-LBS-008 (also known as Tinlarebant) is Belite Bio’s oral tablet for the treatment of Stargardt’s disease (STGD1) and dry AMD
-A 2-year phase 2 trial in adolescent STGD1 and a global phase 3 trial in adolescent STGD1 are ongoing.
-The phase 3, multicenter, randomized, double-masked, placebo-controlled study to evaluate the safety and efficacy of TinlaRebant in the treatment of StArGardt’s disease in adolescent subjects (DRAGON) has begun in the US, the UK , Germany, Belgium, Switzerland, Hong Kong, Taiwan and Australia, and several patients have been enrolled
-LBS-008, Belite Bio’s lead asset, has received Fast Track Designation, Rare Pediatric Disease Designation (RPD) in the US, and Orphan Drug Designation (ODD) in the US and Europe for STGD1
– Conference call and webcast today, August 11, 2022, at 4:30 PM ET
SAN DIEGO, Aug. 10, 2022 (GLOBE NEWSWIRE) — Belite BioInc (NASDAQ: BLTE), a San Diego-based clinical-stage biopharmaceutical drug development company targeting untreatable eye diseases, today announced its financial results for the first six months ended June 30, 2022 and provided a general business update.
“We are pleased to be listed on Nasdaq to continue to advance clinical trials of LBS-008,” said Dr. Tom Lin, Belite’s President and CEO. “With the promising results from the Phase 2 trial in early-onset STGD1 subjects, we have initiated the overall Phase 3 trial for LBS-008 and believe we are on a clear clinical development path to accelerate and advance a promising treatment for STGD1. and dry AMD.”
Commercial highlights of the first half of 2022 and upcoming milestones:
Therapeutic programs targeting STGD1 and dry AMD
LBS-008 (also known as Tinlarebant): RBP4 antagonist administered orally
• LBS-008 is an orally available small molecule retinol-binding protein 4 (RBP4) antagonist that selectively reduces the delivery of vitamin A (retinol) to the eye, resulting in reduced toxic byproducts of vitamin A (bisretinoids) that have been implicated. in the initiation and progression of STGD1. Sponsored by the NIH Blueprint program to treat non-neovascular age-related macular degeneration (Dry AMD), LBS-008 is also endorsed by the NIH as a promising first-in-class oral medication to slow or stop the progression of Dry AMD, a disease which mainly affects the elderly and shares a similar pathophysiology to STGD1.
• There are currently no US Food and Drug Administration (FDA) approved treatments for STGD1 or dry AMD.
•LBS-008 has received FDA Fast Track Designation, Rare Pediatric Disease Designation (RPD) in the US, and Orphan Drug Designation (ODD) in the US and Europe for STGD1.
•Belite has completed three randomized, double-blind, placebo-controlled Phase 1 trials of LBS-008 in healthy adult subjects, including a single-dose ascending or SAD trial in 40 subjects in the US, and a SAD trial in 39 subjects and a multiple ascending dose, or MAD, trial in 32 healthy adult subjects in Australia. These trials were conducted to confirm the safety, toxicity, PK and PD of LBS-008 over a range of SAD (10-50 mg in the US; 25-400 mg in Australia) / MAD (5-25 mg in Australia) levels in healthy adult subjects under fasted/fed conditions.
•Belite is currently conducting a 2-year Phase 2 trial and a 2-year Phase 3 (DRAGON) trial of LBS-008 in STGD1 adolescent subjects.
•The phase 2 trial has enrolled a total of 13 subjects at clinical sites in Australia and Taiwan. Preliminary data from the phase 2 trial at the first 6-month interval show that 8 of 13 patients (or 61.5%) experienced an increase in best-corrected visual acuity (BCVA) in at least one eye, including 2 patients who recorded a BCVA Gain in both eyes. In addition, there were no atrophic lesions in any of the 13 subjects at baseline, and only 1 subject showed evidence of a retinal lesion (~0.3 mm2 in size) at 6 months. Belite expects the next data readout from this phase 2 trial to occur in the last quarter of 2022, when all subjects have completed 12 months of treatment.
•On July 19, 2022, an Investigational New Drug (IND) application was submitted to the FDA to initiate the DRAGON trial in the US. The DRAGON trial is a 2-year, randomised, double-masked, placebo-controlled, global, multicenter trial. -center, study designed to evaluate the safety and efficacy of LBS-008 in adolescent patients with STGD1. Currently, the DRAGON trial has started in the US, UK, Germany, Belgium, Switzerland, Hong Kong, Taiwan and Australia, and multiple patients have been enrolled. Belite has additional plans to file trial requests in other jurisdictions. (For more information, visit clinicaltrials.gov at
• Because the accumulation of toxic bisretinoids has also been implicated in the progression of dry AMD, Belite believes that LBS-008 also has the potential to be effective for the treatment of dry AMD. Belite plans to initiate a phase 2/3 clinical trial for dry AMD in the 4th quarter of 2022.
The company strengthened its balance sheet with an initial public offering
Belite Bio (NASDAQ: BLTE ) went public on the Nasdaq on April 29, 2022 and raised net proceeds of approximately $36.1 million, including the award. The Company expects to use the net proceeds to fund the Phase 3 clinical trial of LBS-008 for STGD1, additional clinical development of LBS-008 for dry AMD, working capital and other general corporate purposes.
Financial results for the first half of 2022:
• Cash and cash equivalents: As of June 30, 2022, the company had $48.7 million in cash.
• R&D Expenses: For the six months ended June 30, 2022, research and development expenses were $2.5 million compared to $3.6 million for the same period last year 2021. Research and development expenses decreased primarily due to increased costs of drug manufacturing and STGD1 toxicity studies. Preparation of phase 3 during the first semester of 2021.
• General and administrative expenses: For the six months ended June 30, 2022, general and administrative expenses were $1.1 million compared to $1.2 million for the same period in 2021 .
• Net Loss: For the six months ended June 30, 2022, the company reported a net loss of $3.5 million, or ($0.23) per share, compared to a net loss of 4.7 million or ($0.49) per share during the same period in 2021. .
Belite Bio will host a conference call/webcast to discuss the company’s financial results and provide a business update. The call is scheduled for August 11, 2022 at 4:30 PM Eastern Time.
Webcast link instructions
You can join a live webcast of the conference call at or the “Presentations and Events” section of the Company’s Investor Relations website a https://investors.belitebio.com/presentations-events/events. A replay will be available approximately two hours after the event for 30 days.
Registration instructions by phone
To participate in the live call, register at https://register.vevent.com/register/BI1ef44339069942b696cb9a1a54d14d41. Once registered, you will receive dial numbers and unique PIN numbers by email. At the time of the call, you will dial the numbers from the confirmation email, and upon entering the unique PIN, it will be sent to the call.
About Belite Bio
Belite Bio is a San Diego-based clinical-stage biopharmaceutical drug development company targeting untreatable eye diseases such as atrophic age-related macular degeneration (commonly known as dry AMD) and Stargardt disease and diseases metabolic For more information, follow us on Twitter, Instagram, LinkedIn, Facebook or visit us at www.belitebio.com.
This press release contains forward-looking statements, including statements about the potential implications of clinical data for patients and Belite Bio’s advancement and planned 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 a number of important factors, including, but not limited to, Belite Bio’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results of its drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by relevant regulatory authorities regarding regulatory approval of Belite Bio’s drug candidates; Belite Bio’s ability to achieve commercial success for its drug candidates, if approved; Belite Bio’s ability to obtain and maintain intellectual property protection for its technology and drugs; Belite Bio’s reliance on third parties to carry out drug development, manufacturing and other services; Belite Bio’s limited operating history and Belite Bio’s ability to obtain additional funds for operations and to complete the development and commercialization of its drug candidates; Belite Bio’s ability to enter into additional collaboration agreements beyond its existing partnerships or strategic collaborations, and the impact of the COVID-19 pandemic on Belite Bio’s clinical development, commercial and other operations, as well as the risks discussed more fully in “Risk Factors”. ” section in Belite Bio’s filings with the US 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 , unless necessary. by law
BELITE BIO, INC
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSSES
(in thousands of US dollars, except for share and per share amounts)
For six months
Ended on June 30
Research and development 3,640 2,457
General and administrative 1,158 1,102
Total operating expenses 4,798 3,559
Operating loss (4,798) (3,559)
Total Other income, net 77 98
Loss before income tax (4,721) (3,461)
Income tax expense — —
Net loss (4,721) (3,461)
Other comprehensive losses
Foreign currency translation adjustments, net of nil taxes (87) (157)
Total Global Loss $(4,808) $(3,618)
Weighted average number of ordinary shares used in the calculation per share:
– Basic and diluted 9,567,997 14,992,848
Net loss per ordinary share
– Basic and diluted (0.49) $ (0.23)
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEET
June 30, 2021
Current assets $17,431 $49,927
Other assets 917 1,130
Total assets $18,348 $51,057
Total liabilities $1,635 $1,426
Total convertible preferred shares 31,806 —
Total net worth (deficit) (15,093) 49,631
Total liabilities, convertible preferred stock and capital (deficit) $18,348 $51,057
Authorized ordinary shares 492,179,086 492,179,086
Ordinary shares issued and in circulation 10,274,403 24,867,408
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