# EDGAR Filing Document

**Accession Number:** 0001477845
**File Stem:** 0001104659-26-007423
**Filing Date:** 2026-1
**Character Count:** 13580
**Document Hash:** 23c532d2ec86dd1748e08dc96b9448ba
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-26-007423.hdr.sgml**: 20260128

**ACCESSION NUMBER**: 0001104659-26-007423

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 39

**CONFORMED PERIOD OF REPORT**: 20260128

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260128

**DATE AS OF CHANGE**: 20260128

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Annovis Bio, Inc.
- **CENTRAL INDEX KEY:** 0001477845
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 262540421
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-39202
- **FILM NUMBER:** 26572882

**BUSINESS ADDRESS:**
- **STREET 1:** 101 LINDENWOOD DRIVE, SUITE 225
- **CITY:** MALVERN
- **STATE:** PA
- **ZIP:** 19355
- **BUSINESS PHONE:** 484-875-3192

**MAIL ADDRESS:**
- **STREET 1:** 101 LINDENWOOD DRIVE, SUITE 225
- **CITY:** MALVERN
- **STATE:** PA
- **ZIP:** 19355

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** QR Pharma, Inc.
- **DATE OF NAME CHANGE:** 20091202

?xml version='1.0' encoding='ASCII'?

**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): January 28, 2026**

**ANNOVIS BIO, INC.**

**(Exact Name of Registrant as Specified in Charter)** 

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| | | |
|:---|:---|:---|
| **Delaware** | **001-39202** | **26-2540421** |
| **(State or Other Jurisdiction**<br> **of Incorporation)** | **(Commission**<br> **File Number)** | **(I.R.S. Employer**<br> **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**

**<u>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Not Applicable&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</u>**

**(Former Name or Former Address, if Changed Since Last Report)**

Securities registered pursuant to Section 12(b) of the Act:

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| | | |
|:---|:---|:---|
| **Title of each class** | **Trading Symbol(s)** | **Name of each exchange on which<br> 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 7.01** | **Regulation FD Disclosure.** |

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On January 28, 2026, Annovis Bio, Inc. (the "Registrant") will conduct a webinar. A copy of the presentation for the webinar is furnished as Exhibit 99 hereto and incorporated herein by reference.

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| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits** |

---

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| | |
|:---|:---|
| **<u>Exhibit Number</u>** | **<u>Description</u>** |

---

[99](tm264292d1_99.htm) [Presentation for Webinar on January 28, 2026](tm264292d1_99.htm)

104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

**<u>SIGNATURES</u>**

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.** | **ANNOVIS BIO, INC.** | **ANNOVIS BIO, INC.** |
| Date: January 28, 2026 | By: | /s/ Maria Maccecchini | /s/ Maria Maccecchini |
|  |  | Name: | Maria Maccecchini |
|  |  | Title: | President and Chief Executive Officer |

---

## Ex-99

**Exhibit 99**

![](tm264292d1_99img001.jpg)

NYSE: ANVS Annovis Webinar January 28, 2026 Presenter: Maria Maccecchini, Ph.D., President and CEO

![](tm264292d1_99img002.jpg)

2 FORWARD - LOOKING STATEMENTS Forward Looking Statements and Other Important Cautions -- This presentation contains "forward - looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, the Company's plans related to clinical trials and financial condition. Forward - looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such risks and uncertainties include, but are not limited to, those related to patient enrollment, the effectiveness of buntanetap, and the timing, effectiveness, and anticipated results of the Company's clinical trials evaluating the efficacy, safety, and tolerabi lit y of buntanetap. Additional risk factors are detailed in the Company's periodic filings with the SEC, including those listed in the "Risk Factors" section of the Company's Annual Report on Form 10 - K and Quarterly Reports on Form 10 - Q. All forward - looking statements in this presentation are based on information available to the Company as of the date of this presentation. The Company expressly disclaims any obligation to update or revise its forward - looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

![](tm264292d1_99img003.jpg)

3 Company highlights Capital - efficient approach Current shares outstanding 26.5m. Cash balance\* $19m, d ebt $0 Raised $40m. in 2025 Drug candidate Our lead asset buntanetap is the only drug that improves cognition in AD and cognition and motor function in PD patients Late - stage opportunity Completed: Phase 2/3 trial in early AD Phase 3 trial in early PD Ongoing: Pivotal Phase 3 in early AD Open Label Extension in PD Unique MOA Buntanetap is RNA - targeting small molecule that inhibits the overproduction of multiple neurotoxic proteins associated with AD and PD Growing market 7M AD patients in the US 1.2M PD patients in the US Intellectual property (IP) Long duration IP estate that extends beyond 2046 \*as of 12/31/25

![](tm264292d1_99img004.jpg)

Pipeline 4

![](tm264292d1_99img005.jpg)

5 Over 1, 2 00 people treated with buntanetap Healthy volunteers Alzheimer's disease Parkinson's disease Summary of clinical studies N=22 2 studies Phase 1/2 N=17 1 study Phase 2 N=346 1 study Phase 2/3 N=760 (ongoing) 1 study Pivotal Phase 3 N=58 1 study Phase 2 N=523 1 study Phase 3 N=500 - 600 (ongoing) 1 study OLE N=120 2 safety studies Phase 1 N=24 Food effect study N=24 Form A/B N=24 ADME

![](tm264292d1_99img006.jpg)

6 Patent portfolio

![](tm264292d1_99img007.jpg)

Alzheimer's disease

![](tm264292d1_99img008.jpg)

8 Phase 2/3 AD Study: Buntanetap improves cognition in patients with mild, not moderate, AD # comparing to baseline \* comparing to placebo \*/# p<0.05 ### p<0.001 From the ITT population: - AD patients were selected by pTau217 inclusion/exclusion. - Mild and moderate AD were determined by MMSE selection.

![](tm264292d1_99img009.jpg)

% Slowing in Adj.MeanAdjusted Mean DiffNo. patients (Bun 30 mg,Placebo)Subgroup Overall Age >=65 Apolipoprotein E4 Carrier Non-Carrier BMI <30 >=30 Ethnicity Hispanic Or Latino Not Hispanic Or Latino Gender Female Male Medication with Psychoanaleptics with Antidepressants No Psychoanaleptics Race Black Or African American White 27, 22 25, 21 18, 15 9, 6 25, 21 2, 1 10, 6 17, 16 18, 15 9, 7 20, 20 8, 6 7, 2 4, 0 20, 22 -2.373 -3.007 -1.937 -3.994 -2.075 -5.098 -1.713 -2.557 -1.62 -3.417 -2.744 -3.57 -0.935 -2.085 -163.5 -239.4 -121.0 -273.6 -127.4 -861.3 -64.9 -278.9 -110.2 -254.9 -210.6 -302.7 -95.8 -149.1 -4 -2 0 2 4 6 8 < Buntanetap Better Placebo Better > Forest plot shows consistency and robustness of efficacy 9

![](tm264292d1_99img010.jpg)

Neuronal damage Inflammation Neurotoxic proteins Biomarker data in mild AD patients (MMSE 21 - 24) 10 Reductions in neurotoxic proteins, inflammation, and neuronal damage

![](tm264292d1_99img011.jpg)

11 FDA - cleared pivotal Phase 3 study (ANVS - 25001): A randomized, double - blind, placebo - controlled, multicenter study of buntanetap in participants with early Alzheimer's disease R 1:1 Placebo QD 30mg buntanetap QD 8 weeks screening 6/18 months treatment n=380 n=380 N=760 Key inclusion c riteria: • Diagnosis AD according to NIA and NIA - AA criteria (2024) • pTau217 level positive for AD • Age 55 to 85 • MMSE 21 - 28 Key clinical o utcomes : Primary endpoints: • ADAS - Cog 13 • ADCS - iADL • vMRI

![](tm264292d1_99img012.jpg)

6 - months 18 - months NDA (Q4 2026) NDA (Q4 2027) Milestones toward approval for Alzheimer's disease (AD) 12 $100 billion/US estimated Market $7 billion/US $20 billion (20%) Our market share $1.4 billion (20%) We are here Market approval

![](tm264292d1_99img013.jpg)

clinical sites in the U.S. 83 total patients 760 Progress of the pivotal Phase 3 trial in early AD enrolled 40% 13

![](tm264292d1_99img014.jpg)

Parkinson's disease

![](tm264292d1_99img015.jpg)

Upcoming milestones for Parkinson's program 15 We are here We are here

![](tm264292d1_99img016.jpg)

16 FDA - approved PD Open Label Extension (OLE) study design Early AD Cohort 1: Invitation Only Cohort 2: DBS Patients 6 weeks screening 36 months treatment N: 500 - 700 Key Inclusion Criteria: • Adults aged up to 85 years • Hoehn and Yahr stage 1 - 3 • MMSE 21 - 30 at screening Cohort 1 : Diagnosis of idiopathic PD and participated in a prior PD clinical trial with buntanetap. Cohort 2 : Diagnosis of idiopathic PD and who has been receiving DBS treatment in either the subthalamic nucleus or the globus pallidus internus for at least 12 months after a successful DBS surgery that achieved the goal.

![](tm264292d1_99img017.jpg)

clinical sites in the U.S. 25 total patients ~500 Progress of the OLE trial in PD Screening began 17

![](tm264292d1_99img018.jpg)

Buntanetap improved cognition in the ITT as well as in MMSE>20. The most pronounced improvement was seen in amyloid - positive, tau - positive PD patients 18 10 mg p = 0.07 20 mg p= 0.57

![](tm264292d1_99img019.jpg)

Biomarker data in cognitively impaired PD patients (MMSE >20) 19 Reductions in plasma levels of pTau217, total tau, and brain - derived (BD) tau

![](tm264292d1_99img020.jpg)

Update on the FDA meeting for PDD study 20 • Cognitive outcome (MMSE) and plasma biomarkers (pTau217) from previous studies opened the door for a new trial – to test buntanetap in amyloid positive PD patients with Parkinson's disease dementia (PDD). • We received guidance from the FDA in January about this new PDD study. • The FDA expressed no objections, however there is currently no consensus on the endpoints in PDD. • We are currently in discussion with KOLs to identify appropriate endpoints that can best capture the treatment effect and lead to regulatory approval.

![](tm264292d1_99img021.jpg)

Summary: buntanetap and cognition in Alzheimer's and Parkinson's disease

![](tm264292d1_99img022.jpg)

Buntanetap shows a unified and reproducible pattern in improving cognition across AD and PD 22 Unified treatment pattern Buntanetap demonstrates the most pronounced cognitive benefit in patients with mild dementia (MMSE >20) and biomarker - confirmed presence of amyloid and tau.

![](tm264292d1_99img023.jpg)

Buntanetap shows a fast improvement of cognition across four studies in Alzheimer's and Parkinson's patients Phase 1/2 studies in early AD and PD 1 month of treatment Phase 2/3 study in early AD 3 months of treatment Phase 3 study in early PD 6 months of treatment 23

![](tm264292d1_99img024.jpg)

24 Disease modification vs symptomatic benefit in the treatment of Alzheimer's disease Kennedy GJ. Primary Psychiatry. Vol 14. No 11. 2007, adapted Annovis

![](tm264292d1_99img025.jpg)

Summary 25 1. The enrollment for the pivotal Phase 3 study in early AD is actively progressing, with the full recruitment completion estimated in Spring 2026. 2. The OLE PD study has begun screening patients. 3. The FDA agrees with us conducting a PDD study and we are discussing the details with KOLs in Parkison's dementia. 4. So far, buntanetap has shown significant cognitive improvement across AD and PD as well as a potential disease - modifying activity as measured by profound reductions in biomarkers linked to neurodegeneration.

![](tm264292d1_99img026.jpg)

Thank you