Sign in

You're signed outSign in or to get full access.

AN

Alto Neuroscience, Inc. (ANRO)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 was steady operationally with cash, cash equivalents, and restricted cash of $161.3M, R&D of $10.0M, G&A of $5.7M, and net loss of $15.2M ($0.56 per share). Cash runway is reiterated “into 2028.”
  • Alto emphasized near-term clinical catalysts: ALTO-203 Phase 2 proof-of-concept topline in 2Q 2025 and ALTO-101 CIAS topline in 2H 2025; late-stage readouts for ALTO-300 (mid-2026) and ALTO-100 in bipolar depression (2H 2026).
  • Versus S&P Global consensus for Q1 2025, EPS of -$0.56 beat the -$0.621 estimate; revenue was expected at $0 and the company did not report product revenue. *
  • Key narrative: biomarker-driven precision psychiatry remains the core differentiator; recent EEG and dopamine-related biomarker data presentations support stratification approach.

What Went Well and What Went Wrong

What Went Well

  • “We have continued to execute across each of our four ongoing clinical trials,” with multiple upcoming data readouts and a strong balance sheet supporting operations into 2028.
  • Biomarker platform advances: EEG-based placebo response biomarker and dopamine-related biomarkers presented, underscoring leadership in precision psychiatry.
  • Favorable interim analysis outcome for ALTO-300 led to continuation and sample re-estimation in Phase 2b adjunctive MDD, aligning biomarker-positive enrollment to optimize success probability.

What Went Wrong

  • ALTO-100 (Phase 2b MDD) previously failed to meet the primary endpoint; efficacy signal was confined to an adjunctive subgroup and compliant biomarker-positive subset, shifting focus to BPD adjunctive.
  • Operating expense intensity persists: Q1 G&A rose to $5.7M vs $4.4M YoY due to public company costs and headcount, pressuring loss profile despite interest income.
  • Topline timing for ALTO-300 moved from 1H 2025 (prior disclosure) to mid-2026 after interim analysis and enrollment refinement—an extension that delays the potential MDD catalyst.

Financial Results

YoY Comparison (Q1 2024 vs Q1 2025)

MetricQ1 2024Q1 2025
Cash, Cash Equivalents & Restricted Cash ($USD Millions)—$161.254
Research & Development ($USD Millions)$9.952 $9.974
General & Administrative ($USD Millions)$4.434 $5.702
Total Operating Expenses ($USD Millions)$14.386 $15.676
Net Loss ($USD Millions)$(13.417) $(15.169)
Diluted EPS ($USD)$(0.76) $(0.56)

Sequential Comparison (Prior Available Quarter vs Q1 2025)

MetricQ3 2024Q1 2025
Cash, Cash Equivalents & Restricted Cash ($USD Millions)$182.201 $161.254
Total Operating Expenses ($USD Millions)$18.886 $15.676
Net Loss ($USD Millions)$(16.783) $(15.169)
Diluted EPS ($USD)$(0.62) $(0.56)

Note: Company issued full-year FY 2024 results on March 20, 2025 without standalone Q4 detail.

Results vs Wall Street Estimates (S&P Global)

MetricConsensus (Q1 2025)Actual (Q1 2025)Delta
EPS ($USD)$(0.621)*$(0.56) +$0.061 (beat)
Revenue ($USD Millions)$0.00*Not reported (pre-commercial) In line

*Values retrieved from S&P Global.

KPIs (Operating Detail)

KPIQ1 2024Q1 2025
Interest Income ($USD Millions)$1.558 $1.827
Interest Expense ($USD Millions)$0.346 $0.598
Total Other Income, Net ($USD Millions)$0.969 $0.507
Weighted Avg. Shares (Millions)17.600 27.049

Segment breakdown: Not applicable; Alto does not report revenue by segment and remains clinical-stage.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayMulti-yearInto 2027 (Q3 2024) Into 2028 (FY 2024; reiterated Q1 2025) Raised (extended)
ALTO-203 toplineMDD POC1H 2025 (Q3 2024) 2Q 2025 (Q1 2025) Clarified timing within 1H
ALTO-300 toplineMDD Phase 2b1H 2025 (Q3 2024) Mid-2026 (FY 2024; reiterated Q1 2025) Extended timeline
ALTO-101 toplineCIAS POC2H 2025 (Q3 2024) 2H 2025 (Q1 2025) Maintained
ALTO-100 toplineBPD Phase 2b2026 (Q3 2024) 2H 2026 (Q1 2025) Refined window

No numeric financial guidance (revenue, margins, OpEx, tax) was provided.

Earnings Call Themes & Trends

Note: A Q1 2025 earnings call transcript was not available in the document catalog. The below tracks thematic evolution using press releases/8-Ks.

TopicPrevious Mentions (Q3 2024, FY 2024)Current Period (Q1 2025)Trend
Biomarker-driven precision psychiatryEmphasis on EEG/cognitive biomarkers; ALTO-100 MDD learnings on adjunctive subgroup and compliance EEG-based placebo response biomarker and dopamine-related biomarkers presented; leadership positioning Strengthening validation and application
ALTO-300 EEG biomarkerStandardization platform and mechanistic tie to 5-HT2C; interim analysis favorable; continuation with biomarker-positive cohort Continued enrollment targeting biomarker-positive; topline mid-2026 Focused execution; extended timeline
Pipeline catalystsTwo MDD readouts guided for 1H 2025 (prior) ALTO-203 in 2Q 2025; ALTO-101 in 2H 2025; later Phase 2b readouts in 2026 Near-term data clarity maintained
Cash runway and financingIPO completed, $169M YE cash; runway into 2028; potential ATM program $161.3M cash at Q1, runway into 2028 reiterated Stable liquidity
Regulatory/legalNo product approvals; clinical focus; IP strengthened for ALTO-300/ALTO-100 Ongoing clinical development milestones; IP not updated in Q1 PR Neutral
R&D executionMulti-study activity; learnings from ALTO-100 MDD inform programs Four ongoing trials on track; enrollment updates detailed Consistent progress

Management Commentary

  • “We have continued to execute across each of our four ongoing clinical trials… We believe the recent presentation of our EEG-based placebo response biomarker and dopamine-related biomarkers highlight our leadership position in targeted neuropsychiatric drug development.” — Amit Etkin, CEO
  • “We are encouraged by the potential benefit of ALTO-100, as demonstrated in the adjunctive population, and of our biomarker approach in patients with confirmed drug compliance…” (Q3 commentary)
  • “We believe the outcome of the recent interim analysis of the ongoing ALTO-300 trial is suggestive of antidepressant activity, and we believe the sample re-estimation improves the overall probability of success in that trial.” (FY 2024 commentary)

Q&A Highlights

A Q1 2025 earnings call transcript was not found; therefore, Q&A topics and tone shifts cannot be assessed. [ListDocuments: earnings-call-transcript returned none]

Estimates Context

  • EPS: Actual -$0.56 vs S&P Global consensus -$0.621 for Q1 2025; a beat of $0.061. This modest beat reflects lower total operating expense vs prior quarter and steady interest income offsetting interest expense. *
  • Revenue: Consensus $0.00; company did not report product revenue for Q1, consistent with clinical-stage status. *

Where estimates may need to adjust: With trial timelines clarified (ALTO-203 2Q 2025; ALTO-300 mid-2026), models likely shift catalyst timing and cash burn trajectories accordingly; EPS sensitivity remains driven by OpEx cadence rather than revenue. *

*Values retrieved from S&P Global.

Key Takeaways for Investors

  • Cash runway into 2028 provides multi-year financing visibility through at least four clinical readouts; liquidity reduces near-term financing overhang.
  • Near-term catalysts: ALTO-203 topline in 2Q 2025 and ALTO-101 topline in 2H 2025—key stock reaction drivers given precision biomarker thesis.
  • ALTO-300 timeline extension to mid-2026 concentrates 2025 sensitivity on ALTO-203/ALTO-101; interim outcome was favorable but pushes out MDD readout.
  • Biomarker platform continues to be de-risked with EEG placebo response and dopamine-related markers; enhances probability of detecting drug signal in stratified cohorts.
  • Operational discipline: Q1 total OpEx of $15.7M and EPS of $(0.56) beat consensus, but G&A growth reflects scaling as a public company—monitor OpEx trajectory vs trial milestones. *
  • Program prioritization: ALTO-100 pivot to BPD adjunctive in Phase 2b (2H 2026 topline) after MDD miss highlights willingness to adapt based on biomarker and compliance learnings.
  • Trading setup: Stock likely to trade on clinical newsflow pace and biomarker readouts; lack of revenue and limited non-GAAP adjustments means EPS variances are primarily OpEx-driven, with catalysts overshadowing quarterly prints. *

*Values retrieved from S&P Global.