Full Press Release Details
Reports First Quarter Fiscal Year 2023 Financial Results and Provides Corporate Update
EDEN PRAIRIE, Minn., February 14, 2023 (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 fiscal first quarter 2023 ended December 31, 2022.
Fiscal First Quarter 2023 and Recent Business
Dave Rosa, CEO of NeuroOne, commented, "We were thrilled to receive
FDA clearance of our Evo sEEG electrode, which was the culmination of years of hard work and determination. This represents the beginning
of our commercialization strategy with Zimmer Biomet. Just as critical, we are well positioned to submit our OneRF Ablation System to
the FDA for 510(k) clearance, marking a key milestone for the Company as we enter the therapeutic space. We continue to explore additional
exciting markets as we seek to improve upon existing technology with the goal of making current procedures safer and more cost effective,
with potential improved efficacy for patients suffering from epilepsy, Parkinson's disease, and chronic pain. We also continue to
explore potential strategic partnerships to expand our presence beyond our current areas of focus."
Upcoming Targeted Milestones
Fiscal First Quarter 2023 Financial Results
Product revenue was $115,000 in
the fiscal first quarter 2023, compared to product revenue of $34,000 in the fiscal first quarter 2022. Collaboration revenue was $1.46
million in the fiscal first quarter 2023, compared to collaboration revenue of $6,000 in the fiscal first quarter 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 first
quarter 2023 were $3.2 million, compared with $2.8 million in the same period of the prior fiscal year. R&D expense
in the fiscal first quarter 2023 was $1.6 million compared with $1.1 million in the same period of fiscal 2022. SG&A
expense in the fiscal first quarter 2023 was $1.7 million compared with $1.7 million in the prior year period.
Net loss was $1.7 million for the
fiscal first quarter 2023, compared to a net loss of $2.8 million in the prior year period.
As of December 31, 2022, the Company
had cash, cash equivalents, and short-term investments of $7.6 million, compared to $11.1 million as of September
30, 2022. The Company had working capital of $7.6 million as of December 31, 2022, compared to working capital of $9.1 million as of September
The Company had no debt outstanding as of December
Conference Call and Webcast Information
Tuesday, February 14, 2023 - 4:30 PM Eastern Time
Participant Dial-In:
877-405-1216 / 201-689-8336
877-660-6853 / 201-612-7415, Access ID: 13736384; available through
Available for 12 months
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, cost reduction of our new cable assembly, shelf life for Evo cortical electrodes, 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; 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.
NeuroOne Medical Technologies Corporation
| December 31, 2022 | September 30, 2022 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 4,667,432 | $ | 8,160,329 | ||||
| Short-term investments | 2,975,194 | 2,981,010 | ||||||
| Accounts receivable | 95,319 | 33,237 | ||||||
| Inventory | 903,554 | 704,538 | ||||||
| Prepaid and other assets | 325,488 | 296,649 | ||||||
| Total current assets | 8,966,987 | 12,175,763 | ||||||
| Intangible assets, net | 106,313 | 111,892 | ||||||
| Right-of-use asset | 252,119 | 181,355 | ||||||
| Property and equipment, net | 334,801 | 353,599 | ||||||
| Total assets | $ | 9,660,220 | $ | 12,822,609 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 861,638 | $ | 927,662 | ||||
| Accrued expenses | 473,085 | 715,839 | ||||||
| Deferred revenue | - | 1,455,188 | ||||||
| Total current liabilities | 1,334,723 | 3,098,689 | ||||||
| Operating lease liability, long term | 153,721 | 119,556 | ||||||
| Total liabilities | 1,488,444 | 3,218,245 | ||||||
| Commitments and contingencies (Note 4) | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.001 par value; 10,000,000 shares authorized as of December 31, 2022 and September 30, 2022; no shares issued or outstanding as of December 31, 2022 and September 30, 2022. | - | - | ||||||
| Common stock, $0.001 par value; 100,000,000 shares authorized as of December 31, 2022 and September 30, 2022; 16,238,464 and 16,216,540 shares issued and outstanding as of December 31, 2022 and September 30, 2022, respectively. | 16,239 | 16,217 | ||||||
| Additional paid-in capital | 60,715,118 | 60,414,959 | ||||||
| Accumulated deficit | (52,559,581 | ) | (50,826,812 | ) | ||||
| Total stockholders' equity | 8,171,776 | 9,604,364 | ||||||
| Total liabilities and stockholders' equity | $ | 9,660,220 | $ | 12,822,609 |
See accompanying notes to condensed financial statements
NeuroOne Medical Technologies Corporation
Statements of Operations
| For the three months ended December 31, | ||||||||
| 2022 | 2021 | |||||||
| Product revenue | $ | 114,579 | $ | 33,748 | ||||
| Cost of product revenue | 126,886 | 46,844 | ||||||
| Product gross loss | (12,307 | ) | (13,096 | ) | ||||
| Collaborations revenue | 1,455,188 | 6,374 | ||||||
| Operating expenses: | ||||||||
| Selling, general and administrative | 1,663,737 | 1,742,141 | ||||||
| Research and development | 1,563,496 | 1,060,462 | ||||||
| Total operating expenses | 3,227,233 | 2,802,603 | ||||||
| Loss from operations | (1,784,352 | ) | (2,809,325 | ) | ||||
| Other income | 51,583 | 1,850 | ||||||
| Loss before income taxes | (1,732,769 | ) | (2,807,475 | ) | ||||
| Provision for income taxes | - | - | ||||||
| Net loss | $ | (1,732,769 | ) | $ | (2,807,475 | ) | ||
| Net loss per share: | ||||||||
| Basic and diluted | $ | (0.11 | ) | $ | (0.18 | ) | ||
| Number of shares used in per share calculations: | ||||||||
| Basic and diluted | 16,230,997 | 15,408,480 |
See accompanying notes to condensed financial statements