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 fiscal fourth quarter and full fiscal
year ended September 30, 2023.
Fiscal Fourth Quarter 2023 and Recent
Business Updates
Financial Highlights:
- Product
revenue of $742,000 in Q4 2023, compared to
$69,000 in Q4 2022
- Product
revenue of $1,952,000 for FY 2023, compared to $171,000 for FY
2022
-
Completed capital raise of $6M in July 2023 with net proceeds of
$5.2M and raised an additional $2.5M using the ATM program at an
average price of $1.77 per share
Evo® sEEG:
- Zimmer
Biomet expanded the launch to new centers as the sites receive
internal approval to evaluate the Evo electrode product line
-
Collected feedback remains positive
- Device
sales and revenue ramp expected to continue quarter by quarter
-
Completed additional sales training for Zimmer Biomet
personnel
OneRF™Ablation System:
- Received
feedback from FDA on 510(k) submission in August 2023 and the
Company responded to FDA questions in November 2023
- Received
FDA clearance for OneRF Ablation System in December 2023
- Placed
component orders for OneRF Ablation System for
commercialization
-
Presented poster on pre-clinical experience with the OneRF Ablation
System at the Congress of Neurological Surgeons (CNS) Meeting in
September 2023
Spinal Cord Stimulation Program:
-
Completed test of an implantable pulse generator (IPG) to test
electrode fluid ingress
-
Successfully performed percutaneous placement of a 9mm paddle
electrode in a human cadaver model with our physician advisory
board
-
Completed histological analysis of a 28-day implanted Company
electrode
Drug Delivery Program:
- Defined
product requirements for drug delivery system for both clinical and
research use in the biotech and pharma industry
-
Developed prototypes for future pre-clinical studies
-
Initiated licensing discussion with gene therapy company for use in
clinical studies
- Received
patent for drug delivery system
Dave Rosa, CEO of NeuroOne, commented, “During
and subsequent to our fiscal fourth quarter, the Company continued
to execute at a high level on our strategic plan. We were proud to
announce the FDA clearance of our OneRF Ablation System, the
Company’s first device that has an indication for both recording
electrical activity as well as ablation of nervous tissue and the
first device with an FDA clearance. We believe this device has the
capability to create a paradigm shift in neurosurgical procedures.
We expect to commercially launch this product either directly or
with a strategic partner in the first half of 2024. This represents
the third FDA clearance in the Company’s history and a monumental
achievement. In addition, Zimmer Biomet continues to expand the
commercial launch of our Evo sEEG electrode as centers receive
approval from their respective product committees to trial the
technology. We continue to be bullish on the opportunity to deliver
drugs or gene therapies and record the impact of these therapies
using our sEEG electrode. We have already held discussions with a
Company that has strong interest in using our electrode in their
clinical trial to evaluate the performance of their therapy. The
Company has made great strides in all areas, and I look forward to
continuing to lead the Company as we execute our strategic
plan.”
Upcoming
Targeted Milestones
Evo sEEG:
- Complete
full sales force training in early 2024
-
Continued product roll-out to additional US centers
OneRF Ablation System:
- Develop
commercialization plan for product launch
- Place
stocking orders for system components
- Present
at the Society of Neuroscience and American Epilepsy Society
meetings
SCS Program:
- Complete
animal protocol to evaluate stimulation and battery performance
using the Company’s spinal cord stimulation electrode
technology
Drug Delivery Program:
- Continue
to gather product requirements for drug delivery system for both
clinical and research use in the biotech and pharma industry
- Conduct
large animal feasibility studies with drug delivery system into the
brain
- Advance
contract discussions with gene therapy company
-
Investigate US regulatory pathway for device clearance
Fourth Quarter and Full Fiscal Year 2023
Financial Results
Product revenue was $742,000 in the
fourth quarter of fiscal 2023 and $1,952,000 for the full fiscal
year, compared to product revenue of $69,000 in the fourth
quarter and $171,000 for the full year of fiscal 2022. The Company
had no collaboration revenue in the fourth quarter of fiscal 2023
and $1,455,000 for the full year of fiscal 2023, compared to
collaboration revenue of $1,942,000 in the fourth quarter and
$1,949,000 for the full year of fiscal 2022. Collaboration revenue
was derived from the Zimmer Development Agreement and represents
the portion of the exclusivity and milestone fee payments eligible
for revenue recognition during the respective periods.
Total operating expenses in the fourth quarter
of fiscal 2023 were $3.4 million, compared with $3.3
million in the same period of the prior year. R&D expense
in the fourth quarter of fiscal 2023 was $1.8
million compared with $1.4 million in the same
period of fiscal 2022. SG&A expense in the fourth quarter of
fiscal 2023 was $1.6 million compared with $1.9
million in the same period of the prior year.
Total operating expenses for the full fiscal
year 2023 were $13.9 million, compared
with $11.9 million in the prior fiscal year. R&D
expense for the full fiscal year 2023 was $6.9
million compared with $4.9 million in fiscal 2022.
SG&A expense for the full fiscal year 2023 was $6.9
million compared with $7.0 million in the same
period of the prior year.
Net loss was $3.1 million for the
fourth quarter of fiscal 2023, compared to a net loss of $1.4
million in the same period of the prior year. Net loss
was $11.9 million for the full year fiscal 2023, compared
to a net loss of $10.0 million in fiscal 2022.
On July 27, 2023, the Company completed an
underwritten public offering of its common stock from which the
Company received $5.2 million in net proceeds. In addition, the
Company sold common stock under the ATM program at an average price
of $1.77 per share, from which the Company received net proceeds of
$2.5 million.
As of September 30, 2023, the Company had
cash, cash equivalents, and short-term investments of $5.3
million, compared to $11.1 million as of September
30, 2022. The Company had working capital of $5.5 million as of
September 30, 2023, compared to working capital of $9.1 million as
of September 30, 2022.
The Company had no debt outstanding as
of September 30, 2023.
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:
800-631-4030
ir@nmtc1.com
NeuroOne Medical Technologies
Corporation Balance Sheets
(unaudited)
|
|
As of September 30, |
|
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
5,322,493 |
|
|
$ |
8,160,329 |
|
Short-term investments |
|
|
— |
|
|
|
2,981,010 |
|
Accounts receivable |
|
|
— |
|
|
|
33,237 |
|
Inventory |
|
|
1,726,686 |
|
|
|
704,538 |
|
Prepaid expenses |
|
|
263,746 |
|
|
|
296,649 |
|
Total current assets |
|
|
7,312,925 |
|
|
|
12,175,763 |
|
Intangible assets, net |
|
|
89,577 |
|
|
|
111,892 |
|
Right-of-use asset |
|
|
169,059 |
|
|
|
181,355 |
|
Property and equipment, net |
|
|
525,753 |
|
|
|
353,599 |
|
Total assets |
|
$ |
8,097,314 |
|
|
$ |
12,822,609 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
685,104 |
|
|
$ |
927,662 |
|
Accrued expenses and other liabilities |
|
|
1,107,522 |
|
|
|
715,839 |
|
Deferred revenue |
|
|
— |
|
|
|
1,455,188 |
|
Total current liabilities |
|
|
1,792,626 |
|
|
|
3,098,689 |
|
Operating lease liability, long term |
|
|
55,284 |
|
|
|
119,556 |
|
Total liabilities |
|
|
1,847,910 |
|
|
|
3,218,245 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies (Note 4) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized as
of September 30, 2023 and 2022; no shares issued or outstanding as
of September 30, 2023 and 2022. |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 100,000,000 shares authorized as of
September 30, 2023 and 2022; 23,928,945 and 16,216,540 shares
issued and outstanding as of September 30, 2023 and 2022,
respectively. |
|
|
23,929 |
|
|
|
16,217 |
|
Additional paid–in capital |
|
|
68,911,778 |
|
|
|
60,414,959 |
|
Accumulated deficit |
|
|
(62,686,303 |
) |
|
|
(50,826,812 |
) |
Total stockholders’ equity |
|
|
6,249,404 |
|
|
|
9,604,364 |
|
Total liabilities and stockholders’ equity |
|
$ |
8,097,314 |
|
|
$ |
12,822,609 |
|
NeuroOne Medical Technologies
CorporationStatements of Operations
(unaudited)
|
|
Years ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
Product revenue |
|
$ |
1,952,441 |
|
|
$ |
171,169 |
|
Cost of product revenue |
|
|
1,495,924 |
|
|
|
241,963 |
|
Product gross profit (loss) |
|
|
456,517 |
|
|
|
(70,794 |
) |
Collaboration revenue |
|
|
1,455,188 |
|
|
|
1,948,872 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
6,926,269 |
|
|
|
6,979,416 |
|
Research and development |
|
|
6,940,686 |
|
|
|
4,929,427 |
|
Total operating expenses |
|
|
13,866,955 |
|
|
|
11,908,843 |
|
Loss from operations |
|
|
(11,955,250 |
) |
|
|
(10,030,765 |
) |
Other income, net |
|
|
95,759 |
|
|
|
31,152 |
|
Net loss |
|
$ |
(11,859,491 |
) |
|
$ |
(9,999,613 |
) |
Net loss per share: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.65 |
) |
|
$ |
(0.63 |
) |
Number of shares used in per share calculations: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
18,121,108 |
|
|
|
15,998,567 |
|
NeuroOne Medical Technol... (NASDAQ:NMTC)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
NeuroOne Medical Technol... (NASDAQ:NMTC)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024