NeuroOne Medical Technologies (NMTC) - 2025 Q3 - Quarterly Results

Executive Summary & Recent Highlights Recent Company Highlights 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][4] - Early FDA submission for the OneRF® Trigeminal Nerve Ablation System for facial pain treatment, with a response expected soon[4] - Received the first order for the sEEG drug delivery system from a major biopharmaceutical company, marking entry into a new market[4] - Received a key patent allowance notice from the USPTO for manufacturing methods of neural and spinal cord stimulation electrodes, enhancing competitive advantage[4] - Strengthened the management team by adding a Chief Medical Advisor, General Counsel, and Senior Director of Quality Assurance and Regulatory Affairs[4] Management Commentary 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] - 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] - Received the first order for the sEEG drug delivery system and is discussing other potential applications with top strategic partners[5] - Initiated ISO 13485 certification program to prepare for international market entry, anticipating additional growth[6] - The intellectual property portfolio includes 17 issued and pending US and international patents, creating a significant competitive advantage[7] - 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] Operational Updates OneRF® Ablation System 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] - Other patients also showed similar results, achieving seizure-free status or significantly reduced seizure frequency[10] - 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] OneRF® Trigeminal Nerve Ablation System 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] - A response from the FDA is expected soon[10] - If FDA 510(k) approval is granted, the OneRF® Trigeminal Nerve Ablation System is expected to contribute revenue by late calendar year 2025[10] OneRF® Basivertebral Nerve Ablation System (BVNA) 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] - Formed a Key Opinion Leader (KOL) advisory board for this application[15] - Initiated implants for chronic animal studies[15] Spinal Cord Stimulation (SCS) Percutaneous Paddle Lead Program 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] sEEG-Based Drug Delivery Program 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] - Completed animal studies for a miniaturized sEEG drug delivery system in small animals[15] International Market Expansion 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] - The company has not yet sold or commercialized any products in international markets, representing a potentially significant revenue opportunity[15] Financial Performance Third Quarter and Nine-Month Financial Results 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 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 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 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 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] - As of June 30, 2025, the company had no outstanding debt[17] Fiscal Year 2025 Financial Guidance 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 About NeuroOne 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] - 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] Conference Call Details 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] - A replay of the call is available via phone and webcast link until August 28, 2025[20] Legal Disclosures 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] - Federal law restricts this device to sale by or on the order of a physician[23] - Patient experiences mentioned are individual cases and do not represent all patient outcomes[24] Unaudited Financial Statements Balance Sheets 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 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) |