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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):
August 6, 2024
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 August 6,
2024, Annovis Bio, Inc. (“The Company”) issued a press release announcing preclinical data with respect to its lead
compound, Buntanetap, when combined with a glucagon-like peptide 1 (“GLP-1”) agonist in a mouse model of
Alzheimer’s disease. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Item
9.01 Financial Statements and Exhibits.
The following exhibits
are being furnished herewith:
(d) Exhibits.
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: August 6, 2024 |
By: |
/s/ Maria Maccecchini |
|
|
Name: Maria Maccecchini |
|
|
Title: President and Chief Executive Officer |
Exhibit 99.1
Annovis’ Lead Compound Enhances Cognition Synergistically
with GLP-1 Agonist
MALVERN, Pa., August 6, 2024 (GLOBE NEWSWIRE) -- via IBN –
Annovis Bio Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering
transformative therapies for neurodegenerative disorders such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), today
announced new preclinical data demonstrating the synergistic effect of its lead compound, buntanetap, when combined with the glucagon-like
peptide 1 (GLP-1) agonist dulaglutide (Trulicity®) in a mouse model of Alzheimer’s disease.
GLP-1 agonists, commonly used to treat diabetes, weight loss, and heart
conditions, are now showing promising potential in the treatment of Alzheimer’s disease. Recent data presented at the Alzheimer’s
Association International Conference® (AAIC®) 2024 revealed that another GLP-1 agonist, liraglutide (Victoza), was able to decrease
cognitive decline in Alzheimer’s patients by 18% and reduce brain shrinkage in regions responsible for cognitive functions.
In 2018, Annovis Bio published data showing that buntanetap fully restored
memory, learning, and synaptic potentiation in an Alzheimer’s mouse model (Teich et al. 2018). Building on this research, Annovis
recently investigated whether combining buntanetap with the GLP-1 agonist dulaglutide would produce a synergistic effect in the same animal
model. The results were compelling: while buntanetap alone restored cognitive function to 100% and dulaglutide alone to 80%, the combination
of these two compounds not only restored cognitive function but also enhanced it beyond levels seen in healthy controls. (Figure 1).
![](https://www.sec.gov/Archives/edgar/data/1477845/000110465924086114/tm2420928d1_ex99-1img001.jpg)
Figure 1. Combination of dulaglutide (Trulicity®)
and buntanetap improves memory and synaptic plasticity in AD mice (*p<0.05, **p<0.01).
The ability of GLP-1 agonists to penetrate the brain is linked to their
molecular structure. Single-chain peptides (i.e. dulaglutide, albiglutide, exenatide) have better blood-brain barrier (BBB) permeability
than bifurcated molecules containing side chains. Due to its excellent BBB permeability, dulaglutide was chosen from other GLP-1 agonists
for combination with buntanetap (Figure 2).
Figure
2. Blood-brain barrier permeability of GLP-1 agonists. Data adapted from Rhea et al., 2023.
“We are excited to see that buntanetap significantly amplifies
the effects of dulaglutide on memory and learning, with a 6- to 10-fold increase in efficacy,” said Maria Maccecchini, Ph.D., Founder,
President, and CEO of Annovis Bio. “This synergy is particularly important for enhancing treatment outcomes while minimizing potential
side effects. As the field of Alzheimer’s research shifts towards combination therapies, we believe our approach holds great promise
for offering more effective treatment options for patients.”
About Buntanetap
Buntanetap
(formerly known as Posiphen) targets neurodegeneration by inhibiting the formation of multiple neurotoxic proteins, including
amyloid beta, tau, alpha-synuclein, and TDP43. This improves synaptic transmission, axonal transport, and reduces neuroinflammation.
Dysregulation of these pathways has been shown to cause nerve cell degeneration and ultimately nerve cell death. By targeting these pathways,
buntanetap has the potential to reverse neurodegeneration in Alzheimer’s, Parkinson’s, and other neurodegenerative diseases,
thereby aiming to restore brain function and improve the quality of life for patients.
About Annovis Bio, Inc.
Headquartered
in Malvern, Pennsylvania, Annovis Bio Inc. is dedicated to addressing neurodegeneration in diseases such as AD and PD. The company’s
innovative approach targets multiple neurotoxic proteins, aiming to restore brain function and improve the quality of life for 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
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. 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 tolerability 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 press release are based on information available to the Company as of the date
of this release. 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.
Contacts
Annovis Bio, Inc.
101 Lindenwood Drive
Suite 225
Malvern, PA 19355
www.annovisbio.com
Investor Contact
Scott McGowan
InvestorBrandNetwork (IBN)
Phone: 310.299.1717
IR@annovisbio.com
Investor Website
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Annovis Bio (NYSE:ANVS)
Gráfica de Acción Histórica
De Ago 2024 a Sep 2024
Annovis Bio (NYSE:ANVS)
Gráfica de Acción Histórica
De Sep 2023 a Sep 2024