Belite Bio, Inc. ADR ((BLTE)) has held its Q4 earnings call. Read on for the main highlights of the call.
The recent earnings call for Belite Bio, Inc. ADR was marked by a cautiously optimistic sentiment. The company highlighted significant advancements in their flagship drug, Tinlarebant, alongside strong clinical trial enrollment and financial stability. However, challenges such as increased expenses, net loss, adverse events in trials, and high dropout rates were also acknowledged. Despite these hurdles, the overall tone remained positive due to the promising progress in clinical trials and the company’s robust financial position.
Tinlarebant’s Significant Advancements
Tinlarebant has achieved several regulatory milestones, including Rare Pediatric Disease and Fast Track designations in the U.S., as well as Pioneer Drug and Orphan Drug designations in Japan, the U.S., and Europe. The Phase 3 DRAGON trial’s interim analysis recommended proceeding without modifications, signaling promising efficacy and potential for future success.
Clinical Trial Enrollment Success
The company reported successful enrollment in their clinical trials, with the DRAGON 2 trial enrolling 11 of the targeted 60 subjects. Additionally, the PHOENIX trial for geographic atrophy (GA) has over 400 subjects enrolled, with plans to increase to 500 due to the good progress being made.
Financial Stability
Belite Bio ended 2024 with $31.7 million in cash and $113.5 million in investments. Furthermore, they raised $15 million in a direct offering, ensuring a full year’s cash runway. This financial stability supports their ongoing research and development efforts.
Increased Expenses and Net Loss
The company reported increased expenses, with R&D costs rising to $29.9 million from $28.8 million in 2023, and G&A expenses increasing to $10.1 million from $6.8 million. Consequently, the net loss grew to $36.1 million from $31.6 million, highlighting the financial challenges faced.
Adverse Events in DRAGON 1 Trial
The DRAGON 1 trial experienced treatment-emergent adverse events such as xanthopsia and delayed dark adaptation, resulting in a 9.6% withdrawal rate. These events were deemed mild and transient, but they underscore the challenges in clinical trials.
High Dropout Rate in GA Trial
The PHOENIX trial for GA reported a dropout rate of approximately 20%, a common occurrence in elderly populations but still a notable challenge for the trial’s success.
Forward-Looking Guidance
Belite Bio provided significant guidance regarding Tinlarebant’s progress for treating Stargardt disease and GA. The Phase 3 DRAGON trial with 104 subjects and the Phase 2/3 DRAGON 2 trial targeting 60 subjects are progressing well, with the DSMB recommending the DRAGON trial proceed without modifications. The PHOENIX trial’s enrollment is also strong, with plans to increase to 500 subjects. Financially, the company remains stable with a full-year cash runway secured.
In conclusion, Belite Bio’s earnings call highlighted a cautiously optimistic outlook. The company is making significant strides with Tinlarebant and maintaining financial stability, despite facing challenges such as increased expenses and high dropout rates in trials. The overall sentiment remains positive, with promising clinical trial progress and strong forward-looking guidance.