Belite Bio Reports Second Quarter 2025 Financial Results and Provides a Corporate Update
Belite Bio (NASDAQ: BLTE) reported Q2 2025 financial results and provided significant updates on its clinical programs. The company achieved two major milestones: FDA Breakthrough Therapy Designation for Tinlarebant in treating Stargardt disease (STGD1) and completion of enrollment with 529 subjects in the Phase 3 PHOENIX trial for geographic atrophy (GA).
Financial highlights include a net loss of $16.3 million for Q2 2025, with $149.2 million in cash and equivalents. The company recently raised $15 million through a registered direct offering. R&D expenses increased to $11.0 million, up from $9.1 million in Q2 2024, while G&A expenses rose to $6.5 million from $1.4 million.
The DRAGON trial for STGD1 is expected to complete by Q4 2025, following positive DSMB recommendations for trial continuation.
Belite Bio (NASDAQ: BLTE) ha comunicato i risultati finanziari del Q2 2025 e ha fornito aggiornamenti significativi sui suoi programmi clinici. L'azienda ha raggiunto due traguardi principali: la designazione Breakthrough Therapy da parte della FDA per Tinlarebant nel trattamento della malattia di Stargardt (STGD1) e il completamento dell'arruolamento con 529 soggetti nello studio di Fase 3 PHOENIX per atrofia geografica (GA).
I punti chiave dal punto di vista finanziario includono una perdita netta di $16.3 milioni per il Q2 2025, con $149.2 milioni in liquidità e mezzi equivalenti. La società ha recentemente raccolto $15 milioni tramite un'offerta diretta registrata. Le spese di R&S sono aumentate a $11.0 milioni, rispetto a $9.1 milioni nel Q2 2024, mentre le spese G&A sono salite a $6.5 milioni da $1.4 milioni.
Lo studio DRAGON per STGD1 dovrebbe concludersi entro il Q4 2025, a seguito delle raccomandazioni positive del DSMB per la prosecuzione del trial.
Belite Bio (NASDAQ: BLTE) informó los resultados financieros del 2T 2025 y proporcionó actualizaciones relevantes sobre sus programas clínicos. La compañía alcanzó dos hitos principales: la designación Breakthrough Therapy de la FDA para Tinlarebant en el tratamiento de la enfermedad de Stargardt (STGD1) y la finalización del reclutamiento con 529 sujetos en el ensayo de fase 3 PHOENIX para atrofia geográfica (GA).
Los aspectos financieros incluyen una pérdida neta de $16.3 millones en el 2T 2025, con $149.2 millones en efectivo y equivalentes. La compañía recaudó recientemente $15 millones mediante una oferta directa registrada. Los gastos de I+D aumentaron a $11.0 millones, desde $9.1 millones en el 2T 2024, mientras que los gastos G&A subieron a $6.5 millones desde $1.4 millones.
Se espera que el ensayo DRAGON para STGD1 concluya en el 4T 2025, tras las recomendaciones favorables del DSMB para la continuación del estudio.
Belite Bio (NASDAQ: BLTE)는 2025년 2분기 재무실적을 발표하고 임상 프로그램에 대한 주요 업데이트를 공유했습니다. 회사는 두 가지 주요 이정표를 달성했습니다: Tinlarebant에 대한 FDA의 Breakthrough Therapy 지정(스타가르트병 STGD1 치료)과 지리성 위축(GA)에 대한 3상 PHOENIX 시험에서 529명의 피험자 등록 완료입니다.
재무적 주요 내용으로는 2025년 2분기 순손실 $16.3백만을 기록했으며, 현금 및 현금성 자산은 $149.2백만입니다. 회사는 최근 등록된 직접 공모를 통해 $15백만을 조달했습니다. 연구개발비는 2024년 2분기의 $9.1백만에서 $11.0백만으로 증가했고, 총무 및 관리비(G&A)는 $1.4백만에서 $6.5백만으로 상승했습니다.
DSMB의 계속 권고에 따라 STGD1 대상 DRAGON 시험은 2025년 4분기(Q4 2025)까지 완료될 것으로 예상됩니다.
Belite Bio (NASDAQ: BLTE) a publié ses résultats financiers du T2 2025 et a fourni des mises à jour importantes sur ses programmes cliniques. La société a atteint deux étapes majeures : la désignation Breakthrough Therapy de la FDA pour Tinlarebant dans le traitement de la maladie de Stargardt (STGD1) et l'achèvement du recrutement avec 529 sujets dans l'essai de phase 3 PHOENIX pour l'atrophie géographique (GA).
Parmi les points financiers, on note une perte nette de $16.3 millions pour le T2 2025, avec $149.2 millions en trésorerie et équivalents. La société a récemment levé $15 millions via une offre directe enregistrée. Les dépenses de R&D ont augmenté à $11.0 millions, contre $9.1 millions au T2 2024, tandis que les frais G&A ont grimpé à $6.5 millions contre $1.4 million.
L'essai DRAGON pour la STGD1 devrait se terminer au T4 2025, à la suite des recommandations favorables du DSMB visant la poursuite de l'étude.
Belite Bio (NASDAQ: BLTE) meldete die Finanzergebnisse für das 2. Quartal 2025 und gab wesentliche Updates zu seinen klinischen Programmen bekannt. Das Unternehmen erreichte zwei bedeutende Meilensteine: die FDA-Zulassung als Breakthrough Therapy für Tinlarebant zur Behandlung der Stargardt-Erkrankung (STGD1) sowie den Abschluss der Rekrutierung mit 529 Probanden in der Phase-3-Studie PHOENIX zur geografischen Atrophie (GA).
Zu den finanziellen Highlights zählen ein Nettoverlust von $16.3 Millionen im 2. Quartal 2025 und $149.2 Millionen an Zahlungsmitteln und Zahlungsmitteläquivalenten. Das Unternehmen hat kürzlich $15 Millionen durch ein registriertes Direct Offering aufgenommen. Die F&E-Ausgaben stiegen auf $11.0 Millionen (vorher $9.1 Millionen im 2Q 2024), während die G&A-Kosten von $1.4 Millionen auf $6.5 Millionen zunahmen.
Die DRAGON-Studie für STGD1 wird voraussichtlich bis zum Q4 2025 abgeschlossen sein, nachdem das DSMB positive Empfehlungen zur Fortführung der Studie ausgesprochen hat.
- None.
- Net loss increased to $16.3 million in Q2 2025 from $9.5 million in Q2 2024
- R&D expenses increased to $11.0 million from $9.1 million year-over-year
- G&A expenses significantly increased to $6.5 million from $1.4 million year-over-year
Insights
Belite Bio secures key regulatory designation and advances trials for novel retinal therapies amid increased R&D spending.
Belite Bio's Q2 results highlight significant regulatory momentum with the FDA granting Breakthrough Therapy Designation for Tinlarebant in Stargardt disease (STGD1), a designation reserved for treatments showing substantial improvement over existing therapies. This is particularly notable as no approved treatments currently exist for STGD1, positioning Belite as a potential first-mover in this indication.
The company has achieved important clinical milestones with the completion of enrollment in the Phase 3 PHOENIX trial for geographic atrophy (GA) with 529 subjects. The DRAGON pivotal trial for STGD1 is on track to complete by Q4 2025. An independent Data Safety Monitoring Board previously recommended continuation of the DRAGON trial without modifications following an interim analysis, maintaining the original sample size of 104 subjects and suggesting submission for regulatory review.
From a financial perspective, Belite maintains a strong cash position of $149.2 million as of June 30, 2025, recently bolstered by an additional $15 million from a registered direct offering. R&D expenses increased to $11.0 million for Q2 (up from $9.1 million in Q2 2024), reflecting the advancement of clinical programs. G&A expenses rose substantially to $6.5 million from $1.4 million in the comparable period, primarily due to increased share-based compensation.
Tinlarebant's mechanism as an RBP4 antagonist that reduces vitamin A delivery to the eye (implicated in STGD1 and GA pathology) represents a novel approach to these degenerative retinal diseases. The compound's extensive regulatory designations (Breakthrough, Fast Track, Rare Pediatric Disease, Orphan Drug, and Sakigake in Japan) underscore its potential and the significant unmet need in these indications.
Belite Bio's Breakthrough Designation and trial progress strengthen its position in untapped retinal disease markets despite widening losses.
Belite Bio's FDA Breakthrough Therapy Designation for Tinlarebant represents a significant regulatory milestone that could accelerate the approval timeline and underscore the drug's potential as a first-in-class treatment for Stargardt disease. This designation is particularly valuable as it acknowledges both substantial clinical evidence and addresses an indication with no existing approved therapies.
The company's clinical development strategy shows methodical execution across multiple fronts. The parallel advancement of the DRAGON trial (for STGD1) and PHOENIX trial (for geographic atrophy) demonstrates a portfolio approach targeting related retinal indications with the same novel compound. This dual-indication strategy maximizes the potential return on R&D investment and creates multiple paths to market.
The completed enrollment of 529 subjects in the PHOENIX trial is particularly noteworthy given that geographic atrophy represents a substantially larger market opportunity than the orphan Stargardt disease indication. GA affects a broader elderly population as part of age-related macular degeneration progression.
From a competitive standpoint, Belite's oral, once-daily RBP4 antagonist approach differentiates it from other GA treatments that typically require intravitreal injections. If successful, this could offer a significant convenience advantage and potentially improve patient compliance and quality of life.
The company's net loss widened to $16.3 million in Q2 2025 from $9.5 million in Q2 2024, reflecting increased investment in late-stage clinical programs and higher administrative costs. While concerning, this increased spending is aligned with the company's advanced stage of development as it approaches potential commercialization. The substantial cash position of $149.2 million, supplemented by the recent $15 million raise, provides an estimated runway of approximately 2-3 years at current burn rates, likely sufficient to reach key milestones for both clinical programs.
- Tinlarebant granted Breakthrough Therapy Designation for Stargardt disease (STGD1) by the U.S. Food and Drug Administration (FDA)
- DRAGON trial completion expected by Q4 2025 (including a three-month follow-up period)
- Enrollment completed with 529 subjects in the pivotal phase 3 PHOENIX trial in geographic atrophy (GA)
- Raised approximately
$15 million in gross proceeds in a registered direct offering on August 8, 2025 - Conference call and webcast on Monday, August 11, 2025, at 4:30 p.m. ET
SAN DIEGO, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE), 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, 2025, and provided a general business update.
“This quarter, we remained on track with the strategic objectives we outlined at the start of the year, including the completion of enrollment in our pivotal Phase 3 PHOENIX trial — an important milestone in our development efforts for people living with geographic atrophy,” said Dr. Tom Lin, Chairman and CEO of Belite Bio. “We also received Breakthrough Therapy Designation for Tinlarebant for the treatment of Stargardt disease from the FDA, underscoring its potential as the first-ever treatment for this patient population and acknowledging the significant unmet need for people living with this debilitating disease. With the DRAGON trial on track to complete by the end of this year, we remain focused on advancing Tinlarebant toward key clinical and regulatory milestones.”
Second Quarter 2025 Business Highlights and Upcoming Milestones:
Clinical Highlights
Tinlarebant (LBS-008) is an oral, potent, once-daily, retinol binding protein 4 (RBP4) antagonist that decreases RBP4 levels in the blood and reduces 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 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, and Japan; and Sakigake (Pioneer Drug) Designation in Japan for the treatment of STGD1.
- DRAGON Trial: Ongoing, 24-month, randomized (2:1, active: placebo), double-masked, placebo-controlled, global, multi-center, pivotal Phase 3 trial in adolescent STGD1 patients.
- Primary efficacy endpoint is the growth rate of atrophic lesions; safety and tolerability will also be assessed.
- Following a pre-specified interim analysis, an independent Data Safety Monitoring Board (DSMB) recommended trial continuation without modifications, maintaining a sample size of 104 subjects, and recommended submission of the data for regulatory review for drug approval.
- The Breakthrough Therapy Designation was supported by the interim data of the DRAGON trial. 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. Currently STGD1 has no approved treatment.
- Belite expects trial completion by Q4 2025 (including a three-month follow-up period) and plans to submit DRAGON trial data for drug approval.
- 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, multicenter trial in adolescent STGD1 patients.
- The Company enrolled 17 subjects in the Phase 2/3 trial, with a target enrollment of approximately 60 subjects, aged 12 to 20 years old, including approximately 10 Japanese subjects. Data from the Japanese subjects are intended to facilitate a future new drug application in Japan.
- Primary efficacy endpoint is the growth rate of atrophic lesions; safety and tolerability will also be assessed.
- DRAGON Trial: Ongoing, 24-month, randomized (2:1, active: placebo), double-masked, placebo-controlled, global, multi-center, pivotal Phase 3 trial in adolescent STGD1 patients.
- 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.
- Enrollment completed with 529 subjects.
- Primary efficacy endpoint is the growth rate of atrophic lesions; safety and tolerability will also be assessed.
- The Company expects to conduct an interim analysis.
- 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
- On August 8, 2025, the Company completed a registered direct offering of its American Depositary Shares with an existing institutional investor of the Company, raising gross proceeds of approximately
$15 million with potential additional proceeds of approximately$15 million if the accompanying warrants were exercised in full.
Second Quarter 2025 Financial Results:
Current Assets:
As of June 30, 2025, the Company had
R&D Expenses:
For the three months ended June 30, 2025, research and development expenses were
G&A Expenses:
For the three months ended June 30, 2025, general and administrative expenses were
Other Income:
For the three months ended June 30, 2025, other income was
Net Loss:
For the three months ended June 30, 2025, the Company reported a net loss of
Webcast Information
Belite Bio will host a webcast on Monday, August 11, 2025, 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/127464226. A replay will be available 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’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 www.belitebio.com.
Important Cautions Regarding Forward Looking Statements
This 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, and Belite Bio’s advancement of, and anticipated preclinical activities, clinical development, regulatory milestones, and commercialization of its product candidates, and any other statements containing the words “expect”, “hope” 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 to complete relevant clinical trials and/or to receive the interim/final data of such clinical trials; the timing to submit trial data to regulatory authorities for drug approval; 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.
| BELITE BIO, INC UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Amounts in thousands of US Dollars, except share and per share amounts) | ||||||||||||||||
| For the Three Months | For the Six Months | |||||||||||||||
| Ended June 30, | Ended June 30, | |||||||||||||||
| 2024 | 2025 | 2024 | 2025 | |||||||||||||
| Expenses | ||||||||||||||||
| Research and development | 9,078 | 11,049 | 15,843 | 20,445 | ||||||||||||
| General and administrative | 1,393 | 6,547 | 2,956 | 12,668 | ||||||||||||
| Total operating expenses | 10,471 | 17,596 | 18,799 | 33,113 | ||||||||||||
| Loss from operations | (10,471 | ) | (17,596 | ) | (18,799 | ) | (33,113 | ) | ||||||||
| Other income: | ||||||||||||||||
| Total other income, net | 977 | 1,276 | 1,440 | 2,516 | ||||||||||||
| Loss before income tax | (9,494 | ) | (16,320 | ) | (17,359 | ) | (30,597 | ) | ||||||||
| Income tax expense | - | - | 6 | - | ||||||||||||
| Net loss | (9,494 | ) | (16,320 | ) | (17,365 | ) | (30,597 | ) | ||||||||
| Other comprehensive income (loss) | ||||||||||||||||
| Foreign currency translation adjustments, net of nil tax | (10 | ) | 128 | (106 | ) | 146 | ||||||||||
| Total comprehensive loss | (9,504 | ) | (16,192 | ) | (17,471 | ) | (30,451 | ) | ||||||||
| Weighted average number of ordinary shares used in per share calculation: | ||||||||||||||||
| - Basic and Diluted | 30,324,132 | 32,585,043 | 30,000,653 | 32,335,958 | ||||||||||||
| Net loss per ordinary share | ||||||||||||||||
| - Basic and Diluted | $ | (0.31 | ) | $ | (0.50 | ) | $ | (0.58 | ) | $ | (0.95 | ) | ||||
| BELITE BIO, INC UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (Amounts in thousands of US Dollars, except share amounts) | ||||||
| December 31, | June 30, | |||||
| 2024 | 2025 | |||||
| Current assets | $ | 147,073 | $ | 150,970 | ||
| Other assets | 5,059 | 5,437 | ||||
| TOTAL ASSETS | $ | 152,132 | $ | 156,407 | ||
| TOTAL LIABILITIES | $ | 6,311 | $ | 6,522 | ||
| TOTAL SHAREHOLDERS’ EQUITY | 145,821 | 149,885 | ||||
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 152,132 | $ | 156,407 | ||
| Ordinary shares authorized | 400,000,000 | 400,000,000 | ||||
| Ordinary shares issued | 31,857,802 | 32,631,133 | ||||
| Ordinary shares outstanding | 31,826,549 | 32,599,298 | ||||
Media and Investor Relations Contact:
Jennifer Wu
ir@belitebio.com
Julie Fallon
belite@argotpartners.com
FAQ
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