Alto Neuroscience, Inc. · NYSE:ANRO
Alto Neuroscience — TD Cowen 45th Annual Health Care Conference (March 2025)
17 slides from Alto Neuroscience's conference presentation, Mar 4, 2025
Slide 1: TD Cowen 45th Annual Health Care Conference
TD Cowen 45th Annual Health Care Conference Founder & CEO – Amit Etkin, M.D., Ph.D. NYSE: ANRO March 4, 2025 1
Slide 2: Disclaimer
Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the progress and timing of the clinical development of the programs across
Slide 3: Alto by the numbers
Alto by the numbers 6 Advancing a leading, clinical-stage precision medicine portfolio for the brain 25+ 4 Into >800 MILLION 2028 Patients Dosed Patient Impact Phase 2 Expected Cash Across studies with Alto’s Opportunity Data Readouts Runway novel product candidates across the portfolio In next 2 ye
Slide 4: Alto's strategy addresses a core problem in psychiatry
Alto’s strategy addresses a core problem in psychiatry Characterizing drug activity and identifying responsive patient populations before advancing Current approach Alto precision approach Unguided trial-and-error treatments in Differentiated drug profile in stratified patient heterogeneous populati
Slide 5: Alto's flywheel goes beyond binary drug outcomes
Alto’s flywheel goes beyond binary drug outcomes Biomarker-based clinical data Predictive algorithms • Large Phase 2a Biomarker Studies • Responder Biomarkers: • Decentralized Trial • ALTO-100 Infrastructure • ALTO-300 • SSRI, ketamine, etc. Biomarkers & phenotypes • Target Engagement By Drug Candid
Slide 6: First biomarker-driven pipeline for mental health conditions
First biomarker-driven pipeline for mental health conditions Multiple independent programs leveraging our biomarker strategy to systematically reduce development risk Phase 1 Phase 2 Phase 3 Product Responder Candidate Lead Indication Safety & Brain Efficacy in Next Anticipated Effects Biomarker Reg
Slide 7: ALTO-300 proposed mechanism of action: synergy between melatonergic agonism and 5-HT2C antagonism
ALTO-300 proposed mechanism of action: synergy between melatonergic agonism and 5-HT2C antagonism ALTO-300 is a multi-modal antidepressant with a broad ALTO-300 range of synergistic neurobiological effects that lead (agomelatine) to antidepressant activity and favorable tolerability MT1/MT2 5-HT2C M
Slide 8: ALTO-300 EEG biomarker has been replicated and reverse translated with clear biologic link to MoA
ALTO-300 EEG biomarker has been replicated and reverse translated with clear biologic link to MoA 1 3 Machine-learning discovered EEG biomarker Reverse translated biomarker in animals 2 Biomarker effect prospectively replicated Dose-dependent response on EEG biomarker establishes this as the first m
Slide 9: ALTO-300 Phase 2b biomarker-guided trial in MDD
ALTO-300 Phase 2b biomarker-guided trial in MDD Evaluating ALTO-300 as an adjunctive to an existing antidepressant with an insufficient response Screening Period 6-Week Double-Blind 8-Week Open Label Treatment Period Extension 25 mg QHS ALTO-300 1:1 Randomization 25 mg QHS ALTO-300 Wearable Behavior
Slide 10: Interim analysis on ALTO-300 Phase 2b informs final sample size
Interim analysis on ALTO-300 Phase 2b informs final sample size Outcome 171 Patients enrolled as of Dec. 17, 2024 interim cutoff Continue study with sample re- Patients prospectively excluded following detailed site and subject case review -- estimation: Enroll Bio + target N of 52 includes removal
Slide 11: ALTO-100: Novel product candidate enhancing neuroplasticity to address depression symptoms
ALTO-100: Novel product candidate enhancing neuroplasticity to address depression symptoms Enhancing neuroplasticity to address depression Clinical data indicate potential in bipolar depression Targeting pathways abnormal in MDD and bipolar depression 239-patient Phase 2a study BDNF • Clear antidepr
Slide 12: Adjunctive population demonstrated clinically meaningful response to ALTO-100 and had significantly higher compliance
Adjunctive population demonstrated clinically meaningful response to ALTO-100 and had significantly higher compliance The study included Bio+ patients taking ALTO-100 as monotherapy (69%) and those taking it adjunctive to an antidepressant (31%) Compliance rate among monotherapy Clear drug effect in
Slide 13: Evidence of drug effect & biomarker enrichment observed in the compliant population in additional analyses
Evidence of drug effect & biomarker enrichment observed in the compliant population in additional analyses Bio + confirmed compliant patients vs. all placebo Bio + vs. bio – in confirmed compliant patients 13 Retrospective analyses conducted within population with measurable PK levels of ALTO-100, i
Slide 14: ALTO-100 Phase 2b biomarker-guided trial in bipolar depression
ALTO-100 Phase 2b biomarker-guided trial in bipolar depression Evaluating ALTO-100 as an adjunctive treatment to an existing mood stabilizer (no antipsychotics) Screening Period 6-Week Double-Blind 7-Week Open Label Treatment Period Extension 40 mg BID ALTO-100 N ≈ 200 40 mg BID ALTO-100 Wearable Be
Slide 15: ALTO-101 positioned as a novel transdermal PDE4 inhibitor with broad pro-cognitive activity
ALTO-101 positioned as a novel transdermal PDE4 inhibitor with broad pro-cognitive activity EEG response links CIAS and PD activity Greater drug exposure and improved tolerability Transdermal formulation (TDS) eliminated rapid Cmax related AEs and maintained steady exposure AUC 170% greater for TDS
Slide 16: ALTO-203: An investigational H3 inverse agonist with demonstrated positive subjective emotional and cognitive effects
ALTO-203: An investigational H3 inverse agonist with demonstrated positive subjective emotional and cognitive effects in humans ALTO-203 represents a unique approach at enhancing the function and control of dopamine in the reward system Demonstrated acute subjective effects in Phase 1 ALTO-203 Dopam
Slide 17: Multiple near-term clinical milestones expected
Multiple near-term clinical milestones expected Capitalized through multiple value generating clinical milestones: ~$168MM* (as of Dec. 31, 2024) → Expected cash runway into 2028 2025 2026 ALTO-203 MDD POC data (1H 2025) • ALTO-300 Phase 2b MDD data (mid-2026) ALTO-101 CIAS POC data (2H 2025) ALTO-1
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