EDEN PRAIRIE, Minn., May 11, 2023 (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 fiscal second quarter 2023 ended March 31, 2023.
Fiscal Second Quarter 2023 and Recent Business Updates
Evo® sEEG:
OneRF™Ablation:
Spinal Cord Stimulation Program:
Drug Delivery Program:
Other Updates:
Dave Rosa, CEO of NeuroOne, commented, “We were excited to officially announce the commercial release of our Evo sEEG electrode and look forward to a successful launch with Zimmer Biomet. In addition, we continued to make critical progress with the OneRF ablation system design verification testing and remain on track to submit a 510(k) to FDA for OneRF in the second calendar quarter of 2023. We made meaningful progress with our spinal cord stimulation program, as well as our recording and drug delivery system. We also filled a key executive role and are excited to have Anthony Millar join our team as our VP of Operations.”
Upcoming Targeted Milestones
Evo sEEG:
OneRF:
SCS Program:
Drug Delivery Program:
Fiscal Second Quarter 2023 Financial Results
Product revenue was $466,000 in the fiscal second quarter 2023, compared to product revenue of $37,000 in the fiscal second quarter 2022. For the first six months of fiscal 2023, product revenue was $581,000, compared to $70,000 for the same period in fiscal 2022. Collaboration revenue was $1.46 million in the first six months of fiscal 2023, compared to collaboration revenue of $6,000 in the first six months of fiscal 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 second quarter 2023 were $3.5 million, compared with $3.0 million in the same period of the prior fiscal year. Research and Development expense in the fiscal second quarter 2023 was $1.7 million compared with $1.2 million in the same period of fiscal 2022. Selling General and Administrative expense in the fiscal second quarter 2023 was $1.8 million compared with $1.8 million in the prior year period. For the first six months of fiscal 2023, total operating expenses were $6.8 million, compared with $5.8 million in the same period of the prior fiscal year. R&D expense in the first six months of fiscal 2023 was $3.3 million compared with $2.3 million in the same period of fiscal 2022. SG&A expense in the first six months of fiscal 2023 was $3.5 million compared with $3.6 million in the prior year period.
Net loss was $3.5 million for the fiscal second quarter 2023, compared to a net loss of $3.1 million in the prior year period. Net loss for the first six months of fiscal 2023 was $5.3 million compared with $5.9 million in the same period of fiscal 2022.
As of March 31, 2023, the Company had cash, cash equivalents, and short-term investments of $4.6 million, compared to $11.1 million as of September 30, 2022. The Company had working capital of $4.8 million as of March 31, 2023, compared to working capital of $9.1 million as of September 30, 2022.
The Company had no debt outstanding as of March 31, 2023.
Conference Call and Webcast Information
Thursday, May 11, 2023 – 4:30 PM Eastern Time
Participant Dial-In:
877-405-1216 / 201-689-8336
Participant Dial-In:
888-645-4404 / 862-298-0702
Live Webcast:
Join here.
Phone Replay:
877-660-6853 / 201-612-7415, Access ID: 13738525; available through May 25, 2023
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 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, receipt of revenues from sale of the sEEG electrodes, timing and success of any clinical and pre-clinical testing, development of our OneRF, 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, 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.
Contact:
800-631-4030
This email address is being protected from spambots. You need JavaScript enabled to view it.
NeuroOne Medical Technologies Corporation
Condensed Balance Sheets
(unaudited)
March 31, 2023 | September 30, 2022 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 3,602,163 | $ | 8,160,329 | ||||
Short-term investments | 995,432 | 2,981,010 | ||||||
Accounts receivable | 213,952 | 33,237 | ||||||
Inventory | 1,174,307 | 704,538 | ||||||
Prepaids | 370,703 | 296,649 | ||||||
Total current assets | 6,356,557 | 12,175,763 | ||||||
Intangible assets, net | 100,734 | 111,892 | ||||||
Right-of-use asset | 225,005 | 181,355 | ||||||
Property and equipment, net | 522,810 | 353,599 | ||||||
Total assets | $ | 7,205,106 | $ | 12,822,609 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 953,446 | $ | 927,662 | ||||
Accrued expenses and other liabilities | 596,940 | 715,839 | ||||||
Deferred revenue | — | 1,455,188 | ||||||
Total current liabilities | 1,550,386 | 3,098,689 | ||||||
Operating lease liability, long term | 121,896 | 119,556 | ||||||
Total liabilities | 1,672,282 | 3,218,245 | ||||||
Commitments and contingencies (Note 4) | ||||||||
Stockholders’ equity: | ||||||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized as of March 31, 2023 and September 30, 2022; no shares issued or outstanding as of March 31, 2023 and September 30, 2022. | — | — | ||||||
Common stock, $0.001 par value; 100,000,000 shares authorized as of March 31, 2023 and September 30, 2022; 16,887,738 and 16,216,540 shares issued and outstanding as of March 31, 2023 and September 30, 2022, respectively. | 16,888 | 16,217 | ||||||
Additional paid–in capital | 61,598,345 | 60,414,959 | ||||||
Accumulated deficit | (56,082,409 | ) | (50,826,812 | ) | ||||
Total stockholders’ equity | 5,532,824 | 9,604,364 | ||||||
Total liabilities and stockholders’ equity | $ | 7,205,106 | $ | 12,822,609 |
See accompanying notes to condensed financial statements
NeuroOne Medical Technologies Corporation
Condensed Statements of Operations
(unaudited)
For the Three Months Ended | For the Six Months Ended | |||||||||||||||
March 31, | March 31, | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Product revenue | $ | 466,176 | $ | 36,584 | $ | 580,755 | $ | 70,332 | ||||||||
Cost of product revenue | 434,673 | 72,807 | 561,559 | 119,651 | ||||||||||||
Product gross profit (loss) | 31,503 | (36,223 | ) | 19,196 | (49,319 | ) | ||||||||||
Collaborations revenue | — | — | 1,455,188 | 6,374 | ||||||||||||
Operating expenses: | ||||||||||||||||
Selling, general and administrative | 1,821,108 | 1,818,207 | 3,484,845 | 3,560,348 | ||||||||||||
Research and development | 1,706,314 | 1,205,380 | 3,269,810 | 2,265,842 | ||||||||||||
Total operating expenses | 3,527,422 | 3,023,587 | 6,754,655 | 5,826,190 | ||||||||||||
Loss from operations | (3,495,919 | ) | (3,059,810 | ) | (5,280,271 | ) | (5,869,135 | ) | ||||||||
Other (expense) income, net | (26,909 | ) | 1,743 | 24,674 | 3,593 | |||||||||||
Loss before income taxes | (3,522,828 | ) | (3,058,067 | ) | (5,255,597 | ) | (5,865,542 | ) | ||||||||
Provision for income taxes | — | — | — | — | ||||||||||||
Net loss | $ | (3,522,828 | ) | $ | (3,058,067 | ) | $ | (5,255,597 | ) | $ | (5,865,542 | ) | ||||
Net loss per share: | ||||||||||||||||
Basic and diluted | $ | (0.21 | ) | $ | (0.19 | ) | $ | (0.32 | ) | $ | (0.37 | ) | ||||
Number of shares used in per share calculations: | ||||||||||||||||
Basic and diluted | 16,414,795 | 16,189,867 | 16,321,891 | 15,794,880 |
See accompanying notes to condensed financial statements
Last Trade: | US$0.76 |
Daily Volume: | 89,171 |
Market Cap: | US$23.350M |
October 31, 2024 September 10, 2024 September 05, 2024 |
Chimerix is on a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company is devoted to filling gaps in the treatment paradigm. Chimerix’s most advanced clinical-stage program is in development for H3 K27M-mutant glioma....
CLICK TO LEARN MORERecursion Pharmaceuticals is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest....
CLICK TO LEARN MOREEnd of content
No more pages to load
COPYRIGHT ©2023 HEALTH STOCKS HUB