In This Article:
-
R&D Expenses: $9.4 million, up from $6.8 million in the same period last year.
-
G&A Expenses: $6.1 million, up from $1.6 million in the same period last year.
-
Net Loss: $14.3 million, compared to a net loss of $7.9 million for the same period last year.
-
Operating Cash Outflow: Approximately $8.3 million.
-
Cash Increase: $12.3 million for the quarter.
-
Cash and Equivalents: $157.4 million, including liquidity funds, time deposits, and US Treasury bills.
-
Cash Runway: Expected to last 4 years, sufficient to complete current clinical trials.
Release Date: May 14, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
-
Belite Bio Inc (NASDAQ:BLTE) has made significant progress in its phase 3 trials for Stargardt disease and geographic atrophy, with promising interim results.
-
The company's lead drug, Tarban, has received multiple designations, including rare pediatric disease and fast track in the US, and orphan drug designation in the US, Europe, and Japan.
-
The interim analysis of the Dragon trial showed no need for sample size increase, indicating strong efficacy, and the DSMB recommended submitting data for regulatory review.
-
Belite Bio Inc (NASDAQ:BLTE) has a strong financial position with a four-year cash runway, allowing it to complete current clinical trials without additional funding.
-
The Phoenix trial for geographic atrophy is progressing well, with enrollment expected to be completed by Q3 2025, and the company is on track to meet its clinical milestones.
Negative Points
-
Belite Bio Inc (NASDAQ:BLTE) reported a net loss of $14.3 million for Q1 2025, an increase from $7.9 million in the same period last year, primarily due to higher R&D and G&A expenses.
-
The dropout rate in the Phoenix trial is approximately 20%, which, while lower than some other studies, still represents a significant challenge.
-
There is uncertainty regarding the impact of President Trump's drug pricing policies on the company's strategy for launching Tarban in ex-US territories.
-
Operating expenses are expected to rise in 2025 and 2026 due to ongoing clinical trials, potentially impacting profitability.
-
The company has not yet finalized its regulatory meetings with the FDA, which could pose a risk to the timeline for drug approval.
Q & A Highlights
Q: Could you provide an update on the Phoenix trial's discontinuation rates and enrollment progress? Also, any updates on regulatory meetings for Stargardt disease trial requirements? A: The dropout rate for the Phoenix trial is approximately 20%, which is lower than previous studies. We are conducting the trial with elderly patients, and compliance remains strong. Regarding regulatory meetings, we have scheduled discussions with regulators and will update as we progress.