NeuroOne Medical Technologies Corporation

Good day, ladies and gentlemen. Welcome to the fourth quarter of fiscal year 2025 Financial Results Conference Call for Norah One 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 U.S. federal securities laws with respect to future operations, financial results, 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 implied by such statements. To see NORA 1'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, NORA 1 undertakes no obligation to update such forward-looking statements. With that, I will turn the call over to Mr. Dave Rosa, CEO of NORA 1. Please go ahead, sir.

Thank you, Operator, and thank you to everyone for joining us today. I'd like to welcome you to our fourth quarter fiscal 2025 financial results conference call. Fiscal year 2025 was the most successful year in the history of Neuron Medical Technologies Corporation and an inflection point for our company. I'd like to start today with a brief overview of the most significant milestones we achieved in fiscal year 2025. Financially, we saw record product sales growth of 163% to $9.1 million. Reduced operating expenses significantly improved our product gross margins to 56.5% and strengthened the balance sheet with an $8.2 million capital raise. Operationally, we received FDA 510K clearance for the 1RF trigeminal nerve ablation system advanced the development of our spinal cord stimulation electrode for lower back pain, initiated a new product development program for basie vertebral nerve ablation for lower back pain, reported sales of our first preclinical drug delivery devices to a large pharmaceutical company, strengthened our infrastructure with key senior executive hires, initiated the process to gain ISO 13485 certification for international commercial expansion, and lastly, bolstered our intellectual property portfolio. Additionally, we plan on providing financial guidance for fiscal year 2026 once we receive a final forecast from our distribution partner, Zimmer Biomat. Also, as previously disclosed, NASDAQ granted us a 180-day extension until May 4, 2026, to regain compliance with NASDAQ's minimum bid price rule for continued listing on the NASDAQ capital market. We will continue to monitor the closing bid price of our common stock and seek to regain compliance with the minimum bid price requirement within the extension period. Moving on to the fourth quarter of fiscal 2025, we continued to make strong financial progress as product revenue increased 907% to $2.7 million and product gross margins increased to 55.8% compared to 51.8% in the fourth quarter of fiscal 2024. This is a direct result of the expansion of commercialization efforts for our 1RF brain ablation system distributed by Zimmer Biomed. What made this most impressive is that we also reduced our operating expenses by 2% versus fiscal Q4 2024. With respect to expanding our product portfolio, we are now pursuing several market opportunities as potential revenue drivers. First, our drug delivery program using our SCEG platform electrode technology has received a great deal of physician interest. In addition, we have been approached by two organizations looking to potentially partner with us to use our technology for gene therapy, cell therapy, and glioblastoma drug delivery development, and we reported the first sales of other preclinical devices to a large pharmaceutical company for testing purposes. This interest gives us confidence that our technology can offer advantages over competitive devices that both caregivers and pharmaceutical organizations value. You will be hearing more about our progress in fiscal 2026, as well as our comprehensive strategy to offer various sizes of both preclinical and clinical use devices that are appropriate for the drug development cycle through commercialization for human use, which is dependent on FDA approval to market. Based on physician feedback, we also believe we have an opportunity to offer a new platform to treat glioblastomas that provides a better solution for both patients and caregivers. Unfortunately, I am sure most of us know someone who has been affected by a brain tumor. At Neuro One, our chief technology officer, Steve Mertens, was diagnosed with one two years ago. Thankfully, he is doing well, but is also committed to trying to help others by advancing Neuro One's technology. Drug delivery represents a potentially massive opportunity when you consider the number of patients suffering with brain-related neurological disorders, such as glioblastomas, epilepsy, and Parkinson's disease, to name a few. In 2026, our goal is to be commercially ready with our preclinical drug delivery offerings, as well as to develop a pathway to gain FDA clearance. Regarding our pain management platform, we have two active programs in development for treating lower back pain. The first is our percutaneously placed paddle electrode, which can be delivered through a 14-gauge needle in the spine, which then expands to offer broader customizable stimulation requiring less energy consumption than traditional standard percutaneous electrodes. We are in the process of finishing chronic animal studies to evaluate histology and other product metrics and expect to initiate additional long-term studies in fiscal Q2 2026. We also continue to explore partnership opportunities with strategic organizations. The second technology in our pain management platform is our VASY vertebral nerve ablation system, which was kicked off in fiscal Q4 2025. This past quarter, we held our first advisory board meeting with leading pain experts that have great experience with performing this procedure. Our strategy is to leverage our existing 1RF generator and SCEG Pro to perform this procedure. To that end, we are in early discussions with strategics regarding this product technology and will seek a partnership with an established organization with a presence in the pain management space. Up next are animal studies with continued R&D testing to confirm that the system will perform as required. In August, we received FDA 510K clearance for our 1RF trigeminal nerve ablation system to treat facial pain by ablating the trigeminal nerve. further validating our technology platform and providing an alternative to pharmaceutical and other surgical treatments. As discussed previously, we indicated that we would have a limited commercial launch in the fourth quarter of calendar 2025. To that end, I am pleased to report that the first two patients were successfully treated at the University Hospitals Cleveland with both patients reporting pain relief from the procedure without any complications. The cases confirm that, unlike traditional ablation systems, our probe required only one placement due to the multiple contacts present on the device. This allowed the neurosurgeon to easily locate the area of the nerve triggering the patient's facial pain. The traditional systems may require multiple probe placements, which can cause additional patient discomfort. As a reminder, this system utilizes the same 1RF brain ablation system. It also includes additional accessories specific to the procedure. We pursued this indication based on neurosurgeon interest and the fact that this is the same customer performing brain ablations with our system. This additional capability also potentially helps justify a financial case given its multi-use capabilities. We will continue to perform additional cases to obtain post-market clinical performance information. Regarding distribution, we currently have interest from a strategic to potentially license this technology, and we'll provide an update on those discussions when appropriate. Regarding the 1RF brain ablation system currently marketed by Zimmer Biomed, we continue to gain traction with accounts as the product is released to additional sites. Clinical outcomes have also continued to be reportedly positive without any adverse events to date. Our temperature control probe is performing exactly as intended and offering an additional safety mechanism during procedures that ensures excessive temperatures do not occur during the ablation. We also recently met with key personnel from sites participating in the 1RF registry, which is intended to gather a variety of performance data for patients that have had ablations with our system. Hospital Institutional Review Board approvals and site contracts are expected to occur during the course of this year and can vary by center. We attended the following trade shows in fiscal Q4 2025 through today. The Society for Neuroscience, Congress of Neurological Surgeons, and the American Epilepsy Society meeting. All meetings included posters and or presentations on our technology, as well as Mayo Clinic physician testimonials on their experience with our technology, at the AES at the Zimmer Biomet booth. As we progress our technology platform and enter new markets, we can currently continue to strengthen our patent portfolio. Recently, we were granted a notice of allowance by the U.S. Patent and Trade Office for both the manufacturing methods used to deposit our contact material onto our electrode, and a second notice of allowance that covers our proprietary temperature control probe when used with our SEEG electrode. On the international front, we have also received our first granted European patent for the temperature probe. In total, the company has 17 issued and pending patents, which were all developed and owned in-house, with the exception of the initial three patents we licensed pertaining to our cortical electrode fans. Before I turn the call over to Ron, I wanted to reiterate our confidence in driving increased revenue from our 1RF ablation system, along with initiating preparation for future international sales. I'd also like to note that our anticipated growth will not include trigeminal neuralgia ablation revenue, strategic agreements for pain management technology, or drug delivery partnerships or sales. The prospects for current and future growth are bright, and our goal is to continue to execute on this plan. I would now like to turn the call over to Ron McClure, Chief Financial Officer, to provide a review of our fiscal fourth quarter and full year financial results.

Ron? Thanks, Dave. Product revenue increased 907% to $2.7 million in the fourth quarter of fiscal 2025. compared to product revenue of $0.3 million in the fourth quarter of fiscal 2024. For the full fiscal year 2025, product revenue increased 163% to $9.1 million, compared to $3.5 million for the full fiscal year 2024. The company also had license revenue of $3 million in fiscal 2025, which is not included in our product revenue. compared to no license revenue in fiscal 2024. License revenue in fiscal 2025 was derived from the expanded exclusive distribution agreement with Zimmer Biomed. Product gross profit increased significantly to 1.5 million or 55.8% of revenue in the fourth quarter of fiscal 2025 compared to product gross profit of 0.1 million or 51.8% of revenue in the same quarter of the prior fiscal year. For the full fiscal year 2025, product gross profit increased significantly to $5.1 million or 56.5% of revenue compared to product gross profit of $1.1 million or 31.3% of revenue in the full fiscal year 2024. Total operating expenses decreased 2% to 2.9 million in the fourth quarter of fiscal 2025, compared to 3.0 million in the same quarter of the prior year. R&D expenses in the fourth quarter of fiscal 2025 was 1.1 million, the same as the fourth quarter of fiscal 2024. SG&A expense in the fourth quarter of fiscal 2025 was 1.8 million, compared to 1.8 million in the same quarter of the prior year. For the full fiscal year 2025, total operating expenses decreased 5% to $12.4 million compared to $13.0 million for the full fiscal year 2024. R&D expense in the full fiscal year 2025 decreased 2% to $5.0 million compared to $5.1 million in fiscal year 2024. SG&A expense in the full fiscal year 2025 decreased 7% to $7.4 million compared to $7.9 million in the fiscal year 2024. Net loss in the fourth quarter of fiscal 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. Net loss for the full fiscal year 2025 improved by 71% to $3.6 million, or $0.09 per share, compared with a net loss of $12.3 million, or $0.46 per share, for full fiscal year 2024. As of September 30, 2025, the company had cash and cash equivalents of $6.6 million compared to $1.5 million as of September 30, 2024. Of note, Neuro One is funded through at least fiscal 2026, potentially longer if key milestones are hit. The company had working capital of $7.9 million as of September 30th, 2025, compared to working capital of $2.4 million as of September 30th, 2024. We had no debt outstanding as of September 30th, 2025. I will now turn the call back over to Dave for his closing remarks.