Autonomix Medical, Inc. Reports Third Quarter FY2024 Financial Results and Reiterates Upcoming Key Milestones
- Autonomix closed an $11.2 million IPO and began trading on NASDAQ under the ticker symbol AMIX.
- The company acquired exclusive worldwide rights to technology for cardiology field use through an $8 million all stock-based transaction.
- Autonomix completed a preclinical safety study for transvascular ablation to treat pancreatic cancer pain.
- The formation of an engineering development team and Ethics Committee approval for a human clinical study were achieved.
- The Company's technology aims to sense neural signals and precisely target nerves for treatment, offering a more effective alternative to current methods.
- Autonomix is focused on addressing the unmet need for pancreatic cancer patients suffering from severe pain, aiming to improve their quality of life.
- The Company's technology is initially targeting the pancreatic cancer market, where current treatments have limited efficacy and potential side effects.
- None.
Insights
The announcement by Autonomix Medical, Inc. regarding its progress in developing a catheter-based technology for the treatment of pancreatic cancer pain represents a significant stride in the field of medical devices and pain management. Pancreatic cancer is notorious for causing severe pain and current treatments often involve opioids, which have a high risk of addiction and tolerance, or invasive procedures that come with their own set of risks. The ability to precisely target nerves responsible for pain could lead to a paradigm shift in patient care.
From a research perspective, the completion of a preclinical safety study is a critical milestone as it paves the way for first-in-human trials. The success of these trials could not only validate the efficacy and safety of the technology but also establish its superiority over existing pain management options. This has potential implications for market share and growth in the multi-billion-dollar pain management sector, which investors should monitor closely.
Autonomix Medical's recent IPO and subsequent fund-raising activities have provided the company with a cash runway into Q1 CY2025, which is crucial for sustaining operations through the critical stages of clinical trials and product development. The $11.2 million in gross proceeds from the IPO and the $8 million all-stock transaction for cardiology field technology rights indicate strong financial planning and resource acquisition. These moves are strategic, as they not only fund the current research but also diversify the company's portfolio into cardiology, which could mitigate risk and potentially increase investor confidence.
Investors should note the timing of the upcoming transvascular RF ablation study, as positive outcomes could significantly impact the company's valuation. However, it is also important to remain cautious due to the inherent risks associated with clinical trials and the regulatory approval process.
Autonomix Medical's focus on a transvascular approach to treating pancreatic cancer pain taps into a growing demand for minimally invasive medical procedures. The global market for such procedures is expanding as they typically offer quicker recovery times and lower risk profiles compared to traditional surgeries. By targeting a specific and underserved segment—pancreatic cancer pain management—the company is positioning itself in a niche yet potentially lucrative market.
Their technology's potential to displace current standards of care, like opioids and ethanol injections, could disrupt the pain management market, especially if it proves to be more effective and safer. Market adoption, however, will depend on clinical trial outcomes, regulatory approvals and subsequent marketing strategies. The launch of corporate social media channels suggests a commitment to engaging with patients and healthcare providers, which could be pivotal in building brand awareness and trust ahead of commercialization.
Company developing potential breakthrough technology for the nervous system
Initially targeting multi-billion-dollar pancreatic cancer market
On track to commence first study ever to evaluate radiofrequency (RF) ablation in a transvascular approach to reduce the pain associated with pancreatic cancer in Q1 CY2024
Cash runway to fund operations into Q1 CY2025
THE WOODLANDS, TX, Feb. 14, 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, reported financial results yesterday for the third quarter FY2024 ended December 31, 2023 and provided a corporate update.
Recent Highlights
- Closed
$11.2 million in gross proceeds from initial public offering (“IPO”) and commenced trading on NASDAQ under the ticker symbol “AMIX”; - Completed
$8,000,000 all stock-based transaction for exclusive worldwide rights to technology for cardiology field use; - Completed preclinical safety study to support program advancement into first in human clinical study to treat pancreatic cancer pain through transvascular ablation;
- Completed formation of engineering development team;
- Received Ethics Committee authorization for proof-of-concept (“PoC”) human clinical study evaluating proprietary ablation technology for treatment of pancreatic cancer pain; and
- Launched corporate social media channels: X, LinkedIn, Instagram and Facebook.
“I am incredibly pleased with the progress we have made on the corporate, financial and clinical fronts in such a short period of time. With the recent close of our IPO, subsequent listing onto NASDAQ, and advancing the development program for our potentially breakthrough technology, the Company is poised for an exciting year. We are grateful for the continued support and remain focused on successfully executing on the milestones laid out ahead of us,” commented Lori Bisson, Chief Executive Officer of Autonomix. “We believe that our technology has the potential to address the significant unmet need for patients with severe, chronic debilitating pain from pancreatic cancer, contributing to an exceptionally difficult quality of life, that currently is not well-treated by pharmacologic approaches. We continue to make solid progress with our PoC human clinical study and remain on track to initiate enrollment imminently.”
The Company’s catheter-based technology is being developed to do two things: sense neural signals associated with pain or disease and precisely target those nerves for treatment. Autonomix believes this technology is a better alternative to the current approaches commonly used today, where doctors either rely on systemic drugs like opioids that lose effectiveness and have unwanted side effects or treat suspected areas blindly in hopes of hitting the right nerves, an approach that is often inaccurate and can miss the target and even cause collateral damage to surrounding parts of the body.
The Company is initially developing its technology to address pancreatic cancer-related pain. Current approaches, primarily relying on opioids or invasive ethanol injections, can provide only limited relief and may lead to risky side effects. For more information about the Company’s technology, please visit autonomix.com.
Development Program Highlights
- Pancreatic cancer pain as the first target indication could offer distinct development benefits that the Company believes may accelerate Autonomix’s market entry, especially in terms of clinical trials. Achieving “proof-of-concept” in this area could open the door to blockbuster diseases, expanding the horizons for the Company’s technology.
- Leveraging a number of cost-efficient advantages, particularly around clinical trial development. The smaller and shorter clinical trials potentially translate to more efficient resource utilization, minimizing overall development costs.
Expected Upcoming Milestones
- Q1 CY2024: PoC human clinical trial site selection and agreements
- Q1 CY2024: Principal Investigator selection and agreements
- Q1 CY2024: Commence enrollment in PoC human clinical study evaluating proprietary ablation technology for treatment of pancreatic cancer pain
- 2024: Complete ablation device design intended for clinical use
- 2025: Complete development of ablation system and catheter in preparation for human pivotal trial
- 2025: Launch combined sensing / ablation clinical trial
- 2026: De novo submission
- 2027: FDA clearance
Additionally, the Company will continue to engage with the industry and investment communities by actively participating in meetings and key conferences over the course of the year. To stay up to date with the Company’s activities visit autonomix.com and connect with the Company on X, LinkedIn, Instagram and Facebook.
Summary of Financial Results for Q3 FY2024 Ended December 31, 2023
For the nine months ended December 31, 2023 and 2022, the Company incurred net losses of
General and administrative expense was
Research and development expense was
As of December 31, 2023 the Company had cash of
The Company estimates its current cash resources, including the approximately
About Autonomix Medical, Inc.
Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class technology platform includes a catheter-based microchip sensing array that has the ability to detect and differentiate neural signals with approximately 3,000 times greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.
We are initially developing our technology for pancreatic cancer pain, a condition that can cause debilitating pain and needs an effective solution. However, our technology constitutes a platform with the potential to address dozens of indications, including in cardiology, renal denervation and chronic pain management across a wide disease spectrum.
For more information, visit autonomix.com and connect with the Company on X, LinkedIn, Instagram and Facebook.
Forward Looking Statements
Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the Company’s ability to successfully meet the milestones set forth in this press release on a timely basis, if at all, and the Company’s cash burn rate forecast. Such forward-looking statements can be identified by the use of words such as ‘should,’ ‘may,’ ‘intends,’ ‘anticipates,’ ‘believes,’ ‘estimates,’ ‘projects,’ ‘forecasts,’ ‘expects,’ ‘plans,’ and ‘proposes.’
Although Autonomix Medical, Inc. (or Autonomix) believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the offering statement filed with the U.S. Securities and Exchange Commission (“SEC”). Forward-looking statements speak only as of the date of the document in which they are contained and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law.
Investor and Media Contact
JTC Team, LLC
Jenene Thomas
833-475-8247
autonomix@jtcir.com
FAQ
What was the gross proceeds from Autonomix's IPO and when did the company commence trading on NASDAQ?
What rights did Autonomix acquire through an $8 million all stock-based transaction?
What study did Autonomix complete to support program advancement into clinical studies for pancreatic cancer pain treatment?
What is the focus of Autonomix's technology development?
What market is Autonomix initially targeting with its technology for pancreatic cancer pain treatment?
