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Neumora Therapeutics(NMRA) - 2025 Q1 - Earnings Call Transcript
2025-05-12 21:32
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]
Neumora Therapeutics(NMRA) - 2025 Q1 - Earnings Call Transcript
2025-05-12 21:30
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]
Neumora Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update
GlobeNewswire News Roomยท 2025-05-12 20:01
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]
Neurocrine(NBIX) - 2025 Q1 - Earnings Call Presentation
2025-05-05 20:32
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]