<SEC-DOCUMENT>0001104659-24-057527.txt : 20240506
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<ACCEPTANCE-DATETIME>20240506171240
ACCESSION NUMBER:		0001104659-24-057527
CONFORMED SUBMISSION TYPE:	DEFA14A
PUBLIC DOCUMENT COUNT:		1
FILED AS OF DATE:		20240506
DATE AS OF CHANGE:		20240506

FILER:

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

	FILING VALUES:
		FORM TYPE:		DEFA14A
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-39202
		FILM NUMBER:		24918567

	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
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Bio, Inc.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; color: #061636; margin: 0pt 0"><B>Annovis Bio CEO Maria Maccecchini Issues Letter
to Stockholders </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; color: #061636; margin: 0pt 0">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; color: #1d2228"><B>MALVERN,
Pa</B></FONT><FONT STYLE="color: #1d2228">. -- <B>May 6, 2024 </B>-- </FONT>Annovis Bio, Inc. (NYSE: ANVS) (&#8220;Annovis&#8221; or the
 &#8220;Company&#8221;), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, announced that
Maria Maccecchini, Founder, President, and CEO of Annovis, issued a letter to stockholders providing a review of Phase II/III data from
its Alzheimer&#8217;s study and sharing next steps.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; color: #242424; margin: 0pt 0; background-color: white">Dear Friends,</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; color: #242424; margin: 0pt 0; background-color: white">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; color: #242424; margin: 0pt 0; background-color: white">The last few days have been
very difficult. I received a lot of emails and phone calls that often expressed anger, uncertainty, and disappointment. Additionally,
our results were questioned and criticized. This reaction not only caused a drastic drop in our share price, but, more importantly, it
saddened the Annovis team. We are determined to develop a drug that treats Alzheimer&#8217;s (AD) and Parkinson&#8217;s diseases (PD)
and makes the life of the afflicted people and their caretakers easier. However, every setback makes it harder to reach this goal.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; color: #242424; margin: 0pt 0; background-color: white">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">At Annovis, we hold rigorous science, open communication, and transparency
seriously, and it is our responsibility to conduct a clinical study in conformance with FDA guidelines and to the highest standards possible.
In science, results are often less than perfect, but they pave the way for a better plan when designing and executing the next steps.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; color: #242424; margin: 0pt 0; background-color: white">The Phase II/III study provided
us with valuable information for an improved Phase III pivotal trial. First, we will prescreen patients for plasma AD biomarkers to confirm
the diagnosis. Second, we will only enroll patients with early and mild Alzheimer&#8217;s (MMSE 21-28), the subpopulation which showed
the highest level of improvement after buntanetap, as seen from our completed AD studies (Table 1).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; color: #242424; margin: 0pt 0; background-color: white">&#160;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: top">
    <TD STYLE="border-top: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; width: 30%; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: black">Study</FONT></TD>
    <TD STYLE="border: Black 1pt solid; width: 15%; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: black">AD patient</FONT></TD>
    <TD STYLE="border-top: Black 1pt solid; border-right: Black 1pt solid; border-bottom: Black 1pt solid; width: 11%; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: black"># <BR>
Patients</FONT></TD>
    <TD STYLE="border-top: Black 1pt solid; border-right: Black 1pt solid; border-bottom: Black 1pt solid; width: 13%; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: black">Endpoint</FONT></TD>
    <TD STYLE="border-top: Black 1pt solid; border-right: Black 1pt solid; border-bottom: Black 1pt solid; width: 10%; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: black">Duration</FONT></TD>
    <TD STYLE="border-top: Black 1pt solid; border-right: Black 1pt solid; border-bottom: Black 1pt solid; width: 10%; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: black">Drug vs<BR>
Baseline</FONT></TD>
    <TD STYLE="border-top: Black 1pt solid; border-right: Black 1pt solid; border-bottom: Black 1pt solid; width: 11%; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: black">Drug vs<BR>
Placebo </FONT></TD></TR>
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    <TD STYLE="border-left: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: black">Phase IIa; 2021</FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: black">MMSE 18-28</FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: black">14</FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: black">ADAS-Cog11</FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: black">1 month</FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: black">-4.4</FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: black">-3.2</FONT></TD></TR>
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    <TD STYLE="border-left: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: black">Phase II/III; 2024</FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: black">MMSE 21-24</FONT></TD>
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    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: black">ADAS-Cog11</FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: black">3 months</FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: black">-3.3</FONT></TD>
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    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: black">ADAS-Cog11</FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: black">3 months</FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: black">-0.65</FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: black">1.79</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; color: #242424; margin: 0pt 0; background-color: white">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; color: #242424; margin: 0pt 0; background-color: white">Table 1. Summary of cognitive
response to buntanetap at different disease stages measured in completed AD studies conducted by Annovis. The table clearly shows a strong
response in patients with early AD (MMSE 18-28 and MMSE 21-24), while in moderate AD patients (MMSE 14-20), the response is obscured by
high placebo effect.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; color: #242424; margin: 0pt 0; background-color: white">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; color: #242424">The
goal of the Phase II/III trial was to learn about the breadth of our drug&#8217;s efficacy and to obtain information for a pivotal disease-modifying
study. This goal was achieved. </FONT>We believe that the FDA will accept buntanetap for symptomatic relief and will allow us to continue
with the next pivotal Phase III study for disease-modification.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>About Buntanetap</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Buntanetap (formerly known as Posiphen or ANVS401) attacks neurodegeneration
by inhibiting the formation of multiple neurotoxic proteins - amyloid beta, tau, alpha synuclein, and TDP43 - thereby improving synaptic
transmission, axonal transport and neuroinflammation. Dysregulation of these pathways has been shown to be the cause of nerve cell degeneration
and ultimately death. By attacking these pathways, buntanetap has the ability to reverse neurodegeneration in Alzheimer&#8217;s, Parkinson&#8217;s,
and other neurodegenerative diseases.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>About Annovis Bio, Inc.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Headquartered in Malvern, Pennsylvania, Annovis Bio, Inc. is a clinical-stage,
drug platform company addressing neurodegeneration, such as Alzheimer&#8217;s Disease (AD), Parkinson&#8217;s Disease (PD), and other
chronic neurodegenerative diseases. The company believes it is the only company developing a drug for both AD and PD designed to inhibit
more than one neurotoxic protein to restore axonal and synaptic activity. By improving brain function, the Company&#8217;s goal is to
treat memory loss and dementia associated with AD as well as body and brain dysfunction associated with PD. For more information about
Annovis Bio, please visit the Company's website www.annovisbio.com and follow us on LinkedIn and Twitter.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-size: 10pt">&#160;</FONT>&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Forward-Looking Statements</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">This press release contains &#34;forward-looking&#34; 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.
All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The Company advises
caution in reliance on forward-looking statements. Forward-looking statements include, without limitation, the Company's plans related
to clinical trials. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results to
differ materially from those implied by forward-looking statements, including regarding 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. See also additional risk factors set forth in the Company's periodic filings with the SEC, including, but not limited to,
those risks and uncertainties listed in the section entitled &#34;Risk Factors,&#34; in the Company's Annual Report on Form 10-K and Quarterly
Reports on Form 10-Q filed with the SEC. All forward-looking statements in this press release are based on information available to the
Company as of the date of this filing. The Company expressly disclaims any obligation to update or alter its forward-looking statements,
whether as a result of new information, future events or otherwise, except as required by applicable law.</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Investor Contacts:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Maria Maccecchini, Ph.D.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">maccecchini@annovisbio.com</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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