Full Press Release Details
Reports Second Quarter Fiscal Year 2022 Financial Results and Provides Corporate Update
EDEN PRAIRIE, Minn., May 12, 2022 (PR
Newswire) -- 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 second quarter of fiscal year 2022 ended March 31, 2022.
Second Quarter and Recent Business Updates
Dave Rosa, CEO of NeuroOne commented, "In
September 2021, NeuroOne received FDA 510(k) clearance for our Evo sEEG product line for less than 24 hour use. Although the FDA did not
provide clearance for longer term use for our sEEG product line, the Company remains confident that the product met ISO 10993 "Biological
Evaluation of Medical Devices - Part 12 and Part 18" requirements for biocompatibility which was the basis of the Company appealing
the FDA decision. We appreciated the FDA's willingness to hear our appeal which occurred on April 14th, 2022. We continue
to remain ready to fulfill our initial stocking order to Zimmer Biomet upon an FDA clearance for less than 30 day use. Additionally, the
development of our RF ablation electrode and hardware remains on schedule as we expect to complete system prototypes by the end of the
third calendar quarter of 2022. We are still targeting submitting for 510(k) clearance for RF ablation in early calendar year 2023. Cost
reduction programs are underway for our cable assembly line, next generation connector and validation of a new electrode supplier in order
to ensure the ability to meet supply requirements to Zimmer Biomet. Our team remains enthusiastic and determined as we make progress across
a number of key commercial and product development objectives for 2022."
Upcoming Targeted Milestones
Second Quarter of Fiscal 2022 Financial
Product revenue was $37,000 in the
second quarter of fiscal 2022, compared to product revenue of $18,000 in the second quarter of fiscal 2021. Collaboration revenue
was delayed in the second quarter of fiscal 2022 due to the FDA decision, compared to collaboration revenue of $20,000 in
the second quarter of fiscal 2021. Collaboration revenue was derived from the Zimmer Development Agreement and represented the portion
of the upfront initial development fee payment eligible for revenue recognition as of March 31, 2022.
Total operating expenses in the second quarter
of fiscal 2022 were $3.0 million, compared with $2.4 million in the same period of the prior year. R&D expense in the second
quarter was $1.8 million, compared with $1.3 million in the same period of fiscal 2021. SG&A expense in the second quarter
of fiscal 2022 was $1.2 million, compared with $1.1 million in the prior year period.
Net loss was $3.1 million for the
second quarter of fiscal 2022, compared to a net loss of $2.4 million in the second quarter of fiscal 2021.
As of March 31, 2022, the Company had
cash of $12.9 million, compared to $16.2 million at December 31, 2021 and $6.9 million at September 30, 2021, our fiscal year
The Company had no debt outstanding at March
Conference Call Information
May 12, 2022 - 4:30 PM Eastern Time
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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. For more information,
visit https://www.n1mtc.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
ablation electrode technology program, applications for, or receipt of, regulatory clearance, the timing and extent of product launch
and commercialization of our technology, expected negotiations with Zimmer Biomet, clinical and pre-clinical testing, 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, 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 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"