDA treatment of buntanetap safety data?

Annovis Bio stated that, because Alzheimer’s and Parkinson’s safety outcomes for buntanetap appear aligned, the FDA indicated it may consider accepting combined safety data in a future NDA. This could streamline safety documentation if efficacy data ultimately support a marketing application.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 02/12/2026 - 09:00 AM

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): February 12, 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. ¨

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
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 of Buntanetap 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.

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

Source: View Original Filing on SEC EDGAR

Filing Exhibits & Attachments

4 documents

Press Releases

EX-99.1 EXHIBIT 99.1 9.3 KB

Annovis DSMB backs Phase 3 Alzheimer’s trial safety