Belite Bio, Inc (BLTE), a clinical-stage drug development company, announced financial results for the first quarter ended March 31, 2026, reflecting a wider net loss and provided an update on the near-term milestones for its lead investigational candidate, Tinlarebant.
Company Profile
Belite Bio focuses on developing therapeutics targeting degenerative retinal diseases, including Stargardt disease type 1 (STGD1) and geographic atrophy (GA) in advanced dry age-related macular degeneration (AMD), as well as specific metabolic diseases. Belite Bio's lead candidate, Tinlarebant, is an oral therapy intended to reduce the accumulation of Bisretinoid toxins in the eye and is being evaluated for the treatment of STGD1 and GA.
Tinlarebant has been granted Breakthrough Therapy, Fast Track, and Rare Pediatric Disease Designations in the U.S., Orphan Drug Designations in the U.S., Europe, Japan, and Switzerland, and the Sakigake Designation in Japan for the treatment of STGD1.
First Quarter Results
For the first quarter, adjusted net loss expanded to $26.94 million or $0.68 per share from $14.28 million or $0.45 per share in the prior year.
Net loss expanded to $13.74 million or $0.34 per share from $7.61 million or $0.24 per share a year ago.
As of March 31, 2026, the company had $276.4 million in cash and cash equivalents.
Near-Term Milestones
The Company has completed a Phase 3 DRAGON trial of Tinlarebant in adolescent subjects with STGD1, and the drug is currently being evaluated in a Phase 2/3 DRAGON II trial in STGD1 subjects, as well as in a Phase 3 PHOENIX trial in subjects with GA.
Based on the DRAGON trial, the firm has initiated a rolling NDA submission with the FDA for Tinlarebant in STGD1 in April 2026. The NDA submission is expected to be completed in the second quarter of 2026.
In the PHOENIX Trial in GA, enrollment is completed with 530 candidates, and the firm expects to conduct an interim analysis.
BLTE has traded between $56.10 and $200 over the last year. The stock closed Tuesday's trade at $139.70, down 2.24%.
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