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 third quarter fiscal year 2024 ended June
30, 2024.
Third Quarter Fiscal Year 2024 and Recent Business
Updates
Financial Highlights:
- Product revenue
of $826,000 in Q3 2024, compared to $630,000 in Q3 2023
- Reduced
operating expenses from $3.8 million in Q3 2023 to $3.1 million in
Q3 2024
- Raised an
additional $1.6 million using the ATM Program in Q3 2024
- Completed $2.65
million private placement and entered into $3.0 million secured
credit facility agreement in August 2024
Evo® sEEG:
- Completed
manufacturing transition from sEEG diagnostic electrodes to OneRF
electrodes
OneRF™ Ablation System:
- Continued
limited commercial launch of the OneRF™ Ablation System, including
first shipments, implants and ablations with OneRF™ Ablation
System
- Completed OneRF™
Ablation System training for four sites and initiated sales quote
process with 12 additional sites
- Implanted ~200
RF electrodes and performed more than 50 RF ablations on 3
patients
- Signed a
non-binding term sheet with an undisclosed global medical
technology company to distribute our OneRF™ Ablation System. The
term sheet is non-binding, and the partnership is subject to the
negotiation and execution of definitive documentation, due
diligence, and other customary closing conditions
- Exhibited the
OneRF™ Ablation System at the Association of Neurological Surgeons
(AANS) Annual Scientific Meeting in May and the American Society
for Stereotactic and Functional Neurosurgery Biennial Meeting in
June
- The Centers for
Medicare and Medicaid Services (CMS) approved and granted a new
ICD-10-PCS (International Classification of Diseases, 10th
Revision, Procedure Coding System) code for the OneRF™ ablation
procedure. The new code will be effective October 1, 2024 and
allows hospital reporting of inpatient procedures that are
performed using the OneRF™ Ablation System ensuring efficient and
accurate documentation, billing, and analysis
- Presented
posters on preclinical evaluation and ex vivo lesion
characterization of OneRF™ Ablation System at the AANS Annual
Scientific Meeting in May
sEEG-Based Drug Delivery Program:
- Completed
feasibility testing in vivo study providing histology data
- Completed drug
compatibility and adsorption testing
- Presented
posters on feasibility bench testing and in vivo studies of
sEEG-based drug delivery into the brain at the American Association
of Pharmaceutical Scientists (AAPS-NBC) and the American Society of
Gene & Cell Therapy (ASGCT) in May
- Continued
discussions with potential targeted strategic partners for use in
clinical studies and research
Spinal Cord Stimulation (SCS) Percutaneous Paddle Lead
Program:
- Successfully
completed acute animal study in large animal model to evaluate
stimulation performance of our percutaneous paddle lead for back
and neck pain
- Successfully
completed cadaver lab with physician key opinion leaders to further
advance the development of a percutaneous implantation technique
for our thin-film SCS percutaneous paddle electrodes
- Finalized
NeuroOne paddle lead design, including testing of electrode
specifications
- Filed a
provisional patent on a connector that is compatible with our
thin-film SCS electrodes
Dave Rosa, CEO of NeuroOne, commented, “We
accomplished several key milestones this quarter. We are most
excited about completing the first RF ablation cases with our
first-to-market OneRF™ Ablation System. We also signed a
non-binding term sheet with a large strategic partner to serve as
our distribution partner and accelerate the launch of the OneRF™
Ablation System. In August, we completed a financing, entered into
a credit facility agreement, and are making good progress with our
product pipeline, including additional RF ablation applications,
sEEG-based drug delivery and a percutaneous paddle lead for spinal
cord stimulation. We are looking forward to securing additional
strategic partners for these exciting programs leveraging our
thin-film electrode platform technology.”
Key Upcoming Milestones
OneRF™ Ablation System:
- Finalize
strategic partnership for distribution of OneRF™ Ablation
System
- Continue to add
new centers for our limited commercial launch
- Exhibit OneRF™
Ablation System at the 2024 World Congress of Stereotactic and
Functional Neurosurgery meeting in September
- Present posters
on OneRF™ Ablation System at the Congress of Neurological Surgeons
2024 annual meeting in September
- Continue to
explore additional ablation applications and strategic partnership
opportunities in other attractive markets that could benefit from
NeuroOne’s high-resolution, thin-film electrode technology and RF
generator
Spinal Cord Stimulation Percutaneous Paddle Lead Program:
- Initiate
discussions with potential strategic partners to license or acquire
the NeuroOne Spinal Cord Stimulation percutaneous paddle lead
product
Third Quarter Fiscal Year 2024 Financial
Results
Product revenue was $826,000 in the third
quarter of fiscal 2024, compared to product revenue of $630,000 in
the third quarter of fiscal 2023. For the first nine months of
fiscal 2024, product revenue was $3.2 million, compared to $1.2
million for the same period in fiscal 2023. The Company had no
collaboration revenue in the first nine months of fiscal 2024,
compared to collaboration revenue of $1.46 million in the first
nine months 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 third quarter of
fiscal 2024 were $3.1 million, compared with $3.8 million in the
same period of the prior fiscal year. Research and Development
(R&D) expense in the third quarter of fiscal 2024 was $1.2
million compared with $1.9 million in the third quarter of fiscal
2023. Selling, General and Administrative (SG&A) expenses were
$1.9 million during each of the three months ended June 30, 2024
and 2023. For the first nine months of fiscal 2024, total operating
expenses were $10.0 million, compared with $10.5 million in the
same period of fiscal 2023. R&D expense in the first nine
months of fiscal 2024 was $4.0 million compared with $5.2 million
in the same period of fiscal 2023. SG&A expense in the first
nine months of fiscal 2024 was $6.1 million compared with $5.3
million in the prior year period.
Net loss was $2.8 million for the third quarter
of fiscal 2024, compared to a net loss of $3.5 million in the third
quarter of fiscal 2023. Net loss for the first nine months of
fiscal 2024 was $9.0 million compared with $8.7 million in the same
period of fiscal 2023.
In the third quarter of fiscal 2024, the Company
sold common stock under the ATM Program at an average price of
$1.19 per share, from which the Company received net proceeds of
$1.6 million.
As of June 30, 2024, the Company had cash and
cash equivalents of $1.6 million, compared to $5.3 million as of
September 30, 2023. The Company had working capital of $2.2 million
as of June 30, 2024, compared to working capital of $5.5 million as
of September 30, 2023.
The Company had no debt outstanding as of June
30, 2024.
On August 2, 2024, the Company completed a $2.65
million private placement, resulting in $2.55 million in net
proceeds, and entered into a $3.0 million secured credit facility
agreement. The Company has not borrowed anything under the credit
facility agreement at this time.
Conference Call and Webcast
Wednesday, August 14, 2024, at 4:30 PM Eastern Time
Participants:
Toll Free: 877-545-0320International: 973-528-0002Participant
Access Code: 579769
Phone Replay:
Toll Free: 877-481-4010International: 919-882-2331Replay
Passcode: 51065Available through August 28, 2024
Live Webcast:
Join here.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 securing a strategic partnership for
distribution of the OneRF™ Ablation System, the addition of new
centers for the Company’s limited commercial launch of the OneRF™
Ablation System, potential strategic partnership opportunities,
continued development of the Company’s electrode technology program
(including our drug delivery program and spinal cord stimulation
program), 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 our strategic
partnerships 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
CorporationCondensed Balance Sheets
|
|
As ofJune 30, |
|
|
As ofSeptember 30, |
|
|
|
2024 |
|
|
2023 |
|
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
1,619,977 |
|
|
$ |
5,322,493 |
|
Accounts receivable |
|
|
410,551 |
|
|
|
— |
|
Inventory |
|
|
1,793,432 |
|
|
|
1,726,686 |
|
Prepaid expenses |
|
|
261,477 |
|
|
|
263,746 |
|
Total current assets |
|
|
4,085,437 |
|
|
|
7,312,925 |
|
Intangible assets, net |
|
|
72,841 |
|
|
|
89,577 |
|
Right-of-use assets |
|
|
281,833 |
|
|
|
169,059 |
|
Property and equipment, net |
|
|
472,486 |
|
|
|
525,753 |
|
Total assets |
|
$ |
4,912,597 |
|
|
$ |
8,097,314 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
759,260 |
|
|
$ |
685,104 |
|
Accrued expenses and other liabilities |
|
|
931,700 |
|
|
|
1,107,522 |
|
Total current liabilities |
|
|
1,690,960 |
|
|
|
1,792,626 |
|
Operating lease liability, long term |
|
|
209,910 |
|
|
|
55,284 |
|
Total liabilities |
|
|
1,900,870 |
|
|
|
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;
27,846,722 and 23,928,945 shares issued and outstanding as of June
30, 2024 and September 30, 2023, respectively. |
|
|
27,847 |
|
|
|
23,929 |
|
Additional paid–in capital |
|
|
74,637,698 |
|
|
|
68,911,778 |
|
Accumulated deficit |
|
|
(71,653,818 |
) |
|
|
(62,686,303 |
) |
Total stockholders’ equity |
|
|
3,011,727 |
|
|
|
6,249,404 |
|
Total liabilities and stockholders’ equity |
|
$ |
4,912,597 |
|
|
$ |
8,097,314 |
|
NeuroOne Medical Technologies
CorporationCondensed Statements of
Operations(unaudited)
|
|
For theThree Months Ended |
|
|
For theNine Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Product revenue |
|
$ |
825,776 |
|
|
$ |
629,906 |
|
|
$ |
3,180,719 |
|
|
$ |
1,210,661 |
|
Cost of product revenue |
|
|
543,904 |
|
|
|
386,240 |
|
|
|
2,242,114 |
|
|
|
947,799 |
|
Product gross profit |
|
|
281,872 |
|
|
|
243,666 |
|
|
|
938,605 |
|
|
|
262,862 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborations revenue |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,455,188 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
1,881,099 |
|
|
|
1,862,389 |
|
|
|
6,057,520 |
|
|
|
5,347,234 |
|
Research and development |
|
|
1,194,674 |
|
|
|
1,891,512 |
|
|
|
3,951,559 |
|
|
|
5,161,322 |
|
Total operating expenses |
|
|
3,075,773 |
|
|
|
3,753,901 |
|
|
|
10,009,079 |
|
|
|
10,508,556 |
|
Loss from operations |
|
|
(2,793,901 |
) |
|
|
(3,510,235 |
) |
|
|
(9,070,474 |
) |
|
|
(8,790,506 |
) |
Other income, net |
|
|
26,376 |
|
|
|
41,462 |
|
|
|
102,959 |
|
|
|
66,136 |
|
Loss before income taxes |
|
|
(2,767,525 |
) |
|
|
(3,468,773 |
) |
|
|
(8,967,515 |
) |
|
|
(8,724,370 |
) |
Provision for income
taxes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
|
$ |
(2,767,525 |
) |
|
$ |
(3,468,773 |
) |
|
$ |
(8,967,515 |
) |
|
$ |
(8,724,370 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.10 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.35 |
) |
|
$ |
(0.52 |
) |
Number of shares used in per
share calculations: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
27,352,660 |
|
|
|
17,578,871 |
|
|
|
25,746,503 |
|
|
|
16,740,546 |
|
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