Financial Data and Key Metrics Changes - Cash and cash equivalents and marketable securities totaled $624.8 million as of June 30, 2025, compared to $754.4 million as of December 31, 2024, indicating a decrease in liquidity [28] - The company anticipates having sufficient cash to fund operations into 2027 based on current operating plans [28] Business Line Data and Key Metrics Changes - The Phase III clinical trial for EZETUCALIMER, EXTOL-two, has completed patient recruitment, with top-line results expected in early 2026 [6][12] - The company is expanding its product portfolio through earlier stage ion channel programs, including KV7 and NAV1.7 [21][23] Market Data and Key Metrics Changes - The company is focusing on the U.S. market for the commercialization of EZETUCALIMER for focal onset seizures [4] - There is significant potential for EZETUCALIMER beyond epilepsy, with initial focus on major depressive disorder (MDD) and bipolar depression [10][17] Company Strategy and Development Direction - The company aims to drive towards Phase III data, NDA submission, and commercialization of EZETUCALIMER [4] - There is a strategic focus on broadening the ASETE COLENDAR opportunity across additional epilepsy and neuropsychiatric indications [5] - The company is also investing in its early-stage pipeline targeting ion channels, which includes multiple promising drug candidates [21][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of EZETUCALIMER to provide a new treatment option for epilepsy, highlighting its differentiated product profile [6][9] - The management team is excited about the upcoming data readouts and the potential for additional indications in neuropsychiatry [20][35] Other Important Information - The company has welcomed Darren Klein as the Chief Commercial Officer to lead the commercial strategy for EZETUCALIMER [29][32] - The company plans to present data at the upcoming International Epilepsy Congress and the American Epilepsy Society [13][14] Q&A Session Summary Question: How quickly do you think they'll be able to file on the back of that top-line FOS data? - Management indicated that they expect approximately six months from top-line data to filing the NDA [40] Question: Can you talk about your confidence regarding safety issues in the NAV1.7 program? - Management believes they have a good handle on safety based on preclinical data and have not seen cardiovascular signals in preclinical safety data [41] Question: When would you expect all the patients to be randomized for EXTOL-two? - Management confirmed that the last patients will go through a baseline period, and they will provide updates as the study progresses [47] Question: Have you seen any compassionate use interest? - Management noted there is significant interest in the mechanism, but currently, there is no compassionate use program in place [53] Question: Can you talk about the molecules profile for NAV1.7? - Management stated that they will provide more information on pharmacokinetics and bioavailability as they progress through the first cohorts in humans [70] Question: How do you see the potential read-through from Biohaven's pending MDD readout? - Management expressed confidence in their mechanism for MDD and is looking forward to seeing Biohaven's data [96] Question: What are the key headwinds you anticipate upon approval and launch? - Management acknowledged the need to overcome inertia among neurologists and epileptologists who are set in their ways [100] Question: Can you provide some color on the difference between Type I and Type II bipolar depression? - Management confirmed that the bipolar depression studies will include a mixture of Type I and Type II patients, with stratification to avoid imbalances [105]