EDEN PRAIRIE, Minn., Sept. 08, 2025 (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, will be participating in the Sidoti & Co. Virtual Small-Cap Conference being held September 17-18, 2025. Dave Rosa, President and Chief Executive Officer, and Ron McClurg, Chief Financial Officer, are scheduled to present on Septem ...

Following the announcement yesterday, the company's shares have gained 7% in today's pre-market trading. Shares have gained 0.5% in the year-to-date period compared with the industry's 1% growth. The S&P 500 has gained 9.6% in the same time frame. The OneRF platform leverages proprietary multi-contact RF probe technology, allowing precise localization and tailored ablation under temperature-controlled conditions. This innovation aims to improve patient safety, reduce procedural time, and expand NMTC's footp ...

Core Viewpoint - NeuroOne Medical Technologies Corporation has received FDA clearance for its OneRF Trigeminal Nerve Ablation System, which offers a minimally invasive alternative for treating trigeminal neuralgia, a chronic pain condition affecting approximately 150,000 people annually in the U.S. [1][2] Group 1: Product and Technology - The OneRF Trigeminal Nerve Ablation System utilizes a proprietary RF generator platform to create radiofrequency lesions for pain treatment and functional neurosurgical procedures [1][2] - This system features a unique multi-contact RF probe that allows for precise localization and tailored ablation of nerve tissue, enhancing safety and accuracy during procedures [3] - The technology aims to reduce procedural time, improve patient comfort, and enhance overall patient safety [3] Group 2: Market Potential and Strategy - The company plans a limited commercial launch of the OneRF system in the fourth quarter of 2025, with expectations to generate revenues from trigeminal nerve ablation by late 2025 [1][4] - NeuroOne's technology platform has potential applications across various neurological disorders and pain management functions, including lower back pain [4] - Current users of the OneRF brain ablation system may also adopt the nerve ablation procedures, justifying further investment in the technology [4] Group 3: Company Overview - NeuroOne Medical Technologies Corporation focuses on developing minimally invasive solutions for various neurological disorders, including epilepsy and chronic pain [5] - The company is exploring additional therapeutic applications, such as treatments for depression, mood disorders, and high blood pressure [5]

Financial Data and Key Metrics Changes - Product revenue increased 105% to $1,700,000 in Q3 2025 compared to $800,000 in Q3 2024, with a year-to-date increase of 100% to $6,400,000 from $3,200,000 [4][13] - Product gross margins improved to 53.9% in Q3 2025 from 34.1% in Q3 2024, with gross profit rising to $900,000 from $300,000 [4][14] - Net loss improved to $1,500,000 or a loss of $0.03 per share in Q3 2025, compared to a net loss of $2,800,000 or a loss of $0.10 per share in Q3 2024 [17] - Cash and cash equivalents increased to $8,000,000 as of June 30, 2025, from $1,500,000 as of September 30, 2024 [18] Business Line Data and Key Metrics Changes - Licensing revenue of $3,000,000 was generated in the first nine months of fiscal 2025, compared to no licensing revenue in the same period of fiscal 2024, derived from an expanded agreement with Zimmer Biomet [13][14] - Total operating expenses decreased 9% to $2,800,000 in Q3 2025 compared to $3,100,000 in Q3 2024, with R&D expenses stable at $1,200,000 [15][16] Market Data and Key Metrics Changes - The company is pursuing market opportunities in pain management, including trigeminal neuralgia and lower back pain treatments, with potential revenue generation expected in late 2025 [6][7] - The spinal cord stimulation market is estimated to generate over $3,000,000,000 in annual revenue, representing a significant opportunity for the company [8] Company Strategy and Development Direction - The company aims to expand its product portfolio in pain management and other therapeutic applications, leveraging its thin film ablation technology [6][7] - Plans to initiate a post-market registry to collect outcomes data for patients treated with the 1RF ablation system, highlighting positive patient outcomes [5][6] Management's Comments on Operating Environment and Future Outlook - Management reiterated expectations of being funded through at least fiscal year 2026 based on contractual minimum orders and potential cash flow breakeven if key milestones are achieved [5][18] - The company is confident in its fiscal year 2025 guidance, expecting product revenue to be in the range of $8,000,000 to $10,000,000, representing a significant increase over fiscal year 2024 [12] Other Important Information - The company has received its first international patent for its spinal cord stimulation electrode and is in the process of securing ISO certification for international commercialization [10][11] - New hires in the management team are expected to contribute positively and bring cost savings [11] Q&A Session Summary Question: Can you provide an update on the drug delivery platform and its testing status? - The devices are currently ordered for initial bench testing, followed by animal testing, with human trials planned if animal testing is successful [21][22] Question: What is the market potential for trigeminal ablation and the physician specialties involved? - Approximately 150,000 people in the US suffer from trigeminal neuralgia, with potential procedures being similar to brain ablations, targeting the same physician specialties [25][26] Question: Can you discuss the design and target levels for spinal cord stimulation? - The therapy targets lower back pain, likely from L3, L4 to S1, with multiple components expected in the system [27][28] Question: Any outlook for 2026? - The company is not providing a forecast for 2026 at this time, but remains confident in its current range due to minimum purchase requirements from Zimmer [30]

Part I – Financial Information [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company's financial position improved significantly by June 30, 2025, with cash increasing to **$8.0 million**, product revenue doubling to **$6.4 million**, and net loss substantially reduced to **$2.0 million** [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) Condensed Balance Sheet Highlights (Unaudited) | Metric | June 30, 2025 ($) | September 30, 2024 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | 8,039,683 | 1,460,042 | +6,579,641 | | Total current assets | 10,170,747 | 4,630,925 | +5,539,822 | | Total assets | 10,819,481 | 5,369,940 | +5,449,541 | | Total liabilities | 2,642,028 | 4,547,927 | -1,905,899 | | Total stockholders' equity | 8,177,453 | 822,013 | +7,355,440 | [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) Operating Results for the Nine Months Ended June 30 (Unaudited) | Metric | 2025 ($) | 2024 ($) | Change (%) | | :--- | :--- | :--- | :--- | | Product revenue | 6,356,767 | 3,180,719 | +99.8% | | Product gross profit | 3,612,785 | 938,605 | +284.9% | | License revenue | 3,000,000 | 0 | N/A | | Loss from operations | (2,855,409) | (9,070,474) | +68.5% | | Net loss | (1,986,153) | (8,967,515) | +77.8% | | Net loss per share (Basic and diluted) | (0.05) | (0.35) | +85.7% | Operating Results for the Three Months Ended June 30 (Unaudited) | Metric | 2025 ($) | 2024 ($) | Change (%) | | :--- | :--- | :--- | :--- | | Product revenue | 1,696,050 | 825,776 | +105.4% | | Product gross profit | 914,835 | 281,872 | +224.5% | | Net loss | (1,500,868) | (2,767,525) | +45.8% | | Net loss per share (Basic and diluted) | (0.03) | (0.10) | +70.0% | [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Cash Flow Summary for the Nine Months Ended June 30 (Unaudited) | Cash Flow Activity | 2025 ($) | 2024 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | (1,311,600) | (8,344,957) | | Net cash used in investing activities | (71,135) | (83,292) | | Net cash provided by financing activities | 7,962,376 | 4,725,733 | | Net increase (decrease) in cash | 6,579,641 | (3,702,516) | | Cash at end of period | 8,039,683 | 1,619,977 | [Notes to Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Key notes detail improved liquidity, revenue recognition from the amended Zimmer agreement, recent equity financing activities, and stock-based compensation plans, with **$8.0 million** cash deemed sufficient for the next twelve months - The company believes its **$8.0 million** in cash and cash equivalents as of June 30, 2025, along with anticipated revenue increases and cost reductions, will be sufficient to fund planned expenditures for at least twelve months, addressing previous going concern issues[25](index=25&type=chunk) - In October 2024, the company entered into an amended distribution agreement with Zimmer, receiving a **$3.0 million** upfront payment for the exclusive distribution license of its OneRF Ablation System, recognized as license revenue in the nine months ended June 30, 2025[84](index=84&type=chunk)[88](index=88&type=chunk)[92](index=92&type=chunk) - In April 2025, the company completed an underwritten public offering, issuing **18.4 million** shares of common stock (including the full exercise of the overallotment option) at **$0.50 per share**, resulting in net proceeds of approximately **$8.2 million**[117](index=117&type=chunk)[140](index=140&type=chunk) - Warrants issued in the August 2024 Private Placement are accounted for as a liability, with a fair value of **$1.04 million** as of June 30, 2025, and the change in fair value resulted in a gain of **$1.1 million** for the nine months ended June 30, 2025, recorded in the statement of operations[40](index=40&type=chunk)[121](index=121&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes improved financial results to the Zimmer agreement, driving **$6.4 million** product revenue and a reduced **$2.0 million** net loss, supported by **$8.2 million** in financing for future operations [Results of Operations](index=31&type=section&id=Results%20of%20Operations) For the nine months ended June 30, 2025, revenue substantially increased to **$6.4 million** in product sales and **$3.0 million** in license revenue, improving gross margin to **56.8%** and reducing net loss to **$2.0 million** Comparison of Nine Months Ended June 30, 2025 and 2024 | Metric | 2025 ($) | 2024 ($) | Key Drivers of Change | | :--- | :--- | :--- | :--- | | Product Revenue | 6.4M | 3.2M | Increased sales of higher-margin OneRF Products under the Zimmer agreement | | Product Gross Profit % | 56.8% | 29.5% | Favorable product mix with more OneRF Products | | License Revenue | 3.0M | 0 | 3.0M upfront payment from Zimmer for OneRF distribution license | | Operating Expenses | 9.5M | 10.0M | Decrease in legal and investor relations costs | | Net Loss | (2.0M) | (9.0M) | Higher revenue, improved margins, and a 1.1M gain on warrant liability fair value | Comparison of Three Months Ended June 30, 2025 and 2024 | Metric | 2025 ($) | 2024 ($) | Key Drivers of Change | | :--- | :--- | :--- | :--- | | Product Revenue | 1.7M | 0.8M | Increased sales of higher-margin OneRF Products | | Product Gross Profit % | 53.9% | 34.1% | Favorable product mix | | Selling, General & Admin | 1.6M | 1.9M | Lower legal and investor relations costs | | Net Loss | (1.5M) | (2.8M) | Higher revenue, improved margins, and a 0.3M gain on warrant liability fair value | [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company held **$8.0 million** in cash, significantly bolstered by **$8.2 million** from April 2025 financing, ensuring sufficient liquidity for at least the next twelve months - The company's cash and cash equivalents increased to **$8.0 million** as of June 30, 2025[177](index=177&type=chunk) - In April 2025, the company raised approximately **$8.2 million** in net proceeds through an underwritten public offering of common stock[180](index=180&type=chunk) - Management concluded that current cash reserves are sufficient to fund planned expenditures and meet obligations for at least twelve months from the financial statement issuance date, mitigating previous substantial doubt about its ability to continue as a going concern[194](index=194&type=chunk) - The company terminated its Debt Facility Agreement in November 2024 without drawing any funds and decreased the available amount under its At-The-Market (ATM) offering to zero in April 2025[184](index=184&type=chunk)[185](index=185&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable as the company is a smaller reporting company - Not applicable for smaller reporting companies[213](index=213&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) The CEO and CFO concluded that disclosure controls and procedures were effective, with no material changes in internal control over financial reporting during the quarter - The company's CEO and CFO concluded that disclosure controls and procedures were effective as of the end of the reporting period[214](index=214&type=chunk) - No changes occurred during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[215](index=215&type=chunk) Part II – Other Information [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings that are expected to have a material adverse effect on its business - The company is not currently involved in any legal proceedings that management believes would have a material adverse effect on the business[217](index=217&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) This section refers to the risk factors discussed in the company's Annual Report on Form 10-K for the year ended September 30, 2024 - For a discussion of risk factors, the report refers to Part I, Item 1A of the Company's Annual Report on Form 10-K for the fiscal year ended September 30, 2024[218](index=218&type=chunk) [Item 5. Other Information](index=40&type=section&id=Item%205.%20Other%20Information) On May 20, 2025, the board amended the 2021 Inducement Plan, increasing available shares by **575,000** to attract qualified employees - On May 20, 2025, the company's board amended the Inducement Plan to increase the aggregate number of shares available for equity incentive awards by **575,000**[223](index=223&type=chunk) [Item 6. Exhibits](index=41&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, the Second Amendment to the 2021 Incentive Plan, the underwriting agreement for the April 2025 financing, and officer certifications

[Executive Summary & Recent Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Recent%20Highlights) [Recent Company Highlights](index=1&type=section&id=Recent%20Company%20Highlights) NeuroOne achieved significant Q3 FY2025 financial improvements, including 105% product revenue growth, 53.9% gross margin, and an $8.2 million financing, alongside key operational milestones Key Financial Highlights for Q3 FY2025 | Metric | Q3 FY2025 | Q3 FY2024 | Change (YoY) | | :-------------------- | :---------- | :---------- | :---------- | | Product Revenue | $1.7 million | $0.8 million | +105% | | Product Gross Margin | 53.9% | 34.1% | +19.8 pp | | Operating Expenses | $2.8 million | $3.1 million | -9% | | Net Capital Raised | $8.2 million | N/A | N/A | - The first OneRF® Ablation System patient achieved one-year seizure-free status, significantly improving quality of life[3](index=3&type=chunk)[4](index=4&type=chunk) - Early FDA submission for the OneRF® Trigeminal Nerve Ablation System for facial pain treatment, with a response expected soon[4](index=4&type=chunk) - Received the first order for the sEEG drug delivery system from a major biopharmaceutical company, marking entry into a new market[4](index=4&type=chunk) - Received a key patent allowance notice from the USPTO for manufacturing methods of neural and spinal cord stimulation electrodes, enhancing competitive advantage[4](index=4&type=chunk) - Strengthened the management team by adding a Chief Medical Advisor, General Counsel, and Senior Director of Quality Assurance and Regulatory Affairs[4](index=4&type=chunk) [Management Commentary](index=1&type=section&id=Management%20Commentary) CEO Dave Rosa highlighted significant Q3 FY2025 financial and operational milestones, emphasizing OneRF® success, market expansion, and a strengthened financial position - Continued successful rollout of the OneRF® Ablation System drove significant revenue and gross profit growth[3](index=3&type=chunk) - Submitted 510(k) application for the OneRF® Trigeminal Nerve Ablation System to the FDA, with a response expected soon and potential revenue generation in calendar year 2025[5](index=5&type=chunk) - Received the first order for the sEEG drug delivery system and is discussing other potential applications with top strategic partners[5](index=5&type=chunk) - Initiated ISO 13485 certification program to prepare for international market entry, anticipating additional growth[6](index=6&type=chunk) - The intellectual property portfolio includes 17 issued and pending US and international patents, creating a significant competitive advantage[7](index=7&type=chunk) - The company's financial position is more robust, with a clearer path to profitability, driven by revenue growth and an **$8.2 million** financing[7](index=7&type=chunk) [Operational Updates](index=2&type=section&id=Operational%20Updates) [OneRF® Ablation System](index=2&type=section&id=OneRF%C2%AE%20Ablation%20System) The OneRF® Ablation System achieved significant progress, with the first patient seizure-free for one year, positive results in others, and ongoing collaboration for training and post-market studies - The first patient treated with NeuroOne's OneRF® Ablation System achieved one-year seizure-free status in June 2025[10](index=10&type=chunk) - Other patients also showed similar results, achieving seizure-free status or significantly reduced seizure frequency[10](index=10&type=chunk) - The company continues to collaborate closely with Zimmer Biomet and physician advisors for advanced training and education on this novel diagnostic and therapeutic procedure[10](index=10&type=chunk) [OneRF® Trigeminal Nerve Ablation System](index=2&type=section&id=OneRF%C2%AE%20Trigeminal%20Nerve%20Ablation%20System) NeuroOne submitted its OneRF® Trigeminal Nerve Ablation System 510(k) application to the FDA in April 2025, with a response expected soon and potential revenue by late calendar year 2025 - Submitted the 510(k) application to the FDA ahead of schedule in April 2025[10](index=10&type=chunk) - A response from the FDA is expected soon[10](index=10&type=chunk) - If FDA 510(k) approval is granted, the OneRF® Trigeminal Nerve Ablation System is expected to contribute revenue by late calendar year 2025[10](index=10&type=chunk) [OneRF® Basivertebral Nerve Ablation System (BVNA)](index=3&type=section&id=OneRF%C2%AE%20Basivertebral%20Nerve%20Ablation%20System%20%28BVNA%29) The company initiated a program to develop a OneRF® system for basivertebral nerve radiofrequency ablation (BVNA) to treat lower back pain, forming a KOL advisory board and starting chronic animal study implants - Initiated a product development program utilizing the OneRF® system for basivertebral nerve radiofrequency ablation (BVNA) to treat lower back pain[15](index=15&type=chunk) - Formed a Key Opinion Leader (KOL) advisory board for this application[15](index=15&type=chunk) - Initiated implants for chronic animal studies[15](index=15&type=chunk) [Spinal Cord Stimulation (SCS) Percutaneous Paddle Lead Program](index=3&type=section&id=Spinal%20Cord%20Stimulation%20%28SCS%29%20Percutaneous%20Paddle%20Lead%20Program) NeuroOne continues discussions with potential strategic partners to further develop and commercialize its percutaneous paddle lead for spinal cord stimulation - Continues discussions with potential strategic partners to further develop and commercialize the company's percutaneous paddle lead[15](index=15&type=chunk) [sEEG-Based Drug Delivery Program](index=3&type=section&id=sEEG-Based%20Drug%20Delivery%20Program) The company received its first order for the sEEG drug delivery system from a major biopharmaceutical company for preclinical research, marking a new market, and completed animal studies for a miniaturized system - Received the first order for the sEEG drug delivery system from a major biopharmaceutical company for preclinical research, representing a new market[15](index=15&type=chunk) - Completed animal studies for a miniaturized sEEG drug delivery system in small animals[15](index=15&type=chunk) [International Market Expansion](index=3&type=section&id=International%20Market%20Expansion) NeuroOne initiated ISO 13485 certification, crucial for international device registration and commercialization, representing a significant revenue opportunity as the company has no prior international sales - Initiated the ISO 13485 certification process, which is necessary for device registration and commercialization in many regions outside the US[15](index=15&type=chunk) - The company has not yet sold or commercialized any products in international markets, representing a potentially significant revenue opportunity[15](index=15&type=chunk) [Financial Performance](index=3&type=section&id=Financial%20Performance) [Third Quarter and Nine-Month Financial Results](index=3&type=section&id=Third%20Quarter%20and%20Nine-Month%20Financial%20Results) NeuroOne achieved significant financial improvements in Q3 FY2025 and the first nine months, with substantial product revenue growth, expanded gross margins, reduced operating expenses, and narrowed net and per-share losses [Revenue and Gross Profit](index=3&type=section&id=Revenue%20and%20Gross%20Profit) Q3 FY2025 product revenue grew **105%** to **$1.7 million**, and nine-month product revenue grew **100%** to **$6.4 million**, with gross margins expanding and **$3.0 million** in license revenue Product Revenue Overview | Metric | Q3 FY2025 | Q3 FY2024 | Change (YoY) | | :----------- | :---------- | :---------- | :---------- | | Product Revenue | $1,696,050 | $825,776 | +105% | | **Metric** | **Nine Months FY2025** | **Nine Months FY2024** | **Change (YoY)** | | Product Revenue | $6,356,767 | $3,180,719 | +100% | Product Gross Profit and Margin Overview | Metric | Q3 FY2025 | Q3 FY2024 | Change (YoY) | | :----------- | :---------- | :---------- | :---------- | | Product Gross Profit | $914,835 | $281,872 | +224.6% | | Product Gross Margin | 53.9% | 34.1% | +19.8 pp | | **Metric** | **Nine Months FY2025** | **Nine Months FY2024** | **Change (YoY)** | | Product Gross Profit | $3,612,785 | $938,605 | +284.9% | | Product Gross Margin | 56.8% | 29.5% | +27.3 pp | License Revenue Overview | Metric | Nine Months FY2025 | Nine Months FY2024 | Change (YoY) | | :----------- | :---------------- | :---------------- | :---------- | | License Revenue | $3,000,000 | $0 | N/A | [Operating Expenses](index=3&type=section&id=Operating%20Expenses) Total operating expenses decreased **9%** to **$2.8 million** in Q3 FY2025 and **5%** to **$9.5 million** for the nine months, with SG&A declining and R&D stable Operating Expenses Overview | Metric | Q3 FY2025 | Q3 FY2024 | Change (YoY) | | :----------- | :---------- | :---------- | :---------- | | Total Operating Expenses | $2,801,435 | $3,075,773 | -9% | | SG&A Expenses | $1,618,950 | $1,881,099 | -14% | | R&D Expenses | $1,182,485 | $1,194,674 | -1% | | **Metric** | **Nine Months FY2025** | **Nine Months FY2024** | **Change (YoY)** | | Total Operating Expenses | $9,468,194 | $10,009,079 | -5% | | SG&A Expenses | $5,602,818 | $6,057,520 | -8% | | R&D Expenses | $3,865,376 | $3,951,559 | -2% | [Net Loss and Earnings Per Share](index=4&type=section&id=Net%20Loss%20and%20Earnings%20Per%20Share) Net loss significantly improved to **$1.5 million** (or **$0.03** per share) in Q3 FY2025 and to **$2.0 million** (or **$0.05** per share) for the nine months Net Loss and Loss Per Share Overview | Metric | Q3 FY2025 | Q3 FY2024 | Change (YoY) | | :----------- | :---------- | :---------- | :---------- | | Net Loss | $(1,500,868) | $(2,767,525) | -45.8% | | Loss Per Share | $(0.03) | $(0.10) | -70% | | **Metric** | **Nine Months FY2025** | **Nine Months FY2024** | **Change (YoY)** | | Net Loss | $(1,986,153) | $(8,967,515) | -77.9% | | Loss Per Share | $(0.05) | $(0.35) | -85.7% | [Liquidity and Capital Position](index=4&type=section&id=Liquidity%20and%20Capital%20Position) As of June 30, 2025, NeuroOne's cash and cash equivalents increased to **$8.0 million** and working capital to **$8.7 million**, a significant improvement driven by an **$8.2 million** financing, with no outstanding debt Cash and Working Capital Overview | Metric | June 30, 2025 | September 30, 2024 | Change | | :-------------------- | :-------------- | :-------------- | :------ | | Cash and Cash Equivalents | $8.0 million | $1.5 million | +$6.5 million | | Working Capital | $8.7 million | $2.4 million | +$6.3 million | - Completed an oversubscribed institutional investor financing in April 2025, with total net proceeds of **$8.2 million**[17](index=17&type=chunk) - As of June 30, 2025, the company had no outstanding debt[17](index=17&type=chunk) [Fiscal Year 2025 Financial Guidance](index=4&type=section&id=Fiscal%20Year%202025%20Financial%20Guidance) The company maintains its FY2025 product revenue guidance of **$8.0 million** to **$10.0 million** (132% to 190% growth) and raised its product gross margin guidance to **50%** to **53%** FY2025 Financial Guidance | Metric | FY2025 Outlook | FY2024 | Growth Rate | | :----------- | :------------- | :--------- | :------- | | Product Revenue | $8.0M - $10.0M | $3.5M | 132% - 190% | | Product Gross Margin | 50% - 53% | 31% | +19 pp - +22 pp | [Additional Information](index=4&type=section&id=Additional%20Information) [About NeuroOne](index=4&type=section&id=About%20NeuroOne) NeuroOne Medical Technologies Corporation develops and commercializes minimally invasive, high-definition solutions for neurological disorders, covering EEG recording, monitoring, ablation, drug delivery, and stimulation, with potential expansion into other areas - NeuroOne is dedicated to developing and commercializing minimally invasive, high-definition solutions for EEG recording, monitoring, ablation, drug delivery, and stimulation[21](index=21&type=chunk) - Primarily targets neurological disorders such as epilepsy, Parkinson's disease, dystonia, essential tremor, and chronic pain, with potential expansion into depression, mood disorders, pain, incontinence, hypertension, and artificial intelligence[21](index=21&type=chunk) [Conference Call Details](index=4&type=section&id=Conference%20Call%20Details) Management hosted an investor conference call and webcast on August 14, 2025, to discuss Q3 FY2025 financial results and company updates, with replays available until August 28, 2025 - An investor conference call and webcast were held on Thursday, August 14, 2025, at 8:30 AM ET[19](index=19&type=chunk) - A replay of the call is available via phone and webcast link until August 28, 2025[20](index=20&type=chunk) [Legal Disclosures](index=5&type=section&id=Legal%20Disclosures) This press release contains forward-looking statements subject to risks and uncertainties, and federal law restricts device sales to or by physicians, with patient experiences not representing all outcomes - This press release may contain forward-looking statements subject to known and unknown risks, uncertainties, and other factors that could cause actual results to differ materially from expectations[22](index=22&type=chunk) - Federal law restricts this device to sale by or on the order of a physician[23](index=23&type=chunk) - Patient experiences mentioned are individual cases and do not represent all patient outcomes[24](index=24&type=chunk) [Unaudited Financial Statements](index=6&type=section&id=Unaudited%20Financial%20Statements) [Balance Sheets](index=6&type=section&id=Balance%20Sheets) The unaudited balance sheets show significant increases in NeuroOne's cash, total assets, and stockholders' equity as of June 30, 2025, reflecting a strengthened financial position after recent capital activities Balance Sheets (Unaudited) | | June 30, 2025 | September 30, 2024 | | :------------------------------------ | :-------------- | :-------------- | | **ASSETS** | | | | Cash and cash equivalents | $8,039,683 | $1,460,042 | | Inventory | $1,897,701 | $2,635,153 | | Total current assets | $10,170,747 | $4,630,925 | | Total assets | $10,819,481 | $5,369,940 | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Total current liabilities | $1,425,790 | $2,213,220 | | Warrant liability | $1,040,894 | $2,140,315 | | Total liabilities | $2,642,028 | $4,547,927 | | Total stockholders' equity | $8,177,453 | $822,013 | [Statements of Operations](index=7&type=section&id=Statements%20of%20Operations) The unaudited statements of operations detail NeuroOne's Q3 FY2025 and nine-month financial performance, highlighting strong product revenue and gross profit growth, alongside significant improvements in net loss and loss per share Statements of Operations (Unaudited) | | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Nine Months Ended June 30, 2025 | Nine Months Ended June 30, 2024 | | :------------------------------------ | :---------------------- | :---------------------- | :---------------------- | :---------------------- | | Product revenue | $1,696,050 | $825,776 | $6,356,767 | $3,180,719 | | Cost of product sales | $781,215 | $543,904 | $2,743,982 | $2,242,114 | | Product gross profit | $914,835 | $281,872 | $3,612,785 | $938,605 | | License revenue | — | — | $3,000,000 | — | | Selling, general and administrative expenses | $1,618,950 | $1,881,099 | $5,602,818 | $6,057,520 | | Research and development expenses | $1,182,485 | $1,194,674 | $3,865,376 | $3,951,559 | | Total operating expenses | $2,801,435 | $3,075,773 | $9,468,194 | $10,009,079 | | Operating loss | $(1,886,600) | $(2,793,901) | $(2,855,409) | $(9,070,474) | | Net loss | $(1,500,868) | $(2,767,525) | $(1,986,153) | $(8,967,515) | | Basic and diluted net loss per share | $(0.03) | $(0.10) | $(0.05) | $(0.35) |

Core Insights - NeuroOne Medical Technologies Corporation has reported a significant improvement in financial results for the third quarter of fiscal year 2025, with a 105% increase in revenue year-over-year and a gross profit margin of 53.9% [3][6][14]. Financial Performance - Product revenue for the third quarter of fiscal year 2025 reached $1.7 million, up from $0.8 million in the same quarter of fiscal year 2024 [6][13]. - For the first nine months of fiscal year 2025, product revenue increased 100% to $6.4 million compared to $3.2 million for the same period in fiscal year 2024 [13]. - License revenue for the first nine months of fiscal year 2025 was $3.0 million, derived from an expanded distribution agreement with Zimmer Biomet [13]. - Operating expenses decreased by 9% to $2.8 million in the third quarter of fiscal year 2025, compared to $3.1 million in the same quarter of the prior year [15]. - The net loss for the third quarter improved to $1.5 million, or $(0.03) per share, compared to a net loss of $2.8 million, or $(0.10) per share, in the same quarter of the prior year [16]. Operational Highlights - The first patient treated with the OneRF Ablation System achieved one year of seizure freedom, indicating the effectiveness of the technology [11]. - The company submitted its 510(k) application to the FDA for the OneRF Trigeminal Nerve Ablation System ahead of schedule, with expected revenue generation in calendar year 2025 upon clearance [4][11]. - NeuroOne received its first order for the sEEG-based drug delivery system from a biopharmaceutical company, marking entry into a new market [4][11]. - The company is pursuing ISO 13485 certification to facilitate entry into international markets, which could provide additional growth opportunities [5][10]. Capital and Market Position - NeuroOne completed an oversubscribed capital raise totaling $8.2 million in net proceeds in April 2025, strengthening its financial position [6][17]. - The company has 17 issued and outstanding patents in the U.S. and internationally, enhancing its competitive advantage [7]. - The company expects product revenue for fiscal year 2025 to range between $8.0 million and $10.0 million, representing an increase of 132% to 190% compared to fiscal year 2024 [18].

Core Viewpoint - NeuroOne Medical Technologies Corporation is set to release its financial results for the fiscal third quarter ended June 30, 2025, on August 14, 2025, before market open [1] Financial Results Announcement - The company will host an investor conference call and webcast on August 14, 2025, at 8:30 a.m. Eastern time to discuss the financial results and provide a corporate update [2] - Participants can join the call using specific dial-in numbers and access codes provided [2] Call Playback Information - A playback of the conference call will be available until August 28, 2025, with specific numbers for U.S. and international listeners [3] Company Overview - NeuroOne is focused on developing minimally invasive and high-definition solutions for EEG recording, brain stimulation, and ablation for neurological disorders such as epilepsy, Parkinson's disease, and chronic pain [4] - The company may also explore applications in other areas including depression, mood disorders, and artificial intelligence [4]

Management will host an investor conference call and webcast at 8:30 a.m. Eastern time on Thursday, May 14, 2025, to discuss the Company's third quarter fiscal year 2025 financial results, provide a corporate update, and conclude with Q&A from telephone participants. To participate, please use the following information: Third Quarter 2025 Earnings Conference Call Date: Thursday, August 14, 2025 Time: 8:30 a.m. Eastern time U.S. Dial-In (Toll Free): 888-506-0062 International Dial-In: 973-528-0011 Participan ...

Core Insights - NeuroOne Medical Technologies Corporation has received a notice of allowance for a key patent related to neural probe technologies, which is expected to enhance its intellectual property portfolio [1][2] - The patent covers novel methods for making neural probe devices, including specific arrangements of probe components and deposition of electrode contact material [1][3] - The company currently holds 17 issued and pending patents in the U.S. and internationally, focusing on thin-film electrode technologies for neural and spinal cord applications [3] Company Overview - NeuroOne is focused on developing minimally invasive and high-definition solutions for various neurological disorders, including epilepsy, Parkinson's disease, and chronic pain [4] - The company aims to improve patient outcomes and reduce procedural costs while exploring applications in other areas such as depression and artificial intelligence [4]