THE WOODLANDS, TX - Autonomix Medical, Inc. (NASDAQ: AMIX), a medical device company, today reported positive preliminary results from its ongoing proof-of-concept human clinical trial concerning pancreatic cancer pain management. The trial involves a novel approach using transvascular energy to ablate nerves responsible for pain in patients with late-stage pancreatic cancer.
The initial results from the trial's first five patients, referred to as the "lead-in" cohort, have shown promising outcomes. All patients from the responder group, treated through femoral access, reported a significant reduction in pain, with their Visual Analog Scale (VAS) scores decreasing from an average of 8.0 pre-procedure to 1.33 at 4-6 weeks post-procedure. Furthermore, these patients were able to discontinue opioid use entirely within the same time frame.
The trial, which is expected to be completed by the end of 2024, aims to provide an alternative to opioid-based pain management. Opioids are currently the primary strategy for managing moderate to severe pain in patients with advanced pancreatic cancer, but they come with risks of addiction and overdose.
Autonomix's technology platform includes a catheter-based microchip sensing array antenna, which the company claims can detect neural signals with significantly greater sensitivity than existing technologies. The technology is designed to enable a precision-guided approach to diagnose and treat diseases involving the peripheral nervous system.
The trial's primary goal is to assess the success rate of the radiofrequency (RF) ablation procedure in mitigating pain. Secondary objectives include monitoring device- and procedure-related adverse events and evaluating changes in pain levels and quality of life post-procedure.
The company has amended the trial protocol to collect additional data on tumor encroachment and other biomarkers that may correlate with effective nerve ablation. Twenty additional patients are set to be enrolled under the revised criteria, with a VAS score of 7 or above now being a requirement for inclusion.
The press release states that the technology is investigational and has not yet been cleared for marketing in the United States. Autonomix has cautioned that the statements regarding the potential of the technology and trial outcomes are forward-looking and involve risks and uncertainties.
This report is based on a press release statement from Autonomix Medical, Inc.
In other recent news, Autonomix Medical has reported significant developments. The medical device company has announced a 1-for-20 reverse stock split, reducing the number of outstanding shares from approximately 23 million to about 1.15 million. This decision comes in the wake of the company's potential delisting from the Nasdaq due to its stock not meeting the minimum bid price requirement.
In addition to the reverse stock split, Autonomix Medical ratified Forvis Mazars, LLP as its independent registered public accounting firm for the fiscal year ending March 31, 2025. The board of directors was also re-elected, with Brad Hauser assuming the role of CEO and former CEO Lori Bisson transitioning to Executive Vice Chairman of the Board.
On the clinical front, Autonomix Medical has made strides in its trial aimed at alleviating pancreatic cancer pain, with a 60% responder group reporting meaningful pain relief. The company also secured a license from RF Innovations for the Apex 6 Radiofrequency Generator technology, an FDA-cleared technology aimed at pain management, and is collaborating with NoiseFigure Research, Inc. to enhance its ASIC microchip, a crucial component of its technology. Furthermore, Autonomix has received Ethics Committee approval for a protocol amendment in its clinical trial. These are among the recent developments that reflect Autonomix's ongoing commitment to advancing its technology and improving treatments for neurological disorders.
InvestingPro Insights
As Autonomix Medical, Inc. (NASDAQ: AMIX) reports positive preliminary results from its clinical trial, it's crucial to consider the company's financial position and market performance. According to InvestingPro data, AMIX has a market capitalization of $8.88 million, reflecting its status as a small-cap biotech company. This valuation aligns with the early-stage nature of its novel pain management technology for pancreatic cancer patients.
InvestingPro Tips highlight that AMIX holds more cash than debt on its balance sheet, which could be advantageous as the company progresses through its clinical trials and potentially moves towards commercialization. However, the company is quickly burning through cash, a common characteristic of biotech firms in the research and development phase.
The stock's recent performance has been challenging, with InvestingPro data showing a significant 70.12% price decline over the past three months. This downturn is further emphasized by the fact that AMIX is trading near its 52-week low, with its current price at just 5.07% of its 52-week high. These metrics suggest that investors may be cautious about the company's short-term prospects despite the positive clinical trial results.
It's worth noting that AMIX is not currently profitable, which is not unusual for a biotech company at this stage of development. The negative P/E ratio of -0.51 (adjusted for the last twelve months) reflects this pre-revenue status. Investors considering AMIX should be aware that the company does not pay a dividend, which is typical for growth-focused biotech firms reinvesting in research and development.
For a more comprehensive analysis, InvestingPro offers 13 additional tips on AMIX, providing deeper insights into the company's financial health and market position.
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