ANVS

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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): November 4, 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 2.02Results of Operations and Financial Condition.

Annovis Bio, Inc. (the “Company”) is providing the following information about its preliminary cash and cash equivalents as of September 30, 2026. Based on preliminary estimates and currently available information, the Company estimates that its cash and cash equivalents were approximately $2.8 million as of September 30, 2026. The Company’s interim financial statements as of and for the three and nine months ended September 30, 2026 are not yet available and the Company has not yet completed its quarterly financial closing processes for the period ended September 30, 2026. As such, the foregoing information reflects the Company’s estimates with respect to cash and cash equivalents, and is based on currently available information, which is preliminary, unaudited and subject to change. The Company’s actual results may differ from these estimates after the completion of financial closing procedures, final adjustments and review by the Company’s staff and management. In addition, the Company’s actual results for the three and nine months ended September 30, 2026 may differ from the Company’s preliminary estimates and are not indicative of the results to be expected for any future period.

These estimates should not be viewed as a substitute for full financial statements prepared in accordance with generally accepted accounting principles in the U.S. and these estimates are not necessarily indicative of the results to be achieved for the stated period, or any other period. The Company does not undertake any obligation to publicly update or revise these preliminary estimates, except as required by law. Accordingly, undue reliance should not be placed on these preliminary financial results. See “Risk Factors,” “Cautionary Note Regarding Forward-Looking Statements,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 for a discussion of certain factors that could result in differences between these preliminary unaudited estimates and the actual results.

These preliminary unaudited estimates of the Company’s cash and cash equivalents have been prepared by and are the responsibility of management. The Company’s independent registered public accounting firm has not conducted a review of and does not express an opinion or any other form of assurance with respect to these preliminary estimates. This information should be read in conjunction with the Company’s financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 202

EX-99.1

2 tm2623272d1_ex99-1.htm

EXHIBIT 99.1

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 J

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