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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 13, 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 November 13, 2026, Annovis Bio, Inc. (the “Registrant”)
issued a press release reporting earnings for the quarter ended September 30, 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 |
|
Press Release Dated November 13, 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: November 13, 2026 |
By: |
/s/ Maria Maccecchini |
| |
|
Name: |
Maria Maccecchini |
| |
|
Title: |
President and Chief Executive Officer |
Exhibit 99.1
Annovis Provides Corporate Updates
and Reports Third Quarter 2026 Financial Results
| · | Last
patient, last visit of the 6-month treatment period in the Phase 3 DUET-AD study is scheduled
for December 31, 2026, with database lock on February 8, 2027, and data readout
in March 2027 |
| · | Parkinson’s
disease open-label extension (OLE-PD) study has enrolled 326 patients, with enrollment scheduled
to close on January 29, 2027 |
| · | Annovis
raised $21.0 million in gross proceeds through an underwritten public offering, which is
expected to fund operations through the 6-month data readout from DUET-AD |
Malvern, PA, November 13, 2026
-- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a Phase 3 clinical-stage biotechnology company
developing buntanetap, an investigational oral therapy for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's
disease (PD), today provided corporate updates and reported financial results for the third quarter ended September 30, 2026.
“The third quarter marked a shift
in our focus from enrolling patients in DUET-AD to executing the trial and preparing for the first data readout and for filing a New
Drug Application (NDA),” said Maria Maccecchini, PhD, President and CEO of Annovis. “We now have dates set for last patient,
last visit of the 6-month treatment period and for database lock, as well as financing in place to carry us through topline results in
March 2027. The team is working very hard to deliver clean data and an on-time readout.”
Clinical
highlights
Alzheimer’s disease –
DUET-AD
| · | Study
description: The pivotal Phase 3 trial has been given the acronym DUET-AD (Dual Efficacy
Trial in Alzheimer’s Disease), reflecting its unique design with two prespecified data
readouts – at 6 months (symptomatic) and at 18 months (disease-modifying). |
| · | Enrollment:
DUET-AD is fully enrolled, with 862 patients who have early AD (MMSE 20-28) and are positive
for the plasma biomarker pTau217. |
Alzheimer’s disease –
open-label extension (OLE-AD)
| · | Activation:
The OLE-AD study will use the same clinical sites as DUET-AD. The rollover of
patients from DUET-AD into OLE-AD is expected to start by the end of November 2026. |
| · | Eligibility:
The OLE-AD study will allow patients from DUET-AD to receive buntanetap after completing
their 18-month treatment period. Patients from both arms – buntanetap and placebo –
will be allowed to join. The OLE-AD study is also open to participants from Annovis’
prior AD clinical trials. |
Parkinson’s disease –
open-label extension (OLE-PD)
| · | Enrollment:
The OLE-PD study has enrolled 326 patients. It accepts participants from Annovis’
prior clinical trials as well as new patients who have deep brain stimulation (DBS). |
| · | Study
design: The OLE-PD study is designed to evaluate buntanetap's safety and long-term efficacy
over 36 months, supported by NeuroRPM, a real-time digital biomarker that measures core PD
symptoms, and a skin biopsy test for alpha-synuclein pathology. |
Regulatory updates
| · | Weave
Bio: In September, Annovis announced a partnership with Weave Bio, an AI platform
for regulatory content and knowledge management, to support preparation of a planned NDA
for buntanetap. The Company aims to prepare a significant part of the NDA before the 6-month
data readout from DUET-AD. |
Corporate updates
| · | Financing:
On November 6, 2026, Annovis closed an underwritten public offering with gross proceeds
of approximately $21.0 million. The Chairman of the Board contributed $5.0 million as part
of the offering. Details can be found in the Company’s SEC filings. |
| · | Webinar:
Annovis hosted a corporate update webinar and live Q&A on September 2, 2026,
covering company progress, ongoing clinical programs, and anticipated milestones. The recording
is available online. |
Upcoming presentations
| · | CTAD
2026 (November 16-19, Boston): Annovis will deliver three presentations at the 19th
Clinical Trials on Alzheimer’s Disease (CTAD) conference: an oral presentation in the
Biotech Showcase on targeting proteostasis in AD, a poster on the design and baseline characteristics
of DUET-AD, and a poster on the use of AI for assessing blood-brain barrier permeability
of AD drug candidates. Details can be found in the latest press release. |
| · | U.S.
Biotech Day 2026 (November 16-17, Philadelphia): Dr. Maccecchini will join
a panel with leaders from Pfizer, Merck, Bristol Myers Squibb and other pharmaceutical companies,
and discuss the translational path of bringing a small-molecule innovation from bench to
late-stage clinical development. |
| · | Pharma
Partnering Summit (November 19-20, Boston): Dr. Maccecchini will present a
company update and hold one-on-one meetings. |
Upcoming milestones
| · | DUET-AD:
Annovis expects last patient, last visit of the 6-month treatment period on December 31,
2026, and database lock on February 8, 2027, with topline results in March 2027.
This milestone defines the 6-month symptomatic analysis and does not mark the end of the
study: patients continue treatment for an additional 12 months to complete the prespecified
18-month period of the study. The Company plans to present the 6-month data at the AD/PD
2027 conference in Barcelona. |
| · | OLE-PD:
Enrollment of new patients for the OLE-PD study is projected to be completed by January 29,
2027. |
Financial results
| · | Annovis’
cash and cash equivalents totaled $2.8 million as of September 30, 2026, compared to
$19.5 million as of December 31, 2025. Annovis had 42.7 million shares of common stock
outstanding as of September 30, 2026. |
| · | Research
and development expenses for the three months ended September 30, 2026, were $15.8 million
compared to $6.3 million for the three months ended September 30, 2025. |
| · | General
and administrative expenses for the three months ended September 30, 2026, were $1.2
million compared to $1.1 million for the three months ended September 30, 2025. |
| · | Annovis
reported a $0.22 basic and diluted net loss per common share for the three months ended September 30,
2026, compared to a $0.37 basic and diluted net loss per common share for the three months
ended September 30, 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. 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, PhD
Director, Strategic Communications
Annovis Bio
ir@annovisbio.com
(Tables to follow)
Annovis Bio, Inc.
Balance Sheets
| | |
September 30, | | |
| |
| | |
2026 | | |
December 31, | |
| | |
(Unaudited) | | |
2025 | |
| Assets | |
| | | |
| | |
| Current assets: | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 2,819,898 | | |
$ | 19,532,338 | |
| Prepaid expenses and other current assets | |
| 2,683,829 | | |
| 1,549,287 | |
| Total assets | |
$ | 5,503,727 | | |
$ | 21,081,625 | |
| Liabilities and stockholders’ (deficit) equity | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 3,053,090 | | |
$ | 2,590,516 | |
| Accrued expenses | |
| 3,211,462 | | |
| 1,044,859 | |
| Total current liabilities | |
| 6,264,552 | | |
| 3,635,375 | |
| Non-current liabilities: | |
| | | |
| | |
| Warrant liability | |
| 12,473,000 | | |
| 595,000 | |
| Total liabilities | |
| 18,737,552 | | |
| 4,230,375 | |
| Commitments and contingencies (Note 6) | |
| | | |
| | |
| Stockholders’ (deficit) 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, 42,686,201 and 27,199,139 shares issued and outstanding at September 30, 2026 and December 31, 2025, respectively | |
| 4,268 | | |
| 2,719 | |
| Additional paid-in capital | |
| 192,354,899 | | |
| 180,552,190 | |
| Accumulated deficit | |
| (205,592,992 | ) | |
| (163,703,659 | ) |
| Total stockholders’ (deficit) equity | |
| (13,233,825 | ) | |
| 16,851,250 | |
| Total liabilities and stockholders’ (deficit) equity | |
$ | 5,503,727 | | |
$ | 21,081,625 | |
Annovis Bio, Inc.
Statements of
Operations
(Unaudited)
| | |
Three Months Ended | | |
Nine Months Ended | |
| | |
September 30, | | |
September 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| Research and development | |
$ | 15,780,102 | | |
$ | 6,291,171 | | |
$ | 44,507,763 | | |
$ | 16,464,609 | |
| General and administrative | |
| 1,189,006 | | |
| 1,143,804 | | |
| 4,851,238 | | |
| 3,524,500 | |
| Total operating expenses | |
| 16,969,108 | | |
| 7,434,975 | | |
| 49,359,001 | | |
| 19,989,109 | |
| Operating loss | |
| (16,969,108 | ) | |
| (7,434,975 | ) | |
| (49,359,001 | ) | |
| (19,989,109 | ) |
| Other income (expense): | |
| | | |
| | | |
| | | |
| | |
| Interest income | |
| 84,868 | | |
| 152,317 | | |
| 382,900 | | |
| 531,324 | |
| Other financing costs (Note 7) | |
| (37,896 | ) | |
| — | | |
| (1,627,232 | ) | |
| — | |
| Change in fair value of warrants (Note 7) | |
| 7,460,000 | | |
| 20,000 | | |
| 8,714,000 | | |
| 438,000 | |
| Total other income (expense), net | |
| 7,506,972 | | |
| 172,317 | | |
| 7,469,668 | | |
| 969,324 | |
| Net loss | |
$ | (9,462,136 | ) | |
$ | (7,262,658 | ) | |
$ | (41,889,333 | ) | |
$ | (19,019,785 | ) |
| Net loss per share (Note 9) | |
| | | |
| | | |
| | | |
| | |
| Basic | |
$ | (0.22 | ) | |
$ | (0.37 | ) | |
$ | (1.16 | ) | |
$ | (1.01 | ) |
| Diluted | |
$ | (0.22 | ) | |
$ | (0.37 | ) | |
$ | (1.16 | ) | |
$ | (1.01 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Weighted-average number of common shares used in computing net loss per share | |
| | | |
| | | |
| | | |
| | |
| Basic | |
| 42,633,062 | | |
| 19,685,071 | | |
| 36,054,066 | | |
| 18,876,078 | |
| Diluted | |
| 42,633,062 | | |
| 19,685,071 | | |
| 36,054,066 | | |
| 18,876,078 | |
