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
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 $1,377,000 in the second quarter of fiscal 2024, compared to product revenue of
Total operating expenses in the second quarter of fiscal 2024 were $3.3 million, compared with $3.5 million in the same period of the prior fiscal year. Research and Development (R&D) expense in the second quarter of fiscal 2024 was $1.3 million compared with $1.7 million in the second quarter of fiscal 2023. Selling, General and Administrative (SG&A) expense in the second quarter of fiscal 2024 was $2.0 million compared with $1.8 million in the prior year period. For the first six months of fiscal 2024, total operating expenses were
Net loss was $2.9 million for the second quarter of fiscal 2024, compared to a net loss of $3.5 million in the second quarter of fiscal 2023. Net loss for the first six months of fiscal 2024 was $6.2 million compared with $5.3 million in the same period of fiscal 2023.
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 $2.4 million, compared to $5.3 million as of September 30, 2023. The Company had working capital of
The Company had no debt outstanding as of March 31, 2024.
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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 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
Caution: Federal law restricts this device to sale by or on the order of a physician.
Contact:
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ir@nmtc1.com
Condensed Balance Sheets
(unaudited)
As of | As of | |||||||
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 |
Condensed Statements of Operations
(unaudited)
For the Three Months Ended | For the Six Months Ended | |||||||||||||||
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 |
Source:
2024 GlobeNewswire, Inc., source