NeuroOne® Reports First Quarter Fiscal Year 2023 Financial Results and Provides Corporate Update
NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) reported its fiscal first quarter 2023 results, highlighting significant advancements in its product offerings. The company received FDA 510(k) clearance for its Evo® sEEG Electrode technology, addressing a $100M market. Product revenue climbed to $115,000 from $34,000 in Q1 2022, while collaboration revenue surged to $1.46 million from $6,000. Operating expenses increased to $3.2 million, with a net loss of $1.7 million, an improvement from a $2.8 million loss a year earlier. Cash reserves decreased to $7.6 million, down from $11.1 million. The firm aims for a commercial launch with Zimmer Biomet and plans to submit the OneRF system for FDA clearance in 2023.
- FDA 510(k) clearance for Evo® sEEG Electrode technology.
- Product revenue increased to $115,000 from $34,000 year-over-year.
- Collaboration revenue rose to $1.46 million from $6,000 year-over-year.
- Improved net loss, decreasing from $2.8 million to $1.7 million.
- Total operating expenses increased to $3.2 million from $2.8 million.
- Cash reserves decreased to $7.6 million from $11.1 million over the quarter.
Fiscal First Quarter 2023 and Recent Business Updates
- Received FDA 510(k) clearance to market the Evo® sEEG Electrode technology for temporary (less than 30 day) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain, enabling NeuroOne to fully address the approximately
$100M - A feasibility animal study of the Company's OneRF® therapeutic radiofrequency ablation electrode system was completed under the guidance of Dr. Jamie Van Gompel at the
Mayo Clinic in Rochester, MN. OneRF is an sEEG probe-guided RF based system to monitor and adjust settings based on temperature throughout an ablation, a feature designed to improve the safety of the procedure. - The first commercial order of Evo® sEEG electrodes for temporary use (less than 30 days) was shipped to the Company's distribution and development partner Zimmer Biomet. NeuroOne continues to build up inventory to meet product forecasts and fulfill additional orders in-house.
- The Company developed and successfully bench tested an early prototype of a first-of-a-kind device that can deliver drugs (or other diagnostic or therapeutic agents) to the brain while also having the capability to stimulate and record before and after application.
- Held discussions with strategic organizations regarding the Company's technology in an effort to potentially expand the product footprint in neurology.
- Exhibited the Evo electrode product family with Zimmer Biomet at the
Congress of Neurological Surgeons annual meeting and theAmerican Epilepsy Society andCongress of Neurological Surgeons annual meetings. - The Company's scientific posters were presented at the following meetings:
Congress of Neurosurgical Surgeons: Title: A Novel Polyimide Stereo-electroencephalographic (sEEG) Electrode: Safety and Performance TestingSociety of Neuroscience Meeting : Title: A Novel Polyimide-Based Electroencephalographic Depth Electrode Array: Safety and Performance TestingAmerican Epilepsy Society Annual Meeting: Title: Novel Polyimide Stereoelectroencephalographic Depth Electrodes: Safety and Performance Testing- CEO
Dave Rosa featured onFox Business Network's 'Mornings with Maria.' Rang Nasdaq Stock Market closing bell to commemorate the FDA clearance milestone for Evo sEEG Electrode technology.
Upcoming Targeted Milestones
- Commercial launch of Evo sEEG electrodes with Zimmer Biomet in the first quarter of calendar year 2023.
- Along with Zimmer Biomet, present the newly launched Evo sEEG system at the
American Association of Neurological Surgeons (AANS) annual meeting at the end ofApril 2023 . - Submit a 510(k) application to the FDA for OneRF in the second quarter of calendar year 2023.
- Complete design verification testing for OneRF confirming that the full feature system meets its design specifications and is fully functional.
- Complete next in vivo animal testing of the OneRF system with multiple surgeons with the objective of gathering additional in vivo data on the system's performance.
- Pre-clinical implantation for spinal cord stimulation (SCS) electrodes intended for permanent implant to treat chronic pain.
Fiscal First Quarter 2023 Financial Results
Product revenue was
Total operating expenses in the fiscal first quarter 2023 were
Net loss was
As of December 31, 2022, the Company had cash, cash equivalents, and short-term investments of
The Company had no debt outstanding as of December 31, 2022.
Conference Call and Webcast Information
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About NeuroOne
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
Caution: Federal law restricts this device to sale by or on the order of a physician.
Balance Sheets | ||||||||
(unaudited) | ||||||||
|
| |||||||
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, | — | — | ||||||
Common stock, | 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 | ||||||||
Statements of Operations | ||||||||
(unaudited) | ||||||||
For the three months ended | ||||||||
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 | ||||||||
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FAQ
What were NeuroOne's fiscal first quarter 2023 earnings results?
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