Latest news with #BeliteBio
Yahoo
21-05-2025
- Business
- Yahoo
Belite Bio Announces FDA Granting of Breakthrough Therapy Designation for Tinlarebant for the Treatment of Stargardt Disease
Designation is based on the pivotal Phase 3 DRAGON trial interim analysis results demonstrating Tinlarebant's efficacy and favorable safety profile Trial completion expected by Q4 2025 (including a three-month follow-up period) Tinlarebant has previously been granted Fast Track and Rare Pediatric Disease Designations in the U.S., Orphan Drug Designation in the U.S., Europe, and Japan, and the Pioneer Drug Designation in Japan for Stargardt disease SAN DIEGO, May 21, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Tinlarebant for the treatment of Stargardt disease (STGD1) based on the previously reported interim data from the ongoing Phase 3 DRAGON trial. There are currently no approved treatments for STGD1. 'Breakthrough Therapy Designation is an exciting milestone that underscores Tinlarebant's potential to address a serious unmet need for patients with STGD1 — a condition where there are currently no approved therapies,' said Dr. Tom Lin, Chairman and CEO of Belite Bio. 'We remain deeply committed to the Stargardt community and to advancing Tinlarebant as we prepare for the DRAGON study readout expected by the end of this year.' The Breakthrough Therapy Designation is supported by a pre-specified interim analysis of the pivotal, global Phase 3 DRAGON trial data of Tinlarebant in adolescent STGD1 patients. The designation is based on preliminary clinical evidence indicating that a drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. In addition, according to the Data Safety and Monitoring Board (DSMB), Tinlarebant continued to demonstrate a favorable safety profile consistent with prior findings and its mechanism of action. Importantly, visual acuity remained stable in the majority of participants, with mean changes from baseline of less than three letters over the course of the two-year study. 'This granting represents a significant achievement for Belite Bio and serves as validation of a therapeutic approach that directly targets the underlying pathophysiology of STGD1 in order to slow or halt the disease process,' stated Dr. Nathan L. Mata, Belite Bio's Chief Scientific Officer. Dr. Mata noted further, 'Although it has been more than 26 years since the development of the first STGD1 mouse model, it is encouraging to know that the learnings from this model, and the many years spent evaluating the therapeutic benefit of targeting retinol binding protein 4 (RBP4) to reduce the accumulation of cytotoxic byproducts of vitamin A, have advanced our understanding of the disease and have led us closer than ever to the realization of an approved treatment for patients living with STGD1.' 'We are very encouraged by the FDA's decision. STGD1 is a progressive condition that typically begins in adolescence and inevitably leads to legal blindness. People living with STGD1 experience a severe loss of quality of life even though they typically have decades of their lives ahead of them,' said Dr. Hendrik Scholl, Chief Medical Officer of Belite Bio. 'Breakthrough Therapy Designation reinforces the importance of our work to develop a potential therapy for people who currently have limited options. We look forward to continuing to evaluate Tinlarebant's safety and efficacy as the DRAGON trial progresses.' About FDA Breakthrough Therapy DesignationThe FDA grants Breakthrough Therapy Designation to expedite the development and regulatory review of drugs that are intended for serious or life-threatening conditions. The designation is based on preliminary clinical evidence indicating that a drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Breakthrough Therapy Designation affords all of the benefits of the fast-track program, including eligibility for rolling review and priority review, as well as additional regulatory engagement to facilitate expedited development, with the aim to bring therapies to patients more quickly. About Phase 3 DRAGONThe pivotal Phase 3 DRAGON trial is a randomized, double-masked, placebo-controlled, global study designed to evaluate the safety and efficacy of Tinlarebant in adolescent patients with Stargardt disease. The trial enrolled 104 subjects across 11 jurisdictions, including the United States, United Kingdom, Germany, France, Belgium, Switzerland, Netherlands, China, Hong Kong, Taiwan, and Australia, with a 2:1 randomization (Tinlarebant:placebo). The primary efficacy endpoint is the growth rate of atrophic lesions, alongside the assessment of safety and tolerability. About TinlarebantTinlarebant is an orally administered, once-a-day tablet intended as an early intervention for maintaining the health and integrity of retinal tissues in Stargardt disease type 1 (STGD1) and Geographic Atrophy (GA) patients. Currently, there are no FDA approved treatments for STGD1 and no approved orally administered treatments for GA. Therefore, if approved, Tinlarebant would be a novel oral therapeutic addressing an unmet medical need in both STGD1 and GA. About Belite BioBelite Bio is a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, such as Stargardt disease type 1 (STGD1) and Geographic Atrophy (GA) in advanced dry age-related macular degeneration (AMD), in addition to specific metabolic diseases. Belite's lead candidate, Tinlarebant, an oral therapy intended to reduce the accumulation of toxins in the eye, is currently being evaluated in a Phase 3 study (DRAGON) and a Phase 2/3 study (DRAGON II) in adolescent STGD1 subjects and a Phase 3 study (PHOENIX) in subjects with GA. For more information, follow us on X, Instagram, LinkedIn, and Facebook or visit us at Important Cautions Regarding Forward Looking StatementsThis press release contains forward-looking statements about future expectations and plans, as well as other statements regarding matters that are not historical facts. These statements include but are not limited to statements regarding the potential implications of clinical data for patients, interim analysis and recommendation from DSMB; Belite Bio's advancement of, and anticipated future activities on preclinical studies, clinical development, regulatory milestones, and commercialization of its product candidates; and any other statements containing the words 'expect', 'hope', 'indicate', 'look forward to', and similar expressions. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Belite Bio's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the timing of potential submission with FDA; the timing to complete relevant clinical trials and/or to receive the interim/final data of such clinical trials; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Belite Bio's drug candidates; the potential efficacy of Tinlarebant, as well as those risks more fully discussed in the 'Risk Factors' section in Belite Bio's filings with the U.S. 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, except as may be required by law. Media and Investor Relations Contact:Jennifer Wu ir@ Julie Fallonbelite@ in to access your portfolio
Yahoo
16-05-2025
- Business
- Yahoo
We're Not Worried About Belite Bio's (NASDAQ:BLTE) Cash Burn
We can readily understand why investors are attracted to unprofitable companies. For example, although software-as-a-service business lost money for years while it grew recurring revenue, if you held shares since 2005, you'd have done very well indeed. But the harsh reality is that very many loss making companies burn through all their cash and go bankrupt. So should Belite Bio (NASDAQ:BLTE) shareholders be worried about its cash burn? For the purposes of this article, cash burn is the annual rate at which an unprofitable company spends cash to fund its growth; its negative free cash flow. We'll start by comparing its cash burn with its cash reserves in order to calculate its cash runway. Our free stock report includes 1 warning sign investors should be aware of before investing in Belite Bio. Read for free now. A company's cash runway is the amount of time it would take to burn through its cash reserves at its current cash burn rate. When Belite Bio last reported its March 2025 balance sheet in May 2025, it had zero debt and cash worth US$145m. In the last year, its cash burn was US$29m. Therefore, from March 2025 it had 4.9 years of cash runway. Importantly, though, analysts think that Belite Bio will reach cashflow breakeven before then. If that happens, then the length of its cash runway, today, would become a moot point. The image below shows how its cash balance has been changing over the last few years. View our latest analysis for Belite Bio Belite Bio didn't record any revenue over the last year, indicating that it's an early stage company still developing its business. So while we can't look to sales to understand growth, we can look at how the cash burn is changing to understand how expenditure is trending over time. Cash burn was pretty flat over the last year, which suggests that management are holding spending steady while the business advances its strategy. Clearly, however, the crucial factor is whether the company will grow its business going forward. For that reason, it makes a lot of sense to take a look at our analyst forecasts for the company. While Belite Bio is showing a solid reduction in its cash burn, it's still worth considering how easily it could raise more cash, even just to fuel faster growth. Issuing new shares, or taking on debt, are the most common ways for a listed company to raise more money for its business. One of the main advantages held by publicly listed companies is that they can sell shares to investors to raise cash and fund growth. By looking at a company's cash burn relative to its market capitalisation, we gain insight on how much shareholders would be diluted if the company needed to raise enough cash to cover another year's cash burn. Since it has a market capitalisation of US$2.0b, Belite Bio's US$29m in cash burn equates to about 1.5% of its market value. That means it could easily issue a few shares to fund more growth, and might well be in a position to borrow cheaply. As you can probably tell by now, we're not too worried about Belite Bio's cash burn. For example, we think its cash runway suggests that the company is on a good path. Its weak point is its cash burn reduction, but even that wasn't too bad! Shareholders can take heart from the fact that analysts are forecasting it will reach breakeven. After considering a range of factors in this article, we're pretty relaxed about its cash burn, since the company seems to be in a good position to continue to fund its growth. An in-depth examination of risks revealed 1 warning sign for Belite Bio that readers should think about before committing capital to this stock. Of course, you might find a fantastic investment by looking elsewhere. So take a peek at this free list of interesting companies, and this list of stocks growth stocks (according to analyst forecasts) Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Insider
14-05-2025
- Business
- Business Insider
Belite Bio reports Q1 EPS (45c), consensus (37c)
As of March 31, 2025, the Company had $157.4 million in cash, liquidity funds, time deposits, and U.S treasury bills. 'We continue to advance the clinical development of Tinlarebant, reaching a major milestone with the favorable interim analysis of our Phase 3 DRAGON trial earlier this year,' said Dr. Tom Lin, Chairman and CEO of Belite Bio (BLTE). 'We are excited by the encouraging feedback from the DSMB on the safety and efficacy outcomes in DRAGON as we work toward trial completion by the end of 2025. We are focused on maintaining strong execution across our late-stage clinical programs as we aim to deliver new treatment options for people living with degenerative retinal diseases, where there is significant unmet need.' Protect Your Portfolio Against Market Uncertainty
Hamilton Spectator
12-05-2025
- Business
- Hamilton Spectator
Belite Bio, Inc to Present at the dbVIC - Deutsche Bank ADR Virtual Investor Conference May 15th
SAN DIEGO, May 12, 2025 (GLOBE NEWSWIRE) — Belite Bio, Inc (NASDAQ: BLTE) a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that CSO, Dr. Nathan L. Mata will present at the dbVIC - Deutsche Bank American Depositary Receipt (ADR) Virtual Investor Conference on May 15, 2025. This virtual investor conference is aimed exclusively at introducing global companies with ADR programs to investors. DATE: May 15th TIME: 12:30 pm ET LINK: REGISTER HERE This will be a live, interactive online event where investors are invited to ask the company questions in real-time. If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available after the event. It is recommended that online investors pre-register and run the online system check to expedite participation and receive event updates. Participation is free of charge. Recent Company Highlights About Belite Bio Belite Bio is a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, such as Stargardt disease type 1 (STGD1) and Geographic Atrophy (GA) in advanced dry age-related macular degeneration (AMD), in addition to specific metabolic diseases. Belite's lead candidate, Tinlarebant, an oral therapy intended to reduce the accumulation of toxins in the eye, is currently being evaluated in a Phase 3 study (DRAGON) and a Phase 2/3 study (DRAGON II) in adolescent STGD1 subjects and a Phase 3 study (PHOENIX) in subjects with GA. For more information, follow us on X , Instagram , LinkedIn , Facebook or visit us at . About Virtual Investor Conferences® Virtual Investor Conferences (VIC) is the leading proprietary investor conference series that provides an interactive forum for publicly traded companies to seamlessly present directly to investors. Providing a real-time investor engagement solution, VIC is specifically designed to offer companies more efficient investor access. Replicating the components of an on-site investor conference, VIC offers companies enhanced capabilities to connect with investors, schedule targeted one-on-one meetings and enhance their presentations with dynamic video content. Accelerating the next level of investor engagement, Virtual Investor Conferences delivers leading investor communications to a global network of retail and institutional investors. CONTACTS: Belite Bio Jennifer Wu ir@ Julie Fallon belite@ Virtual Investor Conferences John M. Viglotti SVP Corporate Services, Investor Access OTC Markets Group (212) 220-2221 johnv@
Yahoo
12-05-2025
- Business
- Yahoo
Belite Bio, Inc to Present at the dbVIC - Deutsche Bank ADR Virtual Investor Conference May 15th
Company invites individual and institutional investors, as well as advisors and analysts, to attend online at SAN DIEGO, May 12, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that CSO, Dr. Nathan L. Mata will present at the dbVIC - Deutsche Bank American Depositary Receipt (ADR) Virtual Investor Conference on May 15, 2025. This virtual investor conference is aimed exclusively at introducing global companies with ADR programs to investors. DATE: May 15th TIME: 12:30 pm ET LINK: REGISTER HERE This will be a live, interactive online event where investors are invited to ask the company questions in real-time. If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available after the event. It is recommended that online investors pre-register and run the online system check to expedite participation and receive event updates. Participation is free of charge. Recent Company Highlights DRAGON trial, a pivotal global Phase 3 trial of Tinlarebant in adolescent Stargardt disease (STGD1) subjects is expected to be completed by Q4 2025 Following a pre-specified interim analysis, an independent DSMB recommended to submit the interim analysis data of DRAGON trial for further regulatory review for drug approval Pivotal global Phase 3 PHOENIX trial of Tinlarebant in geographic atrophy (GA) subjects is ongoing with more than 460 subjects enrolled About Belite BioBelite Bio is a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, such as Stargardt disease type 1 (STGD1) and Geographic Atrophy (GA) in advanced dry age-related macular degeneration (AMD), in addition to specific metabolic diseases. Belite's lead candidate, Tinlarebant, an oral therapy intended to reduce the accumulation of toxins in the eye, is currently being evaluated in a Phase 3 study (DRAGON) and a Phase 2/3 study (DRAGON II) in adolescent STGD1 subjects and a Phase 3 study (PHOENIX) in subjects with GA. For more information, follow us on X, Instagram, LinkedIn, Facebook or visit us at About Virtual Investor Conferences®Virtual Investor Conferences (VIC) is the leading proprietary investor conference series that provides an interactive forum for publicly traded companies to seamlessly present directly to investors. Providing a real-time investor engagement solution, VIC is specifically designed to offer companies more efficient investor access. Replicating the components of an on-site investor conference, VIC offers companies enhanced capabilities to connect with investors, schedule targeted one-on-one meetings and enhance their presentations with dynamic video content. Accelerating the next level of investor engagement, Virtual Investor Conferences delivers leading investor communications to a global network of retail and institutional investors. CONTACTS:Belite BioJennifer Wuir@ Fallonbelite@ Virtual Investor Conferences John M. ViglottiSVP Corporate Services, Investor AccessOTC Markets Group (212) 220-2221johnv@
