NeuroOne® Reports First Quarter Fiscal Year 2024 Financial Results and Provides Corporate Update
- None.
- Net loss increased to $3.3 million in Q1 FY 2024 from $1.7 million in Q1 FY 2023.
- Total operating expenses rose to $3.7 million in Q1 FY 2024 from $3.2 million in Q1 FY 2023.
- Working capital decreased to $3.7 million as of December 31, 2023, from $5.5 million as of September 30, 2023.
The substantial increase in product revenue from $115,000 in Q1 2023 to $978,000 in Q1 2024 for NeuroOne indicates a significant growth trajectory for the company's commercial activities, particularly the Evo sEEG electrode system. This growth is a positive signal to investors, as it reflects the company's ability to monetize its products and suggests potential for scale. However, the absence of collaboration revenue in Q1 2024, in contrast to the $1,455,000 reported in the same quarter of the previous year, raises questions about the sustainability of revenue streams and the company's reliance on periodic payments from strategic partnerships.
NeuroOne's operational expenses have increased, notably the SG&A expenses, which have risen from $1.7 million to $2.2 million. This could be attributed to the expansion efforts and preparation for the OneRF™ Ablation System launch. While increased spending is common in growth phases, it is essential for the company to manage these expenses to avoid long-term financial strain, especially given the reported net loss of $3.3 million in Q1 2024, nearly double the loss from Q1 2023.
The company's liquidity position, with cash and equivalents decreasing from $5.3 million to $2.7 million, is a point of concern for its financial stability. Although no debt is outstanding, the burn rate suggests that additional capital might be required to sustain operations and fund upcoming product launches.
The FDA 510(k) clearance for the OneRF™ Ablation System represents a significant milestone for NeuroOne, allowing the company to penetrate the functional neurosurgical procedures market. The system's dual functionality for recording electrical activity and ablation of nervous tissue could differentiate it in a competitive landscape and potentially disrupt current neurosurgical practices. However, market adoption rates will be critical to monitor, as the medical device industry is known for its stringent regulatory environment and slow adoption curves due to the need for clinician training and demonstration of clinical efficacy.
The company's strategic focus on expanding its product portfolio, including advancements in drug delivery and spinal cord stimulation programs, aligns with the broader industry trend towards integrated therapeutic solutions. The pursuit of strategic partnerships is a prudent approach to mitigate risk and leverage external expertise, but the execution of these partnerships will be essential to realize the potential benefits.
Investors should be aware of the reimbursement landscape challenges, particularly the application for an ICD-10-PCS hospital inpatient code, which is crucial for ensuring that hospitals can process claims for the OneRF™ ablation procedure. Success in securing reimbursement codes will significantly impact the product's commercial viability and adoption.
NeuroOne's proactive engagement with the Centers for Medicare and Medicaid Services (CMS) for the ICD-10-PCS code application is a strategic move to facilitate the adoption of the OneRF™ Ablation System. Reimbursement pathways are a critical factor in the healthcare market, influencing the decision-making process of providers and the accessibility of new technologies for patients. The potential for the OneRF™ Ablation System to shift neurosurgical procedures could have economic implications by potentially reducing procedure times, improving patient outcomes and lowering overall healthcare costs.
However, the healthcare economics landscape is complex and the company's ability to navigate it successfully will depend on several factors, including the demonstration of cost-effectiveness, alignment with healthcare providers' priorities and the evolving policy environment. The long-term success of NeuroOne's products will be contingent not only on their clinical efficacy but also on their economic value proposition in a value-based healthcare system.
EDEN PRAIRIE, Minn., Feb. 13, 2024 (GLOBE 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 first quarter fiscal year 2024 ended December 31, 2023.
First Quarter Fiscal Year 2024 and Recent Business Updates
Financial Highlights:
- Product revenue of
$978,000 in Q1 2024, compared to$115,000 in Q1 2023 - Raised an additional
$2.8 million using the ATM Offering in December 2023 and January 2024
Evo® sEEG:
- Customer feedback remains positive as commercial launch expands with new accounts
- Product exhibited at annual meeting of American Epilepsy Society (AES) in December 2023
- Completed full sales force training for Zimmer Biomet personnel in January 2024
OneRF™ Ablation System:
- Received FDA 510(k) clearance in December 2023 to market the OneRF™ Ablation System for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures
- Placed component orders for OneRF™ Ablation System and began preparing for pending product launch targeted in the second calendar quarter of 2024.
- Submitted an ICD-10-PCS hospital inpatient code application to the Centers for Medicare and Medicaid Services (CMS) for the OneRF™ ablation procedure, to support accurate data collection and processing of reimbursement claims by hospitals for the ablation procedure
- Presented posters on pre-clinical experience with OneRF™ Ablation System at the Society for Neuroscience (SFN) and the AES annual meetings
Drug Delivery Program:
- Completed feasibility bench top testing and animal study demonstrating the ability to deliver a therapy and provide recording capabilities using the sEEG drug delivery system.
- Continued discussions with potential strategic partners for use in clinical studies and research
Spinal Cord Stimulation Program:
- Completed preclinical study of the first acute electrophysiology experiment with NeuroOne’s lead in a sheep model
- Presented poster on pre-clinical experience with thin-film paddle leads at North American Neuromodulation Society (NANS) in January 2024
Dave Rosa, CEO of NeuroOne, commented, “We are very pleased with our results this quarter, highlighted by reaching a milestone achievement with FDA clearance of our OneRF™ Ablation System. This represents the Company’s third product family to be cleared by the FDA and the Company’s first combination device that has an indication for both recording electrical activity and ablation of nervous tissue. We are very excited to be the first to market this novel technology in the United States and are preparing to initiate a limited commercial launch of the OneRF™ Ablation System in the second quarter of calendar year 2024. We believe the OneRF™ Ablation System, with combination diagnostic and therapeutic functionality, has the capability to create a paradigm shift in neurosurgical procedures. We are also pleased with the continued expansion of Zimmer Biomet’s launch of the Evo SEEG electrode and the related increase in revenue over past quarters. We expect this trend to continue with the expansion of additional centers. We believe the launch of the OneRF™ Ablation System will also have a positive impact on Evo sEEG customer demand. Coupled with the progress on our drug delivery and spinal cord stimulation programs, we remain confident in our strategic plan.”
Key Upcoming Milestones
Evo® sEEG:
- Revenue expected to increase with the addition of new accounts by Zimmer Biomet and with the introduction of the OneRF™ Ablation System
OneRF™ Ablation System:
- Initiate a limited commercial launch of the OneRF™ Ablation System in the second quarter of calendar year 2024
- Continue to explore additional applications and strategic partnership opportunities for ablation in neurology and other attractive markets that could benefit from NeuroOne’s high-resolution, thin-film electrode technology
Drug Delivery Program:
- Refine prototype design and testing including preclinical in-vivo study
- Continue to identify potential strategic partners to utilize NeuroOne’s drug delivery device in clinical studies and research
Spinal Cord Stimulation Program:
- Complete animal study to evaluate stimulation and battery performance using the Company’s spinal cord stimulation electrode technology
- Complete cadaver lab with our Spinal Cord Stimulation Advisory Board to further advance the development of the percutaneous implantation technique for NeuroOne’s thin-film paddle electrodes for spinal cord stimulation
First Quarter Fiscal Year 2024 Financial Results
Product revenue was
Total operating expenses in the first quarter of fiscal 2024 were
Net loss was
In December 2023, the Company sold common stock under the ATM Offering at an average price of
As of December 31, 2023, the Company had cash, cash equivalents, and short-term investments of
The Company had no debt outstanding as of December 31, 2023.
Conference Call and Webcast
Tuesday, February 13, 2024 – 4:30 PM Eastern Time
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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 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, the timing and extent of product launch and commercialization of our OneRF Ablation System, the potential capabilities of our OneRF Ablation System, 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 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
Balance Sheets
(unaudited)
| As of December 31, 2023 | As of September 30, 2023 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 2,680,985 | $ | 5,322,493 | ||||
| Accounts receivable | 543,399 | — | ||||||
| Inventory | 1,608,657 | 1,726,686 | ||||||
| Prepaid expenses and other assets | 259,966 | 263,746 | ||||||
| Total current assets | 5,093,007 | 7,312,925 | ||||||
| Intangible assets, net | 83,998 | 89,577 | ||||||
| Right-of-use assets | 140,198 | 169,059 | ||||||
| Property and equipment, net | 505,175 | 525,753 | ||||||
| Total assets | $ | 5,822,378 | $ | 8,097,314 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 760,000 | $ | 685,104 | ||||
| Accrued expenses and other liabilities | 623,240 | 1,107,522 | ||||||
| Total current liabilities | 1,383,240 | 1,792,626 | ||||||
| Operating lease liability, long term | 20,982 | 55,284 | ||||||
| Total liabilities | 1,404,222 | 1,847,910 | ||||||
| Commitments and contingencies (Note 4) | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 24,831 | 23,929 | ||||||
| Additional paid–in capital | 70,424,528 | 68,911,778 | ||||||
| Accumulated deficit | (66,031,203 | ) | (62,686,303 | ) | ||||
| Total stockholders’ equity | 4,418,156 | 6,249,404 | ||||||
| Total liabilities and stockholders’ equity | $ | 5,822,378 | $ | 8,097,314 | ||||
NeuroOne Medical Technologies Corporation
Statements of Operations
(unaudited)
| For the three months ended December 31, | ||||||||
| 2023 | 2022 | |||||||
| Product revenue | $ | 977,649 | $ | 114,579 | ||||
| Cost of product revenue | 711,335 | 126,886 | ||||||
| Product gross profit (loss) | 266,314 | (12,307 | ) | |||||
| Collaborations revenue | — | 1,455,188 | ||||||
| Operating expenses: | ||||||||
| Selling, general and administrative | 2,173,472 | 1,663,737 | ||||||
| Research and development | 1,483,317 | 1,563,496 | ||||||
| Total operating expenses | 3,656,789 | 3,227,233 | ||||||
| Loss from operations | (3,390,475 | ) | (1,784,352 | ) | ||||
| Other income | 45,575 | 51,583 | ||||||
| Loss before income taxes | (3,344,900 | ) | (1,732,769 | ) | ||||
| Provision for income taxes | — | — | ||||||
| Net loss | $ | (3,344,900 | ) | $ | (1,732,769 | ) | ||
| Net loss per share: | ||||||||
| Basic and diluted | $ | (0.14 | ) | $ | (0.11 | ) | ||
| Number of shares used in per share calculations: | ||||||||
| Basic and diluted | 23,995,610 | 16,230,997 | ||||||
FAQ
What was NeuroOne's product revenue in Q1 FY 2024?
What milestone did NeuroOne achieve related to FDA clearance?
What strategic advancements were highlighted by the CEO?
What was the net loss in Q1 FY 2024 compared to Q1 FY 2023?
How much did NeuroOne raise through the ATM Offering?
