BLTE

This article first appeared on GuruFocus. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Belite Bio Inc (NASDAQ:BLTE) received FDA acceptance of its New Drug Application (NDA) for Tinlarabant with Priority Review, establishing a PDUFA date of February 12, 2027. New secondary endpoint data from the Phase 3 DRAGON study presented at ASRS showed that Tinlarabant halted or slightly decreased QAF values (by ~2%) at month 25, compared to a ~20% increase in the placebo group. The company is initiating a pediatric study (PIP) in London to investigate Tinlarabant in patients aged 3 to 11, potentially expanding the label to younger patients. Belite Bio Inc (NASDAQ:BLTE) ended the quarter with a strong cash position of $780 million, providing a runway to commercialize Tinlarabant and advance its pipeline. The company expects to receive a Priority Review Voucher (PRV) upon approval due to its Rare Pediatric Disease designation, which could be monetized. The company is progressing with a parallel regulatory submission in Japan, leveraging the Sakigake designation, with a potential approval timeline roughly three months after the FDA decision. R&D expenses increased significantly to $18.2 million in Q2 2026, up from $11 million in Q2 2025, partly due to a confidential royalty payment for a Phase 3 milestone. SG&A expenses more than doubled to $16.7 million in Q2 2026 from $6.5 million in the prior year, driven by team expansion and professional fees. The company's GAAP net loss widened to $28.4 million in Q2 2026, compared to a $16.3 million loss in the same quarter of 2025. The interim analysis for the Geographic Atrophy (GA) trial has been delayed to Q1 2027, likely after the FDA PDUFA date, due to the company's focus on the regulatory review process. The company remains uncertain about the final FDA label, as discussions have not yet occurred, and it cannot confirm whether the label will include patients over 20 years old. The company is unable to disclose the amount of the royalty payment, which may raise questions about transparency regarding its R&D cost structure. Warning! GuruFocus has detected 4 Warning Signs with BLTE. Is BLTE fairly valued? Test your thesis with our free DCF calculator. Q: What are your thoughts on the role that DRAGON 2 can play for the US filing and/or regulatory process, and do you have trial plans to move the label below 12 years old in the near term? A: Dr. Tom Lin (Chairman and CEO) stated that DRAGON 2 is still primarily a Japan study for the PMDA and is not expected to contribute to the NDA process. Dr. Hendrik Scholl (Chief Medical Officer) added that they are initiating a pediatric study (PIP) in London to investigate Tinlarabet in patients aged 3 to 11, which will inform regulatory processes for patients younger than 12 years old. Q: Could you tell us how much the royalty payment was, the one-timer that's within R&D, and what are your thoughts on European filing? A: Haoyang Zhong (CFO) confirmed the royalty payment is related to the completion of the Phase III study but declined to disclose the specific amount, citing confidentiality with Columbia assets. Dr. Lin stated that the European filing will likely occur after the FDA approval, as the company's top priority is the PDUFA date of February 12, 2027. They want to align all communications with regulatory authorities outside the US following the FDA discussion and approval. Q: Have you stated where your manufacturing site is and whether that facility has completed an FDA inspection recently, and what is your latest thought on the possibility of an ADCOM? A: Dr. Lin confirmed they have both ex-US and US-based CDMOs, but declined to reveal the names, stating they are "big names in the industry." Regarding ADCOM, he stated that no ADCOM is currently planned, but the FDA could request one further down the line. He noted that since they just received the acceptance, they don't have further details at this stage. Q: Do you expect a priority review voucher if you receive approval, and if so, would you look to auction it for cash runway modeling purposes? A: Haoyang Zhong (CFO) confirmed that they expect to receive a priority review voucher upon approval due to the rare pediatric disease designation. However, they have not yet decided whether to sell or use it, and will monitor the market and their own pipeline before making a decision. Q: Could you provide an update on the geographic atrophy (GA) trial, whether you're still planning an interim readout later this year, and the precise timing? A: Dr. Lin explained that the GA interim analysis falls during the busiest time with FDA interactions, given the PDUFA date in mid-February. With the busiest period expected in December and January 2027, the interim analysis for GA will likely occur in the first quarter of next year, probably after February. Q: Has the FDA clearly indicated that the label will include patients over the age of 20 years old? A: Dr. Lin stated that there haven't been any discussions on the label yet, but based on the data, they expect to get a full or broader label. Dr. Hendrik Scholl (Chief Medical Officer) added that lesion growth is not dramatically different across age groups, as shown in the Proxstar study, and since the underlying cause (ABCA4 dysfunction) is the same, there is no reason the label would not include patients older than 20. However, he emphasized they don't want to comment on the potential label while the NDA is under review. Q: What percentage of patients have been compliant with the dosing regimen after 24 months? A: Dr. Nathan Mata (Chief Scientific Officer) confirmed that compliance in the GA study is in excess of 90%. Q: What's your estimated timeline for submission in Japan? A: Dr. Lin stated that Japan will happen concurrently with the FDA process. Given the Sakigake designation, approval in Japan is expected approximately three months after FDA approval. The PMDA submission is happening in parallel with the FDA submission. Q: Could you provide details on the new secondary endpoint data presented at ASRS regarding QAF values? A: Dr. Lin highlighted that at ASRS, they presented data showing subjects treated with Tinlarabet showed a halt to slightly decreased QAF values (decreased by approximately 2% at month 25 compared to baseline), while placebo subjects exhibited an approximately 20% increase in QAF values over the same period. QAF is a marker of toxic bisretinoid accumulation, a key driver of retinal degeneration in Stargardt disease, and its prevention or reduction reinforces the drug's potential to halt or slow lesion growth. Q: Can you explain the increase in R&D and SG&A expenses for the second quarter? A: Haoyang Zhong (CFO) explained that R&D expenses increased to $18.2 million from $11 million in Q2 2025, primarily due to a royalty payment for an additional milestone achieved under the license agreement. SG&A expenses increased to $16.7 million from $6.5 million, driven by increasing professional service fees, wages, and salaries from team expansions. The company ended the quarter with $780 million in cash equivalents and US Treasury bills, providing a strong cash runway to commercialize Tinlarabet following potential regulatory approval. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in Belite Bio, Inc. Sponsored ADR? Here are five stocks we like better. FDA review advances: The FDA accepted Belite Bio’s New Drug Application for tinlarebant, an investigational Stargardt disease treatment, and granted priority review with a Feb. 12, 2027, PDUFA action date. Clinical data supported tinlarebant’s potential: In the Phase III DRAGON study, treated patients saw QAF values decline about 2% from baseline at month 25, compared with an approximately 20% increase for placebo patients. Strong cash position but rising costs: Belite Bio ended the quarter with $780 million in cash and Treasury bills, while its GAAP net loss widened to $28.4 million as R&D and SG&A expenses increased significantly. 3 Lesser-Known Healthcare Names With Major Upside in Store Belite Bio (NASDAQ:BLTE) said the U.S. Food and Drug Administration has accepted its New Drug Application for tinlarebant, an investigational treatment for Stargardt disease, and granted the application priority review. The agency set a Prescription Drug User Fee Act action date of Feb. 12, 2027. Chairman and Chief Executive Officer Dr. Tom Lin said the company is approaching a potential U.S. regulatory approval and is continuing pre-commercial preparations while engaging with medical and patient communities. He said the company views the acceptance of its application as reflecting the “strength, consistency, and depth” of clinical data generated across its development program. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be During the quarter, Belite Bio presented Phase III DRAGON study results at four medical conferences in four countries, including the American Society of Retina Specialists annual meeting. At ASRS, the company reported new secondary-endpoint data involving quantitative autofluorescence, or QAF, a measure associated with toxic lipofuscin accumulation in the retina. According to Lin, patients treated with tinlarebant showed halted to slightly reduced QAF values, declining by about 2% at month 25 versus baseline. Patients in the placebo group, meanwhile, had an approximately 20% increase in QAF values over the same period. → Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand Lin said QAF is a marker of toxic lipofuscin retinal accumulation, which he described as a key driver of retinal degeneration in Stargardt disease. He said prevention or reduction of QAF is aligned with tinlarebant’s mechanism of action and could support the drug’s potential to halt or slow lesion growth. Chief Financial Officer Hao-Yuan Chuang said second-quarter research and development expenses rose to $18.2 million from $11 million in the year-earlier period. The increase was primarily attributed to a royalty payment tied to an additional milestone under a licensing agreement. → On Holding's Price Stumble May Be an Opening for a Company Built to Run On a non-GAAP basis, excluding share-based compensation, R&D expenses were $17.2 million, compared with $8.6 million in the second quarter of 2025. Selling, general and administrative expenses increased to $16.7 million from $6.5 million a year earlier, primarily due to higher professional service fees, wages and salaries associated with team expansion. Non-GAAP SG&A expenses were $10.9 million, compared with $1.3 million in the prior-year quarter. Belite Bio reported a GAAP net loss of $28.4 million for the second quarter, compared with a $16.3 million loss a year earlier. Its non-GAAP net loss was $21.6 million, compared with $8.7 million in the comparable 2025 period. The company ended the quarter with $780 million in cash equivalents and U.S. Treasury bills. Chuang said Belite Bio believes its balance sheet provides sufficient funding to commercialize tinlarebant following a potential regulatory approval and to continue advancing its pipeline. In response to analyst questions, Lin said the company currently views its DRAGON II trial as a Japan-focused study for the Pharmaceuticals and Medical Devices Agency, or PMDA, and does not expect it to contribute to the U.S. NDA process at this stage. Chief Medical Officer Dr. Hendrik Scholl said Belite Bio is initiating a pediatric investigation plan study in London to evaluate tinlarebant in patients ages 3 through 11. The study is intended to inform regulatory processes for patients younger than 12. Lin said the company is concentrating on the FDA review ahead of the February 2027 PDUFA date and expects a European filing to occur after a potential FDA approval. He said the approach would allow the company to align regulatory communications outside the U.S. with discussions and outcomes from the FDA review. The company has U.S. and ex-U.S. contract development and manufacturing organizations, Lin said, though it did not identify them. He also said Belite Bio does not currently believe an FDA advisory committee meeting is being planned, while noting the agency could decide to use one later in the review process. Chuang said Belite Bio expects to receive a priority review voucher if tinlarebant is approved, based on the drug’s rare pediatric disease designation. The company has not decided whether it would sell or use the voucher, he said, adding that management will continue to assess market conditions and its pipeline. Lin said the company expects its interim analysis for its geographic atrophy study to move into the first quarter of 2027, likely after February, as the FDA review of tinlarebant will be its top priority during December and January. Regarding Japan, Lin said PMDA activities are proceeding in parallel with the FDA submission. He said that, given tinlarebant’s Sakigake designation, the company expects Japan could potentially approve the drug about three months after an FDA approval. Scholl said Belite Bio does not want to comment on a potential U.S. label while the NDA remains under review. However, he said lesion-growth progression is not dramatically different across age groups based on the PHOENIX study and that the underlying cause of disease is the same across patient ages. Separately, Chief Scientific Officer Dr. Nathan Mata said dosing compliance in DRAGON II was in excess of 90% after 24 months. Belite Bio, Inc (NASDAQ: BLTE) is a clinical-stage biotechnology company focused on discovering and developing small molecule therapeutics for metabolic and inflammatory diseases. Leveraging a proprietary drug-discovery platform, the company aims to address conditions such as nonalcoholic steatohepatitis (NASH) and obesity by targeting pathways involved in fibrosis, inflammation and metabolic regulation. Belite Bio’s pipeline includes multiple candidates in preclinical and early clinical development stages. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Belite Bio Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) with Priority Review for tinlarebant for the treatment of Stargardt disease type 1 (STGD1); Prescription Drug User Fee Act (PDUFA) target action date of February 12, 2027 Company presented additional positive secondary endpoint data from the Phase 3 DRAGON trial of tinlarebant at the American Society of Retina Specialists (ASRS) Annual Meeting with quantitative autofluorescence (qAF) showing a marked divergence between treatment groups Conference call and webcast on Thursday, August 13, 2026, at 4:30 p.m. ET SAN DIEGO, Aug. 12, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio®” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced its financial results for the second quarter ended June 30, 2026, and provided a business update. "We continue to make significant strides in advancing tinlarebant in Stargardt disease. The FDA's acceptance of our NDA is a pivotal milestone for Belite Bio and the STGD1 community, bringing us meaningfully closer to potentially delivering the first ever approved treatment for STGD1. We believe the Priority Review status reflects the strength of our data and recognizes the tremendous unmet need for people living with this debilitating retinal disease," said Dr. Tom Lin, Chairman and Chief Executive Officer of Belite Bio. “Simultaneously, our launch preparations are well underway, including continuing our team expansion and building out our commercial and operational infrastructures. We believe we will be well positioned for both a strong launch and long-term success." Second Quarter 2026 Business Highlights and Upcoming Milestones: Clinical Highlights STGD1 Disease DRAGON Trial: Completed, 24-month, 104 subjects, aged 12 to 20 years old, randomized (2:1, active: placebo), double-masked, placebo-controlled, global, multi-center, pivotal Phase 3 trial in adolescent and adult STGD1 patients. DRAGON II Trial: Combination of a Phase 1b open-label trial to evaluate the pharmacokinetics and pharmacodynamics of tinlarebant in adolescent Japanese STGD1 patients and a Phase 2/3, 24-month, randomized (1:1, active: placebo), double-masked, placebo-controlled, multi-center trial in adolescent and adult STGD1 patients aged 12 to 20 years old across Japan, the U.S., and the United Kingdom. Geographic Atrophy (GA) PHOENIX Trial: Ongoing, 24-month, randomized (2:1, active: placebo), double-masked, placebo-controlled, global, multi-center, pivotal Phase 3 trial in GA patients. Corporate Highlights Commercialization preparation for STGD1 is underway, and the Company is planning a Commercial Day in September to provide an update. Second Quarter 2026 Financial Results: Cash and Cash Equivalents: As of June 30, 2026, the Company had $279.9 million in cash and cash equivalents, compared with $352.9 million on December 31, 2025. Investments: As of June 30, 2026, the Company had $500.1 million in U.S. treasury bills and U.S. treasury notes, compared to $419.7 million as of December 31, 2025. Research and Development (R&D) Expenses: For the three months ended June 30, 2026, R&D expenses were $18.2 million compared to $11.0 million for the same period in 2025. The increase in R&D expenses in the quarter was primarily attributable to a royalty payment for an additional milestone achieved under the license agreement. For the six months ended June 30, 2026, R&D expenses were $33.9 million compared to $20.4 million for the same period in 2025. The increase in R&D expenses year-to-date was primarily attributable to (i) a royalty payment for an additional milestone achieved under the license agreement, (ii) increases in active pharmaceutical ingredient (“API”) and drug product (“DP”) manufacturing expenses and (iii) increases in consultant fees. On a non-GAAP basis, excluding share-based compensation expenses, non-GAAP R&D expenses for the three months ended June 30, 2026, were $17.2 million compared to $8.6 million for the same period in 2025. For the six months ended June 30, 2026, non-GAAP R&D expenses were $31.0 million compared to $16.0 million for the same period in 2025. Selling, General, and Administrative (SG&A) Expenses: For the three months ended June 30, 2026, SG&A expenses were $16.7 million compared to $6.5 million for the same period in 2025. The increase in SG&A expenses in the quarter was primarily attributable to increases in professional service fees, and wages and salaries resulting from our team expansion. For the six months ended June 30, 2026, SG&A expenses were $33.7 million compared to $12.7 million for the same period in 2025. The increase in SG&A expenses year-to-date was primarily attributable to increases in professional service fees, share-based compensation expenses, and wages and salaries resulting from our team expansion. On a non-GAAP basis, excluding share-based compensation expenses, non-GAAP SG&A expenses for the three months ended June 30, 2026, were $10.9 million compared to $1.3 million for the same period in 2025. For the six months ended June 30, 2026, non-GAAP SG&A expenses were $16.6 million compared to $2.8 million for the same period in 2025. Other Income: For the three months ended June 30, 2026, other income was $6.6 million compared to $1.3 million for the same period in 2025. For the six months ended June 30, 2026, other income was $12.3 million compared to $2.5 million for the same period in 2025. The increase in other income in the quarter and year-to-date was primarily attributable to interest income from bank deposits, U.S. treasury bills and U.S. treasury notes. Net Loss: For the three months ended June 30, 2026, the Company reported a net loss of $28.4 million, compared to a net loss of $16.3 million for the same period in 2025. For the six months ended June 30, 2026, net loss was $55.4 million compared to $30.6 million for the same period in 2025. On a non-GAAP basis, excluding share-based compensation expenses, the Company reported a non-GAAP net loss of $21.6 million for the three months ended June 30, 2026, compared to a non-GAAP net loss of $8.7 million for the same period in 2025. For the six months ended June 30, 2026, non-GAAP net loss was $35.3 million compared to $16.3 million for the same period in 2025. Webcast Information Belite Bio will host a webcast on Thursday, August 13, 2026, at 4:30 p.m. Eastern Time to discuss the Company’s financial results and provide a business update. To join the webcast, please click here. A replay of the event will be available on the Investor Relations section of the Company’s website for approximately 90 days following the event. About Tinlarebant (a/k/a LBS-008) Tinlarebant is a novel oral therapy that is intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that cause retinal disease in Stargardt disease type 1 (STGD1) and also contribute to disease progression in geographic atrophy (GA), or advanced dry age-related macular degeneration (AMD). Bisretinoids are by-products of the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye. By modulating the amount of retinol entering the eye, tinlarebant reduces the formation of bisretinoids. Tinlarebant has been granted Breakthrough Therapy Designation, Fast Track Designation, and Rare Pediatric Disease Designation in the U.S., Orphan Drug Designation in the U.S., Europe, Japan, and Switzerland, and Sakigake Designation in Japan for the treatment of STGD1. About Stargardt Disease STGD1 is the most common inherited macular dystrophy in both adults and children. The disease is caused by mutations in a retina-specific gene (ABCA4), which results in progressive accumulation of bisretinoids leading to retinal cell death and progressive loss of central vision. The fluorescent properties of bisretinoids and the development of high-resolution retinal imaging systems have helped ophthalmologists identify and monitor disease progression. Currently, there are no approved treatments for STGD1. About Geographic Atrophy (GA) GA is a chronic degenerative disease of the retina that leads to blindness in the elderly. Accumulation of bisretinoids has been implicated in the progression of GA. There are currently no FDA-approved, orally administered treatments for GA. About Belite Bio Belite Bio is a clinical-stage 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 Bio’s lead candidate, tinlarebant, is an oral therapy intended to reduce the accumulation of bisretinoid toxins in the eye. The Company has completed a Phase 3 trial (DRAGON) in adolescent and adult subjects with STGD1, which met its primary endpoint, and the drug is currently being evaluated in a Phase 2/3 trial (DRAGON II) in adolescent and adult subjects with STGD1 and a Phase 3 trial (PHOENIX) in subjects with GA. For more information, follow us on X, Instagram, LinkedIn, and Facebook, or visit us at www.belitebio.com. Important Cautions Regarding Forward Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to future expectations, plans and prospects, as well as other statements regarding matters that are not historical facts. These statements include but are not limited to statements regarding Belite Bio’s advancement of regulatory review process, the ability and efficacy of tinlarebant to treat STGD1 and GA, the potential approval of tinlarebant as the first therapy for people living with STGD1, Belite’s ability to successfully launch and market tinlarebant after its potential approval, as well as any other statements regarding matters that are not historical facts, and any other statements containing the words “may”, “will”, “expect”, “believe”, “target”, “plan”, “intend”, “continue”, “hope”, “potential”, “anticipate”, “estimate”, “look forward”, and other similar expressions. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors related to Belite Bio’s business, 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; expectations for the timing of initiation, enrollment and completion of, and data relating to, its clinical trials; the timing to complete any ancillary clinical trials and/or to receive the interim/final data of such clinical trials; the timing to communicate with and submit trial data to regulatory authorities for drug approval in various jurisdictions; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Belite Bio’s drug candidates; Belite Bio’s ability to successfully commercialize tinlarebant, if approved, including its ability to build out commercial infrastructure, achieve market acceptance, and execute a timely product launch; timing for Belite Bio to share additional data at upcoming medical meetings; the potential efficacy of tinlarebant to set a new benchmark for future research in inherited retinal disorders, 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. Discussion of Non-GAAP Financial Measures To supplement the Company’s unaudited condensed consolidated financial results prepared in accordance with GAAP, the Company discloses certain non-GAAP financial measures that exclude share-based compensation, including research and development (non-GAAP), selling, general and administrative (non-GAAP), total operating expenses (non-GAAP), loss from operations (non-GAAP), net loss (non-GAAP), weighted average number of ordinary shares used in per share (non-GAAP) and net loss per ordinary share basic and diluted (non-GAAP). The Company believes that these non-GAAP measures provide supplemental information that may be helpful in understanding period-to-period trends in operating expenses and results when considered together with, and not as a substitute for, the corresponding GAAP financial measures. These measures are intended to increase transparency into expense items that may vary from period to period for reasons such as the timing, structure, and valuation of equity awards. These measures are not intended to replace GAAP financial information and are not considered by management to be superior to GAAP measures. At the Company’s current stage of development as a clinical-stage biotechnology company, the primary expenditures relate to the execution of clinical trials, regulatory activities (including preparation for potential NDA submissions), and the management of ongoing operations. In this context, management believes that the supplemental presentation of operating expenses excluding certain non-cash charges, such as share-based compensation, may assist users in understanding the nature and scale of cash-based operating activities by reducing period-to- period volatility from non-cash items. However, these non-GAAP measures are not intended to represent, and should not be viewed as, measures of liquidity, cash burn rate, or cash flows. Non-GAAP measures have inherent limitations and may differ from similarly titled measures used by other companies. Accordingly, these measures should be viewed as supplemental and evaluated together with the Company’s GAAP results and the reconciliations to the most directly comparable GAAP measures presented in this release. Explanation of Adjustment – Share-based compensation: Share-based compensation expense consists of non-cash charges related to the fair value of equity awards awarded to employees and other non-employees. The amount recognized in any period may vary based on factors such as grant timing, award structure, and valuation assumptions, which may not be directly correlated with the timing or magnitude of cash payments related to the Company’s clinical, regulatory, and operational activities. The exclusion of share-based compensation in the Company’s non-GAAP measures is intended to supplementally illustrate operating expense trends and facilitate period-to-period comparisons of cash-based expenditures. The Company recognizes that share-based compensation is an important component of total compensation, and does not view non-GAAP measures as a replacement for GAAP results, which include the full impact of share-based compensation. Media and Investor Relations Contact:[email protected]

This article first appeared on GuruFocus. R&D Expenses: $15.7 million in Q1 2026, up from $9.4 million in Q1 2025. Non-GAAP R&D Expenses: $13.8 million in Q1 2026, compared to $7.4 million in Q1 2025. SG&A Expenses: $17 million in Q1 2026, up from $6.1 million in Q1 2025. Non-GAAP SG&A Expenses: $5.7 million in Q1 2026, compared to $1.5 million in Q1 2025. GAAP Net Loss: $26.9 million in Q1 2026, compared to $14.3 million in Q1 2025. Non-GAAP Net Loss: $13.7 million in Q1 2026, compared to $7.6 million in Q1 2025. Cash and Cash Equivalents: $799 million at the end of Q1 2026. Warning! GuruFocus has detected 3 Warning Signs with BLTE. Is BLTE fairly valued? Test your thesis with our free DCF calculator. Release Date: May 20, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Belite Bio Inc (NASDAQ:BLTE) has initiated the NDA rolling submission to the FDA for STARGUS disease and is on track to complete it by the second quarter of 2026. The company has completed enrollment in its Phase II/III DRAGON 2 clinical trial, which is a registration-enabling study for approval in Japan. Belite Bio Inc (NASDAQ:BLTE) has a strong cash position with $799 million in cash equivalents and U.S. Treasury bills, providing ample capital to execute its goals. The company is actively building its commercial infrastructure and has hired all commercial leadership positions in preparation for the launch. Belite Bio Inc (NASDAQ:BLTE) is engaging with the retinal community to raise awareness of SARA disease and is focused on preparing for a strong commercial launch. R&D expenses increased significantly to $15.7 million in Q1 2026 from $9.4 million in Q1 2025, driven by higher spending on clinical trials and manufacturing. SG&A expenses also rose to $17 million in Q1 2026 from $6.1 million in Q1 2025, primarily due to increased share-based compensation and team expansion. The GAAP net loss for the quarter was $26.9 million, compared to $14.3 million in the same period last year. There is uncertainty regarding the FDA's requirement for DRAGON 2 study results for U.S. approval, which could impact timelines. The company is still in the process of determining the pricing strategy for its drug, with potential pricing bands ranging from $350,000 to $500,000, but no final decision has been made. Q: On Dragon 2, what confidence do you have based on communication with FDA that readout will not be necessary for an approval decision in the U.S.? A: Yu-Hsin Lin, CEO: We had several meetings with the FDA, and they recommended completing the DRAGON2 study with a possible path to one single study approval based on the robustness of our data. We don't believe DRAGON2 data would be applicable to our FDA filings, but it could serve as confirmatory evidence if needed. Q: What are your latest thoughts on building out the commercial infrastructure, given the concentrated patient population? A: Hao-Yuan Chuang, CFO: We plan to have two teams: one for diagnostic promotion to raise disease awareness and another focused on promoting the drug. We expect to have 30 to 40 team members. We are conducting surveys and will provide a market update in September. Q: Can you discuss the geographic atrophy (GA) interim analysis and potential scenarios if the data is strong? A: Yu-Hsin Lin, CEO: We aim for the GA interim analysis around the end of the year. If the data is strong, it would be a positive development, but we haven't strategized beyond that yet. The data will guide our decisions. Q: What is the timeline for Japan approval for Stargardt disease? A: Yu-Hsin Lin, CEO: With the Sagigake designation, the PMDA aims for approval within three months of FDA approval, and we are on track for that timeline. Q: How are you approaching the ex-U.S. market, particularly in Europe, regarding filing and launch strategy? A: Yu-Hsin Lin, CEO: We are focusing on FDA approval first. The FDA filing will form the basis for submissions in other jurisdictions. The timeline for ex-U.S. filings will depend on FDA responses. Q: Have you conducted any market research with payers regarding potential pricing for Tinlaravans? A: Hao-Yuan Chuang, CFO: We have conducted several pricing projects, and payers have been supportive of the price range we are considering. While it's too early to set a price, we are looking at a reference range of $350,000 to $500,000. Q: Assuming FDA approval in early 2027, how quickly can you launch the drug, and what is the expected patient uptake? A: Hao-Yuan Chuang, CFO: Manufacturing is straightforward, so we expect a quick launch post-approval. We are preparing the supply chain and will provide more detailed patient uptake estimates in September. Q: Should we expect operating expenses to continue increasing as you approach the FDA decision? A: Hao-Yuan Chuang, CFO: Yes, expenses will likely increase due to team expansion and commercialization activities. However, we have a strong cash position with $799 million, which comfortably supports our launch and pipeline development. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in Belite Bio, Inc. Sponsored ADR? Here are five stocks we like better. Belite Bio said it has started a rolling NDA submission to the FDA for Tinlarebant in Stargardt disease and expects to finish by the end of Q2, while also preparing for a potential commercial launch. The company said its commercial buildout is underway, with leadership hires completed and plans for separate teams focused on diagnostic awareness and drug promotion; management also suggested a U.S. launch could happen quickly if approved. Belite Bio ended the quarter with $799 million in cash and investments, but quarterly losses widened as R&D and SG&A spending rose sharply amid clinical development and launch preparation. 3 Lesser-Known Healthcare Names With Major Upside in Store Belite Bio (NASDAQ:BLTE) said it has begun a rolling New Drug Application submission to the U.S. Food and Drug Administration for Tinlarebant in Stargardt disease, while also accelerating preparations for a potential commercial launch. On the company’s first-quarter 2026 earnings call, Chairman and CEO Dr. Tom Lin said Belite Bio received its Phase 3 clinical study report in the first quarter and initiated the rolling NDA submission in April. Lin said the company remains on track to complete the submission by the second quarter of this year. → Vertical Aerospace: Pre-Flight Checks Point to a Breakout “As we approach the completion of the rolling submission, we’re also preparing for our commercial launch,” Lin said. He added that Belite Bio has hired all commercial leadership positions and is continuing to build teams in sales, market access and medical affairs. Lin said the company is working to build commercial infrastructure and engage with the retinal community to raise awareness of Stargardt disease. He described 2026 as a pivotal year as Belite Bio begins transitioning toward a commercial-stage company. → The Pentagon's AI Pivot Supercharges Defense Stocks The company also completed enrollment in its Phase 2/3 DRAGON II trial evaluating Tinlarebant in Stargardt disease. Lin said the study enrolled 73 adolescents and adults ages 12 to 20 from Japan, the U.S. and the U.K. The trial is intended to support registration in Japan. During the question-and-answer portion of the call, Morgan Stanley analyst Judah Frommer asked whether DRAGON II data would be needed for a U.S. approval decision. Lin said Belite Bio had held several meetings with the FDA, including one to discuss strong positive interim data from DRAGON1. He said the FDA recommended that the company complete the DRAGON1 study at two years, with a possible path to approval based on a single study because of the robustness of the data. → A Deep Dive Into NVIDIA’s Latest Portfolio Moves Lin said the company does not believe DRAGON II data would apply to its FDA filing, adding that DRAGON II is primarily intended to meet Japan regulatory requirements. He said that even if the FDA sought additional evidence, interim DRAGON II data could potentially serve as confirmatory evidence. Belite Bio executives said the company is planning a targeted commercial approach for Stargardt disease. Chief Financial Officer Hao-Yuan Zhang said the company expects to have two teams: one focused on diagnostic promotion and disease awareness, including genetic testing, and another focused on drug promotion. Zhang said the total team for those functions could be approximately 30 to 40 people. He said many retina specialists already have databases of Stargardt patients with confirmed genetic testing, and the company is conducting surveys to further define the market. Zhang said Belite Bio hopes to provide an update on its commercial plans, potentially in September. Chief Medical Officer Dr. Hendrik Scholl said the inherited retinal disease and retinal specialist community is well defined and gathers regularly at major ophthalmology meetings. Scholl said retinal specialists have shown enthusiasm about the prospect of a first treatment for Stargardt disease, particularly because Tinlarebant is an oral therapy. He added that more education is still needed regarding Tinlarebant and the DRAGON trial. Scholl said Belite Bio plans to present at the American Society of Retina Specialists meeting in Montreal in July, the Retina Society meeting in Los Angeles in September and the American Academy of Ophthalmology meeting in October. Leerink analyst Marc Goodman asked about the company’s geographic atrophy program. Lin said Belite Bio is currently focused on obtaining FDA approval for Stargardt disease and is aiming for an interim analysis in geographic atrophy around the end of the year. He cautioned that timing depends on coordination with contract research organizations and data readiness. Lin said the geographic atrophy dataset is much larger and logistically more complex than the Stargardt program. Asked about possible outcomes from the interim analysis, Lin said resizing the study is one likely scenario and that decisions would be data-driven. On Japan, Lin said the Pharmaceuticals and Medical Devices Agency is aiming for approval within three months of FDA approval, given Tinlarebant’s Sakigake, or pioneer, designation. He said Belite Bio remains on track in Japan. Asked by Cantor analyst Steve Seedhouse about ex-U.S. strategy, particularly Europe, Lin said the company is prioritizing the FDA process. He said the FDA submission will form the basis of filings in other jurisdictions, and timelines elsewhere will depend on questions and responses during the FDA review period. Mizuho analyst Graig Suvannavejh asked whether Belite Bio had conducted additional payer research after receiving Phase 3 data. Zhang said the company has completed several pricing projects and that payers have been supportive of the price range being evaluated, citing the unmet need in Stargardt disease. Zhang said it remains too early to set a final price. However, he said a reference price of roughly $350,000 in the U.S. and potentially up to $500,000 could be considered when comparing Tinlarebant with existing analogs. He emphasized that Belite Bio has not finalized pricing. Belite Bio reported first-quarter 2026 research and development expenses of $15.7 million, compared with $9.4 million in the first quarter of 2025. Zhang said the increase was mainly driven by higher spending on the DRAGON II trial, increased active pharmaceutical ingredient and drug product manufacturing expenses, and higher consulting and professional service fees. On a non-GAAP basis, excluding share-based compensation, R&D expenses were $13.8 million, compared with $7.4 million a year earlier. Selling, general and administrative expenses rose to $17 million from $6.1 million in the prior-year period. Zhang said the increase was primarily due to higher share-based compensation, professional service fees, wages and salaries tied to team expansion. Non-GAAP SG&A expenses were $5.7 million, compared with $1.5 million in the first quarter of 2025. The company reported a GAAP net loss of $26.9 million for the quarter, compared with $14.3 million in the same period last year. Non-GAAP net loss was $13.7 million, compared with $7.6 million a year earlier. Belite Bio ended the quarter with $799 million in cash equivalents and U.S. Treasury bills, which Zhang said was higher than the balance at the end of 2025 due to proceeds from ESOP and warrant exercises. He said the company’s cash position provides capital to finalize the NDA application, prepare for commercialization in Stargardt disease and complete ongoing clinical trials. Asked by H.C. Wainwright analyst Yi Chen about launch readiness assuming FDA approval in early 2027, Zhang said manufacturing, packaging and distribution are relatively straightforward for a small-market drug. He said Belite Bio expects to be able to launch fairly quickly upon approval and is preparing its supply chain and manufacturing now. Zhang declined to provide a specific estimate for the number of patients who could receive Tinlarebant in 2027, saying the company plans to conduct additional surveys and may provide more detail at a future commercial event. Belite Bio, Inc (NASDAQ: BLTE) is a clinical-stage biotechnology company focused on discovering and developing small molecule therapeutics for metabolic and inflammatory diseases. Leveraging a proprietary drug-discovery platform, the company aims to address conditions such as nonalcoholic steatohepatitis (NASH) and obesity by targeting pathways involved in fibrosis, inflammation and metabolic regulation. Belite Bio’s pipeline includes multiple candidates in preclinical and early clinical development stages. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Belite Bio Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

Initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tinlarebant for the treatment of Stargardt disease type 1 (STGD1); submission expected to be completed in the second quarter of 2026 Commercialization preparation for STGD1 underway; hiring of all key commercial leadership positions completed Cash and cash equivalents, U.S. treasury bills and notes: $798.6 million as of March 31, 2026 Conference call and webcast on Wednesday, May 20, 2026, at 4:30 p.m. ET SAN DIEGO, May 20, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio®” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced its unaudited financial results for the first quarter ended March 31, 2026, and provided a business update. “This has been an exciting start to the year for Belite. In April, we announced the initiation of our rolling NDA submission to the FDA for tinlarebant in STGD1, an important step on our path to becoming a commercial company and potentially bringing the first ever treatment for this devastating disease to patients. We are on track to finalize the NDA submission in the second quarter,” said Dr. Tom Lin, Chairman and CEO of Belite Bio. “Initiatives to advance our pre-commercial efforts, including hiring experienced commercial leaders and building out key teams within our organization, are underway. In tandem, we are taking a thoughtful approach to achieving our mission to make this potential treatment available to as many patients as possible worldwide.” First Quarter 2026 Business Highlights and Upcoming Milestones Clinical Highlights Tinlarebant is an oral, potent, once-daily, retinol binding protein 4 (RBP4) antagonist that is intended to decrease RBP4 levels in the blood and reduce vitamin A (retinol) delivery to the eye without disrupting systemic retinol delivery to other tissues. Vitamin A is critical for normal vision but can accumulate as toxic byproducts in individuals affected with STGD1 and geographic atrophy (GA), the advanced form of dry age-related macular degeneration (AMD), leading to retinal cell death and loss of vision. Stargardt disease (STGD1): Accumulation of cytotoxic vitamin A byproducts (bisretinoids) compounds has been implicated in the onset and progression of STGD1, for which there is no approved treatment. Tinlarebant has been granted Breakthrough Therapy, Fast Track, and Rare Pediatric Disease Designations in the U.S.; Orphan Drug Designation in the U.S., Europe, Japan, and Switzerland; and Sakigake (Pioneer Drug) Designation in Japan for the treatment of STGD1. DRAGON Trial: Completed, 24-month, 104 subjects, aged 12 to 20 years old, randomized (2:1, active: placebo), double-masked, placebo-controlled, global, multi-center, pivotal Phase 3 trial in adolescent STGD1 patients DRAGON II Trial: Combination of a Phase 1b open-label trial to evaluate the pharmacokinetics and pharmacodynamics of tinlarebant in adolescent Japanese STGD1 patients and a Phase 2/3, 24-month, randomized (1:1, active: placebo), double-masked, placebo-controlled, multi-center trial in adolescent STGD1 patients aged 12 to 20 years old across Japan, the U.S., and the United Kingdom. Geographic Atrophy (GA): GA is a chronic degenerative disease of the retina that leads to blindness in the elderly. Accumulation of bisretinoids has been implicated in the progression of GA. There are currently no FDA-approved, orally administered treatments for GA. PHOENIX Trial: Ongoing, 24-month, randomized (2:1, active: placebo), double-masked, placebo-controlled, global, multi-center, pivotal Phase 3 trial in GA patients Corporate Highlights Commercialization preparation for STGD1 is underway; hiring of all key commercial leadership positions has been completed. Unaudited First Quarter 2026 Financial Results: Cash and Cash Equivalents: As of March 31, 2026, the Company had $276.4 million in cash and cash equivalents, compared with $352.9 million on December 31, 2025. Investments: As of March 31, 2026, the Company had $522.2 million in U.S. treasury bills and U.S. treasury notes, compared to $419.7 million as of December 31, 2025. Research & Development Expenses: For the three months ended March 31, 2026, research and development expenses were $15.7 million compared to $9.4 million for the same period in 2025. The increase in research and development expenses in the quarter was primarily attributable to increases in (i) expenses related to the DRAGON II trial, (ii) active pharmaceutical ingredient (“API”) manufacturing expense and drug product (“DP”) manufacturing expense; and (iii) consultant and professional service fees. On a non-GAAP basis, excluding share-based compensation expenses, non-GAAP research and development expenses for the three months ended March 31, 2026, were $13.8 million compared to $7.4 million for the same periods in 2025. Selling, General & Administrative Expenses: For the three months ended March 31, 2026, selling, general and administrative expenses were $17.0 million compared to $6.1 million for the same period in 2025. The increase in selling, general and administrative expenses in the quarter was primarily due to increases in share-based compensation expenses, professional service fees, and wages and salaries resulting from our team expansion. On a non-GAAP basis, excluding share-based compensation expenses, non-GAAP selling, general and administrative expenses for the three months ended March 31, 2026, were $5.7 million compared to $1.5 million for the same period in 2025. Other Income: For the three months ended March 31, 2026, other income was $5.7 million compared to $1.2 million for the same period in 2025. The increase in the quarter was primarily due to interest income from bank deposits, U.S. treasury bills and U.S. treasury notes. Net Loss: For the three months ended March 31, 2026, the Company reported a GAAP net loss of $26.9 million, compared to a GAAP net loss of $14.3 million for the same period in 2025. On a non-GAAP basis, excluding share-based compensation expenses, the Company reported a non-GAAP net loss of $13.7 million for the three months ended March 31, 2026, compared to a non-GAAP net loss of $7.6 million for the same period in 2025. Webcast Information Belite Bio will host a webcast on Wednesday, May 20, 2026, at 4:30 p.m. Eastern Time to discuss the Company’s financial results and provide a business update. To join the webcast, please visit: https://events.q4inc.com/attendee/135456520. A replay of the event will be available on the Investor Relations section of the Company’s website for approximately 90 days following the event. About Belite Bio Belite Bio is a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical need, 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 Bio’s lead candidate, tinlarebant, is an oral therapy intended to reduce the accumulation of bisretinoid toxins in the eye. The Company has completed a Phase 3 trial (DRAGON) in adolescent and adult subjects with STGD1, and the drug is currently being evaluated in a Phase 2/3 trial (DRAGON II) in adolescent and adult subjects with STGD1 and a Phase 3 trial (PHOENIX) in subjects with GA. For more information, follow us on X, Instagram, LinkedIn, and Facebook, or visit us at www.belitebio.com. Important Cautions Regarding Forward Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to future expectations, plans and prospects, 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; Belite Bio’s advancement of, and anticipated preclinical activities, clinical development, regulatory milestones, and commercialization of its product candidates; the ability or potential of tinlarebant to treat STGD1 and GA; the timing to complete relevant clinical trials and/or to receive the interim/final data of such clinical trials; the timing of the completion of the NDA submission for tinlarebant; the timing to submit trial data to regulatory authorities for drug approval, the potential benefits of any regulatory designations, the potential for and timing of any interim analysis of ongoing clinical trials; the design of clinical trials intended to facilitate a future NDA in Japan; the Company’s commercialization preparation activities and hiring progress, as well as any other statements regarding matters that are not historical facts, and any other statements containing the words “expect”, “believe”, “anticipate”, “intend”, “target”, “plan”, “hope”, “potential”, “estimate”, “project”, “may”, “will”, “could”, “should”, “on track”, and other similar expressions. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors related to Belite Bio’s business, 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; expectations for the timing of initiation, enrollment and completion of, and data relating to, its clinical trials; the timing to complete any ancillary clinical trials and/or to receive the interim/final data of such clinical trials; the timing to communicate with and submit trial data to regulatory authorities for drug approval in various jurisdictions; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Belite Bio’s drug candidates; the timing for Belite Bio to share additional data at upcoming medical meetings; the potential efficacy of tinlarebant to set a new benchmark for future research in inherited retinal disorders; Belite Bio’s limited experience in launching and marketing product candidates; Belite Bio’s ability to attract, retain and motivate senior management and qualified employees, 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. Discussion of Non-GAAP Financial Measures To supplement the Company’s unaudited condensed consolidated financial results prepared in accordance with GAAP, the Company discloses certain non-GAAP financial measures that exclude share-based compensation, including research and development (non-GAAP), selling, general and administrative (non-GAAP), total operating expenses (non-GAAP), loss from operations (non-GAAP), net loss (non-GAAP), weighted average number of ordinary shares used in per share (non-GAAP) and net loss per ordinary share basic and diluted (non-GAAP). The Company believes that these non-GAAP measures provide supplemental information that may be helpful in understanding period-to-period trends in operating expenses and results when considered together with, and not as a substitute for, the corresponding GAAP financial measures. These measures are intended to increase transparency into expense items that may vary from period to period for reasons such as the timing, structure, and valuation of equity awards. These measures are not intended to replace GAAP financial information and are not considered by management to be superior to GAAP measures. At the Company’s current stage of development as a clinical-stage biotechnology company, the primary expenditures relate to the execution of clinical trials, regulatory activities (including preparation for potential NDA submissions), and the management of ongoing operations. In this context, management believes that the supplemental presentation of operating expenses excluding certain non-cash charges, such as share-based compensation, may assist users in understanding the nature and scale of cash-based operating activities by reducing period-to-period volatility from non-cash items. However, these non-GAAP measures are not intended to represent, and should not be viewed as, measures of liquidity, cash burn rate, or cash flows. Non-GAAP measures have inherent limitations and may differ from similarly titled measures used by other companies. Accordingly, these measures should be viewed as supplemental and evaluated together with the Company’s GAAP results and the reconciliations to the most directly comparable GAAP measures presented in this release. Explanation of Adjustment – Share-based compensation: Share-based compensation expense consists of non-cash charges related to the fair value of equity awards awarded to employees and other non-employees. The amount recognized in any period may vary based on factors such as grant timing, award structure, and valuation assumptions, which may not be directly correlated with the timing or magnitude of cash payments related to the Company’s clinical, regulatory, and operational activities. The exclusion of share-based compensation in the Company’s non-GAAP measures is intended to supplementally illustrate operating expense trends and facilitate period-to-period comparisons of cash-based expenditures. The Company recognizes that share-based compensation is an important component of total compensation, and does not view non-GAAP measures as a replacement for GAAP results, which include the full impact of share-based compensation. Media and Investor Relations Contact: Jennifer Wu / [email protected] Argot Partners / [email protected]

Image source: The Motley Fool. Wednesday, May 20, 2026 at 4:30 p.m. ET Chief Executive Officer — Yu-Hsin Lin Chief Financial Officer — Hao-Yuan Chuang Chief Medical Advisor — Hendrik Scholl Need a quote from a Motley Fool analyst? Email [email protected] Yu-Hsin Lin: Thank you, Julie. Good afternoon. Thank you for joining our first quarter 2026 financial results and updates. We have made exciting progress so far this year. Have received our Phase 3 clinical study report in Q1 without delay in April we initiated our NDA rolling submission to the FDA for Stargardt disease. We are on track to complete the submission by the second quarter of this year. As we approach the completion of the rolling submission, we are also preparing for our commercial launch. We have hired all commercial leadership positions and continue to build out our teams in sales, market access, and medical affairs, also building out our commercial infrastructure. As well as engaging with the retinal community to raise awareness of Stargardt disease. We are focused on preparing for a strong launch, looking forward to sharing more on our commercial planning in the future. In line with that commitment to bring Tinlarebant to patients around the world, This past quarter, we also announced that we have completed enrollment in our Phase 2/3 Dragon 2 clinical trial evaluating Tinlarebant for Stargardt disease. This trial enrolled 73 adolescents and adult subjects aged 12 to 20 years or from Japan, United States, and UK. This is a registration enabling study to pursue approval in Japan. This is shaping up to be a pivotal year for Belite. As we begin our transition to a commercial stage company. We look forward to providing further updates on our work bringing therapies for retinal degenerative diseases and significant unmet medical needs. I will now turn the presentation over to Hao-Yuan to discuss the financials. Hao-Yuan? Hao-Yuan Chuang: Thank you, Tom. In Q1 26, our R&D expenses were 15.7 million compared to 9.4 million in Q1 25. The increase was mainly driven by higher spending on the Dragon 2 trial, increased APR and drug product manufacturing expenses, and higher consultant and professional service fees. On a non-GAAP basis, excluding share based compensation expenses, R&D expenses in Q1 26, were 13.8 million compared to 7.4 million in Q1 25. SG&A expenses in Q1 26 were 17 million compared to $6.1 million in Q1 25. The increase in SG&A expenses was primarily due to an increase in share-based compensation expenses, professional service fees, wages, and salaries resulting from our team expansion. On a non-GAAP basis, excluding share based compensation expenses, the SG&A expenses in Q1 26 were 5.7 million compared to $1.5 million in Q1 25. GAAP net loss for the quarter was 26.9 million compared to 14.3 million in the same period last year. On a non GAAP basis, excluding share based compensation expenses, net loss was 13.7 million in Q1 26 compared to 7.6 million in Q1 25. Despite the increased investment in R&D and SG and A, our balance sheet remains very strong. Specifically, with proceeds from ESOP and warrant exercise, We ended Q1 with $799 million in cash equivalent, and U. S. Treasury bills. A higher balance than at the end of 25. This strong cash position gives us ample capital to execute on our goals including finalizing our NDA application, preparing for the commercialization in Stargardt disease, and completing our ongoing clinical trials. With that, I will now turn the call back to the operator for Q and A. Operator? Operator: We will now begin the question-and-answer session. If you would like to ask a question, please raise your hand now. If you have dialed in to today's call, please press 9 to raise your hand. 6 to unmute. Please standby as we compile the Q&A roster. And your first question comes from the line of Judah Frommer with Morgan Stanley. Your line is open. Please go ahead. Judah Frommer: Yeah. Hi, guys. Thanks for taking the question, and congrats on all the progress here. On Dragon 2, what confidence do you have based on communication with FDA that readout will not be necessary for an approval decision in The US? And then I guess on the flip side of that, if FDA does imply that they would like to see Dragon 2 results, what are the chances that it is confirmatory? And how could that play into time lines? Thank you. Thanks. Yu-Hsin Lin: Thanks, Judah. So that is a great question. So we had several meetings with the FDA including a meeting with the FDA to discuss the strong positive data interim analysis. And it is the FDA's recommendation that we complete the Dragon 2 study at 2 years with a possible path to 1 single study approval based on the robustness of our data. And obviously, I think you mean Dragon 1, not Dragon 2. Yes. Dragon 1. Sorry. Sorry about that. So we do not believe that the Dragon 2 data would be applicable to our FDA filings. But even if there is a slight chance of that happening, we could always have the Dragon 2 data available, at least the interim part of that to serve as a confirmatory evidence. But Dragon 2 is mostly for Japan regulatory requirements. I hope that answers your question. Yes, that is great. And then just maybe touching on building out the commercial infrastructure. What are your latest thoughts on how targeted the, the commercial team or the field salesforce team could be here, just given how concentrated the patient population is and where they are seen by centers of excellence. Thank you. How about you? it is probably better to answer this. Yeah. Hao-Yuan Chuang: Well, we do expect that we are going to have 2 teams. 1 for the diagnostic promotion to bring more disease awareness and awareness to genetic testing to make sure that is an easy kind of reach out for the patient to be diagnosed and get that testing confirmed. And we will also have another team more focused on, you know, promoting the drug. In total, we are thinking about, you know, 30 to maybe 40 total team members for that regard. We do know that there are many retina specialists that already have, you know, a database of Stargardt disease patients confirmed with genetic testing. We are doing a lot of surveys right now. We do expect to get the market an update about what we know, what we are going to be doing, hopefully, in September. So, you know, you will have a better idea about the whole plan and what has already come from out there. But long story short, we do see that there are many patients are very incentivized to this treatment, and continue to be followed up with their physicians. So we will be focused on, you know, the retina specialist communities, the patient advocacy group to better understand the needs and also, of course, the general ophthalmologist and probably the low vision of optometrist community as well. Great. Thank you. Operator: And your next question comes from the line of Marc Goodman with Leerink. Your line is open. Please go ahead. A reminder that you may need to unmute locally. Marc Goodman: Hey, guys. How are you? Geographic atrophy, can you just talk about how you are thinking about this right now and timing of the interim and what happens if the GA you know, indication ends up looking really, really strong? Yu-Hsin Lin: Thanks, Marc. So for GA, so right now, we are focused on getting the FDA approval for Stargardt disease. We are aiming for the interim for GA, around end of the year. Right now, we do not know what the data is going to be like. And if it is a strong positive data, then it is a good problem to have. But at this time, we do not know what the data looks like, so we have not given it much thought in terms of strategy. So I do not think I have answered for you now, probably near the time when we have it, we will probably have a better idea. Marc Goodman: Right. Okay. So you will have a sense of that. Right? Yu-Hsin Lin: I mean Yes. So we are aiming for end of the year, but it all depends on the coordination and getting the data ready with the CROs and OSO. it is a much, much more bigger data than the Stargardt disease. So I think I think it is a bit more complicated, but we aim for end of the year. Yeah. Marc Goodman: And then just back on Stargardt, what is the timeline for Japan again? Hao-Yuan Chuang: Oh, I think Japan, given that we have Sakigake Designation, the Pioneer Designation, I think the approval, the PMDA is aiming for approval within 3 months of the FDA approval. Got it. Thank you. So we are looking on track for that as well. Thank you. Operator: And your next question comes from the line of Steve Seedhouse with Cantor. Your line is open. Please go ahead. Analyst: Great. Thanks, and thanks for the color on the commercial preparations in The US. I actually just wanted to ask about on the other side ex US, particularly in Europe, sort of how you are thinking about filing timeline, you know, launch strategy, partnering strategy, if relevant, Would love your current thinking on the ex US opportunity. Yu-Hsin Lin: Sure. Sure. So, again, right now, we are focusing on the FDA approval. So within the submission timeline, this 6-month review period we are expecting, you know, to have some questions from the FDA, so we do not wanna overstretch ourselves and file in different jurisdictions while we are focusing on the FDA. So our filing strategy is that the FDA forms the basis of our submission, and rest of the world will be consistent with that f FDA filing. So the timeline will be based on what the responses from the FDA. So at this point, again, the timeline, we will need to update you on that. So the FDA will serve as our priority. Okay. Terrific. And, I just wanna follow-up on the GA analysis around year end as well. Is this the type of situation where, you would, share data in any scenario, resize the study, stop the study either for efficacy or futility, like, can you just talk about maybe just some of the possible scenarios for analysis? So this is just assuming what I think the possible scenario is probably resizing the study So the data will show us, you know, the sample size is going to be after that interim. So again, this will be a data-driven decision and strategy. Analyst: Okay. Thank you very much. Hao-Yuan Chuang: And, Steve, if I can make an additional comment, you know, we definitely are trying everything that we can do, to try to bring this treatment to all the patients around the world. Both on GA and Stargardt. But, like Tom said, some of these will be data driven, and we did recognize that, you know, Stargardt disease in The US will be our first focus. But we will continue to monitor all the other development and definitely try to bring the treatment to all the patients as soon as we can. Thank you. Operator: And your next question comes from the line of Greg Swanovic with Mizuho. Your line is open. Please go ahead. Analyst: Hey, it is Greg. Thanks so much for taking my questions. Congrats on progress. I had 2 questions, if I could. 1, it is been some time now since you have had the data in hand. Have you done any additional testing, market research, wise with payers in terms of potential pricing bands that would be acceptable? What are your latest thoughts on potential pricing? And then second, fully appreciating that you are ramping up your precommercial activities. Can you give a sense of what the level of awareness is of Tinlarebant right now with the prescribing community and whether once you get to a place of launch, how much education will be needed? Thanks. Yu-Hsin Lin: So, I will ask Hendrik to discuss on the data part that you mentioned. And then, Hao, maybe you wanna comment on the commercial side of this question. Hendrik Scholl: Sure. Hendrik, you want to go ahead first? I can start certainly. I mean, the R&D and retina specialist community is a very well defined community that meets regularly at ARVO, ASRS, the American Academy meeting. People know about Belite Bio and Tinlarebant. We can certainly improve on that because our interviews with retinal specialists have shown that they are enthusiastic about the prospect of a first treatment ever for this so far untreatable disease, plus the convenience of this being an oral treatment. But we know that the rate of retina specialists that have in-depth knowledge about Tinlarebant and the DRAGON trial. Needs to be improved. We clearly know that. We will be present at the American Society of Retinal Specialists meeting in Montreal in July. We will be at the Retinal Society meeting in Los Angeles. In September, we will be at American Academy meeting in October, and we have presentations at all of those meetings. So this will be major opportunities to educate the community about this forthcoming treatment for Stargardt disease. But, we are actively pursuing that. Sorry. Yu-Hsin Lin: So that was a long question. So what was the second half of the question regarding the pricing and all that? Yeah. I just wanted to get a sense of whether you, now that you have had the Phase 3 data in hand, whether you have been able to do any additional, payer market research in terms of how you are thinking about pricing? Oh, got it. Hao, did you get that? Hao-Yuan Chuang: Yeah, yeah, I did. So, yep. Greg, so we have done several pricing projects so far. You know, so far, the payers has been super supportive of the price range that we are thinking about. And they definitely recognize the strong unmet need being the first treatment for Stargardt. So I think we appreciate the payers has been showing a lot of on this. And, you know, it is still too early. To really set the price. But, you know, I think we talk about you know, if people want to know maybe a reference price, we think that, you know, the average open drug price in The US $350 thousand. that is a fair kind of reference price. Maybe up to, you know, $500 thousand. That will be the range that, you know, you would consider compared with some of the analogs out there. But we have not really set the price. it is still early, but we do see that you know, this is a range that should be a fair assumptions. Analyst: Okay. Thank you. Operator: And just a reminder that if you would like to ask a question, you can use the raise hand function. Or if you have dialed in to today's call, you can press 9 to raise your hand. 6 to unmute. Your next question comes from the line of Yi Chen with HC Wainwright. Your line is open. Please go ahead. Yi Chen: Thank you for taking my questions. Assuming that you get FDA approval in early 27, can you tell us how quickly you can launch the drug, whether your manufacturing facility is in alignment with that timing, more importantly, can you provide us with a rough estimate as to how many patients could you reasonably expect to receive the Tinlarebant treatment in 2027? Thank you. Yu-Hsin Lin: Hao, you want to carry all of this question as well? Hao-Yuan Chuang: Yes. Yes. So, Yi. Well, this is a small molecule drug. So the manufacturing is not that complicated. And packaging, delivering are all relatively easy compared with most of the other drugs. So we do expect that we should be fairly quickly be able to launch right upon approval. We are, you know, getting all the supply chain and the manufacturing ready right now. In terms of the number of patients at the first year, I think, you know, like I said earlier, we would like to do more survey and maybe give the market a good, you know, thorough kind of survey and numbers probably in September. at a commercial day event. So we are doing everything we can to try to find, you know, all this potential database and doing all the surveys and, you know, all the so called medical affair task to make sure we warm up the community. But I think we cannot provide a specific guidance on today's call yet. Thanks. And a quick question on the operating expenses. I noticed the first quarter numbers are meaningfully higher compared to fourth quarter last year. Shall we expect that the OpEx is expected to continuously increase as you approach the FDA decision. Yi Chen: Oh, yeah. Well, it is a fair, you know, scenario as you get ready for launch. Hao-Yuan Chuang: there is, you know, huge team expansion and we, you know, last year, we were somewhere close to, like, 30 team members now. We are now somewhere close to 90. Right? So we are expanding the team fast and also, you know, doing all these activity that we talk about. So we do not expect that, you know, expenses will go up too much but, you know, it is a fair assumption that, you know, it will go up while we go toward commercialization. And compared to last quarter, that is really not a fair assumption because that was when we just started some of the preparation work. But, you know, like I said, in the presentation, you know, we are sitting on close to $800 million in cash. So we are in a very, very comfortable cash position. To launch Stargardt in The US, you would probably look for probably $300 million. And our existing pipeline as we talk about before, we expect the budget will be about $150 million for, you know, next 3 years. In total, we are talking about $450 million at most for the budget. Well, we are sitting on $800 million. So we think we are very comfortable on cash, and you know, this is gonna be a good investment to be made to make sure that we get all the awareness out there, try to help the patients as fast and as broad as we can. Yi Chen: Got it. Thank you. Operator: Thank you. There are no further questions at this time. This concludes today's call. Thank you for attending. You may now disconnect. 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