<SEC-DOCUMENT>0001104659-22-104829.txt : 20221003
<SEC-HEADER>0001104659-22-104829.hdr.sgml : 20221003
<ACCEPTANCE-DATETIME>20221003060251
ACCESSION NUMBER:		0001104659-22-104829
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20221001
FILED AS OF DATE:		20221003
DATE AS OF CHANGE:		20221003

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			BELITE BIO, INC
		CENTRAL INDEX KEY:			0001889109
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			E9
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-41359
		FILM NUMBER:		221285788

	BUSINESS ADDRESS:	
		STREET 1:		5820 OBERLIN DRIVE, SUITE 101
		CITY:			SAN DIEGO
		STATE:			CA
		ZIP:			92121
		BUSINESS PHONE:		858-246-6240

	MAIL ADDRESS:	
		STREET 1:		5820 OBERLIN DRIVE, SUITE 101
		CITY:			SAN DIEGO
		STATE:			CA
		ZIP:			92121
</SEC-HEADER>
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<TYPE>6-K
<SEQUENCE>1
<FILENAME>tm2227219d1_6k.htm
<DESCRIPTION>FORM 6-K
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<P STYLE="font: bold 13.5pt Times New Roman, Times, Serif; margin: 0pt 103.4pt 0pt 99.6pt; text-align: center">UNITED STATES</P>

<P STYLE="font: 13.5pt Times New Roman, Times, Serif; margin: 0pt 103.4pt 0pt 99.6pt; text-align: center"><B>SECURITIES AND EXCHANGE COMMISSION</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 103.4pt 0pt 99.6pt; text-align: center"><B>WASHINGTON, D.C. 20549</B></P>

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

<P STYLE="font: bold 13.5pt Times New Roman, Times, Serif; margin: 0pt 103.4pt 0pt 99.6pt; text-align: center">FORM 6-K</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 194.15pt 0pt 195.65pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 194.15pt 0pt 195.65pt; text-align: center"><B>REPORT OF FOREIGN PRIVATE
ISSUER PURSUANT TO RULE 13a-16 OR 15b-16 OF THE SECURITIES EXCHANGE ACT OF 1934</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 103.4pt 0pt 99.6pt; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 103.4pt 0pt 99.6pt; text-align: center"><B>For the month of October 2022</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 103.35pt 0pt 101.45pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 103.35pt 0pt 101.45pt; text-align: center">Commission File Number: 001-41359</P>

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

<P STYLE="font: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Belite Bio, Inc</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 103.35pt 0pt 101.45pt; text-align: center">(Exact name of registrant as
specified in its charter)</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; text-align: center"><B>Not Applicable</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 103.35pt 0pt 101.45pt; text-align: center">(Translation of Registrant&acute;s
name into English)</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>5820 Oberlin Drive, Suite 101,</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>San Diego, CA 92121</B></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 103.35pt 0pt 101.45pt; text-align: center">(Address of principal executive
office)</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 103.4pt 0pt 101.45pt; text-align: center">Indicate by check mark whether
the registrant files or will file annual reports under cover Form 20-F or Form 40-F. Form 20-F <FONT STYLE="font-family: Wingdings">x</FONT>
Form 40-F <FONT STYLE="font-family: Wingdings">&uml;</FONT></P>

<P STYLE="font: 10pt Wingdings; margin: 0pt 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 86.1pt 0pt 84.15pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 86.1pt 0pt 84.15pt; text-align: center">Indicate by check mark if the
Registrant is submitting this Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): Yes <FONT STYLE="font-family: Wingdings">&uml;</FONT>&#9;No
<FONT STYLE="font-family: Wingdings">x</FONT></P>

<P STYLE="font: 10pt Wingdings; margin: 0pt 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 86.1pt 0pt 84.15pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 86.1pt 0pt 84.15pt; text-align: center">Indicate by check mark if the
Registrant is submitting this Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): Yes <FONT STYLE="font-family: Wingdings">&uml;</FONT>&#9;No
<FONT STYLE="font-family: Wingdings">x</FONT></P>

<P STYLE="font: 10pt Wingdings; margin: 0pt 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 10.9pt 0pt 8.95pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 10.9pt 0pt 8.95pt; text-align: center">Indicate by check mark whether
the registrant by furnishing the information contained in this Form 6-K is also thereby furnishing the information to the Commission pursuant
to Rule 12g3-2(b) under the Securities Exchange Act of 1934</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.85pt 0pt 0; text-align: center">Yes <FONT STYLE="font-family: Wingdings">&uml;</FONT>&#9;No
<FONT STYLE="font-family: Wingdings">x</FONT></P>

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

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="text-transform: uppercase"><B>Exhibit
Index</B></FONT></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"><A HREF="tm2227219d1_ex99-1.htm" STYLE="-sec-extract: exhibit">Exhibit 99.1 &mdash; Press Release</A></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"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SIGNATURE</B></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">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, thereunto duly authorized.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</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>&nbsp;</TD>
    <TD COLSPAN="2"><FONT STYLE="font-size: 10pt"><B>Belite Bio, Inc</B></FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 50%">&nbsp;</TD>
    <TD STYLE="width: 5%">&nbsp;</TD>
    <TD STYLE="width: 45%">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-size: 10pt">By:</FONT></TD>
    <TD STYLE="border-bottom: Black 1pt solid">/s/ <FONT STYLE="font-size: 10pt">Yu-Hsin Lin</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-size: 10pt">Name:</FONT></TD>
    <TD><FONT STYLE="font-size: 10pt">Yu-Hsin Lin</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-size: 10pt">Title:</FONT></TD>
    <TD><FONT STYLE="font-size: 10pt">Chief Executive Officer and Chairman</FONT></TD></TR>
  </TABLE>
<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">Date: October 1, 2022</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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<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>tm2227219d1_ex99-1.htm
<DESCRIPTION>EXHIBIT 99.1
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<P STYLE="margin: 0">&nbsp;</P>

<P STYLE="text-align: right; margin: 0"><B>Exhibit 99.1</B></P>

<P STYLE="text-align: right; margin: 0"><B>&nbsp;</B></P>

<P STYLE="margin-top: 0; margin-bottom: 0; text-align: center"><B>&nbsp;</B><IMG SRC="image_003.jpg" ALT=""></P>

<P STYLE="margin: 0; text-align: right"><B>&nbsp;</B></P>

<P STYLE="font: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Belite Bio Presented 12-Month Interim Results
of LBS-008 Phase 1b/2 Study in Adolescent Stargardt Disease at AAO Annual Meeting 2022</B></P>

<P STYLE="font: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; background-color: white"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol; font-size: 10pt">&middot;</FONT></TD><TD>LBS-008 (aka Tinlarebant) was safe and well tolerated in adolescent Stargardt Disease (STGD1) subjects at 12-month time point</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; background-color: white"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol; font-size: 10pt">&middot;</FONT></TD><TD>The majority of the subjects showed stabilization of BCVA in at least one eye</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; background-color: white"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol; font-size: 10pt">&middot;</FONT></TD><TD>A trend for preventing or slowing expansion of autofluorescence continue to be observed</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; background-color: white"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol; font-size: 10pt">&middot;</FONT></TD><TD>No atrophic lesion (DDAF) in 12 of 13 subjects at the 12-month treatment period</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; background-color: white"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol; font-size: 10pt">&middot;</FONT></TD><TD>12-month interim data from the ongoing Phase 2 study continue to show stabilization in several parameters, including halting or
                                                                                                                                slowing  lesion growth, preservation in retinal thickness, reduction in Ellipsoid Zone (EZ) defect width, and stabilization of
                                                                                                                                visual acuity</TD></TR></TABLE>

<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">SAN DIEGO, October 1, 2022- <U>Belite Bio, Inc</U> (NASDAQ: BLTE),
a San Diego based clinical stage biopharmaceutical drug development company targeting currently untreatable eye diseases, today presented
one-year data from their ongoing two-year Phase 2 clinical study of Tinlarebant in STGD1 as part of the oral presentation series at the
Annual Meeting of the American Academy of Ophthalmology (AAO) held during September 30 - October 3, 2022 at McCormick Place, Chicago.</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">&ldquo;We are glad that Tinlarebant&rsquo;s Phase 2 results were presented
in a late-breaking oral session at the AAO annual meeting.&rdquo; said Dr. Tom Lin, Belite Bio&rsquo;s Chairman and CEO. &ldquo;The Phase
2 data presented at AAO continue to support Tinlarebant&rsquo;s safety and efficacy profile over the one-year treatment period and reinforce
that this investigational therapy is a promising oral treatment for STGD1 patients.&rdquo;</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">Professor John Grigg, the study&rsquo;s principal investigator and
Head Specialty of Ophthalmology at the University of Sydney and Consultant Ophthalmologist at the Sydney Children&rsquo;s Hospitals Network
at Westmead and Sydney Eye Hospital provided a presentation of the interim study data.</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">To date, all 13 patients have completed one-year of treatment in the
ongoing two-year Phase 2 study of Tinlarebant. The results for safety and tolerability assessments, and retinal imaging data have been
collected for the evaluation of disease progression. Images from spectral-domain optical coherence tomography imaging, an imaging modality
that permits visualization of the retinal anatomy, have shown a stabilization of retinal thickness in many subjects. Fundus autofluorescence
imaging shows no autofluorescence expansion (QDAF) in 7 of 13 (53.8%) subjects, and 12 of 13 (92.3%) subjects also show no atrophic lesion
(DDAF) after one year of treatment. More importantly, 9 of 13 (69.2%) subjects show a stabilization or improvement in visual acuity throughout
the one-year treatment period. A copy of the presentation slides is available at https://investors.belitebio.com/aao-presentation-download-form.</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="text-align: center; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><IMG SRC="image_003.jpg" ALT="">&nbsp;</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">According to the international prospective study of STGD1 (the ProgStar
Study), childhood-onset patients with no atrophic lesion (DDAF) at baseline experienced an average lesion growth rate of 0.66 mm<SUP>2</SUP>
for the left eyes and 0.74 mm<SUP>2</SUP> for the right eyes at one year. In addition, the Prospective Cohort Study of Childhood-Onset
Stargardt Disease by Georgiou et al. reported an average atrophic lesion growth rate (DDAF) of 0.69 mm<SUP>2</SUP>/year for children.
Belite Bio&rsquo;s one-year data from ongoing Phase 2 study showed an average lesion growth rate of 0.03 mm<SUP>2</SUP>/year, demonstrating
a promising trend toward halting or slowing the disease progression in the study cohort.</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">&ldquo;We are very encouraged by the 12-month treatment results from
our Phase 2 Study. While the natural progression of childhood-onset STGD1 is characterized by a rapid visual decline and fast disease
progression leading to permanent visual loss at a very young age, the Phase 2 interim data have shown the stabilization in several structural
and functional parameters.&rdquo; said Dr. Tom Lin.</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">Belite Bio is currently conducting a two-year Phase 2 study and a two-year
Phase 3 study (DRAGON) of Tinlarebant in adolescent STGD1 subjects. Belite Bio expects the next data readout in its Phase 2 STGD1 study
to occur during the second quarter of 2023 when all subjects will complete 18 months of treatment.</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; text-align: justify; background-color: white"><B>About DRAGON Study</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The two-year Phase 3 study named DRAGON is a Multi-Center, Randomized,
<B>D</B>ouble-Masked, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Tinla<B>R</B>ebant in the Treatment of <B>S</B>tAr<B>G</B>ardt
Disease in Ad<B>O</B>lesce<B>N</B>t Subjects. DRAGON study is designed to evaluate the safety and efficacy of Tinlarebant in adolescent
STGD1 patients. To date, Belite Bio has commenced the Phase 3 study in the U.S., the United Kingdom, Germany, Belgium, Switzerland, Hong
Kong, Taiwan, mainland China and Australia. Approximately 60 patients are targeted for enrollment in this study with a 2:1 randomization
(active:placebo). For more information, visit clinicaltrials.gov at <U>https://www.clinicaltrials.gov/ct2/show/NCT05244304?term=belite+bio&amp;draw=2&amp;rank=1)</U></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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<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; text-align: justify; background-color: white"><B>About LBS-008 (aka
Tinlarebant)</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Tinlarebant is a novel oral therapy that prevents the buildup of
toxins in the eye that cause STGD1 and contribute to advanced dry AMD. These toxins are by-products of the visual cycle, which is
dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol
binding protein 4 (RBP4), a carrier protein that transports retinol to the eye. By modulating the amount of retinol entering the
eye, Tinlarebant reduces the formation of toxins that have been implicated in STGD1 and dry AMD. Tinlarebant has been granted Fast Track Designation and Rare Pediatric Disease designation in the U.S., and Orphan
Drug Designation in the U.S. and Europe for the treatment of STGD1.</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; text-align: justify; background-color: white"><B>Stargardt Disease</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">STGD1 is the most common inherited retinal dystrophy (causing
blurring or loss of central vision) in both adults and children. The disease is caused by a dysfunctional retina-specific gene
(ABCA4) which results in massive accumulation of toxic vitamin A byproducts (known as &ldquo;bisretinoids&rdquo;) in the retina
leading to retinal cell death and progressive loss of central vision. The fluorescent properties of bisretinoids and the development
of retinal imaging have helped ophthalmologists identify and monitor disease progression. Importantly, STGD1 and dry AMD share a
similar pathophysiology which is characterized by the excessive accumulation of cytotoxic bisretinoids, retinal cell death, and loss
of vision. Vision loss occurs slowly, despite peripheral expansion of &ldquo;dead retina&rdquo;, until the disease reaches the
center of the eye (the macula).</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"><B>Dry Age-related Macular Degeneration</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Dry AMD is a leading cause of vision loss in the U.S. and has no approved
treatments available. There are an estimated 11 million dry AMD patients in the U.S. and over 196 million patients worldwide with an estimated
global direct healthcare cost of US$255 billion.</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="text-align: center; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><IMG SRC="image_003.jpg" ALT="">&nbsp;</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; text-align: justify; background-color: white"><B>About Belite Bio</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Belite Bio is a San Diego based clinical stage biopharmaceutical drug
development company targeting currently untreatable eye diseases, such as atrophic age-related macular degeneration (commonly known as
dry AMD) and STGD1, in addition to specific metabolic diseases. For more information, follow us on <U>Twitter</U>, <U>Instagram</U>,
<U>LinkedIn</U>, <U>Facebook</U> or visit us at <U>www.belitebio.com</U>.</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"><B>Important Cautions Regarding Forward Looking Statements</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>This press release contains forward-looking statements, including
statements regarding the potential implications of clinical data for patients, and Belite Bio&rsquo;s advancement of, and anticipated
preclinical activities, clinical development, regulatory milestones, and commercialization of its product candidates. Actual results may
differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited
to Belite Bio&rsquo;s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates,
which may not support further development or regulatory approval; the content and timing of decisions made by the relevant regulatory
authorities regarding regulatory approval of Belite Bio&rsquo;s drug candidates; the potential efficacy of Tinlarebant on the treatment
of Dry AMD, as well as those risks more fully discussed in the &ldquo;Risk Factors&rdquo; section in Belite Bio&rsquo;s filings with the
U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Belite Bio, and
Belite Bio undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information,
future events or otherwise, except as may be required by law.</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #1D2228"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #1D2228"><B>Media and Investor Relations Contact:</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="color: #1D2228"><B>Jennifer Wu </B></FONT><U>/ir@belitebio.com</U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="color: #1D2228"><B>Tim McCarthy </B></FONT><U>/tim@lifesciadvisors.com</U></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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