Belite Bio's Q4 2024 Earnings Call: Discrepancies in Regulatory Strategies, Discontinuation Rates, and Trial Design
Monday, Mar 17, 2025 6:44 pm ET
4min read These are the key contradictions discussed in Belite Bio's latest 2024Q4 earnings call, specifically including: DSMB recommendations and regulatory strategies, discontinuation rates in clinical trials, study population and trial design, and regulatory strategy:
Phase 3 Trials Progress:
- Belite Bio has made significant progress in its Phase 3 trials for Tinlarebant, with the DRAGON trial completing an interim analysis and the DSMB recommending no sample size increase.
- The progress is attributed to the strong trial design and promising interim results, which indicate potential efficacy.
Interim Analysis and Regulatory Review:
- The Data Safety Monitoring Board (DSMB) recommended submission of interim data for further regulatory review and drug approval for Tinlarebant in Stargardt disease.
- This positive outcome is a result of the DSMB's confidence in the interim analysis and possible efficacy signals.
Sample Size Increase in GA Trial:
- Belite Bio plans to increase the sample size in the Phase 3 PHOENIX trial for Geographic Atrophy from approximately 450 to 500 subjects.
- This decision is to further boost the chances of success, leveraging the smooth enrollment rate, and maintaining feasibility within the expected timeline.
Adolescent Stargardt Disease Population:
- The current trial population for Stargardt disease consists of adolescents, which represents a significant portion of the real-world diagnosed population.
- The decision to focus on this age group is based on the typical onset of the disease and the potential to approve the drug for a broader patient population with similar disease progression.
total revenue (fy) increase(6514)net income (fy)(6514)diluted eps (fy)(6514)p/e (ttm)(6514)price to book ratio(5528)p/s(6514)
Total Revenue (FY) QoQ growth value2024.12.31  | Net Income (FY)(USD)2024.12.31  | Diluted EPS (FY)(USD)2024.12.31 | P/E(TTM)2025.03.14 | Price to Book Ratio2025.03.17 | P/S2025.03.14 |
|---|---|---|---|---|---|
| 63.17B | 59.25B | 5.53 | 35.41 | 7.25 | 3.29 |
| 49.20B | 3.78B | 12.12 | 24.70 | 2.09 | -- |
| 42.62B | 100.12B | 8.04 | 20.41 | 6.25 | 5.84 |
| 42.62B | 100.12B | 8.04 | 20.15 | 6.16 | 5.76 |
| 39.03B | 260.80M | 7.96 | 12.85 | 2.04 | 0.03 |
| 36.84B | 16.27B | 1.91 | 35.20 | 7.70 | 1.01 |
| 33.95B | 29.76B | 1.19 | 40.73 | 36.77 | 22.75 |
| 33.21B | 88.14B | 11.80 | 31.14 | 9.55 | 10.68 |
| 31.79B | 1.52B | 7.53 | 35.84 | 223.34 | 0.15 |
| 29.60B | 62.36B | 23.86 | 24.69 | 8.39 | 9.36 |
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View 5528 results
Phase 3 Trials Progress:
- Belite Bio has made significant progress in its Phase 3 trials for Tinlarebant, with the DRAGON trial completing an interim analysis and the DSMB recommending no sample size increase.
- The progress is attributed to the strong trial design and promising interim results, which indicate potential efficacy.
Interim Analysis and Regulatory Review:
- The Data Safety Monitoring Board (DSMB) recommended submission of interim data for further regulatory review and drug approval for Tinlarebant in Stargardt disease.
- This positive outcome is a result of the DSMB's confidence in the interim analysis and possible efficacy signals.
Sample Size Increase in GA Trial:
- Belite Bio plans to increase the sample size in the Phase 3 PHOENIX trial for Geographic Atrophy from approximately 450 to 500 subjects.
- This decision is to further boost the chances of success, leveraging the smooth enrollment rate, and maintaining feasibility within the expected timeline.
Adolescent Stargardt Disease Population:
- The current trial population for Stargardt disease consists of adolescents, which represents a significant portion of the real-world diagnosed population.
- The decision to focus on this age group is based on the typical onset of the disease and the potential to approve the drug for a broader patient population with similar disease progression.
Ask Aime: What factors led to the DSMB's recommendation and regulatory strategies in Belite Bio's Phase 3 trials for Tinlarebant?
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