PresentationOperator Good day, ladies and gentlemen, and welcome to the NeuroOne Medical Technologies Corporation Virtual Webinar. Today's call will be conducted by the company's Chief Executive Officer, Dave Rosa, and Ron McClurg, the company's Chief Financial Officer. Before I turn the call over to Mr. Rosa, I'd like to remind you that this conference call will include forward-looking statements within the meaning of U.S. federal securities laws with respect to future operations, financial results, events ...

Group 1 - The conference call is hosted by NeuroOne Medical Technologies Corporation, featuring CEO Dave Rosa and CFO Ron McClurg [1] - The call will include forward-looking statements regarding future operations and financial results, based on management's beliefs and assumptions [2] - There are known and unknown risks that may cause actual results to differ from the forward-looking statements, particularly concerning fiscal 2025 preliminary product revenue [3]

NeuroOne Medical Technologies Conference Call Summary Company Overview - **Company**: NeuroOne Medical Technologies Corporation - **Ticker**: NasdaqCM: NMTC - **Focus**: Transforming diagnosis and treatment of neurological disorders through innovative technology in three areas: brain, pain, and drug delivery [3][4] Core Points and Arguments - **Technology Advantages**: The company's thin film multifunction electrode technology allows for percutaneous placement, reduced hospitalizations, fewer adverse events, and improved patient outcomes [3][4] - **Product Revenue**: Reported product revenues of $9.1 million for fiscal year 2025, a 163% increase year-over-year, meeting guidance of $8 to $10 million [4][9] - **Strategic Partnerships**: Expanded agreement with Zimmer Biomet includes exclusive distribution for the OneRF ablation system and a one-time license revenue of $3 million [5][9] - **Patient Impact**: Highlighted a success story of a patient, Clara, who became seizure-free after using their technology, showcasing the positive impact on quality of life [5][10] - **Financial Position**: Preliminary cash and cash equivalents of $6.6 million as of September 30, 2025, with no debt on the balance sheet [9][10] Development and Future Plans - **Product Launches**: Limited launch of the OneRF trigeminal neuralgia system expected in November 2025, with centers already lined up for cases [6][15] - **Growth Strategy**: Plans to support Zimmer Biomet's commercial expansion, pursue ISO 13485 clearance, and develop partnerships for drug delivery platforms [8][10] - **Market Potential**: The market for drug delivery and pain management technologies is expected to exceed current market participation [7][8] Additional Insights - **Sales and Marketing Efforts**: Increased training of sales reps from Zimmer Biomet has led to heightened interest and utilization of the technology [24][25] - **Patient Awareness**: Collaborations with epilepsy organizations aim to raise patient awareness about available therapies [25][26] - **Reimbursement Support**: The company assists physicians with reimbursement processes, although specific codes are not disclosed [26][27] - **Registry Development**: Efforts to establish a registry to collect and publish patient outcomes data are underway, which is critical for demonstrating the technology's effectiveness [28][29] Conclusion - **Outlook**: The company remains optimistic about future growth potential, emphasizing the meaningful impact of its technology on patients' lives and the successful execution of its strategic goals in fiscal year 2025 [10][34]

Group 1: Telomir Pharmaceuticals Inc. (TELO) - Shares surged 43% in after-hours trading, climbing from $1.42 to $2.03 on light volume of 213,569 shares, below the average daily volume of 4.67 million [2] - The spike reflects renewed interest in recent in vitro data showing Telomir-1's ability to target additional histone demethylase families, indicating a unique epigenetic profile [3] Group 2: Processa Pharmaceuticals Inc. (PCSA) - Shares rose 32.6% in after-hours trading to $0.37, following a 30.9% gain during the regular session, with a closing price of $0.2790 on volume exceeding 31.9 million shares [4] - The price movement occurred without any official news or updates from the company, suggesting speculative momentum or technical positioning [5] Group 3: Reviva Pharmaceuticals Holdings Inc. (RVPH) - Shares increased 33.7% in after-hours trading to $0.8950 after a regular session gain of 22.8%, closing at $0.6693 with significant trading volume of 34.2 million shares [6] - The rally happened despite no recent official news, with the last update being four days prior regarding a healthcare conference [7] Group 4: NeuroOne Medical Technologies Corp. (NMTC) - Shares rose 9.5% in after-hours trading to $1.09, extending a 7.1% gain during the regular session, with a closing price of $0.9956 and trading volume of 1.21 million shares [8] - The increase followed the announcement of preliminary unaudited product revenue of $9.1 million for fiscal year 2025, up 163% from the prior year, and an upcoming virtual webinar [9] Group 5: BioRestorative Therapies Inc. (BRTX) - Shares edged 4.6% higher in after-hours trading to $1.60, following a modest 2% gain during the regular session, with a closing price of $1.53 and trading volume of 415,798 shares [10] - The increase followed the announcement of a $1.085 million registered direct offering priced at $1.60 per share, with proceeds aimed at advancing clinical trials and other corporate purposes [11]

[General Information](index=1&type=section&id=General%20Information) Provides foundational details about NeuroOne Medical Technologies Corporation, its incorporation, and registered securities - Registrant: **NeuroOne Medical Technologies Corporation**, incorporated in Delaware[2](index=2&type=chunk) Securities Registered | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :------------------ | :---------------- | :---------------------------------------- | | Common Stock, par value $0.001 per share | NMTC | The Nasdaq Stock Market LLC | - The registrant is not an emerging growth company[4](index=4&type=chunk) [Item 2.02 Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) Details the announcement of preliminary, unaudited financial results for the fiscal year ended September 30, 2025 - NeuroOne Medical Technologies Corporation announced preliminary, unaudited financial results for the fiscal year ended September 30, 2025, via a press release on October 6, 2025[5](index=5&type=chunk) - Information in this Item 2.02 and Exhibit 99.1 is furnished, not filed, and not incorporated by reference in Securities Act filings unless expressly stated[6](index=6&type=chunk) [Item 8.01 Other Events](index=2&type=section&id=Item%208.01%20Other%20Events) Covers additional significant events, including preliminary financial results for the fiscal year 2025 [Preliminary Results](index=2&type=section&id=Preliminary%20Results) For the fiscal year ended September 30, 2025, NeuroOne reported approximately $9.1 million in annual total product revenue and held approximately $6.6 million in cash and cash equivalents Preliminary Financial Highlights (FY2025) | Metric | Amount (approx.) | | :------------------------------------ | :--------------- | | Annual Total Product Revenue | $9.1 million | | Cash and Cash Equivalents (as of Sep 30, 2025) | $6.6 million | [Item 9.01 Financial Statements and Exhibits](index=2&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) Lists the exhibits filed with the Form 8-K, including a press release and interactive data file Exhibits Filed with Form 8-K | Exhibit No. | Description | | :---------- | :-------------------------------------------------- | | 99.1 | Press Release, dated October 6, 2025 | | 104 | Cover Page Interactive Data File (embedded with Inline XBRL document) | [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) Addresses cautionary information regarding future-oriented statements, their inherent uncertainties, and the company's disclosure obligations - This Current Report includes forward-looking statements concerning revenue, financial outlook, product demand, and growth expectations, based on current management expectations[8](index=8&type=chunk) - Preliminary, estimated financial results are unaudited, subject to final reviews and closing procedures, and may be materially inaccurate[8](index=8&type=chunk) - Actual future results may differ materially due to factors such as Nasdaq compliance, strategic partnerships, technology performance, capital needs, regulatory changes, and intellectual property rights; NeuroOne disclaims any obligation to update these statements[8](index=8&type=chunk) [Signatures](index=3&type=section&id=SIGNATURES) Confirms the official signing of the report by NeuroOne Medical Technologies Corporation's Chief Executive Officer - The report was signed on behalf of **NeuroOne Medical Technologies Corporation** by **David Rosa**, Chief Executive Officer, on October 6, 2025[12](index=12&type=chunk)

Core Insights - Biotech stocks experienced strong after-hours gains, driven by Pfizer's announcement of U.S. drug price cuts and a $70 billion investment in domestic manufacturing [1] Group 1: Ovid Therapeutics Inc. (OVID) - Ovid Therapeutics saw a 7.69% increase in after-hours trading, reaching $1.40 after a regular session decline of 7.14% to $1.30 [2] - The stock's regular session selloff was marked by elevated trading volume of over 2.93 million shares, significantly above the average of 2.07 million shares [2] - Recent coverage from Lucid Capital initiated a Buy rating with a price target of $5.50, highlighting Ovid's pipeline assets in Phase 1 trials for drug-resistant epilepsies [3] Group 2: NeuroOne Medical Technologies Corp. (NMTC) - NeuroOne Medical Technologies rose 6.98% in after-hours trading to $0.9506 after a modest decline of 1.27% during the regular session [4] - The trading volume was relatively light at 134,720 shares, below the average of 315,000 shares [4] - The company announced a virtual roadshow webinar scheduled for October 7 to discuss operations and recent FDA clearance [5] Group 3: PepGen Inc. (PEPG) - PepGen experienced a 3.03% rise in after-hours trading, reaching $4.76 after closing at $4.62 [6] - The stock has surged over 120% in the past week due to positive clinical and financial updates [6] - A recent $100 million public offering was completed, expected to support the development of PGN-EDODM1 and PGN-EDO51 [9] Group 4: Reviva Pharmaceuticals Holdings Inc. (RVPH) - Reviva Pharmaceuticals rose 5.81% in after-hours trading to $0.3900 after a 19.56% surge during the regular session [10] - The trading volume was significantly elevated at over 26 million shares, well above the average of 3.9 million shares [10] - The company recently announced a $9 million public offering priced at $0.30 per share [11] Group 5: Anika Therapeutics Inc. (ANIK) - Anika Therapeutics saw a 5.53% increase in after-hours trading, reaching $9.92 after closing at $9.40 [11] - The stock's regular session strength followed a quiet news cycle, with no new filings or press releases [12] - Anika is in focus ahead of its scheduled earnings report on October 30, 2025 [12]

NeuroOne Medical Technologies Conference Summary Company Overview - **Company Name**: NeuroOne Medical Technologies Corporation - **Ticker Symbol**: NMTC - **Industry**: Medical Technology focusing on neurological disorders - **Core Business Segments**: Brain, Pain, and Drug Delivery [2][4] Key Products and Technology - **FDA-Cleared Products**: Four products with FDA clearance, including the OneRF ablation system for facial pain and devices for epilepsy treatment [3][5] - **Partnerships**: - **Mayo Clinic**: Long-term partner involved in technology development and investor [4] - **Zimmer Biomet**: Invested $8.5 million for licensing rights to commercialize diagnostic and ablation systems [4] - **Technology Advancements**: - Thin film electrode technology allows for less invasive procedures and dual functionality (diagnostic and therapeutic) [3][6] - OneRF ablation system combines diagnostic and therapeutic functions, reducing the need for multiple surgeries [6][8] Market Potential - **Market Size**: The market for the technologies being pursued is currently generating $3 billion in revenue [11] - **Upcoming Products**: - Percutaneously placed electrode for lower back pain in development [5] - Drug delivery system utilizing sEEG electrodes, with initial orders from a large pharma company [11] Financial Overview - **Revenue Guidance**: Projected revenue for fiscal year 2025 is between $8 million and $10 million [12] - **Gross Margins**: Increased guidance for product gross margins to 50% to 53% [12][30] - **Funding Status**: Company is debt-free and funded through at least fiscal year 2026 [12][28] Competitive Landscape - **Market Position**: NeuroOne is positioned as a leader in developing technologies that integrate diagnostics and therapeutics, unlike competitors who focus solely on diagnostics [25][26] - **Innovation Focus**: Continuous innovation to maintain a competitive edge, with plans to expand into facial pain and back pain markets [26] Strategic Partnerships and Sales - **Sales Strategy**: Currently, all sales are through Zimmer Biomet, with potential for a separate sales force for drug delivery technology [22][23] - **International Expansion**: Plans to expand into international markets with ISO 13485 certifications [28] Clinical and Regulatory Considerations - **Clinical Trials**: No human trials required for certain devices used in acute settings; however, drug delivery systems will require studies tied to specific drugs [19][20] - **Regulatory Pathways**: Strategy to partner with pharmaceutical companies to streamline the approval process for drug delivery systems [20][21] Investment Proposition - **Value Proposition**: NeuroOne offers a diversified technology platform with multiple applications in neurology, minimizing investment risk compared to single-application companies [32][33] - **Future Outlook**: Strong potential for revenue growth and market penetration across various neurological disorders [12][14][32]

Core Viewpoint - NeuroOne Medical Technologies Corporation is actively participating in the Sidoti & Co. Virtual Small-Cap Conference, aiming to enhance its visibility among institutional investors and discuss its recent operational achievements and financial performance [1][2]. Financial Performance - In the third quarter of fiscal year 2025, NeuroOne reported a revenue increase of 105%, reaching $1.7 million compared to the previous year [2]. - The company expanded its gross margin to 53.9% during the same period [2]. Operational Milestones - NeuroOne received FDA 510(k) Clearance for its OneRF® Trigeminal Nerve Ablation System, which is designed to treat facial pain [2]. - The company is funded through at least fiscal year 2026, indicating a stable financial position for ongoing operations and growth initiatives [2]. 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 [3]. - The company is also exploring applications in other areas such as depression, mood disorders, and artificial intelligence [3].

Company Overview - NeuroOne Medical Technologies Corporation (NMTC) received FDA 510(k) clearance for its OneRF Trigeminal Nerve Ablation System, a minimally invasive solution for treating severe facial pain [1][7] - The OneRF platform utilizes proprietary multi-contact RF probe technology for precise localization and tailored ablation under temperature-controlled conditions, enhancing patient safety and reducing procedural time [2][9] - NMTC plans a limited commercial launch of the OneRF system in the fourth quarter of 2025, targeting revenue growth opportunities [1][7] Market Potential - The FDA clearance is a significant growth catalyst for NMTC, expanding its OneRF platform into the large pain management market, which is expected to create near-term revenue potential [4] - The global trigeminal neuralgia treatment market was valued at $255.09 million in 2024 and is projected to reach $392.34 million by 2033, with a CAGR of 4.9% [11] - The increasing incidence of trigeminal neuralgia and the growing geriatric population are expected to drive market expansion [12] Stock Performance - Following the FDA clearance announcement, NMTC's shares gained 7% in pre-market trading, with a year-to-date increase of 0.5% compared to the industry's 1% growth [3] - NMTC currently has a market capitalization of $40.9 million [6]

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]