NeuroOne Medical Technologies Corporation Q1 FY2026 earnings call

• First quarter sales were sequentially higher than previous quarter and down slightly from initial stocking order of 1RF brain ablation system. Projecting fiscal year 2026 sales to be at least $10,500,000, a minimum 17% increase from fiscal year 2025.
• 1RF brain ablation system: Nearly half of all ablations since launch in fiscal Q1 2026. Establishing registry to capture outcomes, hope to enroll first patient by end of third fiscal quarter. Exhibited at American Epilepsy Society meeting, doctors from Mayo Clinic shared experience. Working towards ISO 13485 certification for international commercialization.
• 1RF trigeminal nerve ablation system: Received FDA 510(k) clearance in August 2025. Initiated limited commercial launch in 2026, first two patients treated at University Hospitals Cleveland with pain relief. Nine total patients treated at three centers, all pain free. In diligence discussions with strategic for potential license.
• Drug delivery program: Accelerated program, expect devices available for commercial use in investigational clinical studies or animals in Q3 fiscal 2026, six months sooner than originally expected. Organizing advisory board of oncology experts. Continuing discussions with pharma and biotech companies regarding device use. Evaluating opportunities with two organizations for partnership.
• Lower back pain management programs: 14-gauge needle: Plan to initiate long-term animal study next month in preparation for first human implant. Actively engaged in diligence discussions with strategic organizations. Basivertebral nerve ablation system: Held multiple advisory board meetings, confident in strategy leveraging existing 1RF and sEEG probe. In diligence discussions with strategics regarding potential partnership.
• Appointed Jason Mills to board of directors, believes his expertise will help address business development opportunities.

Product revenue in 2026 was $2,900,000, compared to $3,300,000 in 2025. Product gross profit in 2026 was $1,600,000, or 54.2% of revenue, compared to $1,900,000, or 58.9% of revenue in the same quarter of the prior fiscal year. Total operating expenses in 2026 were $3,300,000 compared to $3,200,000 in the same quarter of the prior year. Research and development expense in 2026 was $1,400,000 compared to $1,200,000 in the same quarter of the prior year. Selling, general, and administrative expense in 2026 decreased to $1,900,000 compared to $2,000,000 in the same quarter of the prior year. Net loss in 2026 was $1,400,000, or a loss of $0.03 per share, compared to net income of $1,800,000, or $0.06 per share, in the same quarter of the prior year.

• Projecting fiscal year 2026 sales to be at least $10,500,000, a minimum 17% increase from fiscal year 2025.
• Expect to complete limited launch of 1RF trigeminal nerve ablation system by 2026.
• Drug delivery program devices expected available for commercial use in investigational clinical studies or animals in Q3 fiscal 2026, six months sooner than originally expected.
• SG&A expected to be fairly flat the rest of the year, R&D may fluctuate depending on project phases.

Q: Could you talk about trigeminal, number of physicians/centers that did the nine cases, and interest from Zimmer and/or others trigeminal?

A: Nine cases done at three centers, one was Dr. Grewal's. Patients were pain free. Advantage of technology is placing device once due to multiple contacts. Discussions underway with strategic, goal to conclude diligence as soon as possible, prepared to commercialize if not in diligence.

Q: Sense of number of physicians or number of centers for which Zimmer is present domestically?

A: Do not have that information.

Q: OpEx generally speaking, would you expect that to be fairly flattish off of Q1 levels for the balance of the year?

A: SG&A expected to be fairly flat the rest of the year, R&D may fluctuate depending on project phases.

Q: Any clinical feedback from neurologists or surgical teams using installed products?

A: Device successful in reducing or eliminating seizures, results measured over time, started registry for long-term capture. Feedback on ease of use of device and system, procedures done at patient's bedside.

Q: Specific region in U.S. where Zimmer seeing most traction and adoption of technology?

A: Do not have that information.

Q: Sales and marketing expectations for 2026, share burden with Zimmer or fully on Zimmer's shoulder?

A: Responsibility for all marketing and sales costs lies with Zimmer, responsible for providing training and field support as reasonable.

Q: Revenue breakdown for first quarter, predominantly restocking or additional purchases by Zimmer?

A: Most of the revenue is restocking, replenishing and selling into the market, year ago was initial stocking order, everything since then is continuation and restocking.