Release Date: August 13, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Mineralys Therapeutics Inc (MLYS, Financial) has made significant progress in advancing the development of lorundrostat, their lead asset, particularly in their hypertension registration program.
- Enrollment in the Advance-HTN trial is approximately 90% complete, with top-line data expected in the first quarter of 2025.
- The company has aligned with the FDA to maintain the original primary endpoint for the Advance-HTN trial, ensuring consistency and robustness in data collection.
- Enrollment in the Launch-HTN trial is ahead of schedule, with top-line data expected in the second half of 2025.
- Mineralys Therapeutics Inc (MLYS) ended the quarter with $311.1 million in cash, cash equivalents, and investments, providing sufficient funding for planned clinical trials and corporate operations into 2026.
Negative Points
- The timeline for the Advance-HTN trial's top-line data readout has been extended to the first quarter of 2025, which may disappoint some stakeholders.
- R&D expenses increased significantly to $39.3 million for the quarter, up from $11.9 million in the same quarter of 2023, primarily due to higher preclinical and clinical costs.
- G&A expenses also rose to $5.9 million for the quarter, compared to $3.9 million in the same quarter of the prior year, driven by higher compensation expenses and professional fees.
- Net loss for the quarter was $41 million, a substantial increase from $12.1 million in the same quarter of 2023.
- The Explore-CKD trial's top-line data readout has been adjusted from Q4 2024 to Q1-Q2 2025, indicating potential delays in the trial's progress.
Q & A Highlights
Q: Can you provide more clarity on why the timelines for Advance-HTN and the CKD trial were extended?
A: The timeline adjustments were based on more accurate projections as enrollment progressed. For Advance-HTN, the rigorous and complex nature of the trial made early projections difficult. Now, with 90% enrollment, we are confident in a Q1 2025 readout. Similarly, for the CKD trial, a protocol amendment improved enrollment, leading us to adjust the readout to Q1-Q2 2025.
Q: Why did the FDA decide to keep the primary endpoint for the Phase 2 advanced hypertension trial at 12 weeks?
A: The FDA's decision was based on the substantial amount of accrued data. We will conduct a full analysis at both 4 weeks and 12 weeks, ensuring clarity and maintaining the integrity of the trial.
Q: What patients will be included in the 12-week endpoint analysis for Advance-HTN?
A: The primary analysis at 12 weeks will compare placebo with each active arm. Patients who started on 50 mg and ended on 50 mg will be analyzed separately from those who titrated to 100 mg. Both groups will be compared to placebo.
Q: Why is the 4-week measurement important in the Advance-HTN trial?
A: By 4 weeks, the maximum benefit is typically achieved. Having data points at both 4 weeks and 12 weeks helps manage various issues, including predictive value and statistical modeling. It also allows pooling of replicate groups for more powerful subset analyses.
Q: How do you reconcile the differences between 24-hour blood pressure monitoring and automated office blood pressure measurements?
A: 24-hour monitoring provides more precise data due to frequent measurements, but it typically shows lower baseline pressures and smaller treatment effects compared to office measurements. The systematic differences are due to factors like white coat hypertension, which is mitigated in 24-hour monitoring.
Q: What was the rationale for using the 25 mg dose instead of 50 mg in the Explore-CKD study?
A: The 25 mg dose was chosen out of an abundance of caution to minimize the risk of hyperkalemia in patients with lower eGFR. Nephrology advisors are comfortable using potassium binders if needed, but this is an exploratory stage.
Q: Do you expect a difference in efficacy between uncontrolled and resistant hypertensive patients in the Advance-HTN study?
A: We have separately block-randomized uncontrolled and resistant patients, ensuring full statistical power for comparisons. While we didn't see a difference in the Target-HTN trial, we will wait for the Advance-HTN results before making any predictions.
Q: What is the threshold of systolic blood pressure reductions you are looking for in the Explore-CKD study to advance lorundrostat into a larger trial?
A: The primary focus is on hypertension, with albuminuria as a secondary endpoint. We aim to target a subpopulation with both hypertensive and metabolic syndrome components, differentiating our drug from other approaches in the CKD space.
Q: How do you view the recent data from other MRAs and ASIs in the context of your CKD studies?
A: MRAs generally have similar mechanisms but are limited by on-target side effects like hyperkalemia. Our ASI, lorundrostat, can achieve maximum therapeutic benefit without these limitations. Long-term, we believe our drug will differentiate through its effects on various pathways beyond the MR, such as inflammation and fibrosis.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
