Pipeline Highlights - Neumora is advancing a broad neuroscience pipeline targeting prevalent diseases with novel mechanisms [18] - Multiple catalysts are expected over the next 12 months, including data readouts for Navacaprant and NMRA-511, and advancing NMRA-861 and NMRA-898 to the clinic [20, 21] NMRA-215 (Obesity) - By 2030, 1.13 billion people worldwide are projected to be living with obesity, driving a significant market for obesity treatments estimated at $130-$170 billion [26] - NMRA-215 demonstrated best-in-class monotherapy weight loss of up to 19% in preclinical studies [29, 47] - Combination therapy with NMRA-215 and semaglutide resulted in up to 26% weight loss [30, 50] - NMRA-215 monotherapy matches semaglutide weight loss, while preserving lean mass [56] NMRA-511 (Alzheimer's Disease Agitation) - Approximately 7 million U S adults have Alzheimer's Disease, and this number is expected to increase to 13 million by 2050 [19, 72] - Over 70% of people with Alzheimer's Disease experience agitation at some point [72] - NMRA-511 Phase 1b study data is anticipated around the end of 2025 [66, 142] M4 PAM Franchise (Schizophrenia) - An estimated 3 million patients in the U S have schizophrenia [19, 100] - Neumora has multiple chemically distinct, highly selective M4 muscarinic receptor PAMs, including NMRA-861 and NMRA-898 [99] - NMRA-861 and -898 potentially have more potency than emraclidine across multiple assays [116]

Core Insights - Neumora Therapeutics has initiated a Phase 1 single-ascending dose/multiple-ascending dose study for NMRA-898, a new M4 muscarinic receptor positive allosteric modulator, which is structurally distinct from NMRA-861 [1][2] - The M4 franchise, including NMRA-861 and NMRA-898, aims to provide improved therapeutic profiles for schizophrenia and other neuropsychiatric disorders compared to standard treatments [2][4] - Neumora plans to provide a comprehensive update on its M4 franchise by mid-2026, evaluating the potential advancement of one or both programs based on safety and pharmacokinetic data [2][3] Company Overview - Neumora Therapeutics is a clinical-stage biopharmaceutical company focused on redefining neuroscience drug development with a pipeline of seven programs targeting novel mechanisms for various diseases [6] - The company has licensed intellectual property rights for NMRA-898 from Vanderbilt University, with patent protection extending to 2044 [4] - Neumora's mission is to improve treatment outcomes and quality of life for patients suffering from brain diseases through innovative therapies [6] Industry Context - Schizophrenia affects approximately 3 million adults in the United States, with significant unmet medical needs due to the side effects of current therapies [5] - Current antipsychotics primarily target D2 dopamine receptors, while Neumora's approach focuses on the M4 muscarinic receptor, which may reduce side effects associated with traditional treatments [4][5] - The high discontinuation rate of schizophrenia medications, with about 75% of patients stopping treatment within 18 months, highlights the need for more effective and tolerable options [5]

Core Points - Alkermes plc will host a conference call and webcast presentation on October 28, 2025, at 8:00 a.m. ET to discuss its third quarter financial results [1] - The conference call can be accessed via specific phone numbers for U.S. and international callers, and a replay will be available on the company's website [2] - Alkermes is a global biopharmaceutical company focused on developing innovative medicines in neuroscience, with a portfolio addressing alcohol dependence, opioid dependence, schizophrenia, and bipolar I disorder [2] - The company has a pipeline of clinical and preclinical candidates for neurological disorders, including narcolepsy and idiopathic hypersomnia [2] - Alkermes is headquartered in Ireland, with additional offices in Massachusetts and a manufacturing facility in Ohio [2] Additional Information - Joshua Reed has been appointed as Chief Financial Officer, effective September 15, 2025 [3] - Alkermes has announced the launch of its 8th Annual Alkermes Pathways Research Awards program [4]

Core Insights - Neumora Therapeutics, Inc. is hosting a virtual R&D Day on October 27, 2025, to showcase its innovative therapeutic pipeline targeting various diseases [1][4] Group 1: R&D Day Highlights - The R&D Day will feature NMRA-215, a potent NLRP3 inhibitor, with preclinical results from diet-induced obesity mouse models [2] - Upcoming Phase 1b topline data for NMRA-511, a vasopressin 1a receptor antagonist for Alzheimer's agitation, will also be discussed [2] - Additional focus will be on Neumora's M4 franchise, including NMRA-861 and NMRA-898, and navacaprant, a kappa opioid receptor antagonist in Phase 3 studies [2] Group 2: Company Overview - Neumora Therapeutics is a clinical-stage biopharmaceutical company dedicated to addressing significant medical challenges through innovative treatment approaches for brain diseases [4] - The company has a pipeline of seven programs targeting novel mechanisms of action for a range of prevalent diseases [4] - Neumora aims to redefine neuroscience drug development by introducing next-generation therapies that enhance treatment outcomes and patient quality of life [4]

Core Insights - Neumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for brain diseases through novel mechanisms of action [3] Company Participation in Conferences - The company will participate in three investor conferences in September 2025, including one-on-one meetings and a fireside chat [4] - Specific conferences include the Wells Fargo Healthcare Conference on September 4, the Morgan Stanley Annual Global Healthcare Conference on September 8, and the H.C. Wainwright Annual Global Investment Conference on September 9 [4] Therapeutic Pipeline - Neumora's pipeline consists of seven programs targeting a range of underserved and prevalent diseases [3] - The company's mission is to redefine neuroscience drug development to improve treatment outcomes and quality of life for patients [3]

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 Performance - Total Neurocrine net product sales reached $682 million in Q2 2025, representing a 21% quarter-over-quarter (QoQ) growth and a 17% year-over-year (YoY) growth compared to Q1 2025 and Q2 2024, respectively [11] - INGREZZA net product sales were $624 million in Q2 2025, reflecting a 15% QoQ growth and an 8% YoY growth compared to Q1 2025 and Q2 2024, respectively [11] - CRENESSITY net product sales amounted to $53 million in Q2 2025, including 664 total new patient enrollment forms [11] - The company narrowed INGREZZA net sales guidance for 2025 to $2.50 - $2.55 billion, reflecting double-digit volume growth partially offset by a lower net price due to expanded access [7, 11] - Cash and investments totaled approximately $1.8 billion as of June 30, 2025 [7] Research and Development - The company initiated all Phase 3 registrational programs for osavampator (AMPA PAM) for MDD and NBI-'568 (Selective M4 Agonist) for schizophrenia [11] - A Phase 1 study was initiated for NBIP-'1435, a long-acting CRF-1 receptor antagonist, for the potential treatment of classic CAH [11] - Phase 2 studies are expected to be initiated for NBI-'568 in bipolar mania and NBI-'570 (Selective Dual M1 / M4 Agonist) for schizophrenia [11] - Top-line data is expected to be reported in Q4 2025 for the Phase 3 study of valbenazine for dyskinetic cerebral palsy and the Phase 2 study of NBI-'770 (NMDA NR2B NAM) for the treatment of MDD [11] Pipeline and Portfolio - The company has a pipeline of 12 programs, including the first biologic program NBIP-'1435 [8] - The company expects Phase 1 muscarinic agonist results for NBI-'567 (Selective M1 Agonist), NBI-'569 (Selective M4 Agonist), and NBI-'570 [11]

Core Insights - Neumora Therapeutics has initiated a Phase 1 study for NMRA-861, a positive allosteric modulator of the M4 muscarinic receptor, targeting schizophrenia and other neuropsychiatric disorders [1][2] - NMRA-861 is expected to demonstrate a favorable therapeutic profile compared to current antipsychotics, with potential for once-daily dosing and reduced side effects [2][3] - Schizophrenia affects approximately 3 million adults in the U.S., with significant unmet medical needs due to limitations of current treatments [5] Company Overview - Neumora Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapies for brain diseases, with a pipeline of seven neuroscience programs [6] - The company has licensed intellectual property related to NMRA-861 from Vanderbilt University, with patent protection extending to 2044 [4] - Neumora aims to redefine neuroscience drug development by utilizing innovative mechanisms of action to improve treatment outcomes for patients [6] Drug Development Insights - NMRA-861 has shown robust activity in preclinical efficacy models and has been well-tolerated in toxicology studies, with no convulsions observed in multiple species [1][2] - Targeting M4 receptors is considered a promising approach for treating schizophrenia, potentially leading to better tolerability and efficacy compared to traditional antipsychotics [3][4] - The Phase 1 SAD/MAD study is expected to provide safety, tolerability, and pharmacokinetic data in early 2026 [1][2]

Company Overview - Neumora Therapeutics aims to redefine neuroscience drug development with novel therapies for brain diseases[2, 3] - The company has raised $850 million since 2021, providing a cash runway into 2027 to support growth[6, 81] - Neumora's clinical-stage pipeline targets approximately 30 million patients, with IP extending into 2041+[10] Pipeline Programs - Navacaprant (NMRA-140) is in Phase 3 development for Major Depressive Disorder (MDD), targeting 21 million U S adults[11, 16] - Topline data for KOASTAL-3 is expected in Q1 2026, and KOASTAL-2 in Q2 2026[13, 35] - NMRA-511, a V1aR antagonist, is in Phase 1b for Agitation in Alzheimer's Disease, with data expected around year-end 2025[13, 38] - The company plans to advance an M4 PAM program for Schizophrenia into the clinic by mid-2025, addressing a market of 3 million patients in the U S [13, 68] Navacaprant (KOASTAL-1) Trial Data - KOASTAL-1 enrolled 383 adult patients with MDD[92] - In the Intent-to-Treat (ITT) population, the change from baseline to Week 6 in MADRS total score was -12 5 for both Navacaprant (n=191) and Placebo (n=192) groups (p=0 993)[33, 92] - The discontinuation rate due to Treatment-Emergent Adverse Events (TEAEs) was low for both navacaprant (2 1%) and placebo (3 1%)[34] Alzheimer's Disease Agitation - Approximately 7 million U S adults currently have Alzheimer's Disease, projected to increase to 13 million by 2050[42] - Over 70% of people with Alzheimer's Disease experience agitation at some point[45]

Company Overview - Serina Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing a pipeline of drug candidates for neurological diseases and other indications, utilizing its proprietary POZ Platform for drug optimization [5]. Leadership Appointment - Dr. Stephen Brannan has been appointed to the Board of Directors, bringing over 30 years of experience in neuroscience and neuropsychiatry drug development [2][3]. - Dr. Brannan previously served as Chief Medical Officer at Karuna Therapeutics, where he led the clinical strategy for KarXT, a groundbreaking therapy for schizophrenia that contributed to Karuna's $14 billion acquisition by Bristol Myers Squibb in 2024 [2][3]. Strategic Focus - The company aims to advance long-acting treatments for movement disorders and other CNS conditions, aligning with Dr. Brannan's expertise in designing data-driven clinical trials and understanding patient and commercial needs [3]. Previous Experience - Dr. Brannan has held senior roles at Takeda, Novartis, Cyberonics (now LivaNova), and Eli Lilly, directing clinical development programs in various CNS conditions [3]. - He is a founding member of the CNS Summit Leadership Council and has served on the Executive Committee of the International Society for CNS Clinical Trials and Methodology (ISCTM) [3]. Board Changes - Remy Gross has departed from the Board of Directors, with the company expressing gratitude for his contributions during its transition from a private to a public entity [5].