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].

Financial Data and Key Metrics Changes - The net loss for Q1 2025 was $68 million, compared to $53.7 million for the same period in 2024 [20] - The company ended the quarter with $249.4 million in cash, cash equivalents, and marketable securities as of March 31, 2025 [20] Business Line Data and Key Metrics Changes - The company is advancing multiple programs towards key milestones, including NMRA511 for Alzheimer's disease agitation and Avacoprant in the phase three COASTal program for major depressive disorder (MDD) [9][10] - The company expects to deliver top-line data for NMRA511 by the end of 2025 and for the COASTal studies in early to mid-2026 [9][10] Market Data and Key Metrics Changes - The company has entered into a $125 million debt facility with K2 Health Ventures, with $40 million available for draw this year, which strengthens its financial position [10][11] - The company expects its cash and the K2 facility to support operations into 2027, well beyond anticipated clinical data milestones [11] Company Strategy and Development Direction - The company aims to address the global brain disease crisis, which affects over 1.5 billion people, by advancing an industry-leading pipeline targeting novel mechanisms of action [6][7] - The company is focused on clinical execution and maintaining financial discipline to support its pipeline and achieve value-creating milestones [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of their pipeline to revolutionize the treatment of brain diseases and emphasized the importance of addressing unmet medical needs [6][7] - The management highlighted the strong intellectual property portfolio supporting their programs, with patents extending into 2040 [11] Other Important Information - The company is implementing operational changes to improve patient enrollment in clinical trials, ensuring appropriate patient selection [12][14] - The company is focused on enhancing the safety and efficacy of its treatments, particularly in the M4 PAM franchise and NMRA511 for Alzheimer's disease agitation [12][18] Q&A Session Summary Question: Impact of operational changes on enrollment pace - Management noted that operational changes have already shown benefits in identifying appropriate participants for the studies, maintaining confidence in enrollment timelines [24][27] Question: Details on K2 financing and prepayment limitations - The company clarified that the K2 facility extends their cash runway into 2027, with flexibility for additional capital drawdowns as needed [29][31] Question: Patient population tracking in COASTal program - Management confirmed that they are ensuring proper patient history assessments and do not plan for interim analyses in the ongoing studies [38][39] Question: Differentiation of Avacoprant from competitors - Management expressed confidence in Avacoprant's pharmacology and study design, believing it reflects the most appropriate approach for the mechanism [41][43] Question: Timing for increasing enrollment in COASTal studies - Management indicated flexibility in enrollment numbers for COASTal studies and will provide updates as necessary [56] Question: Comparison of MADRS baseline scores in studies - Management confirmed that the patient demographics in K2 and K3 are more representative compared to K1, with a balanced gender distribution [61]

Financial Data and Key Metrics Changes - The net loss for the first quarter of 2025 was $68 million, compared to $53.7 million for the same period in 2024 [18] - The company ended the quarter with $249.4 million in cash, cash equivalents, and marketable securities as of March 31, 2025 [18] - The company expects its cash on hand and the $20 million drawn from the K2 facility to support operations into 2027 [19] Business Line Data and Key Metrics Changes - The company is advancing multiple programs towards key milestones, including top-line data for NMRA 511 in Alzheimer's disease agitation expected by the end of the year [7] - The Avacoprant program is progressing with top-line data from COSTAL-three anticipated in Q1 2026 and COSTAL-two in Q2 2026 [7][9] - The M4 PAM franchise is set to bring a best-in-class candidate into the clinic in mid-2025 [14] Market Data and Key Metrics Changes - The company is focused on addressing the global brain disease crisis, which affects over 1.5 billion people [4] - The pipeline includes programs targeting novel mechanisms of action with potential to address prevalent brain diseases [5] Company Strategy and Development Direction - The company aims to revolutionize neuroscience drug development by advancing an industry-leading pipeline of programs [5] - Financial discipline is emphasized as a core tenet of the company's operations, with a focus on maintaining diligent stewardship of capital [8] Management's Comments on Operating Environment and Future Outlook - Management believes they have the right science, people, and strategy to achieve their vision of revolutionizing brain disease treatment [5] - The company is well-positioned to generate value from multiple programs supported by a strong financial foundation [9] Other Important Information - The company has entered into a $125 million debt facility with K2 Health Ventures, with up to $40 million available for draw this year [8] - The intellectual property portfolio supports the pipeline with worldwide rights and patents extending into 2040 [9] Q&A Session Summary Question: Impact of operational changes on enrollment pace for Avacoprant - Management noted that the operational changes have already shown benefits in identifying inappropriate participants, which helps ensure appropriate patients are randomized [21][22] Question: K2 financing details regarding prepayment limitations - Management indicated that the facility allows for flexibility in bringing more capital onto the balance sheet, with the initial $20 million sufficient to extend the cash runway into 2027 [26][28] Question: Patient population tracking for COSTAL program - Management confirmed that they are ensuring proper patient history is assessed for enrollment in K2 and K3, avoiding issues seen in COSTAL-one [33][34] Question: Differentiation of Avacoprant from competitor products - Management expressed confidence in Avacoprant's pharmacology and study design, believing it reflects the most appropriate approach for the mechanism [37][39] Question: Timing for increasing enrollment in COSTAL studies - Management stated that there is flexibility in the enrollment numbers for K2 and K3, with updates to be provided at the appropriate time [53] Question: Comparison of MADRS baseline scores in studies - Management explained that the MADRS scores in K1 are consistent with moderate to severe MDD populations, and the demographic mix in K2 and K3 is more representative historically [57][58]

Core Insights - Neumora Therapeutics is advancing its clinical pipeline with multiple upcoming data readouts and has secured a $125 million venture debt facility to support its operations into 2027 [2][9][10] Pipeline Highlights - The company is on track to report topline data from NMRA-511 in Alzheimer's disease agitation by the end of 2025 [7] - Enrollment for KOASTAL-2 and KOASTAL-3 studies resumed in March 2025, with topline data expected in Q1 2026 and Q2 2026 respectively [5][6] - The M4 positive allosteric modulator (PAM) program is expected to enter clinical trials in mid-2025 [8] Financial Overview - As of March 31, 2025, Neumora had cash, cash equivalents, and marketable securities totaling $249.4 million [16] - Research and development expenses for Q1 2025 were $52.2 million, an increase from $45.8 million in Q1 2024 [16] - The company reported a net loss of $68.0 million for Q1 2025, compared to a net loss of $53.7 million for the same period in 2024 [16][18]

Financial Performance & Guidance - INGREZZA net product sales reached $545 million in Q1 2025, representing an 8% year-over-year growth[12] - CRENESSITY net product sales were $145 million in Q1 2025, including 413 total patient enrollment forms[11] - The company reaffirms INGREZZA net sales guidance of $250 billion to $260 billion for 2025[6, 11] - Cash and investments totaled approximately $18 billion as of March 31, 2025[6] - Non-GAAP R&D expense was $2402 million in Q1 2025, an increase from $1424 million in Q1 2024[12] - Non-GAAP SG&A expense was $245 million in Q1 2025, compared to $216 million in Q1 2024[12] Pipeline Development - Phase 3 registrational program initiated for osavampator as an adjunctive therapy for the treatment of MDD in adults[11] - Phase 1 studies initiated for NBI-'355 (Nav12 / 16 Inhibitor) for Epilepsy and NBI-'675 (VMAT2 Inhibitor) for Movement Disorders[11] Market & Product - Approximately 800000 people in the US are estimated to be affected by Tardive Dyskinesia[21] - Chorea affects approximately 90% of the 40000 patients with Huntington's Disease in the US[24] - CRENESSITY is the first new treatment available for Classic CAH in 70 years, targeting approximately 20000 pediatric and adult patients in the US[30, 31]