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Belite Bio Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update

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Belite Bio (NASDAQ: BLTE) has reported its Q4 and full-year 2024 financial results. The company's Phase 3 DRAGON trial for Stargardt 1 (STGD1) treatment received DSMB recommendation to proceed without modifications, with completion expected in Q4 2025. The PHOENIX trial for geographic atrophy has enrolled 406 subjects.

Key financial highlights: Cash position of $31.7 million as of December 31, 2024, with additional $113.5 million in investments. The company raised $15 million through a registered direct offering in February 2025. Full-year 2024 results showed R&D expenses of $29.9 million (up from $24.8M in 2023) and G&A expenses of $10.1 million (up from $6.8M in 2023). Net loss for 2024 was $36.1 million or ($1.18) per share.

Tinlarebant, their lead drug candidate, is advancing in multiple trials including the DRAGON trial for STGD1 and PHOENIX trial for geographic atrophy. The drug has received Fast Track, Rare Pediatric Disease, and Orphan Drug Designations in various regions.

Belite Bio (NASDAQ: BLTE) ha riportato i risultati finanziari del quarto trimestre e dell'intero anno 2024. La fase 3 dello studio DRAGON per il trattamento della Stargardt 1 (STGD1) ha ricevuto la raccomandazione del DSMB per procedere senza modifiche, con completamento previsto nel quarto trimestre del 2025. Lo studio PHOENIX per l'atrofia geografica ha arruolato 406 soggetti.

Principali evidenze finanziarie: Posizione di cassa di $31.7 milioni al 31 dicembre 2024, con ulteriori $113.5 milioni in investimenti. L'azienda ha raccolto $15 milioni attraverso un'offerta diretta registrata a febbraio 2025. I risultati per l'intero anno 2024 hanno mostrato spese per R&S di $29.9 milioni (in aumento rispetto ai $24.8 milioni del 2023) e spese generali e amministrative di $10.1 milioni (in aumento rispetto ai $6.8 milioni del 2023). La perdita netta per il 2024 è stata di $36.1 milioni o ($1.18) per azione.

Tinlarebant, il loro principale candidato farmaco, sta avanzando in diversi studi, inclusi lo studio DRAGON per STGD1 e lo studio PHOENIX per l'atrofia geografica. Il farmaco ha ricevuto le designazioni Fast Track, Rare Pediatric Disease e Orphan Drug in varie regioni.

Belite Bio (NASDAQ: BLTE) ha reportado sus resultados financieros del cuarto trimestre y del año completo 2024. El ensayo de fase 3 DRAGON para el tratamiento de Stargardt 1 (STGD1) recibió la recomendación del DSMB para continuar sin modificaciones, con finalización esperada en el cuarto trimestre de 2025. El ensayo PHOENIX para la atrofia geográfica ha inscrito a 406 sujetos.

Aspectos financieros clave: Posición de efectivo de $31.7 millones al 31 de diciembre de 2024, con $113.5 millones adicionales en inversiones. La empresa recaudó $15 millones a través de una oferta directa registrada en febrero de 2025. Los resultados del año completo 2024 mostraron gastos de I+D de $29.9 millones (aumento de $24.8M en 2023) y gastos generales y administrativos de $10.1 millones (aumento de $6.8M en 2023). La pérdida neta para 2024 fue de $36.1 millones o ($1.18) por acción.

Tinlarebant, su principal candidato a fármaco, está avanzando en múltiples ensayos, incluyendo el ensayo DRAGON para STGD1 y el ensayo PHOENIX para la atrofia geográfica. El fármaco ha recibido designaciones de Fast Track, Rare Pediatric Disease y Orphan Drug en varias regiones.

Belite Bio (NASDAQ: BLTE)는 2024년 4분기 및 연간 재무 결과를 발표했습니다. Stargardt 1 (STGD1) 치료를 위한 3상 DRAGON 시험은 DSMB의 수정 없이 진행하라는 권고를 받았으며, 2025년 4분기 완료가 예상됩니다. 지리적 위축을 위한 PHOENIX 시험에는 406명의 피험자가 등록되었습니다.

주요 재무 하이라이트: 2024년 12월 31일 기준 현금 보유액은 $31.7 백만이며, 추가로 $113.5 백만의 투자금이 있습니다. 회사는 2025년 2월에 등록된 직접 공모를 통해 $15 백만을 모금했습니다. 2024년 전체 결과는 연구개발(R&D) 비용이 $29.9 백만 (2023년 $24.8M에서 증가)이고, 일반관리(G&A) 비용이 $10.1 백만 (2023년 $6.8M에서 증가)으로 나타났습니다. 2024년 순손실은 $36.1 백만 또는 주당 ($1.18)입니다.

그들의 주요 약물 후보인 Tinlarebant는 STGD1을 위한 DRAGON 시험과 지리적 위축을 위한 PHOENIX 시험을 포함한 여러 시험에서 진행 중입니다. 이 약물은 다양한 지역에서 신속 승인, 희귀 소아 질환 및 고아 약물 지정을 받았습니다.

Belite Bio (NASDAQ: BLTE) a publié ses résultats financiers pour le quatrième trimestre et l'ensemble de l'année 2024. L'essai de phase 3 DRAGON pour le traitement de Stargardt 1 (STGD1) a reçu la recommandation du DSMB pour se poursuivre sans modifications, avec une finalisation prévue au quatrième trimestre 2025. L'essai PHOENIX pour l'atrophie géographique a recruté 406 sujets.

Points financiers clés : Position de trésorerie de $31.7 millions au 31 décembre 2024, avec $113.5 millions supplémentaires en investissements. L'entreprise a levé $15 millions grâce à une offre directe enregistrée en février 2025. Les résultats de l'année complète 2024 ont montré des dépenses en R&D de $29.9 millions (en hausse par rapport à $24.8M en 2023) et des dépenses générales et administratives de $10.1 millions (en hausse par rapport à $6.8M en 2023). La perte nette pour 2024 s'élevait à $36.1 millions ou ($1.18) par action.

Tinlarebant, leur principal candidat médicament, progresse dans plusieurs essais, y compris l'essai DRAGON pour STGD1 et l'essai PHOENIX pour l'atrophie géographique. Le médicament a reçu les désignations Fast Track, Rare Pediatric Disease et Orphan Drug dans diverses régions.

Belite Bio (NASDAQ: BLTE) hat seine Finanzzahlen für das vierte Quartal und das Gesamtjahr 2024 veröffentlicht. Die Phase-3-DRAGON-Studie zur Behandlung von Stargardt 1 (STGD1) erhielt die Empfehlung des DSMB, ohne Änderungen fortzufahren, wobei der Abschluss im vierten Quartal 2025 erwartet wird. Die PHOENIX-Studie zur geografischen Atrophie hat 406 Probanden eingeschlossen.

Wichtige finanzielle Highlights: Barbestand von $31.7 Millionen zum 31. Dezember 2024, mit zusätzlichen $113.5 Millionen an Investitionen. Das Unternehmen hat im Februar 2025 $15 Millionen durch ein registriertes Direktangebot gesammelt. Die Ergebnisse für das Gesamtjahr 2024 zeigten F&E-Ausgaben von $29.9 Millionen (steigend von $24.8M in 2023) und allgemeine und Verwaltungskosten von $10.1 Millionen (steigend von $6.8M in 2023). Der Nettoverlust für 2024 betrug $36.1 Millionen oder ($1.18) pro Aktie.

Tinlarebant, ihr führender Arzneimittelkandidat, schreitet in mehreren Studien voran, einschließlich der DRAGON-Studie für STGD1 und der PHOENIX-Studie für geografische Atrophie. Das Medikament hat in verschiedenen Regionen die Auszeichnungen Fast Track, Rare Pediatric Disease und Orphan Drug erhalten.

Positive
  • DSMB recommended DRAGON Phase 3 trial continuation without modifications
  • Strong cash position with $145.2M total ($31.7M cash + $113.5M investments)
  • Successfully raised $15M in February 2025 offering
  • Increased other income to $3.9M from investments
Negative
  • Net loss increased to $36.1M in 2024 from $31.6M in 2023
  • R&D expenses increased 20.6% to $29.9M
  • G&A expenses rose 48.5% to $10.1M
  • Cash decreased from $88.2M to $31.7M year-over-year

Insights

Belite Bio's financial results reveal a strategic shift in their asset allocation with $31.7 million in cash (down from $88.2 million in 2023), while simultaneously building a $113.5 million investment position in liquidity funds, time deposits, and U.S. Treasury bills. This demonstrates prudent treasury management to generate interest income while maintaining liquidity for ongoing clinical operations.

The company's burn rate has increased with R&D expenses rising to $29.9 million for 2024 (up 20.6% from 2023), primarily driven by royalty payments and share-based compensation. G&A expenses similarly increased to $10.1 million (up 48.5%). The net loss of $36.1 million ($1.18 per share) represents a modest 14.2% increase from 2023's $31.6 million loss.

Their February 2025 registered direct offering raising $15 million (with potential additional proceeds of $15 million from warrant exercises) strengthens their financial position. With $145.2 million in combined cash and investments, Belite appears well-capitalized to fund their clinical programs through critical milestones, particularly the completion of the DRAGON trial expected by Q4 2025.

The increased investment in clinical development, while expanding losses in the short term, is strategically sound considering the orphan drug designations and potential market exclusivity for Tinlarebant. Their financial statements reflect a biopharmaceutical company appropriately allocating capital toward late-stage clinical trials with significant potential returns if successful.

Belite Bio's Tinlarebant (LBS-008) is showing promising progression through its clinical development pipeline for both Stargardt disease (STGD1) and geographic atrophy (GA). The Data Safety Monitoring Board's recommendation to continue the DRAGON trial without modifications represents a critical derisking event for the program, suggesting acceptable safety profile at this interim analysis point.

For the DRAGON trial, the maintained sample size of 104 subjects indicates statistical assumptions remain valid, with trial completion expected by Q4 2025. This timeline includes a three-month follow-up period, which is appropriate for assessing the primary endpoint of atrophic lesion growth rate - a clinically relevant biomarker for STGD1 progression.

The parallel DRAGON II trial's completion of its Phase 1b portion in Japanese subjects demonstrates Belite's commitment to global development and regulatory strategy, particularly important for Japan where the drug has received Sakigake designation. The expansion of the PHOENIX trial for GA from 430 to 500 subjects (with 406 already enrolled) suggests confidence in the program while potentially increasing statistical power.

Tinlarebant's mechanism as an RBP4 antagonist that reduces vitamin A delivery to the eye without disrupting systemic retinol delivery represents a targeted approach to address the accumulation of cytotoxic vitamin A byproducts implicated in both STGD1 and GA. This mechanistic rationale, combined with regulatory designations including Fast Track, Rare Pediatric Disease, Orphan Drug, and Sakigake, positions Tinlarebant as a potentially groundbreaking therapy for these degenerative retinal diseases with significant unmet needs.

  • Following a pre-specified interim analysis, the Data Safety Monitoring Board (DSMB) recommended the DRAGON trial, a pivotal Phase 3 trial in adolescent Stargardt 1 (STGD1) subjects, proceed without any modification; trial completion expected Q4 2025 (including a three-month follow-up period)
  • Pivotal global Phase 3 PHOENIX trial of Tinlarebant in geographic atrophy (GA) subjects is ongoing with 406 subjects enrolled
  • Raised $15 million in gross proceeds in a registered direct offering on February 5, 2025
  • Conference call and webcast on Monday, March 17, 2025, at 4:30 p.m. ET

SAN DIEGO, March 17, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced its financial results for the fourth quarter and full-year ended December 31, 2024, and provided a business update.

“We made exciting progress in our clinical development efforts over the past year, and the recent completion of the interim analysis of the Phase 3 DRAGON trial was an important milestone that brought us one step closer to realizing Tinlarebant’s potential to slow progression of STGD1,” said Dr. Tom Lin, Chairman and CEO of Belite. “We are very excited with the DSMB’s recommendation and the safety profile of Tinlarebant, and we remain on track to complete the trial by the fourth quarter of 2025. With the continued execution in our Phase 3 trials and the close of our recent $15 million registered direct offering on February 5, 2025, we remain well positioned through key milestones as we advance Tinlarebant as a novel therapeutic for people living with degenerative retinal diseases.”

Full Year 2024 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) has been implicated in the onset and progression of STGD1, for which there are no approved treatments. Tinlarebant has been granted 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 subjects
      • Following a pre-specified interim analysis, an independent DSMB recommended trial continuation without modifications, maintaining a sample size of 104 subjects
      • In addition, the DSMB recommended to submit the data for further regulatory review for drug approval 
      • Primary efficacy endpoint is the growth rate of atrophic lesions; safety and tolerability will also be assessed
      • Trial completion expected by Q4 2025 (including a three-month follow-up period)
    • DRAGON II Trial: Combination of a Phase 1b open-label trial to evaluate the pharmacokinetics and pharmacodynamics of Tinlarebant in Japanese adolescent STGD1 subjects and a Phase 2/3, 24-month, randomized (1:1, active: placebo), double-masked, placebo-controlled, multicenter trial in adolescent STGD1 subjects
      • Completed the Phase 1b portion of the trial with six subjects evaluated in Japan in Q3 of 2024
      • Enrolled 11 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 is 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
  • Geographic Atrophy (GA): GA, is a chronic degenerative disease of the retina that leads to blindness in the elderly. Accumulation of toxic vitamin A byproducts (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 subjects
      • Sample size increased from approximately 430 subjects to 500 subjects. 406 subjects have been enrolled
      • Primary efficacy endpoint is the growth rate of atrophic lesions; safety and tolerability will also be assessed
      • Company expects to conduct an interim analysis

Corporate Highlights

  • In February 2025, the Company completed a registered direct offering priced at the market, raising gross proceeds of $15 million, with the potential for additional proceeds of approximately $15 million from the exercise of five-year warrants issued in the offering.

Audited Full Year 2024 and Reviewed Fourth Quarter 2024 Financial Results:

Cash: As of December 31, 2024, the Company had $31.7 million in cash, as compared with $88.2 million on December 31, 2023.

Investments: As of December 31, 2024, the Company had $113.5 million in liquidity fund, time deposits and U.S treasury bills, as compared with nil on December 31, 2023.

R&D Expenses:

For the three months ended December 31, 2024, research and development expenses were $7.3 million compared to $4.9 million for the same period in 2023. The increase resulted primarily from share-based compensation granted in the third quarter of 2024 and higher R&D expenses in the fourth quarter of 2024 as the PHOENIX trial reached certain milestones.

For the year ended December 31, 2024, research and development expenses were $29.9 million compared to $24.8 million for the same period in 2023. The increase in research and development expenses was primarily attributable to (i) an increase in royalty payments for the completion of a Phase 2 trial, (ii) an increase in share-based compensation granted in the third quarter of 2024 and (iii) a decrease in clinical trial expenses, which was mainly attributed to fewer contract research organization milestone payments related to the DRAGON trial, partially offset by the increase in the DRAGON II trial expenses and the Australian research and development tax incentive, which is recognized as a reduction to research and development expenses.

G&A Expenses:

For the three months ended December 31, 2024, general and administration expenses were $4.2 million compared to $2.1 million for the same period in 2023. For the year ended December 31, 2024, general and administration expenses were $10.1 million compared to $6.8 million for the same period in 2023. The increase for both the quarter and full year was primarily driven by an increase in share-based compensation granted in the third quarter of 2024.

Other Income (expense):

For the three months ended December 31, 2024, other income was $1.4 million compared to other expense $0.04 million for the same period in 2023. For the year ended December 31, 2024, other income was $3.9 million compared to $0.05 million for the same period in 2024. The increase in other income was interest derived from cash in banks, our investments in liquidity funds, U.S. treasury bills, and time deposits from financial institutions.

Net Loss:

For the three months ended December 31, 2024, the Company reported a net loss of $10.1 million or ($0.32) per share compared to $7.0 million or ($0.25) per share for the same period in 2023. For the year ended December 31, 2024, the Company reported a net loss of $36.1 million or ($1.18) per share, compared to a net loss of $31.6 million or ($1.19) per share for the same period in 2023.

Webcast Information

Belite Bio will host a webcast on Monday, March 17, 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/481614529. A replay will be available for approximately 90 days following the event at the Company’s Investor Relations website at https://investors.belitebio.com/presentations-events/events.

About Belite Bio

Belite Bio is a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical 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 TwitterInstagramLinkedInFacebook 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 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
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Amounts in thousands of US Dollars, except share and per share amounts)
 
 For the Year 
 Ended December 31, 
 2023  2024 
Expenses       
Research and development 24,844   29,939 
General and administrative 6,824   10,057 
Total operating expenses 31,668   39,996 
Loss from operations (31,668)  (39,996)
Other income       
Total other income, net 45   3,858 
Loss before income tax (31,623)  (36,138)
Income tax expense 9   6 
Net loss (31,632)  (36,144)
Other comprehensive income (loss)       
Foreign currency translation adjustments, net of nil tax 18   (286)
Total comprehensive loss (31,614)  (36,430)
Weighted average number of ordinary shares used in per share calculation:       
- Basic and Diluted 26,593,673   30,538,378 
Net loss per ordinary share       
- Basic and Diluted$(1.19) $(1.18)


 For the Three Months 
 Ended December 31, 
 2023  2024 
 (Unaudited and
Unreviewed)
  (Unaudited) 
Expenses       
Research and development 4,862   7,254 
General and administrative 2,093   4,203 
Total operating expenses 6,955   11,457 
Loss from operations (6,955)  (11,457)
Other expense       
Total other income (expense), net (36)  1,357 
Loss before income tax (6,991)  (10,100)
Income tax expense -   - 
Net loss (6,991)  (10,100)
Other comprehensive income (loss)       
Foreign currency translation adjustments, net of nil tax 133   (259)
Total comprehensive loss (6,858)  (10,359)
Weighted average number of ordinary shares used in per share calculation:       
- Basic and Diluted 28,316,251   31,453,211 
Net loss per ordinary share       
- Basic and Diluted$(0.25) $(0.32)
 


BELITE BIO, INC
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands of US Dollars, except share amounts)
 
 December 31 
 2023  2024 
ASSETS       
Current Assets       
Cash$88,157  $31,677 
Investments -   113,472 
Other receivables 818   575 
Prepayments and other current assets 947   1,349 
Other receivables due from related parties 18   - 
Total current assets 89,940   147,073 
Property and equipment, net 490   444 
Intangible assets -   31 
Prepayments and other non-current assets 3,297   3,960 
Security deposits 104   103 
Operating lease right-of-use asset, net 811   521 
TOTAL ASSETS$94,642  $152,132 
LIABILITIES AND SHAREHOLDERS’ EQUITY       
Current liabilities       
Accrued expenses and other liabilities 3,325   5,761 
Other payables to related parties -   13 
Operating lease liabilities – current 308   276 
Total current liabilities 3,633   6,050 
Non-current liabilities       
Operating lease liabilities –non – current 578   261 
TOTAL LIABILITIES 4,211   6,311 
Shareholders’ equity       
Ordinary shares, par value of US$0.0001 per share; 400,000,000 shares authorized; 29,184,475 and 31,857,802 shares issued; 29,149,444 and 31,826,549 shares outstanding as of December 31, 2023 and 2024, respectively 3   3 
Additional paid-in capital 162,305   254,125 
Accumulated other comprehensive loss (374)  (660)
Accumulated deficit (71,503)  (107,647)
Total shareholders’ equity 90,431   145,821 
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY$94,642  $152,132 
 

Media and Investor Relations Contact:
Jennifer Wu
ir@belitebio.com
Julie Fallon
belite@argotpartners.com


FAQ

What were Belite Bio's (BLTE) key financial results for full-year 2024?

BLTE reported a net loss of $36.1M ($1.18/share), R&D expenses of $29.9M, and G&A expenses of $10.1M. Cash position was $31.7M with $113.5M in investments as of December 31, 2024.

When is Belite Bio's DRAGON Phase 3 trial expected to complete?

The DRAGON Phase 3 trial for Stargardt 1 disease is expected to complete in Q4 2025, including a three-month follow-up period.

How many subjects are enrolled in BLTE's PHOENIX trial for geographic atrophy?

406 subjects are currently enrolled in the PHOENIX trial, with the target increased from 430 to 500 subjects.

What regulatory designations has Tinlarebant received for STGD1 treatment?

Tinlarebant has received Fast Track and Rare Pediatric Disease Designations in the U.S., Orphan Drug Designation in the U.S., Europe, and Japan, and Sakigake Designation in Japan.

How much capital did BLTE raise in their February 2025 offering?

Belite Bio raised $15 million in gross proceeds through a registered direct offering, with potential for additional $15M from warrant exercises.
Belite Bio, Inc

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