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, today reported financial
results for the fiscal year 2024 ended March 31, 2024 and provided
a corporate update.
Recent Highlights
- Completed its initial public
offering (IPO) of common stock. The Company raised gross proceeds
of $11.2 million and net proceeds of $9.8 million;
- Completed site initiation for its
PoC human clinical study evaluating the use of transvascular RF
ablation for the treatment of pancreatic cancer pain;
- Entered into a clinical site
agreement with “АКFА MEDLINE” Ltd., for its PoC human clinical
trial evaluating the use of transvascular RF ablation for the
treatment of pancreatic cancer pain;
- Commenced enrollment and announced
the safe completion of the first three patient procedures for its
PoC human clinical trial evaluating the use of transvascular RF
ablation for the treatment of pancreatic cancer pain;
- Appointed Jennifer Cook as Chief
Business Officer;
- Announced successful results from
an animal study evaluating the Company’s proprietary catheter-based
sensing technology for use in the renal artery;
- Announced issuance of U.S. patent
covering proprietary catheter-based technology for the treatment of
cancer related pain;
- Entered into a service agreement
with NoiseFigure Research, Inc. (NFR), a premier application
specific integrated circuits (ASICs) service provider to develop
next generation of its proprietary microchip; and
- Announced the successful completion
of an animal study evaluating the ability of targeted nerve
ablation to impact tumor metastases. Results from the preclinical
study demonstrated statistically significant reduction of
metastases and statistically significant reduction in tumor
mass.
“I am incredibly pleased with the progress we
have made on the corporate, financial and clinical fronts over the
course of our fiscal year 2024. We are grateful for the continued
support and remain focused on successfully executing on the
milestones laid out ahead of us. We continue to make promising
progress in our PoC human clinical study and look forward to
announcing topline data from the first patients in the near
future,” commented Lori Bisson, Chief Executive Officer of
Autonomix. “We remain steadfast in our belief 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
are committed to continuing our clinical execution with excellence
and are poised for an exciting remainder of the 2024 calendar
year.”
The Company’s catheter-based sensing 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, may provide only limited relief and 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
- Q2 CY2024: Announce topline results
from first five patients in human clinical study evaluating the use
of transvascular RF ablation for the treatment of pancreatic cancer
pain;
- CY2024: Complete ablation device
design intended for clinical use;
- CY2025: Complete development of
ablation system and sensing catheter in preparation for human
pivotal trial;
- CY2025: Launch combined sensing /
ablation clinical trial;
- CY2026: De novo submission;
and
- CY2027: FDA clearance.
Summary of Financial Results for Fiscal Year 2024 Ended
March 31, 2024
For the fiscal year ended March 31, 2024 the
Company incurred net losses of $15.4 million compared to $2.0
million for the same period in 2023. The net losses for 2024
included a non-cash loss of $8.0 million on warrants noted
below.
General and administrative (G&A) expenses
were $5.2 million and $1.2 million for the fiscal years ended March
31, 2024 and 2023, respectively. The $4.0 million increase in
G&A expenses was primiarly due to increases in advertising of
$1.7 million related to the Company’s IPO, officer and employee
compensation and benefits of $0.7 million as the Company expanded
its headcount in anticipation of its IPO, $0.6 million in
stock-based compensation and $1.0 million for professional, legal,
travel and insurance expenses.
Research and development expenses were $2.2
million and $0.7 million for the fiscal years ended March 31, 2024
and 2023, respectively. The increase of $1.5 million was primarily
due to the Company’s clinical trial execution and product
development costs.
Warrant expenses were non-cash of $4.6 million
and $3.4 million relating to a license termination agreement and
the corresponding mark-to-market adjustments required on the
license termination agreement for the fiscal year ended March 31,
2024.
As of March 31, 2024 the Company had cash of
$8.6 million. 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 that was subsequently received in May
2024.
The Company estimates its current cash resources
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 technology for
pancreatic cancer pain, a condition that causes debilitating pain
and is without an effective solution. Our technology constitutes a
platform to address dozens of indications, including cardiology,
hypertension 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 milestones set forth in the
section “Expected Upcoming Milestones” above, the potential of the
Company’s technology to treat hypertension 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 offering circular filed with the U.S.
Securities and Exchange Commission (“SEC”) on January 26, 2024.
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
Thomas833-475-8247autonomix@jtcir.com
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