NeuroOne® Reports Second Quarter Fiscal Year 2024 Financial Results and Provides Corporate Update
NeuroOne Medical Technologies (NASDAQ: NMTC) reported its financial results for Q2 FY2024, ending March 31, 2024. Product revenue increased to $1,377,000 from $466,000 in Q2 FY2023. The company raised an additional $2 million through the ATM Program. Key product updates include the commercial launch of the OneRF Ablation System and expanded use of the Evo sEEG system by Zimmer Biomet.
R&D expenses decreased to $1.3 million, while SG&A expenses rose to $2 million. Total operating expenses were $3.3 million. The net loss dropped to $2.9 million from $3.5 million in Q2 FY2023. Cash and cash equivalents fell to $2.4 million from $5.3 million as of September 2023.
Key upcoming milestones include transitioning to OneRF electrodes, enhancing the drug delivery program, and refining the spinal cord stimulation program.
- Product revenue increased to $1,377,000 in Q2 FY2024 from $466,000 in Q2 FY2023.
- Raised $2 million through the ATM Program.
- Zimmer Biomet expanded the Evo sEEG system to new accounts.
- Completed site training and initiated the commercial launch of the OneRF Ablation System.
- Completed feasibility testing for drug delivery and spinal cord stimulation programs.
- Reduced R&D expenses to $1.3 million, down from $1.7 million in Q2 FY2023.
- Net loss decreased to $2.9 million from $3.5 million in Q2 FY2023.
- Total operating expenses were high at $3.3 million.
- SG&A expenses increased to $2 million from $1.8 million in Q2 FY2023.
- Net loss for the first six months of FY2024 increased to $6.2 million from $5.3 million in FY2023.
- Cash and cash equivalents fell significantly to $2.4 million from $5.3 million as of September 2023.
- Working capital decreased to $3.2 million from $5.5 million as of September 2023.
- No collaboration revenue was reported for the first six months of FY2024, compared to $1.46 million in FY2023.
Insights
The financial results for NeuroOne Medical Technologies Corporation for Q2 2024 show a significant increase in product revenue, rising to
Operating expenses slightly decreased for Q2 2024, reaching
The additional
The recent developments in NeuroOne's portfolio are quite promising. The continued expansion of the Evo® sEEG product line by Zimmer Biomet indicates strong market acceptance and potential for revenue growth. The OneRF™ Ablation System has completed initial site training and launched limited commercialization, signaling progress toward broader market penetration. The fact that NeuroOne is the first to receive FDA 510(k) clearance for this technology is monumental, potentially positioning them for a competitive advantage.
The advancements in the drug delivery program and spinal cord stimulation (SCS) research are also noteworthy. Successful feasibility testing and animal studies pave the way for future clinical trials, which could unlock new avenues for revenue and partnerships. The ability to combine diagnostic and therapeutic capabilities in their systems could revolutionize treatment protocols in neurological surgery, enhancing both patient outcomes and market appeal. Investors should be aware of the long lead times associated with these developments, as clinical trials and regulatory hurdles could delay market entry.
EDEN PRAIRIE, Minn., May 14, 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 second quarter fiscal year 2024 ended March 31, 2024.
Second Quarter Fiscal Year 2024 and Recent Business Updates
Financial Highlights:
- Product revenue of
$1,377,000 in Q2 2024, compared to$466,000 in Q2 2023 - Raised an additional
$2.0 million using the ATM Program in Q2 2024
Evo® sEEG:
- Zimmer Biomet continued to expand into new accounts
- Product exhibited by Zimmer Biomet at the American Association of Neurological Surgeons (AANS) in May
OneRF™ Ablation System:
- Completed site training and initiated limited commercial launch of the OneRF™ Ablation System in late March
- Successfully implanted five patients
- Completed initial manufacturing run for limited commercial launch
- Presented ICD-10-PCS hospital inpatient code application to the Centers for Medicare and Medicaid Services (CMS) in March for the OneRF™ ablation procedure to support accurate data collection and processing of reimbursement claims by hospitals for the ablation procedure
- Exhibited the OneRF™ Ablation System at the AANS meeting in May
Drug Delivery Program:
- Completed feasibility bench top testing and animal study demonstrating the ability to deliver a therapeutic agent 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 animal study to evaluate stimulation and battery performance using the Company’s spinal cord stimulation electrode technology
- Led by our Spinal Cord Stimulation Advisory Board, completed cadaver study to further advance the development of the percutaneous implantation technique for NeuroOne’s thin-film paddle electrodes for spinal cord stimulation
- Presented posters on pre-clinical experience with thin-film paddle leads at North American Neuromodulation Society (NANS) and Gordon Research Conference on Neuroelectronic Interfaces
Dave Rosa, CEO of NeuroOne, commented, “We made excellent progress this quarter across multiple fronts. Revenue growth continued regarding our sEEG product line as new customer sites were added by Zimmer Biomet. We also initiated the limited commercial launch of the OneRF™ Ablation System, an exciting accomplishment given we are the first company to receive FDA 510(k) clearance to market this novel technology in the United States. Customer interest has been strong and we believe the OneRF™ Ablation System, with combination diagnostic and therapeutic functionality, has the capability to create a paradigm shift in neurosurgical procedures. Moving forward, we will investigate other applications to leverage our ablation system. We continue to believe strongly in the market opportunity for our drug delivery system as we believe it has the potential to create a unique platform for both identifying the target area in the brain, delivering the pharmacologic agent and monitoring its performance.”
Key Upcoming Milestones
OneRF™ Ablation System:
- Transition manufacturing from sEEG diagnostic electrodes to OneRF electrodes
- Add new centers for our limited commercial launch
- Exhibit OneRF™ Ablation System and present posters at the 2024 American Society for Stereotactic and Functional Neurosurgery (ASSFN) meeting in June
- 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 complete biocompatibility study
- Continue to identify potential strategic partners to utilize NeuroOne’s drug delivery device in clinical studies and research
Spinal Cord Stimulation Program:
- Finalize electrode design
- Present poster on feasibility of implantation of epidural thin-film paddle leads at International Neuromodulation Society’s (INS) World Congress
Second Quarter Fiscal Year 2024 Financial Results
Product revenue was
Total operating expenses in the second quarter of fiscal 2024 were
Net loss was
In the second quarter of fiscal 2024, the Company sold common stock under the ATM Program at an average price of
As of March 31, 2024, the Company had cash and cash equivalents of
The Company had no debt outstanding as of March 31, 2024.
Conference Call and Webcast
Tuesday, May 14, 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 transition of manufacturing from sEEG diagnostic electrodes to OneRF electrodes, the addition of new centers for the Company’s limited commercial launch, 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 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
Condensed Balance Sheets
(unaudited)
| As of March 31, | As of September 30, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 2,434,655 | $ | 5,322,493 | ||||
| Accounts receivable | 555,639 | — | ||||||
| Inventory | 1,311,673 | 1,726,686 | ||||||
| Prepaid expenses | 407,777 | 263,746 | ||||||
| Total current assets | 4,709,744 | 7,312,925 | ||||||
| Intangible assets, net | 78,419 | 89,577 | ||||||
| Right-of-use assets | 110,724 | 169,059 | ||||||
| Property and equipment, net | 496,015 | 525,753 | ||||||
| Total assets | $ | 5,394,902 | $ | 8,097,314 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 780,839 | $ | 685,104 | ||||
| Accrued expenses and other liabilities | 759,620 | 1,107,522 | ||||||
| Total current liabilities | 1,540,459 | 1,792,626 | ||||||
| Operating lease liability, long term | — | 55,284 | ||||||
| Total liabilities | 1,540,459 | 1,847,910 | ||||||
| Commitments and contingencies (Note 4) | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 26,322 | 23,929 | ||||||
| Additional paid–in capital | 72,714,414 | 68,911,778 | ||||||
| Accumulated deficit | (68,886,293 | ) | (62,686,303 | ) | ||||
| Total stockholders’ equity | 3,854,443 | 6,249,404 | ||||||
| Total liabilities and stockholders’ equity | $ | 5,394,902 | $ | 8,097,314 | ||||
NeuroOne Medical Technologies Corporation
Condensed Statements of Operations
(unaudited)
| For the Three Months Ended | For the Six Months Ended | |||||||||||||||
| March 31, | March 31, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Product revenue | $ | 1,377,294 | $ | 466,176 | $ | 2,354,943 | $ | 580,755 | ||||||||
| Cost of product revenue | 986,875 | 434,673 | 1,698,210 | 561,559 | ||||||||||||
| Product gross profit | 390,419 | 31,503 | 656,733 | 19,196 | ||||||||||||
| Collaborations revenue | — | — | — | 1,455,188 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Selling, general and administrative | 2,002,949 | 1,821,108 | 4,176,421 | 3,484,845 | ||||||||||||
| Research and development | 1,273,568 | 1,706,314 | 2,756,885 | 3,269,810 | ||||||||||||
| Total operating expenses | 3,276,517 | 3,527,422 | 6,933,306 | 6,754,655 | ||||||||||||
| Loss from operations | (2,886,098 | ) | (3,495,919 | ) | (6,276,573 | ) | (5,280,271 | ) | ||||||||
| Other income (expense), net | 31,008 | (26,909 | ) | 76,583 | 24,674 | |||||||||||
| Loss before income taxes | (2,855,090 | ) | (3,522,828 | ) | (6,199,990 | ) | (5,255,597 | ) | ||||||||
| Provision for income taxes | — | — | — | — | ||||||||||||
| Net loss | $ | (2,855,090 | ) | $ | (3,522,828 | ) | $ | (6,199,990 | ) | $ | (5,255,597 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic and diluted | $ | (0.11 | ) | $ | (0.21 | ) | $ | (0.25 | ) | $ | (0.32 | ) | ||||
| Number of shares used in per share calculations: | ||||||||||||||||
| Basic and diluted | 25,910,478 | 16,414,795 | 24,947,813 | 16,321,891 | ||||||||||||
FAQ
What were NeuroOne's product revenues for Q2 FY2024?
How much additional funding did NeuroOne raise in Q2 FY2024?
What key product updates did NeuroOne announce for Q2 FY2024?
What were NeuroOne's R&D expenses in Q2 FY2024?
What were NeuroOne's SG&A expenses in Q2 FY2024?
What was NeuroOne's net loss in Q2 FY2024?
How much cash and cash equivalents did NeuroOne have as of March 31, 2024?
What are NeuroOne's key upcoming milestones?
