Neuraxis, Inc. Lytham Partners Fall 2026 Investor Conference

Hello everyone, and thank you all for joining us during the Litham Partners Fall 2026 Investor Conference. My name is Ben Shamsian, Vice President at Litham Partners, and today Brian Carrico, CEO of NeurAxis, will be taking us through a brief slide presentation. NeurAxis trades under the ticker NRXS. Let's get started. Brian, welcome, and I'll turn the floor over to you for your presentation.

Thank you, Ben. welcome to those who are new to the NeurAxis story and to those who've been following the story since the IPO several years ago. NeurAxis is a—so who are we? So NeurAxis is a first-to-market growth-stage medtech company. We're focused on neuromodulation therapies for chronic and debilitating conditions in GI, specifically disorders of the gut, brain, and interaction in pediatrics. And now adults. We've always been a pediatric company, where pediatric company first, but we are transitioning into the adult space, which we'll talk about today. From a corporate overview standpoint, for those who follow medtech, you understand how critical it is to have a category-1 CPT code. This is a 7 or 8-year venture for a company that's first-to-market. We secured our category-1 CPT code effective January 1, 2026, so we're about 8 to 9 months into that category-1 CPT code. We just recently had a large announcement around new insurance policy coverage with Cigna. That added about $18 million covered lives, which took us, following the anthem announcement late last year, early this year, that took us—anthem took us to about $100 million and then Cigna took us to—and so we had some other small victories in there that took us to $120 million covered lives.

This obviously translates to revenue. The anthem and the category-1 CPT code translated to revenue. 2025 first half was $1.8 million, 2026 first half was $3.5 million, and gross margins from 2025 first half to 2026 increased from 84% to 86%. And I expect, as we continue to gain more insurance policy coverage in the coming months and quarters, that that gross margin continues to tick up a little bit. So what indications do we have in the market today? As I mentioned earlier, we are a pediatric company first, so we have—we had functional abdominal pain and functional dyspepsia and nausea. In patients 8 to 21, in children, and then late last year we were able to do a reverse extrapolation or an extrapolation, however you look at it, with the FDA, and that took us into the adult space. So now we have these indications for 8 and over for all of—for both of these indications: abdominal pain and IBS, functional dyspepsia, and nausea. And the important part around those indications are that 8 to 21 years of age is where all of our insurance coverage lies, and over 21 years of age, we have no insurance policy coverage as of general rule because we've not done any adult-specific studies.

So to combat that and to gain insurance policy coverage there, we just began a—what was started as an RCT, double-blind placebo-controlled trial at the Cleveland Clinic. That's now turned into a multi-site RCT, which will be Cleveland Clinic, Stanford, Hoge, IU, Louisville, and Marshall. So that will kick off this fall, and that will be 350 to 400 patient RCT. The final point I would make about the adult space is we do have a federal supply schedule with the Veterans Administration, VA hospitals, and as I mentioned on our last earnings call, we just hired 10 or 12 1099 reps to sell IB STEM in the VA for adults. So what are some highlights about the company? First, I tell—I've always told investors, we've been very disciplined when it comes to strong data. We built this company on a foundation of data, and that strong data turns into strong policy coverage and reimbursement, and that turns into strong revenue growth. So we've got a very large global market opportunity, with a significant unmet need. We have a clear commercial pathway as we were first-to-market through the FDA de novo clearance. We now have a category-1 technology-specific category-1 CPT code.

Major insurance policy coverage in place. Unique, innovative product. We have the highest-grade evidence via the academic society guidelines, and we're now around 100—1,000 published patients, and our seasoned management board, which we have an exciting announcement about today, we just hired a chief commercial officer. We announced that this morning through a PR, and he comes, and we'll talk more about him later, but he comes with the experience necessary to take this company where we expect it to go in the coming quarters and years. This is a quick slide on the total addressable market, which breaks down into the serviceable available market in the pediatric side, and the adult side. So right now we've got about $5 billion market opportunity in the pediatric side, and about a $2 billion market opportunity in the adult side, with the adult FAP private side insurance policy coverage pending the RCT. So again, back to—we'll touch high level on the data. So disorders of the gut, brain, and interaction. This is what we're treating. Functional dyspepsia, irritable bowel syndrome, and then cyclic vomiting syndrome is also a pediatric gastroenterology call point, and that RCT is in play right now, and we'll find out late next year what that data looks like.

So DGBIs. This is what we're treating. This is a problem with an unmet need. For 50 years, these children have just simply received medications that are off-label. They have FDA black box warnings, and there have been no FDA-approved therapies for children's or adults with functional dyspepsia, and only one peripheral-acting drug approved for pediatric IBS. These are disorders that are negatively affecting kids' quality of life. This means they're not going to school, or they're missing school. They're missing sports. They're missing social activities. There's insufficient data to support the use of most prescribed drugs. Many of these, as I mentioned, with serious side effects. So what's the technology look like? This is what our current technology looks like. We're in the process of redeveloping this to make it look more like—I would tell you an Apple product. It's smaller. It looks nicer. And this technology right now is $1,200, and each patient gets 4. So it's a 4,800 to our company, to NeurAxis, and then the children's hospital, bills the insurance company, and then they're reimbursed based on their contract. So this technology is placed on a Monday, for example, by a physician, a pediatric gastroenterologist, or a nurse practitioner, or a PA, and then that patient wears that device for 5 days, so they would wear it until Saturday.

The patient would take that device off and throw it away, come back on Monday for a second device, and they do that for 4 weeks, and after that, at that point, we have significant research showing long-term relief at 12 months. With that technology. This slide sums up who we are at this, as I've mentioned 3 times now. Strong data equals strong policy coverage and reimbursement equals strong revenue growth. We have 21 PENFS technology in NeurAxis-related studies, we've done 10 different types of research at 13 children's hospital study sites. We've done every type of research that you could possibly do, with this technology, including long-term research, head-to-head against pharmaceuticals, which is quote-unquote the standard of care, just because there has been no other option. So how does this technology work? There are needles. This is not painful. There's no anesthetic. There's no anesthesia. No local anesthetic. These needles break the skin around the auricular, and we target the cranial nerves 5, 7, 9, and 10, including the vagus nerve. This neural modulation frequency stimulates and stimulation reduces the firing of the amygdala. This changes and induces changes in the brain pathways and connectivity, and this is how we get long-term relief.

As I mentioned about the pharmaceuticals earlier, there's no data to support the use of antidepressants in children. With functional abdominal pain. Amitriptyline is a common pharmaceutical that's used. It did not be placebo. Citalopram did not be placebo. These are TCAs, SSRIs. These drugs have an increased risk of suicidal ideation. They have black box warnings. They cause mood changes, weight gains, increased long-term risk of dementia. No physician wants to give a teenage boy or teenage girl this medication unless they really have to, and parents certainly don't want. Their children taking these unless they really have to. So this has been—this IB STEM technology has been a welcome gain to the pediatric GI community. In the double-blind placebo-controlled trial that was published in Lancet, we had improvement in global symptoms in patients with irritable bowel syndrome. You can see the PENFS versus the SHAM device here. In this slide, you can see what's called a number-needed-to-treat. That's the number of patients that need to be treated for one patient to get the targeted improvement of greater than 30% improvement. IB STEM, number-needed-to-treat, is 3. IBS, drugs in adults that ranges from 6 to 14. So you can clearly see the superiority here, with the IB STEM technology and data relative to the pharmaceuticals.

Functional disability scores at long-term follow-up. This was outstanding. So in order to—we moved from moderate to minimal disability, which is not easy. You can move from moderate disability with one check mark or one section on a scale, and we moved 4 sections. So this was not easy, but it was—we also were very successful in this functional disability, which, if you listen to the physicians and the disability improves before the pain, we need to get these patients functioning back to school, and then the pain improves. We also did the largest pediatric registry in children with DGBIs. You can see here, we had a pediatric registry at 7 centers around 300 patients. This was real-world data. We took all comers. There were no inclusion/exclusion criteria. We took everyone. You can see that 61% of patients had failed at least 4 medications prior to treatment, and we had sustained efficacy in abdominal pain 6 to 12 months after the treatment. We went head-to-head with the medications. As you can see here, and we could talk more about this in detail on a separate call, but we went head-to-head against the quote-unquote standard of care, and we're successful. So that's the data. So what's the go-to-market strategy look like?

Well, number 1, I'll tell you, we have a W-2 Salesforce, and that W-2 Salesforce is significantly increasing. I said all along that as we began—as we would begin to gain more insurance policy coverage, we would turn around and, in parallel, increase the commercial footprint, the commercial leadership, which I touched on earlier, and I'll touch on it in a second. So W-2 Salesforce did significantly expand in areas where we have insurance policy coverage. You can see on this slide that we have now over 30 insurance medical policy coverage plans. We have over 120 million covered lives. The category 1 code is in effect as of January 1, and our list price is $1,195, and then each patient gets 4 devices, as I mentioned earlier. IP portfolio. Very strong. Runs through 2039 as of now. We're in the process of lengthening that as well. Contract manufacturing is here in the States. Everything except the needles are sourced here in the U.S., manufactured in the United States, and we also, of course, have a backup manufacturing site in case of a natural disaster. And significant product on hand, 9 to 12 months of product at all times.

Medical advisory board. You can see some of the leading children's hospitals are represented here in Boston, nationwide. Boston Cincinnati, UNC, and Yale. This advisory board has been very helpful to us as we've progressed through this process. Our management team. This was a big announcement as of this morning. We now have added Craig Blanchard, as our Chief Commercial Officer. We wanted to bring someone in here that had the experience, and Craig started his career as an attorney, with a law degree, but did not practice law. Went straight to guidance corporation, and held multiple roles in the commercial side, HR, marketing, sales, sales director, then went through that acquisition to Boston Scientific, was corporate sales director there, then he went to NICO when that was in the early stages, and they were acquired by Stryker in 2024. Craig is—we're extremely excited to have Craig on board, and he started yesterday, and we made that announcement this morning, and we look forward to him helping us get to where we all expect to go in the coming quarters and years. Board of directors, as we've talked about oftentimes before, and then I want to finish here with the capital structure.

As Ben mentioned earlier, we're on the NYSE American. NeurAxis, NRXS, our share price as of the September 21 was $714. Shares outstanding, 13.6 million. You can see the warrants in the RSUs here. The cash position as of that date was $4 million, with no debt. So that is high level, where the company is today, where we expect to go. But from a priority standpoint, it's very clear. Number 1, continue to finalize insurance policy coverage across the country in the coming quarters, and number 2, significantly ramp our commercial force from a sales and marketing standpoint to drive the revenues we all expect in the children's hospitals and then the third priority, of course, is to continue to work on this multi-site adult RCT to gain positive data is the goal, and then gain insurance policy coverage in the adult space, which would drastically increase our total addressable market. So with that, thank you very much, and Ben, I'll turn this over to you.

All right. Well, thank you, Brian, and thank you, everyone, for watching. If you have any questions, or would like to schedule a meeting with NeurAxis, please send me an email at shamsian@lythampartners.com. S-H-A-M-S-I-A-N at Litham Partners dot com. If you'd like to learn more about Litham Partners, you can visit our website, or follow us on LinkedIn, and YouTube to stay connected about future events.