EDEN
PRAIRIE, Minn., Dec. 22,
2022 /PRNewswire/ -- 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, announces financial results for the fiscal
fourth quarter and full fiscal year ended September 30,
2022.
Dave Rosa, CEO of NeuroOne,
commented, "The Company made great progress in fiscal 2022 in a
wide variety of areas including commercialization, development and
capital raises, which will allow us to continue to execute our
plan, with the intent to introduce meaningful advances in electrode
technology for a variety of neurological applications.
"Our independent registered public accounting firm has completed
its audit procedures and we have filed our Annual Report on Form
10-K for the fiscal year ended September 30,
2022. Following are our financial results."
Fourth Quarter and Full Year Fiscal 2022 Financial
Results
Product revenue was $69,000 in the fourth quarter of
fiscal 2022 and $171,000 for the full
fiscal year, compared to product revenue of $48,000 in the fourth quarter and
$178,000 for the full year of fiscal
2021. Collaboration revenue was $1,942,000 in the fourth
quarter of fiscal 2022 and $1,949,000
for the full fiscal year, compared to collaboration revenue of
$5,000 in the fourth quarter and
$65,000 for the full year of fiscal
2021. 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 2022
were $3.3 million, compared
with $2.6 million in the same period of the prior
year. R&D expense in the fourth quarter of fiscal 2022
was $1.4 million compared with $1.0 million in
the same period of fiscal 2021. SG&A expense in the fourth
quarter of fiscal 2022 was $1.9 million compared
with $1.6 million in the prior year period.
Total operating expenses for the full fiscal year 2022
were $11.9 million, compared
with $10.2 million in the prior fiscal year. R&D
expense for the full fiscal year 2022 was $4.9
million compared with $3.9 million in fiscal 2021.
SG&A expense for the full fiscal year 2022 was $7.0
million compared with $6.2 million in the prior
fiscal year.
Net loss was $1.4 million for the fourth quarter of
fiscal 2022, compared to a net loss of $2.6 million in
the prior year period. Net loss was $10.0
million for the full year fiscal 2022, compared to a net loss
of $9.9 million in fiscal 2021.
As of September 30, 2022, the Company had cash, cash
equivalents, and short-term investments of $11.1 million,
compared to $6.9 million as of September 30, 2021.
The Company had working capital of $9.1
million as of September 30,
2022, compared to working capital of $6.1 million as of September 30, 2021.
The Company had no debt outstanding at September 30,
2022.
About NeuroOne Medical Technologies Corporation
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 https://www.n1mtc.com .
Forward Looking Statements
This press release contains 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 presentation 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
"may," "might," "will," "could," "would," "should," "expect,"
"intend," "plan," "upcoming," "target," "objective," "anticipate,"
"believe," "estimate," "predict," "project," "potential," "target,"
"seek," "contemplate," "continue" 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 timing and extent of
product launch and commercialization of our technology, clinical
and pre-clinical testing, 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; risks
that our sEEG electrodes may not be ready for commercialization in
a timely manner or at all, whether due to supply chain disruptions
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 the COVID-19 pandemic will
continue to adversely impact our business; 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"
NeuroOne Medical Technologies
Corporation
|
Balance Sheets
(unaudited)
|
|
|
|
As of
September 30,
|
|
|
|
2022
|
|
|
2021
|
|
Assets
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
8,160,329
|
|
|
$
|
6,901,346
|
|
Short-term
investments
|
|
|
2,981,010
|
|
|
|
—
|
|
Accounts
receivable
|
|
|
33,237
|
|
|
|
48,336
|
|
Inventory
|
|
|
704,538
|
|
|
|
98,287
|
|
Prepaid and other
assets
|
|
|
296,649
|
|
|
|
244,043
|
|
Total current
assets
|
|
|
12,175,763
|
|
|
|
7,292,012
|
|
Intangible assets,
net
|
|
|
111,892
|
|
|
|
134,207
|
|
Right-of-use
asset
|
|
|
181,355
|
|
|
|
288,948
|
|
Property and equipment,
net
|
|
|
353,599
|
|
|
|
223,329
|
|
Total assets
|
|
$
|
12,822,609
|
|
|
$
|
7,938,496
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
927,662
|
|
|
$
|
528,829
|
|
Accrued
expenses
|
|
|
715,839
|
|
|
|
644,249
|
|
Deferred
revenue
|
|
|
1,455,188
|
|
|
|
8,622
|
|
Total current
liabilities
|
|
|
3,098,689
|
|
|
|
1,181,700
|
|
Operating lease
liability, long term
|
|
|
119,556
|
|
|
|
202,895
|
|
Total
liabilities
|
|
|
3,218,245
|
|
|
|
1,384,595
|
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies (Note 4)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Preferred stock, $0.001
par value; 10,000,000 shares authorized as of September 30, 2022
and 2021; no shares issued or outstanding as of September 30, 2022
and 2021.
|
|
|
—
|
|
|
|
—
|
|
Common stock, $0.001
par value; 100,000,000 shares authorized as of September 30, 2022
and 2021; 16,216,540 and 12,010,019 shares issued and outstanding
as of September 30, 2022 and 2021, respectively.
|
|
|
16,217
|
|
|
|
12,010
|
|
Additional paid–in
capital
|
|
|
60,414,959
|
|
|
|
47,369,090
|
|
Accumulated
deficit
|
|
|
(50,826,812)
|
|
|
|
(40,827,199)
|
|
Total stockholders'
equity
|
|
|
9,604,364
|
|
|
|
6,553,901
|
|
Total liabilities and
stockholders' equity
|
|
$
|
12,822,609
|
|
|
$
|
7,938,496
|
|
See accompanying notes to the financial statements
NeuroOne Medical Technologies
Corporation
|
Statements of
Operations (unaudited)
|
|
|
|
Years ended
September 30,
|
|
|
|
2022
|
|
|
2021
|
|
Product
revenue
|
|
$
|
171,169
|
|
|
$
|
178,146
|
|
Cost of product
revenue
|
|
|
241,963
|
|
|
|
275,895
|
|
Product gross
loss
|
|
|
(70,794)
|
|
|
|
(97,749)
|
|
|
|
|
|
|
|
|
|
|
Collaborations
revenue
|
|
|
1,948,872
|
|
|
|
64,812
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
|
|
6,979,416
|
|
|
|
6,260,266
|
|
Research and
development
|
|
|
4,929,427
|
|
|
|
3,925,008
|
|
Total operating
expenses
|
|
|
11,908,843
|
|
|
|
10,185,274
|
|
Loss from
operations
|
|
|
(10,030,765)
|
|
|
|
(10,218,211)
|
|
Interest
expense
|
|
|
—
|
|
|
|
(3,053)
|
|
Net valuation change of
instruments measured at fair value
|
|
|
—
|
|
|
|
1,974
|
|
Other income
|
|
|
31,152
|
|
|
|
271,122
|
|
Net loss
|
|
$
|
(9,999,613)
|
|
|
$
|
(9,948,168)
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share:
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
$
|
(0.63)
|
|
|
$
|
(0.93)
|
|
|
|
|
|
|
|
|
|
|
Number of shares used
in per share calculations:
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
15,998,567
|
|
|
|
10,696,799
|
|
See accompanying notes to the financial statements
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SOURCE NeuroOne Medical Technologies Corporation