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]

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]