Autonomix plans to unveil topline data in the first half of 2025 for its proof-of-concept study evaluating its microchip sensing array in pancreatic cancer pain treatment.
The company outlined its upcoming milestones as part of its financial results for Q1 of the 2025 fiscal year.
US-based Autonomix aims to report four-to-six-week data from the first lead-in patients in Q3 this year, with enrolment slated to be completed in the following quarter for the trial being conducted in Eastern Europe.
Shares in the Nasdaq-listed company opened 6% higher at market open compared to a pre-announcement market close. Autonomix has a market cap of $15.8m.
Autonomix is targeting patients experiencing severe pain arising from pancreatic tumours. It says its device offers a minimally invasive alternative option for pain reduction.
The company has already announced positive seven-day topline results from the trial for the first five lead-in patients, with 60% of subjects responding with a reduction of pain on a pain scale assessment. All members of the responder group had clinically meaningful pain relief at seven days post-procedure. There were no immediate procedural-related complications or significant adverse events.
Autonomix’s technology uses a catheter-based microchip sensing array antenna to detect and differentiate affected target nerves. The company claims its platform does this with up to 3,000 times greater sensitivity than currently available technologies. Nerves are then killed using radiofrequency ablation.
Autonomix states that current methods, which include opioids or ethanol injections, provide only limited relief, as well as the potential for side effects.
The company has identified pancreatic cancer as the “most direct and cost-effective path towards a potential approval”, which unlocks abdominal pain indications.
Autonomix reported losses of $2.7m in Q1 of the fiscal year compared to $0.9m for the same period last year. The company said it expects to incur increased research and development costs in the future as it continues to conduct the clinical trial.
Autonomix’s CEO Brad Hauser said: “We continue to make key advancements toward our expected milestones ahead and 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,” commented Brad Hauser, chief executive officer of Autonomix.
Shares in the company soared 34% early last month when it agreed to an IP licence for RF Innovations’s ablation technology. Autonomix gave 250,000 shares of its common stock to RF Innovations for the use of the Apex 6 radiofrequency (RF) generator.
