Core Insights - Neumora Therapeutics has initiated a Phase 1 single-ascending dose/multiple-ascending dose study for NMRA-861, with data expected in Q1 2026 [1][4] - The company has prioritized obesity as the lead indication for NMRA-215, a highly brain-penetrant NLRP3 inhibitor, with data from preclinical studies expected in 2025 [1][6][7] - Neumora is entering a catalyst-rich period with up to six clinical data readouts anticipated over the next 18 months, including Phase 3 data for navacaprant in major depressive disorder and Phase 1b data for NMRA-511 in Alzheimer's disease agitation [1][3][8][9] - The company reported a strong financial position with $217.6 million in cash, cash equivalents, and marketable securities, expected to support operations into 2027 [1][14] Pipeline Highlights - NMRA-861, an M4 positive allosteric modulator, has entered Phase 1 clinical studies targeting schizophrenia and other neuropsychiatric disorders [4][5] - NMRA-215 has shown potential for best-in-class brain penetration and is being developed for obesity, with clinical studies expected to start in Q1 2026 [6][7] - Navacaprant is currently in Phase 3 trials for major depressive disorder, with topline data expected in the first half of 2026 [8] - NMRA-511 is on track to report data from a Phase 1b study for Alzheimer's disease agitation by the end of 2025 [9] Financial Overview - For Q2 2025, Neumora reported research and development expenses of $38.7 million, down from $48.6 million in the same period of 2024, primarily due to reduced stock-based compensation and clinical trial costs [14][16] - General and administrative expenses for Q2 2025 were $15.3 million, slightly up from $15.2 million in Q2 2024 [14][16] - The net loss for Q2 2025 was $52.7 million, compared to a net loss of $58.7 million in Q2 2024 [14][16]

Financial Data and Key Metrics Changes - Total operating expenses for Q4 2024 were $58.8 million, down from $108.7 million in Q4 2023, while full-year operating expenses increased slightly to $243.8 million from $235.9 million in 2023 [32] - As of December 31, 2024, the company had $307.6 million in cash, cash equivalents, and marketable securities, expected to support operations into mid-2026 [33] Business Line Data and Key Metrics Changes - The company is advancing navacaprant, currently in Phase 3 development for MDD, and has made changes to optimize ongoing studies based on learnings from the KOASTAL-1 study [11][12] - NMRA-511 is being investigated in a Phase 1b study for Alzheimer's disease agitation, with top-line data expected by the end of 2025 [15][17] Market Data and Key Metrics Changes - Approximately 70% of the estimated 7 million people living with Alzheimer's disease experience agitation, indicating a significant unmet need in this market [16] Company Strategy and Development Direction - The company aims to deliver transformative medicines for brain diseases, focusing on a pipeline of seven programs targeting novel mechanisms of action [7] - The strategy for the KOASTAL program includes enhancing patient monitoring and site selection to improve study outcomes [25][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of navacaprant despite previous study results, citing a strong pipeline and a commitment to addressing unmet needs in brain disease treatment [19][31] - The company is focused on disciplined capital allocation to leverage its strong balance sheet for future catalysts across its programs [32] Other Important Information - The company has discontinued the Phase 2 trial for navacaprant in bipolar depression to prioritize resources for the KOASTAL program [14] - The company is advancing four preclinical programs targeting various brain disorders, including Alzheimer's agitation and schizophrenia [29] Q&A Session Summary Question: Differences between KOASTAL-1 vendor and SAFER - The company is enhancing medical monitoring to confirm patient diagnoses and is partnering with Mass General Hospital's SAFER for independent reviews [37][39] Question: Enrollment status of KOASTAL-2 and 3 - The company is not disclosing specific enrollment numbers but is optimistic about the changes made to improve outcomes in these studies [51] Question: Placebo response in KOASTAL-1 - The company identified that site experience significantly impacted performance, particularly in male patients, and is focusing on site selection for future studies [46][48] Question: Cash runway and financing strategies - The company maintains a strong financial position and is exploring various funding mechanisms to support operations [66][70] Question: Interim analysis for KOASTAL studies - No interim analysis is planned for KOASTAL-2 and 3 due to the short duration of the studies [87] Question: Update on NMRA-266 clinical hold - The company is working to determine the path forward for NMRA-266 while progressing follow-on compounds in the M4 franchise [92]