Executive Summary

Q1 FY2025 (quarter ended June 30, 2024) reflected pre-revenue operations with net loss of $2.70M and basic/diluted EPS of $(0.14), driven by higher G&A and R&D as clinical activities ramped .
Management reiterated near-term milestones: complete PoC enrollment in Q4 CY2024 and topline PoC data in 1H CY2025, then a U.S. pivotal program and De Novo submission (2026) toward potential FDA clearance in 2027 .
Clinical signals are encouraging: 60% responders among first five lead-in patients with mean 6.33 VAS pain reduction at 7 days; preliminary data later showed 79% responder rate at 7 days and 100% of lead-in responders at zero opioid use at 4–6 weeks .
Corporate actions strengthen the pathway: RF Innovations Apex 6 RF generator IP licensed (FDA-cleared tech) to align with Autonomix’s ablation system; leadership appointment of Brad Hauser as CEO .
As of Q3 FY2025, cash runway extended (cash $11.82M) following the November 2024 underwritten offering; company executed a 1-for-20 reverse stock split in October 2024 aiming to maintain Nasdaq compliance .

What Went Well and What Went Wrong

What Went Well

PoC clinical trial progress and pain reduction outcomes: “60% of subjects responded with a mean 6.33 reduction of pain (VAS) at 7 days,” and later “79% responder rate…with zero opioid use at 7 days for first 15 patients; 100% of lead-in responders at zero opioid use at 4–6 weeks” .
Strategic IP license: non-exclusive, worldwide, royalty-free license to FDA-cleared Apex 6 RF generator to streamline regulatory pathway; consideration of 250,000 shares issued .
Clear milestone cadence maintained: topline PoC in 1H CY2025, U.S. pivotal initiation in 2025, De Novo in 2026, potential clearance 2027 .
CEO commentary highlights execution: “We remain focused on successfully executing our near-term development objectives…to expand into high-value indications and drive shareholder value” – Brad Hauser .

What Went Wrong

Continued operating losses as pre-revenue: Q1 net loss $2.70M; G&A and R&D increased YoY as trial and development expanded .
Reverse stock split and fractional rounding uncertainty: 1-for-20 split effective Oct 24, 2024; DTCC notice on 271,846 rounding shares under inquiry, posing dilution and liability risk if required .
Need for additional capital: company estimates $30–35M more financing to reach commercialization; going-concern statements across filings despite improved runway .

Financial Results

Quarterly comparison (oldest → newest):

Metric	Q1 2025 (Jun 30, 2024)	Q2 2025 (Sep 30, 2024)	Q3 2025 (Dec 31, 2024)
Revenue ($USD Millions)	$0.0	$0.0	$0.0
Net Loss ($USD Millions)	$2.699	$2.807	$2.712
EPS (Basic/Diluted, $)	$(0.14)	$(2.47)	$(1.46)
G&A Expense ($USD Millions)	$1.799	$1.662	$1.703
R&D Expense ($USD Millions)	$0.954	$1.174	$1.044
Cash & Equivalents ($USD Millions)	$6.751	$5.155	$11.823

Notes:

EPS comparability impacted by 1-for-20 reverse stock split effective Oct 24, 2024; earlier quarters not retro-adjusted in Q1 filing .
YoY context for Q1: net loss $0.865M in prior-year quarter; G&A $0.503M; R&D $0.368M (reflects ramp in FY2025) .

KPIs (clinical trial):

Lead-in 5 patients: 60% responders; mean 6.33 VAS reduction (8.0 to 1.67) at day 7; pain relief as quick as 1 day; femoral access favored; quality-of-health +78%, quality-of-life +45% (responders) .
First 15 patients: 79% responder rate at 7 days; zero opioid use among responders at 7 days; 100% of lead-in responders zero opioid at 4–6 weeks .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
PoC enrollment completion	Q4 CY2024	Complete enrollment by Q4 CY2024	Reaffirmed completion by Q4 CY2024	Maintained
PoC topline data	1H CY2025	Topline PoC in 1H CY2025	Reaffirmed 1H CY2025	Maintained
U.S. clinical trials initiation	CY2025	Initiate U.S. clinical trials in 2025	Reaffirmed 2025	Maintained
De Novo submission	CY2026	De Novo in 2026	Reaffirmed 2026	Maintained
Potential FDA clearance	CY2027	Potential clearance in 2027	Reaffirmed 2027	Maintained
Device design locks	CY2024–CY2025	Complete ablation device design in 2024	Q2/Q3 updates: RF ablation catheter design lock achieved; ASIC microchip progress	Advanced per plan

Earnings Call Themes & Trends

(No earnings call transcript filed for Q1 FY2025.)

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q1 FY2025)	Trend
Clinical efficacy signals	Lead-in 5 patients: 60% responders; strong pain reduction; early QoL gains	Q1 reiterated 7-day topline results and milestone timing	Improving evidence base
Technology platform (sensing + RF ablation)	Platform sensitivity ~3,000×; transvascular approach described	Transvascular RF ablation core to trial; sensing to be combined in future pivotal	Execution toward combined system
Regulatory pathway	Apex 6 generator is FDA-cleared; licensed IP to align regulatory path	Milestones reaffirmed for De Novo and clearance timeline	De-risking steps maintained
Financing/cash runway	As of Q2, cash $5.2M; runway into Q2 CY2025	As of Q3, cash $11.82M post Nov offering; runway into Q1 CY2026	Runway extended
Listing/compliance	1-for-20 reverse split; DTCC fractional shares inquiry noted	Reverse split effective; inquiry ongoing	Compliance actions ongoing

Management Commentary

“We are extremely pleased with the progress and clinical data…We continue to make key advancements toward our expected milestones ahead and remain focused on successfully executing our near-term development objectives…” – Brad Hauser, CEO .
“We are very pleased with these initial positive results…highly encouraged with the level of pain reduction…” – Dr. Robert Schwartz, CMO (lead-in cohort procedural learnings) .
“We remain focused on successfully executing…to expand into additional high-value indications and drive shareholder value.” – Brad Hauser .
“We are dedicated to building momentum and driving shareholder value…complete enrollment by year-end and topline data in 1H 2025.” – Brad Hauser .

Q&A Highlights

No Q1 FY2025 earnings call transcript was filed; therefore, analyst Q&A highlights and clarifications are unavailable.

Estimates Context

Wall Street consensus (S&P Global) for Q1–Q3 FY2025 EPS and revenue was unavailable at time of request due to SPGI quota limits. As a result, comparison vs consensus cannot be provided.
Where estimates are required by process, note they are unavailable; thus no beat/miss analysis vs Street can be performed at this time.

Key Takeaways for Investors

Near-term catalyst: topline PoC data in 1H CY2025; a positive safety/efficacy readout could be a major valuation inflection and support the planned U.S. pivotal initiation in 2025 .
Clinical signal strength: consistent pain reduction and opioid-use reduction signals across lead-in and initial patient sets support the mechanism; watch full dataset for durability and generalizability .
Regulatory de-risking: Apex 6 RF generator IP license (FDA-cleared) aligns with Autonomix’s system, potentially simplifying the path; monitor integration into ablation system and combined sensing/ablation trials .
Runway extended but capital needs remain: post-Nov 2024 offering, cash was $11.82M with runway into Q1 CY2026; management still estimates $30–35M needed to reach commercialization, implying further financing risk and potential dilution .
Listing/compliance and technical overhangs: 1-for-20 reverse split accomplished; fractional rounding shares inquiry could introduce uncertainty/dilution risk if resolved against the company; monitor warrant structures from the offering (Series A and Representative’s warrants) for potential overhang .
Execution focus: watch for device design locks (ASIC microchip, RF catheter), trial enrollment completion and IDE/De Novo milestones as pacing indicators for 2025–2027 roadmap .
Trading implications: pending topline data and regulatory steps likely drive sentiment; financing cadence and any resolution of fractional-share issue may influence near-term volatility .

Appendix: Additional Context and Prior Periods

Q2 FY2025 press release summarized advancements (83% pain reduction at 4–6 weeks among lead-in responders; 79% responder rate at 7 days across first 15 patients; 60% enrollment reached) .
Q3 FY2025 press release noted design locks achieved and reiterated regulatory timeline (IDE, U.S. trials in 2025) .
Q1 FY2025 8-K included 7-day lead-in data and milestone roadmap; also leadership changes and Apex 6 licensing .

Autonomix Medical, Inc. (AMIX)·Q1 2025 Earnings Summary