EDEN PRAIRIE, Minn., Aug. 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 third quarter fiscal year 2024 ended June 30, 2024.
Third Quarter Fiscal Year 2024 and Recent Business Updates
Financial Highlights:
Evo® sEEG:
OneRF™ Ablation System:
sEEG-Based Drug Delivery Program:
Spinal Cord Stimulation (SCS) Percutaneous Paddle Lead Program:
Dave Rosa, CEO of NeuroOne, commented, “We accomplished several key milestones this quarter. We are most excited about completing the first RF ablation cases with our first-to-market OneRF™ Ablation System. We also signed a non-binding term sheet with a large strategic partner to serve as our distribution partner and accelerate the launch of the OneRF™ Ablation System. In August, we completed a financing, entered into a credit facility agreement, and are making good progress with our product pipeline, including additional RF ablation applications, sEEG-based drug delivery and a percutaneous paddle lead for spinal cord stimulation. We are looking forward to securing additional strategic partners for these exciting programs leveraging our thin-film electrode platform technology.”
Key Upcoming Milestones
OneRF™ Ablation System:
Spinal Cord Stimulation Percutaneous Paddle Lead Program:
Third Quarter Fiscal Year 2024 Financial Results
Product revenue was $826,000 in the third quarter of fiscal 2024, compared to product revenue of $630,000 in the third quarter of fiscal 2023. For the first nine months of fiscal 2024, product revenue was $3.2 million, compared to $1.2 million for the same period in fiscal 2023. The Company had no collaboration revenue in the first nine months of fiscal 2024, compared to collaboration revenue of $1.46 million in the first nine months of fiscal 2023. Collaboration revenue in 2023 was derived from the Zimmer Development Agreement and represents the portion of the exclusivity and milestone fee payments eligible for revenue recognition during the period.
Total operating expenses in the third quarter of fiscal 2024 were $3.1 million, compared with $3.8 million in the same period of the prior fiscal year. Research and Development (R&D) expense in the third quarter of fiscal 2024 was $1.2 million compared with $1.9 million in the third quarter of fiscal 2023. Selling, General and Administrative (SG&A) expenses were $1.9 million during each of the three months ended June 30, 2024 and 2023. For the first nine months of fiscal 2024, total operating expenses were $10.0 million, compared with $10.5 million in the same period of fiscal 2023. R&D expense in the first nine months of fiscal 2024 was $4.0 million compared with $5.2 million in the same period of fiscal 2023. SG&A expense in the first nine months of fiscal 2024 was $6.1 million compared with $5.3 million in the prior year period.
Net loss was $2.8 million for the third quarter of fiscal 2024, compared to a net loss of $3.5 million in the third quarter of fiscal 2023. Net loss for the first nine months of fiscal 2024 was $9.0 million compared with $8.7 million in the same period of fiscal 2023.
In the third quarter of fiscal 2024, the Company sold common stock under the ATM Program at an average price of $1.19 per share, from which the Company received net proceeds of $1.6 million.
As of June 30, 2024, the Company had cash and cash equivalents of $1.6 million, compared to $5.3 million as of September 30, 2023. The Company had working capital of $2.2 million as of June 30, 2024, compared to working capital of $5.5 million as of September 30, 2023.
The Company had no debt outstanding as of June 30, 2024.
On August 2, 2024, the Company completed a $2.65 million private placement, resulting in $2.55 million in net proceeds, and entered into a $3.0 million secured credit facility agreement. The Company has not borrowed anything under the credit facility agreement at this time.
Conference Call and Webcast
Wednesday, August 14, 2024, at 4:30 PM Eastern Time
Participants:
Toll Free: 877-545-0320
International: 973-528-0002
Participant Access Code: 579769
Phone Replay:
Toll Free: 877-481-4010
International: 919-882-2331
Replay Passcode: 51065
Available through August 28, 2024
Live Webcast:
Join here.
Webcast replay available for 12 months
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 securing a strategic partnership for distribution of the OneRF™ Ablation System, the addition of new centers for the Company’s limited commercial launch of the OneRF™ Ablation System, 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 our strategic partnerships 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
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NeuroOne Medical Technologies Corporation
Condensed Balance Sheets
| As of June 30, | As of September 30, | |||||||
| 2024 | 2023 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 1,619,977 | $ | 5,322,493 | ||||
| Accounts receivable | 410,551 | — | ||||||
| Inventory | 1,793,432 | 1,726,686 | ||||||
| Prepaid expenses | 261,477 | 263,746 | ||||||
| Total current assets | 4,085,437 | 7,312,925 | ||||||
| Intangible assets, net | 72,841 | 89,577 | ||||||
| Right-of-use assets | 281,833 | 169,059 | ||||||
| Property and equipment, net | 472,486 | 525,753 | ||||||
| Total assets | $ | 4,912,597 | $ | 8,097,314 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 759,260 | $ | 685,104 | ||||
| Accrued expenses and other liabilities | 931,700 | 1,107,522 | ||||||
| Total current liabilities | 1,690,960 | 1,792,626 | ||||||
| Operating lease liability, long term | 209,910 | 55,284 | ||||||
| Total liabilities | 1,900,870 | 1,847,910 | ||||||
| Commitments and contingencies (Note 4) | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued or outstanding. | — | — | ||||||
| Common stock, $0.001 par value; 100,000,000 shares authorized; 27,846,722 and 23,928,945 shares issued and outstanding as of June 30, 2024 and September 30, 2023, respectively. | 27,847 | 23,929 | ||||||
| Additional paid–in capital | 74,637,698 | 68,911,778 | ||||||
| Accumulated deficit | (71,653,818 | ) | (62,686,303 | ) | ||||
| Total stockholders’ equity | 3,011,727 | 6,249,404 | ||||||
| Total liabilities and stockholders’ equity | $ | 4,912,597 | $ | 8,097,314 | ||||
NeuroOne Medical Technologies Corporation
Condensed Statements of Operations
(unaudited)
| For the Three Months Ended | For the Nine Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Product revenue | $ | 825,776 | $ | 629,906 | $ | 3,180,719 | $ | 1,210,661 | ||||||||
| Cost of product revenue | 543,904 | 386,240 | 2,242,114 | 947,799 | ||||||||||||
| Product gross profit | 281,872 | 243,666 | 938,605 | 262,862 | ||||||||||||
| Collaborations revenue | — | — | — | 1,455,188 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Selling, general and administrative | 1,881,099 | 1,862,389 | 6,057,520 | 5,347,234 | ||||||||||||
| Research and development | 1,194,674 | 1,891,512 | 3,951,559 | 5,161,322 | ||||||||||||
| Total operating expenses | 3,075,773 | 3,753,901 | 10,009,079 | 10,508,556 | ||||||||||||
| Loss from operations | (2,793,901 | ) | (3,510,235 | ) | (9,070,474 | ) | (8,790,506 | ) | ||||||||
| Other income, net | 26,376 | 41,462 | 102,959 | 66,136 | ||||||||||||
| Loss before income taxes | (2,767,525 | ) | (3,468,773 | ) | (8,967,515 | ) | (8,724,370 | ) | ||||||||
| Provision for income taxes | — | — | — | — | ||||||||||||
| Net loss | $ | (2,767,525 | ) | $ | (3,468,773 | ) | $ | (8,967,515 | ) | $ | (8,724,370 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic and diluted | $ | (0.10 | ) | $ | (0.20 | ) | $ | (0.35 | ) | $ | (0.52 | ) | ||||
| Number of shares used in per share calculations: | ||||||||||||||||
| Basic and diluted | 27,352,660 | 17,578,871 | 25,746,503 | 16,740,546 | ||||||||||||
| Last Trade: | US$0.76 |
| Daily Volume: | 89,171 |
| Market Cap: | US$23.350M |
October 31, 2024 September 10, 2024 September 05, 2024 | |
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