For the segment, Brad Hauser, Chief Executive Officer of Autonomix, discussed the Company's recently announced definitive agreement with RF Innovations, Inc., a privately held medical technology company, to license the intellectual property underlying its Apex 6 Radiofrequency Generator and what this agreement means for the Company's development program. We are initially developing technology for the treatment of pain, with initial trials focused on pancreatic cancer, a condition that causes debilitating pa ...

Brad Hauser, Chief Executive Officer of Autonomix, discusses the Company's agreement to license FDAcleared ablation technology from RF Innovations, Inc. For the segment, Brad Hauser, Chief Executive Officer of Autonomix, discussed the Company's recently announced definitive agreement with RF Innovations, Inc., a privately held medical technology company, to license the intellectual property underlying its Apex 6 Radiofrequency Generator and what this agreement means for the Company's development program. Ab ...

Core Viewpoint - Autonomix Medical (NASDAQ:AMIX) experienced significant stock volatility, with a notable rally followed by a decline in share price due to market reactions and company announcements [1][6]. Group 1: Stock Performance - AMIX stock rallied 130% during normal trading hours yesterday, with approximately 152 million shares traded, significantly above its daily average of about 3 million shares [5]. - Following the rally, AMIX stock is down 16.7% as of Tuesday morning, indicating a correction after the previous day's gains [6]. Group 2: Company Developments - Autonomix Medical announced a definitive agreement with RF Innovations to license the intellectual property of its Apex 6 Radiofrequency Generator, expected to be completed by the end of the month [2]. - The company provided updates on its pancreatic cancer pain management device, reporting positive results from a clinical trial that utilizes radiofrequency (RF) ablation to alleviate pain in pancreatic cancer patients [4].

Per the release, Autonomix intends to leverage the technology in its strategic therapeutic units to enhance value for its pipeline. "This transaction represents a significant step forward for the development and commercialization of our innovative technology platform and can potentially simplify our regulatory strategy, as the Apex 6 Generator is already FDA-cleared in pain management," stated President and CEO Brad Hauser. At the same time, Autonomix is a speculative enterprise. The company made its public ...

Core Viewpoint - Autonomix Medical, Inc. has entered into a definitive agreement with RF Innovations to license the Apex 6 Radiofrequency Generator, which aligns with the specifications required for Autonomix's ablation system and supports its FDA regulatory pathway [1][2][3] Group 1: Transaction Details - The transaction involves 250,000 shares of common stock and grants Autonomix a perpetual non-exclusive worldwide and royalty-free license for the Apex 6 Generator intellectual property [2] - The deal is expected to close before the end of July 2024 [1] Group 2: Technology and Development - The Apex 6 Generator is an FDA-cleared ablation technology designed for pain management in the peripheral nervous system [1] - Autonomix plans to utilize this technology to enhance its therapeutic areas and drive value across its pipeline [2][3] - The company is initially focusing on developing technology to address pancreatic cancer-related pain, which currently lacks effective solutions [4][6] Group 3: Strategic Implications - The licensing agreement is seen as a significant advancement for Autonomix's technology platform and may simplify its regulatory strategy due to the existing FDA clearance of the Apex 6 Generator [3] - Autonomix aims to adapt the technology for its specific use case, which could accelerate its journey towards commercialization [3] Group 4: Company Overview - Autonomix Medical, Inc. is dedicated to advancing innovative technologies for diagnosing and treating diseases involving the nervous system [5] - The company's technology platform includes a catheter-based microchip sensing array that detects neural signals with approximately 3,000 times greater sensitivity than current technologies [5]

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].