Autonomix Medical, Inc. Reports Positive Subgroup Results Demonstrating Sustained Improvements in Quality of Life from Post Hoc Analysis of Pancreatic Cancer PoC Study

Rhea-AI Summary

Autonomix Medical (NASDAQ: AMIX) announced a post-hoc subgroup analysis of its first-in-human PoC 1 study reporting sustained, clinically meaningful quality-of-life gains after targeted transvascular nerve ablation for severe pancreatic cancer pain.

Key numeric findings: symptom scores improved 14.53 points at 4–6 weeks (n=9) and 26.07 points at 3 months (n=6); functionality rose 8.15 and 25.56 points; global QOL improved 8.33 and 18.06 points. Stage 4/metastatic subgroup exceeded EORTC ≥10-point meaningful-change thresholds at multiple timepoints.

The company said results will inform its multicenter U.S. clinical trial planned to start in 2026.

Positive

• Symptom improvement 26.07 points at 3 months (n=6)
• Functionality gain 25.56 points at 3 months
• Global quality-of-life +18.06 points at 3 months
• Stage 4 metastatic subgroup exceeded 10-point EORTC threshold

Negative

• Post-hoc analysis based on modest patient numbers (e.g., n=6 at 3 months)
• Results are retrospective and require prospective validation

Insights

Clinical trial & outcomes analyst

Post-hoc subgroup data show clinically meaningful QoL gains but sample size and retrospective design limit definitive conclusions.

Autonomix reports large, sustained improvements in EORTC QLQ-C30 symptom, function, and global scores at 4–6 weeks and 3 months, with several 3-month results exceeding the EORTC clinically meaningful threshold (≥10 points). The data set is small and post-hoc, yet the magnitude of change—paired with the previously reported near 60% reduction in VAS pain and opioid-free outcomes—signals a consistent pattern linking pain control to multi-domain quality-of-life gains.

These findings depend on retrospective subgrouping, limited responder counts (n values cited) and exploratory analysis methods. Such constraints raise risks of selection bias and overestimation of effect size; the company acknowledges the need for prospective validation. Procedural refinements described as guiding the U.S. trial may improve reproducibility but require confirmation in a larger, controlled study.

Watch for the planned U.S. multicenter study beginning in 2026 that will prospectively evaluate pain relief and quality-of-life endpoints; key near-term milestones include trial initiation and predefined endpoint definitions and sample sizes. If the prospective trial reproduces these results, the evidence would move from exploratory to confirmatory over the subsequent 12–24 months.

EORTC QLQ-C30 subgroup results confirm broad and durable quality-of-life improvements across disease stages and metastasis status, complementing previously reported pain reduction and opioid-free outcomes

Late-stage patients showed substantial improvements, suggesting ablation provided clinically meaningful changes even in advanced severe disease

THE WOODLANDS, TX, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company dedicated to advancing precision nerve-targeted treatments, today announced results from a post-hoc exploratory subgroup analysis of its previously reported first-in-human proof-of-concept study (PoC 1) evaluating the safety and effectiveness of delivering transvascular energy to ablate relevant problematic nerves and mitigate pain in patients with severe pancreatic cancer pain. The analysis evaluated patient-reported quality-of-life, symptom and functional outcomes as a secondary endpoint of the study using the EORTC QLQ-C30 scale (a validated measure of cancer-specific quality of life) across multiple patient subgroups, including tumor stage and metastatic status. Results from this post-hoc exploratory analysis suggested that Autonomix’s targeted ablation therapy may have produced improvements in symptom burden, functionality, and global quality of life following Autonomix’s targeted ablation therapy.

The analysis also provided new procedural findings that will be used to guide Autonomix’s U.S. clinical trial, which is on track to commence in 2026.

Key Findings from the Subgroup Analysis:

• Consistent Improvements Across All Responders: Across all responding patients, average symptom scores improved by 14.53 points at 4–6 weeks (n=9)² and 26.07 points at 3-months (n=6)², functionality increased by 8.15 and 25.56 points, and global quality of life improved by 8.33 and 18.06 points, respectively. All 3-month¹ results exceeded the EORTC threshold for clinically meaningful change (≥10 points).
• Advanced Disease in Stage 4, Distant Metastatic Subgroup Shows Strong Response: Patients with Stage 4 pancreatic cancer, with both distant and regional metastases, achieved a 32.48 point symptom improvement and 11.85 point functional gain by 4–6 weeks, maintaining significant benefit at 3-months (29.49 and 25.56 point improvements, respectively). Global quality of life scores improved by 19.44 points at 4-6 weeks and 25.00 points at 3-months. All timepoint results surpassed the EORTC’s threshold for clinically meaningful change. These findings confirm that ablation may provide durable, multidimensional relief even in metastatic and late-stage disease.

“These subgroup findings provide deeper insight into how and why our ablation approach is improving outcomes across varied patient types,” said Brad Hauser, President and Chief Executive Officer of Autonomix. “The fact that patients with late-stage and metastatic disease achieved large, durable improvements in symptoms, function, and global quality of life underscores the broad applicability and real-world impact of our therapy. While this is a retrospective post-hoc analysis with modest patient numbers that will require prospective validation, it will inform our future work in our larger, multicenter U.S. clinical trials.”

This post-hoc exploratory subgroup analysis of the PoC 1 study assessed EORTC QLQ-C30 domains – Symptoms, Functionality, and Global Health Status – at 24-hours, 7-days, 4–6 weeks, and 3-months post-procedure.

The data complement previously reported results showing nearly 60% reduction in VAS pain intensity and reported opioid-free outcomes by 4–6 weeks, potentially supporting a consistent link between pain control, functional recovery, and improved quality of life.

These subgroup insights will guide trial design, patient selection, and endpoint strategy for Autonomix’s upcoming U.S.-based multicenter clinical study, currently planned to begin in 2026, which will formally evaluate pain relief and quality-of-life outcomes as endpoints.

About the Proof-of-Concept Study

The goal of the PoC 1 study is to assess pain reduction via RF ablation. The Company’s catheter-based microchip sensing array used to detect and differentiate neural signaling was not used in this study and will be evaluated in future studies.

The primary objective of the study’s PoC 1 phase was to assess the success rate of ablating relevant nerves to mitigate pain in patients with pancreatic cancer pain utilizing RF ablation in a transvascular approach to the nerves in the region. Secondary objectives included assessing the incidence of device- and procedure-related adverse events up to 4-6 weeks post-procedure; estimating the change in pain levels from pre- to post-procedure; and estimating the change in quality of life from pre- to post-procedure. All patients who had a successful procedure were evaluated at 7-days, 4-6 weeks, and at 3-months post-procedure. All patients entered the study with severe abdominal pain from unresectable pancreatic cancer and had a life expectancy of 3 months or more.

The Company enrolled twenty (20) patients in PoC 1, including the first five (5) “lead-in” patients. Based on consistent, corresponding evidence that successfully met the trial objectives, the Company determined there was a sufficient number of patients and concluded its initial phase of the study. Notable findings from the study² included statistically significant pain relief as early as 24-hours post-procedure, providing patients with rapid relief. Responding femoral patients represented 84% of treated patients and had pain reduction that remained consistently positive at 7-days, 4-6 weeks and 3-months post-procedure with a mean 4.16 (53.3%), 4.67 (59.2%) and 5.08 (65.6%) pain reduction on the VAS pain scale, respectively. 100% of responding patients were able to go to zero opioid use at 7-days post-procedure, while 73% were at zero opioid use at 4-6 weeks post-procedure and 100% were at zero opioid use at 3-months post-procedure. Responding patients also reported an improved quality of life during end-stage cancer and the procedure demonstrated a strong safety profile.³

As previously announced, based on the positive results demonstrated in PoC 1, Autonomix has initiated a follow-on PoC 2 phase in a market expansion opportunity that will double the potential addressable market beyond pancreatic cancer pain by evaluating additional visceral cancers that signal pain through the Celiac Plexus and earlier stage pancreatic cancers with moderate to severe pain. The PoC 2 phase will provide a concentrated focus on interventional cancer pain management applications like pancreatic, gall bladder, liver, and bile duct, with potential further expansion in cardiology, oncology, gastroenterology, and other sectors where the Company has established key opinion leader relationships and emerging preclinical evidence.

About Autonomix Medical, Inc.

Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class platform system technology includes a catheter-based microchip sensing array that may have the ability to detect and differentiate neural signals with greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.

We are initially developing this technology for the treatment of pain, with initial trials focused on pancreatic cancer, a condition that causes debilitating pain and is without a reliable solution. Our technology constitutes a platform to address dozens of potential indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. Our technology is investigational and has not yet been cleared for marketing in the United States.

For more information, visit autonomix.com and connect with the Company on X, LinkedIn, Instagram and Facebook.

Forward Looking Statements

Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Forward-looking statements include, without limitation, the commencement date of the planned U.S.-based multicenter clinical study. Such forward-looking statements can be identified by the use of words such as “should,” “might,” “may,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” and “proposes.”

Although Autonomix believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on May 29, 2025, and from time to time, our other filings with the SEC. Forward-looking statements speak only as of the date of this press release and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law.

Investor and Media Contact
JTC Team, LLC
Jenene Thomas
908.824.0775
autonomix@jtcir.com

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¹ As to be expected in seriously ill patient populations, the 3-month post-procedure follow up ranged from three to five months due to disease progression and the patient’s inability of the patient to travel.

² Of the 20 subjects enrolled, three (3) patients with brachial access showed no improvement and one (1) patient was enrolled and not treated due to unsuccessful catheter placement because of an existing celiac trunk stenosis (narrowing of the vessel). 16 patients were treated using femoral access and three (3) patients using brachial access. 100% of patients (16) with femoral access responded to treatment, while the three (3) patients with brachial access showed no improvement in pain scores, representing a key procedural learning. At 7-days post procedure, data was captured on 16 responding patients. At 4-6 weeks post-procedure, a total of four (4) responders succumbed to their disease before the follow-up appointment which was attributed to disease progression and not related to the procedure. Three (3) responding patient VAS scores, three (3) responding patient quality of life scores and one (1) responding patient opioid status were not reported at the 4–6-week post-procedure follow-up due to the inability

³ There were no device or procedure-related serious adverse events. As to be expected with surgical procedures in seriously ill patient populations, there were 8 serious adverse events (6 subjects succumbed to their disease before the 4-6 week follow up, which were not related to the procedure, and 2 events resulting in hospitalization also unrelated to the procedure) and 14 adverse events (including 8 events of expected arterial constrictions due to spasms and temporary artery occlusion). In a separate clinical patient population of three subjects, there was a procedural-related serious adverse event of a hematoma at the access site resulting in hospitalization.

FAQ

What did Autonomix (AMIX) report on November 17, 2025 about pancreatic cancer pain?

Autonomix reported a post-hoc subgroup analysis showing sustained, clinically meaningful EORTC QLQ-C30 quality-of-life improvements after targeted ablation.

How large were the symptom improvements reported by Autonomix (AMIX) at 3 months?

Symptom scores improved by 26.07 points at 3 months in the overall responders subgroup (n=6).

Did Autonomix (AMIX) show benefit for Stage 4 metastatic pancreatic cancer patients?

Yes; the Stage 4 metastatic subgroup showed symptom and function gains surpassing the EORTC ≥10-point meaningful-change threshold at multiple timepoints.

Will Autonomix (AMIX) run a follow-up clinical trial and when?

Autonomix plans a multicenter U.S. clinical trial currently planned to begin in 2026 to prospectively evaluate pain and quality-of-life endpoints.

How do these quality-of-life results relate to previously reported pain outcomes for AMIX?

The subgroup data complement earlier PoC results showing nearly 60% VAS pain reduction and opioid-free outcomes by 4–6 weeks.

What are the main limitations investors should note about the AMIX subgroup analysis?

The analysis is retrospective with modest sample sizes and therefore requires prospective validation before clinical conclusions.