RF Innovations' Apex 6 Generator aligns with specifications required for Autonomix's ablation system and facilitates ongoing development Transaction further reinforces Autonomix's FDA regulatory pathway THE WOODLANDS, TX, July 15, 2024 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ:AMIX) ("Autonomix" or the "Company"), a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated, today announced it has entered ...

Financial Performance and Funding - Future financial performance is dependent on successfully raising additional equity or debt financing to fund operations[21]. - The company currently has no source of product sales revenue, indicating a need for successful commercialization of product candidates[21]. Competition and Market Risks - The company is facing competition from existing products and potential new products that may emerge in the market[21]. - General economic uncertainty may adversely affect spending on medical procedures, impacting the company's market[21]. Regulatory and Compliance Risks - There are risks associated with compliance to U.S. and foreign regulatory requirements, which could limit or withdraw marketing approvals[21]. Operational Dependencies - The company is reliant on third-party supply and manufacturing partners for materials and components necessary for research and development[21]. - Future growth is contingent upon the ability to attract and retain key management and technical personnel[21]. Financial Reporting and Stockholder Concerns - The company has identified material weaknesses in its control over financial reporting, which could impact financial performance[21]. - The company is exposed to volatility in the market price of its stock, which could affect investor confidence[21]. - Potential dilution to current stockholders may occur from the issuance of equity awards[21].

Financial Performance - The company reported a net loss of $15.4 million for the fiscal year 2024, compared to a net loss of $2.0 million in 2023, with a non-cash loss of $8.0 million on warrants included in the 2024 losses [10]. - General and administrative expenses increased to $5.2 million in 2024 from $1.2 million in 2023, primarily due to a $1.7 million increase in advertising related to the IPO and other operational costs [11]. - Research and development expenses rose to $2.2 million in 2024 from $0.7 million in 2023, driven by clinical trial execution and product development costs [12]. - As of March 31, 2024, the company had cash resources of $8.6 million, which are expected to fund operations into the first quarter of calendar year 2025 [13][14]. Initial Public Offering - The company raised gross proceeds of $11.2 million and net proceeds of $9.8 million from its initial public offering (IPO) [3]. Product Development and Research - The company is focused on developing a catheter-based sensing technology aimed at treating pancreatic cancer-related pain, which is currently underserved by existing treatments [4][5]. - Upcoming milestones include announcing topline results from the first five patients in the human clinical study in Q2 CY2024 and completing the ablation device design intended for clinical use in CY2024 [15]. - The company has entered into a service agreement with NoiseFigure Research, Inc. to develop the next generation of its proprietary microchip [7]. - The company believes that achieving proof-of-concept in treating pancreatic cancer pain could accelerate market entry and open opportunities for addressing other significant diseases [8]. - The company has successfully completed an animal study demonstrating a statistically significant reduction in tumor metastases and tumor mass through targeted nerve ablation [7].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to__________ Commission file number 001-41940 Autonomix Medical, Inc. (Exact Name of Registrant as Specified in Its Charter) De ...