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 roadmap 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 three different areas: brain, pain, and drug delivery with our novel thin film multifunction electrode technology. Because the technology has multifunctional 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 and 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. 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- $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 ablation 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 one-time 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 eight 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 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 Advisor. 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 percutaneously 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 have 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 and 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.
Certainly. At this time, we will be conducting a question- and- answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Your first question for today is from Jeffrey Cohen with Ladenburg Thalmann.
Hey, Dave and Ron, thanks for taking our questions.
Thanks for joining the call, Jeff.
My pleasure. 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 and float time carriers? That's all I'm getting you. As far as getting commercial on it, are you thinking about this after you're thinking about partnerships, at least domestically?
Sure. 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 two 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. We expect that the four 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. 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. Maybe talk about what drove that in particular and what kind of pull-through we'll see into 2026.
Again, we sell to our partners Zimmer 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 in the new centers that are coming on board.
I would just add to that, Jeff, that we've definitely seen an uptick in cases probably over the last six to eight weeks. 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. I would expect that trend to continue in 2026.
Okay. Got it. 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?
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. 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. The initial condition would be epilepsy. 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. 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. 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 one to two locations with utilization of two to four devices per patient.
Okay. That's helpful. 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. We'll set that earnings call date right around the time we file.
Got it. Okay. Perfect. Thanks for taking our questions.
Thank you, Jeff.
Your next question for today is from Anthony Vendetti with Maxim Group.
Thank you. I just wanted to talk a little bit about the quarter. Dave, you said the momentum you're seeing from this quarter, you think will continue. In terms of the pipeline for fiscal year 2026, is the momentum you're seeing just based on patient volume, on what you're seeing from or hearing from the physicians? I know it's a multi-part 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? If so, how?
It's an excellent question. I think the initial answer is that we've trained additional sales reps from Zimmer . There are now more sales reps that have access to the sites, and just from that sheer change, we're seeing additional interest.
The question about patients, we're actually doing some work with [CURE], which is an epilepsy organization, as well as the Epilepsy Foundation. 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? 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. The ones that are more recent are much more aggressive and open to surgery, while some of the ones that were trained many years ago really are much more conservative.
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. We did have some patients contact the company directly after Clara was featured on Good Morning America. 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. On the reimbursement process, how are you assisting the physicians with that particular piece of it?
We, as a company, can't go out there and tell them, "Oh, use this particular code." 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. The sites are really using different strategies with respect to reimbursement, meaning different codes.
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 you have more salespeople? Is there any other social media way of reaching out and making everyone more aware of it, whether it's, like you said, individuals?
I think one of the things that we touched on was this registry. It doesn't matter really which device you sell today for whatever indication. There's always a question of, what's the data? 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.
I think one of the things that we have to do is educate the neurologists as well as neurosurgeons on the results that we're having. It's so critical for us to be able to get the message out, whether it's social media, through the organizations, or through the sales force, 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. That's why we've put together an effort to 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.
After that, this is going to be a major focus for us moving forward.
Okay, great. Thanks for all the call. That was very helpful. I'll hop back in the queue.
Your next question is a follow-up question from Jeffrey Cohen. Jeffrey, your line is live.
Sure. I thought of 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?
Yeah, I think the partnerships that we're really looking to develop with the technology are really pain management, you know, one of the pillars that we're going after. 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. 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. 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. We decided to develop our own generator, RF generator, because that was a much easier undertaking than a stimulator. That's really the main benefit in doing that.
We also want to leverage the RF generator. 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. There's also the opportunity. We've been approached by a few strategics regarding our interest in partnership. Those are two areas that hopefully we'll be able to talk more about. Drug delivery, it's really partnerships with primarily pharma companies. That's what I think we can look for.
Super. Thanks for taking that. Thanks.
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 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.