Neumora Therapeutics (NMRA) Q2 2025 Earnings Call August 06, 2025 04:30 PM ET Speaker0Ladies and gentlemen, thank you for standing by. This is RG, your conference operator today. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that today's conference is being recorded.I would like now to turn the conference over to Helen Robenstein, Vice President of Investor Relations and Communications. Please go ahe ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 001-41802 NEUMORA THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) ...

Exhibit 99.1 Neumora Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update Initiated Phase 1 single-ascending dose/multiple-ascending dose (SAD/MAD) study with M4 positive allosteric modulator (PAM) NMRA-861, with data expected in the first quarter of 2026 Announces prioritization of obesity as lead indication for NMRA-215, a highly brain-penetrant NLRP3 inhibitor, with data from diet-induced obesity (DIO) mouse model expected in 2025 Entering catalyst-rich period with up t ...

Initiated Phase 1 single-ascending dose/multiple-ascending dose (SAD/MAD) study with M4 positive allosteric modulator (PAM) NMRA-861, with data expected in the first quarter of 2026 Announces prioritization of obesity as lead indication for NMRA-215, a highly brain-penetrant NLRP3 inhibitor, with data from diet-induced obesity (DIO) mouse model expected in 2025 Entering catalyst-rich period with up to six clinical data readouts in patients over the next 18 months, including Phase 3 data for navacaprant in m ...

Core Insights - Neumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for brain diseases, with a pipeline that includes seven programs, three of which are in clinical stages [1][3] - The company will host a conference call and live webcast on August 6, 2025, to report its second quarter 2025 financial results and provide a business update [1][2] Company Overview - Neumora's mission is to address the global brain disease crisis by innovating the development of treatments for neuropsychiatric disorders and neurodegenerative diseases [3] - The therapeutic pipeline targets novel mechanisms of action and is supported by a suite of translational, clinical, and computational tools aimed at enabling precision medicine [3]

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]

Redefining Neuroscience Drug Development May 2025 Our Mission We are focused on redefining neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from brain diseases 3 Redefining Neuroscience Drug Development Built at scale with strong balance sheet; $850M raised since 2021 Cash runway into 2027 supporting company growth Industry leading CNS pipeline with long- dated IP into the 2040s Multiple ...

NEW YORK, May 14, 2025 /PRNewswire/ -- Kuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of Neumora Therapeutics, Inc. (NASDAQ: NMRA) breached their fiduciary duties to shareholders. According to a federal securities lawsuit, Insiders at Neumora Therapeutics caused the company to misrepresent or fail to disclose (1) in order for Neumora to justify conducting its Phase Three Program, Neumora was forced to amend BlackThorn's original Phase Two Trial in ...

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]