Executive Summary

Autonomix reported FY 2024 (year ended March 31, 2024) results alongside its Q4 2024 update: no product revenue, FY net loss of $15.4M, and cash of $8.6M with runway into, but not beyond, the first calendar quarter of 2025 . The company reiterated a pre-revenue profile and development-stage status in its 10‑K .
Subsequent quarters showed steady operating cadence: Q1 FY2025 net loss $2.7M and cash $6.8M; Q2 FY2025 net loss $2.8M and cash $5.2M, reflecting continued R&D and G&A spend as the PoC trial advanced .
Clinical PoC signals strengthened: 60% 7‑day responders with mean 6.33 VAS reduction (8.0→1.67) in first five lead‑in patients; later disclosures cited 79% responder rate at 7 days in first 15 patients, 83% pain reduction at 4–6 weeks, and 100% of the responder group at zero opioid use at 4–6 weeks .
Guidance focus remained on development milestones (enrollment completion, topline PoC in 1H 2025, pivotal trial in 2025, de novo in 2H 2026, potential clearance 1H 2027); no financial guidance was provided. There was no Q4 2024 earnings call transcript available to analyze; estimate comparisons were unavailable via S&P Global at the time of research .

What Went Well and What Went Wrong

What Went Well

Clinical efficacy signals: “60% of subjects responded with a mean 6.33 reduction in VAS pain (8.0 to 1.67) at 7 days,” with pain relief as fast as 1 day post‑procedure in the lead‑in cohort .
Opioid use and durability: Preliminary results showed “100% of the lead‑in patient responder group went to zero opioid use at 4–6 weeks,” and an “83% reduction of pain” at 4–6 weeks; 79% responder rate at 7 days in the first 15 patients with quality‑of‑life improvement .
Technology and leadership progress: The company completed a licensing transaction for the Apex 6 RF generator and appointed a new CEO, reinforcing the path to an integrated sensing/ablation platform and organizational execution .

Management quotes:

“We continue to make promising progress in our PoC human clinical study and look forward to announcing topline data from the first patients in the near future.” – Lori Bisson, CEO (May 31, 2024) .
“We are extremely pleased with the progress and clinical data we have generated to date... focused on successfully executing our near‑term development objectives.” – Brad Hauser, CEO (Aug 13, 2024) .
“We have made significant progress... with completion on enrollment expected by calendar year end.” – Brad Hauser, CEO (Nov 11, 2024) .

What Went Wrong

Limited runway and going‑concern risk: FY2024 cash of $8.6M projected to fund operations only into Q1 CY2025; the 10‑K cites substantial doubt about continuing as a going concern absent new financing .
Rising operating expenses: FY2024 G&A rose to $5.2M (advertising related to IPO, compensation, stock‑based comp, legal, professional), and R&D rose to $2.2M as trials and development ramped .
Structural risks: Reliance on a single manufacturer and pre‑revenue R&D stage raise execution risk; no product sales, with regulatory and clinical pathway risks highlighted extensively in the 10‑K -.

Financial Results

Selected P&L and Operating Metrics (oldest → newest)

Metric	FY 2024 (ended 3/31/24)	Q1 FY2025 (ended 6/30/24)	Q2 FY2025 (ended 9/30/24)
Net Loss ($USD Millions)	$(15.4)	$(2.7)	$(2.8)
G&A Expense ($USD Millions)	$5.2	$1.8	$1.7
R&D Expense ($USD Millions)	$2.2	$1.0	$1.2

Notes: The Q4 2024 press release presented full‑year results; quarterly revenue and EPS were not disclosed in the Q4 release. The company states it has “no source of product sales revenue” in the 10‑K .

Liquidity

Metric	FY 2024 (ended 3/31/24)	Q1 FY2025 (ended 6/30/24)	Q2 FY2025 (ended 9/30/24)
Cash Balance ($USD Millions)	$8.6	$6.8	$5.2

Revenue, EPS, Margins vs Estimates

Revenue: No product revenue; company indicates no source of product sales revenue .
EPS and margins: Not disclosed in the Q4 2024 press release; FY detail focuses on net loss and expenses .
Street estimates: S&P Global consensus was unavailable at the time of research; thus, we cannot present vs‑consensus comparisons for Q4 2024. Values retrieved from S&P Global were unavailable due to access limitations.

Clinical KPIs (PoC pain study)

KPI	Timepoint	Result
7‑day responder rate (lead‑in 5 pts)	7 days post‑procedure	60% responders with mean 6.33 VAS reduction (8.0→1.67)
Onset of pain relief (responder group)	As early as	1 day post‑procedure
Responder opioid use	4–6 weeks	100% of responder group at zero opioid use
Pain reduction (lead‑in)	4–6 weeks	83% pain reduction
Responder rate (first 15 pts)	7 days	79% responders; zero opioid use; QoL improvement

Guidance Changes

Metric/Area	Period	Previous Guidance (May 31, 2024)	Current Guidance (Nov 11, 2024)	Change
PoC: Topline from first five patients	Q2 CY2024	“Q2 CY2024: Announce topline results from first five patients”	Subsequent updates emphasized 4–6 week data Q3 CY2024; topline PoC in 1H 2025	Refined timeline; topline shifted to 1H 2025
PoC enrollment completion	CY2024	Not explicitly stated as “complete enrollment” in May update	“Q4 CY2024: Complete enrollment in PoC”	New specificity (timeline set)
Ablation device design	CY2024	“CY2024: Complete ablation device design”	“Q4 CY2024: Complete ablation device design”	More precise timing
Development of ablation system/catheters	CY2025	“CY2025: Complete development of ablation system and sensing catheter”	“2025: Complete development of ablation system and catheters”	Maintained (wording refined)
Combined sensing/ablation clinical trial	CY2025	“CY2025: Launch combined sensing/ablation clinical trial”	“2025: Initiate combined sensing/ablation clinical trial”	Maintained
Pivotal trial (U.S.)	2025	Not specified in May as “pivotal U.S.”	“2025: Initiate multi‑centered pivotal trial in the U.S.”	Strengthened (added pivotal U.S. specificity)
De novo submission	2026	“CY2026: De novo submission”	“2H 2026: De novo submission”	Narrowed to 2H 2026
Potential FDA clearance	2027	“CY2027: FDA clearance”	“1H 2027: Potential FDA clearance”	Narrowed to 1H 2027

No financial guidance (revenue, margins, OpEx) was provided in these disclosures .

Earnings Call Themes & Trends

Note: No Q4 2024 earnings call transcript was available to review; themes below reflect company disclosures across Q4 2024 (FY release) and the next two quarters’ press releases.

Topic	Previous Mentions (Q‑2 and Q‑1)	Current Period (Q4 2024)	Trend
Clinical efficacy signals in pancreatic cancer pain	Q2 FY25: 83% pain reduction at 4–6 weeks; 100% of responder group at zero opioid use; 79% 7‑day responders in first 15 pts	FY update focused on PoC initiation and near‑term topline from first patients	Strengthening efficacy narrative
Opioid‑sparing outcome	Q2 FY25: 100% of responder group at zero opioid use at 4–6 weeks	Not quantified at FY release	Positive emerging KPI
Enrollment cadence	Q2 FY25: 60% enrollment; completion targeted Q4 CY2024	FY release: early PoC progress	On track; timeline specified later
Technology platform sensitivity (3,000x)	Reiterated in Q1/Q2 FY25 pressers	Emphasized in 10‑K narrative -	Consistent messaging
Regulatory path (de novo)	Q2 FY25: 2H 2026 de novo; 1H 2027 potential clearance	FY: CY2026 de novo; CY2027 clearance	Timeline narrowed in later updates
Capital and runway	Q2 FY25 cash $5.2M; continued spend	FY: cash $8.6M; runway into Q1 CY2025	Runway tightening; funding need flagged

Management Commentary

“We continue to make promising progress in our PoC human clinical study and look forward to announcing topline data from the first patients in the near future.” – Lori Bisson, CEO (May 31, 2024) .
“We are extremely pleased with the progress and clinical data we have generated to date... remain focused on successfully executing our near‑term development objectives and proof‑of‑concept studies in order to expand into additional high‑value indications and drive shareholder value.” – Brad Hauser, CEO (Aug 13, 2024) .
“Looking ahead, we are focused on the successful execution of our trial, with completion on enrollment expected by calendar year end.” – Brad Hauser, CEO (Nov 11, 2024) .

Q&A Highlights

No Q4 2024 earnings call transcript was available; there were no Q&A disclosures to analyze for clarifications or tone shifts. Company messaging across press releases emphasized PoC progress, opioid‑sparing outcomes, and milestone timelines .

Estimates Context

Wall Street consensus (S&P Global) for Q4 2024 revenue/EPS was unavailable at the time of research; therefore, we cannot present vs‑consensus comparisons. Values retrieved from S&P Global were unavailable due to access limitations.
Given the company’s pre‑revenue status, the absence of disclosed revenue and EPS in the Q4 2024 materials, and lack of accessible consensus, near‑term estimate revisions will likely center on clinical timing (topline 1H 2025) rather than P&L expectations .

Key Takeaways for Investors

The clinical efficacy/utility signals (VAS pain reduction, opioid‑sparing) are increasingly compelling and constitute the primary near‑term value driver; topline PoC data in 1H 2025 is the key catalyst .
Execution remains the gating factor: enrollment completion by Q4 CY2024 and on‑time data delivery in 1H 2025 will determine momentum into pivotal planning in 2025 .
Capital runway is limited (into Q1 CY2025) and financing risk is elevated; funding events are likely ahead of pivotal workstreams .
Regulatory timeline is now more precise (de novo 2H 2026; potential FDA clearance 1H 2027), which can anchor scenario modeling but still carries typical device development risk .
Operating expenses are rising as development scales (higher G&A and R&D), pressuring cash; monitor cash burn against milestones and any non‑dilutive options .
Absence of product revenue and EPS disclosure in Q4 2024 underscores that valuation will be clinical/regulatory‑driven near‑term; Street estimate frameworks may remain sparse until commercialization visibility improves .
Watch for further platform validation beyond pancreatic cancer pain (technology sensitivity claims and broader indications) as medium‑term thesis expanders -.

References: Q4 2024 8‑K and Exhibit 99.1 (May 31, 2024) -; 10‑K FY2024 (May 31, 2024) -; Q1 FY2025 8‑K/PR (Aug 13, 2024) -; Q2 FY2025 8‑K/PR (Nov 11–12, 2024) -.

Autonomix Medical, Inc. (AMIX)·Q4 2024 Earnings Summary