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Belite Bio, Inc. (NASDAQ: BLTE) is a clinical-stage biopharmaceutical company based in San Diego, California. Specializing in the development of novel therapeutics for untreatable age-related metabolic and degenerative retinal diseases, Belite Bio targets conditions such as macular degeneration, liver disease, and diabetes.
The company's flagship product, lbs-008 (Tinlarebant), is developed using its proprietary anti-RBP4 technology platform. Tinlarebant is currently in a Phase I clinical trial for dry age-related macular degeneration (AMD) and its juvenile form, Stargardt disease (STGD1). Both diseases involve retinal degeneration that can lead to permanent blindness. Tinlarebant has been granted orphan drug status in the U.S. and Europe, as well as rare pediatric disease status in the U.S.
Recent Achievements:
- Completed Phase 2 trial of Tinlarebant in childhood-onset Stargardt Disease, demonstrating promising results in slowing retinal lesion growth and stabilizing visual acuity.
- Initiated Phase III trials for GA and Stargardt disease, with enrollment completed for the Stargardt trial.
- Received positive results and feedback during presentations at major ophthalmology conferences.
Belite Bio is currently conducting the DRAGON trial and the PHOENIX trial, targeting different stages of these degenerative diseases. The company remains focused on its mission to deliver novel, oral therapies for eye diseases with significant unmet medical needs. Financially, Belite Bio reported strong liquidity with $95.5 million in cash and U.S. Treasury bills as of March 31, 2024, following a successful $25 million registered direct offering in April 2024.
Looking ahead, the company plans to continue its clinical trials and further the development of its pipeline products, while maintaining a strong balance sheet. Investors should note the potential tax implications related to the company's classification under U.S. tax laws.
For more information, follow Belite Bio on Twitter, Instagram, LinkedIn, and Facebook, or visit their website at www.belitebio.com.
Belite Bio (NASDAQ: BLTE), a clinical-stage biopharmaceutical company focused on developing novel therapeutics for degenerative retinal diseases, has announced a webcast scheduled for August 12, 2024, at 4:30 p.m. Eastern Time. The purpose of this webcast is to discuss the company's financial results for the second quarter ended June 30, 2024, and provide a business update.
Investors and interested parties can access the live webcast through the provided link or via the 'Presentations & Events' section of Belite Bio's Investor Relations website. A replay of the webcast will be available for approximately 90 days after the event, allowing those unable to attend the live session to review the information at their convenience.
Belite Bio (NASDAQ: BLTE), a clinical-stage biopharmaceutical firm specializing in treatments for degenerative retinal diseases, announced that its Chief Scientific Officer, Dr. Nathan Mata, will present a corporate update at the JonesHealthcare Seaside Summit. The event will take place in Encinitas, CA, on July 15, 2024, at 1:00 pm PT. The presentation will be available via webcast on the Belite Bio website under the 'Events' tab, with a replay accessible for 90 days post-presentation.
Belite Bio has received the Sakigake (Pioneer Drug) designation from Japan's MHLW for its lead drug, Tinlarebant, aimed at treating Stargardt Disease (STGD1). Tinlarebant, an oral tablet, has shown promise in a 24-month Phase 2 trial by slowing the progression of atrophic lesions in adolescent STGD1 patients. 42% of participants with known ABCA4 mutations didn't develop new lesions, and no change in existing lesions was observed.
The global Phase 3 trial for adolescent STGD1, named 'DRAGON,' has completed enrollment, with interim results expected in Q4 2024. Additionally, the DRAGON II trial has started, and a global Phase 3 trial for Geographic Atrophy (GA) in Dry AMD, termed 'PHOENIX,' is ongoing. Tinlarebant has also received Orphan Drug Designation in Japan for STGD1 treatment.
Belite Bio (NASDAQ: BLTE), a clinical-stage biopharmaceutical firm, announced its participation in the Benchmark’s 4th Annual Healthcare House Call Investor Conference. The event, set for May 21 and 22, 2024, will be held virtually. Belite Bio's executive management will host a fireside chat at 3:00 pm ET on May 21, 2024. The company focuses on developing novel therapeutics for degenerative retinal diseases with significant unmet medical needs.
Belite Bio (NASDAQ: BLTE) announced its Q1 2024 results and provided a corporate update. The company highlighted positive data from its Phase 2 trial of Tinlarebant in STGD1 patients, showing sustained lower atrophic lesion growth. Tinlarebant is also being evaluated in ongoing Phase 3 trials (DRAGON and PHOENIX) for STGD1 and GA, respectively. Interim data from these trials are expected in Q4 2024. Financially, Belite raised $25 million through a direct offering and reported a net loss of $7.9 million for Q1 2024, up from $6.9 million in Q1 2023. The company held $95.5 million in cash and U.S. treasury bills as of March 31, 2024.
Belite Bio, Inc. (NASDAQ: BLTE) will participate in the H.C. Wainwright 2nd Annual BioConnect Investor Conference in New York on May 20, 2024. The company will host a fireside chat at 3:30 pm ET, accessible via webcast on their investor relations website.
Belite Bio, Inc. (NASDAQ: BLTE) will host a webcast on May 14, 2024, to discuss the first quarter 2024 financial results and provide a business update. The company is a clinical-stage biopharmaceutical drug development company focused on degenerative retinal diseases. The webcast will be held at 4:30 p.m. Eastern Time.
Belite Bio, Inc. (BLTE) will participate in a Key Opinion Leader Webinar to discuss Stargardt Disease and Geographic Atrophy and share insights on Tinlarebant, a novel therapeutic. The webinar, moderated by Cantor Fitzgerald, will feature Dr. Michel Michaelides, a renowned expert. Tinlarebant is a promising treatment with Fast Track, Rare Pediatric Disease, and Orphan Drug designations.
Belite Bio presented additional analysis from a Phase 2 study of Tinlarebant in Stargardt Disease at the ARVO Annual Meeting. The 24-month trial showed promising results in slowing lesion growth and stabilizing visual acuity. Genetic profiling revealed that despite severe ABCA4 variants, 42% of treated subjects did not develop atrophic retinal lesions. A novel lesion size quantification method was able to detect atrophic lesions more accurately. The drug is now being evaluated in Phase 3 trials for Stargardt Disease and Geographic Atrophy.
Belite Bio presented promising data on Tinlarebant, an oral tablet aimed at slowing disease progression in patients with retinal diseases at ARVO 2024. The Phase 2 trial showed a significant reduction in atrophic lesion growth in STGD1 patients compared to standard treatment. Enrollment for Phase 3 trials is complete, with interim data expected in Q4 2024.
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