Full Press Release Details
Reports Second Quarter Fiscal Year 2025 Financial Results; Gross Margin Improves Significantly YoY to 55.6%
Filed 510(k)Submission with FDA for OneRF
Trigeminal Nerve Ablation System to Treat Facial Pain Ahead of Schedule
Company Fully Funded
Through at Least Fiscal Year 2026 Following Oversubscribed $8.2 Million Capital Raise
EDEN PRAIRIE, Minn., May 13, 2025 -- NeuroOne Medical Technologies
Corporation (Nasdaq: NMTC) ("NeuroOne" or the "Company"), a medical technology company dedicated to transforming
the surgical diagnosis and treatment of neurological disorders, has reported financial results for the second quarter of fiscal year 2025
ended March 31, 2025.
Recent Company Highlights
Management Commentary
"The second quarter of fiscal 2025 was highlighted by our significant
operational progress with our commercial OneRF Ablation System technology platform, which is increasingly being validated
as a versatile and scalable platform across multiple applications," said Dave Rosa, CEO of NeuroOne. "Not only did we continue
to have clinical success with patients who are remaining seizure free after being treated with our system, but we also successfully filed
our 510(k) submission to the FDA for the OneRF Trigeminal Nerve Ablation System to treat facial pain well ahead of schedule.
"We believe there is a potential to generate revenues from trigeminal
nerve ablation as soon as late calendar year 2025 if cleared by the FDA. Building upon this momentum, we are in discussions with a number
of top-tier strategic partners for other applications leveraging our patented OneRF System, including spinal cord nerve
ablation and spinal cord stimulation for back pain management, and the sEEG-Based drug delivery program.
"To execute on these opportunities, we successfully completed
an oversubscribed capital raise with institutional investors totaling $8.2 million in net proceeds, which we believe will fully fund us
through at least the end of fiscal year 2026, based on Zimmer making the minimum purchase requirements set forth in our expanded agreement.
In fact, if we achieve some of the key milestones currently in progress, this capital could bring us to cash flow breakeven and support
our long-term growth plans with no need for additional dilutive financing."
"Today, we stand as a larger, more mature company than ever before
as we focus on significantly ramping revenues and expanding our product margins. We have a world class strategic partner, the necessary
capital to execute on our strategic growth initiatives and several upcoming milestones that present significant opportunities to grow
shareholder value," concluded Rosa.
OneRF Ablation System:
Trigeminal Nerve Ablation System:
Spinal Cord Stimulation (SCS) Percutaneous Paddle Lead Program:
sEEG-Based Drug Delivery Program:
Outside the U.S. (OUS) Distribution
Second Quarter Financial Results
Product revenue was $1.4 million in
the second quarter of fiscal 2025, compared to product revenue of $1.4 million in the same quarter of the prior year. For
the first six months of fiscal 2025, product revenue increased 98% to $4.7 million, compared to $2.4 million for the same period in fiscal
2024. The Company also had license revenue of $3.0 million in the first six months of fiscal 2025 which is not included in product
revenue, compared to no license revenue in the first six months of fiscal 2024. License revenue in fiscal 2025 was derived from the expanded
exclusive distribution agreement with Zimmer.
Product gross profit increased significantly
to $0.8 million, or 55.6% of revenue, in the second quarter of fiscal 2025, compared to product gross profit of $0.4 million, or 28.3%
of revenue in the same quarter of the prior year. For the first six months of fiscal 2025, product
gross profit increased significantly to $2.7 million, or 57.9% of revenue, compared to product gross profit of $0.7 million, or 27.9%
of revenue in the first six months of fiscal 2024.
Total operating expenses were $3.5 million
in the second quarter of fiscal 2025, compared to $3.3 million in the same quarter of the prior year. R&D expense in the
second quarter of fiscal 2025 was $1.5 million, compared with $1.3 million in the same quarter of the prior year.
SG&A expense in the second quarter of fiscal 2025 was $1.9 million, compared to $2.0 million in the same quarter
of the prior year. For the first six months of fiscal 2025, total operating expenses decreased 4% to $6.7
million, compared to $6.9 million in the same period of fiscal 2024. R&D expense in the first six months of fiscal
2025 decreased 3% to $2.7 million, compared to $2.8 million in the same period of fiscal 2024. SG&A expense in
the first six months of fiscal 2025 decreased 5% to $4.0 million, compared to $4.2 million in the prior year period.
Net loss in the second quarter of fiscal 2025
improved to $2.3 million, or ($0.07) per share, compared to a net loss of $2.9 million, or $(0.11) per share, in the same quarter
of the prior year. Net loss for the first six months of fiscal 2025 improved significantly to $0.5 million,
or $(0.02) per share, compared with $6.2 million, or $(0.25) per share, in the same period of fiscal 2024.
As of March 31, 2025, the Company had
cash and cash equivalents of $1.3 million, compared to $1.4 million as of September 30, 2024. The Company had working
capital of $2.0 million as of March 31, 2025, compared to working capital of $2.4 million as of September 30, 2024. The Company had no
debt outstanding as of March 31, 2025.
In the second quarter of fiscal 2025, the
Company sold common stock under the ATM Program at an average price of $1.16 per share, from which the Company received net proceeds of
$0.3 million. In April 2025, the Company completed an oversubscribed capital raise with institutional investors totaling $8.2 million
in net proceeds and eliminated all availability under the ATM program.
Full Fiscal Year 2025 Financial Guidance
The Company continues to expect product revenue for fiscal year 2025
to range between $8.0 million and $10.0 million, representing an increase of between 132% and 190% when compared to product revenue of
$3.5 million in fiscal year 2024. The Company continues to expect product gross margin in fiscal year 2025 to range between 47% and 51%,
compared to product gross margin of 31% in fiscal year 2024.
Conference Call and Webcast
Management will host an investor conference call and webcast today,
Tuesday, May 13, 2025, at 8:30 a.m. Eastern time to discuss the Company's second quarter fiscal year 2025 financial results, provide
a corporate update, and conclude with Q&A from telephone participants. To participate, please use the following information:
Date: Tuesday, May 13, 2025
Time: 8:30 a.m. Eastern time
U.S. Dial-In (Toll Free): 888-506-0062
International Dial-In: 973-528-0011
Participant Access Code: 655933
Webcast: 2Q25 Webcast Link
Please join at least five minutes before the start of the call to ensure
timely participation.
A playback of the call will be available through Tuesday, May 27, 2025.
To listen, please call 877-481-4010 within the United States or 919-882-2331 when calling internationally, using replay passcode 52404.
A webcast replay will also be available using the webcast link above through May 27, 2025.
NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) is developing
and commercializing minimally invasive and hi-definition solutions for EEG recording, brain stimulation and ablation solutions for patients
suffering from epilepsy, Parkinson's disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related
neurological disorders that may improve patient outcomes and reduce procedural costs. The Company may also pursue applications for other
areas such as depression, mood disorders, pain, incontinence, high blood pressure, and artificial intelligence. For more information,
Forward Looking Statements
This press release may include forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.
Except for statements of historical fact, any information contained in this press release may be a forward-looking statement that
reflects NeuroOne's current views about future events and are subject to known and unknown risks, uncertainties and other factors
that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed
or implied by these forward-looking statements. In some cases, you can identify forward-looking statements by the words or phrases
"may," "might," "will," "could," "would," "should," "expect,"
"intend," "plan," "forecasts," "objective," "anticipate," "believe,"