Belite Bio, Inc. (NASDAQ:BLTE) reported first-quarter results on Wednesday that came in ahead of analyst forecasts, with the clinical-stage biotech group posting an adjusted loss per share of -$0.34 versus consensus expectations of -$0.64.
Shares of the company gained 2.49% in premarket trading following the earnings announcement.
Losses widen as research and commercialization spending increases
Belite Bio reported an adjusted net loss of $13.7 million for the three months ended March 31, 2026, compared with an adjusted net loss of $7.6 million recorded during the same quarter a year earlier.
On a GAAP basis, the company posted a net loss of $26.9 million, or -$0.68 per share, compared with a net loss of $14.3 million, or -$0.45 per share, in the first quarter of 2025.
“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,” said Dr. Tom Lin, Chairman and CEO of Belite Bio.
FDA submission advances for Stargardt disease treatment
The company said it began a rolling New Drug Application submission to the U.S. Food and Drug Administration in April 2026 for tinlarebant as a treatment for Stargardt disease type 1, with the full submission expected to be completed during the second quarter of 2026.
Belite Bio also confirmed that it has filled all key commercial leadership positions as it prepares for a potential product launch.
Research and development expenses increased to $15.7 million from $9.4 million year over year, mainly due to costs tied to the DRAGON II clinical trial and manufacturing activities.
Selling, general and administrative expenses rose to $17.0 million from $6.1 million in the prior-year period, driven by higher share-based compensation, professional service expenses and increased staffing costs linked to the company’s expansion efforts.
Strong cash position supports development plans
As of March 31, 2026, Belite Bio held $798.6 million in cash, cash equivalents and U.S. Treasury securities, providing substantial liquidity to support its ongoing clinical and commercial development strategy.