Financial Data and Key Metrics Changes - The company ended Q3 2025 with cash, cash equivalents, and investments totaling $209.1 million, following a successful public offering that raised approximately $259 million in gross proceeds [19][20] - R&D expenses for Q3 2025 were $31 million, up from $17.2 million in Q3 2024, reflecting an increase of $13.8 million primarily due to MM120 program expenses [21] - The net loss for Q3 2025 was $67.3 million, compared to $13.7 million for the same period in 2024, significantly impacted by changes in the fair value of financing warrants [22] Business Line Data and Key Metrics Changes - The company is advancing its clinical programs, particularly MM120 for generalized anxiety disorder (GAD) and major depressive disorder (MDD), with strong enrollment trends across pivotal studies [10][12] - The phase 2B trial results for MM120 were published in the Journal of the American Medical Association, demonstrating a statistically significant 7.7-point greater reduction in Hamilton Anxiety Scale (HamA) scores compared to placebo [11] Market Data and Key Metrics Changes - The company anticipates three pivotal data readouts for MM120 in 2026, with strong enrollment across ongoing studies, indicating a robust market interest in new treatment options for GAD and MDD [5][10] - The potential market for MM402, targeting autism spectrum disorder (ASD), is significant due to the growing prevalence and unmet need in this area [8][17] Company Strategy and Development Direction - The company aims to accelerate the development of MM120 and MM402, with plans to initiate a phase 2A study for MM402 by the end of 2025 and a second pivotal study for MDD in mid-2026 [5][9] - The strategy includes reducing administrative barriers to adoption and ensuring providers are compensated for their services, which is crucial for market penetration [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's positioning for a transformational 2026, with multiple catalysts expected to drive value for shareholders and patients [5][24] - The ongoing dialogue with the FDA is constructive, and the company believes it is well-positioned to deliver compelling evidence of the safety and efficacy of its products [6][15] Other Important Information - The company has successfully expanded its investor base, attracting high-quality healthcare-dedicated funds and mutual funds, reflecting confidence in its mission [4] - The company plans to prepare for a New Drug Application (NDA) submission for MM120 ODT as soon as possible, aiming for a robust commercial launch if approved [20] Q&A Session Summary Question: Inquiry about blinded sample size re-estimation - Management has not disclosed any public information regarding sample size re-estimation for the GAD studies, but enrollment remains strong [26][27] Question: Difficulty in finding psychedelic inexperienced patients - Enrollment is challenging, but the company aims for a representative sample that reflects the general GAD population, with approximately 15% having some psychedelic experience [30][33] Question: Differences in durability of effect between MDD and GAD - The company is studying the differences in treatment durability and expects to characterize these in ongoing studies [77][79] Question: Feedback on JAMA publication and physician response - The publication has received overwhelmingly positive feedback, highlighting the potential for significant change in psychiatric treatment [44][46] Question: Market potential overlap between MDD and GAD - The company sees the overlap as an opportunity to treat both conditions rather than cannibalizing the market, as many patients may qualify for both diagnoses [52][54]