Belite Bio, Inc.
We are a clinical biopharmaceutical drug development company focused on novel therapeutics targeting currently untreatable eye diseases involving retinal degeneration such as atrophic age-related macular degeneration (commonly known as dry AMD) and autosomal recessive Stargardt disease, or STGD1, both of which progressively lead to permanent blindness, and metabolic diseases such as non-alcoholic fatty liver disease (NAFLD) as well as non-alcoholic steatohepatitis (NASH) and Type 2 diabetes (T2D) and gout. (Note: This is an IPO of 6.0 million American Depositary Shares (ADS), representing 6.0 million ordinary shares. Belite Bio, Inc. is a Cayman Islands exempted holding company with headquarters in San Diego, and operations in the United States and Australia.)
We believe our lead product candidate, LBS-008, or Tinlarebant, if approved, would provide a novel treatment option where there currently is none. LBS-008 is an oral once-a-day treatment that can reduce and maintain the delivery of vitamin A (retinol) to the eye as a means to reduce the accumulation of toxic vitamin A by-products in ocular tissue. This effect is achieved through the ability of LBS-008 to reduce and maintain the level of serum retinol binding protein 4, or RBP4, which carries retinol from the liver to the eye. In clinical trials, LBS-008 has demonstrated its target specificity and potency that we believe could be clinically meaningful to treat STGD1 patients. We initiated an open-label, dose-finding Phase 1b/2 clinical trial in adolescent STGD1 patients in mid-2020 in Australia and Taiwan. The study design includes two portions: Phase 1b and Phase 2. We have completed the Phase 1b portion of this study in 11 adolescent STGD1 patients, which has extended into a two-year Phase 2 study with 13 adolescent STGD1 patients in Australia and Taiwan. The preliminary data from the Phase 1b portion has shown that LBS-008 can achieve a mean RBP4 reduction of > 70%, relative to baseline values. We are currently conducting the Phase 2 portion of this study. See “—Phase 1b/2 Clinical Trial in STGD1” below for more information.
As of the date of this prospectus, we have initiated our Phase 3 clinical trial, to evaluate the safety and efficacy of LBS-008 in adolescent STGD1 patients and received approval to commence patient enrollment in Taiwan, the U.K., Hong Kong and Switzerland. In addition, we are in the process of applying for the necessary approvals to conduct the same clinical trial in other relevant jurisdictions.
STGD1 is a rare monogenetic juvenile-onset macular dystrophy that is characterized by the aberrant and excessive accumulation of toxic vitamin A by-products known as bisretinoids and cellular debris, or lipofuscin, which precedes the death of retinal tissue and loss of vision. Although an orphan disease, STGD1 is the most common juvenile macular degeneration.
Dry AMD is a heterogenous condition that arises from a complex interplay between age, genetics and environmental factors such as diet and smoking, but has a pathology and course of disease that strongly resembles that of STGD1, particularly in intermediate and advanced stages. There are no approved therapies for STGD1 or dry AMD.
(Note: Belite Bio, Inc. priced its IPO on April 28, 2022, in line with the terms in its prospectus: 6.0 million shares at $6 – the mid-point of its $5.50-to-$6.50 range – to raise $36 million. Lin Bioscience International Ltd., Belite Bio’s principal shareholder, agreed to buy $15.0 million of ADS in the IPO, the company said.)
|Address||5820 Oberlin Drive, Suite 101, San Diego, CA 92121|
|View Prospectus:||Belite Bio, Inc.|
|Revenues||$0 mil (last 12 months)|
|Net Income||$-9.67 mil (last 12 months)|
|Price range||$6.00 - $6.00|
|Est. $ Volume||$36.0 mil|
|Manager / Joint Managers||The Benchmark Company|
|Expected To Trade:||4/29/2022|
|Quiet Period Expiration Date:||Available only to Subscribers|
|Lock-Up Period Expiration Date:||Available only to Subscribers|
|SCOOP Rating||Available only to Subscribers|
|Rating Change||Available only to Subscribers|