Financial Data and Key Metrics Changes - Fiscal year 2025 marked the most successful year in the history of the company, with record product sales growth of 163% to $9.1 million [3] - Fourth quarter product revenue increased 907% to $2.7 million compared to $0.3 million in the same quarter of fiscal 2024 [15] - Product gross margins improved to 55.8% in Q4 2025 from 51.8% in Q4 2024, with a full-year gross margin of 56.5% compared to 31.3% in fiscal 2024 [15][16] - Net loss in Q4 2025 improved by 52% to $1.6 million, or $0.03 per share, compared to a net loss of $3.4 million, or $0.11 per share, in Q4 2024 [17] - Cash and cash equivalents increased to $6.6 million as of September 30, 2025, from $1.5 million a year earlier [17] Business Line Data and Key Metrics Changes - The company received FDA 510(k) clearance for the OneRF trigeminal nerve ablation system and advanced the development of spinal cord stimulation electrodes for lower back pain [4] - The drug delivery program using SEEG platform electrode technology has garnered significant physician interest, with potential partnerships for gene therapy and glioblastoma drug delivery [5][6] - The company reported its first preclinical drug delivery device sales to a large pharmaceutical company [6] Market Data and Key Metrics Changes - The OneRF brain ablation system, marketed by Zimmer Biomet, continues to gain traction, with positive clinical outcomes reported [12] - The company is pursuing several market opportunities as potential revenue drivers, particularly in drug delivery and pain management [5][8] Company Strategy and Development Direction - The company plans to provide financial guidance for fiscal year 2026 after receiving a final forecast from its distribution partner, Zimmer Biomet [4] - The strategy includes leveraging existing technologies for new applications, such as the basivertebral nerve ablation system for lower back pain [9][38] - The company aims to strengthen its patent portfolio, with 17 issued and pending patents [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in driving increased revenue from the OneRF ablation system and preparing for future international sales [14] - The company anticipates significant growth opportunities in drug delivery and pain management platforms, with a focus on FDA clearance for new products [8][18] Other Important Information - The company has received a 180-day extension from Nasdaq to regain compliance with the minimum bid price rule [4] - Total operating expenses decreased by 2% in Q4 2025 compared to the same quarter in the previous year [16] Q&A Session Summary Question: Will there be more procedures for facial pain before year-end? - Management indicated that three other centers have planned cases, pending some ancillary equipment [22] Question: Were the two procedures done back to back? - Yes, both cases were performed back to back, which allows for better scheduling of future cases [23] Question: What is the status of the drug delivery program with the large pharma player? - Additional orders are expected mid-year for preclinical testing, with ongoing efforts to validate manufacturing processes [25] Question: What is the timing for establishing the epilepsy registry? - The registry is expected to be established by Q2 2026, pending internal approvals from participating sites [28] Question: How is the company navigating the reimbursement landscape? - The company is utilizing established reimbursement codes, and the cost advantages of its technology have not hindered adoption [44]

Financial Data and Key Metrics Changes - Fiscal year 2025 was the most successful year in the history of NeuroOne Medical Technologies, with record product sales growth of 163% to $9.1 million [3][16] - In Q4 2025, product revenue increased 907% to $2.7 million compared to $0.3 million in Q4 2024, with product gross margins improving to 55.8% from 51.8% [5][16] - Total operating expenses decreased by 2% to $2.9 million in Q4 2025, and net loss improved by 52% to $1.6 million, or $0.03 per share [17][18] Business Line Data and Key Metrics Changes - The company received FDA 510(k) clearance for the OneRF trigeminal nerve ablation system and advanced the development of spinal cord stimulation electrodes for lower back pain [4][10] - The drug delivery program using SEEG platform electrode technology has garnered significant physician interest, with initial sales reported to a large pharmaceutical company [6][7] Market Data and Key Metrics Changes - The company is pursuing several market opportunities, including partnerships for gene therapy and glioblastoma drug delivery development [6][7] - The OneRF brain ablation system is gaining traction with accounts as it is released to additional sites, with positive clinical outcomes reported [12] Company Strategy and Development Direction - The company plans to provide financial guidance for fiscal year 2026 after receiving a final forecast from distribution partner Zimmer Biomet [4] - NeuroOne aims to leverage existing technologies and partnerships to expand its product offerings in pain management and drug delivery [9][40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in driving increased revenue from the OneRF ablation system and preparing for future international sales [15][19] - The company anticipates strong growth prospects and plans to execute its strategy effectively [15][19] Other Important Information - The company raised $8.2 million in capital, strengthening its balance sheet [3] - NeuroOne has received a 180-day extension from Nasdaq to regain compliance with minimum bid price requirements [4] Q&A Session Summary Question: Will there be more procedures for facial pain before year-end? - Management indicated that there are three other centers planning cases, pending some equipment installations [22][23] Question: Were the initial procedures back to back? - Yes, both cases were performed back to back, and scheduling for future cases is expected to be more convenient [24] Question: Will there be more orders from the large pharma player for drug delivery? - Additional orders are anticipated around mid-year as the company prepares to ship more preclinical devices [26] Question: What is the timing for establishing the epilepsy registry? - The registry is expected to be established by Q2 2026, pending site approvals [28][29] Question: What strategies are in place for raising patient awareness? - The company is partnering with organizations like the Epilepsy Foundation to enhance visibility and share patient success stories [30][32] Question: Can you elaborate on the distribution agreement with Zimmer Biomet? - The agreement has expanded to include the brain ablation system, with potential for further growth [41][42] Question: How is the company navigating the reimbursement landscape? - The company is utilizing established reimbursement codes, and the cost advantages of its technology have not hindered adoption [43][45]

Financial Data and Key Metrics Changes - Fiscal year 2025 was the most successful year in the history of the company, with record product sales growth of 163% to $9.1 million [3] - In Q4 2025, product revenue increased 907% to $2.7 million compared to $0.3 million in Q4 2024 [14] - Product gross margins improved to 55.8% in Q4 2025 from 51.8% in Q4 2024 [5] - Net loss in Q4 2025 improved by 52% to $1.6 million, or $0.03 per share, compared to a net loss of $3.4 million, or $0.11 per share, in the same quarter of the prior year [16] - Total operating expenses decreased 2% to $2.9 million in Q4 2025 compared to $3.0 million in Q4 2024 [15] Business Line Data and Key Metrics Changes - The company received FDA 510(k) clearance for the OneRF trigeminal nerve ablation system and advanced the development of spinal cord stimulation electrodes for lower back pain [4] - The drug delivery program using SEEG platform electrode technology has garnered significant physician interest, with potential partnerships for gene therapy and glioblastoma drug delivery [6] - The OneRF brain ablation system continues to gain traction, with positive clinical outcomes reported [11] Market Data and Key Metrics Changes - The company is pursuing several market opportunities as potential revenue drivers, particularly in drug delivery and pain management [5] - Interest from strategic partners in using the technology for various therapies indicates a growing market potential [6] Company Strategy and Development Direction - The company plans to provide financial guidance for fiscal year 2026 after receiving a forecast from distribution partner Zimmer Biomet [4] - The strategy includes expanding the product portfolio and pursuing international commercial expansion through ISO 13485 certification [4] - The company aims to leverage existing technologies for new applications in pain management and drug delivery [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in driving increased revenue from the OneRF ablation system and preparing for future international sales [17] - The company anticipates significant growth opportunities in drug delivery and pain management platforms [7] Other Important Information - The company raised $8.2 million in capital, strengthening its balance sheet [3] - As of September 30, 2025, the company had cash and cash equivalents of $6.6 million, compared to $1.5 million a year earlier [16] - The company has 17 issued and pending patents, enhancing its intellectual property portfolio [12] Q&A Session Summary Question: Will there be more procedures for facial pain before year-end? - Management indicated that there are three other centers planning cases, pending some ancillary equipment [19][20] Question: Were the two procedures done back to back? - Yes, both cases were performed back to back, which allows for better scheduling and support [21][22] Question: Will there be more orders from the large pharma player for drug delivery? - Additional orders are expected around mid-year as the company prepares to ship preclinical devices [23] Question: What is the status of the epilepsy registry? - The registry is expected to be established by Q2, pending internal approvals from participating sites [24] Question: What strategies are being implemented to raise patient awareness? - The company is partnering with organizations like CURE and the Epilepsy Foundation to increase visibility [25][26] Question: Can you elaborate on the distribution agreement with Zimmer Biomet? - The agreement has expanded to include the brain ablation system, with potential for further growth [27][33] Question: How is the company navigating the reimbursement landscape? - The company is utilizing established reimbursement codes, which have not hindered adoption by neurosurgeons [34][35]

[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)

Market Opportunities - The epilepsy market presents a significant opportunity, with approximately 3,000,000 patients in the U.S. and an estimated annual cost of $15.5 billion[30] - The chronic back pain market, particularly through spinal cord stimulation (SCS), is valued at approximately $2.5 to $3 billion globally[36] - The total market for Basivertebral Nerve Ablation (BVNA) procedures in the U.S. is estimated at around $100 million per year, with over 10,000 procedures performed annually[40] - The Parkinson's disease market includes around 1,000,000 patients in the U.S., with 60,000 new diagnoses each year, highlighting a significant treatment need[42] - The company is developing a drug delivery system that has already been ordered by a large biopharmaceutical company, representing a new market opportunity exceeding $50 million[41] Product Development and Regulatory Approvals - The company has received 510(k) clearance for four devices, including the Evo Cortical and OneRF Brain Ablation System, enhancing its product portfolio for brain-related conditions[23] - The OneRF TN Ablation System features a "first-of-its-kind" multi-contact RF probe, potentially reducing procedural time and improving patient safety[25] - The company is pursuing FDA clearance for a new drug delivery device intended for neurological therapies, which could expand its market reach significantly[27] - The company is pursuing a 510(k) clearance with the FDA for its drug delivery system and BVNA product[54] - Four products have received 510(k) clearance from the FDA: Evo Cortical, Evo sEEG, OneRF Ablation System, and OneRF TN Ablation System, while other products are still under development[173] Financial Performance and Funding - In fiscal 2025, the company generated approximately $9.1 million in product revenue from the Evo Cortical, Evo sEEG, and OneRF Brain Ablation System[50] - The company raised approximately $8.2 million from the sale of 16 million shares at $0.50 per share in April 2025[70] - As of September 30, 2025, the company had an accumulated deficit of $78.6 million, primarily due to expenses from operations and research and development programs[144] - The company has incurred significant operating losses since inception and does not expect to achieve profitability in the foreseeable future[145] - The company had cash and cash equivalents of approximately $6.6 million as of September 30, 2025, which is insufficient to fund ongoing operating expenses[156] Competition and Market Dynamics - The company faces competition in the epilepsy diagnosis market from Ad-Tech Medical Instrument Corporation, PMT Corporation, and Dixi Medical, among others[84] - The market for trigeminal neuralgia treatment includes competition from Boston Scientific and Avanos RF ablation systems[87] - The company faces significant competition from established players in the medical device industry, which may impact market acceptance[212] - Competitors may have advantages such as more experienced sales forces, greater name recognition, and established distribution networks[215] - The company may face challenges in developing and commercializing new products due to competition and market dynamics[214] Regulatory Compliance and Risks - The company is subject to extensive governmental regulation, and failure to comply could adversely affect its business[146] - The FDA classifies medical devices into three classes (I, II, III) based on risk, with Class III requiring the most regulatory control and typically a Premarket Approval (PMA) process[108] - Non-compliance with regulatory requirements can lead to significant consequences, including product recalls, fines, and potential criminal prosecution[128] - The PMA approval process can be lengthy and costly, with many devices never receiving approval despite applications being submitted[120] - Regulatory compliance and scrutiny will continue to be a significant responsibility for the company, even after obtaining product approvals[181] Research and Development - Research and development expenses for the years ended September 30, 2025, and 2024 were $5.0 million and $5.1 million, respectively, indicating a slight decrease[82] - The company is focused on developing comprehensive neuromodulation solutions for neurological disorders, including epilepsy and Parkinson's disease[148] - Clinical testing for new products is expensive and time-consuming, with potential delays impacting the ability to generate revenue[174] - The company may need to conduct additional clinical trials or testing, which could delay marketing approval for its technologies[177] - The company is exploring partnerships for drug delivery systems capable of therapy delivery and monitoring for up to 30 days[50] Intellectual Property and Partnerships - The patent estate includes multiple issued patents and pending applications, with expiration dates ranging from 2028 to 2045, highlighting the importance of intellectual property protection[94] - The partnership with Mayo is crucial for licensing know-how for the development and commercialization of technology, and its termination would harm the business[221] - The Mayo Development Agreement includes exclusive licensing of certain improvements and non-exclusive licensing of thin film electrode technology know-how[221] Operational Challenges - The company relies on reimbursement from private third-party healthcare payors and Medicare, which is critical for its success, but future coverage levels are uncertain[74] - The company relies on a limited number of third-party suppliers for components, which exposes it to risks related to pricing, availability, and quality[168] - The inability to obtain a supply of components and raw materials could materially adversely affect the company's business and financial condition[163] - The company faces fierce competition in recruiting and retaining qualified personnel, which could harm business if competitors are more successful[216] - The company has faced substantial doubt about its ability to continue as a going concern due to ongoing losses and negative cash flows from operations[156]

Core Points - NeuroOne Medical Technologies Corporation is conducting a virtual webinar led by CEO Dave Rosa and CFO Ron McClurg [1] - The conference 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 and uncertainties that may cause actual results to differ from forward-looking statements, particularly concerning fiscal 2025 preliminary product revenue [3]

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]

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]