Belite Bio reports rise in Q4 preliminary net loss

Overview

• Clinical-stage drug developer's preliminary Q4 and FY 2025 results show increased net loss

• Company completed $402 mln public offering to support commercialization and pipeline expansion

• Tinlarebant Phase 3 trial met primary endpoint, NDA submission expected in Q2 2026

Outlook

• Belite Bio plans to submit NDA for tinlarebant to FDA in Q2 2026

Result Drivers

• DRAGON TRIAL RESULTS - Phase 3 trial of tinlarebant showed a 35.7% reduction in macular lesion growth rate, meeting primary efficacy endpoint

• PUBLIC OFFERING - Completed $402 mln public offering to support commercialization and pipeline expansion

• R&D EXPENSES - For the three months ended December 31, 2025, research and development expenses were $14.6 million compared to $7.3 million for the same period in 2024.

Company press release: ID:nGNX1XkyGQ

Key Details

Analyst Coverage

• The current average analyst rating on the shares is "buy" and the breakdown of recommendations is 8 "strong buy" or "buy", no "hold" and no "sell" or "strong sell"

• The average consensus recommendation for the biotechnology & medical research peer group is "buy"

• Wall Street's median 12-month price target for Belite Bio Inc is $193.00, about 1.4% above its February 27 closing price of $190.30

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