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 $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 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, LLCJenene
Thomas833-475-8247autonomix@jtcir.com
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