Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the
“Company”), a medical device company focused on advancing precision
nerve-targeted treatments, today reported financial results for the
second quarter fiscal year 2025 ended September 30, 2024 and
provided a corporate update.
Recent Highlights
- Announced 83% reduction of pain at
4-6 week follow-up from lead-in patients in ongoing human clinical
trial in pancreatic cancer pain patients;
- Announced 100% of the lead-in
patient responder group went to zero opioid use at 4-6 weeks
post-procedure in preliminary results demonstrating Autonomix’s
proprietary RF ablation technology’s ability in its ongoing human
clinical trial;
- Reached 60% enrollment in ongoing
human clinical trial in pancreatic cancer pain patients;
- Reported 79% responder rate with
zero opioid use and quality of life improvement at 7 days
post-procedure from first 15 patients highlighting significant
impact on treatment of pancreatic cancer pain with maintained pain
reduction; and
- Presented at premier scientific
conferences including the Cardiovascular and Interventional
Radiological Society of Europe (CIRSE) Annual Congress and Octane
Medical Innovation Forum.
“Over the course of the past quarter we have
made significant progress in our ongoing human clinical trial and
generated a growing body of encouraging data. Looking ahead, we are
focused on the successful execution of our trial, with completion
on enrollment expected by calendar year end. Based on the data
demonstrated to date, we believe our technology has the potential
to revolutionize the treatment paradigm for pancreatic cancer pain
and bring an effective solution to additional high-value expansion
opportunities. We are dedicated to building momentum and driving
shareholder value in the near and long term,” commented Brad
Hauser, Chief Executive Officer of Autonomix.
The Company’s first-in-class transvascular
technology platform utilizes a catheter-based microchip sensing
array antenna that has the ability to detect and differentiate
neural signals with up to 3,000 times greater sensitivity than
currently available technologies. Once target nerves are
identified, Autonomix uses its proprietary radio frequency (“RF”)
ablation technology to kill targeted nerves, enabling a precision
guided sense, treat and verify approach to addressing a number of
disease categories from chronic pain management to hypertension and
cardiology. Current approaches, primarily relying on opioids or
invasive ethanol injections, can provide only limited relief and
may lead to risky side effects.
Expected Upcoming
Milestones
- Q4 CY2024: Complete enrollment in
PoC human clinical study evaluating proprietary ablation technology
for treatment of pancreatic cancer pain
- Q4 CY2024: Complete ablation device
design intended for clinical use
- 1H 2025: Report topline data from
PoC trial
- 2025: Initiate multi-centered
pivotal trial in the United States
- 2H 2026: De novo submission
- 1H 2027: Potential FDA
clearance
For more information about the Company’s
technology, please visit autonomix.com.
Summary of Financial Results
for Three and Six Months Ended
September 30, 2024
For the three months ended September 30, 2024
and 2023, the Company incurred net losses of $2.8 million and $6.0
million, respectively.
General and administrative expense was $1.7
million for the three months ended September 30, 2024 compared to
$0.8 million for the same period in 2023. This $0.9 million
increase was driven primarily by increases in officer and employee
compensation and benefits of $0.4 million, as we expanded our
management team, stock-based compensation of $0.2 million,
insurance expense of $0.1 million, franchise tax of $0.1 million,
and other expenses of $0.1 million.
Research and development expense was $1.2
million for the three months ended September 30, 2024 compared to
$0.5 million for the same period in 2023. The increase in research
and development expenses during the current quarter was mainly
attributed to our clinical trial and product development costs.
For the six months ended September 30, 2024 and
2023, the Company incurred net losses of $5.5 million and $6.9
million, respectively.
General and administrative expense was $3.5
million for the six months ended September 30, 2024 compared to
$1.3 million for the same period in 2023. This $2.2 million
increase was driven primarily by increases in officer and employee
compensation and benefits of $1.0 million, as we expanded our
management team, stock-based compensation of $0.6 million, legal
and professional fees of $0.2 million, insurance expense of $0.2
million, franchise tax of $0.2 million, and board of directors
compensation of $0.1 million, offset by a decrease in advertising
expense of $0.1 million.
Research and development expense was $2.1
million for the six months ended September 30, 2024 compared to
$0.8 million for the same period in 2023. The increase in research
and development expenses during the current year was mainly
attributed to our clinical trial and product development costs.
As of September 30, 2024 the Company had cash of
$5.2 million.
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 platform system technology includes a
catheter-based microchip sensing array that may have 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 this technology for
the treatment of pain, with initial trials focused on pancreatic
cancer, a condition that causes debilitating pain and is without a
reliable solution. Our technology constitutes a platform to address
dozens of indications, including cardiology, hypertension and
chronic pain management, across a wide disease spectrum. Our
technology is investigational and has not yet been cleared for
marketing in the United States.
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 events set forth in the section
“Expected Upcoming Milestones”, the potential of the technology to
treat pain associated with pancreatic cancer, to successfully
enroll patients within the specific timeframe, and to complete its
clinical study in pancreatic cancer pain. Such forward-looking
statements can be identified by the use of words such as “should,”
“might,” “may,” “intends,” “anticipates,” “believes,” “estimates,”
“projects,” “forecasts,” “expects,” “plans,” and “proposes.”
Although 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 Annual Report on Form 10-K filed with
the U.S. Securities and Exchange Commission (“SEC”) on May 31,
2024, and from time to time, our other filings with the 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 ContactJTC Team, LLCJenene
Thomas908-824-0775autonomix@jtcir.com
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