NeuroOne Medical Technologies Corporation

Good 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 forward-looking statements. within the meaning of US federal securities laws with respect to future operations, financial results, including our 2026 revenue guidance, events, trends, and performance, which are based on management's beliefs and assumptions as of today's call. Forward-looking statements may involve known and unknown risks, uncertainties, and other factors, which may cause actual results to differ materially from those expressed or implied by such statements. See NeuroOne's financial results press release and SEC filings for information regarding specific risks and uncertainties that could cause actual results to differ. Except, as required by law, NeuroOne undertakes no obligation to update such forward-looking statements. With that, I will turn the call over to Mr. Dave Rosa, CEO of NeuroOne. Please go ahead, sir.

Thank you, Operator, and thank you to everyone for joining us today. I'd like to welcome you to our first quarter fiscal 2026 financial results conference call. The company continued the positive momentum from fiscal year 2025 by making progress in a number of different areas of the business. Our first quarter sales were sequentially higher than the previous quarter and down slightly as expected from the initial stocking order that was placed in Q1 of fiscal 2025 with the launch of the 1RF brain ablation system. We are also projecting fiscal year 2026 sales to be at least $10.5 million, which is a minimum 17% increase from fiscal year 2025. With respect to our existing product portfolio, we continue to make exciting progress across all of our programs. First, Regarding our 1RF brain ablation system, the number of ablations performed in fiscal Q1, 2026 was nearly half of all ablations performed since the launch of the technology. This demonstrates continued penetration and adoption of the technology in the market. We also reported that Mark Burnell, a professional pianist from Chicago, was able to resume his career after receiving an ablation with our system. These types of success stories are not only exciting to hear, but also confirm our enthusiasm for future potential growth with this platform. As previously mentioned, we are also establishing a registry to capture these outcomes and hope to enroll the first patient by the end of the third fiscal quarter. We also attended the American Epilepsy Society meeting in December, where our system was exhibited at Zimmer Biomet's booth. In addition, doctors from the Mayo Clinic in Jacksonville, Florida, provided their experience with the system at the booth. We also believe there's an opportunity internationally for our technology and continue to work towards receiving ISO 13485 certification as a first step towards commercializing internationally. Moving on to our 1RF trigeminal nerve ablation system, we previously disclosed that in August of 2025, we received FDA 510K clearance for this system to treat facial pain by ablating the trigeminal nerve. In the first quarter of fiscal 2026, we initiated a limited commercial launch and reported that the first two patients were treated at the University Hospitals Cleveland with both patients reporting pain relief from the procedure. To date, nine total patients have been treated at three centers, and all are reported pain-free, which is extremely encouraging. As a reminder, unlike traditional ablation systems, our probe was intended to be placed once due to the multiple contacts present on the device. Traditional systems typically require multiple probe placements, which can cause additional patient discomfort. Given the positive outcomes to date, we expect to complete this limited launch by the end of Q2 fiscal 2026. We are currently in diligence discussions with a strategic to potentially license this technology and look to conclude these discussions as quickly as possible. Regarding our drug delivery program, we were able to accelerate the program and expect that we will have devices available for commercial use in investigational clinical studies for animals in Q3 fiscal 2026. This is approximately six months sooner than originally expected. We are currently organizing an advisory board of leading oncology experts that treat challenging brain tumors such as glioblastomas, to provide guidance in utilizing the system to deliver therapies to the brain for this application. We are also continuing discussions with various pharma and biotech companies regarding the potential use of the device for animal and or investigational human studies for gene and cell therapies in development. As reported last quarter, we are evaluating opportunities with two organizations interested in forming a partnership to use our drug delivery technology to deliver their experimental therapies to the brain to treat a variety of different neurological conditions. Moving on to our two lower back pain management programs, I will first provide an update on our percutaneously placed paddle electrode. This system is designed to offer broader, customizable stimulation less energy consumption, and can be inserted through a 14-gauge needle, eliminating the need for an incision in the patient's back. We plan to initiate a long-term animal study next month in preparation for our first human implant. We are actively engaged in diligence discussions with strategic organizations regarding their interest in this platform. The second technology in development to treat lower back pain is our basivertebral nerve ablation system. This past quarter, we held multiple advisory board meetings with leading pain experts to confirm the product requirements as well as to validate the system's potential benefits compared to existing technologies. We are confident in our strategy to leverage our existing 1RF generator and and SEEG Pro for this application. We are also in diligence discussions with strategics regarding this product technology and the potential partnership. Next up in development is to identify firms that can provide manufacturing or required access tools for the system. Finally, we were excited to announce the appointment of Jason Mills to our Board of Directors. Jason is currently the Executive Vice President of Strategy for Penumbra Incorporated, which was recently acquired by Boston Scientific for $14.5 billion. Prior to that, Jason was Managing Director at Canaccord Genuity and has held similar roles in other investment banks over his career. We believe his expertise will translate smoothly into helping address the company's business development opportunities currently in process. I would now like to turn the call over to Ron McClurg, Chief Financial Officer, to provide a review of our first quarter fiscal 2026 financial results.

Thanks, Dave. Product revenue was $2.9 million in the first quarter of fiscal 2026, compared to product revenue of $3.3 million in the first quarter of fiscal 2025, which included Zimmer's initial stocking On a sequential basis, revenue increased 5.5% from $2.7 million in the fourth quarter of fiscal 2025. The company had no license revenue in the first quarter of fiscal 2026 compared to license revenue of $3 million in the first quarter of fiscal 2025, which was derived from the expanded exclusive distribution agreement with Zimmer. Product gross profit was $1.6 million, or 54.2% of revenue in the first quarter of fiscal 2026, compared to product gross profit of 1.9 million, or 58.9% of revenue in the same quarter of the prior fiscal year. On a sequential basis, product gross profit increased 2.6% from 1.5 million in the fourth quarter of fiscal 2025. Total operating expenses were 3.3 million in the first quarter of fiscal 2026, compared to $3.2 million in the same quarter of the prior year. Research and development expense in the first quarter of fiscal 2026 was $1.4 million, compared to $1.2 million in the same quarter of the prior year. Selling general and administrative expense in the first quarter of fiscal 2026 decreased 7.7% to $1.9 million, compared to $2 million in the same quarter of the prior year. Net loss in the first quarter of 2026 was $1.4 million, or a loss of 3 cents per share, compared to net income of $1.8 million, or 6 cents per share, in the same quarter of the prior year. Net income in the first quarter of fiscal 2025 included the license revenue of $3 million related to the distribution license granted to Zimmer for the 1RF product in October of 2024. As of December 31st of 2025, the company had cash and cash equivalents of $3.6 million compared to $6.6 million as of September 30th, 2025. Of note, NeuroOne is funded through fiscal 2026, potentially longer if key milestones are hit. The company had working capital of $6.8 million as of December 31st, 2025 compared to working capital of $7.9 million as of September 30th, 2025. Narawan had no debt outstanding as of December 30th, 2025. I'll now turn the call back over to Dave for his closing remarks.