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 third quarter 2023 ended June 30,
2023.
Fiscal Third
Quarter 2023 and Recent
Business Updates
Financial Highlights
- Product
revenue of $630,000 in Q3 2023, compared to
$32,000 in Q3 2022
-
Collaboration revenue of $1.46 million in first nine months of FY
2023, compared to $6,000 in first nine months of FY 2022
-
Operating cash burn reduction expected with the completion of
development of the OneRF™ Ablation System beginning in Fiscal Q4
2023
Evo® sEEG:
-
Completed limited launch at target centers by end of July; full
launch with Zimmer Biomet expected by end of fiscal fourth
quarter
- Positive
user feedback received on product evaluation forms
-
Initiation of new sites expected to ramp in fiscal fourth
quarter
- Received
first order for calendar 2024 product supply from Zimmer
Biomet
OneRF™Ablation:
-
Submitted 510(k) to FDA on June 8th
- Poster
presentation on OneRF Ablation System preclinical study at the
Neurological Disorders Summit (NDS 2023) in Italy
- Received
feedback from FDA regarding 510(k) submission for OneRF Ablation
System
Spinal Cord Stimulation Program:
-
Completed 28 day animal implants of the Company’s thin film spinal
cord stimulation paddle electrodes without any adverse events or
neurological complications
- Filed a
non-provisional patent for a novel conformable thin film paddle
lead for spinal cord placement
Drug Delivery Program:
-
Successfully completed proof of concept testing of drug delivery
into the brain in a small animal model at the Mayo Clinic in
Rochester, Minnesota
Dave Rosa, CEO of NeuroOne, commented, “The
Company continues to execute on a number of commercial, development
and financing objectives. We are now beginning to expand the
commercial launch of our Evo sEEG electrode with Zimmer Biomet
after a successful limited launch. In addition, we received
encouraging feedback from the FDA regarding the Company’s recent
510(k) FDA submission of the OneRF Ablation System and believe our
previous timelines remain on track. We are excited by the potential
of our drug delivery system currently in development after recent
testing at the Mayo Clinic in Rochester Minnesota. We also recently
raised gross proceeds of $6.0 million through a public offering
which included new fundamental institutional investors without
having to offer warrants and $2.5 million through the use of an ATM
(at-the-market) facility. I am pleased with the Company’s continued
execution on our strategic plan and I look forward to our future
progress in the areas outlined.”
Upcoming Targeted Milestones
Evo sEEG:
- Full
market launch of Evo sEEG system with Zimmer Biomet
- Expand
sales training of the sEEG product line to Zimmer personnel
OneRF Ablation:
- Poster
presentation planned for the Congress of Neurological Surgeons
(CNS) Meeting in September
- Initiate
component orders for OneRF ablation system for future
commercialization
SCS Program:
- Complete
testing of an implantable pulse generator (IPG) for fluid
ingress
- Perform
percutaneous placement of a paddle electrode in a human cadaver
model
Drug Delivery Program:
- Define
product requirements for drug delivery system for both clinical and
research use in the biotech and pharma industry
- Complete
large animal feasibility studies for drug delivery system into the
brain.
Fiscal Third Quarter
2023 Financial
Results
Product revenue was $630,000 in the
fiscal third quarter 2023, compared to product revenue of
$32,000 in the fiscal third quarter 2022. For the first nine
months of fiscal 2023, product revenue was $1.2 million, compared
to $102,000 for the same period in fiscal 2022. Collaboration
revenue was $1.46 million in the first nine months of fiscal
2023, compared to collaboration revenue of $6,000 in the first nine
months 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 fiscal third
quarter 2023 were $3.8 million, compared
with $2.8 million in the same period of the prior
fiscal year. Research and Development (R&D) expense in the
fiscal third quarter 2023 was $1.9 million compared
with $1.2 million in the same period of fiscal 2022.
Selling, General and Administrative (SG&A) expense in the
fiscal third quarter 2023 was $1.9 million compared
with $1.5 million in the prior year period. For the first
nine months of fiscal 2023, total operating expenses were $10.5
million, compared with $8.6 million in the same
period of the prior fiscal year. R&D expense in the first nine
months of fiscal 2023 was $5.2 million compared
with $3.5 million in the same period of fiscal 2022.
SG&A expense in the first nine months of fiscal 2023
was $5.3 million compared with $5.1 million in
the prior year period.
Net loss was $3.5 million for the
fiscal third quarter 2023, compared to a net loss of $2.8
million in the prior year period. Net loss for the first nine
months of fiscal 2023 was $8.7 million compared
with $8.6 million in the same period of fiscal 2022.
As of June 30, 2023, the Company had cash
and cash equivalents of $3.1 million, compared to $8.1
million in cash and cash equivalents and $3.0 million in short term
investments as of September 30, 2022. The Company had
working capital of $3.1 million as of June 30, 2023, compared to
working capital of $9.1 million as of September 30, 2022.
On July 27, 2023, the Company consummated 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 from which the
Company received net proceeds of $2.5 million.
The Company had no debt outstanding as
of June 30, 2023.
Conference Call and Webcast
Information
Monday, August 14, 2023 – 4:30 PM Eastern
Time
Participant Dial-In:800-267-6316/+1
203-518-9783Conference ID (required for entry): NEURO
Live Webcast: Join
here.
Phone Replay: 877-660-6853 /
201-612-7415,Available through August 28, 2023
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 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 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,
development of our OneRF, 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, the impact of COVID-19 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 Condensed
Balance Sheets (unaudited)
|
|
June 30, 2023 |
|
|
September 30, 2022 |
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
3,083,458 |
|
|
$ |
8,160,329 |
|
Short-term investments |
|
|
— |
|
|
|
2,981,010 |
|
Accounts receivable |
|
|
— |
|
|
|
33,237 |
|
Inventory |
|
|
1,516,527 |
|
|
|
704,538 |
|
Prepaids and other |
|
|
278,786 |
|
|
|
296,649 |
|
Total current assets |
|
|
4,878,771 |
|
|
|
12,175,763 |
|
Intangible assets, net |
|
|
95,156 |
|
|
|
111,892 |
|
Right-of-use asset |
|
|
197,324 |
|
|
|
181,355 |
|
Property and equipment, net |
|
|
586,873 |
|
|
|
353,599 |
|
Total assets |
|
$ |
5,758,124 |
|
|
$ |
12,822,609 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
958,811 |
|
|
$ |
927,662 |
|
Accrued expenses and other liabilities |
|
|
789,097 |
|
|
|
715,839 |
|
Deferred revenue |
|
|
— |
|
|
|
1,455,188 |
|
Total current liabilities |
|
|
1,747,908 |
|
|
|
3,098,689 |
|
Operating lease liability, long term |
|
|
88,918 |
|
|
|
119,556 |
|
Total liabilities |
|
|
1,836,826 |
|
|
|
3,218,245 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies (Note 4) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized as
of June 30, 2023 and September 30, 2022; no shares issued or
outstanding as of June 30, 2023 and September 30, 2022. |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 100,000,000 shares authorized as of
June 30, 2023 and September 30, 2022; 17,862,162 and 16,216,540
shares issued and outstanding as of June 30, 2023 and September 30,
2022, respectively. |
|
|
17,862 |
|
|
|
16,217 |
|
Additional paid–in capital |
|
|
63,454,618 |
|
|
|
60,414,959 |
|
Accumulated deficit |
|
|
(59,551,182 |
) |
|
|
(50,826,812 |
) |
Total stockholders’ equity |
|
|
3,921,298 |
|
|
|
9,604,364 |
|
Total liabilities and stockholders’ equity |
|
$ |
5,758,124 |
|
|
$ |
12,822,609 |
|
See accompanying notes to condensed financial
statements
NeuroOne Medical
Technologies CorporationCondensed
Statements of Operations
(unaudited)
|
|
For theThree Months Ended |
|
|
For theNine Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Product revenue |
|
$ |
629,906 |
|
|
$ |
32,049 |
|
|
$ |
1,210,661 |
|
|
$ |
102,381 |
|
Cost of product revenue |
|
|
386,240 |
|
|
|
38,462 |
|
|
|
947,799 |
|
|
|
158,113 |
|
Product gross profit (loss) |
|
|
243,666 |
|
|
|
(6,413 |
) |
|
|
262,862 |
|
|
|
(55,732 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborations revenue |
|
|
— |
|
|
|
— |
|
|
|
1,455,188 |
|
|
|
6,374 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
1,862,389 |
|
|
|
1,529,670 |
|
|
|
5,347,234 |
|
|
|
5,090,018 |
|
Research and development |
|
|
1,891,512 |
|
|
|
1,225,351 |
|
|
|
5,161,322 |
|
|
|
3,491,193 |
|
Total operating expenses |
|
|
3,753,901 |
|
|
|
2,755,021 |
|
|
|
10,508,556 |
|
|
|
8,581,211 |
|
Loss from operations |
|
|
(3,510,235 |
) |
|
|
(2,761,434 |
) |
|
|
(8,790,506 |
) |
|
|
(8,630,569 |
) |
Other income, net |
|
|
41,462 |
|
|
|
1,707 |
|
|
|
66,136 |
|
|
|
5,300 |
|
Loss before income taxes |
|
|
(3,468,773 |
) |
|
|
(2,759,727 |
) |
|
|
(8,724,370 |
) |
|
|
(8,625,269 |
) |
Provision for income
taxes |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
— |
|
Net loss |
|
$ |
(3,468,773 |
) |
|
$ |
(2,759,727 |
) |
|
$ |
(8,724,370 |
) |
|
$ |
(8,625,269 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.20 |
) |
|
$ |
(0.17 |
) |
|
$ |
(0.52 |
) |
|
$ |
(0.54 |
) |
Number of shares used in per
share calculations: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
17,578,871 |
|
|
|
16,193,442 |
|
|
|
16,740,546 |
|
|
|
15,927,734 |
|
See accompanying notes to condensed financial
statements
NeuroOne Medical Technol... (NASDAQ:NMTC)
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NeuroOne Medical Technol... (NASDAQ:NMTC)
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