"This milestone further validates the intended benefits of our OneRF platform," said Dave Rosa, CEO of NeuroOne. "Our next step is to leverage the technology for other applications, including our OneRF Trigeminal Nerve Ablation System to treat facial pain, for which we filed a 510(k) submission to the FDA in April 2025." "Around this time last year, I was having multiple seizures every day, which interfered with so many things in my life," stated Clara. "However, since the procedure, I completely stopped ha ...

Dr. Brin Freund, who has overseen Clara's epilepsy treatment, stated: "Our interaction with the OneRF® Ablation System has been positive and shown excellent results for Clara. I believe there is a compelling case for further clinical and research opportunities using this platform to expand treatment capabilities." About NeuroOne NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) is developing and commercializing minimally invasive and hi-definition solutions for EEG recording, monitoring, ablation, dr ...

Core Insights - NeuroOne Medical Technologies Corporation has appointed Emily Johns as General Counsel and Corporate Secretary, enhancing its management team [1][2] - The appointment is expected to reduce overall legal costs and support the company's strategic growth initiatives [2] Management Team Enhancement - Emily Johns brings nearly a decade of experience working with NeuroOne and has a strong background in legal matters related to biotechnology companies [2] - Her previous role as a partner at Honigman LLP involved representing NeuroOne in transactional work since 2017 [2] - The company believes her legal expertise will be invaluable as it scales its operations [2] Stock Options and Compensation - In connection with her appointment, Ms. Johns received an option to purchase 500,000 shares of the company's common stock at an exercise price of $0.611 per share [3] - The new senior director of quality assurance and regulatory affairs was also granted an option to purchase 75,000 shares under similar terms [3] Company Overview - NeuroOne is focused on developing minimally invasive and high-definition solutions for neurological disorders, including epilepsy and Parkinson's disease [4] - The company aims to improve patient outcomes and reduce procedural costs while exploring applications in other areas such as depression and chronic pain [4]

Company Overview - NeuroOne Medical Technologies Corporation focuses on improving surgical care options and outcomes for patients with neurological disorders [1] - The company is developing minimally invasive and high-definition solutions for EEG recording, brain stimulation, and ablation for conditions such as epilepsy, Parkinson's disease, and chronic pain [4] - NeuroOne may also explore applications in areas like depression, mood disorders, pain management, incontinence, high blood pressure, and artificial intelligence [4] Conference Participation - NeuroOne will participate in the MedInvest MedTech, AI and Digital Health Conference on June 3-4, 2025, in San Francisco, CA [1][3] - The event will include panel discussions, keynote talks, and corporate presentations focused on medical devices, imaging technologies, diagnostics, AI/data analytics, and digital health [2] Investor Engagement - Dave Rosa, President and CEO of NeuroOne, will meet with investors during the conference [2]

Financial Data and Key Metrics Changes - Product revenue increased by 97% to $4.7 million for the first half of fiscal year 2025 compared to $2.4 million in the same period of fiscal year 2024 [4][13] - Product gross margins improved to 57.9%, more than double the gross margin of 27.9% in the first half of fiscal year 2024 [4][14] - Net loss for the second quarter of fiscal year 2025 improved to $2.3 million or $0.07 per share, compared to a net loss of $2.9 million or $0.11 per share in the same quarter of the prior fiscal year [16] Business Line Data and Key Metrics Changes - The company reported a product revenue of $1.4 million in the second quarter of fiscal year 2025, consistent with the same quarter in fiscal year 2024 [13] - License revenue of $3 million was recognized in the first six months of fiscal year 2025, compared to no license revenue in the same period of fiscal year 2024 [14] Market Data and Key Metrics Changes - The company is focusing on expanding its market presence through strategic partnerships, particularly with Zimmer Biomet, which includes exclusive distribution rights in the U.S. and certain other countries [8][9] - The company is initiating a process to secure ISO 13485 certification to commercialize and obtain regulatory approvals internationally, which could represent significant revenue in the future [9] Company Strategy and Development Direction - The company aims to achieve mass adoption of its technology by fostering relationships with initial targeted sites and expanding to new centers [6] - The company is pursuing additional applications for its technology platform, including spinal cord nerve ablation and spinal cord stimulation for back pain management [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow breakeven if key milestones are met, reiterating fiscal year 2025 guidance of product revenue between $8 million and $10 million [11][10] - The company believes that the FDA clearance of its trigeminal nerve ablation system could generate revenues as soon as late calendar year 2025 [8] Other Important Information - The company has no debt and anticipates being fully funded through at least fiscal year 2026, following a successful capital raise that added $8.2 million in net proceeds [10][17] - The addition of a chief medical advisor is expected to enhance product development and clinical outcomes tracking [24] Q&A Session Summary Question: Clarification on revenue guidance excluding licensing fee - The guidance of $8 million to $10 million excludes the $3 million licensing fee received in the first quarter [20] Question: Revenue sources for the current year - Almost all revenue is expected to come from the Zimmer Biomet agreement, with only about 6% from early centers in the first half of the year [21] Question: Current cash position - As of April, the company had $9.4 million in cash on hand, including recent financing [22] Question: Significance of adding a chief medical advisor - The chief medical advisor's clinical background aligns with the company's current and future clinical areas, aiding in product development and patient outcomes tracking [23][24]

Financial Data and Key Metrics Changes - Product revenue increased 97% to $4,700,000 for the first half of fiscal 2025 compared to $2,400,000 for the same period in fiscal 2024 [5][15] - Product gross margins improved to 57.9%, more than double the gross margin in the first half of fiscal 2024 [5] - Net loss for the second quarter improved to $2,300,000 or $0.07 per share compared to a net loss of $2,900,000 or $0.11 per share in the same quarter of the prior fiscal year [18] - Total operating expenses decreased 4% to $6,700,000 for the first six months of fiscal 2025 compared to $6,900,000 in the same period of fiscal 2024 [17] Business Line Data and Key Metrics Changes - The company recognized $3,000,000 in license revenue in the first six months of fiscal 2025, derived from the expanded exclusive distribution agreement with Zimmer [16] - Product gross profit for the second quarter was $800,000 or 55.6% of revenue, compared to $400,000 or 28.3% of revenue in the second quarter of fiscal 2024 [16] Market Data and Key Metrics Changes - The company is targeting the trigeminal nerve ablation market, with approximately 150,000 people diagnosed with trigeminal neuralgia annually in the U.S. [8] - The company is initiating a process to secure ISO 13485 certification for international commercialization, which could represent significant revenue in the future [11] Company Strategy and Development Direction - The company aims to achieve mass adoption of its technology by fostering relationships with initial targeted sites and expanding to new centers [7] - The strategic partnership with Zimmer includes exclusive distribution rights in the U.S. and certain additional countries for the 1RF ablation system [10] - The company is exploring additional applications leveraging its platform technology, including spinal cord nerve ablation and stimulation [10] Management's Comments on Operating Environment and Future Outlook - Management reiterated fiscal year 2025 guidance, expecting product revenue to be in the range of $8,000,000 to $10,000,000, representing an increase of 132% to 190% over fiscal 2024 [13] - The company believes it is fully funded through at least fiscal 2026 and could reach cash flow breakeven if key milestones are achieved [12] Other Important Information - The company has no debt and has bolstered its balance sheet with $8,200,000 in net proceeds from a successful capital raise [12][19] - The addition of a chief medical advisor is expected to enhance product development and clinical requirements [25][26] Q&A Session Summary Question: Is the guidance excluding the $3 million from the first quarter? - Yes, it is correct that the guidance excludes the licensing fee received in the first quarter [21] Question: Will revenue for the full year come from Zimmer Biomet? - Almost entirely from Zimmer Biomet, with about 6% of revenue from early centers in the first half [23] Question: What is the current cash position? - As of April, the company had $9,400,000 in cash on hand [24] Question: What is the significance of adding a chief medical advisor now? - The chief medical advisor's clinical background fits perfectly with the company's current and future areas, including product development and patient outcome tracking [25][26]

Exhibit 99.1 NeuroOne Reports Second Quarter Fiscal Year 2025 Financial Results; Gross Margin Improves Significantly YoY to 55.6% Filed 510(k)Submission with FDA for OneRF Trigeminal Nerve Ablation System to Treat Facial Pain Ahead of Schedule Company Fully Funded Through at Least Fiscal Year 2026 Following Oversubscribed $8.2 Million Capital Raise EDEN PRAIRIE, Minn., May 13, 2025 -- NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) ("NeuroOne" or the "Company"), a medical technology company dedicat ...

PART 1 – FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed financial statements for Q1 2025, highlighting a significant reduction in net loss and improved liquidity [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) The condensed balance sheet as of March 31, 2025, shows decreased assets and liabilities, primarily due to reduced inventory and warrant liability Condensed Balance Sheet Comparison (in thousands) | Account | March 31, 2025 | September 30, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $1,320 | $1,460 | | Total current assets | $3,754 | $4,631 | | **Total assets** | **$4,457** | **$5,370** | | **Liabilities & Equity** | | | | Total current liabilities | $1,763 | $2,213 | | Warrant liability | $1,361 | $2,140 | | **Total liabilities** | **$3,331** | **$4,548** | | **Total stockholders' equity** | **$1,126** | **$822** | [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) Net loss for the six months ended March 31, 2025, significantly improved, driven by new license revenue and higher product gross profit Statement of Operations Summary (Six Months Ended March 31) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Product Revenue | $4,660,717 | $2,354,943 | | Product Gross Profit | $2,697,950 | $656,733 | | License Revenue | $3,000,000 | $0 | | Loss from Operations | ($968,809) | ($6,276,573) | | **Net Loss** | **($485,285)** | **($6,199,990)** | | **Net Loss Per Share** | **($0.02)** | **($0.25)** | [Condensed Statements of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) Stockholders' equity increased from September 30, 2024, to March 31, 2025, driven by stock-based compensation and equity financings - Total stockholders' equity increased from **$822,013** on September 30, 2024, to **$1,125,858** on March 31, 2025[12](index=12&type=chunk) [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash provided by operating activities significantly improved for the six months ended March 31, 2025, driven by a smaller net loss and working capital changes Cash Flow Summary (Six Months Ended March 31) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $151,905 | ($5,984,554) | | Net cash used in investing activities | ($27,587) | ($68,491) | | Net cash (used in) provided by financing activities | ($264,109) | $3,165,207 | | **Net decrease in cash** | **($139,791)** | **($2,887,838)** | [Notes to Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) The notes provide critical context, detailing business focus, improved liquidity from recent financing, the Zimmer agreement, and revenue concentration - The company is focused on developing and commercializing thin film electrode technology for diagnosing and treating neurological disorders. It has received FDA 510(k) clearance for three devices: Evo cortical electrode, Evo sEEG electrode, and the OneRF ablation system[16](index=16&type=chunk)[17](index=17&type=chunk) - As of March 31, 2025, the company had **$1.3 million** in cash. Subsequent to the quarter end, it received net proceeds of approximately **$8.2 million** from the April 2025 Financing. Management believes this is sufficient to fund operations for at least **twelve months**[24](index=24&type=chunk)[125](index=125&type=chunk) - In October 2024, the company amended its distribution agreement with Zimmer, granting an exclusive license for its OneRF Ablation System for an upfront payment of **$3.0 million**. This amount was recognized as license revenue in the period[82](index=82&type=chunk)[89](index=89&type=chunk) - For the three and six months ended March 31, 2025, one customer (Zimmer) accounted for **100%** and **94%** of product revenue, respectively[109](index=109&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, highlighting improved revenue and profitability for the six months ended March 31, 2025, attributing changes to the Zimmer agreement and recent financing [Overview](index=26&type=section&id=MD%26A_Overview) NeuroOne is a medical technology company focused on thin film electrode technology, with FDA-cleared devices and an accumulated deficit of **$75.5 million** - The company develops and commercializes thin film electrode technology for cEEG, sEEG, spinal cord stimulation, and other neurological applications[133](index=133&type=chunk) - Three devices have received FDA 510(k) clearance: Evo cortical electrode, Evo sEEG electrode, and the OneRF ablation system[134](index=134&type=chunk) - As of March 31, 2025, the company had an accumulated deficit of **$75.5 million**[135](index=135&type=chunk) [Recent Developments](index=27&type=section&id=Recent%20Developments) Recent developments include an April 2025 FDA 510(k) submission, an **$8.2 million** financing, and the October 2024 Zimmer agreement with a **$3.0 million** upfront payment - On April 22, 2025, the company filed a 510(k) submission to the FDA for its OneRF® Trigeminal Nerve Ablation System[139](index=139&type=chunk) - In April 2025, the company raised approximately **$8.2 million** in net proceeds from an underwritten public offering[140](index=140&type=chunk) - The amended distribution agreement with Zimmer in October 2024 included a **$3.0 million** upfront payment for the OneRF license and potential for a **$1.0 million** sales milestone[141](index=141&type=chunk)[143](index=143&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) This section provides a comparative analysis of financial results, showing increased product revenue, improved gross margin, and a reduced net loss for the six months ended March 31, 2025 Comparison of Three Months Ended March 31 | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Product Revenue | $1,386,550 | $1,377,294 | $9,256 | | Product Gross Profit | $771,061 | $390,419 | $380,642 | | Loss from Operations | ($2,680,016) | ($2,886,098) | $206,082 | | **Net Loss** | **($2,270,607)** | **($2,855,090)** | **$584,483** | Comparison of Six Months Ended March 31 | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Product Revenue | $4,660,717 | $2,354,943 | $2,305,774 | | License Revenue | $3,000,000 | $0 | $3,000,000 | | Loss from Operations | ($968,809) | ($6,276,573) | $5,307,764 | | **Net Loss** | **($485,285)** | **($6,199,990)** | **$5,714,705** | - The increase in gross profit percentage for both the three and six-month periods was largely due to higher-margin OneRF Products being sold under the amended Zimmer agreement[160](index=160&type=chunk)[168](index=168&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity, primarily from equity financings and revenues, was significantly bolstered by an April 2025 financing of **$8.2 million**, expected to fund operations for at least **twelve months** - As of March 31, 2025, cash and cash equivalents were **$1.3 million**. In April 2025, the company received net proceeds of approximately **$8.2 million** from a financing[176](index=176&type=chunk)[179](index=179&type=chunk) - Management believes current cash, anticipated revenues, and forecasted operating expense reductions will be sufficient to fund planned expenditures for at least **twelve months** from the issuance date of the financial statements[191](index=191&type=chunk) Cash Flow Summary (Six Months Ended March 31) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $151,905 | ($5,984,554) | | Net cash used in investing activities | ($27,587) | ($68,491) | | Net cash (used in) provided by financing activities | ($264,109) | $3,165,207 | [Critical Accounting Estimates](index=36&type=section&id=Critical%20Accounting%20Estimates) Management identifies critical accounting estimates requiring subjective judgments, including revenue recognition, stock-based compensation, warrant liability, income tax assets, and contingencies - Critical accounting estimates include Revenue Recognition, Stock-based Compensation, Fair Value of Warrant Liability, Income Tax Assets and Liabilities, and Contingencies[204](index=204&type=chunk)[205](index=205&type=chunk)[207](index=207&type=chunk)[208](index=208&type=chunk)[209](index=209&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not applicable as the company qualifies as a smaller reporting company - Not applicable for smaller reporting companies[211](index=211&type=chunk) [Item 4. Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures are effective as of the end of the period covered by the report[212](index=212&type=chunk) - There were no material changes in internal control over financial reporting during the quarter[213](index=213&type=chunk) PART II – OTHER INFORMATION [Item 1. Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings likely to have a material adverse effect on its business - The company is not currently a party to any legal proceedings that are likely to have a material adverse effect on its business[215](index=215&type=chunk) [Item 1A. Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) This section refers to the comprehensive risk factors detailed in the company's Annual Report on Form 10-K for FY2024 - The report refers to the risk factors detailed in the Company's Annual Report on Form 10-K for the year ended September 30, 2024[216](index=216&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=38&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds during the period - None[217](index=217&type=chunk) [Item 3. Defaults Upon Senior Securities](index=38&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[218](index=218&type=chunk) [Item 4. Mine Safety Disclosures](index=38&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable to our Company[219](index=219&type=chunk) [Item 5. Other Information](index=39&type=section&id=Item%205.%20Other%20Information) No Rule 10b5-1 trading plans were adopted or terminated by directors or Section 16 officers during the three months ended March 31, 2025 - During the three months ended March 31, 2025, none of the Company's directors or Section 16 officers adopted or terminated any Rule 10b5-1 trading plan[222](index=222&type=chunk) [Item 6. Exhibits](index=39&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including corporate governance documents, incentive plans, and officer certifications - A list of exhibits filed with the report is provided, including corporate governance documents, incentive plans, and officer certifications[223](index=223&type=chunk)

Core Insights - NeuroOne Medical Technologies Corporation has made significant operational progress with its OneRF® Ablation System, including a successful 510(k) submission to the FDA for the Trigeminal Nerve Ablation System to treat facial pain ahead of schedule [3][6] - The company completed an oversubscribed capital raise of $8.2 million, which is expected to fully fund operations through at least fiscal year 2026 [5][6] - The company anticipates potential revenue generation from the trigeminal nerve ablation as early as late calendar year 2025, contingent upon FDA clearance [4][6] Recent Company Highlights - The OneRF® Ablation System has shown clinical success, with patients remaining seizure-free after treatment [3] - The company has strengthened its management team by hiring Dr. Parag Patil as Chief Medical Advisor and Emily Johns as General Counsel [6] - Significant media interest has been secured, including features on major news outlets [6] Financial Performance - Product revenue for the second quarter of fiscal 2025 was $1.4 million, consistent with the same quarter of the previous year, while for the first six months, it increased by 98% to $4.7 million compared to $2.4 million in the same period of fiscal 2024 [9][10] - License revenue of $3.0 million was recorded in the first six months of fiscal 2025, derived from an expanded distribution agreement with Zimmer [9] - Product gross profit increased to $0.8 million, or 55.6% of revenue, in the second quarter of fiscal 2025, compared to 28.3% in the same quarter of the prior year [10] Operating Expenses and Losses - Total operating expenses for the second quarter of fiscal 2025 were $3.5 million, slightly higher than $3.3 million in the same quarter of the prior year [11] - The net loss improved to $2.3 million, or ($0.07) per share, compared to a net loss of $2.9 million, or ($0.11) per share, in the same quarter of the prior year [12] Future Outlook - The company maintains its fiscal year 2025 product revenue guidance of $8.0 million to $10.0 million, representing an increase of 132% to 190% compared to fiscal year 2024 [15] - Expected product gross margin for fiscal year 2025 is projected to range between 47% and 51%, compared to 31% in fiscal year 2024 [15]

Significant Neurological Expertise to Help Drive Clinical Development Strategy and Growth with New Technologies EDEN PRAIRIE, Minn., May 12, 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, today announced it has appointed Parag G. Patil, M.D., Ph.D., as Chief Medical Advisor (CMA), after serving on the compan ...