Financial Data and Key Metrics Changes - The company ended Q3 2025 with cash, cash equivalents, and investments of $593.6 million, a significant increase from $198.2 million as of December 31, 2024, indicating strong liquidity to support operations into 2028 [16] - R&D expenses for Q3 2025 were $31.5 million, down from $54 million in Q3 2024, primarily due to the conclusion of the lorandirostat pivotal program [16][17] - Net loss for Q3 2025 was $36.9 million, a decrease from $56.3 million in Q3 2024, reflecting improved expense management [18] Business Line Data and Key Metrics Changes - The company is advancing its clinical programs, particularly lorandirostat, which has shown clinically meaningful reductions in systolic blood pressure across diverse patient populations [6][10] - The EXPLORE-CKD trial demonstrated a significant reduction in systolic blood pressure and a clinically meaningful reduction in urinary albumin-creatinine ratio, indicating potential renal protection [10] Market Data and Key Metrics Changes - The company is focusing on market access planning and payer engagement to ensure the value of lorandirostat is well understood, which is crucial for its commercial readiness [13] - The ongoing phase II EXPLORE-OSA trial aims to evaluate lorandirostat's efficacy in patients with obstructive sleep apnea and hypertension, with results expected in Q1 2026 [11] Company Strategy and Development Direction - The company is preparing for an NDA submission for lorandirostat, expected by the end of 2025 or early 2026, following positive pre-NDA feedback from the FDA [5][36] - The strategy includes expanding lorandirostat's profile to address comorbid conditions associated with hypertension, such as chronic kidney disease and obstructive sleep apnea [12][41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the clinical data supporting lorandirostat as a best-in-class therapy for uncontrolled and resistant hypertension [14][64] - The company is optimistic about upcoming milestones, including the NDA submission and results from the EXPLORE-OSA trial, which could enhance the drug's profile [64] Other Important Information - The company has emphasized the importance of diverse patient representation in clinical trials, particularly for Black or African American populations, which are often underrepresented in hypertension studies [54] - The management highlighted the need for partnerships to maximize the value of lorandirostat, both in the U.S. and internationally [38][49] Q&A Session Summary Question: What would the systolic blood pressure reduction be without adjusting for discontinuations? - Management indicated that they have not performed that specific analysis, as it was not part of the study plan [20][21] Question: Have you looked at the day and night blood pressure differences in the Advanced HTN trial? - Management confirmed that they are comfortable with the 24-hour control and have measured blood pressure at trough, but have yet to publish nighttime data [26][28] Question: Can you provide more details on the pre-NDA feedback? - Management stated that there were no surprises in the feedback and expressed confidence in the data set prepared for submission [35][36] Question: What are your expectations for the open label extension trial? - Management noted that the trial is progressing well, with no surprises, and results will be published once the last subject completes the study [40] Question: How do you expect to leverage data from the EXPLORE-OSA trial? - Management aims to enhance lorandirostat's profile by demonstrating its benefits beyond blood pressure reduction, addressing related comorbidities [41] Question: What differences in efficacy do you see with lorandirostat in the African American population? - Management highlighted that over 50% of participants in the Advance HTN trial were Black or African American, showing that race does not determine response to lorandirostat [54][56]