NeuroOne Medical Technologies Corporation Common Stock 2026 Q3 Earnings Call

Sir, please go ahead. Thank you, operator, and thank you to everyone for joining us today.

I would like to welcome you to our third quarter fiscal 2026 financial results conference call. Before I begin, I want to first welcome both Chris Volker, the company's Chief Financial Officer, and David Wambach, the company's Chief Business Officer, as both will be presenting for the first time in their respective roles. Now, let's get started with a brief financial summary of the quarter. Product revenue for the OneRF® Brain Ablation System in the third quarter of fiscal 2026 grew 16% year over year to $2 million, compared to $1.7 million in the third quarter of fiscal 2025. Orders for the quarter totaled $2.7 million, and we expect aggregate fiscal year 2026 product orders of approximately $11.2 million.

Recognized revenue for the fiscal year is expected to be between $9.2 million-$10.5 million, depending on the timing of shipment of those orders. We are working closely with our suppliers to expedite manufacturing in order to address any remaining backlog by the end of the fourth calendar quarter of 2026. Moving forward, we are working towards the qualification of a second manufacturing site, which will increase capacity and potentially reduce lead times. We also saw gross margins expand to 59.9% during the quarter, compared to 53.9% year over year, due to a favorable product mix. More recently, following the end of the quarter, our lead investor also increased their holdings from 7.4% to 12.5%. Moving on from current revenue growth, let's discuss future growth opportunities and new geographical markets.

As you may recall from previous releases, the company has been pursuing ISO 13485 certification, which is the international quality standard that companies must meet to market products internationally. I am very proud to announce that we received our certification recently, which now provides the opportunity to enter international markets with our OneRF® Brain Ablation System, OneRF® Trigeminal Nerve Ablation System, and Evo Cortical and SEEG diagnostic product lines. We will be working closely with our distribution partner, Zimmer Biomet, to start the process to enter geographies that optimize their existing customer relationships and with a focus on countries that have favorable economics. For those geographies that remain exclusive to NeuroOne, we will explore independent partnerships. As a reminder, certain geographies have additional requirements, which could range from providing additional documentation and submissions to providing clinical data.

This is another major milestone that the company has reached earlier than projected and really speaks to the quality of our procedures, processes, quality system, and employees. Now, let's discuss the exciting progress we've made with our product portfolio. Regarding our OneRF® Brain Ablation System, as I mentioned earlier, we experienced 16% year-over-year revenue growth for the quarter, while purchase orders for our product showed growth of 43% year-over-year. We also had a significant clinical milestone this month, as the Journal of Neurosurgery published a retrospective observational study completed by the Mayo Clinic in Jacksonville, Florida, titled "Stereoelectroencephalography-guided radiofrequency thermocoagulation in Patients with Implanted Neuromodulation Devices: A Patient Series." The study evaluated the use of NeuroOne's OneRF® Brain Ablation System in patients who have implanted neuromodulation devices.

The article concluded that these procedures may be performed without interfering with existing hardware, as well as providing meaningful seizure reduction. This was exciting to hear, as it expands the pool of treatable patients to include those with existing neuromodulation implants. We continue to build a compelling series of clinical experience that supports our goal of providing meaningful improvements for patients suffering with seizures or trigeminal neuralgia. Regarding our OneRF® Trigeminal Nerve Ablation System, I want to share a recent experience that highlights the potential impact of this therapy. A patient recently treated with the OneRF® Trigeminal Nerve Ablation System was featured in a television interview on Cleveland 19 News, an affiliate of the CBS Television Network. She described living with trigeminal neuralgia as being worse than experiencing childbirth 10 times, and that the condition made her feel like a zombie.

Following her treatment, we are happy to state that she reported being pain-free. Stories like this underscore both the devastating burden of this disease and the life-changing potential of our technology. Stories like this continue to demonstrate successful clinical outcomes as measured by freedom from pain, enhanced patient comfort, while also having the potential to significantly reduce procedure times. The U.S. market for disposables, excluding hardware, is estimated at $40 million. Because the majority of these cases are performed in approximately 30 centers, we plan on leveraging current personnel in combination with independent distributors to expand commercialization. Based on our limited market release experience, we also expect a short learning curve, which will minimize the cost of having to support every case. We are currently interviewing distributors with the intent to hire them once the agreements are finalized.

Now I'm turning the call over to David Wambeke to provide an update on our drug delivery system, which we have named StereoCED.

Thanks, Dave. I joined NeuroOne a little over 5 months ago, and since then, I've had the opportunity to fully assess the intracranial drug delivery landscape. The more I've learned, the more convinced I've become that we have a definitive technological edge. Brain-delivered therapeutics are approaching a major inflection point. Dozens of promising programs are now in development, but one challenge continues to stand out. How do you deliver these therapies efficiently, reproducibly, and in a way that hospitals can realistically adopt at scale? While today's delivery technologies have enabled important clinical progress, many current procedures remain complex and resource-intensive. Depending on the indication, procedures can range from 8 to 12 hours in the operating room and rely entirely on intraoperative MRI guidance. We believe those workflow challenges matter even more at commercial scale. That's exactly the future StereoCED is designed for.

Our robotic-assisted platform is intended to leverage neurosurgical equipment and workflows already established in leading hospitals. We believe it has the potential to significantly reduce procedure times through simultaneous multi-trajectory delivery while avoiding the need for hospitals to purchase an entirely new robotic platform. Before discussing our progress, I'd like to highlight an important industry milestone. In June, the FDA reversed its earlier position, allowing uniQure to submit an accelerated approval BLA, or Biologics License Application, for AMT-130 in Huntington's disease based on its existing 3-year clinical data. If approved, AMT-130 could become the first commercially approved blockbuster therapy delivered directly into the brain. Wall Street analysts project global peak sales exceeding $2 billion, but also highlight the commercial risk associated with a complex workflow and lengthy procedures that can take 8 to 12 hours.

We were pleased to recently publish a white paper highlighting the potential scalability of our StereoCED platform. We anticipate that it will be ready for investigational human clinical studies by the end of September, and possibly sooner for animal research. The feedback we've received from pharmaceutical companies and key opinion leaders has been extremely encouraging. A common theme is the familiarity of the platform. Thousands of NeuroOne SEEG electrodes have already been implanted in patients, making drug delivery feel like a natural extension of an already familiar technology. On the preclinical front, we've also made excellent progress. We've announced collaborations with the University of Minnesota in epilepsy and with Mayo Clinic in diffuse midline glioma. The first animal studies are scheduled to begin this month, and we expect data from both programs this fall to support future clinical development.

In parallel, we are expanding our academic collaborations and expect our first device sales to a pharmaceutical company for a non-human primate study later this year. In closing, I believe we are still in the early innings of what could become a transformational growth opportunity for NeuroOne. There is strong pull from potential customers, and we are eager to have devices ready for human investigational studies shortly. I will now turn the call back over to Dave.