NYSE: ANRO
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for the Brain is Here.
Precision Medicine
OUR MISSION
Redefining psychiatry by leveraging individuals' neurobiology to develop personalized and highly effective medicines, helping patients get better faster.
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Alto by the numbers
Advancing
202 8a leading, clinical-stage precision medicine portfolio for the brain
>800 + 25 4MILLION
Into
Patients Dosed
Across studies with Alto's novel product candidates and precision approach
Patient Impact
Opportunity across the portfolio
Mid- to Late-Stage Data Readouts
In next ~2 years
Expected Cash
Runway
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CNS is the next frontier in precision medicine
Oncology
Cardiovascular
predictive biomarkers
target specificity or genetics
CNS /
Alto is the only company taking a precision biomarker-based approach to patient identification aiming to drive better clinical outcomes in CNS
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Unmet needs pervade mental health disorders
Depression and schizophrenia are leading causes of disability worldwide
Lancet, 2017
13% of U.S.
adults take antidepressants
Brody, 2020
$280B spent on mental health services in 2020
SAMHSA
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Alto's strategy addresses a core problem in psychiatry
Characterizing drug activity and identifying responsive patient populations before advancing
Current approach
Unguided trial-and-error treatments in heterogeneous populations work poorly
Alto precision approach
Differentiated drug profile in stratified patient populations
No human target engagement
Uncontrolled and unmeasured patient heterogeneity
Broad utilization of pharmacodynamic biomarkers
Discover and prospectively replicate objective biomarkers for patient selection
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First biomarker-driven pipeline for mental health conditions
Multiple independent programs leveraging our biomarker strategy to systematically reduce development risk; all programs remain on track to achieve upcoming milestones
Phase 1
Phase 2
Phase 3
Product Candidate (MOA/Target) | Lead Indication | Safety s Brain Effects | Clinical Effect in Biomarker Positive | Registration Trial(s) | Next Anticipated Milestone |
ALTO-207 (D3/D2 C 5-HT3) | Ph. 2b Initiation 1H 2026 (Topline 2027) Ph. 3 Initiation planned by early '27 | ||||
TRD Potentially Pivotal Study*/Phase 2b & Ph. 3 Planned | |||||
ALTO-300 (MT1/2 C 5HT2C) | Topline Data mid-2026 | ||||
MDD Phase 2b Ongoing | |||||
ALTO-100 (BDNF) | Topline Data 2H 2026 | ||||
Bipolar Depression Phase 2b Ongoing | |||||
ALTO-101 (PDE4) | Topline Data 1Q 2026 | ||||
Schizophrenia (CIAS)^ Phase 2 POC Ongoing | |||||
ALTO-203 (H3) | |||||
MDD Phase 2 POC Completed | |||||
ALTO-202 (NMDA NR2B) | |||||
MDD | |||||
ALTO-208 (D3/D2 C NK-1) | |||||
Parkinson's Disease | |||||
^Fast Track Designation 88
*Study qualifying as pivotal is subject to FDA feedback and review of data
Platform
Alto's suite of biomarkers designed to segment patients to
drive improved outcomes
Heterogeneous Clinical Populations
Alto Biomarker Platform
Example Alto Biomarker
Biomarker Characterized Population
Likely Responder to Alto Product Candidate
600
500 40
400
20
300
200 0
ALTO-100
Behavior Cognitive Profile
EEG
Wearable
EEG Signature
Sleep/Activity pattern
ALTO-300
Other Product Candidates
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