Neuraxis, Inc.

Good day, everyone, and welcome to the NeurAccess Report Second Quarter 2025 Financial Results. At this time, all participants are in a listen-only mode. After the presentation, there will be a question-and-answer session. To participate, you will need to press star 1-1 on your telephone, and you will hear a message advising your hand is raised. To withdraw your question, simply press star 1-1 again. If you would like to ask the question via the webcast, please use the box and enter your question. Please note that this conference is being recorded. Now it's my pleasure to turn the call over to Ben Shamsian. Please go ahead.

Thank you. Good morning, everyone. Thank you for joining us for NARAC's second quarter 2025 financial results and corporate update conference call. Joining us on the call today is Brian Carrico, CEO of NeurAccess, and Tim Hendricks, CFO of NeurAccess. At the conclusion of today's prepared remarks, we will open the call to questions. If you are listening through the webcast, you can send in a question through the portal or simply email me at nrxs at lithiumpartners.com. If you are dialed into the call live and would like to ask a question, you can follow the instructions provided by the operator pressing star, one, one, and the button. Today's event is being recorded and will be available for replay through the webcast information provided in the press release. Finally, I'd 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 results of NeurAccess. 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 in the company's filings with the SEC. NeurAxis undertakes no obligation to update or revise any of these forward-looking statements. With that said, now I would like to turn over the event to Brian Carrico, Chief Executive Officer of NeurAxis. Brian, please proceed.

Thank you, Ben. Good morning, and thank you for attending the second quarter 2025 earnings call. During today's call, I will highlight the continued execution of our commercialization strategies for IV STEM, our neuromodulation technology, and RED, our product for patients with evacuation disorder. These achievements have set the stage for strong growth in the recent quarters and even stronger growth in 2026 and beyond. We will recap Q2 and discuss the milestones and growth plans for the balance of 2025 as we come off an excellent quarter of both execution and growth. Following my remarks, Tim Hendricks, our CFO, will review our financial results for the second quarter of 2025. I want to begin today by focusing on how our efforts continue to translate to revenue growth and why we continue to be bullish on significant revenue growth as we achieve critical milestones and move closer to national insurance coverage and the effective date for the Category 1 CPT codes. While our revenue growth has accelerated in recent quarters, the facts remain that we are still treating virtually no one within the addressable market because national policy coverage and the Category 1 CPT code have yet to be put in place. The positive change we do see here is largely due to accounts getting more comfortable with billing and coding, physicians seeing the academic society guidelines stating PENFS is one of only a few therapies with the highest rate evidence, PNFS being the only FDA-approved or cleared treatment recommended in the guidelines, and only minimal medical policy coverage taking effect. On average, selling prices for patients receiving IB STEM through financial assistance are about 65% below our list price. The insurance barrier continues to cause us to leave significant dollars on the table. As insurance coverage increases across the country, the percentage of sales through the full price purchase orders will also increase. This is why our number one priority continues to be written medical policy coverage as we now know the category one CPT code will become effective on January 1st. Our internal prior authorization team continues to grow and be successful as it reduces the administrative burden on hospital staff and allows greater access for patients, and ultimately assist in acquiring a permanent CPT code. We believe that, in time, most accounts will move their prior authorizations for IV STEM to the NeurAccess team as we see more and more added each quarter. I now want to focus on and highlight the catalyst for what we expect to be continued revenue growth in the coming quarters. As we've said several times before, in the perfect world that we have been working toward and are nearing, patients could access blanket medical policy coverage and physicians could utilize a Category 1 CPT code. For IV stem to be successful at any institution, two key components must be in place. First, insurance coverage is essential to ensure patients can access treatment. Second, provider compensation through RVUs, or relative value units, is necessary to recognize physicians for their time and expertise. With the assignment of a Category 1 CPT code, physicians will now receive RVU credit for each placement, aligning clinical value with institutional incentives. Regarding blanket medical policy coverage, we have now reached about 53 million covered lives. We have consistently emphasized that policy-level coverage is the key driver for exponential revenue growth. The academic society and the physicians within the society who treat these patients throughout the U.S. children's hospitals have been aware and are supportive, thanks to robust clinical evidence and peer-reviewed publications in leading medical journals, including the recently published practice guidelines. Still, medical policy coverage in the Category 1 CPT code are imperative to expand treatment access. Additionally, and as expected, we have numerous payers currently in the review process, and we are cautiously optimistic that the recently published academic society guidelines will bring this evidence-based treatment to policy. The second part of the seamless treatment for patients, along with medical policy coverage, is the category one CPT code. Now I want to talk about the three major milestones that were hit in Q2, including the FDA indication expansion, the publication of the clinical practice guidelines, and the assignment of proposed Category 1 CPT values. As I just mentioned, we're coming off another strong quarter of year-over-year growth, with Q2 coming in at 46%, marking the fourth consecutive quarter of double-digit growth. But more importantly, we hit multiple milestones, and now the big picture comes more into focus. These milestones include the indication expansion to functional dyspepsia with nausea symptoms nearly doubling our market opportunity, the NASFGN Academic Society Guidelines being published, and the Category 1 CPT Code with proposed work RVUs of 1.46 RVUs per placement, and equally important, strong proposed reimbursement values for the PENFS or IB STEM procedures. We have been laser focused on these milestones for years, and they are all coming to fruition as expected as we lead up to the new CPT Code becoming effective January 1st. We continue to execute at a high level on our growth objectives, rooted in the continued foundation that strong published data will drive coverage expansion, leading to sustainable revenues and margins. We laid out these objectives in previous calls and are now putting the final pieces in place to allow blanket insurance coverage and, in turn, the scaling of PENFS revenues. In recent months, we've made significant achievements as we advanced and hit milestones aiming for cash flow break-even and profitability. Regarding IV STEM, we are primarily focused on revenue trajectory, and looking back four quarters, we had significant growth of 40% in Q3 of 2024, 43% in Q4 of 2024, 39% in Q1 of this year, and 46% in Q2 of 2025. We continue, as I mentioned earlier, to see only the very beginnings of recent medical policy covers take an effect. Regarding the guidelines, I will start by saying the clinical practice guidelines are what we expected as we are the only FDA approved or FDA cleared treatment in the publication and therefore the only FDA approved or cleared treatment that is recommended. This is further validation of clinical acceptance within the pediatric gastroenterologist community. The most important recognition any medical technology can receive is independent guidelines by the academic society because this is an independent review of the literature and a grade is assigned. which the health insurers generally accept as the standard. We announced previously that a systematic review by the academic societies of Espigan and Naspigan to the European Society and the North American Society combined were released showing our technology has the highest grade certainty level and largest magnitude effect. This systematic review has now been published and again have been told by the largest payers that this publication is necessary for medical policy coverage. So the question, what are we doing now that the guidelines are out, and how do we see the guidelines affecting the timing of new policy covers? As soon as the guidelines were published, we repackaged all data, academic society support letters, and the guidelines and sent them to the payers where we still need policy covers. As you may or may not know, payers have annual review dates that span the course of the 12-month with some of those review dates coming in the next 60 days and some not coming until Q1 of 2026. For those that come late 2025 and early 2026, we have asked for an interim review and are cautiously optimistic we will be granted this request based on new data in the form of published academic society guidelines. As one example, one significant payer responded to our email request and said they would review the policy in the coming 90 days instead of late Q1, 2026. We don't have an exact date, and we don't know when we will be notified of their decision, but they have committed to reviewing sooner. Now I want to talk about the Category 1 CPT code. As everyone is well aware, we have achieved the company's most important milestone to date in the form of a Category 1 CPT code, which will allow for more seamless coding, billing, and reimbursement. This is a permanent CPT code that becomes effective on January 1, 2026. The reason this code is so critical is that it brings a permanent code, making it much easier for providers to build a procedure. It will bring reimbursement amounts for transparency and consistency, and it will provide RVUs, which is how most physicians' productivity is measured. One could argue that physicians in a children's hospital today are treating patients for free because there is not currently work RVUs associated with this time. This will no longer be the case come January 1st. As mentioned earlier, the code has been assigned by the American Medical Association, CPT panel, and will become effective January 1st. Most importantly, the proposed RVU and payment values were released in July, and we are very pleased with those numbers. Furthermore, the CAT-1 code is expected to remove the prior authorization response of no authorization required barriers. Currently, our CAT III code receives a no authorization required response about 70% of the time. When a no authorization required is received, two things happen. First, this means there is no guarantee for payment, which means the family is responsible for all costs and therefore will likely not move forward with treatment. Second, there is no opportunity for appeal, which means the patient has no chance to state their case and no opportunity to utilize the patient assistance program. This means that about 70% of those patients who want to get treatment have no opportunity to get treatment, and we expect this to be nearly eliminated with the Category 1 CPT code. Now I want to talk about the FDA milestone, the FDA expansion. We've expanded the IB STEM label to include a patient population beyond the previous 11 to 18 to 8 to 21, which we had mentioned earlier, significantly increasing the number of children we can treat. And just this past quarter, we expanded our FDA indication for functional dyspepsia with nausea symptoms in children 8 to 21 years of age. This is critical because it nearly doubles our market opportunity. Additionally, this indication will rely on the same Category 1 CPT code, the same children's hospitals, the same call point within the children's hospital as the pediatric gastroenterologist physician, and will utilize the same commercial sales force, and marketing force that we have in place today. We expect revenue growth to accelerate meaningfully as we move toward our goal of cash flow break-even based on two catalysts, the continued increase of payer medical policy coverage combined with the new CPT code becoming effective. I want to now speak about RED, the Rectal Expulsion Device product, which we continue to believe to be a great opportunity for InterAxis. We're still in the soft launch phase. but getting closer to a hard-launched commercial effort. The current treatment involves much trial and error by the physician as to which treatment will work, and REDD will allow the physician to choose the best treatment option for patients with chronic constipation after the first visit, which is a win for the patient. Because the technology already has a Category 1 CPT code assigned to the procedure and strong national reimbursement, we're beginning to see the providers not only bring this clinically, but be able to see financial benefit to the practice. As we continue the soft launch, we are learning a lot about the workflow and reimbursement, which will allow us to go into a hard commercial launch with the necessary information. In summary, we couldn't be more pleased with continued execution, especially the milestones this past quarter relative to future growth. We have been talking for some time about these critical milestones, and seeing them come to life is good for all shareholders, but most importantly, for the 1 million debilitated patients in need of PENFS or IV stems. As we look ahead, our priorities remain focused to continuing to secure broad medical policy coverage and advancing disciplined commercial execution to drive utilization and scale. I will now turn the call over to our CFO, Tim Hendricks, to discuss the financials. Tim?