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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) reported Q3 2024 financial results and clinical progress. The company has dosed the first patient in Phase 2/3 DRAGON II trial for Stargardt disease treatment and enrolled over 280 subjects in the Phase 3 PHOENIX trial for geographic atrophy. Cash position stands at $109.0 million, with Q3 net loss of $8.7 million. R&D expenses decreased to $6.8 million from $8.7 million year-over-year. The company appointed Dr. Hendrik Scholl as CMO and received $28.75 million from warrant exercises. An interim analysis from the Phase 3 DRAGON trial is expected by end of 2024 or early 2025.
Belite Bio (NASDAQ: BLTE) announced it will host a webcast on November 12, 2024 at 4:30 p.m. Eastern Time to discuss its third quarter 2024 financial results and provide a business update. The clinical-stage biopharmaceutical company, which focuses on developing novel therapeutics for degenerative retinal diseases, will make the webcast available through their website. A replay will be accessible for approximately 90 days following the event.
Belite Bio (NASDAQ: BLTE) has secured US$28.75 million through the exercise of warrants at US$44.14 per share for 651,380 ordinary shares. In exchange for this immediate cash exercise, the company will issue new unregistered warrants for the same number of shares with an exercise price of US$70.00 per share, valid for five years. If these new warrants are fully exercised, they could generate additional gross proceeds of approximately US$45.6 million. The company plans to use the proceeds for general corporate purposes.
Belite Bio, Inc (NASDAQ: BLTE), a clinical-stage biopharmaceutical company focusing on degenerative retinal diseases, has announced its participation in the American Academy of Ophthalmology Annual Meeting (AAO 2024) from October 18-21, 2024, in Chicago. The company will present data from its completed Phase II adolescent Stargardt disease trial.
Two presentations are scheduled:
- A podium presentation titled "Tinlarebant (LBS-008) for Adolescents with Stargardt Disease" by Dr. Quan Dong Nguyen on October 19, 2024, at 10:33 AM CDT.
- An e-poster presentation titled "Investigation of an Oral Retinol Binding Protein 4 Antagonist in the Treatment of Childhood-onset Stargardt Disease" by Dr. Nathan L Mata, available on-demand.
These presentations will showcase Belite Bio's progress in developing novel therapeutics for Stargardt disease, a degenerative retinal condition with significant unmet medical needs.
Belite Bio, a clinical-stage biopharmaceutical company (NASDAQ: BLTE) focusing on novel therapeutics for degenerative retinal diseases, has announced its participation in the Maxim Group 2024 Healthcare Virtual Summit. Dr. Hendrik P.N. Scholl, the company's Chief Medical Officer, will be part of the 'Ocular Drug Development' panel discussion.
The event is scheduled for Tuesday, October 15, 2024, at 11:00 am ET. Interested parties can access the live panel discussion through Maxim's M-Vest website. For registration and additional information, visitors are directed to https://m-vest.com/events/healthcare-10152024.
This participation underscores Belite Bio's commitment to advancing treatments for unmet medical needs in the field of degenerative retinal diseases.
Belite Bio (NASDAQ: BLTE) has dosed the first patient in the Phase 2/3 DRAGON II trial of Tinlarebant for Stargardt Disease (STGD1) treatment. The trial will evaluate the efficacy, safety, and tolerability of Tinlarebant in about 60 adolescent STGD1 subjects across the U.S., U.K., and Japan. Tinlarebant, an oral therapy designed to reduce vitamin A-based toxin accumulation causing retinal disease, has received Orphan Drug and Sakigake Designation in Japan. The trial follows a completed Phase 1b study in Japan and is part of Belite's efforts to address unmet needs in STGD1 treatment. Simultaneously, Belite's Phase 3 PHOENIX trial for Tinlarebant in Geographic Atrophy (GA) is ongoing with over 200 subjects enrolled.
Belite Bio (NASDAQ: BLTE), a clinical-stage biopharmaceutical company focusing on degenerative retinal diseases, has announced its participation in three upcoming investor conferences. The executive management team will attend:
1. H.C. Wainwright 26th Annual Global Investment Conference in New York on September 9, 2024, at 9:30 am ET for a fireside chat.
2. 2024 Cantor Global Healthcare Conference in New York on September 18, 2024, at 3:40 pm ET for a corporate presentation.
3. Deutsche Bank Depositary Receipts Virtual Investor Conference on September 25, 2024, at 11:00 am ET for a virtual corporate presentation.
Webcasts of all presentations will be available on Belite Bio's investor relations website and archived for 90 days after each event.
Belite Bio (NASDAQ: BLTE) has appointed Dr. Hendrik P. N. Scholl as its new Chief Medical Officer. Dr. Scholl is a globally recognized expert in ophthalmology, specializing in Stargardt disease and age-related macular degeneration (AMD). He brings decades of experience to Belite Bio's lead drug candidate, Tinlarebant, which targets these conditions.
Dr. Scholl's impressive career includes founding the Institute of Molecular and Clinical Ophthalmology Basel, serving as Professor of Ophthalmology at the University of Basel, and holding leadership positions at Johns Hopkins University. He is the coordinating principal investigator of the largest natural history study of Stargardt disease and has authored over 280 peer-reviewed articles.
Belite Bio (NASDAQ: BLTE) reported its Q2 2024 financial results and provided a corporate update. Key highlights include:
1. Tinlarebant, their novel oral therapy for Stargardt Disease (STGD1) and Geographic Atrophy (GA), is progressing in clinical trials.
2. The DRAGON II trial for STGD1 has completed Phase 1b enrollment with six subjects in Japan.
3. The PHOENIX trial for GA has enrolled approximately 200 subjects.
4. Q2 2024 financials: $112.3 million in cash and equivalents, R&D expenses of $9.1 million, and a net loss of $9.5 million.
5. The company raised $25 million in a registered direct offering in April 2024.
6. Interim analysis from the pivotal Phase 3 DRAGON trial is expected in Q4 2024.
Belite Bio (NASDAQ: BLTE), a clinical-stage biopharmaceutical company focusing on degenerative retinal diseases, has announced its participation in the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference. Dr. Nathan Mata, the company's Chief Scientific Officer, will present a corporate update on August 15, 2024, at 7:00 am ET.
The presentation will be available as a webcast under the "Events" tab on Belite Bio's investor relations website. Interested parties can access the replay, which will be archived for 90 days following the presentation date. This event provides an opportunity for Belite Bio to showcase its progress in developing novel therapeutics for unmet medical needs in retinal diseases.
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