Alto Neuroscience

What Alto Neuroscience does

Alto Neuroscience is a clinical-stage biopharmaceutical company founded in 2019 by Stanford psychiatrist Dr. Amit Etkin and listed on the NYSE under ticker ANRO. The company develops precision medicines for major neuropsychiatric conditions, with an initial focus on major depressive disorder, treatment-resistant depression, bipolar depression, and cognitive impairment in schizophrenia. Its core technology is the Precision Psychiatry Platform™, a proprietary, machine-learning-driven discovery engine that recruits large real-world clinical populations and combines objective biological measurements — EEG brain activity and connectivity, performance-based computerized cognitive tests, and wearable-derived sleep/activity data — to derive biomarker-defined patient profiles most likely to respond to specific drug candidates. The company is pre-revenue: it has no approved products, generates no commercial product revenue, and is funded entirely by equity capital (IPO plus follow-on PIPEs totaling approximately $264M of cash as of Q1 2026, with runway through 2029).

The pipeline consists of multiple biomarker-paired clinical drug candidates: lead asset ALTO-207 (a pramipexole/ondansetron fixed-dose combination for treatment-resistant depression, acquired from Chase Therapeutics in 2025 and now in a potentially registrational Phase 2b with 2H 2027 topline), ALTO-300 (a melatonergic/serotonergic small molecule in Phase 2b for MDD with EEG-biomarker patient selection), ALTO-100 (an oral pro-plasticity agent in Phase 2b for bipolar depression, supported by an $11.7M Wellcome Trust award), ALTO-203 (an H3 receptor inverse agonist for anhedonia in MDD, missed primary endpoint in 2025), ALTO-101 (a transdermal PDE4 inhibitor deprioritized in 2026 after a Phase 2 miss in CIAS despite prior FDA Fast Track), ALTO-202 (an oral NMDA NR2B negative allosteric modulator in early development), and ALTO-208 (a pramipexole/aprepitant fixed-dose combination for Parkinson's disease). Each candidate is paired with the platform's biomarker strategy to translate mechanistic insight into targeted, biomarker-enriched development programs.

Alto's go-to-market model is currently clinical-trials-driven: patients are accessed through US and UK clinical trial sites (e.g., 178 adults in the ALTO-207 Phase 2b, 83 patients across 13 US sites in the prior ALTO-101 trial), with no commercial distribution, no disclosed pricing, and an explicit expanded-access policy that does not provide access to investigational medications outside trials. Future revenue is intended to derive from commercialization of approved biomarker-paired drugs — likely via a combination of direct sales and partnerships — targeting large unmet-need populations such as the estimated 6–7 million US treatment-resistant depression patients. The company is incorporated in Delaware, headquartered in Mountain View, California, and led by Etkin as Founder/President/CEO with a board and management team that draws heavily from CNS drug-development veterans (Karuna, KarXT, Cerevel, Otsuka, Janssen, Lundbeck, Bain Capital Life Sciences).

Name

Alto Neuroscience

Legal name

Alto Neuroscience, Inc.

Website

https://altoneuroscience.com

Company type

Public

Founded year

2019

Operating status

Operating

Headcount range

51–100 employees

Short description

Alto Neuroscience is a clinical-stage biopharmaceutical company that uses its AI-driven Precision Psychiatry Platform™ to develop biomarker-paired precision medicines for major depressive disorder, treatment-resistant depression, bipolar depression, and cognitive impairment in schizophrenia; it is pre-revenue with multiple Phase 2-stage candidates.

Ownership category

akta.pro rank

Product category

Clinical-Stage Neuropsychiatric Pharmaceuticals

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Other Scientific and Technical Consulting Services (54169)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Computer Integrated Systems Design (7373)

akta.pro primary industry

Neurology & Psychiatry (CNS) Pharmaceuticals (HLAIAAAF)

akta.pro secondary industries

AI/ML Platforms for Drug Discovery & Experiment Optimization (HLAGAJAO), SaMD – Digital Biomarkers & Algorithmic Endpoints (HLACANAF), Cognitive & Behavioral Neurology (Dementia/Memory Disorders) (HLAKAIAH), Medical Imaging AI (HDAAAEAH)

Keywords

• Precision psychiatry therapeutics
• Biomarker-driven drug development
• CNS clinical-stage biopharmaceuticals
• Neuropsychiatric precision medicines
• Machine learning drug discovery

Headquarters

HQ city

Los Altos

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Others

Revenue model

1. Pre-revenue (clinical-stage): Alto Neuroscience is a clinical-stage biopharmaceutical company; the SEC Form D filing (2025-10-27) states the company has "no revenues or assets." It has no approved products and generates no commercial product revenue. R&D expenses doubled to $20.3M in Q1 2026 with a net loss of $26.2M, and full-year 2025 net loss was $63M, funded by equity raises and capital markets.
2. Future pharmaceutical sales (TRD lead asset ALTO-207): Future revenue model is based on commercializing internally developed drug candidates and those acquired (e.g., ALTO-207 from Chase Therapeutics, acquired 2025 with $1.75M upfront and up to $71.5M in milestones). Targeting an estimated 6–7 million patient market for treatment-resistant depression.

Go-to-market motion3 records

Distribution channels1 record

Marketing channels6 records

Core offering

Alto Neuroscience is a clinical-stage biopharmaceutical company that develops precision medicines for neuropsychiatric conditions using its Precision Psychiatry Platform™. The machine learning-driven platform combines EEG biomarkers, computerized cognitive testing, and wearable-derived sleep/activity data to identify biologically defined patient profiles most likely to respond to specific drug candidates. The company is advancing a pipeline of clinical-stage precision drug candidates targeting treatment-resistant depression, major depressive disorder, bipolar depression, and cognitive impairment associated with schizophrenia.

Product overview

Alto Neuroscience is a clinical-stage biopharmaceutical company whose offering is structured as a platform-plus-portfolio model: a single machine-learning driven discovery engine (the Precision Psychiatry Platform) generates the biological and clinical insights that guide a suite of independent, biomarker-paired drug candidates. The Platform recruits diverse real-world neuropsychiatric populations, measures brain biology (EEG, cognition, wearables), and applies machine learning to derive responder biomarkers that de-risk each program. Built on top of it, the company is advancing a pipeline of clinical-stage precision medicines — most prominently ALTO-207 (lead Phase 2b asset in treatment-resistant depression, a pramipexole/ondansetron fixed-dose combination acquired from Chase Therapeutics), ALTO-300 (Phase 2b melatonergic/serotonergic adjunct in MDD with EEG biomarker selection), ALTO-100 (Phase 2b pro-plasticity agent in bipolar depression), ALTO-101 (deprioritized PDE4 inhibitor formerly in Phase 2 for cognitive impairment in schizophrenia), ALTO-203 (H3 inverse agonist for anhedonia in MDD), ALTO-202 (NMDA NR2B modulator), and ALTO-208 (pramipexole/aprepitant combination for Parkinson's disease). Each candidate is paired with the Platform's biomarker strategy to translate mechanistic insight into targeted development programs.

Differentiator

Problem solved

Functional benefit

Brands

• Precision Psychiatry Platform: Alto Neuroscience's proprietary machine learning-driven platform that generates biological and clinical insights to match patients with treatments based on EEG and other biomarkers.

Products and services

• Precision Psychiatry Platform Alto's machine learning-driven discovery and development platform that recruits large real-world clinical populations, objectively measures brain function via EEG, computerized cognitive tests, and wearable-derived sleep/activity data, then uses these signatures to identify biomarker-characterized patient profiles most likely to benefit from each drug candidate. It de-risks and characterizes drug effects on the brain to inform dosing, indication selection, and later-stage trial design.
• ALTO-207 Fixed-dose combination of pramipexole (dopamine D3-preferring D3/D2 agonist) and ondansetron (selective 5-HT3 receptor antagonist) acquired from Chase Therapeutics. Designed to enable rapid titration and higher dosing of pramipexole by mitigating dose-limiting adverse events. Lead indication is treatment-resistant depression; Phase 2b initiated April 2026 with topline data expected 2H 2027.
• ALTO-300 Small molecule melatonergic agonist and serotonergic antagonist that increases dopamine and norepinephrine levels. Approved for MDD in Europe and Australia but not the U.S. Developed as adjunctive treatment for U.S. MDD patients characterized by a machine-learning-derived EEG biomarker. In Phase 2b; topline readout shifted to 2027.
• ALTO-100 First-in-class oral small molecule believed to work through enhancing neural plasticity in the hippocampus. In Phase 2b as adjunctive treatment for bipolar depression, targeting patients showing a cognitive profile indicative of a neuroplasticity deficit. Supported by an $11.7M Wellcome Trust award.
• ALTO-101 Brain-penetrant PDE4 inhibitor in a novel transdermal formulation developed for cognitive impairment associated with schizophrenia (CIAS). Phase 2 POC trial missed primary endpoint in April 2026; company deprioritized the program and is exploring a modified-release formulation and strategic partnering. Previously received FDA Fast Track Designation.
• ALTO-203 Novel oral small molecule histamine H3 receptor inverse agonist being developed for patients with MDD and higher levels of anhedonia. Phase 2a trial missed primary efficacy endpoint in June 2025 due to higher-than-expected placebo response.
• ALTO-202 Orally bioavailable negative allosteric modulator of the GluN2B subunit of the NMDA receptor. Builds on the antidepressant effects observed with NMDA receptor antagonists like ketamine but is oral and has not exhibited the common dissociative adverse effects. Demonstrated a favorable safety profile across various clinical populations.
• ALTO-208 Fixed-dose combination (formerly CTC-413) of pramipexole and aprepitant (antiemetic, neurokinin-1 (NK-1) receptor antagonist). Being developed for patients with Parkinson's Disease (PD).

Quantifiable outcome

• ALTO-207 Phase 2a: Cohen's d=1.67 (p=0.0004) at Week 6 and d=1.1 (p=0.025) at Week 8 on MADRS scores in 32 MDD patients
• +4 more outcomes

Segments5 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability7 records

Feature7 records

Partnerships

Two partnerships are on record, tiered core and flagship.

• Lund UniversitycoreStrategic or Co-development Partner · 15 June 2026Lund University (Sweden) conducted the independent PRIME-PRAXOL randomized, double-blind, placebo-controlled trial of pramipexole in over 80 patients with major depressive disorder, bipolar depression, or dysthymia. The study was published in Nature Medicine in June 2026 and showed pramipexole significantly reduced anhedonia scores (Hedges' g=0.62, p=0.006) with benefits maintained over 6 months. Findings bolster the rationale for Alto's drug candidate ALTO-207.
• Chase TherapeuticsflagshipStrategic or Co-development Partner · 3 June 2025Alto Neuroscience acquired assets related to dopamine agonist drug combinations for treatment-resistant depression from Chase Therapeutics via a deal valued at over $100 million, with an upfront payment of $1.75 million and milestone payments up to $71.5 million. The most advanced program was ALTO-207 (formerly CTC-501), which showed promising results in Phase 2a trials, leading to a Phase 2b trial initiated in 2026 with topline data expected in 2H 2027.

Scale indicators18 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Axsome Therapeutics: Axsome develops CNS therapeutics with approved products in depression (Auvelity) and migraine, directly competing for the same treatment-resistant depression patient population Alto targets with ALTO-207.
• Sage Therapeutics: Sage Therapeutics develops CNS therapies with approved Zurzuvae for postpartum depression and an active pipeline in MDD — directly comparable in CNS/neuropsychiatry development focus and clinical-stage profile.
• Neumora Therapeutics: Neumora Therapeutics is a clinical-stage precision neuroscience company targeting brain diseases with biomarker-driven patient stratification, nearly identical in approach and clinical-stage status to Alto's Precision Psychiatry Platform.
• Compass Pathways: Compass Pathways is a mental health care company developing psilocybin therapy for treatment-resistant depression, directly competing for the same TRD market Alto targets with ALTO-207.
• Praxis Precision Medicines: Praxis develops precision medicines for CNS disorders including depression and epilepsy, with a similar clinical-stage profile and biomarker-guided patient selection approach as Alto.
• Karuna Therapeutics (acquired by BMS): Karuna developed COBENFY (KarXT) for schizophrenia and was acquired by BMS for $14B in 2024; Alto board member Andrew Miller was Karuna's founder/President of R&D and the lead inventor of KarXT, making Karuna's CNS strategy directly comparable to Alto's.

Emerging players

• BioXcel Therapeutics: BioXcel Therapeutics uses AI-driven drug discovery to identify novel CNS therapies, with an approved product (IGALMI) in neuropsychiatric indications — comparable technology approach but earlier-stage commercialization.
• Mind Medicine (MindMed): MindMed is a clinical-stage neuropsychiatry company developing psychedelic-inspired therapies for anxiety, depression, and ADHD — overlapping patient population with Alto's TRD and MDD programs but with a distinct mechanism class.

Broad incumbents

• Acadia Pharmaceuticals: Acadia is an established CNS biopharmaceutical company with commercial products (NUPLAZID, DAYBUE) in neuroscience — broader portfolio overlap with Alto's CNS focus but at a much later commercialization stage.
• Intra-Cellular Therapies (AbbVie): Intra-Cellular Therapies developed CAPLYTA for schizophrenia and depression and was acquired by AbbVie for ~$14.6B in 2024; comparable in CNS neuropsychiatry development focus, now part of a large pharma commercialization platform.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/altoneuro
• LinkedInlinkedin.com/company/altoneuroscience

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Funding overview

Funding rounds14 records

Investors38 records

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M&A1 record

Investments

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Frequently asked questions about Alto Neuroscience