NeuroOne Medical Technologies Corporation Q3 FY2025 earnings call

• Financial progress: Product revenue increased 105% to $1.7 million in Q3 2025 with product gross margins at 53.9%, debt-free, and funded through at least fiscal 2026 based on Zimmer Biomet contract.
• Patient outcomes: First patient reached 1-year seizure freedom, planning post-market registry for OneRF ablation system outcomes.
• Product portfolio expansion: Submitted 510(k) for trigeminal neuralgia pain management, pursuing basivertebral nerve ablation and spinal cord stimulation electrode animal studies, drug delivery system initial bench testing.
• Intellectual property: Received notice of allowance for manufacturing method, first international patent for spinal cord stimulation electrode.
• Management team: Hired Chief Medical Adviser and General Counsel, with cost savings from new hires.

Product revenue in the third quarter of fiscal year 2025 increased 105% to $1.7 million compared to $0.8 million in the third quarter of fiscal year 2024. For the first 9 months of fiscal year 2025, product revenue was $6.4 million, a 100% increase from $3.2 million in the same period of fiscal year 2024. Product gross margins in the third quarter of fiscal year 2025 were 53.9% compared to 34.1% in the third quarter of fiscal year 2024. For the first 9 months of fiscal year 2025, product gross profit was $3.6 million, 56.8% of revenue, compared to $0.9 million, 29.5% of revenue in the first 9 months of fiscal year 2024. Licensing revenue in the first 9 months of fiscal year 2025 was $3 million, which was not present in the first 9 months of fiscal year 2024.

• Fiscal 2025 product revenue expected to be in the range of $8 million to $10 million, a 132%-190% increase over fiscal year 2024.
• Product gross margin expectations revised to between 50% and 53% versus previous guidance of 47% to 51%.
• Funded through at least fiscal 2026 based on contractual minimum orders with Zimmer Biomet, potentially longer if key milestones are hit.

• Forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those expressed. Specific risks and uncertainties are detailed in NeuroOne's financial results press release and SEC filings.

Q: Talk about the AG drug delivery platform? And give us a sense of is testing being done in animals now? Or will there be some human testing going on this year?

A: Right now, the devices were ordered for initial testing just on the bench. And then from there, assuming that's successful, they will be used in animals. And then ultimately, if the testing is successful in animals, then it would roll into a future clinical trial in humans.

Q: Could you jump over to trigeminal ablation? And talk about the marketplace and talk about the specific physician specialties that you could envision a commercial presence in?

A: From what we've been able to find in market research as well as through discussions with some of our neurosurgeon advisers that participated in our advisory board for brain ablation. Roughly, there's about 150,000 people in the U.S. that suffer from this condition. In terms of actual numbers of procedures, it's less defined. But again, just in having discussions with the physicians who are doing these procedures it seems like the opportunity is similar as to what the numbers are for brain ablations, maybe a little less. I think we'll get our idea of this as we go out to these actual centers. But the physicians performing this procedure and why it made so much sense for us to pursue it is that the same doctors who were doing brain ablations for these epilepsy patients are the same ones that are treating facial pain. So that's kind of an overview of the market as well as who's doing the procedures.

Q: With regard to SCS. Could you talk about is the design and the product lockdown, there's one SKU and implants would be -- could you guesstimate what level of this line?

A: So what we're talking about in terms of the patient population, this is lower back pain. So I would say anywhere from L3, L4 down to S1 would more than likely be the targets for this type of therapy. In terms of the SKUs, we're not at that point yet, but there are going to be multiple components to the system. There'll be a delivery system, the electrode itself. So it's likely that there would be much like what you see in brain ablation as well as facial pain multiple SKUs for -- that represents the additional components.

Q: As far as Q4 goes, thanks, Ron, for the 8 to 10 confirmation. And any outlook for '26 that you want to talk about at this point in time?

A: We are not giving a forecast yet for 2026. We do -- we are confident in the range, but we just have not made that public. Again, that's due to the minimum purchase requirements that are in Zimmer amended contract.