Autonomix Medical, Inc. Reports Third Quarter FY2024 Financial Results and Reiterates Upcoming Key Milestones

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) -- (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: , , and .

“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 .

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 and connect with the Company on , , and .

 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 $10.0 million and $1.3 million, respectively.

General and administrative expense was $3.7 million for the nine months ended December 31, 2023 compared to $1.0 million for the same period in 2022. This $2.7 million increase was driven primarily by increases in advertising of $1.3 million in preparation for our IPO, officer compensation of $0.5 million, as the Company expanded its management team, stock-based compensation of $0.4 million, legal and professional fees of $0.4 million, and other expenses of $0.1 million.

Research and development expense was $1.4 million for the nine months ended December 31, 2023 compared to $0.3 million for the same period in 2022. The increase in research and development expenses during the current year was mainly attributed to clinical trial planning and development cost.

As of December 31, 2023 the Company had cash of $1.2 million. Subsequent to the quarter, on January 26, 2024, the Company consummated its IPO. In the IPO, the Company sold a total of 2,234,222 shares of common stock at a purchase price of $5.00 per share for gross proceeds of $11.2 million and net proceeds of $9.8 million. As part of the IPO closing, $0.3 million was retained by the Company’s marketing partner as a holdback to be paid 90-days after the IPO.

The Company estimates its current cash resources, including the approximately $9.8 million of net proceeds from the IPO is sufficient to fund its operations into, but not beyond, the first quarter of calendar year 2025.

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 and connect with the Company on , , and .

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