EDEN PRAIRIE, Minn.,
Aug. 13, 2021 /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 today financial
results for the quarter ended June 30,
2021.
Third Quarter and Fiscal 2021 Recent Business Updates
- Uplisted to the Nasdaq Capital Market under existing ticker
symbol "NMTC"
- Launched the first product, the Evo Cortical Electrode, with
Zimmer Biomet
- Submitted a 510(k) to FDA for Company's Evo sEEG Electrode
- Initiated testing for electrodes intended to provide
therapeutic stimulation for back pain which represents over a
$3 billion market in the United States
- Completed the initial manufacturing run for miniaturized
electrodes that may be useful in more complex conditions requiring
artificial intelligence
- Formed an advisory board of leading neurosurgeons to assist in
accelerating its ablation electrode program
-
- Multifunction electrode intended to both record brain activity
and ablate the problematic brain tissue
- Expected to reduce hospitalizations, eliminate the need for a
separate second surgery and reduce overall time and cost
- Company intends to market the hardware and software as
well
- Completed first performance milestone in Zimmer Biomet
agreement
- Announced first human commercial use of its Evo Cortical
diagnostic electrode at Mayo Clinic in Rochester, Minnesota
- Appointed 30-year finance executive, Ronald McClurg, as Chief Financial Officer
- Appointed 20-year Medtronic veteran, Hijaz Haris, as Vice
President of Marketing
- Closed a $12.5 million private
placement with certain prominent institutional investors
Dave Rosa, CEO of NeuroOne
commented, "During our fiscal third quarter and year to date, we
made significant progress across our product portfolio. We began
the period with the first human commercial use of our first FDA
approved diagnostic product at Mayo Clinic. We submitted a 510(k)
for our second diagnostic product line and remain on target to
commercialize by calendar year end. We continue to make great
progress on our ablation electrode, which will be our first
therapeutic device, and are targeting a launch in the next eighteen
months. Additionally, we expect data on our chronic use
electrode technology later this year. Coupled with adding key
personnel, prominent institutional investors in a $12.5 million capital raise, and uplisting to the
Nasdaq Capital Market, we've had a strong fiscal 2021 to date and
are focused on executing upcoming milestones to maximize
shareholder value."
Upcoming Targeted Milestones
- Commercialize Evo sEEG Depth Diagnostic Electrode in Calendar
2021
-
- Uses include epilepsy surgery and awake brain mapping
- Triggers a milestone payment from Zimmer for licensing fee
- ~$100 million addressable
market
- Complete the design of the Ablation Therapeutic Electrode and
longer pacing item pulse generator in Calendar 2021
-
- Multifunction electrode intended to both record brain activity
and ablate the problematic brain tissue
- Expected to reduce hospitalizations, eliminate the need for a
separate second surgery and reduce overall time and cost
- Company intends to market the hardware and software as
well.
- Complete animal studies for the Ablation Therapeutic Electrode
in Calendar 2021
- Generate accelerated aging testing data for Chronic Use
Electrode in Calendar 2021
-
- Uses include deep brain stimulation, spinal cord stimulation,
and future artificial intelligence applications
- ~$6-billion addressable
market
- Commercialize the Ablation Therapeutic Electrode in the next
eighteen months
Third Quarter 2021 Financial Results
Product revenue was $40,000 in the
third quarter of fiscal 2021 and collaboration revenue was
$17,000, compared to no revenue in
the prior year period.
Total operating expenses in the third quarter of fiscal 2021
were $3.0 million, compared with
$1.6 million in the same period
of the prior year. R&D expense in the third quarter was
$2.1 million compared with
$1.1 million in the same period
of fiscal 2020. SG&A expense in the third quarter of fiscal
2021 was $0.9 million compared with
$0.45 million in the prior year
period.
Net loss was $3.0 million for the
third quarter fiscal 2021, compared to a net loss of $7.1 million in the prior year period.
As of June 30, 2021, the Company
had cash of $9.0 million, compared to
$4.0 million at September 30, 2020, the end of the Company's most
recent fiscal year. The Company had no debt outstanding at
June 30, 2021.
Conference Call Information
NeuroOne will host a conference call to discuss financial
results for its third quarter ended June 30,
2021, on August 13, 2021, at
9:00 AM ET.
Dial-in:
|
(346)
248-7799
|
Meeting
ID:
|
95665935395
|
Passcode:
|
902419
|
Webcast:
https://audience.mysequire.com/webinar-view?webinar_id=ebb66f45-34a2-4d94-b4b9-f830d498fc2f
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 .
The Company previously announced it had successfully met the
first performance milestone in the distribution and development
agreement signed with Zimmer Biomet on July 20, 2020 . In
addition to acquiring exclusive global distribution rights to
NeuroOne's Evo™ (Evo) patented electrode technology, the
partnership also offered the potential for NeuroOne to earn
back-end milestone payments if certain events were met within a
specified time frame.
NeuroOne received FDA clearance for its Evo cortical technology
in November 2019.
In partnership with Mayo Clinic, Wisconsin Alumni Research
Foundation (WARF) and other prominent academic medical centers, the
Company began developing its cortical electrode technology in 2015.
The Company initially focused its efforts on the epilepsy and
intraoperative tumor monitoring markets. NeuroOne intends to
continue to develop the technology for use in therapeutic
applications for Parkinson's disease, epilepsy and pain management
due to failed back surgery procedures.
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," "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 Company's ablation electrode technology
program, the receipt of regulatory clearance, the timing and extent
of product launch and commercialization of the technology, what the
future may hold for electrical stimulation and NeuroOne's potential
role, 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; risks that our technology will not perform as expected based
on results of our pre-clinical and clinical trials, our ability to
raise additional funds, uncertainties inherent in the development
process of our technology, changes in regulatory requirements or
decisions of regulatory authorities, the size and growth potential
of the markets for our technology, clinical trial patient
enrollment, the results of clinical trials, our ability 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
|
Condensed Balance
Sheets
|
|
|
|
As of
June 30,
2021
|
|
|
As of
September 30,
2020
|
|
|
|
(unaudited)
|
|
|
|
|
Assets
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash
|
|
$
|
8,990,741
|
|
|
$
|
4,036,397
|
|
Accounts
receivable
|
|
|
40,096
|
|
|
|
—
|
|
Inventory
|
|
|
52,182
|
|
|
|
—
|
|
Prepaid
and other assets
|
|
|
188,409
|
|
|
|
118,611
|
|
Total current
assets
|
|
|
9,271,428
|
|
|
|
4,155,008
|
|
Intangible
assets, net
|
|
|
139,786
|
|
|
|
156,523
|
|
Right-of-use asset
|
|
|
241,156
|
|
|
|
282,211
|
|
Property
and equipment, net
|
|
|
156,353
|
|
|
|
166,031
|
|
Total
assets
|
|
$
|
9,808,723
|
|
|
$
|
4,759,773
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
296,410
|
|
|
$
|
762,538
|
|
Accrued
expenses
|
|
|
436,846
|
|
|
|
512,762
|
|
Convertible promissory notes (Note 8)
|
|
|
—
|
|
|
|
1,007,206
|
|
Deferred
revenue
|
|
|
13,596
|
|
|
|
73,434
|
|
Total current
liabilities
|
|
|
746,852
|
|
|
|
2,355,940
|
|
Operating
lease liability
|
|
|
206,966
|
|
|
|
254,328
|
|
Other
liabilities
|
|
|
—
|
|
|
|
83,333
|
|
Total
liabilities
|
|
|
953,818
|
|
|
|
2,693,601
|
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies (Note 4)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Preferred
stock, $0.001 par value; 10,000,000 shares authorized as of June
30,
2021 and September 30, 2020; no shares
issued or outstanding as of June 30,
2021 and September 30, 2020.
|
|
|
—
|
|
|
|
—
|
|
Common
stock, $0.001 par value; 100,000,000 shares authorized as of June
30,
2021 and September 30, 2020; 11,981,380 and
7,393,637 shares issued and
outstanding as of June 30, 2021 and September
30, 2020, respectively.
|
|
|
35,801
|
|
|
|
22,181
|
|
Additional
paid–in capital
|
|
|
47,003,140
|
|
|
|
32,923,022
|
|
Accumulated deficit
|
|
|
(38,184,036)
|
|
|
|
(30,879,031)
|
|
Total stockholders'
equity
|
|
|
8,854,905
|
|
|
|
2,066,172
|
|
Total liabilities and
stockholders' equity
|
|
$
|
9,808,723
|
|
|
$
|
4,759,773
|
|
NeuroOne Medical
Technologies Corporation
|
Condensed
Statements of Operations
|
(unaudited)
|
|
|
|
For the
Three Months Ended
|
|
|
For the
Nine Months Ended
|
|
|
|
June 30,
|
|
|
June
30,
|
|
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
Product
revenue
|
|
$
|
40,096
|
|
|
$
|
—
|
|
|
$
|
129,810
|
|
|
$
|
—
|
|
Cost of product
revenue
|
|
|
61,935
|
|
|
|
—
|
|
|
|
210,429
|
|
|
|
—
|
|
Product gross
loss
|
|
|
(21,839)
|
|
|
|
—
|
|
|
|
(80,619)
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborations
revenue
|
|
|
17,451
|
|
|
|
—
|
|
|
|
59,838
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and
administrative
|
|
|
2,129,474
|
|
|
|
1,146,339
|
|
|
|
4,636,586
|
|
|
|
3,493,761
|
|
Research and
development
|
|
|
901,134
|
|
|
|
447,154
|
|
|
|
2,916,721
|
|
|
|
1,291,075
|
|
Total operating
expenses
|
|
|
3,030,608
|
|
|
|
1,593,493
|
|
|
|
7,553,307
|
|
|
|
4,784,836
|
|
Loss from
operations
|
|
|
(3,034,996)
|
|
|
|
(1,593,493)
|
|
|
|
(7,574,088)
|
|
|
|
(4,784,836)
|
|
Interest
expense
|
|
|
—
|
|
|
|
(4,749,263)
|
|
|
|
(3,053)
|
|
|
|
(7,446,770)
|
|
Net valuation change
of instruments measured at fair value
|
|
|
—
|
|
|
|
1,269,543
|
|
|
|
1,974
|
|
|
|
1,175,685
|
|
Loss on note
extinguishment
|
|
|
—
|
|
|
|
(2,017,847)
|
|
|
|
—
|
|
|
|
(2,017,847)
|
|
Other
income
|
|
|
83,387
|
|
|
|
—
|
|
|
|
270,162
|
|
|
|
—
|
|
Loss before income
taxes
|
|
|
(2,951,609)
|
|
|
|
(7,091,060)
|
|
|
|
(7,305,005)
|
|
|
|
(13,073,768)
|
|
Provision for income
taxes
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
Net loss
|
|
$
|
(2,951,609)
|
|
|
$
|
(7,091,060)
|
|
|
$
|
(7,305,005)
|
|
|
$
|
(13,073,768)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
$
|
(0.25)
|
|
|
$
|
(1.33)
|
|
|
$
|
(0.71)
|
|
|
$
|
(2.70)
|
|
Number of shares used
in per share calculations:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
11,959,101
|
|
|
|
5,346,439
|
|
|
|
10,269,216
|
|
|
|
4,843,587
|
|
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SOURCE NeuroOne Medical Technologies Corporation