Belite Bio Inc

Belite Bio, Inc. is a biopharmaceutical company engaged in the research and development of drugs. Its focus is on the treatment of eye diseases involving retinal degeneration such as atrophic age-related macular degeneration and autosomal recessive Stargardt disease. It also caters to metabolic diseases such as non-alcoholic fatty liver disease, nonalcoholic steatohepatitis, type 2 diabetes, and gout. The company was founded by Yu-Hsin Lin on March 27, 2018 and is headquartered in San Diego, CA.

Earnings data Q2 2023

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Earnings data Q2 2024

Earnings data Q3 2024

Earnings data Q4 2024

Belite Bio Inc advances oral therapy for retinal diseases

Belite Bio Inc's financials show solid cash reserves and strategic investments in research, while clinical trials progress positively with enrollment milestones and upcoming data releases.
The company's focus on safety, efficacy, and market differentiation for their oral therapeutic presents both challenges and opportunities in a competitive landscape.
Overall, Belite Bio Inc's innovative approach to treating Stargardt disease and GA shows promise, supported by regulatory designations and a clear path for future growth.

Belite Bio Inc reports revenue growth and progresses in Phase III trials

Belite Bio Inc shows positive revenue growth and financial stability but faces challenges in trial enrollment and managing expenses.
Tinlarebant's designations and progress in Phase III trials offer promising opportunities for future growth and FDA approval.
Balancing innovation with financial sustainability will be crucial for Belite Bio Inc's long-term success in the biopharmaceutical industry.

Belite Bio Inc reports Q4 loss, eyes positive trial outcomes

Belite Bio Inc's Q4 2023 performance reflects ongoing investment in research and development, with a focus on advancing treatments for retinal diseases.
The company's financial stability and upcoming milestones in 2024 position it well for future growth and progress in clinical trials.
Challenges in trial management and data handling require careful navigation, while opportunities lie in presenting key findings and exploring treatment synergies.

Belite Bio advances novel treatment for retinal diseases, financials stable

Belite Bio's Q1 2024 earnings call highlighted progress with Tinlarebant, a promising treatment for Stargardt disease and Geographic Atrophy. Despite financial challenges, the company's strong cash position and ongoing clinical trials position it well for future growth and potential market success.

Belite Bio Inc progresses in Stargardt trials, maintains strong cash position

Belite Bio Inc's Q2 2024 earnings call highlighted advancements in Tinlarebant trials, positive Phase II study results, and a robust financial position despite reporting a net loss. The company's focus on addressing Stargardt disease with Tinlarebant presents promising opportunities for future growth and market approval.

Belite Bio reports progress in clinical trials and financial stability

Belite Bio's Q3 performance reflects positive clinical and financial outcomes, positioning the company well for future growth and innovation in ocular disease treatments.
While facing challenges in patient tolerance monitoring and trial operations, Belite Bio's strengths in balance sheet stability and therapeutic efficacy offer opportunities for market success and expansion.
With strategic leadership additions and ongoing clinical advancements, Belite Bio is poised to make significant strides in addressing unmet medical needs in Stargardt disease and geographic atrophy.

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The webinar will take place on Wednesday, May 10, 2023 at 1:00 PM ET SAN DIEGO, May 04, 2023 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE), a clinical stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting retinal degenerative eye diseases which have significant unmet medical needs, today announced it will host a virtual Key Opinion Leader event on focusing on adolescent patients with Stargardt disease (STGD1) on Wednesday, May 10, 2023 at 1:00 PM Eastern Time. The event will feature Michel Michaelides, BSc, MB BS, MD(Res), FRCOphth, FACS (Moorfields Eye Hospital and UCL Institute of Ophthalmology) who will discuss progression of childhood-onset STGD1 and Belite Bio's Phase 2 study evaluating the safety and efficacy of Tinlarebant (LBS-008) in adolescent STGD1 patients.

Belite Bio to Host Key Opinion Leader Webinar Discussing Progression of Childhood-onset STGD1 and Relevance of the Tinlarebant 18-month Phase 2 Data

SAN DIEGO, April 25, 2023 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting retinal degenerative eye diseases which have significant unmet medical needs, today presented 18-month data from its ongoing two-year, open-label Phase 2 clinical study of Tinlarebant in adolescent STGD1 patients (“LBS-008-CT02”) as part of the poster presentation at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting (Presentation: April 25th 8:45 am – 10:45 am, CST).

Belite Bio Presented 18-Month Interim Data from a 24-Month Phase 2 Study of Tinlarebant in Adolescent Stargardt Disease at the 2023 ARVO Meeting

Virtual event on Wednesday, May 3 rd at 1:00 PM ET will feature key opinion leader Hendrik Scholl, M.D. from the University of Basel, Switzerland

Belite Bio to Host Key Opinion Leader Webinar on RBP4 Antagonist Tinlarebant in Late-Stage Development for Stargardt Disease 1

Belite Bio, Inc (NASDAQ:BLTE ) Q4 2022 Earnings Conference Call April 3, 2023 4:30 PM ET Company Participants Tom Lin - Chief Executive Officer Nathan Mata - Chief Scientific Officer Hao-Yuan Chuang - Chief Financial Officer Conference Call Participants Jennifer Kim - Cantor Fitzgerald Lachlan Hanbury-Brown - William Blair Yi Chen - H.C. Wainwright Bruce Jackson - The Benchmark Company Yuan Zhi - B.

Belite Bio, Inc (BLTE) Q4 2022 Earnings Call Transcript

SAN DIEGO, March 31, 2023 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite” or the “Company”), a San Diego based clinical stage biopharmaceutical drug development company targeting eye diseases with significant unmet medical needs, today announced its financial results for the full-year ended December 31, 2022 and provided a general business update.

Belite Bio Reports Full-Year 2022 Operational Highlights and Financial Results

SAN DIEGO, March 31, 2023 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug development company targeting eye diseases with significant unmet medical needs, will host a live webcast on Monday, April 3, 2023, at 4:30 p.m. Eastern time to discuss the Company's financial results for the full year ended December 31, 2022, and provide a general business update. The financial results will be issued in a press release on Friday, March 31, 2023.

Belite Bio to Host Webcast on April 3, 2023 to Discuss 2022 Full Year Financial Results

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SAN DIEGO, Nov. 18, 2022 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug development company targeting currently untreatable eye diseases, today announced that, following discussions with the FDA, it has finalized the study design for its planned Phase 3 clinical trial to evaluate efficacy and safety of Tinlarebant (a/k/a LBS-008) in patients with geographic atrophy (GA) associated with Dry AMD.

Belite Bio Finalizes Phase 3 Clinical Trial Plans for Advanced Dry AMD Treatment with Tinlarebant (LBS-008)

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“Potential Early Intervention with an Oral Treatment for Stargardt Disease and Dry Age-Related Macular Degeneration”

Belite Bio to Host Key Opinion Leader Webinar on October 27, 2022 to discuss LBS-008 Interim Data

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Apellis and Belite Bio were among the worst-performing biotech stocks Monday after presenting test results in two eye diseases. The post Why Top-Rated Biotechs Apellis, Belite Are Among The Worst Performers Today appeared first on Investor's Business Daily.

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SAN DIEGO, Oct. 01, 2022 (GLOBE NEWSWIRE) -- Belite Bio, Inc (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.

Belite Bio Presented 12-Month Interim Results of LBS-008 Phase 1b/2 Study in Adolescent Stargardt Disease at AAO Annual Meeting 2022

SAN DIEGO, Sept. 23, 2022 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug development company targeting currently untreatable eye diseases, today announced that the 1-year interim data from the 2-year Phase 1b/2 trial of LBS-008 in adolescent STGD1 will be presented at the “Late Breaking Development” session at the American Academy of Ophthalmology Annual Meeting (AAO 2022) being held September 30 – October 3, 2022 in Chicago.

Belite Bio Announces Late-Breaking Presentation at the American Academy of Ophthalmology 2022 Annual Meeting

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SAN DIEGO, Sept. 16, 2022 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug development company targeting currently untreatable eye diseases, today announced the approval from the National Medical Products Administration (NMPA) of China to initiate the Phase 3 clinical trial of LBS-008 in adolescent STGD1 in China.

Belite Bio Receives Approval of LBS-008 Phase 3 Clinical Trial in China

SAN DIEGO, Aug. 22, 2022 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug development company targeting currently untreatable eye diseases, today announced that it has commenced enrollment for the U.S. Phase 3 clinical trial of LBS-008 in patients with Stargardt Disease (STGD1), a progressively blinding disease with no approved treatment.

Belite Bio Initiates Pivotal Phase 3 Clinical Trial of LBS-008 in Stargardt Disease in the U.S.

Belite Bio, Inc (NASDAQ:BLTE ) Q2 2022 Earnings Conference Call August 11, 2022 4:30 PM ET Company Participants Tom Lin – Chief Executive Officer Nathan Mata – Chief Scientific Officer Hao-Yuan Chuang – Chief Financial Officer Conference Call Participants Bruce Jackson – The Benchmark Company Unidentified Company Representative [Call Starts Abruptly] First Half 2022 Financial Results Conference Call. After today's presentation, there will be an opportunity to ask questions.

Belite Bio, Inc's (BLTE) CEO Tom Lin on Q2 2022 Results - Earnings Call Transcript

SAN DIEGO, Aug. 10, 2022 (GLOBE NEWSWIRE) -- Belite Bio, Inc (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.

Belite Bio Reports First Half 2022 Operational Highlights and Financial Results

SAN DIEGO, Aug. 01, 2022 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug development company targeting untreatable eye diseases, will host a conference call on Thursday, August 11, 2022, at 4:30 p.m. Eastern time to discuss the Company's financial results for the first half, ended June 30, 2022, and provide a corporate progress update. The financial results will be issued in a press release on Wednesday, August 10, 2022.

Belite Bio to Host Conference Call on August 11, 2022 to Discuss First Half 2022 Financial Results

SAN DIEGO, July 19, 2022 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite” or the “Company”), a San Diego based clinical stage biopharmaceutical drug development company targeting untreatable eye diseases, today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to support Phase 3 development of LBS-008, the Company's orally administered treatment for Stargardt Disease (STGD1), a rare genetic eye disease that causes progressive vision loss in children and adults.

Belite Bio Submits Investigational New Drug (IND) Application to FDA for Approval to Proceed with LBS-008 Phase 3 Clinical Trial for the Treatment of Stargardt Disease

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SAN DIEGO, May 12, 2022 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite” or the “Company”), a clinical stage biopharmaceutical drug development company targeting currently untreatable eye diseases such as dry AMD and Stargardt disease, and metabolic diseases, today announced that the underwriters of its previously announced initial public offering (the “IPO”) have exercised in part their over-allotment option to purchase an additional 772,091 American Depositary Shares (the “ADS”) of the Company at the IPO price of $6.00 per ADS. Each ADS represents one ordinary share of Belite.

Belite Bio Announces Partial Exercise of Over-Allotment Option in Initial Public Offering

SAN DIEGO, May 05, 2022 (GLOBE NEWSWIRE) -- Belite Bio, Inc (the “Company”) (Nasdaq: BLTE),  a San Diego based clinical stage biopharmaceutical drug development company targeting currently untreatable eye diseases, such as atrophic Age-related Macular Degeneration (dry AMD) and Stargardt disease (STGD1), and metabolic diseases, presented interim results of a Phase 1b/2 study of LBS-008 in adolescent STGD1 at The Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2022. LBS-008 is Belite Bio's lead asset being developed for the treatment of STGD1 and Dry AMD. To view the full abstract click here.

News for Belite Bio Inc Stock (BLTE)