Neuroone Medical Technologies (NasdaqCM:NMTC) Q1 2026 Earnings call February 17, 2026 08:30 AM ET Company ParticipantsDave Rosa - CEORon McClurg - CFOConference Call ParticipantsJeffrey Cohen - AnalystJeremy Pearlman - SVP and Equity Research AnalystOperatorGood day, ladies and gentlemen, and welcome to the first quarter fiscal 2026 financial results conference call for NeuroOne Medical Technologies Corporation. Today's call will be conducted by the company's Chief Executive Officer, Dave Rosa, and Ron McCl ...

Financial Data and Key Metrics Changes - The company reported product revenue of $2.9 million in Q1 fiscal 2026, down from $3.3 million in Q1 fiscal 2025, but up 5.5% from $2.7 million in Q4 fiscal 2025 [11][12] - The net loss for Q1 fiscal 2026 was $1.4 million, or a loss of $0.03 per share, compared to a net income of $1.8 million, or $0.06 per share, in the same quarter of the prior year [13] - Cash and cash equivalents as of December 31, 2025, were $3.6 million, down from $6.6 million as of September 30, 2025 [13][14] Business Line Data and Key Metrics Changes - The OneRF brain ablation system saw nearly half of all ablations performed since its launch in Q1 fiscal 2026, indicating strong market penetration [4] - The OneRF trigeminal nerve ablation system initiated a limited commercial launch, treating nine patients across three centers, all reporting pain relief [5][6] Market Data and Key Metrics Changes - The company is working towards receiving ISO 13485 certification to facilitate international commercialization of its technology [5] - The company attended the American Epilepsy Society meeting, showcasing its technology and receiving positive feedback from medical professionals [4] Company Strategy and Development Direction - The company is projecting fiscal year 2026 sales to be at least $10.5 million, representing a minimum 17% increase from fiscal year 2025 [3] - The company is in discussions with strategic partners for potential licensing of its trigeminal nerve ablation technology and is prepared to commercialize independently if necessary [7][22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the continued positive momentum from fiscal year 2025 and the progress across various programs [3][16] - The company is focused on accelerating its drug delivery program, expecting devices for commercial use in investigational studies by Q3 fiscal 2026, six months ahead of schedule [7][8] Other Important Information - The company appointed Jason Mills to its board of directors, bringing valuable experience from his previous roles in strategy and investment banking [10] - The company had no debt outstanding as of December 30, 2025, indicating a strong financial position [14][15] Q&A Session Summary Question: Update on trigeminal nerve ablation cases and interest from Zimmer - The nine cases were performed at three centers, with all patients reporting pain relief. Discussions with strategic partners are ongoing, but the company is ready to commercialize independently if needed [21][22] Question: Expectations for operating expenses for the rest of the year - SG&A expenses are expected to remain flat, while R&D expenses may fluctuate based on project phases [25] Question: Clinical feedback from neurologists or surgical teams - Feedback indicates success in reducing or eliminating seizures, with procedures being performed at patients' bedsides, enhancing ease of use [33][35] Question: Sales and marketing responsibilities with Zimmer - Zimmer is responsible for all marketing and sales costs, while the company provides training and field support [37] Question: Revenue breakdown for Q1 - Most revenue was from restocking, following the initial stocking order in the previous fiscal year [38]

Neuroone Medical Technologies (NasdaqCM:NMTC) Q1 2026 Earnings call February 17, 2026 08:30 AM ET Speaker3Good day, ladies and gentlemen, and welcome to the first quarter fiscal 2026 financial results conference call for NeuroOne Medical Technologies Corporation. 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 forwa ...

Exhibit 99.1 NeuroOne Reports Fiscal Q1 2026 Financial Results; Expects Product Revenue of At Least $10.5 Million in Fiscal Year 2026 Nearly 50% of all Ablations Since OneRF Ablation System Product Launch in 2024 were Performed in Fiscal Q1 2026, Showing Growing Adoption Following FDA 510(k) Clearance, Successfully Completed Nine Trigeminal Neuralgia Cases to Date, with All Patients Reportedly Pain Free* Management to Host Conference Call Today at 8:30 a.m. Eastern Time EDEN PRAIRIE, Minn., February 17, 202 ...

Revenue and Profit - Product revenue for the three months ended December 31, 2025, was $2,892,635, a decrease of $381,532 compared to $3,274,167 in the same period of 2024[154] - Product gross profit for the same period was $1,567,828, down from $1,926,889, reflecting a decrease of $359,061[154] - License revenue was $0 for the three months ended December 31, 2025, compared to $3,000,000 in the same period of 2024, a decrease of $3,000,000[154] - Product revenue for the three months ended December 31, 2025, was $2.9 million, with a gross profit of $1.6 million and a gross profit percentage of 54.2%[155] - License revenue was $3.0 million for the three months ended December 31, 2024, but no license revenue was generated during the same period in 2025[157] Expenses - Total operating expenses increased to $3,275,135 for the three months ended December 31, 2025, from $3,215,682 in 2024, an increase of $59,453[154] - Selling, general and administrative expenses were $1,885,455 for the three months ended December 31, 2025, down from $2,043,454 in 2024, a decrease of $157,999[154] - Research and development expenses increased to $1,389,680 for the three months ended December 31, 2025, from $1,172,228 in 2024, an increase of $217,452[154] - Selling, general and administrative expenses decreased to $1.9 million for the three months ended December 31, 2025, from $2.0 million in the prior year[158] - Research and development expenses increased to $1.4 million for the three months ended December 31, 2025, compared to $1.2 million in the same period of 2024[159] Net Loss and Financial Position - The net loss for the three months ended December 31, 2025, was $1,437,890, compared to a net income of $1,785,322 in the same period of 2024, a change of $3,223,212[154] - As of December 31, 2025, the accumulated deficit was $80.0 million, primarily due to research and development expenses and other operational costs[136] - The net loss for the three months ended December 31, 2025, was $1.4 million, which included non-cash expenses and a net cash use of approximately $1.9 million due to changes in operating assets and liabilities[188] - The company experienced a net decrease in cash of $3.0 million for the three months ended December 31, 2025, compared to a decrease of $325,692 in the same period of 2024[187] Cash Flow and Financing - As of December 31, 2025, cash and cash equivalents totaled approximately $3.6 million, raising concerns about the company's ability to continue as a going concern[164][179] - The company anticipates significant cash requirements for ongoing product development and commercialization operations, including royalty obligations[173] - The company entered into an underwriting agreement in April 2025, resulting in net proceeds of approximately $8.2 million from the sale of 16 million shares of common stock[166] - The company has issued 5,544,489 shares under the ATM Program for gross proceeds of $8.0 million through December 31, 2025[171] - The company has a delayed draw term loan facility of up to $3.0 million, which was terminated in November 2024 without any amounts drawn[172] - The company expects to satisfy its short-term and long-term obligations through cash on hand and future revenue from commercial sales[176] - Net cash used in operating activities was $3.1 million for the three months ended December 31, 2025, compared to a net cash provided of $0.2 million in the same period of 2024[188][189] - Net cash used in investing activities was $41,000 for the three months ended December 31, 2025, compared to $24,000 in the same period of 2024, both related to purchases of property and equipment[190] - Net cash provided by financing activities was $148,000 for the three months ended December 31, 2025, primarily from the exercise of warrants amounting to $174,000[191] Operational Developments - The company initiated a limited market release of the OneRF TN Ablation System in December 2025[139] - The company has received FDA 510(k) clearance for four devices, including the Evo Cortical and OneRF Ablation System[133] Accounting and Financial Reporting - The financial statements are prepared in accordance with U.S. generally accepted accounting principles, requiring estimates and judgments that can affect reported amounts[194] - The company has not had significant variable consideration adjustments related to product revenue, indicating stable revenue recognition practices[195] - The warrants issued in connection with the August 2024 Private Placement are classified as liabilities and will be adjusted for fair value changes until certain conditions are met[196] Cash Flow Dynamics - The increase in accounts receivable was linked to the Zimmer Distribution Agreement, impacting cash flow negatively[188][189] - The company reported a decrease in accrued expenses and accounts payable, which also contributed to the cash flow dynamics observed[188]

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]