Neumora Therapeutics(NMRA) - 2025 Q2 - Quarterly Results

Executive Summary & Business Update Neumora Therapeutics reported strong Q2 2025 financial results and significant pipeline advancements, including the initiation of a Phase 1 study for NMRA-861 and prioritization of obesity for NMRA-215, with multiple clinical data readouts anticipated Second Quarter 2025 Highlights Neumora Therapeutics reported Q2 2025 financial results and provided a business update, highlighting the initiation of a Phase 1 study for NMRA-861, prioritization of obesity for NMRA-215, and an upcoming period with up to six clinical data readouts. The company maintains a strong financial position, expected to support operations into 2027 - 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[1] - Announced 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[1] - Entering a catalyst-rich period with up to six clinical data readouts in patients over the next 18 months, including Phase 3 data for navacaprant in major depressive disorder (MDD) and Phase 1b data for NMRA-511 in Alzheimer's disease agitation[1] - Strong financial position with $217.6 million in cash, cash equivalents and marketable securities expected to support operations into 2027[1] CEO Commentary on Strategic Progress CEO Paul L. Berns emphasized the company's R&D efforts leading to multiple upcoming clinical data readouts and advancements in the preclinical pipeline, particularly the prioritization of obesity for NMRA-215, citing the unmet need and potential for centrally acting drugs. He also highlighted the potential of NMRA-861 for schizophrenia - R&D efforts have fueled multiple upcoming catalysts, with up to six clinical data readouts in patients over the next 18 months[3] - Prioritized obesity as the lead indication for NMRA-215, a highly brain-penetrant NLRP3 inhibitor, with clinical studies expected to initiate in the first quarter of 2026[3] - Anticipates data from the NMRA-861 Phase 1 study in early 2026, highlighting its potential as a therapeutic option for people with schizophrenia[3] Key Pipeline Highlights The company provided updates on its key pipeline assets, including the initiation of a Phase 1 study for NMRA-861, prioritization of NMRA-215 for obesity, ongoing Phase 3 enrollment for navacaprant, and upcoming data for NMRA-511 M4 Positive Allosteric Modulator (PAM) Franchise Neumora initiated a Phase 1 SAD/MAD study for NMRA-861, a highly potent and selective M4 PAM, for schizophrenia and other neuropsychiatric disorders, with data expected in Q1 2026. The company also plans to bring another M4 PAM, NMRA-898, into the clinic in 2025 - Initiated a Phase 1 single-ascending dose/multiple-ascending dose (SAD/MAD) study of NMRA-861 in healthy adult participants and adults with stable schizophrenia in July 2025[4] - NMRA-861 is a highly potent and selective M4 PAM with potential best-in-class pharmacology for the treatment of schizophrenia and other neuropsychiatric disorders[4] - Expects to report data from the Phase 1 SAD/MAD study for NMRA-861 in the first quarter of 2026, including safety, tolerability, and human pharmacokinetic data[5] - The Company expects to bring another M4 PAM, NMRA-898, into the clinic in 2025[5] NMRA-215: Obesity Prioritized as Lead Indication for NLRP3 Inhibitor Program Neumora has prioritized obesity as the lead indication for NMRA-215, a potential best-in-class, highly potent, and brain-penetrant NLRP3 inhibitor. Preclinical data from DIO studies are expected in 2025, with clinical initiation planned for Q1 2026 - Obesity prioritized as the lead indication for NMRA-215, a potential best-in-class, highly potent and brain-penetrant NLRP3 inhibitor[6] - NMRA-215 has demonstrated potential best-in-class brain penetration, target engagement and pharmacodynamic activity in relevant animal models[6] - Currently conducting preclinical DIO studies with data expected in 2025, and expects to progress NMRA-215 into the clinic in the first quarter of 2026[7] Navacaprant: Phase 3 KOASTAL Program Enrollment is ongoing in the Phase 3 KOASTAL program for navacaprant in Major Depressive Disorder (MDD), with topline data from KOASTAL-3 expected in Q1 2026 and KOASTAL-2 in Q2 2026 - Topline data with navacaprant in MDD from KOASTAL-3 expected in the first quarter of 2026[8] - Topline data with navacaprant in MDD from KOASTAL-2 expected in the second quarter of 2026[8] NMRA-511: Phase 1b Study in AD Agitation Neumora is on track to report data from its Phase 1b signal-seeking study evaluating NMRA-511 for Alzheimer's Disease (AD) agitation around the end of 2025 - Data from a Phase 1b signal-seeking study evaluating NMRA-511 as a treatment for AD agitation expected around the end of 2025[9] Second Quarter 2025 Financial Results Neumora reported its second quarter 2025 financial results, detailing a strong cash position, decreased R&D expenses, and an improved net loss compared to the prior year Q2 2025 Financial Summary Neumora reported a cash position of $217.6 million as of June 30, 2025, providing runway into 2027. R&D expenses decreased to $38.7 million, while G&A expenses remained stable at $15.3 million. The net loss for the quarter improved to $52.7 million compared to the prior year Q2 2025 Key Financials | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (YoY) | | :----- | :----------------- | :----------------- | :----------- | | Cash, Cash Equivalents & Marketable Securities | $217.6 | N/A | N/A | | R&D Expense | $38.7 | $48.6 | -$9.9 (-20.4%) | | G&A Expense | $15.3 | $15.2 | +$0.1 (+0.7%) | | Net Loss | $52.7 | $58.7 | -$6.0 (-10.2%) | - Cash, cash equivalents and marketable securities of $217.6 million as of June 30, 2025, expected to fund its operating plan into 2027[10] Unaudited Consolidated Statements of Operations and Comprehensive Loss For Q2 2025, Neumora reported a net loss of $52.7 million, an improvement from $58.7 million in Q2 2024, primarily driven by a decrease in R&D expenses. For the six months ended June 30, 2025, the net loss was $120.7 million, compared to $112.4 million in the prior year Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | Three Months Ended June 30, 2025 (Thousands) | Three Months Ended June 30, 2024 (Thousands) | Six Months Ended June 30, 2025 (Thousands) | Six Months Ended June 30, 2024 (Thousands) | | :-------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Research and development | $38,724 | $48,628 | $90,875 | $94,385 | | General and administrative | $15,316 | $15,194 | $34,101 | $29,511 | | Total operating expenses | $54,040 | $63,822 | $124,976 | $123,896 | | Loss from operations | $(54,040) | $(63,822) | $(124,976) | $(123,896) | | Interest income, net | $1,814 | $5,271 | $4,888 | $11,636 | | Net loss | $(52,731) | $(58,700) | $(120,723) | $(112,421) | | Net loss per share, basic and diluted | $(0.33) | $(0.37) | $(0.75) | $(0.71) | Unaudited Condensed Consolidated Balance Sheets As of June 30, 2025, Neumora reported total assets of $223.8 million, a decrease from $317.0 million at December 31, 2024. Cash, cash equivalents, and marketable securities stood at $217.6 million. Total stockholders' equity decreased to $182.9 million from $287.1 million over the same period Condensed Consolidated Balance Sheets (in thousands) | Metric | June 30, 2025 (Thousands) | December 31, 2024 (Thousands) | | :-------------------------------- | :------------ | :---------------- | | Cash, cash equivalents and marketable securities | $217,588 | $307,578 | | Total assets | $223,825 | $316,972 | | Total liabilities | $40,946 | $29,908 | | Total stockholders' equity | $182,879 | $287,064 | Additional Company Information This section provides supplementary company information, including conference call details, an overview of Neumora Therapeutics, a cautionary note on forward-looking statements, and contact information Conference Call Information Neumora hosted a live conference call and webcast on August 6, 2025, at 4:30 p.m. ET to discuss the updates, with a replay available on their website - Neumora hosted a live conference call and webcast at 4:30 p.m. ET on August 6, 2025, to review updates[11] - A live webcast of the event is available on the events and presentations section of the Company's website at www.neumoratx.com, with a replay archived for up to 30 days[11] About Neumora Neumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for brain diseases, with a pipeline of seven programs targeting underserved, prevalent diseases. Its mission is to redefine neuroscience drug development for improved patient outcomes - Neumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company founded to confront medical challenges by developing treatments for brain diseases[12] - The therapeutic pipeline currently consists of seven programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases[12] - Neumora's mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients[12] Cautionary Note Regarding Forward-Looking Statements This section provides a standard disclaimer regarding forward-looking statements, highlighting inherent risks and uncertainties in clinical drug development, regulatory approvals, reliance on third parties, and intellectual property. It advises readers to refer to SEC filings for detailed risk factors - This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to be materially different[13] - Risks include inherent uncertainty of clinical drug development, unpredictability of regulatory approvals, reliance on third parties, and potential for serious or undesirable side effects of therapeutic candidates[13] - Readers should refer to the risk factors identified in the Company's filings with the SEC, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2025[13] Neumora Contact Provides contact information for Neumora Therapeutics - Contact: Helen Rubinstein, 617-402-5700, Helen.Rubinstein@neumoratx.com[18]