NeuroOne Medical Technologies Corporation (NASDAQ: NMTC)
(“NeuroOne” or the “Company”), a medical technology company focused
on improving surgical care options and outcomes for patients
suffering from neurological disorders, today announces its
operating results for the first quarter fiscal year 2024 ended
December 31, 2023.
First Quarter Fiscal Year 2024 and
Recent Business UpdatesFinancial Highlights:
- Product revenue
of $978,000 in Q1 2024, compared to $115,000 in Q1
2023
- Raised an additional $2.8 million
using the ATM Offering in December 2023 and January 2024
Evo® sEEG:
- Customer feedback remains positive
as commercial launch expands with new accounts
- Product exhibited at annual meeting
of American Epilepsy Society (AES) in December 2023
- Completed full sales force training
for Zimmer Biomet personnel in January 2024
OneRF™ Ablation System:
- Received FDA 510(k) clearance in
December 2023 to market the OneRF™ Ablation System for creation of
radiofrequency lesions in nervous tissue for functional
neurosurgical procedures
- Placed component orders for OneRF™
Ablation System and began preparing for pending product launch
targeted in the second calendar quarter of 2024.
- Submitted an ICD-10-PCS hospital
inpatient code application to the Centers for Medicare and Medicaid
Services (CMS) for the OneRF™ ablation procedure, to support
accurate data collection and processing of reimbursement claims by
hospitals for the ablation procedure
- Presented posters on pre-clinical
experience with OneRF™ Ablation System at the Society for
Neuroscience (SFN) and the AES annual meetings
Drug Delivery Program:
- Completed feasibility bench top
testing and animal study demonstrating the ability to deliver a
therapy and provide recording capabilities using the sEEG drug
delivery system.
- Continued discussions with
potential strategic partners for use in clinical studies and
research
Spinal Cord Stimulation Program:
- Completed preclinical study of the
first acute electrophysiology experiment with NeuroOne’s lead in a
sheep model
- Presented poster on pre-clinical
experience with thin-film paddle leads at North American
Neuromodulation Society (NANS) in January 2024
Dave Rosa, CEO of NeuroOne, commented, “We are
very pleased with our results this quarter, highlighted by reaching
a milestone achievement with FDA clearance of our OneRF™ Ablation
System. This represents the Company’s third product family to be
cleared by the FDA and the Company’s first combination device that
has an indication for both recording electrical activity and
ablation of nervous tissue. We are very excited to be the first to
market this novel technology in the United States and are preparing
to initiate a limited commercial launch of the OneRF™ Ablation
System in the second quarter of calendar year 2024. We believe the
OneRF™ Ablation System, with combination diagnostic and therapeutic
functionality, has the capability to create a paradigm shift in
neurosurgical procedures. We are also pleased with the continued
expansion of Zimmer Biomet’s launch of the Evo SEEG electrode and
the related increase in revenue over past quarters. We expect this
trend to continue with the expansion of additional centers. We
believe the launch of the OneRF™ Ablation System will also have a
positive impact on Evo sEEG customer demand. Coupled with the
progress on our drug delivery and spinal cord stimulation programs,
we remain confident in our strategic plan.”
Key Upcoming Milestones
Evo® sEEG:
- Revenue expected to increase with
the addition of new accounts by Zimmer Biomet and with the
introduction of the OneRF™ Ablation System
OneRF™ Ablation System:
- Initiate a limited commercial
launch of the OneRF™ Ablation System in the second quarter of
calendar year 2024
- Continue to explore additional
applications and strategic partnership opportunities for ablation
in neurology and other attractive markets that could benefit from
NeuroOne’s high-resolution, thin-film electrode technology
Drug Delivery Program:
- Refine prototype design and testing
including preclinical in-vivo study
- Continue to identify potential
strategic partners to utilize NeuroOne’s drug delivery device in
clinical studies and research
Spinal Cord Stimulation Program:
- Complete animal study to evaluate
stimulation and battery performance using the Company’s spinal cord
stimulation electrode technology
- Complete cadaver lab with our
Spinal Cord Stimulation Advisory Board to further advance the
development of the percutaneous implantation technique for
NeuroOne’s thin-film paddle electrodes for spinal cord
stimulation
First Quarter Fiscal Year 2024 Financial
Results
Product revenue was $978,000 in the
first quarter of fiscal 2024, compared to product revenue of
$115,000 in the first quarter of fiscal 2023. The Company had
no collaboration revenue in the first quarter of fiscal 2024,
compared to collaboration revenue of $1,455,000 in the first
quarter of fiscal 2023. Collaboration revenue in 2023 was derived
from the Zimmer Development Agreement and represents the portion of
the exclusivity and milestone fee payments eligible for revenue
recognition during the period.
Total operating expenses in the first quarter of
fiscal 2024 were $3.7 million, compared with $3.2
million in the first quarter of fiscal 2023. R&D expense
in the first quarter of fiscal 2024 was $1.5
million compared with $1.6 million in the same
period of fiscal 2023. SG&A expense in the first quarter of
fiscal 2024 was $2.2 million compared with $1.7
million in the first quarter of fiscal 2023.
Net loss was $3.3 million for the
first quarter of fiscal 2024, compared to a net loss of $1.7
million in the first quarter of fiscal 2023.
In December 2023, the Company sold common stock
under the ATM Offering at an average price of $1.45 per share, from
which the Company received net proceeds of $1.2 million.
As of December 31, 2023, the Company had
cash, cash equivalents, and short-term investments of $2.7
million, compared to $5.3 million as of September
30, 2023. The Company had working capital of $3.7 million as of
December 31, 2023, compared to working capital of $5.5 million as
of September 30, 2023.
The Company had no debt outstanding as
of December 31, 2023.
Conference Call and Webcast
Tuesday, February 13, 2024 – 4:30 PM Eastern
Time
Participant Dial-In:888-506-0062 / +1
973-528-0011
Access Code: 540724
Live Webcast: Join
here.
Phone Replay: 877-481-4010/ +1
919-882-2331Available through February 27, 2024
Webcast
Replay: Available
for 12 months
About NeuroOne
NeuroOne Medical Technologies Corporation is a
developmental stage company committed to providing 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, 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,"
"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 development of the Company's electrode
technology program, applications for, or receipt of, regulatory
clearance, the timing and extent of product launch and
commercialization of our technology, receipt of revenues from sale
of the sEEG electrodes, timing and success of any clinical and
pre-clinical testing, the timing and extent of product launch and
commercialization of our OneRF Ablation System, the potential
capabilities of our OneRF Ablation System, SCS and drug delivery
programs, 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 risks that the partnership
with Zimmer Biomet 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 relate 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.
Contact:
800-631-4030ir@nmtc1.com
NeuroOne Medical Technologies
Corporation Balance Sheets
(unaudited)
|
|
As of December 31, 2023 |
|
|
As of September 30, 2023 |
|
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
2,680,985 |
|
|
$ |
5,322,493 |
|
Accounts receivable |
|
|
543,399 |
|
|
|
— |
|
Inventory |
|
|
1,608,657 |
|
|
|
1,726,686 |
|
Prepaid expenses and other assets |
|
|
259,966 |
|
|
|
263,746 |
|
Total current assets |
|
|
5,093,007 |
|
|
|
7,312,925 |
|
Intangible assets, net |
|
|
83,998 |
|
|
|
89,577 |
|
Right-of-use assets |
|
|
140,198 |
|
|
|
169,059 |
|
Property and equipment, net |
|
|
505,175 |
|
|
|
525,753 |
|
Total assets |
|
$ |
5,822,378 |
|
|
$ |
8,097,314 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
760,000 |
|
|
$ |
685,104 |
|
Accrued expenses and other liabilities |
|
|
623,240 |
|
|
|
1,107,522 |
|
Total current liabilities |
|
|
1,383,240 |
|
|
|
1,792,626 |
|
Operating lease liability, long term |
|
|
20,982 |
|
|
|
55,284 |
|
Total liabilities |
|
|
1,404,222 |
|
|
|
1,847,910 |
|
|
|
|
|
|
|
|
|
|
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;
24,831,090 and 23,928,945 shares issued and outstanding as of
December 31, 2023 and September 30, 2023, respectively. |
|
|
24,831 |
|
|
|
23,929 |
|
Additional paid–in capital |
|
|
70,424,528 |
|
|
|
68,911,778 |
|
Accumulated deficit |
|
|
(66,031,203 |
) |
|
|
(62,686,303 |
) |
Total stockholders’ equity |
|
|
4,418,156 |
|
|
|
6,249,404 |
|
Total liabilities and stockholders’ equity |
|
$ |
5,822,378 |
|
|
$ |
8,097,314 |
|
NeuroOne Medical Technologies
CorporationStatements of Operations
(unaudited)
|
|
For the three months endedDecember 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
Product revenue |
|
$ |
977,649 |
|
|
$ |
114,579 |
|
Cost of product revenue |
|
|
711,335 |
|
|
|
126,886 |
|
Product gross profit (loss) |
|
|
266,314 |
|
|
|
(12,307 |
) |
|
|
|
|
|
|
|
|
|
Collaborations revenue |
|
|
— |
|
|
|
1,455,188 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
2,173,472 |
|
|
|
1,663,737 |
|
Research and development |
|
|
1,483,317 |
|
|
|
1,563,496 |
|
Total operating expenses |
|
|
3,656,789 |
|
|
|
3,227,233 |
|
Loss from operations |
|
|
(3,390,475 |
) |
|
|
(1,784,352 |
) |
Other income |
|
|
45,575 |
|
|
|
51,583 |
|
Loss before income taxes |
|
|
(3,344,900 |
) |
|
|
(1,732,769 |
) |
Provision for income
taxes |
|
|
— |
|
|
|
— |
|
Net loss |
|
$ |
(3,344,900 |
) |
|
$ |
(1,732,769 |
) |
Net loss per share: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.14 |
) |
|
$ |
(0.11 |
) |
Number of shares used in per
share calculations: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
23,995,610 |
|
|
|
16,230,997 |
|
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