Neumora Therapeutics, Inc. · NASDAQ:NMRA
Neumora Therapeutics — Investor Presentation (January 2025)
32 slides from Neumora Therapeutics's investor presentation, Jan 13, 2025
Slide 1: Redefining Neuroscience Drug Development
Redefining Neuroscience Drug Development January 2025 Exhibit 99.1
Slide 2: Important Disclosures
Important Disclosures This presentation contains forward-looking statements about Neumora Therapeutics, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including statements related to: Neumora’s intention to redefine neuroscience drug development by brin
Slide 3: Our Mission
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
Slide 4: Redefining Neuroscience Drug Development
Redefining Neuroscience Drug Development Built at scale with strong balance sheet; $850M raised since 2021 Cash runway into mid-2026 supporting company growth World-class team with differentiated approach Maximizing probability of success with team and proprietary approach Industry leading CNS pipel
Slide 5: Neumora is Tackling One of the Largest Population Health Challenges
Navacaprant MDD Navacaprant BPD NMRA-511 AD Agitation M4 PAM SCZ Navacaprant MDD Navacaprant BPD NMRA-511 AD Agitation Navacaprant MDD Navacaprant BPD Navacaprant MDD Neumora is Tackling One of the Largest Population Health Challenges 1National Institutes of Health. Our Biggest Health Challenges. Ac
Slide 6: Advancing a Leading Neuroscience Pipeline
PROGRAM Target/Mechanism INDICATION U.S. Prevalence Preclinical Phase 1 Phase 2 Phase 3 MILESTONE Guidance Neuropsychiatry Programs Navacaprant (NMRA-140) KOR Antagonist Major Depressive Disorder 21M KOASTAL-2 and -3 topline data To be updated in 10-K Bipolar Depression 7M Phase 2 data 2H25 NMRA-511
Slide 7: MDD Represents a Major Population Health Challenge
Many people have inadequate response to medication and experience tolerability issues MDD Represents a Major Population Health Challenge >70% of people with MDD experience anhedonia8 60–85% of patients treated with monotherapy9 21M adults in the U.S. have MDD2; the median onset is ~32.5 years of age
Slide 8: The Role of Kappa Opioid Receptor Antagonism in MDD
The Role of Kappa Opioid Receptor Antagonism in MDD The kappa opioid receptor (KOR) / dynorphin system is a well-characterized pathway, and results from preclinical studies support its potential to modulate depression, anhedonia, and anxiety KOR system overactivation in response to stress and mediat
Slide 9: Near-term Clinical Development Plan for Navacaprant
Phase 2 Placebo-controlled RCT evaluating efficacy and safety of navacaprant in patients with BPD Near-term Clinical Development Plan Focused on MDD and Bipolar Depression with Opportunity for Further Expansion Navacaprant Clinical Development Programs1 KOASTAL-1 Conducted in U.S. Topline data annou
Slide 10: KOASTAL Pivotal Study Design
KOASTAL Pivotal Study Design Randomized, double-blind treatment Baseline WK 6 Navacaprant 80 mg QD Placebo QD R 1:1 Opportunity to enroll in KOASTAL-LT WK 1 WK 2 KOASTAL Pivotal Efficacy Studies KOASTAL-1, KOASTAL-2, KOASTAL-3 Summary Inclusion Criteria: Adults ages 18 – 65 diagnosed with MDD MADRS
Slide 11: KOASTAL-1 Topline Data: Demographics and Baseline Characteristics
KOASTAL-1 Topline Data: Demographics and Baseline Characteristics Intent-to-Treat Population Navacaprant n = 191 Placebo N = 192 Age, mean (SD) 40.7 (14.0) 41.1 (13.2) Sex, n (%) Male Female 86 (45.0%) 105 (55.0%) 86 (44.8%) 106 (55.2%) Race, n (%) White Black or African American Asian Other Missing
Slide 12: KOASTAL-1 Topline Data: Primary & Key Secondary Endpoint
KOASTAL-1 Topline Data: Primary & Key Secondary Endpoint Improvement Improvement MADRS = Montgomery-Åsberg Depression Rating Scale SHAPS = Snaith-Hamilton Pleasure Scale
Slide 13: KOASTAL-1 MADRS: Efficacy Differences Between Female and Male Participants
KOASTAL-1 Topline Data MADRS: Efficacy Differences Observed Between Female and Male Participants Improvement Improvement ITT = Intent-to-Treat Population MADRS = Montgomery-Åsberg Depression Rating Scale SHAPS = Snaith-Hamilton Pleasure Scale
Slide 14: KOASTAL-1 SHAPS: Efficacy Differences Between Female and Male Participants
KOASTAL-1 Topline Data SHAPS: Efficacy Differences Observed Between Female and Male Participants Improvement Improvement ITT = Intent-to-Treat Population MADRS = Montgomery-Åsberg Depression Rating Scale SHAPS = Snaith-Hamilton Pleasure Scale
Slide 15: KOASTAL-1 Topline Data: Favorable Safety Profile Demonstrated
KOASTAL-1 Topline Data: Favorable Safety Profile Demonstrated Navacaprant was safe and generally well tolerated, with no serious adverse events reported No signal for increased suicidal ideation or suicidal behavior1 Low discontinuation rate due to TEAEs (navacaprant 2.1%; placebo 3.1%) 83.3% of nav
Slide 16: Navacaprant Development Program Key Learnings & Next Steps
Navacaprant Development Program Key Learnings & Next Steps Neumora plans to provide additional information and update program guidance in 10-K KOASTAL-1 key learnings based on comprehensive analytics with topline data Potential adjustments to navacaprant development program Higher placebo response r
Slide 17: Navacaprant Well-Suited for Evaluation in Bipolar Depression
Navacaprant Well-Suited for Evaluation in Bipolar Depression Signal-Seeking Study Designed to Efficiently Generate Data to Inform Development Path Randomized, double-blind treatment Baseline WK 6 Navacaprant 80 mg QD (n = 30) Placebo QD (n = 30) Bipolar II Depression Signal-Seeking Study BIPOLAR II
Slide 18: NMRA-511 is a Best-in-Class Vasopressin 1a Receptor Antagonist
Rationale Vasopressin plays a role in the regulation of aggression, affiliation, stress and anxiety response Indication Agitation in Alzheimer’s disease Status Phase 1b study underway with data anticipated in 2H25 Drug Profile Oral, BID dosing Strong IP Protection Expect exclusivity through 2042+, b
Slide 19: Alzheimer's Disease Agitation Represents Large Market Opportunity
Alzheimer’s Disease Agitation Represents in Large Market Opportunity with Significant Unmet Need Agitation in Alzheimer’s disease impacts a significant portion of the U.S. population; that number is expected to increase as the population ages1 1Alzheimer’s Association. Alzheimer’s Disease Facts and
Slide 20: V1a Receptor Antagonists Have Therapeutic Potential for Reducing Agitation
Several Lines of Evidence Indicate that V1a Receptor Antagonists Have Therapeutic Potential for Reducing Symptoms of Agitation In healthy volunteers, vasopressin enhances reactivity to threatening stimuli and disrupts emotional control1-2 Exogenously administered vasopressin increases autonomic resp
Slide 21: NMRA-511 Profile Supports Advancement into Alzheimer's Disease Agitation
NMRA-511 Profile Supports Advancement into Alzheimer’s Disease Agitation Best-in-Class Pharmacology1 Strong Pre-Clinical Data Translates to Humans2 PK and Safety Data from Phase 1 Support Advancement1 Highly potent at V1a High selectivity over V1b, V2, and oxytocin receptors Excellent brain penetrat
Slide 22: NMRA-511 Signal Seeking Study in Alzheimer's Disease Agitation
NMRA-511 Signal Seeking Study in Alzheimer’s Disease Agitation Part A: 2-Week Evaluation Period Enrolling Healthy Elderly Participants NMRA-511 Phase 1b Study Part A Inclusion Criteria: Healthy elderly adult participants aged 65-80 years Part B Inclusion Criteria: Adults aged 55-90 years with mild-s
Slide 23: M4 PAM Franchise: Potentially Differentiated M4R PAMs for Schizophrenia
M4 PAM Franchise: Potentially Differentiated M4R PAMs for Schizophrenia 1Wander, C. Am J Manag Care. 2020;26:S62-S68. 2NMRA data on file; 3CERE Company data. Note: Data on this slide is presented for illustrative purposes only and the data for emraclidine were not derived from Neumora clinical trial
Slide 24: Pre-Clinical Pipeline of Four Novel Programs
Pre-Clinical Pipeline of Four Novel Programs, Each with A Strong Biological Rationale NMRA-GCASE Focused on elevating activity of the GCase enzyme, which is encoded by the GBA1 gene, and may help to degrade toxic a-synuclein aggregates Potential Indications Parkinson’s disease NMRA-NLRP3 Focused on
Slide 25: Redefining Neuroscience Drug Development
Redefining Neuroscience Drug Development Built at scale with strong balance sheet; $850M raised since 2021 Cash runway into mid-2026 supporting company growth World-class team with differentiated approach Maximizing probability of success with team and proprietary approach Industry leading CNS pipel
Slide 26: Appendix
Appendix S)
Slide 27: Led by Experienced Company Builders and Leading Neuroscience Drug Developers
Led by Experienced Company Builders and Leading Neuroscience Drug Developers Leadership Paul L. Berns Co-Founder and Executive Chairman Carol Suh Chief Operating Officer and Co-Founder Henry Gosebruch Chief Executive Officer Mary Chamberlain-Tharp, Ph.D. Chief Business Officer Nick Brandon, Ph.D. Ch
Slide 28: KOASTAL Study Design Compared with Prior Study
Phase 2 Phase 3 Rationale Study Design Study Population Included Mild to Moderate MDD Moderate to Severe MDD FDA guidance for drug development in MDD Primary Endpoint CFB to Week 8 in HAMD-17 CFB to Week 6 in MADRS MADRS better suited to navacaprant pharmacology Inclusion Criteria Mild-to-severe dep
Slide 29: KOASTAL-1 Topline Study Summary Results
KOASTAL-1 Topline Study Summary Results MADRS Total Score SHAPS Total Score Outcome Navacaprant 80 mg Placebo LSMD Navacaprant 80 mg Placebo LSMD ITT population CFB at Week 6 (Primary Endpoint) -12.5 (n = 191) -12.5 (n = 192) 0.0 (p = 0.993) -5.8 (n = 191) -5.5 (n = 192) -0.3 (p = 0.648) Female popu
Slide 30: Navacaprant Would Enter Large MDD Market with a Highly Differentiated Profile
U.S. MDD diagnosed, pharmacologically treated prevalent population (2018-41F) Millions of people Navacaprant Would Enter Large MDD Market with a Highly Differentiated Profile 1Kern et al. Treatment patterns and sequences of pharmacotherapy for patients diagnosed with depression in the United States:
Slide 31: Schizophrenia Market Supports Multiple Treatment Options
Schizophrenia Market Supports Multiple Treatment Options Historically the schizophrenia market has supported multiple branded products with similar MOAs, with new entrants driving higher overall market sales volume Sales of Branded 5-HT2 to D2 Receptor Antagonists (1995 – 2013) Sales ($M) Product La
Slide 32: Neumora
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