Exhibit
99.1
NeuroOne® Reports
Fiscal Q3 2026 Financial Results, Revenues Increase 16% YoY to $2.0 Million; Gross Margins Expand to 59.9%
$2.7 Million in Product
Orders Outpace Shipments of $2.0 Million
Company Has Received
Product Orders for Fiscal Year 2026 of $11.2 Million; Working with Suppliers to Maximize Product Shipments Through End of Fiscal Year
Received ISO 13485
Certification Ahead of Schedule; International Expansion Planned
StereoCED™ Drug
Delivery System Expected to be Available for Research and Investigational Clinical Studies by the End of Fiscal Year 2026
Management to Host
Conference Call at 8:30 a.m. Eastern Time Today
EDEN PRAIRIE, Minn., August 13, 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 provided
a business update for the third quarter of fiscal year 2026 ended June 30, 2026.
FY Q3 2026 Financial Highlights
| ● | Product revenue increased 16% to $2.0 million,
compared to $1.7 million in the same year-ago period. |
| ● | The
Company received $2.7 million of new product orders to ship during the quarter, representing
43% growth in product orders year over year. Product orders exceeded recognized revenue during the quarter
with backlog of $1.7 million as of June 30, 2026. |
| | | |
| ● | The
Company has received product orders of $11.2 million for fiscal year 2026. Recognized revenue
is expected to range from $9.2 million to $10.5 million depending primarily on manufacturing
completion and timing of shipments, with any unshipped orders contributing to backlog. The
Company is working closely with manufacturing partners to maximize shipments. |
| ● | Product
gross profit increased 29% to $1.2 million, compared to $0.9 million in the same year-ago
quarter. |
| ● | Product
gross margins increased to 59.9%, compared to 53.9% in the same year-ago quarter. |
| ● | Subsequent to quarter end, our
lead investor increased ownership of NeuroOne’s outstanding common stock from 7.4% to 12.5%. |
Recent
Operational Highlights
| ● | The
Company received ISO 13485:2016 Certification enabling the Company to commercialize across
different countries. Geographies may have additional requirements to gain commercial access,
although this is a major achievement signaling that the Company follows an internationally
recognized quality management system that will provide near term commercial opportunities
to help grow product revenues. |
| ● | The
Journal of Neurosurgery published an article by the Mayo Clinic in Jacksonville, Florida
titled, “Stereo-electroencephalography–guided radiofrequency thermocoagulation
in patients with implanted neuromodulation devices: patient series” which evaluated
the use of NeuroOne’s OneRF® Brain Ablation System in patients who have
implanted neuromodulation devices. The article concluded that these procedures may be performed
without interfering with existing hardware as well as providing meaningful seizure reduction.
This expands the pool of treatable patients to include those with existing neuromodulation
implants. |
| ● | NeuroOne
expects its StereoCED™ platform to be available by the end of fiscal year 2026 for
animal research and FDA IDE approved studies. In advance of this, the Company released a
breakthrough white paper titled “StereoCED™ - A Scalable Platform for CNS Drug
Delivery” – highlighting how its drug delivery platform leverages robotic stereotactic
systems already established in neurosurgical operating rooms and has the potential to significantly
reduce procedure time while addressing key barriers to the scalable commercial delivery of
brain therapeutics. The white paper comes at a pivotal time, as the first potential blockbuster
intraparenchymal brain-delivered therapy could receive FDA approval as early as 2027. |
| ● | Expanded
drug delivery program through collaboration with Mayo Clinic supporting a newly funded research
program by CURE Childhood Cancer to evaluate a novel treatment approach for pediatric diffuse
midline glioma (DMG), one of the most aggressive and difficult-to-treat childhood brain cancers.
The study will utilize NeuroOne’s StereoCED™ drug delivery platform, which combines
precision intracranial drug delivery with a simultaneous neural recording, offering investigators
additional insight into both drug delivery and the effects on the surrounding neural environment.
|
| ● | Advanced
brain drug delivery platform through collaboration with University of Minnesota to advance
a study evaluating next-generation epilepsy therapies using NeuroOne’s StereoCED™
drug delivery platform. The study is designed to test novel therapeutics delivered locally
into specific brain regions involved in sustaining seizures with the goal of improving clinical
efficacy and lowering systemic toxicity and off-target effects. |
| ● | Advanced
discussions underway with a tier-one potential strategic partner to develop and supply the
access tools for our basivertebral nerve ablation system to treat lower back pain. |
| ● | The
Company was added to the Russell Microcap Index as part of the semi-annual June 2026 reconstitution
of the Russell US Indexes. |
Management
Commentary
“This
quarter marked another period of revenue growth compared to 2025, with product revenue increasing 16% year-over-year to $2.0
million,” said Dave Rosa, CEO of NeuroOne. “Importantly, this growth is improving margins – product gross margins
reached a record 59.9%, driven by a 29% increase in product gross profit to $1.2 million compared to the prior year period. Even more encouraging is that new product
orders of $2.7 million during the quarter meaningfully outpaced revenue recognized during the quarter, growing our backlog to $1.7
million.
“Looking
at the rest of the fiscal year, there’s a lot to be excited about: the launch of our StereoCED™ drug delivery platform for
investigational and animal studies, continued growth of the OneRF® Brain Ablation System, onboarding independent distributor reps
for the OneRF® Trigeminal Nerve Ablation System, selecting a partner for our basivertebral nerve ablation access tools, and planning
for international expansion. In total, we continue to make meaningful progress with our technology platform across all verticals while
adding to the patient success stories for those who are treated with our technology. This is our driving motivation.”
Summary
of NeuroOne Therapies
OneRF®
Trigeminal Nerve Ablation System:
| ● | Scheduling
evaluations at new centers based on interest generated at the American Society for Stereotactic
and Functional Neurosurgery Biennial Meeting this past June. |
| | | |
| ● | Interviewed
distributors to expand commercialization efforts to support a direct regional sales distribution
model. |
SteroeCED™
Drug Delivery Program:
| ● | White
paper released discussing potential benefits of the system. |
| | | |
| ● | Preparing
for launch of animal research studies and FDA approved IDE gene and/or cell therapies by
the end of fiscal year 2026. |
| | | |
| ● | Selected
by the Mayo Clinic in Rochester, Minnesota to supply devices for a study to treat a form
of pediatric glioblastomas (brain tumors). |
| | | |
| ● | Selected
by the University of Minnesota to supply devices for a study to treat drug resistant epilepsy. |
Basivertebral
Nerve Ablation:
| ● | Regulatory
strategy complete; expected FDA 510(k) pathway. |
| | | |
| ● | In
discussions with potential partner to develop access tools for system. |
| | | |
| ● | Device
optimization for target lesion size in process. |
OneRF®
Ablation System in the Brain:
| ● | ISO
13485 certification received in August 2026. This will allow the Company to selectively target
international markets. |
| | | |
| ● | Expect
to enroll first patient by the end of September for the brain ablation post-market registry,
with five centers currently participating. |
| | | |
| ● | The
Journal of Neurosurgery published an article by the Mayo Clinic in Jacksonville, Florida
titled: “Stereo-electroencephalography–guided radiofrequency thermocoagulation
in patients with implanted neuromodulation devices: patient series” which evaluated
the use of NeuroOne’s OneRF® Brain Ablation System in patients who have implanted
neuromodulation devices. |
Third
Quarter Fiscal 2026 Financial Results
Product
revenue increased to $2.0 million in the third quarter of fiscal 2026, a 16% increase compared to $1.7 million in the same year-ago quarter.
The increase was primarily driven by higher sales of OneRF® Products.
Product
gross profit increased 29% to $1.2 million, driving a product gross margin expansion to a record 59.9% in the third quarter of fiscal
2026, compared to $0.9 million, or 53.9%, in the same year-ago quarter. This 6.0 percentage point increase reflects a more favorable
sales mix toward higher margin products.
Total
operating expenses were $3.6 million in the third quarter of fiscal 2026, compared to $2.8 million in the same year-ago quarter. Selling,
General & Administrative expenses were $2.2 million, compared to $1.6 million as a result of increased headcount, sales and marketing
costs, professional fees and other operating costs in the same year-ago quarter. Research & Development expenses were $1.4 million,
compared to $1.2 million in the same year-ago quarter, reflecting the timing of product development activities.
Net
loss in the third quarter of fiscal 2026 was $2.0 million, or ($0.23) per basic share and ($0.28) per diluted share, compared to net
loss of $1.5 million, or ($0.19) per basic share and ($0.19) per diluted share, in the prior-year quarter.
As
of June 30, 2026, cash and cash equivalents totaled $2.0 million, compared to $6.6 million as of September 30, 2025. Accounts receivable
were $1.1 million as of June 30, 2026, compared to $1.3 million as of September 30, 2025, and inventory, net was $2.3 million as of June
30, 2026, compared to $2.2 million as of September 30, 2025. During the third quarter of fiscal 2026, the Company raised $0.4 million
through its at-the-market offering program. Through June 30, 2026, the Company raised gross proceeds of $8.4 million under the at-the-market (“ATM”) program.
Subsequent to quarter-end, on July 13, 2026, the Company raised another $1.0 million through the issuance of 400,346 shares under the
ATM program representing the second time in calendar 2026 the ATM was utilized.
The
Company had working capital of $3.7 million as of June 30, 2026, compared to working capital of $7.9 million as of September 30, 2025.
The Company had no debt outstanding as of June 30, 2026.
All
share and per share amounts in this release have been retroactively adjusted to reflect the one-for-six reverse stock split of the Company’s
issued and outstanding common stock, which began trading on a split-adjusted basis on The Nasdaq Capital Market on April 16, 2026.
Conference
Call and Webcast
Management
will host an investor conference call and webcast today, Thursday, August 13, 2026, at 8:30 a.m. Eastern time to discuss the Company’s
fiscal third quarter 2026 financial results, provide a corporate update, and conclude with Q&A from telephone participants. To participate,
please use the following information:
Date:
Thursday, August 13, 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: 549778
Webcast:
NMTC FY Q3 2026 Earnings Call Webcast
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 Thursday, August 27, 2026. To listen to the replay, please call 877-481-4010 within the
United States or 919-882-2331 when calling internationally, using replay passcode 54304. A webcast replay will also be available using
the webcast link above through August 13, 2027.
About
NeuroOne
NeuroOne
Medical Technologies Corporation (NASDAQ: NMTC) 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 diagnostic and therapeutic functions. The Company is engaged
in research and development for drug delivery, basivertebral nerve ablation and spinal cord stimulation programs. For more information,
please 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 potential sales of the StereoCEDTM drug
delivery platform in investigational clinical studies or animals in Q4 fiscal 2026, 2026 guidance, the collaborations with the
University of Minnesota and other companies, our ability to expand internationally, our ability to ship back-ordered product, our
ability to expand the sales of our OneRF® Trigeminal Nerve Ablation System, our and the Company’s ability to expand
revenue. 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 risks related to whether the Company will continue to maintain compliance with all Nasdaq continued listing
requirements, risks that our strategic partnerships may not facilitate the commercialization or market acceptance of our technology
whether due to supply chain disruptions, labor shortages or otherwise risks that our technology will not perform as expected based
on results of our pre-clinical and clinical trials risks related to uncertainties associated with the Company’s capital
requirements to achieve its business objectives and ability to raise additional funds: the risk that we may not be able to secure or
retain coverage or adequate reimbursement for our technology uncertainties inherent in the development process of our technology
risks related to changes in regulatory requirements or decisions of regulatory authorities that we may not have accurately estimated
the size and growth potential of the markets for our technology risks related to clinical trial patient enrollment and the results
of clinical trials that we may be unable to protect our intellectual property rights and other risks, uncertainties and assumptions,
including those described under the heading “Risk Factors” in our filings with the Securities and Exchange Commission.
These forward looking statements speak only as of the date of this press release and NeuroOne undertakes no obligation to revise or
update any forward looking statements for any reason, even if new information becomes available in the future.
Caution:
Federal law restricts this device to sale by or on the order of a physician.
| * | Disclaimer:
This recounts several patients’ experiences and may not be representative of all patient outcomes. |
IR
Contact
MZ
Group – MZ North America
NMTC@mzgroup.us
NeuroOne
Medical Technologies Corporation
Condensed
Balance Sheets
| | |
As
of | |
| | |
June
30, | | |
September
30, | |
| | |
2026 | | |
2025 | |
| | |
(Unaudited) | | |
| |
| Assets | |
| | |
| |
| Current
assets: | |
| | | |
| | |
| Cash
and cash equivalents | |
$ | 2,047,596 | | |
$ | 6,570,382 | |
| Accounts
receivable | |
| 1,098,965 | | |
| 1,264,805 | |
| Inventory,
net | |
| 2,290,254 | | |
| 2,226,805 | |
| Deferred
offering costs | |
| 33,046 | | |
| 22,920 | |
| Prepaid
expenses | |
| 318,940 | | |
| 141,372 | |
| Total
current assets | |
| 5,788,801 | | |
| 10,226,284 | |
| Intangible
assets, net | |
| 28,210 | | |
| 44,946 | |
| Right-of-use
asset | |
| 166,751 | | |
| 255,195 | |
| Property
and equipment, net | |
| 202,333 | | |
| 259,222 | |
| Total
assets | |
$ | 6,186,095 | | |
$ | 10,785,647 | |
| | |
| | | |
| | |
| Liabilities
and Stockholders’ Equity | |
| | | |
| | |
| Current
liabilities: | |
| | | |
| | |
| Accounts
payable | |
$ | 905,716 | | |
$ | 1,010,369 | |
| Accrued
expenses and other liabilities | |
| 1,135,711 | | |
| 1,292,714 | |
| Total
current liabilities | |
| 2,041,427 | | |
| 2,303,083 | |
| Warrant
liability | |
| 303,805 | | |
| 1,266,894 | |
| Operating
lease liability, long term | |
| 73,320 | | |
| 143,148 | |
| Total
liabilities | |
| 2,418,552 | | |
| 3,713,125 | |
| | |
| | | |
| | |
| Commitments
and contingencies (Note 4) | |
| | | |
| | |
| | |
| | | |
| | |
| Stockholders’
equity: | |
| | | |
| | |
| Preferred
stock, $0.001 par value; 10,000,000 shares authorized; no shares issued or outstanding. | |
| — | | |
| — | |
| Common
stock, $0.001 par value; 100,000,000 shares authorized; 8,702,982 and 8,334,336 shares issued and outstanding as of June 30, 2026
and September 30, 2025, respectively. | |
| 8,703 | | |
| 8,334 | |
| Additional
paid–in capital | |
| 88,194,870 | | |
| 85,673,975 | |
| Accumulated
deficit | |
| (84,436,030 | ) | |
| (78,609,787 | ) |
| Total
stockholders’ equity | |
| 3,767,543 | | |
| 7,072,522 | |
| Total
liabilities and stockholders’ equity | |
$ | 6,186,095 | | |
$ | 10,785,647 | |
NeuroOne
Medical Technologies Corporation
Condensed
Statements of Operations
(unaudited)
| | |
For
the Three Months Ended June 30, | | |
For
the Nine Months Ended June 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| Product
revenue | |
$ | 1,973,105 | | |
$ | 1,696,050 | | |
$ | 6,727,790 | | |
$ | 6,356,767 | |
| Cost
of product revenue | |
| 790,496 | | |
| 781,215 | | |
| 2,987,089 | | |
| 2,743,982 | |
| Product
gross profit | |
| 1,182,609 | | |
| 914,835 | | |
| 3,740,701 | | |
| 3,612,785 | |
| | |
| | | |
| | | |
| | | |
| | |
| License
revenue | |
| — | | |
| — | | |
| — | | |
| 3,000,000 | |
| | |
| | | |
| | | |
| | | |
| | |
| Operating
expenses: | |
| | | |
| | | |
| | | |
| | |
| Selling,
general and administrative | |
| 2,181,768 | | |
| 1,618,950 | | |
| 5,986,594 | | |
| 5,602,818 | |
| Research
and development | |
| 1,425,153 | | |
| 1,182,485 | | |
| 4,282,923 | | |
| 3,865,376 | |
| Total
operating expenses | |
| 3,606,921 | | |
| 2,801,435 | | |
| 10,269,517 | | |
| 9,468,194 | |
| Loss
from operations | |
| (2,424,312 | ) | |
| (1,886,600 | ) | |
| (6,528,816 | ) | |
| (2,855,409 | ) |
| Fair
value change in warrant liability | |
| 405,702 | | |
| 319,625 | | |
| 620,171 | | |
| 1,099,421 | |
| Financing
costs | |
| — | | |
| (9,325 | ) | |
| — | | |
| (334,063 | ) |
| Other
income | |
| 12,279 | | |
| 75,432 | | |
| 82,402 | | |
| 103,898 | |
| Loss
before income taxes | |
| (2,006,331 | ) | |
| (1,500,868 | ) | |
| (5,826,243 | ) | |
| (1,986,153 | ) |
| Provision
for income taxes | |
| — | | |
| — | | |
| — | | |
| — | |
| Net
loss | |
$ | (2,006,331 | ) | |
$ | (1,500,868 | ) | |
$ | (5,826,243 | ) | |
$ | (1,986,153 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Net
loss per share (Note 3): | |
| | | |
| | | |
| | | |
| | |
| Basic | |
$ | (0.23 | ) | |
$ | (0.19 | ) | |
$ | (0.68 | ) | |
$ | (0.32 | ) |
| Diluted | |
$ | (0.28 | ) | |
$ | (0.19 | ) | |
$ | (0.75 | ) | |
$ | (0.32 | ) |
| Number
of shares used in per share calculations (Note 3): | |
| | | |
| | | |
| | | |
| | |
| Basic | |
| 8,661,624 | | |
| 8,100,603 | | |
| 8,511,313 | | |
| 6,141,509 | |
| Diluted | |
| 8,739,505 | | |
| 8,100,603 | | |
| 8,621,075 | | |
| 6,141,509 | |