Autonomix Medical (AMIX) Q1 2026 earnings summary

Executive summary

• Completed enrollment in first-in-human proof-of-concept study for pancreatic cancer pain, showing significant pain reduction and no device-related serious adverse events. Initiated expanded PoC 2 study to include additional visceral cancers and earlier-stage patients.

• Advanced product development with engineering refinements and issued two new U.S. patents supporting the technology platform.

• Held pre-submission meeting with FDA, finalized GLP preclinical study, and targeting De Novo approval in 2028.

Financial highlights

• Net loss of $3.3 million for the quarter ended June 30, 2025, compared to $2.7 million for the same period in 2024.

• Operating expenses increased 24% year-over-year to $3.4 million, driven by higher R&D costs.

• No revenue generated; accumulated deficit reached $53.7 million as of June 30, 2025.

• Cash and cash equivalents were $8.6 million, with working capital of $7.0 million at quarter-end.

Outlook and guidance

• Current cash resources are expected to fund operations into, but not beyond, Q2 2026.

• Additional financing of $32–$40 million will be required to reach commercialization.

• Plans to submit 90-day GLP data by end of 2025 and initiate U.S. Early Feasibility Study in first half of 2026.