Financial Data and Key Metrics Changes - The company ended Q1 with just under $700 million on the balance sheet, guiding that this cash runway extends into 2027, supporting an ambitious clinical program in epilepsy and psychiatry [72]. Business Line Data and Key Metrics Changes - The lead molecule, ZetuCalder, is in a Phase III epilepsy program, with data expected in early 2026. The company is also ramping up late-stage clinical programs in major depression and bipolar depression [3][6][5]. - The Phase III clinical trial for focal onset seizures (XTOL-two) is nearing completion of patient screening, maintaining consistency with the Phase II study [17][18]. Market Data and Key Metrics Changes - Approximately 3 million Americans have epilepsy, with 60% experiencing focal onset seizures. An estimated 30% to 50% of these patients do not achieve good seizure control, indicating a significant market opportunity for ZetuCalder [21][22]. Company Strategy and Development Direction - The company focuses on validated targets in neurology, particularly ion channels, to maintain a competitive advantage. The strategy includes building a commercial infrastructure in the U.S. while seeking partners for international markets [9][40][43]. - The company is advancing its early-stage pipeline, including molecules targeting KV7 and Nav1.7, with plans for clinical trials in the near future [74][76]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the efficacy of their lead product and highlighted the importance of clinical data in shaping future commercial strategies. They noted a data-rich period ahead with multiple clinical milestones expected [20][73]. - The management acknowledged the challenges in the regulatory landscape but emphasized their preparedness for filing an NDA based on the ongoing clinical trials [30][31]. Other Important Information - The company has made significant changes in its Phase III clinical trial design for major depression, including increasing sample size and adjusting primary endpoints to reduce variability and enhance data quality [45][50][51]. - The company is also exploring bipolar depression, leveraging existing safety data from previous studies to support this new indication [68][70]. Q&A Session Summary Question: Can you provide an update on trial execution and enrollment for XTOL-two? - The company is close to completing patient screening for XTOL-two, with data expected in early 2026 [17][18]. Question: How does the company plan to approach pricing for ZetuCalder? - The company believes it can price ZetuCalder competitively within the specialty neurology drug market, with a focus on indication-specific pricing strategies [20][22]. Question: What is the company's strategy for commercialization outside the U.S.? - The company plans to build commercial infrastructure in the U.S. and will seek partners for market access in international markets [40][43]. Question: How is the company addressing placebo responses in clinical trials? - The company is focusing on enrolling a more severe depressed population to minimize placebo effects and has implemented a one-to-one randomization strategy [54][66]. Question: What is the current status of the early-stage pipeline? - The company is advancing several early-stage programs, including those targeting KV7 and Nav1.7, with plans for clinical trials in the near future [74][76].