Executive Summary

Pre-revenue quarter with disciplined spend: Q3 FY2025 total operating expenses fell 6% YoY to $2.75M and net loss improved to $2.71M vs. $3.11M in Q3 FY2024; cash ended at $11.82M after a November underwritten offering, extending runway into (but not beyond) Q1 CY2026 .
Milestones on track: management reaffirmed topline PoC data in 1H 2025 for pancreatic cancer pain, targeting IDE submission and initiation of US trials in 2025; design locks achieved for the ASIC microchip and RF ablation catheter .
Strategic financing: $10M gross raised in Nov-2024 (partial overallotment exercised) to support clinical and regulatory plans; warrants classified in equity; Series A warrants include change-of-control settlement mechanics .
Key catalyst path: 1H 2025 PoC readout and 2025 US trial initiation underpin the near-term narrative; however, the company still flags going-concern risk and anticipates needing ~$30–35M to reach first indication commercialization .

What Went Well and What Went Wrong

What Went Well
- Achieved design locks (ASIC microchip and RF ablation catheter) and completed animal testing; strengthened regulatory and quality teams ahead of IDE process .
- Extended runway via $10M underwritten offering in Nov-2024, boosting cash to $11.82M at 12/31 and supporting 2025 clinical plans .
- Clinical momentum: prior-quarter updates showed encouraging PoC signals (e.g., 83% pain reduction at 4–6 weeks for lead-in responders; 100% of responder group at zero opioid use at 4–6 weeks) supporting confidence into the Q3 reaffirmation of 1H 2025 topline .
What Went Wrong
- Pre-revenue with ongoing losses; Q3 net loss was $2.71M (though improved YoY), reflecting continued R&D and G&A needed to execute trials and regulatory prep .
- Internal control material weaknesses and going-concern disclosure persisted; management cites limited staffing and control environment as areas under remediation .
- Reverse split operational frictions: DTCC fractional-share rounding request (271,846 shares) under inquiry; potential liability risk if issuance ultimately required .

Financial Results

Timeframe: AMIX fiscal Q3 ended December 31, 2024. Comparatives shown vs. prior quarters and prior-year Q3.

Metric	Q3 FY2024 (Dec 31, 2023)	Q1 FY2025 (Jun 30, 2024)	Q2 FY2025 (Sep 30, 2024)	Q3 FY2025 (Dec 31, 2024)
Revenues ($M)	$0.00	$0.00	$0.00	$0.00
General & Administrative ($M)	$2.24	$1.80	$1.66	$1.70
Research & Development ($M)	$0.69	$0.95	$1.17	$1.04
Total Operating Expenses ($M)	$2.92	$2.75	$2.84	$2.75
Net Loss ($M)	$(3.11)	$(2.70)	$(2.81)	$(2.71)
Diluted EPS ($)	$(3.07)	$(0.14)	$(2.47)	$(1.46)
Cash & Equivalents ($M)	n/a	$6.75	$5.16	$11.82

Notes: Q1 FY2025 EPS reflects pre–reverse-split reporting in that 10-Q; Q2–Q3 EPS reflect reverse-split–adjusted reporting. Use net loss for period-to-period comparability .

KPIs and Operating Metrics

KPI	Q1 FY2025	Q2 FY2025	Q3 FY2025
PoC clinical progress	First five lead-in patients completed protocols; 60% responder rate at 7 days with clinically meaningful pain relief	83% reduction in pain at 4–6 weeks for responder group; 100% of responder group at zero opioid use; ~60% enrollment; QoL improvement highlighted	Topline data reaffirmed for 1H 2025; US trials planned in 2025; design locks achieved (ASIC and RF catheter)
Runway outlook	Cash $6.75M; runway to 2Q CY2025; additional ~$40M estimated to reach commercialization (earlier view)	Cash $5.16M; runway to 2Q CY2025	Cash $11.82M; runway into (but not beyond) 1Q CY2026; ~$30–35M estimated to commercialization

Segment reporting: Single operating segment; no segment revenue/margin breakdown available .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
PoC topline readout timing	1H 2025	1H 2025 (reiterated since Q1)	1H 2025 reaffirmed	Maintained
IDE submission/US trials	CY2025	“Initiate US trials in 2025”	“Initiate US clinical trials in 2025”	Maintained
De Novo submission	CY2026	2H 2026 / CY2026	2026	Maintained
Potential FDA clearance	CY2027	1H 2027 / CY2027	2027	Maintained
Cash runway	Liquidity	Into 2Q CY2025	Into (but not beyond) 1Q CY2026	Raised
Est. capital to first indication commercialization	Multi-year	~$40M (earlier view)	~$30–35M	Improved estimate

Earnings Call Themes & Trends

No earnings call transcript was found in company filings for Q3 FY2025. Themes below derive from press releases and 10-Q MD&A.

Topic	Previous Mentions (Q1 & Q2 FY2025)	Current Period (Q3 FY2025)	Trend
Clinical efficacy signals (pancreatic cancer pain)	Positive early signals: 60% responder rate at 7 days; no immediate serious adverse events in first five lead-in patients	Prior-quarter data recapped: 83% pain reduction at 4–6 weeks in responder group; 100% of responders at zero opioid use at 4–6 weeks; topline reaffirmed for 1H 2025	Improving evidence base (preliminary)
US regulatory path	IDE/US trials planned for 2025; De Novo in 2026; clearance in 2027	Timeline reaffirmed; design locks achieved for ASIC and RF catheter supporting readiness	Stable/Executing
Financing and runway	Runway into 2Q CY2025; planning additional capital; ~$40M to commercialization	$10M gross offering closed Nov-2024; runway into 1Q CY2026; ~$30–35M to commercialization	Improved runway/estimate
Internal controls & going concern	Material weaknesses disclosed; going-concern noted	Material weaknesses and going-concern remain; remediation actions ongoing	Persistent risk
Capital markets mechanics	n/a in Q1	Reverse split executed; dispute over fractional rounding (DTCC 271,846 shares) under inquiry	New operational/legal risk

Management Commentary

“We remain on track to report topline data from our PoC trial in the first half of 2025 and have made significant progress toward initiating studies in the US in the second half of this year... We have achieved design lock for our ASIC microchip and RF ablation catheter” — Brad Hauser, CEO .
“Looking ahead, we are focused on the successful execution of our trial... Based on the data demonstrated to date, we believe our technology has the potential to revolutionize the treatment paradigm for pancreatic cancer pain” — CEO commentary during prior quarter update .

Q&A Highlights

No Q3 FY2025 earnings call transcript was available in company filings or earnings materials; therefore, Q&A themes and clarifications could not be assessed from primary sources [No call transcript found via filing search].

Estimates Context

Wall Street consensus estimates (revenue/EPS) via S&P Global Capital IQ were not available at the time of this analysis due to retrieval limits; as a result, we cannot assess beats/misses vs. consensus for Q3 FY2025. Values from S&P Global were unavailable at the time of request.

Key Takeaways for Investors

The near-term stock narrative hinges on 1H 2025 PoC topline data and 2025 US trial initiation; timelines were reaffirmed, and device design locks reduce execution risk on hardware readiness .
Runway improved meaningfully to 1Q CY2026 following the $10M raise; however, management still anticipates ~$30–35M to reach first indication commercialization, implying additional capital needs and potential dilution risk .
Operating discipline: Q3 OpEx declined 6% YoY; G&A normalized from IPO-related spend, while R&D rose YoY in support of trials and product development .
Structural risks remain: continuing going-concern language and material weaknesses in internal controls; investors should monitor remediation progress and audit commentary each quarter .
Corporate actions: reverse split completed; the DTCC fractional-share discrepancy remains under inquiry, representing a potential dilution/legal overhang until resolved .
Optionality beyond pancreatic cancer pain exists (platform claims across nerve-related diseases), but value inflection requires human clinical data and regulatory milestones over 2025–2027 .

Appendix: Additional Detail

Other relevant Q3-period press releases and filings

Reverse Stock Split/DTCC fractional-share notice (8-K Other Events): company disputes 271,846 “rounding” shares; inquiry underway; may face liability if issuance required .
10-Q Q3 FY2025 liquidity and runway: cash $11.82M; runway into (but not beyond) Q1 CY2026; additional capital needed; single operating segment .
Prior quarter clinical highlights (for trend): significant pain reduction and opioid discontinuation among lead-in responders in PoC; ~60% enrollment by Q2 .

Sources

Q3 FY2025 8-K Earnings Press Release (Ex. 99.1): financial and milestone update .
Q3 FY2025 10-Q: full financials, liquidity, risk factors, controls .
Q2 FY2025 10-Q and 8-K Press Release: quarterly financials and interim clinical data .
Q1 FY2025 10-Q and 8-K Press Release: baseline quarterly financials and early clinical update .
8-K Other Events (Nov 4, 2024): reverse split fractional-share issue .

Autonomix Medical, Inc. (AMIX)·Q3 2025 Earnings Summary