NeuroOne Medical Technologies Corp Aktie

Good day, ladies and gentlemen, and welcome to the NeuroOne Medical Technologies Corporation's Third Quarter Fiscal 2026 Financial Results Conference Call. Today's call will be conducted by the company's Chief Executive Officer, Dave Rosa; Chris Volker, the company's Chief Financial Officer; and Dave Wambecke, the company's Chief Business 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 the U.S. federal securities laws with respect to future operations, financial results, including events, trends and performance, including our 2026 guidance, 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.

Sir, please go ahead.

Thank you, operator, and thank you to everyone for joining us today. I'd 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 Wambecke, 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 to $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 Neuralgia 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 products 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. 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 am turning the call over to David Wambecke to provide an update on our drug delivery system, which we have named StereoCED.

Thanks, Dave. I joined NeuroOne a little over five 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 agreement, 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're expanding our academic collaborations and expect our first device sales to a pharmaceutical company for a nonhuman primate study later this year. In closing, I believe we're 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'll now turn the call back over to Dave.

Thanks, David. Before I provide an update on our BVNA, or Basivertebral Nerve Ablation System, for back pain, I just want to reiterate what I said last quarter with the hiring of David Wambecke. He brings invaluable expertise in the gene and cell therapy space and has made a great impact in the short time he has been with us.

Okay. Moving on to our BVNA back pain management program. This quarter, we completed the user design requirements for the system and initiated preclinical testing to support continued development of the program. Our strategy remains to leverage our existing OneRF generator, temperature accessory and ablation electrode while outsourcing access tools either through outside vendors or potential distribution partners. In addition, we also completed our assessment of the regulatory path to gain clearance and reconfirm that it is likely a 510(k) submission. You may remember that the total time it took to gain clearance for our OneRF Trigeminal Nerve Ablation System was approximately 4 months, which is lightning speed in medical regulatory submissions.

While there are no guarantees, we have experienced success with both of our 510(k) submissions to FDA and expect to submit this for FDA clearance in the second half of calendar 2027. Finally, I want to reiterate that everything we develop at NeuroOne must offer unique device advantages over our competitors and the potential for better clinical outcomes for patients in a cost-effective manner. We believe these goals will also enhance shareholder value and appreciate the support we have received during volatility in the world today.

I would now like to turn the call over to Chris Volker to provide a review of our third quarter fiscal 2026 financial results.

Thanks, Dave. Product revenue was $2.0 million in the third quarter of fiscal 2026, a 16% increase compared to product revenue of $1.7 million in the third quarter of fiscal 2025. The increase was driven by higher sales of OneRF products. The company received $2.7 million for the new product orders during the quarter, representing 43% year-over-year growth. Product orders exceeded recognized revenue during the quarter with a backlog of $1.7 million as of June 30, 2026.

Product gross profit was $1.2 million or 59.9% of product revenue in the third quarter of fiscal 2026 compared to product gross profit of $0.9 million or 53.9% of product revenue in the same quarter of the prior fiscal year. The increase in gross profit percentage was due to a more favorable sales mix toward higher-margin products. Total operating expenses were $3.6 million in the third quarter of fiscal 2026 compared to $2.8 million in the same quarter of the prior year.

Research and development expense in the third 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 third quarter of fiscal 2026 was $2.2 million compared to $1.6 million in the same quarter of the prior year, with the increase being driven by increased headcount and sales and marketing costs. Net loss in the third quarter of fiscal 2026 was $2.0 million or $0.23 per basic share and $0.28 per diluted share compared to a net loss of $1.5 million or $0.19 per basic share and $0.22 per diluted share in the same quarter of the prior year. The net loss in the third quarter of fiscal 2026 was favorably impacted by a $0.4 million gain from the fair value change in the warrant liability.

All share and per share amounts have been retroactively adjusted to reflect the 1-for-6 reverse stock split of the company's issued and outstanding common stock, which began trading on a split-adjusted basis on the NASDAQ Capital Market on April 16, 2026. As of June 30, 2026, the company had cash and cash equivalents of $2.0 million compared to $6.6 million as of September 30, 2025. The company also had $1.1 million in accounts receivable as of June 30, 2026, which should be converted to cash in the fourth quarter of fiscal 2026 based on normal collection patterns.

During the third quarter of fiscal 2026, the company raised $0.4 million through its at-the-market offering program. Subsequent to quarter end, on July 13, 2026, the company raised another $1.0 million through the issuance of 400,346 shares under the ATM program, representing the second time in calendar 2026, the ATM was utilized. The company had working capital of $3.7 million as of June 30, 2026, compared to working capital of $7.9 million as of September 30, 2025. NeuroOne had no debt outstanding as of June 30, 2026.

I'll now turn the call back to Dave for his closing remarks.

Thank you, Chris. In summary, this was a very successful quarter for the company. We delivered 16% year-over-year product revenue growth, increased gross margins of 59.9% and received product orders of $2.7 million, representing an increase of 43% received ISO 13485 clearance, paving the way for international revenue growth, was selected by prestigious teaching institutions for upcoming animal and human studies and identified potential partners to accelerate the development of our BVNA system.

Moving forward, the catalysts include continued commercial expansion of the OneRF Brain Ablation System and OneRF Trigeminal Neuralgia Ablation Systems in the U.S. and internationally, commercial availability of our drug delivery system for FDA-approved IDE studies and animal research and continued progress on the development of our BVNA system. When I look at what we have accomplished and what is ahead of us, I believe the NeuroOne story offers compelling value to doctors, patients and investors.

With that, operator, at this time, we can open up the call for questions.

[Operator Instructions] our first question today is coming from Jeffrey Cohen with Ladenburg Thalmann.

I guess, firstly, can we talk about the study at University of Minnesota for epilepsy? Could you give us a sense of is that focal or general epilepsy that's being studied and what the size of the study is and what you would anticipate from a timeline perspective?

Yes. Thanks for attending today, Jeff. Good to talk to you again. So at the University of Minnesota, it pertains to focal. And the first step in the process is for them to actually conduct preclinical testing on the therapy they've developed. And that will happen literally expectedly most likely in the next quarter. And then once they've been able to successfully complete the testing and assuming that it's showing any efficacy, then they would look to go to a Phase I where they would then start testing it in patients. But the preclinical work is going to be happening very shortly.

Okay. Got it. And then give us a sense of the your supplier and backlog into fourth quarter. Is it related to components or it's related to labor? And then give us a sense of the second site that's come online with that -- do you expect to catch up with all the backlog during the fourth quarter and balance of the year? And also, could you talk about some of the ex-U.S. discussions you're having as far as distribution, at least in the case of OneRF?

I couldn't hear the last part of what you said, but let me take the first big question and then whatever I don't answer, just let me know. So the supplier situation is we -- the company has lead times and the lead times are roughly -- it can take as long as 6 months. So there is an ordering process that's in place with Zimmer Biomet today, where they give us orders in advance so that we can manufacture the product and then ship it to them on time. But we basically build to order to minimize the cost of having to carry a lot of inventory.

So what happens is that if there's any changes to the product mix, if they specify on a particular order that, for example, they want 1,000 devices at a particular size and then 500 -- and if they come back a few months later, our ability to respond in the time frame is limited based on the way the ordering is done now. So we've experienced less of that in the past. I would say more of that this year. So there's a few ways of dealing with this. One is you carry inventory and work with your partner to make sure that it's not impacting the company from a cost perspective. But I think the most effective way is to get our second site up and running. And that's what we're working on now. That's what we expect to go online in the first part of 2027.

So we're going through all the work to do that. And if you've got two facilities capable of manufacturing product and the second one is actually much larger than the one we use now. That should allow you to address it. Now there is the other option that if, say, for example, the product mix involved maybe 500 units that, well, would the company consider placing a onetime order for that difference. Then what happens if you do that is your gross margins obviously are impacted and you're not able to take advantage of the economies of scale. So we try to place big orders in, which has worked very well for us from a margin perspective. So it makes it much more difficult if we're making small changes here and there, it's just not as efficient.

So what was the other question that I may not have answered?

So could you talk about the ISO certification of the second site and maybe give us a sense of some OUS potential opportunities for OneRF as far as distributors and territories?

Yes. So the ISO certification is kind of like the key to admission to be able to ship product internationally. And there are certain geographies that will recognize FDA clearance and at times, just rely on the company registering the product in that geography. Other geographies might require that you supply documentation of your quality system, your design records. And then others, when you look at Europe, for the most part, you've got to be able to provide also data.

So depending upon which area you're going to, there's going to be different timelines to that. Zimmer, per our last amendment that we signed over a year ago, they have certain geographies internationally, and they're assessing which ones they want to go to first. And again, the idea is how can we hit the ground running. And it's really -- you really have to work on your targets, everything from where you can go today to start planning on how do you get to Europe as well. And there's ways of even addressing the clinical data. We just released, obviously, information on the study that was done in the Mayo Clinic in Jacksonville. There was an earlier press release that talked about a number of patients they treated. So if you're able to use some existing data, you may be able to even shorten that time line. So that's all in process.

Now that's the geographies that Zimmer has, but there's others that they do not have. And those are the areas where we're assessing are the economics in those geographies, do they make sense? Are there distributors that we can utilize to commercialize the products there. That's all in process. And I don't expect that we'll have a firm answer on that until probably next quarter when we've had time to sit down with Zimmer and go through this.

Our next question is coming from Justin Walsh with Jones Trading.

I was wondering if you could provide some additional color on how you view the StereoCED opportunity. Do you think it's meaningful when used with drugs in the development stage? Or do you think it has to be adopted as a standard for an approved agent?

That's a good question. So the answer is no. I think it could be used in both the clinical stage -- well, actually, the preclinical stage, which is what we're seeing now with like the University of Minnesota as well as the clinical stage and then obviously, the commercialization piece as well. We really feel there's some significant differences and advantages of our system, even as it pertains to just how much time it takes to infuse a patient that may have one of these neurological conditions.

Now the limitations that you would see with the device being used in a clinical study is if a pharmaceutical company has an ongoing clinical study, say they've completed their Phase I, they're happy with the results. They're not going to make any changes. No company would be interested in introducing a new technology, even if it's a delivery device, into a Phase II, you can never really predict what might happen. So just as a way for them to mitigate any risk, if they start with a particular technology, unless there's issues with their clinical data or with that technology, they're likely to stay with that through clearance. But once clearance has been gained, then a company like us would submit an application under what we would expect to be a 510(k) to be able to be used with whatever approved therapy has just been granted FDA approval.

Our next question is coming from Jeremy Pearlman with Maxim Group.

Firstly, related to Trigeminal. I mean, again, maybe I'm -- just correct me if I'm not reading between the lines correctly. You said you're going to leverage existing personnel that you have on staff and then other distributors for that product. Does that mean that Zimmer was not -- is not interested in adding that or amending that on to their agreement? Or maybe I'm just misinterpreting that?

Yes, that may be what it sounds like, but it's not the case at all. When you look at discussions that we've had in the past with any strategics that we've spoken to, you always think that it should take a lot less time, but there's other factors that may be going on and not even our company, the potential partner that may delay those things. So I think at some point, you -- we, as a company, have to say, look, we need to move forward. We can't sit and wait to conclude these discussions. But it does not mean that there is no interest. There is interest on their end. Some of what's delayed us with Trigeminal is this backlog that we're dealing with, with the Brain Ablation devices.

So we've really prioritized the units that go to Zimmer because that is today the larger opportunity. But as we make progress on that, we'll start to get more devices for Trigeminal sales. And like currently, this month, we have cases scheduled at the sites that did our limited market release. We have additional sites that I even talked about last quarter that want to do an evaluation. And what you don't want to do when you're trying to address demand from another area, and that's your biggest source of revenue, you don't want to shortchange that by an opportunity that while compelling is smaller.

So we haven't opened up additional centers, but we will be beyond this quarter. So it hasn't been, I would say, a major issue for us to address because we weren't able to really do much given the backlog that we experienced on the other side. So short answer, they're definitely interested. It doesn't mean that it won't happen, but we're going to move forward. And if there's an opportunity, then great.

Okay. Understood. And then lastly, I mean, in the past, you've guided towards revenue of at least $10.5 million. I know there's been some manufacturing delays. And in this -- in the press release you put out this morning, you said I think it was between $9.2 million and $10.5 million. Is that just basically you'll hit any of that within that range is based on how many -- the manufacturing, how fast you can get those products made and shipped out? Or is there anything else that's baked into that range?

No, it's manufacturing. I mean it's also the reason why we did alert the market that our orders actually are $11.2 million. Based on the feedback that we have from vendors, the multiple vendors, that number is very unlikely to happen. We think what's more reasonable, more conservative is that range, but it's completely dependent on everything from the vendors being able to deliver what they say they deliver with some risk that we've built into that. But from an order standpoint, the number that we -- if we were able to meet the manufacturing would have been almost around $11.2 million.

Okay. Understood. Great. And then just last question from us. Maybe -- I mean, you might not have this. I know Zimmer is the one who's pushing the OneRF Ablation device and -- but is there any data or maybe KPIs you have regarding new accounts versus utilization in pre-existing accounts, how that's going, growth within those accounts -- you can share...

Yes. So we don't get -- we -- contractually, we are not -- we don't have the right to get that information. We have asked for more detailed information. Zimmer, and it's not just Zimmer, it's other companies as well. They like to keep that close to the vest.

In other companies, you wouldn't see them reporting on an area like this either. And Zimmer does it because they don't want their competitors to really know what's going on. But in anecdotal discussions, their feedback is they're continuing to gain additional traction. But as far as giving you hard numbers, I don't have that.

That appears to be the last question at this time. So I'd like to turn the call back over to Mr. Rosa.

I just want to thank everyone again for attending the call today. And we really look forward to connecting with the investor community throughout this quarter and beyond. If we were unable to answer any of your questions today, please reach out to our Investor Relations firm, the MZ Group, and they'd be more than happy to follow up.

Thank you. Ladies and gentlemen, this concludes today's conference. We thank you for your participation. You may disconnect your lines at this time, and have a great day.

Good day, ladies and gentlemen, and welcome to NeuroOne Medical Technologies Corporation's Second Quarter Fiscal 2026 Financial Results Conference Call. 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, including 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 results -- 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, Chief Executive Officer 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 second quarter fiscal 2026 financial results conference call. Product revenue for the OneRF brain ablation system in the second quarter of fiscal 2026 grew 72% year-over-year to $2.4 million compared to $1.4 million in the second quarter of fiscal 2025.

We continue to be energized by reports of the positive impact this therapy is having on people's lives. Most recently, the U.S. Department of Veterans Affairs published an article regarding Dr. Garrett Banks experience with the technology. The article discussed the challenges that Navy veteran Derek Harpole had to endure after being diagnosed with epilepsy.

For more than 2 decades, he was unable to work, drive or hunt alone. Dr. Banks and his team at the Houston VA performed their first OneRF brain ablation procedure on Derek. He woke up the morning after the procedure bright-eyed and bushy-tailed in his words. With his seizures dramatically reduced, he now has hope that he can regain the life he once had.

Through our partnership with Zimmer Biomet, our goal is to expand this therapy into new centers in order to change other people's lives as well. The company also had several important corporate developments I'd like to highlight.

First, we appointed David Wambeke as Chief Business Officer to lead our drug delivery program, oversee Investor Relations and support business development. As a meaningful sign of his confidence, David purchased 1 million shares of NeuroOne common stock on a pre-split basis.

We were also pleased to announce that we regained compliance with NASDAQ's minimum bid price requirement following a 1-for-6 reverse split of our common stock. Finally, we are always excited to welcome new investors, and we're pleased to learn a new high net worth investor acquired approximately 7.4% of our outstanding common stock in the open market.

Now let's move on to discuss the exciting progress we have made with our existing product portfolio. Regarding our OneRF brain ablation system, as I mentioned in the opening, we experienced 72% year-over-year revenue growth. We believe there is upside for growth domestically and internationally.

Domestically, we are developing a webinar that will highlight clinical experience with the device that we can expand exposure to neurologists and neurosurgeons that may not be aware of the exciting results that are being reported.

With respect to international commercialization progress, we completed the Stage 2 audit of our Minnesota facility for ISO 13485 certification and remain bullish on certification in the latter part of 2026, which is a key step in the process of enabling international distribution of our products.

We also had an important clinical milestone this quarter with the publication of a peer-reviewed case series that validates what physicians using our platform have been telling us. That real-time temperature monitoring during SEEG-guided RF ablation is an important technology feature when performing brain ablations on patients with drug-resistant epilepsy.

The OneRF brain ablation system was also highlighted at Zimmer Biomet's booth at the American Association of Neurological Surgeons meeting in San Antonio, Texas, alongside presentations on the technology.

Moving on to our OneRF trigeminal nerve ablation system. We have continued to gain clinical experience and have experienced clinical success following our FDA 510(k) clearance and limited market release. To date, we have successfully completed 16 cases using the ablation system for the treatment of facial pain known as trigeminal neuralgia, with all patients reportedly pain-free after the procedure.

We continue to be optimistic regarding the advantages and clinical performance of the device for treating facial pain. As a reminder, unlike traditional ablation systems, our product is intended to be placed once due to the multiple contacts present on the device, whereas traditional systems typically require multiple probe placements that can cause additional patient discomfort and extend treatment times.

We were also pleased to be highlighted in the Business Research Company's April 24, 2026 report, which noted that emerging growth patterns are driving expansion in the trigeminal neuralgia market valued at approximately $780 million toward stereotactic surgery using technology similar to our OneRF trigeminal nerve ablation system.

Regarding our drug delivery program, we remain on track for commercial availability of the system in the second half of fiscal 2026 for use in investigational clinical studies or animal studies. Also, we are currently evaluating distributors for commercialization of the product.

In addition, we announced a collaboration with the Department of Neurology's Division of Epilepsy at the University of Minnesota Medical School to advance a study evaluating next-generation epilepsy therapies using our drug delivery platform.

Moving on to our two lower back pain management programs. I will first provide an update on our Basivertebral nerve ablation system. This quarter, we completed the user design requirements for the system and initiated preclinical testing to support continued development of the program. Our strategy remains to leverage our existing OneRF generator, temperature accessory and ablation electrode while outsourcing access tools either through outside vendors or potential distribution partners.

We continue to remain excited about the prospects of the system given the potential clinical advantages it offers. Now let's move on to our spinal cord stimulation percutaneous paddle lead program. As a reminder, this system is designed to offer broader customizable stimulation, lower energy consumption and can be inserted through a 14-gauge needle, eliminating the need for an incision in the patient's back.

During the quarter, we concluded our chronic animal study and identified opportunities to enhance performance. In addition, the system was also displayed at the North American Neuromodulation Society or otherwise known as NANS, and we received a great deal of interest from physicians that stopped by our booth.

Finally, we also announced a CFO transition plan. Ron McClurg, who has served as our CFO with great distinction for over 5 years, will retire as CFO effective June 30, 2026, and remain a senior adviser to the company through year-end. Effective July 1, 2026, Chris Volker, our current Chief Operating Officer, will assume the role of Chief Financial Officer. We are confident that this transition will be seamless and support continued execution against our strategic priorities.

I also want to personally thank Ron for all his efforts, his commitment and his willingness to remain through this transition, and I am confident that Chris Volker is a great fit for this role.

I would now like to turn the call over to Ron to provide a review of our second quarter fiscal 2026 financial results.

Thanks, Dave. Product revenue was $2.4 million in the second quarter of fiscal 2026, a 72% increase compared to product revenue of $1.4 million in the second quarter of fiscal 2025. The increase was driven by higher sales of OneRF products. For the 6 months ended March 31, 2026, Product revenue was $5.3 million, an increase of 13% compared to $4.7 million in the same period of the prior fiscal year.

The company had no license revenue in the second quarter or first 6 months of fiscal 2026 compared to license revenue of $3 million in the first 6 months of fiscal 2025, which was derived from the expanded exclusive distribution agreement with Zimmer Biomet.

Product gross profit was $1.3 million or 53.8% of product revenue in the second quarter of fiscal 2026 compared to product gross profit of $0.8 million or 55.6% of product revenue in the same quarter of the prior fiscal year.

For the 6 months ended March 31, 2026, product gross profit was $2.9 million or 54.0% of product revenue compared to $2.7 million or 57.9% of product revenue in the same period of the prior fiscal year.

Total operating expenses were $3.4 million in the second quarter of fiscal 2026 compared to $3.5 million in the same quarter of the prior year. Research and development or R&D expense in the second quarter of fiscal 2026 was $1.5 million compared to $1.5 million in the same quarter of the prior year.

Selling, general and administrative or SG&A expense in the second quarter of fiscal 2026 was $1.9 million compared to $1.9 million in the same quarter of the prior year. For the first 6 months of fiscal 2026, total operating expenses were $6.7 million compared to $6.7 million in the same period of fiscal 2025.

R&D expense in the first 6 months of fiscal 2026 was $2.9 million compared to $2.7 million in the same period of fiscal 2025. SG&A expense in the first 6 months of fiscal 2026 decreased 4% to $3.8 million compared to $4.0 million in the prior year period.

Net loss in the second quarter of fiscal 2026 was $2.1 million or $0.25 per basic and diluted share compared to a net loss of $2.3 million or $0.44 per basic and diluted share in the same quarter of the prior year. The net loss in the second quarter of fiscal 2025 was favorably impacted by a $0.4 million gain from the fair value change in the warrant liability.

For the 6 months ended March 31, 2026, net loss was $3.5 million or $0.42 per basic share and $0.44 per diluted share compared to a net loss of $0.5 million or $0.09 per basic and diluted share in the same period of the prior year. The lower net loss in the first 6 months of fiscal 2025 reflected a $3 million of license revenue recognized in the first quarter of fiscal 2025.

As of March 31, 2026, the company had cash and cash equivalents of $2.8 million compared to $6.6 million as of September 30, 2025. The company also had $2.4 million in accounts receivable as of March 31, 2026, which should be converted to cash in the third quarter of fiscal 2026 based on normal collection patterns.

The company had working capital of $5.7 million as of March 31, 2026, compared to working capital of $7.9 million as of September 30, 2025. NeuroOne had no debt outstanding as of March 31, 2026.

Before I turn the call back to Dave for his closing remarks, I would like to thank Dave and the Board of Directors for giving me the opportunity to be part of such a talented team. It has been a privilege to serve as NeuroOne's Chief Financial Officer for over 5 years and to see the life-changing results our products are providing for patients. I look forward to watching the continued growth and success of NeuroOne.

Thank you, Ron. In summary, this was a very productive quarter for the company. We delivered 72% year-over-year product revenue growth, gained meaningful clinical experience with our OneRF trigeminal nerve ablation system, completed the Stage 2 ISO 13485 audit, paving the way for international distribution, regained NASDAQ compliance and added two highly experienced executives and Dave Wambeke as Chief Business Officer; and effective July 1, Christopher Volker as our next Chief Financial Officer.

Looking ahead, the catalysts are clear: continued commercial expansion of the OneRF brain ablation and OneRF trigeminal neuralgia ablation systems, commercial availability of our drug delivery system later this year, continued progress in our back pain technologies and future international commercial expansion.

I am proud of what our team has built and believe we remain well positioned for the future. Finally, I look forward to sharing more of our story with investors at the Planet MicroCap Conference in Las Vegas in June.

With that, operator, at this time, we can open up the call for questions.

[Operator Instructions] Our first question is coming from Jeff Cohen with Ladenburg Thalmann.

This is Destiny on for Jeff. Can we start with the drug delivery timing and strategy? I know you mentioned that it would be available for partnering and clinical evaluation in the second half of '26. So I'm curious what's left on your end to do?

And this is -- I think this is the first time I've heard you mention working with a distributor. Can you just walk us through that and that strategy a bit?

Sure. And thanks for joining the call, Destiny. So really, what's left is for us to finish our sterilization testing and validation in packaging. Once that's done, and it usually takes about 3 months, we'll be in a position to start shipping the product. And again, it's for any animal use as well as any approved human IDE studies.

And we obviously don't have a direct sales force today. So the best way, we think, of really being able to commercialize the technology, at least initially for animal use is to identify the distributors that sell into those areas. So that's the plan there.

And yes, I think you probably also heard that we just partnered with the University of Minnesota regarding some of the therapies that they would like to test. They're not the only health care system that's approached us. We expect to have more of those as well in the future.

Okay. Got it. And then turning to face pain for a second. I'm wondering how that commercialization strategy has changed or evolved as you're getting more of these procedures done. And then I wanted to follow up on one of my questions from -- I think it was December about scheduling. Are you seeing the same trends? I know you only had a couple when I asked the question originally, but are you seeing consistent trends with these physicians performing multiple ablations in different patients a day? Or has that kind of changed?

I'll answer the second question first. No, that's remained, and I expect that it will continue to be that way. It's a lot easier to really schedule these cases than it is the brain ablation cases because there's always the waiting period on the brain ablation cases to identify the focal area. Here, when the patient comes in, they know they're getting an ablation. So the neurosurgeons at the sites that we're at are stacking these cases in a day, and that makes it really easy to plan for that.

The commercialization strategy really hasn't changed. I still expect that we'll be partnering with another company. But until any agreement is final, we'll continue to do what we're doing, which is really opening up centers ourselves.

Got it. Okay. And then lastly, I just wanted to ask on guidance. I know you gave a top line of, I think it's 10.5% for product revenue for 2026. I'm wondering if that outlook kind of remains the same. And I know it did not include anything for drug delivery or facial pain. So I'm wondering if you can give us any updates there?

It still remains the same, the guidance. And you're correct. It doesn't include anything from those areas. I think by the time we get to commercialize drug delivery, it will be late in our fiscal year. So I'm not expecting any major contributions from that area. And in terms of facial pain, it also really depends on how quickly we're able to finalize an agreement.

Our next question is coming from Jeremy Pearlman with Maxim Group.

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Firstly, I wanted to speak a little bit about the international opportunity. You hope to get certification by the end of '26. Is that going to be -- is that commercial rollout going to be with Zimmer? Is that -- or is that potentially there with Zimmer? Or is it going to be through other distributors?

And also maybe are there countries that you've targeted to be the first ones for that launch? Or maybe any update on that would be great?

Yes. Thanks for joining the call as well. So yes, the initial plan will be to enter international markets with Zimmer. In our agreement with Zimmer, they actually have certain geographies as part of the agreement, but there are some additional geographies that they don't have distribution rights to. So there is a chance that we will partner with other distributors for geographies that Zimmer has not signed up for.

In terms of where we're going to focus on first, that's really in process right now with the Zimmer folks. The good news is that they're more than willing to help us help support any registrations or regulatory clearances that we need.

But we are waiting to come up with a final list of at least the initial territories that we're looking to target. We would like to go to those geographies that accept FDA clearance so that there aren't any additional requirements for the company. But I expect next quarter to have more information on that.

Okay. Great. And then maybe, again, these are some KPIs. I don't know if you have all this information because I know it's sold a lot of it through Zimmer. Can you quantify how many procedures this quarter were performed by VP physicians versus, let's say, first-time users, so we can get some sense of how it's trending both within the current installed base and then potentially new users?

Yes, we don't have that information from Zimmer.

Okay. Understood. And I mean -- and then jumping to the trigeminal, -- is there -- could you remind us, I'm not sure if this information might have slipped my head. Is there a CPT code that covers that procedure? Or is it being billed under an existing CPT code? Maybe how should we look at the reimbursement landscape for the trigeminal ablation device?

Yes. It is being built under an existing code.

I don't -- in terms of what the code number is, I don't know that off the top of my head.

Our next question is coming from Justin Walsh with JonesTrading.

This is Bill on for Justin Walsh at Jones.

We are curious on how are you driving new physician adoption for your OneRF system for facial pain.

I'm sorry, could you repeat the question? I just couldn't hear very clearly.

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How are you driving new physician adoption for your OneRF system for facial pain?

Sure. So we're targeting centers that already have a generator at their facility. And if you remember, the surgeons that are performing the facial pain procedures are the same ones that are performing the brain ablation procedures. And I think if you look at the results to date, what we've said publicly is that 16 cases that we've currently done, all are pain-free.

So I think being able to really broadcast that data as we go to new sites that the system, in addition to seeing that so far, patients are pain-free, it also is a much more comfortable procedure for the patient because our device only has to be placed a single time as opposed to other existing technologies where the probe has to be placed multiple times until the neurosurgeon has found the area of the nerve that's triggering pain.

Because we have multiple contacts on the electrode, we can place it once and then test each of those contacts. So in other words, the patient doesn't have to get that probe placed multiple times.

So that typically leads to shorter procedures and certainly a higher level of comfort. And the surgeons so far that we've gone to understand that and can appreciate it. So I don't think it's going to be that difficult to continue to show the advantages of our system.

Okay. And would you please expand on your time line for your spinal cord stimulation percutaneous paddle program?

I'm sorry, again, I'm having a little trouble hearing. Could you repeat that?

Yes, of course. Would you expand on your time line for your spinal cord stimulation percutaneous paddle program? What's the time line for that program?

Yes. So we haven't put out a time line yet. And now with some of the adjustments that we want to make, we'll have to figure out what that time line is going to look like. But at this point, we're still trying to investigate the steps for what we want to do to make some enhancements on the system. So that will be something that we'll likely provide, I would assume, in the next 1 to 2 quarters.

That appears to be the last question at this time. So I would like to turn the call back over to Mr. Dave Rosa for any closing remarks.

Thank you, operator. I would like to thank everyone again for attending the call and look forward to connecting with the investor community throughout the quarter.

If we were unable to answer any of your questions today, please reach out to our IR firm, MZ Group, who would be more than happy to assist.

Thank you. Ladies and gentlemen, this concludes today's conference. We thank you for your participation, and you may disconnect your lines at this time, and we hope you have a great day.

Good morning, ladies and gentlemen. Welcome to the NeuroOne Medical Technologies Corporation Virtual Investor Webinar. Today's call will be hosted by the company's Chief Executive Officer, Dave Rosa; and Chief Financial Officer, Ron McClurg. 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, 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 thanks, everyone, for joining us today. I'd like to welcome all of you to today's virtual investor webinar, where I hope to take you in more detail with what the company is looking to accomplish. So let's start. The company's goal from inception was to deliver a thin film electrode platform technology that offered multiple functions using the same device. And we intended that for a wide variety of neurological conditions. I would say that most of you are aware of epilepsy, Parkinson's disease, back pain. And maybe some of you have even heard about the promise that gene therapies and other brain tumor cancer drugs in development have. We always believed that if we were successful in developing these therapies that patients, doctors and other companies would also be interested. And today, I'm pleased to say that I think we've accomplished this mission. Today, we do have a total of 4 devices that have FDA clearance.

As you can see on the slide, 3 are for brain applications and 1 is for facial pain. We also have a number of patents that have been granted or pending. We've been fortunate enough to have 2 current partnerships, one with the Mayo Clinic as well as one with Zimmer Biomet. Zimmer is our exclusive distribution partner for our brain-related devices. I still believe there's a great opportunity to partner with other companies based on the interest that we currently have. We go to next slide. What makes our technology unique? I get asked this question often. I would say really 2 properties. One, the thin film design. And what that does is it really allows for less invasive placement even to the point where it could be delivered through a small needle. There's been many companies that have attempted to accomplish this, but have failed at it. And then second, I would say, is our ability to perform both diagnostic and therapeutic functions.

And by doing that, what we can offer is the potential to reduce the number of surgeries, the number of hospitalizations as well as potentially improve patient outcomes. We're still the only company that has an FDA 510(k) clearance for both diagnostic and therapeutic use for using the same device. Next, the first partnership that the company formed was with the Mayo Clinic. Doctors Worrell and Van Gompel had previously worked on the development of a similar thin film technology and really became intrigued when we showed them our ideas and prototypes. They have participated in a great deal of the initial testing that were done with these devices. And today, they really remain a close partner. More recently, they've become engaged with us on our drug delivery technology. Next, our second partnership was formed in 2020 with Zimmer Biomet. Zimmer Biomet is a leader in robotic technology that's used primarily for brain-related neurosurgeries. To date, the company has received $8.5 million in licensing fees in exchange for exclusive distribution rights in the U.S. and then other certain international geographies.

What's been exciting more recently is that we've seen signs of device adoption ramping. As in the last quarter, we recently reported that almost half of all the patients that have received an ablation since Zimmer has launched the product were done in that quarter. We also believe there is upside internationally as well, and we've been working to secure ISO 13485 certification, which is required to be able to ship product internationally. Next, with regards to market opportunity, all of our devices play in markets that have multibillion-dollar opportunities. Now today, some of these markets like spinal cord stimulation, they're already generating revenue in the billions of dollars, while others, say, for example, like drug delivery, epilepsy and basivertebral nerve ablation for lower back pain, they all have the potential to grow into $1 billion revenue-generating businesses. Next, moving on to our product portfolio. Looking at the table, the first 2 devices received 510(k) clearance, specifically for diagnostic purposes.

The third device that's listed there, the OneRF ablation system for the brain, that represents the majority of our revenue today, given it has both the ability to perform the diagnostic function as well as to ablate or destroy the tissue in an effort to reduce or eliminate seizures. Next up on the table is our trigeminal nerve ablation system for facial pain and then our basivertebral nerve ablation technology, which is in development, our thin film paddle electrode that's intended for lower back pain as well. And then finally, our drug delivery device. All of these technologies are based on the same platform. It's the thin film technology that we started out the company with. And today, Zimmer Biomet has distribution rights for the first 3 products that are listed in the table. Next, the first product I'm going to cover are the Evo sEEG and cortical electrodes. As I mentioned in the last slide, these were the first devices that were commercialized and were primarily just for diagnostic use. Most of those devices have been cannibalized with the OneRF ablation system.

Speaking of which we can go to the next slide. The OneRF ablation system for brain is the first and only FDA-cleared technology for both diagnostic and therapeutic use. That's what we designed this for. The intent was to reduce surgeries, the number of surgeries, hospitalizations, along with improving really the safety of the procedures. And we did that through the incorporation of our proprietary temperature probe. So far, our experience has been outstanding with the system. There's been no reported serious adverse events with many of the patients either reportedly seizure-free or experiencing a reduction in their seizures. And that's all in a single visit. Another advantage of this technology is that it allows the neurosurgeon to ensure that there's no remaining seizure activity before the patient is discharged. So for example, once the ablation is performed, the doctor can then use the device to monitor the brain again.

And if there's any evidence of remaining seizure activity, what they can then do is perform another ablation until the neurosurgeon is satisfied with the results. Because of the success the device has had, we're actively making efforts to provide the clinical results and share the results so that other patients and doctors are aware of the outcomes. Just recently, there was an article published in PubMed by doctors from the Cleveland Clinic that highlighted their initial experience with the technology as well as the different ways it was used. It's studies like this that we believe are essential to increasing interest and adoption in the technology. Next. Next up is the OneRF trigeminal nerve ablation system.

This technology is used to treat a condition referred to as trigeminal neuralgia. So trigeminal neuralgia is an excruciating facial pain condition that's triggered by the trigeminal nerve. It's also referred to in the medical community as the suicide condition. Some of the data that I was able to find show reports that say as high as 25% of patients diagnosed with the condition actually commit suicide. Our device, really the benefits versus traditional therapies is that you only have to place the device once versus multiple times from competing devices to locate the trigger point on the trigeminal nerve that's actually causing the patient this excruciating pain.

So this obviously should reduce patient discomfort if you're only needing to place the device once as well as potentially shorten the procedural time. So to date, we have completed 9 cases in a limited market launch. All the patients are reported the pain-free after the procedure was completed. We have additional cases scheduled for this month and expect to really conclude the limited release by the end of the month. And then at that time, assuming the results continue to be what we're saying, we would then open it up to other centers as well. We've been asked the question, why did you even pursue this indication? It doesn't seem similar to the brain surgery for epilepsy. We actually learned about this through our advisory board, and that's the advisory board that we had for the OneRF brain ablation system. And the reason for that is the neurosurgeons that are performing the brain ablation procedures are often the same ones performing the facial pain procedures. We've mentioned this before, but we are in discussions with a few strategic organizations regarding licensing this technology for this specific application.

Next, moving on to our spinal cord percutaneous paddle lead. This is an electrode that can also be used for diagnostic and therapeutic purposes. So for patients suffering with lower back pain, and this is where the pain is traveling down the leg. Spinal cord stimulation has really been well established as a potentially pain-reducing therapy. And today, it actually represents over $3 billion in annual revenue for devices sold for this application. Most devices today are similar in design to our sEEG device. That's one of the first devices I showed you. They're wire-like devices. They use a significant amount of energy. They also lack the ability to customize the stimulation. And our device, even though it's not that needle-like device and is more of a film technology, we have a proprietary delivery system that allows the pain specialists or neurosurgeon to actually deliver the film electrode through the same needle that these sEEG-like devices are implanted.

The other advantages are less battery usage with design like ours, which really equates to patients needing to recharge less frequently, which is one of the major complaints with some of the systems that are commercial today. And then the other is our technology also allows really for the customization of where the doctor wants to deliver the stimulation. And that's more based on patient feedback with respect to pain relief. Many companies have attempted to develop a technology like this unsuccessfully. We're definitely excited by the progress we've made in this area and are really aiming to be ready to perform our first implant by the end of this calendar year. We have mentioned before that we're looking for a partnership with a company that already is established commercially in the space. And the reason for that is it could significantly reduce our time to market. Next. Next up is our BVNA technology. That's the basivertebral nerve ablation technology uses the same platform as brain ablation and facial ablation. And what this is being designed for is to perform ablations of the basivertebral nerve.

And the basivertebral nerve for those of you that aren't familiar with it, it's located in the vertebral body, which is the bony area in between the discs in your lower spine and changes into the endplates, which are on the below and above the disc. So changes in those end plates actually are what contribute to this lower back pain. And what our design does is that, number one, it allows the neurosurgeon -- sorry, the pain specialist to really improve the safety behind the procedure by utilizing our temperature probe, but it also gives the pain specialists more flexibility in where the device is placed due to the fact that we have multiple contacts in multiple areas on that electrode where you can ablate. So in essence, we're giving the pain specialist a larger sweet spot. This procedure is actually becoming one of the faster-growing lower back pain procedures in the market. We also believe the technology has a shorter regulatory path to market, but that's based on the assumption that we can pursue a 510(k) regulatory path, which we believe we can.

Boston Scientific and Stryker Corporation currently have systems on the market today for this application. And as I've mentioned with some of our other devices, we're also in discussions with multiple organizations regarding a potential partnership for this specific technology. You can go to the next slide. The final technology I'm really going to cover is our drug delivery platform, which I'm extremely excited about. This technology was designed to record brain activity before, during and after delivery of whatever therapeutic agent the doctor is administering, whether it's a gene therapy, a cell therapy, and they're able to deliver it directly through the lumen of our electrode, which looks very, very similar to our sEEG electrode or OneRF ablation electrode. And one of the other features of it is it also like our other electrodes that look like this, you're also able to stimulate as well using that device if the clinician so chooses.

Now while these particular features are more unique, I'll say, to our technology, the device, the other advantage is that it can be placed with Zimmer's robotic system, the one that's being used for brain ablations. So you don't need the time and cost associated with placing these devices in an MRI lab. It also has an extremely low profile. So it's very small in size. And you also have the capability to place more than just 1 or 2 of these devices if needed, unlike some of the other systems that are available today. We're designing the technology to be also used in a variety of animal models, different sized animals so that as these novel therapies progress through development, our device can be actually used by the pharma company or whoever is developing the therapy all the way through human studies to commercialization. And the other exciting thing is really the opportunity to offer improvements in treatment for patients that have and really suffer badly with glioblastomas.

So stay tuned for more on that application. You can go to the next slide. In terms of leadership experience, we've got employees that have a blend of small and large company experience. I think that's critical, especially for developing companies. A number of the companies that many of us have worked at Boston Scientific, Medtronic, St. Jude Medical, Abbott, there's others as well. But we also have technology experts that have come from companies like Neuralink, which is Elon Musk's brain Company. So for us, this experience has been really critical to all the accomplishments we've achieved to date. We also recently announced the appointment of David Wambeke, who I actually believe will be a key addition to help expedite our drug delivery development and commercialization efforts. Ron?

Thanks, Dave. You can go to the next slide, [ Larry ]. Just a very brief financial overview from our fiscal first quarter, which ended in December. We've got a debt-free balance sheet. We had $3.6 million in cash on hand, but we also had $2.7 million of accounts receivable from our current distribution partner, Zimmer Biomet. That has since been collected in full. For the first quarter, we had product revenue of $2.9 million, which is a 5.5% sequential increase. And in Q1, we had product gross margin of 54.2%. Our gross profit increased 2.6% on a sequential basis as well. Some of the catalysts that we've got going forward are the new potential partnerships that Dave discussed, which are focused primarily on pain management and drug delivery. We expect our product revenue to increase to at least $10.5 million in fiscal 2026. And that is a baseline forecast for us, does not include things that Dave talked about, such as the trigeminal nerve ablation revenue and potential revenue for international sales. And so we're very excited and bullish on what this year is going to bring for us. Dave, I'll turn it back to you.

All right. Next slide. So in terms of upcoming potential catalysts, I'm not going to read all the bullets that are on the slide. But I would say to summarize those, the critical ones, revenue growth for the OneRF brain ablation system via Zimmer Biomet. That's clearly a catalyst that needs to be watched closely. the full launch of our trigeminal nerve ablation system, being able to close our limited market release by the end of this month and then expand the number of centers. Commercialization for drug delivery. Now again, to be clear, this is for selling devices for animal studies as well as for any potentially approved IDE studies by pharma companies. ISO certification, checking that box to really open the door to allow us to start looking at different international markets, primarily through Zimmer.

And then I mentioned this before, but we have a number of discussions going on regarding licensing agreements/partnerships for every device that we've talked about today, trigeminal neuralgia, drug delivery, both back pain technologies, all of them. So keep your ears and your eyes open for updates on that. You can go to the next slide. So maybe just some of the key takeaways. I guess when I think about the company and the message I'd like to give is that we do have a novel platform technology. And to investors, what we're offering are really multiple shots on goal. And that's multiple shots on goal with growing revenue, strong partnerships, the potential for additional partnerships really in large markets. I mean when you look at the company, we've proven that we can develop products.

We've proven that we can develop regulatory strategies that can get these products successfully to commercialization that actually also offer unique benefits to not just doctors but patients as well for a whole variety of neurological conditions. And when you look at it, I've personally worked in small and large companies, and I'm extremely proud of all the progress, all the accomplishments we've made. When you look at the fact that at most, we've had 16 employees or less. There's a number of different areas here, a number of different technologies, all of the technology that many companies have tried to develop and have been unsuccessful in doing so. So with that, I would say that's the end of the formal presentation. Go ahead, operator.

[Operator Instructions] Your first question for today is from Jeffrey Cohen with Ladenburg Thalmann.

A couple of questions for you. Firstly, Dave, could you just review for folks out there, talk a little bit about the pharmaceutical space and talk about some of the trial work and number of trials that are going on in neurological indications that are being pursued by the pharmaceutical companies and how you anticipate that your drug delivery is superior on the developmental side.

Sure. Maybe the -- and thanks for joining, Jeff. Maybe the first question about how many are there of these studies, too many for me to list. But when you look at the ones that really pertain to what we're doing, you're talking about conditions like epilepsy, which are right in line with our other objectives. Parkinson's disease, those are probably the 2 larger that get attention with epilepsy being #1 right now. And so there are a number of studies. And when you look at what we're doing with respect to the therapies that are out there, well, first, the therapies are primarily gene therapies. There are some pharma companies pursuing cell therapies, but the fact that patients have to remain on immunology is really a sticking point. So I'm assuming that in most cases, gene therapies will be preferred. But our device, especially from a development standpoint, can be utilized, and we've already sold some devices last year for this application for testing purposes, but can be used to really assist these companies in testing the therapies all the way from early stage through commercialization.

We have different devices that can accommodate different animal sizes. So it's kind of like as they grow and progress, we grow and progress in being able to sell them devices from the beginning through the end. Now for studies that are already underway, human studies, I don't think there's any pharma company that would switch devices because then it introduces a new question mark in the study. But for any that haven't started, the door is open for us. I think the other area that has generated extremely exciting interest is the glioblastoma area. So there are already drugs out there that are used for patients that suffer with these deadly like tumors and being able to provide a better therapy, a better quality of life for patients is at the top of list of the list of every oncologist we've spoken to. And there's a belief that our technology can do that. So we're also taking steps to really fully investigate that space, but I think it's a unique opportunity for us and one that really has a major need, not just for patients, but also for the oncologists that are treating them.

That's helpful. So next, I wanted to ask you about your Evo platform. And talk about Evo and talk about current standard of care or I should say, wires predominantly. And what's the benefit and what's the comparison on better control and delivery of energy in a larger area versus conventional therapy?

Yes. So you're talking about spinal cord stimulation for lower back pain where the pain is radiating down the leg. So if I put a tiny wire in front of you and I put a film that, let's just say, is 4 inches by 2 inches, you would look at that and you would probably come to the conclusion that the bigger device is going to offer more stimulation. So number one, one of the differences is we're just providing more stimulation because we're a larger device. Number two, when you use the wire-like devices, the contacts, they look like rings around the electrode. So all the stimulation is traveling in a 360-degree path. So you have stimulation that's going upwards, sideways, downward.

You want all your stimulation down towards the spinal cord. And when you use a film that's placing down to the spinal cord, all the energy goes down. So you're basically wasting energy with these wire-like devices because you're not directing it to the target, which is the spinal cord. Our device, you can actually steer it if you need to, to ensure that it's actually placed in the proper position so that all the energy is emanating downward. So that's why even though we have a larger device, these types of devices are more energy efficient. And patients hate having to recharge frequently. It's one of the pieces of feedback that pain specialists tell us all the time. And then the third one is the ability to customize.

So if you think of our film that has a number of dots that are contacts that stimulation goes through, over the years, there's been a belief that patients become -- their bodies become more adaptive to stimulation. So sometimes there's -- they experience pain maybe a year or 2 years later. And sometimes that's just because the area of stimulation needs to change. So what you can do with our device, number one, is you don't have to stimulate through all the contacts if the doctor is able to provide the patient with pain relief and say maybe 4 out of the 20 contacts. So you're spending -- you're using even less energy there. And then maybe 6 months from now, the patient comes back and says, doctor, I'm still not experiencing pain relief.

And he decides to stimulate maybe through 2 different rows or columns of electrodes and he finds that, aha, now this is providing pain relief. You don't have those opportunities with the wire like. They call them percutaneous leads, but they're wire-like devices. And the beauty -- so some people would say, well, this has been -- what you're doing has been attempted before and failed. That's because the devices weren't thin enough to place through the same type of needle that these wire-like devices are placed in. So the value here is if you can give them all these benefits, but you're not changing the way the device is placed by the pain specialist who, by the way, doesn't want to make incisions in a patient's back. He wants to put a needle in, put the device in. This gives them the opportunity really of having the best of both worlds.

I have one more quick one for you. I'm sorry for the nagging. So talk about your sEEG technology and how that compares with and/or how is it used with traditional EEG as far as procedures and interventions that are under imaging. or different mapping conditions?

Yes. So if you're just referring to diagnostic-only procedures, devices look pretty similar. Ours is slightly smaller. But from really the initiation of the company, the goal here was and the value here was is let's eliminate some of the procedures required for patients and let's also give the doctor an ability to check his work. Now when you have these devices placed in the brain, the purpose is with all of them is to find the problem area. We all can find the problem area. I'm not sure there's that much difference between all of them other than maybe size and flexibility. But when you add the therapeutic component to it, you immediately put yourself in a separate category, which really gives the patient the ability to come in potentially one time in one hospitalization when that ability isn't there today. Now most of the doctors are using either what's called stereotactic frames or a robot platform to place the devices.

So if you don't have a robot, you use a stereotactic frame, but in neither situation, do you need MRI to place the devices. All of them are really perform a similar way. But to be able to treat the patient to diagnose and treat them all in the same procedure, and even perform the procedure while they're sitting in their bed at bedside and have an outcome that's like they have a very, very strong likelihood of not having seizures or having a greatly reduced number of them is extremely exciting. I mean we have a site that they ablate every single patient. And the philosophy is, if I'm going in there to find the problem, I'm going to be going back in there if I need to, to remove the problem area. So since we're not having -- I say we, meaning the center, since they're not having safety issues, why not ablate every patient? And that's the kind of data, Jeff, that we need to get out there that I think will even further accelerate adoption of the technology.

We will now take webcast questions.

Our first question asks, can you talk about potential partnership that could accelerate commercialization of the OneRF platform of our FDA-cleared product families?

Yes. I think there's -- I would honestly say all of them, but I think the ones that could really accelerate the most quickly are trigeminal. Obviously, we have a product that we feel is close to salable, if not salable, and being able to get it into a larger group of hands. That would be one. And then I think the back pain technologies really lend themselves for different reasons. So when you look at our BVNA, the ablation technology for the basivertebral nerve, what we know and what we're good at is developing the ablation technology, the electrode. The area that we don't have capabilities in are the access devices. So how do you get your device into that space. So a partnership with a company that already has the capabilities or already building devices like that can greatly reduce the time to market for us.

So that -- I would say that one. And then spinal cord stimulation for sure. Again, what we're good at is the electrode. For us to get to the market as quickly as possible, we would really need to partner with a company that already has an FDA-approved device for this indication. It would greatly reduce the amount of time, dollars and effort to get to market if we were able to partner with them and they would just simply file an amendment to their existing approval that would allow us to be able to launch the electrode through them.

Our next question asks, can you expand on Dave Wambeke's appointment and what that brings to the table. Clearly, he saw something and put his own capital into the company.

Yes. This is kind of an interesting story. You never know where things are going to go in life, and this is a great example. So what people really don't know is that David actually was the banker that completed a financing for the company years ago when he was a banker at Craig-Hallum Investment Bank. And he actually, at that time, became an investor, a personal investor into the company. And over the course of time, David would keep in touch with me and get updates on how things were going. But he always seemed to have a personal interest in what we were doing. And then just by chance, when he became available, I reached out to him. And we had a discussion regarding his ability to maybe accelerate our development and commercialization for drug delivery because he does have experience in the pharma space. And he's got a great understanding of both our technology and the advantages of it as well as the pharma world. So I mean he's only been with the company a few weeks. And I mean, I've been impressed with how much he knew going into it and how quickly he's getting up to speed.

Our next question asks, can you go into any additional detail on expectations and timing of anticipated milestones you talked about or upcoming incremental announcements we should be looking for?

Yes. In terms of some of them, like, for example, the trigeminal limited market release that we had, I'm very confident that by the end of the month, we will have gathered the information we need to be comfortable to release the product more broadly. And we also are looking to be in a position to have the drug delivery system available by the end of calendar Q2 this year. And again, that's for animal use or approved IDE studies. I think we're in a very good position for that. I think the other ones there that most people become curious about are the strategic discussions. And those are much harder to predict, but with every one of these devices, again, that we've mentioned, these companies are in different stages of diligence. So the problem with this is you can never control how long it's going to take. You can only control how quickly you respond to their requests. And so that one is a little bit trickier, but I'm really excited by the number of companies that are interested and interested enough to actually do diligence.

Next question asks, are you still confident that fiscal year 2026 product revenue will come in at least $10.5 million?

Yes.

Our next question asks, across your different programs, which one do you feel is most likely to drive the next partnership, the trigeminal nerve ablation system?

I think trigeminal has probably the greatest potential to be the next one. But again, I always hesitate because it's -- you're never going to be 100% sure. But yes, given the fact that the product is already out being sold and that we are at the stage of discussions that we are, yes, I would -- if I had to make an educated guess, I would say that would be it, but there's no guarantee.

Our next question asks, with regard to the ablation system for the brain and what looks like a growing adoption, what is needed to continue this ramp up?

I'll go back to kind of what I touched on, and that is being able to get the results of the clinical cases to both neurologists and neurosurgeons. It's been interesting. I've had discussions with both over the course of the last couple of years regarding adoption. And some of the feedback that I've received is that the gatekeepers for many of these procedures are neurologists. And there are a large number of neurologists that are conservative in nature and obviously would -- if you can manage this condition through medications, then that's what you would want to do. But there's still a large population, over 1 million people that aren't managed with it. And I think some of them are intimidated by the procedure and have concerns about safety.

And I gave the example of this one center that has said they ablate every patient as pretty much the standard practice. And I think as more physicians hear about the safety profile of the device as well as the results and the other benefits we've mentioned, I think it's going to have a greater chance to drive that ramp that we saw occurring last quarter. So it gets a little bit trickier to get centers to be willing to provide that data. It's one of the reasons why we set up a registry specifically with companies that signed up for this. But I think it's really, really critical to share the success stories of patients being treated as well as just a broad set of data showing the efficacy and safety profile.

And our last webcast question asks, back pain appears to be the largest potential market by far. Can you talk more about the regulatory pathway for entry into that market?

Sure. So with respect to the basivertebral nerve ablation system, where we're ablating the nerve, that appears to be a straightforward 510(k), which, by the way, is the regulatory path that we followed for every device that we have that's commercial today. So it seems pretty straightforward there. With respect to the spinal cord stimulation device, if we were to go this alone, in addition to having to develop the stimulator itself, the piece of hardware, we would likely have to conduct a large trial, and it would follow a PMA pathway, which is more expensive, more time-consuming, more complicated, more risky. So going back to why are we so interested in the partnership, especially with this one, it's because if we are able to partner with an existing company that's selling today, assuming that all the safety testing went well, it would be a much faster path to commercialization, significantly less time than having to do it alone. These companies could literally add as a supplement to their existing approval, our technology to be able to gain clearance for them to commercialize it.

That appears to be the last question at this time. And I would now like to turn the call back to Dave Rosa.

Thanks, operator. I just want to thank everyone again for attending the webinar. We really look forward to providing you all with updates, not just on the platform and commercialization, but as well the partnership discussions. If we're unable to answer any of the questions that you had today, feel free to reach out to our Investor Relations firm, the MZ Group, who would be more than happy to help. Thank you again.

Thank you. This concludes today's virtual investor webinar. We thank you for your participation. You may disconnect your lines at this time, and have a great day.

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 U.S. 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 OneRF 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 OneRF 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 OneRF trigeminal nerve ablation system. We previously disclosed that in August of 2025, we received FDA 510(k) 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 2 patients were treated at the University Hospitals Cleveland with both patients reporting pain relief from the procedure. To date, 9 total patients have been treated at 3 centers and all our 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 pro 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 and investigational clinical studies or animals in Q3 fiscal 2026.

This is approximately 6 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 2 organizations interested in forming a partnership to use our drug-related technology to deliver their experimental therapies to the brain to treat a variety of different neurological conditions.

Moving on to our 2 lower back pain management programs, I will first provide an update on our percutaneously placed pad electrode. This system is designed to offer broader customizable stimulation less energy consumption and can be concerted 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 and development to treat lower back pain is our base vertebral 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 OneRF generator 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 for 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 Inc., 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 and to 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 38.9% 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 '26 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 $0.03 per share compared to net income of $1.8 million or $0.06 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 OneRF product in October of 2024.

As of December 31, 2025, the company had cash and cash equivalents of $3.6 million compared to $6.6 million as of September 30, 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 31, 2025, compared to working capital of $7.9 million as of September 30, 2025. NeuroOne had no debt outstanding as of December 30, 2025.

I'll now turn the call back over to Dave for his closing remarks.

Thank you, Ron. As I mentioned at the top of the call, we continued the positive momentum from fiscal year 2025 by making progress across all of our programs. In addition, we are projecting revenues of at least $10.5 million in fiscal 2026 and look forward to providing updates on our progress in other areas of the business as well throughout the year. In addition, we will be attending the Oppenheimer 36th Annual Healthcare Medtech and Services Conference and invite investors to meet with NeuroOne March 16 through 19 and join our presentation at 1:20 p.m. Eastern Time on Tuesday, March 17.

Lastly, before we move into the Q&A portion of today's call, I and everyone at NeuroOne would like to extend our sympathies for the unexpected loss of Dr. Sanjit Grewal, a brilliant neurosurgeon, valued collaborator and friend to NeuroOne. Our deepest condolences to his wife Angela, his children and the entire Mayo Clinic family.

Operator, at this time, we can open up the call for questions.

[Operator Instructions] Our first question is coming from Jeffrey Cohen with Ladenburg Thalmann.

A couple of questions from our end. Could you talk about trigeminal firstly? I know congrats on getting up to 9 cases. Could you give us a sense of number of physicians or number of centers that do the non cases and then maybe talk about interest from Zimmers or others for trigeminal, please?

Sure. I'll take that. So the 9 cases that we've done were done at 3 centers. One of those centers, by the way, was Dr. Grewal that I mentioned just recently passed away. But in all 9 cases, the patients were reportedly being free. That's really the objective of the study. So that was very encouraging to see. And really one of the major advantages of the technology is that due to the multiple contacts on the electrode itself, you're able to place the device once instead of multiple times to really find the area of the nerve that's triggering the pain.

So it's a much more comfortable procedure, let's say, for patients and may require less time because you're only placing the device once. And in terms of strategic interest, yes, there are discussions underway. Obviously, you would always like to conclude those discussions as soon as possible. And that's really the goal. But right now, we're in diligence with the company, but would be prepared -- if we don't move forward in diligence to commercialize this ourselves.

Okay. Got it. And could you give us a sense -- I don't know how much clarity or transparency you have. could you give us a sense of number of physicians or a number of centers for which consumer is present domestically?

Yes. We don't have that information. The information that I referred to earlier in the discussion was that they've told us that the first fiscal quarter in terms of number of patients that they were almost half of all the patients they've treated since they launched this were actually completed in the first fiscal quarter, but we don't have clarity on the number of centers or the number of cases.

Okay. Got it. And then one more, if I may. Maybe a question for Ron. Could you talk about OpEx, generally speaking, would you expect that to be fairly flattish off of Q1 levels for the balance of the year?

We would expect that the SG&A would be fairly flat the rest of the year, but we do expect that the R&D may fluctuate as we're depending on what phase of the projects that we're working on. As Dave mentioned before, we did accelerate our drug delivery project and made significant progress there. And so we're not sure exactly that there will be some near-term expenses and then that project will start to taper off a little bit.

Got it. Okay. So the animal studies for drug delivery and also spinal cord will pick up in the back half of the year, it looks like Q2 and Q3.

Yes. Yes. Not significantly, but it will pick up a little bit.

Our next question is coming from Jeremy Pearlman with Maxim Group.

A question regarding the -- any clinical feedback you may have received from neurologists or surgical teams that are using the installed products so far that you could share?

So yes. In general, what we're finding is that the device is very successful or has been successful in either reducing the amount of pain -- sorry, reducing the number of seizures that patients are having or completely eliminating them. Now those metrics are really measured over time. So one of the reasons why we want to capture those despite our enthusiasm for it, this is the main reason why we started the registry as a way to really capture what the results are long term.

But I think the results speak for themselves to date. The system, the feedback that we had is the actual generator of the device that creates the ablation. It's very easy to use, and the system itself is very easy to use. And these procedures do not require patients in the operating room to -- again, the operating room for it at least from what we know, all of them to date have been done at the patient's bed side, that is the actual ablation itself. So I've never seen a procedure -- the surgical procedure done by a patient's bedside. So it's kind of exciting to really see the results that we're getting and really the feedback on ease of use.

Okay. That's great to hear. And then maybe, again, this might -- you might not have this information. It might be more at Zimmer's end, but is there a specific region in the U.S. where they are seeing the most traction and adoption of the technology? And then maybe how do they replicate that across the rest of the country?

Yes, that information, we don't have.

Okay. And then just last question. Sales and marketing, your expectations for '26, is that going to be -- are you going to share that burden with Zimmer to promote the products? Or is that fully on Zimmer's shoulders?

Yes. Part of our agreement that we signed way back in 2020, the responsibility for all marketing and sales costs lie with Zimmer. We're obviously responsible for providing all the training and field support as is reasonable, and it's working very well. But it's actually their responsibility to cover all commercialization and marketing costs.

Okay. All right. Great. And then just last question. The revenue breakdown for the first quarter, was that just predominantly are all just restocking? Or was there any additional purchases at Zimmer made maybe beyond what they had originally expected to use the device and that you were restocking with -- even within the quarter?

Most of the revenue -- yes, I'll take that, Dave. Most of the revenue is what you're calling restocking, which is replenishing and selling into the market. A year ago, if you remember, in the first quarter of fiscal 2025, that was their initial stocking order. And pretty much everything since then has been the continuation in restocking.

That appears to be the last question at this time. So I would like to turn the call back over to Mr. Dave Rosa for any closing remarks.

Thank you, operator. I would like to thank everyone again for attending the call, and we look forward to connecting with the investor community throughout the quarter. If we were unable to answer any of your questions today, please reach out to our Investor Relations firm, MZ Group, who would be more than happy to assist.

Thank you. Ladies and gentlemen, this concludes today's conference. We thank you for your participating. You may now disconnect your lines at this time, and have a great rest of the day.

Good day, ladies and gentlemen. Welcome to the Fourth Quarter of Fiscal Year 2025 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 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 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 fourth quarter fiscal 2025 financial results conference call.

Fiscal year 2025 was the most successful year in the history of NeuroOne 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 510(k) clearance for the OneRF trigeminal nerve ablation system, advanced the development of our spinal cord stimulation electrode for lower back pain, initiated a new product development program for basivertebral 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 Biomet. 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 continue 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 OneRF brain ablation system distributed by Zimmer Biomet. 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 sEEG platform electrode technology has received a great deal of physician interest. In addition, we have been approached by 2 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 NeuroOne, our Chief Technology Officer, Steve Mertens, was diagnosed with one 2 years ago. Thankfully, he is doing well, but is also committed to trying to help others by advancing NeuroOne'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 2 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 basivertebral 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 OneRF generator and sEEG probe 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 510(k) clearance for our OneRF 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 2 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 OneRF brain ablation system, yet 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 OneRF brain ablation system currently marketed by Zimmer Biomet, 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 in 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 OneRF 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 concurrently 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 3 patents we licensed pertaining to our cortical electrode family.

Before I turn the call over to Ron, I wanted to reiterate our confidence in driving increased revenue from our OneRF 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 McClurg, 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 Biomet.

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, NeuroOne 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 30, 2025, compared to working capital of $2.4 million as of September 30, 2024. We had no debt outstanding as of September 30, 2025.

I will now turn the call back over to Dave for his closing remarks.

Thank you, Ron. As I stated at the top of the call, fiscal 2025 was the most successful year in the history of the company. From our FDA 510(k) clearance for the OneRF trigeminal nerve ablation system to our expanded partnership with Zimmer Biomet, our first preclinical sales for our drug delivery platform, initiation of a new product development program for basivertebral nerve ablation and strong financial performance and balance sheet, NeuroOne Medical Technologies successfully executed our technical, commercial and financial plan.

We also have great momentum leading into fiscal year 2026 with the recent announcement that our first 2 OneRF trigeminal neurology cases were successfully performed. Expect to hear more about advancements with our brain, pain management and drug delivery platforms in the near future.

Finally, in January, we will be attending the JPMorgan Healthcare Conference and invite investors and analysts to meet with NeuroOne January 12, 13 or 14 to learn more about our amazing company and its story.

Operator, at this time, I think we can open up for questions.

[Operator Instructions] Your first question for today is from Jeff Cohen with Ladenburg.

This is Destiny on for Jeff. I'd like to start with face pain, if we could. I know that you had those 2 patients treated earlier this month, so congratulations on that. I'm wondering if we should expect any more procedures prior to year-end. I know we're getting into the thick of the holidays. So I'm just curious.

Yes. Thanks for joining the call, Destiny. We do have 3 other centers that have indicated that they have cases that they have planned. The question is more around getting some of the ancillary equipment that they need to do the procedure, not our equipment. And at one of the centers, local centers here, they're also waiting to get the generator installed in the facility. So the cases are there. There's just a few more steps that we have to go through. And we do think that there's a good chance we'll have more cases done this month.

Okay. Great. And I know historically, you had said that with this type of procedure, they could be stacked. So the treating physicians could do more. I'm wondering, first of all, were these procedures back-to-back, maybe even not -- maybe if not on the hour, but in terms of the days. And then based on what you heard just from those 2, do you still feel like that's something that is feasible or attainable?

Yes. So both of those cases were back to back. I'm not sure they were done within an hour, but they were done back-to-back. And yes, that's one of the nice things, I think, about these trigeminal neurology cases is that the neurosurgeons will schedule them in advance.

It makes it a lot more convenient for us to support those cases, too, because we know that the ablation is going to be done in that particular case as opposed to brain ablations where there's usually a waiting period until the [indiscernible] has been identified. So yes, we expect that moving forward.

Okay. Great. And I know you mentioned a strategic partner here. At what point do you feel like you would just go forward and do it yourself?

Well, if discussions didn't appear to be going in a fruitful direction, we could do that. But I feel confident that we'll be able to reach an agreement with a strategic partner for this.

Okay. Okay. And then just a couple on drug delivery, if I may. I'm wondering if there will be more orders from this large pharma player. And I'm not sure how much visibility you have there, but are they going to do additional testing? Is there the opportunity to expand a bit? What are you seeing there?

Yes, I do think that somewhere around midyear will be in a situation where we'll be able to ship additional units. These units are all going to be for preclinical testing. But really, the work that we're doing now is to get the devices manufactured to get our processes validated, so that we can be in a position mid-year to ship preclinical devices.

Okay. Got it. And then for epilepsy, I missed what you said about the registry. What is the timing on getting that established and opened?

Yes. So in terms of like the protocol, we feel very confident that the protocol that we have makes sense. We just met at AES, which was the first week in December with sites that had agreed to participate. They have some comments, offered some suggestions and also each site has its own internal process that it has to go through to be able to participate in these registries and get sign off from administration. Some are a matter of months; some could take longer.

So I really think that in terms of when that paperwork is done and the actual sites get signed off, I don't think we'll see that happen until Q2. But it really helped at this meeting in December, getting a better idea of when some of these sites are going to be able to actually start enrolling.

Okay. Great. And then last one for me. I know you've mentioned raising patient awareness. And I'm wondering if you've kind of implemented any strategies or initiatives there that we could -- that could maybe help with awareness in 2026, like another Clara story, if you will.

Yes. So we have done some work with the Care organization, which is -- sorry, Cure, which is an epilepsy organization. And we're also talking to the Epilepsy Foundation to be able to partner with them to make this therapy more visible to patients.

We just recently posted about a recent patient that was a professional pianist in Chicago and was unable to continue his career because of seizures. And we found out this case was done this summer. And there were a couple of articles published in the Chicago newspapers that were sent to us by the neurosurgeon who performed the procedure. We were completely unaware of it. But it's stories like that and getting that information out to other patients, that's really critical.

I mean, in this particular gentleman's case, he was able to resume his professional career when he was told there really weren't any other options. And lucky for him, he heard about that the patient Clara that we've reported on in the past went to the same doctor and had a very positive outcome. So we are still continuing to figure out in terms of partnering with these organizations on the best way of getting the message out through their help.

Got it. Okay. I appreciate you taking the questions and looking forward to seeing you at JPMorgan.

Thanks, Destiny.

Your next question for today is from Anthony Vendetti with Maxim Group.

Dave, I was wondering if you could expand on the distribution agreement that you have with Zimmer Biomet. I mean, I know you said it has expanded, but can you provide a little more color on what that includes?

And then just on the lower back pain, you said you advanced the development of that product. Can you talk about what that -- the development program looks like for lower back pain? And then I'll hop back in with one other question.

Sure. And thanks for joining the call. So let's talk about back pain first. That's probably the longer of the 2 questions.

We actually have 2 programs for lower back pain. One that is the paddle electrode that I spoke about that can be placed percutaneously through a 14-gauge needle. So that program is ongoing. We did some testing last year in a chronic animal model. And we received some biocompatibility, some histology information. We also have some stimulation testing that we still need to do, which is what we'll be initiating in early next year.

But that program is strictly the electrode, and the goal here is to really partner with an established company in the space. We've mentioned that we're having discussions with some of the larger companies that are well established in spinal cord stimulation.

And the reason for that is twofold. One, we don't have internal resources for developing pulse generators. And I really don't feel like that's a core competency that the company has. The larger companies have this. We have the razor blade, and they have the razor, and we can provide something that they can't, or they haven't been able to at this point, which has advantages over the therapy today.

But the real great advantage in my mind is the ability to kind of piggyback onto their PMA. Clearly, they've already gotten FDA clearances for their systems. And if we're able to do that, it's going to shave years off of our time line to get to market. So that's that program.

The second one is the BVNA or the Basivertebral Nerve Ablation system and completely different concept, completely different condition that patients experience for this type of lower back pain. And what we're doing is, again, leveraging the generator that we're using for brain ablation, now facial ablation to really utilize that same system with our electrode to be able to go in and ablate the basivertebral nerve.

So we've put together an advisory board of leading pain specialists who are very familiar with this procedure. We've had multiple meetings with them. We feel pretty confident that what we have will be able to offer advantages over the existing systems. Our multi-contact device has advantages over existing probes today. And of course, our temperature probe also has -- provides additional safety features when you're doing any of these ablations. But like our other pain management ablation systems, we will have to source other accessories to allow the pain specialists to be able to access the basivertebral nerve.

So with respect to that program, we also are having separate discussions with strategics that have established businesses in treating lower back pain. One of the strategics that we're talking to is actually interested in both the basivertebral system as well as the spinal cord stimulation platform.

So we still do need to do additional testing on the generator to ensure that we're able to develop the same size lesions for the basivertebral nerve that pain specialists are looking for. And then obviously, the development of the accessories through a third party.

So that's the work that's needed on that program, but the goal is to really leverage what we already have, which is really the same strategy that we've employed over the last couple of years with the generator.

And then with respect to the agreement, so the expansion really pertains to a year ago when we expanded the agreement beyond just the diagnostic sEEG electrodes with Zimmer to include the brain ablation system. So that was from, I believe, October a year ago. So there's also the potential to expand beyond that. We obviously have the facial pain technology. So there's a potential that the relationship could grow beyond that as well.

Okay. So just to be clear, right now, the OneRF for trigeminal nerve ablation is not part of the Zimmer agreement and as well as the lower back pain, it sounds like you're speaking to strategic about that. It doesn't mean Zimmer Biomet wouldn't be one of the strategics, but you're having discussions with other strategics for those 2 programs, correct?

Yes. That's absolutely correct. Today, Zimmer does not have any distribution rights for facial pain. And the strategics that we're talking to for back pain do not include Zimmer Biomet. Zimmer, actually a few years ago, it may have been longer than that, divested their spine business. So this is not an active area that they participate in today.

Okay. Great. And then my last question is on reimbursement, the reimbursement landscape and the challenges that are always present when an emerging growth company comes to market with new technologies. Maybe just talk about a little bit of how you're navigating that?

Yes. So -- and that's a big question because the devices that we have in development have all different reimbursement codes. Some are well established. Some are -- some codes are more or less catchall codes in the event that there isn't one in particular for a certain procedure.

I think the reimbursement codes for the devices in development are very well established. When you're talking about brain ablation, there is some generic codes that neurosurgeons or hospitals have been using to gain reimbursement, but not a specific code per se.

It really hasn't seemed to, I'll say, be a hindrance with any of these neurosurgeons in terms of adoption. There's clearly cost advantages in using our brain ablation system. And the one that is pretty obvious is ablations today done with other competing systems are done in the operating room. And to our knowledge, there hasn't been one brain ablation done in the operating room. They've been done at the patient's bedside.

And the cost of tying up an operating room for most of a given day are extreme. So the ability to do this at the patient's bedside without occupying the operating room is a huge cost advantage in the hospital today. But so far, we've been very fortunate. Neurosurgeons see the value of the technology, and it hasn't gotten in our way to date.

Okay. Great. Appreciate it.

Thank you.

[Operator Instructions] That appears to be the last question at this time. I would now like to turn the call back to Dave Rosa.

Thank you, operator. I would like to first thank everyone again for attending the call, and we look forward to connecting with the investor community throughout the quarter. If we were unable to answer any of your questions today, please reach out to our Investor Relations firm, MZ Group, who would be more than happy to assist.

Thank you. This concludes today's conference. We thank you for your participation. You may disconnect your lines at this time, and have a great day.

Good day, ladies and gentlemen, and welcome to the NeuroOne Medical Technologies Corporation Virtual Webinar. 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, including statements regarding our fiscal 2025 preliminary product revenue 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 releases 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. Rosa, CEO of NeuroOne. Please go ahead, sir.

Thanks, operator, and thank you to everyone for joining us today. With the completion of our 2025 fiscal year, I wanted to share our achievements as well as our strategy and technology road map moving forward. First, for those of you that are new to NeuroOne, our mission is to transform the diagnosis and treatment of neurological disorders in 3 different areas: brain, pain and drug delivery with our novel thin-film multifunction electrode technology.

Because the technology has multifunction capabilities to record, ablate, stimulate, deliver and monitor gene and cell-based therapies, it has the potential to offer the following unique advantages: percutaneous or less invasive placement, reduced hospitalizations and surgeries, fewer adverse events and improved patient outcomes and streamlined procedures. Our goal is to provide advanced solutions for patients, pain specialists, neurologists, neurosurgeons and pharmaceutical and biotech companies.

We believe that this may also offer investors the opportunity to have a more diversified risk portfolio given our multiple opportunities that are all at various stages of development or commercialization. We also have reported our strategic relationships with the Mayo Clinic and Zimmer Biomet with the latter having an exclusive distribution agreement for our OneRF Ablation System in both the U.S. and select international markets.

We believe that these key relationships, interest from potential additional strategic partners for our programs in development as well as the great progress we have made over the past fiscal year provide validation in our strategic plan as well as our technology. And speaking of our progress over the past fiscal year, we accomplished the following milestones. Product revenues of $9.1 million, which comfortably met our guidance of $8 million to $10 million we communicated last year.

This represented an increase of 163% year-over-year. In addition, we expanded our July 2020 agreement with Zimmer Biomet to include our OneRF affablation system, which is the only FDA cleared device to use the same electrode for both diagnostic and therapeutic functions for patients suffering from debilitating seizures associated with epilepsy. The expanded agreement with Zimmer Biomet also included a onetime license revenue of $3 million.

In addition, we are thrilled to see the positive impact our technology has had on patients' lives. You may have seen the story about Clara, a young lady who suffered with 8 to 10 seizures a night. She was unable to attend school, play sports or attend social functions. Her story was featured on Good Morning America and how she has been seizure-free for approximately 15 months, started college and has regained the quality of life she had prior to being diagnosed with epilepsy.

Our goal is to continue to make a meaningful difference for physicians that use our technology, patients and strategic partners. The company also completed a financing of $8 million with prestigious institutional investors to support our development and commercialization efforts while reducing our operating expenses from the prior fiscal year. We also strengthened our management team through the hiring of Emily Johns as our General Counsel, and Dr. Parag Patil as our Chief Medical Adviser.

The company also received FDA clearance much earlier than projected for our OneRF TN system to treat patients suffering with debilitating pain associated with trigeminal neuralgia. We are targeting a limited launch of that product in the near future. With respect to back pain, the company continued to develop our percutaneously placed spinal cord stimulation electrode for lower back pain and also started an advisory board to guide our development of a basivertebral RF ablation system, which would leverage our existing RF technology to treat patients suffering from lower back pain attributed to the basivertebral nerve.

Regarding our drug delivery program, we were excited to announce that we received our first order from a large pharmaceutical firm for evaluation purposes, also validating our belief that it offers value to companies developing gene and cell-based therapies. The market potential for our drug delivery and pain management technologies exceeds the current markets that we currently participate in. We will continue to evaluate additional opportunities to leverage our thin film technology where we believe it can offer unique benefits for patients and physicians while offering significant revenue potential.

Moving forward, our growth strategy is to pursue the following: support Zimmer Biomet's commercial expansion of the OneRF ablation system, ISO 13485 clearance in order to expand revenue opportunities outside of the U.S., initiate the OneRF registry to collect and publish patient outcomes data, launch the OneRF trigeminal neuralgia system in the U.S., either direct or via partnership, leverage the RF ablation generator and temperature control system to treat lower back pain attributed to the basivertebral nerve, strategic partnerships for our drug delivery platform and continue to develop our percutaneous placed spinal cord stimulation electrode and secure a strategic partnership.

I would now like to turn the call over to Ron McClurg to provide some additional color on our financial standing and expectations moving forward.

Thanks, Dave. As mentioned previously, we are reporting preliminary fiscal year product revenue of $9.1 million, which is in line with the guidance provided throughout the year. We also had license revenue of $3 million from the expanded exclusive distribution agreement with Zimmer Biomet. Additionally, as of September 30, 2025, the company had preliminary cash and cash equivalents of $6.6 million. I believe we have significantly improved our cost discipline and recent hires within the management team have led to reduced expenses.

With continued cost controls and execution, we believe we are funded through at least fiscal 2026, potentially longer if key milestones are hit. Looking forward, we are excited about the growth opportunities and how our financial position allows for us to take advantage of those opportunities. We have a world-class partner in Zimmer Biomet that can help accelerate our growth in the future. We set our budgets and spending conservatively and base spending primarily on revenue from our minimum buying requirements from Zimmer without including potential additional revenue opportunities when budgeting.

We have no debt on the balance sheet and an ATM in place should we need additional capital to extend the runway. I'll turn the call back over to Dave quickly for some final thoughts before opening up the line for questions.

Thanks, Ron. We're extremely excited about the progress we made in fiscal year 2025, yet even more excited about the future potential for the business. Our technology is having a meaningful impact on patients' lives, and we believe our other products in development can have a similar impact. 2025 represented a year of successful execution with the goals we established for this fiscal year, and we remain optimistic regarding our growth potential given what we discussed today.

Operator, at this time, I think we can open up for questions.

[Operator Instructions] Your first question for today is from Jeffrey Cohen with Ladenburg Thalmann.

Ron, just a quick one. The $6.6 million of cash from the end of September, does that include the $3 million Zimmer as well?

Yes. We received that $3 million back in early November of 2024.

Got it. Can you talk a little bit about the face pain 510(K). Congrats on clearing it and as well as getting commercial on it. Are you thinking about direct or you thinking about partnerships, at least domestically?

Sure. So the -- really, the target for when we would expect to do a limited launch is November, so it would be early next month. We have centers lined up. What's a little bit easier for us with facial pain is that the neurosurgeons are able to schedule these cases in advance the ablations that is, unlike brain ablations because obviously, neurologists and neurosurgeons for brain ablations need to figure out first, the target area for the ablation, which sometimes can take up to 2 weeks. In this case, they're able to stack the patients who are suffering from this, and they're able to do the cases relatively quickly. So we expect that the 4 centers that we've chosen will have cases in November.

We want to make sure like we do with every product that we've launched, Jeff, that there's no surprises. We do have interest from a strategic. We've told them once we're done with the cases and the results, we'll sit down with them to discuss a partnership. If for some reason, that doesn't occur, then we would be prepared to go direct if we had to.

Okay. And Dave, how many cases do you think will be performed through the balance of this year?

Probably around 10 is what we're thinking based on just preliminary numbers.

Okay. Got it. I guess back to you, Ron. It looks like Q4 was nearly $1 million higher than Q3. So maybe talk about what drove that in particular? And what kind of pull-through we'll see into '26?

Well, again, we sell to our partner, Zimmer and Biomet. And so we don't have as good a handle on the end-user pull-through. We are continuing to work with them and train additional reps and distributors that they have so that we can continue to support the cases and the new centers that are coming on board.

Yes. So I would just add to that, Jeff, that we've definitely seen an uptick in cases probably over the last 6 to 8 weeks. And while we're not in every case that Zimmer does, we are in a fair amount of the ablation cases and things are definitely increasing. So I would expect that trend to continue in 2026.

Okay. Got it. And one more, if I may. You spoke a little bit about drug delivery with pharmaceuticals. Could you give us a sense of perhaps drug volumes or perhaps locations of the body?

So at least initially, our device would be used in the brain, and it would be used for neurological conditions. The discussion and the company that we referred to that had placed an initial order, they're looking to treat epilepsy. So this is right in our wheelhouse. The neurosurgeons who would place the device in the brain would be really the same people that are using our device today, plus I'm sure some that aren't. But the initial condition would be epilepsy.

The device -- we've also had some questions about the device being used in other areas of the body. Depending on the application, there's definitely opportunity for that. But really, what makes this seamless for us is going to the same call point that we're going to today, and that's the neurosurgeon for brain-related conditions.

And in terms of -- I think you had another question on volume. It appears that when these devices are used in clinical trials, the partner that we've been referring to has indicated this would be 1 to 2 locations with utilization of 2 to 4 devices per patient.

Okay. That's helpful. And any sense on timing on the K to be filed?

We plan to file the 10-K in early December, and we have not settled on a specific date yet, and we'll set that call date, that earnings call date right around the time we file.

Your next question for today is from Anthony Vendetti with Maxim Group.

Yes. So I just wanted to talk a little bit about the quarter. And Dave, you said the momentum you're seeing from this quarter, you think will continue. In terms of the pipeline for fiscal year '26, is the momentum you're seeing just based on patient volume, on the -- what you're seeing from or hearing from the physicians? And then I know it's a multipart question, but when you look at where this is coming from, obviously, it's mostly coming from the physicians, but are patients becoming also more aware of your offering? And if so, how?

So it's an excellent question. I think the initial answer is that we've trained additional sales reps from Zimmer. So there are now more sales reps that have access to the sites. And just from that sheer change, we're seeing obviously additional interest. But the question about patients, we're actually doing some work with Care, which is an Epilepsy Organization as well as the Epilepsy Foundation. And the goal here is really to make patients more aware of the therapy so that they're also going in and asking physicians about maybe getting access to this.

It's interesting. I've heard some feedback from some of the neurosurgeons that we've partnered with. And one of the questions is like why don't more patients come in for the surgery. And one of the answers was that neurologists that were trained 15, 20 years ago are much more conservative than the neurologists that have been trained more recently. So the ones that are more recent are much more aggressive and open to surgery, while as some of the ones that were trained many years ago really are much more conservative.

And I think just organically, as more and more neurologists are trained and exposed to this technology, I would think that we will see additional utilization just because of that. But we did have some patients contact the company directly after Clara was featured on Good Morning America. So we think there's an opportunity to generate more interest by working with the associations that really focus on epilepsy.

Okay. Great. That makes a lot of sense. And then on the reimbursement process, how are you assisting the physicians with that particular piece of it?

Yes. So we, as a company, can't go out there and tell them, oh, use this particular code. I mean there are codes that have been established off the top of my head. I don't remember the code number, but it's a catch-all code. And the sites are really using different strategies with respect to reimbursement, meaning different codes. So unless I was in touch with the actual centers doing reimbursement, I can't tell you the exact codes off the top of my head that they're using.

Okay. Is there anything else about the onboarding process or physician support other than these associations going forward to recruit other physicians, make them more aware of it, whether it's -- you have more salespeople, but is there any other social media way of reaching out and making everyone more aware of it, whether it's like you said, individuals, go ahead...

Sorry. I think one of the things that we touched on was this registry -- so it doesn't matter really which device you sell today for whatever indication. There's always a question of, well, what's the data? And I think traditionally, many of the neurosurgeons who have tried RF ablation many years ago were skeptical that we would be seeing patients that are seizure-free and certainly, we are. So I think one of the things that we have to do is educate the neurologists as well as neurosurgeons on really the results that we're having.

So it's, I think, so critical for us to be able to get the message out, whether it's social media, whether it's through the organizations or really through the sales force of like, look, we're treating these patients and the majority of them are improving and some to the point where they're no longer seizure free. So that's why we put together an effort to really try to get this registry up and running as quick as possible. It was one of the reasons why we brought on Dr. Patil. We thought this was an area that he could really drive for us.

We already have verbal commitments from some of the centers. We still need to get through the paperwork. But after that, this is going to be a major focus for us moving forward.

Your next question is a follow-up question from Jeffrey Cohen.

Sure. I thought one more. Dave, could you talk a little bit about the thin film development and thin film technology and your partnership there and what we may see over throughout 2026?

Yes. I think the partnerships that we're really looking to develop with the technology are really pain management, one of the pillars that we're going after. And the reason why we're really interested in a partnership there is we'd love to partner with a strategic that already has an FDA clearance for a complete stimulation system to treat back pain, and it doesn't have to be back pain. We're just starting with back pain because it happens to be the largest market in terms of revenue generated.

But if we're able to form a partnership and literally use their PMA to piggyback off of our path to a U.S. clearance is much faster than if we have to develop our own. Now we decided to develop our own generator RF generator because that was a much easier undertaking than a stimulator. But that's really the main benefit in doing that. And then we also want to leverage the RF generator. I mean you've seen now that after brain ablation, we got clearance for facial pain ablation.

And now we're moving to treat low back pain with the same system with some modifications. So there's also the opportunity. We've been approached by a few strategics regarding our interest in partnership. So those are 2 areas that hopefully, we'll be able to talk more about. And then drug delivery, it's really partnerships with primarily pharma companies. So that's what I think we can look for.

Any other questions, operator?

There are no other questions in queue. I would like to turn the floor back to you, Dave, for any closing remarks.

I would just like to again thank everyone for attending the call, and we're really looking forward to connecting with you and the investor community in the near future. Thanks, and have a great rest of the day.

Thank you. This does conclude today's conference call. We thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.