Full Press Release Details
NeuroOne Reports Fiscal
Q1 2026 Financial Results; Expects
Product Revenue of At Least $10.5 Million in Fiscal Year 2026
Nearly 50% of all Ablations
Since OneRF Ablation System Product Launch in 2024
were Performed in Fiscal Q1 2026, Showing Growing Adoption
Following FDA 510(k)
Clearance, Successfully Completed Nine Trigeminal Neuralgia
Cases to Date, with All Patients Reportedly Pain Free*
Conference Call Today at 8:30 a.m. Eastern Time
EDEN PRAIRIE, Minn., February 17, 2026 --
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 and a business
update for the first quarter of fiscal year 2026 ended December 31, 2025.
Management Commentary
"The momentum we established in fiscal 2025
has accelerated into the first quarter, with progress across all target markets leveraging our OneRF platform technology,"
said Dave Rosa, CEO of NeuroOne. "With a record number of ablations performed in the first quarter of fiscal 2026, we've demonstrated
the continued expansion and real-world benefits of our technology. Following our FDA 510(k) clearance to treat facial pain in August,
we successfully completed our first nine cases, with all patients reportedly pain free*. In addition, we scheduled chronic animal studies
to start next quarter for our percutaneous paddle electrode system for lower back pain, confirmed the validity of our basivertebral nerve
ablation system for lower back pain and expect to be commercial-ready for our drug delivery system to be used in investigational clinical
studies or animal studies by the end of the third quarter of fiscal 2026."
"With several new markets targeted, we have
also advanced discussions with a number of potential tier-one strategic partners to accelerate our growth. Today, we are more confident
than ever in our ability to deliver technologies that offer both patient and physician benefits compared to competing systems. As of today,
we expect product revenue in fiscal year 2026 to be at least $10.5 million, representing an increase of at least 17% when compared to
fiscal year 2025," concluded Rosa.
Operational Highlights and Updates
sEEG-Based Drug Delivery Program:
OneRF Ablation System in the Brain:
OneRF Trigeminal Nerve Ablation System:
Spinal Cord Stimulation Percutaneous Paddle
Basivertebral Nerve Ablation
First Quarter Fiscal 2026 Financial Results
Product revenue was $2.9 million in the first
quarter of fiscal 2026, compared to product revenue of $3.3 million in the first quarter of fiscal 2025. The slight decrease was due to
the initial stocking order from Zimmer, which occurred in the first quarter of fiscal 2025. On a sequential basis, product revenue increased
5.5%, compared to $2.7 million in the fourth quarter of fiscal 2025. The Company had no license revenue in the first quarter of fiscal
2026, compared to license revenue of $3.0 million in the first quarter of fiscal 2025, which was derived from the expanded exclusive distribution
agreement with Zimmer.
Product gross profit
was $1.6 million, or 54.2% of revenue, in the first quarter of fiscal 2026, compared to product gross profit of $1.9 million, or 58.9%
of revenue, in the same quarter of the prior fiscal year. On a sequential basis, product gross profit increased 2.6%, compared to $1.5
million in the fourth quarter of fiscal 2025.
Total operating expenses
were $3.3 million in the first quarter of fiscal 2026, compared to $3.2 million in the same quarter of the prior year. Research &
Development expense in the first quarter of fiscal 2026 was $1.4 million, compared to $1.2 million in the same quarter of the prior year.
Selling, General & Administrative expense in the first quarter of fiscal 2026 decreased 7.7% to $1.9 million, compared to $2.0 million
in the same quarter of the prior year.
Net loss in the first
quarter of fiscal 2026 was $1.4 million, or ($0.03) per share, compared to net income of $1.8 million, or $0.06 per share, in the same
quarter of the prior year. Net income in the first quarter of fiscal 2025 included license revenue of $3.0 million related to the distribution
license granted to Zimmer for the OneRF brain ablation system in October 2024.
As of December 31, 2025,
the Company had cash and cash equivalents of $3.6 million, compared to $6.6 million as of September 30, 2025. Of note, NeuroOne believes
it is funded through fiscal 2026, potentially longer if certain milestones are hit.
The Company had working
capital of $6.8 million as of December 31, 2025, compared to working capital of $7.9 million as of September 30, 2025. The Company had
no debt outstanding as of December 31, 2025.
Conference Call and Webcast
Management will host an investor conference call
and webcast today, Tuesday, February 17, 2026, at 8:30 a.m. Eastern time to discuss the Company's first quarter fiscal 2026 financial
results, provide a corporate update, and conclude with Q&A from telephone participants. To participate, please use the following information:
Date: Wednesday, February 17, 2026
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: 393318
Webcast: 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, March 3, 2026. To listen, please call 877-481-4010 within the United States or 919-882-2331 when calling internationally, using
replay passcode 53566. A webcast replay will also be available using the webcast link above through Tuesday, March 3, 2026.
NeuroOne Medical Technologies Corporation is a
medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders.
NeuroOne markets a minimally invasive and high-definition/high-precision electrode technology platform with four FDA-cleared product families:
Evo Cortical Electrodes, Evo sEEG Electrodes, OneRF Ablation System (for brain), and OneRF Trigeminal Nerve Ablation
System. These solutions offer the potential to reduce the number of hospitalizations and surgical procedures, lower costs, and improve
patient outcomes by offering combination diagnostic and therapeutic functions. The Company is engaged in research and development for
drug delivery and spinal cord stimulation programs. For more information, visit nmtc1.com.
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," "estimate," "predict," "project," "potential," "target,"
"seek," "contemplate," "continue, "focused on," "committed to" and "ongoing,"
or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward-looking
statements may include statements regarding the Company's 2026 revenue guidance; the continued development of the Company's
electrode technology program (including its drug delivery program, Basivertebral Nerve Ablation System and spinal cord stimulation program);
business strategy, market size, potential growth opportunities, future operations, future efficiencies, and other financial and operating
information. Although NeuroOne believes that we have a reasonable basis for each forward-looking statement, we caution you that these
statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot
be certain. Our actual future results may be materially different from what we expect due to factors largely outside our control, including