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Autonomix Medical, Inc. (AMIX)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 FY2025 (quarter ended September 30, 2024) remained pre‑revenue with net loss of $2.81M and diluted EPS of $‑2.47; losses narrowed materially year‑over‑year from $6.04M and EPS $‑8.78 due to absence of prior‑year warrant charges .
  • Clinical execution was a bright spot: preliminary PoC trial data showed 83% pain reduction at 4–6 weeks, 79% responder rate with zero opioid use at 7 days, and 100% of the lead‑in responder group off opioids at 4–6 weeks; enrollment reached 60% .
  • Liquidity tightened sequentially: quarter‑end cash was $5.16M with management flagging going‑concern risk and a runway into but not beyond Q2 calendar 2025; subsequent Q3 cash improved to $11.8M after financing .
  • No financial guidance or EPS/revenue consensus from S&P Global was disclosed/available; investor focus remains on clinical milestones (topline PoC data in 1H 2025, U.S. trial initiation in 2025) as potential stock catalysts .

What Went Well and What Went Wrong

What Went Well

  • Strong clinical signals: “Announced 83% reduction of pain at 4–6 week follow‑up” and “100% of the lead‑in patient responder group went to zero opioid use at 4–6 weeks” in the ongoing PoC trial; management emphasized the potential to “revolutionize the treatment paradigm for pancreatic cancer pain” .
  • Operational progress: Reached 60% enrollment in the PoC trial and presented at key conferences (CIRSE, Octane), supporting trial momentum and visibility .
  • Strategic milestones ahead: Company reiterated 1H 2025 topline PoC data and 2025 U.S. clinical initiation; later reported design locks (ASIC and RF catheter) and a patent grant, underpinning platform readiness .

What Went Wrong

  • Liquidity and going‑concern risk: Cash was $5.16M at Q2‑end and management disclosed substantial doubt about continuing as a going concern, with runway into but not beyond second calendar quarter of 2025 absent additional financing .
  • Elevated OpEx: G&A rose to $1.66M and R&D to $1.17M (reflecting team build‑out and clinical/product development), driving continued operating losses despite improvement year‑over‑year from prior‑year warrant expense .
  • Corporate overhangs: Post‑reverse split fractional‑share dispute (271,846 shares) and uncertainty tied to Nasdaq compliance and rounding shares created potential dilution/liability risk .

Financial Results

MetricQ2 FY2024 (Q2 2024)Q1 FY2025 (Q1 2025)Q2 FY2025 (Q2 2025)
Revenue ($USD Millions)$0.00 $0.00 $0.00
Net Loss ($USD Millions)$6.04 $2.70 $2.81
Diluted EPS ($USD)$‑8.78 $‑0.14 $‑2.47
G&A Expense ($USD Millions)$0.79 $1.80 $1.66
R&D Expense ($USD Millions)$0.47 $0.95 $1.17
Liquidity MetricQ1 FY2025 (6/30/24)Q2 FY2025 (9/30/24)Q3 FY2025 (12/31/24)
Cash & Equivalents ($USD Millions)$6.75 $5.16 $11.80
Going‑Concern DisclosureSubstantial doubt; runway into but not beyond Q2 CY2025 Substantial doubt; runway into but not beyond Q2 CY2025 Not reiterated in 8‑K; cash increased

KPIs (Clinical)

KPIQ2 FY2025 Status
Pain reduction at 4–6 weeks83% reduction (lead‑in patients)
Opioid cessation at 4–6 weeks100% of lead‑in responder group at zero opioid use
7‑day responder rate79% responders with zero opioid use and QoL improvement
Trial enrollment60% enrolled

Estimate comparison

  • EPS and revenue consensus (S&P Global): unavailable for Q2 FY2025; cannot assess beat/miss. Values retrieved from S&P Global were unavailable due to access limits.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Complete PoC enrollmentQ4 CY2024“Q4 CY2024: Complete enrollment…” “Completion… expected by calendar year end” Maintained
Topline PoC data1H 2025“1H 2025: Report topline data” “1H 2025: Report topline data” Maintained
Initiate U.S. clinical trials2025“2025: Initiate combined sensing/ablation clinical trial” “2025: Initiate clinical trials in the United States” Maintained/clarified
De Novo submission2026“2026: De novo submission” “2H 2026: De novo submission” Refined timing
Potential FDA clearance2027“2027: FDA clearance” “1H 2027: Potential FDA clearance” Refined timing

No financial guidance (revenue, margins, OpEx, OI&E, tax rate, dividends) was provided; focus remains on clinical/technical milestones .

Earnings Call Themes & Trends

Note: No Q2 FY2025 earnings call transcript was found/posted.

TopicPrevious Mentions (Q1 FY2025)Previous Mentions (Q2 FY2025)Current Period (Q3 FY2025)Trend
AI/technology initiativesPlatform microchip sensing array; ~3,000× sensitivity vs market devices (animal data) Same platform emphasis; transvascular RF ablation approach Design lock for ASIC microchip and RF ablation catheter Advancing from concept to design lock
Supply chainNot discussed Not discussed Not highlighted Neutral
Tariffs/macroNot discussed Not discussed Not highlighted Neutral
Product performanceEarly clinical signals: 7‑day pain and opioid metrics Stronger multi‑week pain reduction and opioid cessation Continued progress; readiness for U.S. trials Improving clinical validation
Regulatory/legalIDE submission plans; De Novo pathway ahead On track for U.S. trials and De Novo Patent grant, team bolstered for FDA process Building toward regulatory filings
R&D executionTrial planning; sensing/ablation roadmap 60% enrollment; extended clinical data Design locks achieved; animal testing successes Executing milestones
Health features/pain mgmtPancreatic cancer pain as initial indication Meaningful QoL and opioid cessation metrics Positioning for broader applications post‑approval Expanding narrative

Management Commentary

  • “Looking ahead, we are focused on the successful execution of our trial, with completion on enrollment expected by calendar year end… we believe our technology has the potential to revolutionize the treatment paradigm for pancreatic cancer pain…” — Brad Hauser, CEO .
  • “We are making significant progress across multiple fronts… we remain on track to report topline data from our PoC trial in the first half of 2025… With important key data readouts on the horizon and continued progress toward potential FDA approval, we believe we are positioned for a strong year ahead.” — Brad Hauser, CEO .

Q&A Highlights

  • No Q2 FY2025 earnings call transcript or Q&A was posted/found; no call‑driven guidance clarifications available [ListDocuments returned none for transcript; 2024‑11 window showed no transcript].

Estimates Context

  • S&P Global consensus estimates for Q2 FY2025 EPS and revenue were unavailable at time of analysis; therefore, results could not be benchmarked to Wall Street consensus. Values retrieved from S&P Global were unavailable due to access limits.

Key Takeaways for Investors

  • Clinical momentum is the principal driver: multi‑week pain reduction and opioid cessation metrics are compelling early signals and, if confirmed in topline data in 1H 2025, could be a material catalyst for sentiment and capital access .
  • Liquidity risk persists: Q2 cash $5.16M and explicit going‑concern disclosure indicate funding needs before Q2 CY2025; subsequent Q3 cash improved to $11.8M after capital actions, but continued financing is likely ahead of U.S. trial launch .
  • Operating leverage awaits revenue: rising R&D and G&A reflect clinical and platform build‑out; with no revenue and no GAAP/non‑GAAP adjustments disclosed, losses will continue near‑term until clinical/regulatory milestones translate to commercialization .
  • Regulatory path is clearer: De Novo submission targeted for 2H 2026 and potential FDA clearance in 1H 2027; investors should track IDE progress, U.S. trial initiation, and device design locks as gating steps .
  • Corporate mechanics bear watching: reverse split and fractional‑share dispute create dilution/liability uncertainty; resolution could remove an overhang .
  • Trading setup: With absent S&P consensus and pre‑revenue status, stock reaction is likely tied to clinical readouts, financing announcements, and regulatory progress rather than quarterly P&L .
  • Medium‑term thesis: If clinical efficacy and safety are validated and regulatory milestones hit on the stated timeline, the platform’s addressable indications (pain, cardiology, hypertension) could support a multi‑indication roadmap; funding discipline and trial execution are critical .