Ladies and gentlemen, thank you for standing by. Welcome to the NeurAxis, Inc. fourth quarter 2025 financial results. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to turn the conference over to Ben Shamsian, Investor Relations. Please go ahead.

Thank you. Good morning, everyone, and thank you for joining us for NeurAxis, Inc.’s fourth quarter and full-year 2025 financial results and corporate update conference call. Joining us on the call today is Brian Carrico, CEO of NeurAxis, Inc., and Timothy Robert Henrichs, CFO of NeurAxis, Inc. At the conclusion of today's prepared remarks, we will open the call to questions. If you are listening through the webcast, please follow the operator's instructions, or you can send me an email at nrxx@listenpartners.com with your question. If you are dialed into the live phone line, you can again follow the operator's instructions. Today's event is being recorded and available through the webcast information provided in the press release. Finally, I would like to call your attention to the customary safe harbor disclosures regarding forward-looking information. The conference call today will contain certain forward-looking statements, including statements regarding the goals, strategies, beliefs, expectations, and future potential operating results of NeurAxis, Inc. Although management believes these statements are reasonable based on estimates, assumptions, and projections as of today, these statements are not guarantees of future performance. Time-sensitive information may no longer be accurate at the time of any telephonic or webcast replay. Actual results may differ materially as a result of risks, uncertainties, and other factors, including, but not limited to, the factors set forth by the company's filings with the SEC. NeurAxis, Inc. undertakes no obligation to update or revise any of these forward-looking statements. With that said, I will now turn the call over to Brian Carrico, Chief Executive Officer of NeurAxis, Inc. Brian, please proceed.

Good morning, and thank you for attending our fourth quarter and full-year 2025 earnings call. During today's call, I will highlight the continued execution of our commercialization strategy for IV Stem, our neuromodulation technology for both the pediatric and adult patient populations. The continued execution has set the stage for the growth we expect in 2026. Today, we will recap Q4 and quickly turn to the first quarter, which I believe is most important and what everyone is looking to hear. To recap Q4 in a nutshell, we continued our commercial scaling strategy, we picked up 45 million covered lives for our proprietary PNFS technology, and were granted a federal FSS contract with IV Stem as our first listed product to allow our teams to sell within the VA. Following my remarks, Timothy Robert Henrichs, our CFO, will review our financial results for 2025. Let us first talk about the commercial execution of reimbursement progress. As we have mentioned in the past, the years leading up to January 1 focused on achieving two critical milestones: securing a Category I CPT code and obtaining written insurance policy coverage to enable widespread, sustainable growth. Once it became clear that the Category I CPT code would become effective on January 1, 2026, we implemented a more focused commercial strategy, and that strategy remained unchanged through the first quarter. The objective for the first quarter was straightforward: deploy the strategy, gather real-world data, and learn as much as possible about what drives adoption and what gaps remain. With the knowledge gained during Q1 to date, we now have a much clearer and more actionable growth roadmap. For the first time, the story has become significantly easier to understand. With a Category I CPT code in place, more than 100 million covered lives, our focus…

the fundamental barriers that historically limited adoption are now being systematically removed. With the Category I code in place, expanding medical policy coverage, accelerating patient utilization, and a scalable commercial infrastructure now operational, we believe IV Stem has entered the early stages of its true commercialization phase. Execution is now the primary driver of growth. As coverage expands and utilization continues to scale across hospitals, payers, and federal health care systems, we believe the gap between clinical demand and current adoption will continue to close. Our focus remains disciplined, data-driven, and centered on building long-term sustainable value.

children's hospitals that have strong insurance policy coverage, at least one physician champion, and adequate IV Stem clinic time are performing extremely well. The void of any one of these three is a barrier to making sure every child has access. Written insurance coverage is essential to patients being treated through insurance. We learned which gaps need addressed as clinical reinforcement to ensure all physicians are aware of the data, along with keeping IV Stem top of mind. We learned communication is key to understand which barriers or perceived barriers still exist. We learned the economics are very strong for the PNFS procedure in children's hospitals. Delivery of this information to the administrators and financial stakeholders in the children's hospitals will be a strong focus of our team going forward. And finally, revenue has been surprisingly better than I expected in Q1. It has also been heavier at the top than I expected, but that is great in the fact that we now know what a children's hospital with all pieces in place can do, and that is outstanding for our future. Make no mistake. We have work to do and gaps to fill, but the hurdles we face today are nowhere near the hurdles we have overcome to be in this situation. We have never been better positioned operationally, commercially, or strategically than we are today, and we believe the progress underway in 2026 represents the beginning of a multiyear growth cycle for the company. I will now turn the call over to our CFO, Timothy Robert Henrichs, to discuss the financials.

Thank you, Brian. And let me add my welcome to everyone joining us on this call. These financial results were included within our press release, which was issued earlier this morning, and were also provided in more detail within our 10-K. I will provide some additional details in key areas such as our financial results and liquidity position, as well as an outlook on certain areas. The 2025 marked the sixth straight quarter of double-digit revenue growth year over year. 2025 was a year of significant milestones for the company, including FDA indication expansion to functional abdominal pain and functional dyspepsia with associated nausea symptoms in both children and adults; IV Stem label expansion from 11–18 years of age to eight and up, including an increase of devices per patient for a course of treatment to four; the published NASPA and academic society guidelines; the new Category I CPT code and RVUs; the introduction of the RED device; an FSS contract; and, last but not least, medical policy coverage representing approximately 45 million health plan members from a major national health insurer in December. The accomplishments position the company extremely well as we continue to grow revenue with stronger gross margins and operating expense leverage. With that, I will go through the financial highlights in detail. Revenues in Q4 2025 were $968,000, up 27% compared to $761,000 in Q4 2024. Unit deliveries increased 35% compared to the prior year, due to volume growth from patients with full reimbursement health insurance; a market shift from our historical mix of the company's discounted financial assistance program outpacing the growth of higher-margin full reimbursement patients. In fact, 2025 marked the seventh straight quarter of double-digit unit growth. Although our average selling price in Q4 2025 was lower than in 2024, it reached its…

Thanks, Tim. To summarize, we are very happy with the way Q1 is coming along. I would just say that revenue, as I said, is better than I expected. Most importantly, we have learned what gaps need to be filled, and we can finally be able to turn this into the commercial strategy and hire the people to have the comprehensive footprint that we need. I will now turn this back to the operator, and I look forward to questions.

Thank you. As a reminder, to ask a question, please press star 11, and to withdraw your question, please press star 11 again. The first question will come from Chase Richard Knickerbocker with Craig-Hallum. Your line is open.

Good morning. Thanks for taking the questions, and congrats on all the progress here. Lots of things to go through, but maybe first, Brian, in Q1, can you give us a sense for the magnitude of inflection in PA requests and any improvement in PA rates since that Level I code? And then, last on that front, with that large payer win in Q4, can you confirm under that coverage policy that there is not a PA that is being required in the market right now? Thanks.

Yes, Chase, good to talk to you. Two good questions. Let us first talk about the prior authorization. We do—and this number will change—but in the first quarter, if we did $100 in revenue in Q1, $20 is revenue that comes from accounts that we do the prior authorizations for. So I can only speak for what we see. We are continuing to do prior authorizations for more and more children's hospitals. The submission rate is up close to 10x from what we saw in 2025. That is first, which is outstanding. That does not mean the approval rate is that high. On the Q1 call, I will give more specifics about the exact numbers that we see, and I will also talk about approval percentage that we see. For example, if last year 1% of submissions were approved, and this year it is 2%—now those are just made-up numbers, and they are not even close to accurate—but I will give more information on the approval rate and percentage to give everybody a general idea along with some examples on the Q1 call. Regarding the large payer, that is correct. There is no prior authorization required from the large payer as long as they have the correct diagnosis codes in place. That has been very beneficial. I will go ahead and get ahead of one of these questions coming with that payer. Yes, of course we are seeing a direct effect from a revenue standpoint in certain areas where that payer has significant presence. But at the same time, we have countless children's hospitals that—let us just say their hospital has 20% or 25% of their patients with that payer. That sounds wonderful, but when the other 75% of their patients are not covered, they are still essentially not treating. Maybe one or two of their physicians are, but as a group, they are not treating because they still view this as a health equity issue. If the majority of their patients cannot have access to it, they are not giving access to even that small group. With bigger payers and additional larger payers coming on board, you will not just get the benefit of that new large payer. You will get the benefit of the payers we have plus the new one because they want to see that 50%, 60%, 70% of their patients are covered before they start to offer this across the board with all physicians from a referring standpoint. There are other small barriers that will just take time, and I can give more examples of those around IV Stem clinic time as we get further into the questions. Chase, I hope that answers your question. If not, I will go into more detail.

No, good color. Maybe along those lines, on the number of accounts since January 1 with all these developments aligning, can you give us a sense for the number of new accounts? And then on your highest adopters—I think some of those have a fair amount of exposure to that payer you won at the end of the year—can you give us a sense for utilization trends there, if you have seen a meaningful inflection in Q1? It certainly sounds like you have, but maybe just some color there.

Yes, it has been top heavy. I would just say that I have been pleasantly surprised with the children's hospitals that have access to and are heavy with that payer, and had IV Stem clinic time already built in. Those that can adapt to that and have physician champions are doing extremely well. But as I mentioned on the call, if they only have that one payer or they do not have the IV Stem clinic time put in place, I will give you an example. One of the states that is 80% that payer has submitted to us—just call it 20 patients in the first eight weeks of the year. You would think that 75%–80% of those patients would be from that payer, and it is not the case. Only 25% were. So let us use numbers of five out of 20. Of those patients, five were from that payer. The other 15 were other payers from around the country or other payers we do not have policy with. Although only 25% of their patients are with that payer, they are already booking IV Stems out to September. Now they are fixing that. They are adding more IV Stem clinic time. But when I spoke to the account last week, the director said, “We have to put together a plan. We have to present those to a committee, and that has to go to another committee. This is going to take until May or June.” The point is the good news is they are treating a tremendous amount of patients even though it is only 20% or 25% of their patients that are being approved. It takes time. These children's hospitals take time. The good news is that excellent financial story, which I referenced, and now that we have…

Got it. I know you are not giving 2026 guidance at this time. I wanted to get some initial thoughts, if you have them. I understand it is very dynamic. Maybe the best way for me to ask it is: as we sit here in Q1—you had about a 20% sequential inflection from Q3 to Q4—with all this commentary, I would expect that materially accelerates. Any goalposts that you could give us for the revenue inflection that you are seeing thus far through Q1?

No. I think I may have mentioned in Q4 that I thought Q1 had the potential to be light or in line with Q4 just because of the delay in prior authorizations in January and because of IV Stem clinic time getting set up, like the example I just gave. I am only going to say that I am pleasantly surprised. We have five or six weeks until the next call. I will just wait and give detailed KPIs. We are going to give some nice KPIs going forward that are relevant to growth and show the opportunity, and I am going to wait until then to do so.

Great. Tim, just last one. Right way to think about SG&A growth in 2026 as you are expanding your commercial capabilities?

Yes. When we move into 2026, when you look at our three buckets, we have one large payer. It is not if, but when we get another large payer, we will then invest back into our selling expenses and our commercial team.

But I—

I do not think that rate would be much different than the rate that we are seeing at our current pace. I do believe our R&D expenses will tick up because we are continuing to enhance the device here in 2026. From a G&A perspective, year over year, remember in 2025, we had a one-time nonrecurring legal settlement. The charge was about $630,000, so that will be a tailwind. That in and of itself would put us ahead of next year, but we have been really focusing on G&A expenses and either taking them down or keeping them flat so that we have the runway to invest in R&D and in selling expenses. I expect increases in selling. I expect increases in R&D. I am not expecting much of an increase per se in G&A, but that can all change for all the right reasons as we pick up additional health insurance coverage and need to invest in the business. I do believe we are going to get operating expense leverage. To your question, Chase, we are not going to add operating expenses anywhere near the pace that revenue is going to grow, and that is going to help us from a cash flow perspective as well.

Great. Thanks, guys. Congrats again.

Thank you. The next question is going to come from Lindsay Leeds with MicroCap Opportunities. Your line is open.

Thank you, and congratulations on a strong Q4. I wanted to ask about the hospital rollouts. You were talking about a hospital that was scheduling all the way into September. What can you say about what kind of staff the hospital needs to schedule these, and what are the barriers to getting that program rolling?

Well, those are two very separate questions. First, what staff is required depends on the size of the children's hospital, how many physicians are treating, and how many physicians are referring. We have children's hospitals with champions where there might be 25 or 50 physicians, and there are only one or two specific physicians that are treating IV Stem, and only their patients are treating IV Stem. This goes back to needing more and more IV Stem clinic time so that everyone can refer their patients, and we are working through that. The staff that is needed—you need a nurse practitioner or a physician's assistant or a physician to place the device. So that is important. From a barrier standpoint—and let me back up, Lindsay—if you have two new patients per week every week, then because there are four devices per week, that means you need two new patients per week. After four weeks, you have eight placements, and they continue to roll over. You would need, say, a Tuesday morning from 8:00 to 12:00. You need eight 30-minute slots. You would need to staff that, and this is where the economics come into play. That is our job to make sure that is clear as we meet with these children's hospitals. From a barrier standpoint, I mentioned an example a second ago of a children's hospital where they have known since February they were already booking out March, April, May; now they are into September. Now that they get to these committees, that should come back, and they should have plenty of time beginning in, let us call it, May or June at the latest. But then I expect they will need to expand again. When I look through Q1, we have some outstanding results, but I would argue…

Okay. Thank you. Are you able to talk about your Veterans Affairs program? Will you be hiring additional staff in Q2, or do you know how long it will take you to know the trajectory of that rollout?

Well, a few things about the VA. The response and the reception of this technology and the data behind the technology has been stronger than I expected—better than we expected. As I said on the call, I did not expect orders in Q1. The VAs, by nature, move a little slower, but we have seen several facilities order, and we are seeing reorders, which is excellent. As I see more facilities order and more reorders, we will be a little quicker to hire more people, and we are looking at a bigger-picture commercial rollout where we are considering making the reps that are covering the VA also cover children's hospitals. You start to have a national sales force and national payer landscape. It does not make sense to have—I am in Indiana, so I will use that as an example—it does not make sense to have someone in Indiana calling on the VAs and someone else in Indiana calling on the children's hospitals. We need to be able to scale the commercial operation. As we continue to transition throughout 2026, we will move towards that model. One thing that sticks out to me is there was an article I read two weeks ago about the VA: the FSS contract is just a license to go to the VA and be able to move the technology. I would argue that anytime you have an FDA indication, it is just a license to be able to go to the hospital and sell. This is really no different. Are there some barriers in the VA from a resource standpoint? Of course. There are resource barriers in children's hospitals. There are resource barriers everywhere. This has been no different, but I am pleasantly surprised with the uptick in response and positive feedback and initial adoption in the VA. So yes, as we move into Q2, I expect there will be additional hires. I expect by 2027 that we are beginning to marry the children's hospitals and the VA from a commercial standpoint. We will talk more about that as we get closer. Make no mistake. We have been very lean, and that is because we needed a revenue source in the Category I CPT code and an FSS contract. As lean and calculated as we have been, we are going to be measured and calculated going forward, but we are going to be very aggressive from a commercial standpoint.

Excellent. Do you have any adult data at all that you are able to take with you to the Veterans Affairs hospitals to promote this IV Stem treatment, or are you basing that mainly on the pediatric data?

There is no large randomized controlled trial yet. But there is absolutely adult data. First off, the fMRI data that was done at the Atlanta VA was done at the Atlanta VA, showing cognitive changes in patients using the technology. Many of our studies have patients in their twenties. From a pathophysiology difference, there should be no difference between a 21-year-old and a 45-year-old. The physicians have understood this, and we have gotten very little pushback on the fact that there is no large randomized controlled trial in adults. As I mentioned, we have begun that trial at the Cleveland Clinic in adults, and we expect that to be very meaningful. We are also expecting a publication in a study with patients up to 35 years of age in the coming months from an institution. On the surface, that might appear as a barrier, but it has not been a barrier to date, and I do not expect it to be a large barrier if you understand the science.

Okay. Perfect. Thank you so much. That is all my questions.

The next question comes from Karen Sterling with Kingswood Capital Partners. Your line is open.

Thank you. Good morning. Hi, Brian. I would like to pick up where Lindsay left off on the IV Stem trial in adults. Could you give us a little bit more detail on how that trial is laid out and what your expectations are? How do you expect it to benefit the company going forward?

I expect a large randomized controlled trial at the Cleveland Clinic with a sham arm, in addition to all the data we already have from a mechanistic standpoint. As I mentioned, the other study that is going to be published soon in patients up to 35 should be strong enough to convince the academic society, who in turn can request coverage from payers. I expect this to help gain us insurance policy coverage on the adult side. One thing I have not talked about is the amount of inquiries and requests from adult gastroenterologists to utilize IV Stem. The reality is it would be on a cash basis. There is no patient assistance program due to federal guidelines on the adult side now that there is a Category I CPT code. This is a cash pay, and there is no insurance coverage on the adult side. This is extremely important to us. It is why we are doing such a large study. From a medical device standpoint—look, this is not a pharmaceutical. It is not a drug. It does not have the same risk and side effects, of course, which is one of the many reasons that a pharmaceutical trial is so large. But for a medical device, from a power calculation standpoint, this will be a really strong study at the Cleveland Clinic, and that is the goal of the study. It may take, let us call it, 18 months to do this study. We will know more in the next 90 days about how many patients are being enrolled, and we will be able to have a closer idea and prediction as to when this study will be completed. Then, because we have the data and we already have the indication, we will be able to go directly to the insurance companies. Karen, that is the ultimate goal. This is an extremely large market opportunity. As we talked about earlier, this was the first FDA indicated, approved, or cleared treatment specifically for functional dyspepsia in adults. Right now, the focus is on the VAs, where there is an FSS contract, and we can help people. In the interim, the focus is on this study and ensuring that it is done as quickly and efficiently as possible.

Got it. Okay. Apart from the approved indications in dyspepsia and IBS, do you have any plans for opening up additional expansion markets?

Now are you talking about additional countries, or are you talking about additional indications?

Additional indications.

We have a few studies in place. We have the randomized controlled trial for cyclic vomiting syndrome, which would also be in children's hospitals—the same call point, pediatric gastroenterology. We have a couple of other studies that are underway. I would point to the cyclic vomiting syndrome study as potentially the most meaningful.

Okay. Can you give us a timeline on that?

That is probably also 18 months out, similar to the adult RCT.

Okay. Perfect. Thank you. And—

And it is on clinicaltrials.gov. There is another study in post-op pain at UPMC. It is about a 300-patient RCT showing opioid reduction or lack of opioid use—eliminating the use of opioids in open bowel surgery. That should be done this spring. There is a lot to discuss about that before I am going to discuss it publicly. Our focus is on the children's hospital. The opportunity there is incredible, and that is where our focus is.

Thanks very much.

Thank you. I am showing no further questions in the queue at this time. I would now like to turn the call back over to Brian for closing.

Thank you. Thank you all very much for being with us today. I look forward to communicating with everyone again soon. If there are follow-up meetings or follow-up calls or additional questions, as most of you know, I look forward to those and am happy to meet. With that, have a great day. We will talk soon. Thank you.

This concludes today's conference call. Thank you for participating. You may now disconnect.