Neumora Therapeutics(NMRA)
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Neumora Therapeutics (NasdaqGS:NMRA) 2025 Conference Transcript
2025-11-12 20:00
Neumora Therapeutics Conference Call Summary Company Overview - **Company**: Neumora Therapeutics (NasdaqGS: NMRA) - **Event**: 2025 Conference on November 12, 2025 - **Key Speakers**: Josh Pinto (President), Helen Rubinstein (Head of IR) Key Points Clinical Programs and Pipeline - Neumora has six clinical readouts planned across four main clinical stage assets over the next 12 months [2][5] - **NMRA-215**: An NLRP3 inhibitor showing class-leading weight loss data in diet-induced obesity models, with plans to move into human clinical trials in Q1 2026 and deliver proof-of-concept data by the end of 2026 [2][3] - **NMRA-511**: A phase 1b study for Alzheimer's disease agitation is ongoing, with readout expected by the end of 2025. The study is randomized, double-blind, and placebo-controlled, focusing on agitation levels [3][18] - **M4 PAM Franchise**: Two molecules, NMRA-898 and NMRA-861, are in clinical trials, with updates expected by mid-2026 [4][33] - **Navacaprant**: A selective kappa opioid receptor antagonist, with COASTAL 2 and 3 studies on track for readouts in Q1 and Q2 2026 [5] Financial Position - Neumora ended Q3 with over $170 million on the balance sheet, providing a cash runway into 2027 to fund operational plans and clinical catalysts [5] NLRP3 Inhibitor Insights - High correlation (up to 0.9) between diet-induced obesity models and clinical weight loss supports confidence in NMRA-215's potential [6][14] - NMRA-215 achieved IC90 concentrations in the CNS, which is critical for unlocking weight loss potential, unlike other NLRP3 inhibitors [8][11] V1aR Program - The vasopressin system is linked to stress response and agitation, with NMRA-511 showing promise in reducing agitation in Alzheimer's patients [16][17] - The ongoing study includes multiple endpoints to assess the impact on patient agitation and caregiver experience [20] M4 PAM Differentiation - Neumora believes that targeting the M4 receptor through a PAM approach can reduce adverse effects compared to selective agonists [32] - NMRA-898 and NMRA-861 are designed for high CNS penetration, addressing limitations seen in first-generation M4 PAMs [33][36] Strategic Outlook - Neumora aims to position itself as a significant neuroscience company by the end of 2026, with a focus on delivering high-quality data from its clinical programs [46] Additional Considerations - The company is open to various strategic paths for its programs, including collaborations or out-licensing, depending on the data outcomes [29] - Emphasis on the importance of CNS penetration and pharmacology in the development of its compounds [36][41] Conclusion Neumora Therapeutics is at a pivotal stage with multiple clinical programs advancing, a strong financial position, and a clear strategy to leverage its innovative pipeline in neuroscience. The upcoming clinical readouts will be critical in determining the future direction of the company and its assets.
Neumora Therapeutics (NasdaqGS:NMRA) FY Conference Transcript
2025-11-10 20:30
Neumora Therapeutics Conference Call Summary Company Overview - **Company**: Neumora Therapeutics (NasdaqGS: NMRA) - **Event**: FY Conference on November 10, 2025 Key Updates and Core Points NMRA-215 Development - Neumora has completed DIO studies for NMRA-215, an NLRP3 inhibitor targeting obesity, showing class-leading weight loss of 15%-19% in monotherapy settings, comparable to semaglutide [2][7] - NMRA-215 demonstrated up to 26% weight loss when combined with semaglutide, indicating potential for enhanced efficacy through combination therapy [8] - The company plans to initiate first-in-human studies in Q1 2026, with 12-week proof-of-concept data expected by the end of 2026 [3][5] Other Clinical Programs - NMRA-511, a V1A receptor antagonist for Alzheimer's disease agitation, is currently in a phase 1B study, with data expected by year-end [3][21] - Two M4 PAM programs, NMRA-898 and NMRA-861, have entered clinical trials, with updates anticipated by mid-2026 [4][30] Financial Position - As of Q3 2025, Neumora has approximately $170 million in cash, providing a runway into 2027 to fund ongoing clinical trials [5] Pharmacological Insights - Neumora emphasizes the translatability of DIO model data to clinical outcomes, citing a correlation coefficient above 0.9 for weight loss predictions [6] - The company believes its CNS-penetrant pharmacology for NLRP3 inhibitors is superior to competitors, achieving necessary IC90 concentrations in the brain for effective weight loss [12][13] Safety and Patient Quality Improvements - Neumora has partnered with Massachusetts General Hospital to enhance patient selection for clinical trials, aiming to improve the quality of participants in COASTAL studies [35] - The COASTAL II and III studies will have a base size of 332 patients, with potential for a 25% increase based on protocol flexibility [37] Regulatory Considerations - Neumora aims to have two positive studies to support an NDA filing, although one positive study with supportive evidence could also be sufficient [39] Additional Insights - The company is focused on the obesity market as a primary therapeutic area, with plans to explore additional indications based on clinical data outcomes [16][17] - Neumora is preparing to capture biomarker data during its first-in-human studies to inform future development [17] Conclusion - Neumora Therapeutics is positioned for significant clinical milestones in the coming year, with multiple programs advancing through clinical trials and a strong financial foundation to support its initiatives [41]
Neumora Therapeutics(NMRA) - 2025 Q3 - Quarterly Report
2025-11-06 21:02
Financial Performance - The net loss for the three months ended September 30, 2025, was $56.8 million, an improvement of $20.8 million compared to a net loss of $72.5 million in the same period of 2024[144]. - The net loss for the nine months ended September 30, 2025 was $177.5 million, while the net loss for the same period in 2024 was $185.0 million, indicating a decrease in loss of 4.0%[166][167]. - The accumulated deficit as of September 30, 2025, was $1,124.7 million[160]. Operating Expenses - The company reported total operating expenses of $57.7 million for the three months ended September 30, 2025, a decrease of $23.9 million compared to $76.6 million in the same period of 2024[144]. - Total operating expenses for the nine months ended September 30, 2025, were $182.7 million, a decrease of $17.9 million from $200.5 million for the same period in 2024[152]. - General and administrative expenses decreased by $3.8 million, or 24%, to $12.2 million for the three months ended September 30, 2025, from $16.0 million for the same period in 2024[147]. - Research and development expenses were $40.5 million for the three months ended September 30, 2025, down from $60.6 million in the prior year, reflecting a reduction of $20.1 million[144]. - Research and development expenses for the nine months ended September 30, 2025, decreased by $23.6 million, or 15%, to $131.4 million from $155.0 million for the same period in 2024[152]. Cash Flow and Financing - As of September 30, 2025, the company had $171.5 million in cash, cash equivalents, and marketable securities[159]. - Net cash used in operating activities for the nine months ended September 30, 2025 was $158.5 million, compared to $132.6 million for the same period in 2024, reflecting an increase of 19.5%[166][167]. - Net cash provided by investing activities for the nine months ended September 30, 2025 was $125.9 million, a significant increase from a net cash used of $28.2 million in the same period of 2024[168][169]. - Net cash provided by financing activities for the nine months ended September 30, 2025 was $18.3 million, up from $6.0 million in the same period of 2024, representing a 205.0% increase[170][171]. - The company expects to need additional financing in the future to fund operations and pursue long-term business plans[162]. - The company entered into a Loan Agreement with K2HV, borrowing $20.0 million, and subsequently amended the agreement to borrow an additional $40.0 million[172]. Research and Development - The company is advancing a Phase 3 program for navacaprant, with topline data expected in Q1 and Q2 of 2026[127]. - The company plans to initiate a Phase 1 study for NMRA-215, a potential best-in-class NLRP3 inhibitor for obesity, in Q1 2026[126]. - The company is developing NMRA-511 for agitation associated with Alzheimer's disease, with Phase 1b data expected around year-end 2025[127]. - The company achieved a $2.0 million development milestone in October 2023 related to the Vanderbilt License Agreement, which was paid in cash in November 2023[133]. - The company has contingent consideration obligations of up to $365 million related to navacaprant and $100 million for NMRA-511, contingent on development and regulatory milestones[132]. - Acquired in-process research and development expenses of $5.0 million for the three months ended September 30, 2025, were related to a Phase 1 development milestone under the Vanderbilt License Agreement[148]. Interest Income and Economic Factors - Interest income decreased by $2.5 million to $1.7 million for the three months ended September 30, 2025, from $4.2 million for the same period in 2024[149]. - Interest income for the nine months ended September 30, 2025, decreased by $8.8 million, or 56%, to $7.0 million from $15.8 million for the same period in 2024[157]. - The term loan with K2HV bears a variable interest rate, which could increase due to changes in the prime rate, potentially impacting debt service obligations[183]. - The company does not expect significant impact from fluctuations in interest rates on its financial condition due to the short-term nature of its cash and marketable securities[184]. - Inflation has not had a material effect on the company's results of operations during the nine months ended September 30, 2025[187]. - The company has exposure to foreign currency exchange rate fluctuations but considers this exposure to be immaterial[185].
Neumora Therapeutics(NMRA) - 2025 Q3 - Quarterly Results
2025-11-06 12:05
Financial Position - Neumora reported a cash position of $171.5 million as of September 30, 2025, expected to support operations into 2027[8]. - An additional $40 million in non-dilutive capital was drawn from the existing facility with K2 HealthVentures, strengthening the company's financial position[3]. - Total operating expenses for Q3 2025 were $57.7 million, down from $76.6 million in Q3 2024[11]. Research and Development - Research and development expenses for Q3 2025 were $40.5 million, down from $60.6 million in Q3 2024, primarily due to reduced clinical trial costs[8]. - Neumora announced class-leading data for NMRA-215, a highly brain-penetrant NLRP3 inhibitor, with plans to initiate a Phase 1 study in Q1 2026[1][4]. - The company is advancing Phase 1 studies for NMRA-861 and NMRA-898, with a comprehensive update expected by mid-2026[1][5]. - Data from the Phase 1b study of NMRA-511 in Alzheimer's disease agitation is expected to be reported around the end of 2025[1][6]. - Enrollment is ongoing in the Phase 3 KOASTAL program for navacaprant in major depressive disorder, with topline data expected in 1H 2026[1][7]. Expenses and Losses - General and administrative expenses decreased to $12.2 million in Q3 2025 from $16.0 million in Q3 2024, attributed to lower consulting and personnel costs[8]. - The net loss for Q3 2025 was $56.8 million, compared to a net loss of $72.5 million for the same period in 2024[8].
Neumora Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-11-06 12:00
Core Insights - Neumora Therapeutics announced promising data for NMRA-215, a highly brain-penetrant oral NLRP3 inhibitor, showing class-leading weight loss in diet-induced obesity mouse models, with plans to initiate a Phase 1 study in Q1 2026 [1][4] - The company is advancing Phase 1 studies for two positive allosteric modulators, NMRA-861 and NMRA-898, with a comprehensive update expected by mid-2026 [1][5] - Neumora is on track to report data from a Phase 1b study of NMRA-511 for Alzheimer's disease agitation by the end of 2025 [1][6] - The company has drawn $40 million in non-dilutive capital from K2 HealthVentures, strengthening its financial position [1][3] - As of September 30, 2025, Neumora has $171.5 million in cash, cash equivalents, and marketable securities, expected to support operations into 2027 [1][10] Business Updates - Neumora's CEO highlighted the strength of the pipeline and the differentiated approach to address significant medical challenges, particularly emphasizing the data for NMRA-215 [2] - The company is committed to addressing unmet needs in schizophrenia and neuropsychiatric disorders through the expansion of its M4 muscarinic receptor PAM franchise [2] Financial Performance - For Q3 2025, Neumora reported a net loss of $56.8 million, a decrease from $72.5 million in Q3 2024, attributed to reduced R&D expenses and lower general and administrative costs [10][11] - Research and development expenses for Q3 2025 were $40.5 million, down from $60.6 million in the same period of 2024 [10][11] - General and administrative expenses decreased to $12.2 million in Q3 2025 from $16.0 million in Q3 2024 [10][11]
Needham Lifts PT on Neumora Therapeutics (NMRA) to $8 From $6, Keeps a Buy Rating
Yahoo Finance· 2025-10-31 03:29
Group 1 - Neumora Therapeutics, Inc. (NASDAQ:NMRA) is recognized as one of the best stocks under $5 with significant upside potential, with Needham raising its price target from $6 to $8 while maintaining a Buy rating [1] - Guggenheim upgraded Neumora Therapeutics, Inc. from Neutral to Buy on October 27, setting a price target of $14, citing compelling preclinical obesity data as a key factor [2] - The company focuses on integrating neuroscience and data science to develop precision medicine for brain diseases, particularly targeting therapeutically relevant areas in CNS diseases [2] Group 2 - The positive outlook for Neumora Therapeutics is driven by its broad pipeline showcased during the R&D Investor Event, which has increased investor optimism [1] - Guggenheim highlighted the NLRP3i program in obesity and related disorders as a significant driver for value creation for Neumora Therapeutics [2]
Neumora Therapeutics, Inc. (NMRA) Discusses NMRA-215 Preclinical Results and Portfolio Updates, Including Obesity and Alzheimer's Disease Programs Transcript
Seeking Alpha· 2025-10-27 17:57
Core Points - Neumora is conducting a presentation in lieu of its formal earnings call for the quarter [2] - The company plans to report its third quarter 2025 financial results on November 6, with a press release available on its Investor Relations website [2] Group 1 - The presentation includes forward-looking statements based on current expectations and beliefs [2] - Key members of Neumora's management team are present, including CEO Paul Berns and other executives [3]
Neumora Therapeutics (NasdaqGS:NMRA) 2025 R&D Day Transcript
2025-10-27 13:02
Summary of Neumora Therapeutics 2025 R&D Day Conference Call Company Overview - **Company**: Neumora Therapeutics (NasdaqGS: NMRA) - **Event**: 2025 R&D Day held on October 27, 2025 - **Key Participants**: Paul Burns (CEO), Josh Pinto (President), Nick Brandon (Chief Scientific Officer), Bill Arora (Chief Operating and Development Officer), Dr. Anton P. Porstenson (Alzheimer's expert) Core Industry and Company Insights Alzheimer's Disease and NMRA-511 - **NMRA-511**: A vasopressin 1a receptor antagonist aimed at treating agitation in Alzheimer's disease, which affects over 70% of individuals with Alzheimer's dementia [39][40] - **Unmet Need**: Current treatments have limited efficacy and significant side effects, creating a demand for safer, more effective options [45][62] - **Clinical Evidence**: Preclinical studies indicate that B1A receptor antagonists can reduce agitation symptoms, supported by various studies showing the involvement of the vasopressin system in emotional regulation [40][41] Obesity Treatment and NMRA-215 - **NMRA-215**: A next-generation NLRP3 inhibitor designed for obesity treatment, showing promising weight loss results in preclinical studies [7][13] - **Weight Loss Data**: NMRA-215 demonstrated up to 19% body weight loss as a monotherapy, comparable to leading injectable GLP-1s [14][27] - **Combination Therapy**: When combined with semaglutide, NMRA-215 achieved 26% weight loss, indicating potential for enhanced efficacy in obesity treatment [30][31] Key Data and Findings NMRA-215 Clinical Data - **DIO Models**: NMRA-215 showed dose-dependent weight loss, with significant reductions in food intake and preservation of lean mass compared to semaglutide [15][33] - **Biomarker Improvements**: NMRA-215 also demonstrated positive effects on cardiovascular biomarkers, suggesting additional health benefits beyond weight loss [36] NMRA-511 Clinical Data - **Phase I Study**: NMRA-511 has shown a favorable safety profile in healthy adults and elderly participants, with no serious adverse events reported [42][43] - **Phase Ib Study Design**: The ongoing study aims to assess the efficacy of NMRA-511 in reducing agitation symptoms in Alzheimer's patients, with multiple outcome measures to evaluate its impact [44][72] Strategic Vision and Future Outlook - **Pipeline Potential**: Neumora believes it has assembled an industry-leading pipeline with the potential to deliver significant therapeutic breakthroughs in brain diseases [10] - **Cash Runway**: The company has a cash runway extending into 2027, allowing for continued development and clinical trials across its portfolio [8] - **Upcoming Milestones**: Key data readouts for NMRA-511 and NMRA-215 are expected in the near term, with plans to initiate clinical studies for NMRA-215 in 2026 [9][37] Conclusion - Neumora Therapeutics is positioned to address significant unmet needs in the treatment of Alzheimer's disease and obesity through innovative therapies like NMRA-511 and NMRA-215. The company is focused on advancing its clinical programs while maintaining a strong financial position to support ongoing research and development efforts.
Neumora Therapeutics (NasdaqGS:NMRA) 2025 Earnings Call Presentation
2025-10-27 12:00
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]
Neumora Therapeutics Announces Initiation of Phase 1 Clinical Study of M4 Positive Allosteric Modulator NMRA-898
Globenewswire· 2025-10-27 11:00
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]