NMTC

Image source: The Motley Fool. Thursday, Aug. 13, 2026 at 8:30 a.m. ET Chief Executive Officer - Dave Rosa Chief Financial Officer - Chris Volker Chief Business Officer - Dave Wambecke Operator: 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. David Rosa: 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. David Wambecke: 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. David Rosa: 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. Christopher Volker: 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. David Rosa: 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: [Operator Instructions] our first question today is coming from Jeffrey Cohen with Ladenburg Thalmann. Jeffrey Cohen: 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? David Rosa: 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. Jeffrey Cohen: 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? David Rosa: 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? Jeffrey Cohen: 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? David Rosa: 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. Operator: Our next question is coming from Justin Walsh with Jones Trading. Justin Walsh: 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? David Rosa: 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. Operator: Our next question is coming from Jeremy Pearlman with Maxim Group. Jeremy Pearlman: 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? David Rosa: 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. Jeremy Pearlman: 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? David Rosa: 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. Jeremy Pearlman: 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... David Rosa: 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. Operator: That appears to be the last question at this time. So I'd like to turn the call back over to Mr. Rosa. David 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. Operator: 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. Before you buy stock in NeuroOne Medical Technologies, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and NeuroOne Medical Technologies wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. NeuroOne (NMTC) Q3 2026 Earnings Call Transcript was originally published by The Motley Fool

This article first appeared on GuruFocus. Product Revenue: $2.0 million in Q3 fiscal 2026, a 16% increase year-over-year compared to $1.7 million in Q3 fiscal 2025. Product Orders: $2.7 million in Q3 fiscal 2026, representing 43% year-over-year growth. Product Gross Profit: $1.2 million, or 59.9% of product revenue, compared to $0.9 million, or 53.9%, in the prior year quarter. Total Operating Expenses: $3.6 million in Q3 fiscal 2026, compared to $2.8 million in the prior year quarter. Research and Development Expense: $1.4 million in Q3 fiscal 2026, compared to $1.2 million in the prior year quarter. Selling, General and Administrative Expense: $2.2 million in Q3 fiscal 2026, compared to $1.6 million in the prior year quarter. Net Loss: $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 prior year quarter. Cash and Cash Equivalents: $2.0 million as of June 30, 2026, compared to $6.6 million as of September 30, 2025. Working Capital: $3.7 million as of June 30, 2026, compared to $7.9 million as of September 30, 2025. Backlog: $1.7 million as of June 30, 2026. Fiscal 2026 Product Orders Guidance: Approximately $11.2 million. Fiscal 2026 Recognized Revenue Guidance: Expected between $9.2 million and $10.5 million. Warning! GuruFocus has detected 4 Warning Signs with NMTC. Is NMTC fairly valued? Test your thesis with our free DCF calculator. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Product revenue for the 1MRF Brain Ablation System grew 16% year-over-year to $2 million, with purchase orders showing a stronger 43% growth to $2.7 million. Gross margins expanded significantly to 59.9% in Q3 fiscal 2026, up from 53.9% in the same quarter of the prior year, driven by a favorable product mix. Received ISO 13485 certification, a major milestone that paves the way for entering international markets with its 1RF brain ablation, trigeminal neuralgia, and EVO diagnostic product lines. A study published in the Journal of Neurosurgery by the Mayo Clinic concluded that NeuroOne's 1RF brain ablation system can be used safely in patients with existing neuromodulation implants, expanding the treatable patient pool. The company's STEREO CED drug delivery platform is making rapid progress, with collaborations at the University of Minnesota and Mayo Clinic, and is expected to be ready for investigational human clinical studies by the end of September. The lead investor increased their holdings from 7.4% to 12.5%, signaling strong confidence in the company's future prospects. The company has no debt outstanding as of June 30, 2026, and is working to qualify a second manufacturing site to increase capacity and reduce lead times. The company faces significant manufacturing and supply chain constraints, with supplier lead times of up to six months, leading to a product backlog of $1.7 million as of June 30, 2026. Due to manufacturing delays, the company lowered its fiscal year 2026 revenue guidance to a range of $9.2 million to $10.5 million, down from its previous expectation of at least $10.5 million, despite receiving $11.2 million in orders. Cash and cash equivalents decreased sharply to $2.0 million as of June 30, 2026, down from $6.6 million as of September 30, 2025, and the company has had to utilize its at-the-market (ATM) offering program to raise additional capital. Net loss widened in Q3 fiscal 2026 to $2.0 million, or $0.23 per basic share, compared to a net loss of $1.5 million, or $0.19 per basic share, in the same quarter of the prior year, driven by increased operating expenses. Total operating expenses increased to $3.6 million in Q3 fiscal 2026, up from $2.8 million in the prior year quarter, due to higher headcount and sales and marketing costs. The company lacks visibility into key performance indicators for its 1RF brain ablation system, as its distribution partner Zimmer Biomet does not provide detailed data on new versus existing account utilization. The commercialization of the trigeminal neuralgia system has been delayed as the company prioritizes manufacturing for the larger brain ablation opportunity with Zimmer Biomet, leaving the smaller product line under-supported. Q: Could you provide additional color on how you view the Stereo CED opportunity? Do you think it's meaningful when used with drugs in the development stage, or does it have to be adopted as a standard for an approved agent?A: Dave Rosa (CEO) explained that the Stereo CED platform is valuable across all stagespreclinical, clinical, and commercial. He noted that while pharmaceutical companies are unlikely to change delivery technology mid-clinical trial to mitigate risk, once a therapy gains FDA approval, NeuroOne would submit a 510(k) application to enable the use of its device with the approved therapy. The platform's key advantages include significantly reduced procedure times through simultaneous multi-trajectory delivery and leveraging existing neurosurgical equipment, avoiding the need for hospitals to purchase new robotic platforms. Q: Can you give us a sense of the supplier and backlog situation into the fourth quarter? Is it related to components or labor? Will the second site help you catch up with all the backlog during the fourth quarter?A: Dave Rosa (CEO) clarified that the backlog issue stems from supplier lead times of up to six months and the company's strategy of building to order to minimize inventory costs. Changes in product mix from Zimmer Biomet can limit responsiveness. The most effective solution is qualifying a second, larger manufacturing site, expected to come online in the first part of 2027. He noted that placing small one-time orders would negatively impact gross margins, so the company prefers larger, more efficient orders. Q: Regarding the trigeminal nerve ablation system, you said you're going to leverage existing personnel and independent distributors. Does that mean Zimmer was not interested in adding that to their agreement?A: Dave Rosa (CEO) clarified that Zimmer is definitely interested, but discussions have been delayed. The primary reason for the delay is the backlog of brain ablation devices, which is currently the larger revenue opportunity and has been prioritized. He stated that the company is moving forward with its own commercialization plans, including interviewing distributors, and will not wait indefinitely for the partnership to conclude. Additional centers will be opened beyond this quarter as manufacturing capacity improves. Q: In the past, you've guided towards revenue of at least $10.5 million. The press release says between $9.2 million and $10.5 million. Is that just based on how fast you can get products made and shipped?A: Dave Rosa (CEO) confirmed that the revised guidance range is entirely due to manufacturing constraints. While total orders for the fiscal year are expected to be approximately $11.2 million, the company believes it is unlikely to recognize all of that revenue due to vendor delivery risks. The $9.2 million to $10.5 million range reflects a more conservative estimate based on feedback from multiple suppliers and built-in risk factors. Q: Do you have any data or KPIs regarding new accounts versus utilization in pre-existing accounts for the 1RF ablation device?A: Dave Rosa (CEO) stated that contractually, the company does not have the right to receive detailed account-level data from Zimmer Biomet. He noted that Zimmer, like other companies, keeps such information close to the vest to avoid revealing competitive intelligence. However, anecdotal discussions with Zimmer indicate they are continuing to gain additional traction, though no hard numbers were provided. Q: Can you talk about the study at University of Minnesota for epilepsy? Is it focal or general epilepsy, and what is the size and timeline?A: Dave Rosa (CEO) explained that the University of Minnesota collaboration pertains to focal epilepsy. The first step is preclinical testing of the therapy they've developed, which is expected to occur in the next quarter. If the preclinical work shows efficacy, they would then progress to a Phase 1 study in patients. The immediate focus is on completing the animal studies first. Q: Could you talk about the ISO certification and give us a sense of some OUS potential opportunities for 1RF as far as distributors and territories?A: Dave Rosa (CEO) explained that ISO certification is the key to shipping products internationally. Different geographies have varying requirementssome recognize FDA clearance, others require documentation of quality systems, and Europe may require clinical data. Zimmer Biomet has certain international geographies under their agreement and is assessing which to prioritize. For geographies exclusive to NeuroOne, the company is evaluating economics and potential distributors. A firm answer is expected next quarter after discussions with Zimmer. Q: Regarding the Stereo CED platform, can you provide more detail on the preclinical collaborations and expected timeline for data?A: David Wambecke (Chief Business Officer) highlighted collaborations with the University of Minnesota in epilepsy and Mayo Clinic in diffuse midline glioma. The first animal studies are scheduled to begin this month, with data expected from both programs this fall to support future clinical development. He also noted the company expects its first device sales to a pharmaceutical company for a non-human primate study later this year, and anticipates the platform will be ready for investigational human clinical studies by the end of September. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Revenue growth of 16% was driven by strong demand for the OneRF Brain Ablation System, though recognized revenue was constrained by manufacturing lead times. Gross margins expanded to 59.9% due to a favorable product mix, reflecting the company's focus on higher-margin disposable components. The receipt of ISO 13485 certification serves as a critical strategic gateway, enabling the company to enter international markets with its diagnostic and ablation product lines. Management attributed the current order backlog to 6-month supplier lead times and shifts in product mix that exceeded existing manufacturing flexibility. The StereoCED platform is positioned to address the 'commercial risk' of complex neurosurgical workflows by leveraging existing hospital equipment and robotic-assisted multi-trajectory delivery. Strategic focus for the Trigeminal Nerve Ablation System involves a hybrid commercialization model using internal personnel and independent distributors to target 30 high-volume centers. Clinical validation was bolstered by a Mayo Clinic study confirming that OneRF procedures can be performed safely in patients with existing neuromodulation implants, expanding the addressable patient pool. Fiscal 2026 recognized revenue guidance of $9.2 million to $10.5 million is contingent on the timing of shipments and supplier ability to meet the $11.2 million order demand. Qualification of a second, larger manufacturing site is expected to go online in early 2027 to increase capacity, reduce lead times, and improve responsiveness to product mix changes. The company anticipates submitting a 510(k) for the Basivertebral Nerve Ablation (BVNA) system in the second half of calendar 2027, leveraging the existing OneRF generator infrastructure. StereoCED is projected to be ready for investigational human clinical studies by late September 2026, with initial device sales to pharmaceutical partners expected later this year. International expansion strategy involves collaborating with Zimmer Biomet for specific geographies while exploring independent partnerships for territories where NeuroOne retains exclusivity. A 1-for-6 reverse stock split was implemented in April 2026 to maintain compliance and adjust the company's capital structure. The company utilized its at-the-market (ATM) offering program twice in 2026, raising $1.4 million total to support working capital requirements. Lead investor holdings increased from 7.4% to 12.5% following the quarter, signaling strengthened internal support despite market volatility. Manufacturing concentration risk is being addressed through the second site qualification to mitigate the impact of the current 6-month lead time bottleneck. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management explained that the backlog stems from 6-month lead times and build-to-order constraints that make responding to small product mix changes inefficient. The second manufacturing site, expected in early 2027, will be significantly larger and is the primary strategy for addressing long-term capacity issues without sacrificing margins. ISO certification allows for immediate registration in geographies that recognize FDA clearance, while others like Europe will require additional clinical data. NeuroOne will meet with Zimmer Biomet next quarter to finalize which international territories the partner will target first versus which ones NeuroOne will manage independently. Management noted that while pharmaceutical companies rarely switch delivery devices mid-trial (Phase II/III), StereoCED is being positioned for new preclinical starts and as a post-approval 510(k) bridge for existing therapies. The platform aims to solve the '8 to 12 hour' procedure time bottleneck currently associated with brain-delivered therapeutics. Management clarified that using independent distributors for Trigeminal Neuralgia does not indicate a lack of interest from Zimmer Biomet; rather, it allows NeuroOne to move forward while Zimmer focuses on the larger Brain Ablation opportunity. Current Trigeminal sales have been intentionally limited to prioritize manufacturing capacity for the higher-volume OneRF Brain Ablation orders.

$2.7 Million in Product Orders Outpace Shipments of $2.0 Million Company Has Received Product Orders for Fiscal Year 2026 of $11.2 Million; Working with Suppliers to Maximize Product Shipments Through End of Fiscal Year Received ISO 13485 Certification Ahead of Schedule; International Expansion Planned StereoCED(TM) Drug Delivery System Expected to be Available for Research and Investigational Clinical Studies by the End of Fiscal Year 2026 Management to Host Conference Call at 8:30 a.m. Eastern Time Today EDEN PRAIRIE, MINN. - August 13, 2026 (NEWMEDIAWIRE) - NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) ("NeuroOne" or the "Company"), a medical technology company dedicated to transforming the surgical diagnosis and treatment of neurological disorders, has reported financial results and provided a business update for the third quarter of fiscal year 2026 ended June 30, 2026. FY Q3 2026 Financial Highlights Product revenue increased 16% to $2.0 million, compared to $1.7 million in the same year-ago period. The Company received $2.7 million of new product orders to ship during the quarter, representing 43% growth in product orders year over year. Product orders exceeded recognized revenue during the quarter with backlog of $1.7 million as of June 30, 2026. The Company has received product orders of $11.2 million for fiscal year 2026. Recognized revenue is expected to range from $9.2 million to $10.5 million depending primarily on manufacturing completion and timing of shipments, with any unshipped orders contributing to backlog. The Company is working closely with manufacturing partners to maximize shipments. Product gross profit increased 29% to $1.2 million, compared to $0.9 million in the same year-ago quarter. Product gross margins increased to 59.9%, compared to 53.9% in the same year-ago quarter. Subsequent to quarter end, our lead investor increased ownership of NeuroOne's outstanding common stock from 7.4% to 12.5%. Recent Operational Highlights The Company received ISO 13485:2016 Certification enabling the Company to commercialize across different countries. Geographies may have additional requirements to gain commercial access, although this is a major achievement signaling that the Company follows an internationally recognized quality management system that will provide near term commercial opportunities to help grow product revenues. The Journal of Neurosurgery published an article by the Mayo Clinic in Jacksonville, Florida titled, "Stereo-electroencephalography–guided radiofrequency thermocoagulation in patients with implanted neuromodulation devices: patient series" which evaluated the use of NeuroOne's OneRF(R) 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 expands the pool of treatable patients to include those with existing neuromodulation implants. NeuroOne expects its StereoCED(TM) platform to be available by the end of fiscal year 2026 for animal research and FDA IDE approved studies. In advance of this, the Company released a breakthrough white paper titled "StereoCED(TM) - A Scalable Platform for CNS Drug Delivery" – highlighting how its drug delivery platform leverages robotic stereotactic systems already established in neurosurgical operating rooms and has the potential to significantly reduce procedure time while addressing key barriers to the scalable commercial delivery of brain therapeutics. The white paper comes at a pivotal time, as the first potential blockbuster intraparenchymal brain-delivered therapy could receive FDA approval as early as 2027. Expanded drug delivery program through collaboration with Mayo Clinic supporting a newly funded research program by CURE Childhood Cancer to evaluate a novel treatment approach for pediatric diffuse midline glioma (DMG), one of the most aggressive and difficult-to-treat childhood brain cancers. The study will utilize NeuroOne's StereoCED(TM) drug delivery platform, which combines precision intracranial drug delivery with a simultaneous neural recording, offering investigators additional insight into both drug delivery and the effects on the surrounding neural environment. Advanced brain drug delivery platform through collaboration with University of Minnesota to advance a study evaluating next-generation epilepsy therapies using NeuroOne's StereoCED(TM) drug delivery platform. The study is designed to test novel therapeutics delivered locally into specific brain regions involved in sustaining seizures with the goal of improving clinical efficacy and lowering systemic toxicity and off-target effects. Advanced discussions underway with a tier-one potential strategic partner to develop and supply the access tools for our basivertebral nerve ablation system to treat lower back pain. The Company was added to the Russell Microcap Index as part of the semi-annual June 2026 reconstitution of the Russell US Indexes. Management Commentary "This quarter marked another period of revenue growth compared to 2025, with product revenue increasing 16% year-over-year to $2.0 million," said Dave Rosa, CEO of NeuroOne. "Importantly, this growth is improving margins – product gross margins reached a record 59.9%, driven by a 29% increase in product gross profit to $1.2 million compared to the prior year period. Even more encouraging is that new product orders of $2.7 million during the quarter meaningfully outpaced revenue recognized during the quarter, growing our backlog to $1.7 million. "Looking at the rest of the fiscal year, there's a lot to be excited about: the launch of our StereoCED(TM) drug delivery platform for investigational and animal studies, continued growth of the OneRF(R) Brain Ablation System, onboarding independent distributor reps for the OneRF(R) Trigeminal Nerve Ablation System, selecting a partner for our basivertebral nerve ablation access tools, and planning for international expansion. In total, we continue to make meaningful progress with our technology platform across all verticals while adding to the patient success stories for those who are treated with our technology. This is our driving motivation." Summary of NeuroOne Therapies OneRF(R) Trigeminal Nerve Ablation System: Scheduling evaluations at new centers based on interest generated at the American Society for Stereotactic and Functional Neurosurgery Biennial Meeting this past June. Interviewed distributors to expand commercialization efforts to support a direct regional sales distribution model. SteroeCED(TM) Drug Delivery Program: White paper released discussing potential benefits of the system. Preparing for launch of animal research studies and FDA approved IDE gene and/or cell therapies by the end of fiscal year 2026. Selected by the Mayo Clinic in Rochester, Minnesota to supply devices for a study to treat a form of pediatric glioblastomas (brain tumors). Selected by the University of Minnesota to supply devices for a study to treat drug resistant epilepsy. Basivertebral Nerve Ablation: Regulatory strategy complete; expected FDA 510(k) pathway. In discussions with potential partner to develop access tools for system. Device optimization for target lesion size in process. OneRF(R) Ablation System in the Brain: ISO 13485 certification received in August 2026. This will allow the Company to selectively target international markets. Expect to enroll first patient by the end of September for the brain ablation post-market registry, with five centers currently participating. The Journal of Neurosurgery published an article by the Mayo Clinic in Jacksonville, Florida titled: "Stereo-electroencephalography–guided radiofrequency thermocoagulation in patients with implanted neuromodulation devices: patient series" which evaluated the use of NeuroOne's OneRF(R) Brain Ablation System in patients who have implanted neuromodulation devices. Third Quarter Fiscal 2026 Financial Results Product revenue increased to $2.0 million in the third quarter of fiscal 2026, a 16% increase compared to $1.7 million in the same year-ago quarter. The increase was primarily driven by higher sales of OneRF(R) Products. Product gross profit increased 29% to $1.2 million, driving a product gross margin expansion to a record 59.9% in the third quarter of fiscal 2026, compared to $0.9 million, or 53.9%, in the same year-ago quarter. This 6.0 percentage point increase reflects 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 year-ago quarter. Selling, General & Administrative expenses were $2.2 million, compared to $1.6 million as a result of increased headcount, sales and marketing costs, professional fees and other operating costs in the same year-ago quarter. Research & Development expenses were $1.4 million, compared to $1.2 million in the same year-ago quarter, reflecting the timing of product development activities. 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 net loss of $1.5 million, or ($0.19) per basic share and ($0.19) per diluted share, in the prior-year quarter. As of June 30, 2026, cash and cash equivalents totaled $2.0 million, compared to $6.6 million as of September 30, 2025. Accounts receivable were $1.1 million as of June 30, 2026, compared to $1.3 million as of September 30, 2025, and inventory, net was $2.3 million as of June 30, 2026, compared to $2.2 million as of September 30, 2025. During the third quarter of fiscal 2026, the Company raised $0.4 million through its at-the-market offering program. Through June 30, 2026, the Company raised gross proceeds of $8.4 million under the at-the-market ("ATM") 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. The Company had no debt outstanding as of June 30, 2026. All share and per share amounts in this release have been retroactively adjusted to reflect the one-for-six 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. Conference Call and Webcast Management will host an investor conference call and webcast today, Thursday, August 13, 2026, at 8:30 a.m. Eastern time to discuss the Company's fiscal third quarter 2026 financial results, provide a corporate update, and conclude with Q&A from telephone participants. To participate, please use the following information: Date: Thursday, August 13, 2026 Time: 8:30 a.m. Eastern time U.S. Dial-In (Toll Free): 888-506-0062 International Dial-In: 973-528-0011 Participant Access Code: 549778 Webcast: NMTC FY Q3 2026 Earnings Call Webcast Please join at least five minutes before the start of the call to ensure timely participation. A playback of the call will be available through Thursday, August 27, 2026. To listen to the replay, please call 877-481-4010 within the United States or 919-882-2331 when calling internationally, using replay passcode 54304. A webcast replay will also be available using the webcast link above through August 13, 2027. About NeuroOne NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) is a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders. NeuroOne markets a minimally invasive and high-definition/high-precision electrode technology platform with four FDA-cleared product families: Evo(R) Cortical Electrodes, Evo(R) sEEG Electrodes, OneRF(R) Ablation System (for brain), and OneRF(R) Trigeminal Nerve Ablation System. These solutions offer the potential to reduce the number of hospitalizations and surgical procedures, lower costs, and improve patient outcomes by offering diagnostic and therapeutic functions. The Company is engaged in research and development for drug delivery, basivertebral nerve ablation and spinal cord stimulation programs. For more information, please visit nmtc1.com. Forward Looking Statements This press release may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for statements of historical fact, any information contained in this press release may be a forward looking statement that reflects NeuroOne's current views about future events and are subject to known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward looking statements by the words or phrases "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "forecasts," "objective," "anticipate," "believe," "estimate," "predict," "project," "potential," "target," "seek," "contemplate," "continue, "focused on," "committed to" and "ongoing," or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward looking statements may include statements regarding the potential sales of the StereoCEDTM drug delivery platform in investigational clinical studies or animals in Q4 fiscal 2026, 2026 guidance, the collaborations with the University of Minnesota and other companies, our ability to expand internationally, our ability to ship back-ordered product, our ability to expand the sales of our OneRF(R) Trigeminal Nerve Ablation System, our and the Company's ability to expand revenue. Although NeuroOne believes that we have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. Our actual future results may be materially different from what we expect due to factors largely outside our control, including risks related to whether the Company will continue to maintain compliance with all Nasdaq continued listing requirements, risks that our strategic partnerships may not facilitate the commercialization or market acceptance of our technology whether due to supply chain disruptions, labor shortages or otherwise risks that our technology will not perform as expected based on results of our pre-clinical and clinical trials risks related to uncertainties associated with the Company's capital requirements to achieve its business objectives and ability to raise additional funds: the risk that we may not be able to secure or retain coverage or adequate reimbursement for our technology uncertainties inherent in the development process of our technology risks related to changes in regulatory requirements or decisions of regulatory authorities that we may not have accurately estimated the size and growth potential of the markets for our technology risks related to clinical trial patient enrollment and the results of clinical trials that we may be unable to protect our intellectual property rights and other risks, uncertainties and assumptions, including those described under the heading "Risk Factors" in our filings with the Securities and Exchange Commission. These forward looking statements speak only as of the date of this press release and NeuroOne undertakes no obligation to revise or update any forward looking statements for any reason, even if new information becomes available in the future. Caution: Federal law restricts this device to sale by or on the order of a physician. * Disclaimer: This recounts several patients' experiences and may not be representative of all patient outcomes. IR ContactMZ Group – MZ North [email protected] NeuroOne Medical Technologies CorporationCondensed Balance Sheets View the original release on www.newmediawire.com

White Paper Highlights How StereoCED(TM) is Designed to Address Key Barriers to the Scalable Commercial Delivery of Brain Therapeutics Through a Streamlined Robotic-Assisted Workflow Device Availability for Research and Investigational Clinical Studies Expected by Fiscal Year-End EDEN PRAIRIE, MINN. - July 30, 2026 (NEWMEDIAWIRE) - NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) ("NeuroOne" or the "Company"), a medical technology company dedicated to transforming the surgical diagnosis and treatment of neurological disorders, today announced the release of a new white paper titled "StereoCED(TM) - A Scalable Platform for CNS Drug Delivery". The white paper can be downloaded from the Scientific Resources section of www.nmtc1.com or, click here. The white paper highlights how advances in cell and gene therapies, biologics, and other central nervous system (CNS) therapeutics are increasing the demand for efficient, reproducible methods of delivering therapies directly to the brain. While convection-enhanced delivery (CED) has demonstrated the ability to bypass the blood-brain barrier and achieve targeted drug distribution, many current approaches may present challenges as therapies expand into broader commercial use. The StereoCED(TM) drug delivery platform is being designed to address these challenges by leveraging robotic stereotactic systems already established in neurosurgical operating rooms. Rather than requiring specialized workflows and lengthy sequential infusions, the platform is being designed to support simultaneous, multi-trajectory intracranial drug delivery through a streamlined robotic workflow. This approach has the potential to significantly reduce procedure time while enabling reproducible, scalable therapeutic delivery. The StereoCED(TM) drug delivery platform is currently under development and has not been cleared or approved by the U.S. Food and Drug Administration for commercialization. "Brain-delivered therapeutics are approaching an important inflection point," said Dave Rosa, President and Chief Executive Officer of NeuroOne. "As these therapies move toward commercialization, certain intracranial infusion procedures lasting 8 to 12 hours may become a significant bottleneck to commercial adoption. We believe healthcare systems will need solutions that leverage established neurosurgical workflows, significantly reduce procedure time, and support scalable delivery across hospitals. StereoCED(TM) is being designed with those needs in mind, and we look forward to device availability for research and investigational clinical studies by fiscal year-end." About NeuroOne NeuroOne Medical Technologies Corporation is a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders. NeuroOne markets a minimally invasive and high-definition/high-precision electrode technology platform with four FDA-cleared product families: Evo(R) Cortical Electrodes, Evo(R) sEEG Electrodes, OneRF(R) Ablation System (for brain), and OneRF(R) Trigeminal Nerve Ablation System. These solutions offer the potential to reduce the number of hospitalizations and surgical procedures, lower costs, and improve patient outcomes by offering diagnostic and therapeutic functions. The Company is engaged in research and development for drug delivery, basivertebral nerve ablation and spinal cord stimulation programs. For more information, visit nmtc1.com. Forward Looking Statements This press release may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for statements of historical fact, any information contained in this press release may be a forward–looking statement that reflects NeuroOne's current views about future events and are subject to known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward–looking statements by the words or phrases "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "objective," "anticipate," "believe," "estimate," "predict," "project," "potential," "target," "seek," "contemplate," "continue, "focused on," "committed to" and "ongoing," or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward–looking statements may include statements regarding the development of the StereoCED(TM) Drug Delivery Platform, including the potential for it to be available at fiscal year-end, its ability to support simultaneous, multi-trajectory intracranial drug delivery through a streamlined robotic workflow, and potential to significantly reduce procedure time while enabling reproducible, scalable therapeutic delivery. Although NeuroOne believes that we have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. Our actual future results may be materially different from what we expect due to factors largely outside our control, including risks that the StereoCED(TM) Drug Delivery Platform may not receive any regulatory clearance or approval, or achieve its design goals, our partnerships may not facilitate the commercialization or market acceptance of our technology; whether due to supply chain disruptions, labor shortages, risks that our technology will not perform as expected based on results of our pre-clinical and clinical trials; risks related to uncertainties associated with the Company's capital requirements to achieve its business objectives and ability to raise additional funds: the risk that we may not be able to secure or retain coverage or adequate reimbursement for our technology; uncertainties inherent in the development process of our technology; risks related to changes in regulatory requirements or decisions of regulatory authorities; that we may not have accurately estimated the size and growth potential of the markets for our technology; risks related to our ability to protect our intellectual property rights; and other risks, uncertainties and assumptions, including those described under the heading "Risk Factors" in our filings with the Securities and Exchange Commission. These forward–looking statements speak only as of the date of this press release and NeuroOne undertakes no obligation to revise or update any forward–looking statements for any reason, even if new information becomes available in the future. IR ContactMZ Group – MZ North [email protected]

Ongoing Business Not Affected, Company Reaffirms Product Revenue Guidance of at Least $10.5 Million for Fiscal Year 2026 Customer Order Modification at Quarter-End Resulted in Revenue Overstatement of Approximately $0.5 Million and Net Loss Understatement of Approximately $0.3 Million; No Prior Periods Impacted EDEN PRAIRIE, MINN. - May 22, 2026 (NEWMEDIAWIRE) - NeuroOne Medical Technologies Corporation (Nasdaq: NMTC), a medical technology company dedicated to transforming the surgical diagnosis and treatment of neurological disorders, today announced that it plans to amend and restate its financial statements included in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed on May 12, 2026 (the "Form 10-Q"). During a post-release review process, on May 18, 2026, management identified an error in revenue recognition that was attributed to a customer order modification on product shipment at the end of the quarter. The restatement does not affect the Company's product revenue guidance for fiscal year 2026, its cash position as of March 31, 2026, or continued business activities or growth plans. "This one-time correction does not change our revenue projections for the year," said Dave Rosa, CEO of NeuroOne. "Our operations remain strong, our growth strategy is unchanged, and we continue to anticipate product revenue for fiscal 2026 of at least $10.5 million." The restatement corrects a one-time revenue overstatement of approximately $0.5 million against initially reported revenue of $2.4 million for the quarter. This adjustment was driven by a customer modification to certain purchase orders and related shipping documents at the end of the quarter, which inadvertently resulted in the overstatement of related revenue entries. As a result, gross profit was overstated by approximately $0.3 million and operating loss and net loss were understated by approximately $0.3 million for the three months ended March 31, 2026. No prior periods were impacted. The Company has initiated and will continue to implement measures designed to improve its internal controls over financial reporting. On May 21, 2026, the Audit Committee of the Board of Directors, after discussion with management, determined that the Company would restate its unaudited condensed financial statements included in the Form 10-Q, and amend its related disclosures making reference to those results. As a result, the Company's Form 10-Q, and other documents referencing those results should no longer be relied upon. The Company intends to file an amendment to the Form 10-Q in the next few weeks. The estimates provided in this release reflect preliminary information based on facts available to the Company's management as of the date of this release and is subject to potential further changes upon completion of the Company's financial review and restatement procedures. About NeuroOne NeuroOne Medical Technologies Corporation is a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders. NeuroOne markets a minimally invasive and high-definition/high-precision electrode technology platform with four FDA-cleared product families: Evo(R) Cortical Electrodes, Evo(R) sEEG Electrodes, OneRF(R) Ablation System (for brain), and OneRF(R) Trigeminal Nerve Ablation System. These solutions offer the potential to reduce the number of hospitalizations and surgical procedures, lower costs, and improve patient outcomes by offering diagnostic and therapeutic functions. The Company is engaged in research and development for drug delivery, basivertebral nerve ablation and spinal cord stimulation programs. For more information, visit nmtc1.com. Forward-Looking Statements This press release may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for statements of historical fact, any information contained in this press release may be a forward looking statement that reflects NeuroOne's current views about future events and are subject to known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward looking statements by the words or phrases "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "forecasts," "objective," "anticipate," "believe," "estimate," "predict," "project," "potential," "target," "seek," "contemplate," "continue, "focused on," "committed to" and "ongoing," or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward looking statements may include statements regarding the Company's future financial results, including its 2026 revenue guidance, the Company's growth strategies and pipeline, the Company's intention to amend and restate the financial statements in the Form 10-Q, and the expected timing of filing the amendment to the Form 10-Q. Although NeuroOne believes that we have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. Our actual future results may be materially different from what we expect due to factors largely outside our control, including risks related to whether the Company will continue to maintain compliance with all Nasdaq continued listing requirements, risks that our strategic partnerships may not facilitate the commercialization or market acceptance of our technology whether due to supply chain disruptions, labor shortages or otherwise risks that our technology will not perform as expected based on results of our pre-clinical and clinical trials risks related to uncertainties associated with the Company's capital requirements to achieve its business objectives and ability to raise additional funds: the risk that we may not be able to secure or retain coverage or adequate reimbursement for our technology uncertainties inherent in the development process of our technology risks related to changes in regulatory requirements or decisions of regulatory authorities that we may not have accurately estimated the size and growth potential of the markets for our technology risks related to clinical trial patient enrollment and the results of clinical trials that we may be unable to protect our intellectual property rights and other risks, uncertainties and assumptions, including those described under the heading "Risk Factors" in our filings with the Securities and Exchange Commission. These forward looking statements speak only as of the date of this press release and NeuroOne undertakes no obligation to revise or update any forward looking statements for any reason, even if new information becomes available in the future. IR ContactMZ Group MZ North [email protected] View the original release on www.newmediawire.com

This article first appeared on GuruFocus. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Product revenue for the 1RF brain ablation system grew 72% year-over-year to $2.4 million. NeuroOne Medical Technologies Corp (NASDAQ:NMTC) regained compliance with Nasdaq's minimum bid price requirement. The company completed the Stage 2 audit for ISO 13,485 certification, paving the way for international distribution. The 1RF trigeminal nerve ablation system has shown clinical success, with all patients reportedly pain-free after procedures. NeuroOne Medical Technologies Corp (NASDAQ:NMTC) announced a collaboration with the University of Minnesota Medical School to advance epilepsy therapies using their drug delivery platform. The company had no license revenue in the second quarter or first six months of fiscal 2026, compared to $3 million in the first six months of fiscal 2025. Product gross profit margin decreased to 53.8% from 55.6% in the same quarter of the prior fiscal year. Net loss in the second quarter of fiscal 2026 was $2.1 million, compared to a net loss of $2.3 million in the same quarter of the prior year. Cash and cash equivalents decreased to $2.8 million as of March 31, 2026, from $6.6 million as of September 30, 2025. The company has not yet finalized a commercialization strategy for its drug delivery program, which is expected to be available in the latter half of fiscal 2026. Warning! GuruFocus has detected 2 Warning Sign with NMTC. Is NMTC fairly valued? Test your thesis with our free DCF calculator. Q: Could you provide an update on the drug delivery program's timing and strategy, and explain the role of distributors in this process? A: (Dave Rosa, CEO) We are finalizing sterilization, testing, and packaging, which should take about three months. Once completed, the product will be ready for animal use and approved human IDE studies. Since we lack a direct sales force, we plan to use distributors to commercialize the technology, especially for animal use. We have also partnered with the University of Minnesota for testing therapies, and expect more collaborations in the future. Q: How has the commercialization strategy for the 1RF trigeminal nerve ablation system evolved, and are you seeing consistent scheduling trends for procedures? A: (Dave Rosa, CEO) The strategy remains unchanged; we plan to partner with another company while continuing to open centers ourselves. Scheduling for these procedures is easier compared to brain ablations, as patients know they are getting an ablation, allowing neurosurgeons to stack cases in a day. Q: Does the guidance for 2026 product revenue remain at $10.5 million, and does it include contributions from drug delivery or facial pain? A: (Dave Rosa, CEO) The guidance remains the same and does not include contributions from drug delivery or facial pain. We expect drug delivery commercialization late in the fiscal year, with no major contributions anticipated. Facial pain contributions depend on finalizing an agreement. Q: What is the international commercialization strategy, and will Zimmer be involved? A: (Dave Rosa, CEO) We plan to enter international markets with Zimmer, who has certain geographic rights. For regions not covered by Zimmer, we may partner with other distributors. We are currently working with Zimmer to finalize the initial target territories, focusing on regions accepting FDA clearance to avoid additional requirements. Q: How are you driving new physician adoption for the 1RF system for facial pain? A: (Dave Rosa, CEO) We target centers with existing generators, as the same surgeons perform both facial pain and brain ablation procedures. The system's advantages, such as single placement and patient comfort, are emphasized. We have completed 16 cases with all patients pain-free, which helps demonstrate the system's benefits to new sites. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Product Revenue of $2.4 Million up 72% Year Over Year Successfully Completed 16 Trigeminal Neuralgia Cases to Date, With All Patients Reportedly Pain Free* Management to Host Conference Call Today at 8:30 a.m. Eastern Time EDEN PRAIRIE, MINN. - May 12, 2026 (NEWMEDIAWIRE) - NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) ("NeuroOne" or the "Company"), a medical technology company dedicated to transforming the surgical diagnosis and treatment of neurological disorders, has reported financial results and a business update for the second quarter of fiscal year 2026 ended March 31, 2026. Company Highlights Product revenue was $2.4M for the quarter, a 72% increase versus product revenue of $1.4 million in the second quarter of fiscal 2025. To date, the Company successfully completed 16 cases using the OneRF(R) Trigeminal Nerve Ablation System for the treatment of facial pain known as trigeminal neuralgia, with all patients reportedly pain free after the procedure.* A new high-net-worth investor acquired approximately 7.4% of NeuroOne's outstanding common stock in the open market. David Wambeke appointed Chief Business Officer to lead NeuroOne's drug delivery program, oversee investor relations, and support business development. Mr. Wambeke also purchased 1,000,000 shares of NeuroOne common stock, pre-split. Targeted commercial availability of the Company's drug delivery system in the second half of fiscal 2026 for use in investigational clinical studies or animal studies, with final product builds underway. Successfully regained Nasdaq compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2), and the matter is closed. 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 NeuroOne's sEEG-based platform. Peer-reviewed case series was published supporting the use of NeuroOne's FDA-cleared OneRF Ablation System in existing stereotactic workflows, with bedside treatment capability and reported reductions in seizure burden in drug-resistant epilepsy patients.* Launched strategic initiative to secure a second manufacturing source, strengthening the Company's supply chain and expanding capacity to meet increased demand of future product introductions. Completed the stage 2 audit of the Company's Minnesota facility, advancing toward ISO 13485 certification. If received, ISO certification, combined with the necessary regulatory approvals in target geographies, is expected to enable international distribution of NeuroOne's products. Completed user design requirements for the basivertebral nerve ablation system; initiating animal studies to support continued development of the program. Presented at the North American Neuromodulation Society and the American Association of Neurological Surgeons. Management Commentary "This was a very productive quarter for NeuroOne. Product revenue grew 72% year-over-year, we continued to gain clinical experience with our OneRF Trigeminal Neuralgia Ablation System and have completed 16 procedures to date with all patients reportedly pain free. We continue to be optimistic regarding the advantages and clinical performance of the device for treating facial pain. We also had a peer-reviewed clinical publication validate what physicians using our platform have been telling us – that real-time temperature monitoring during sEEG-guided RF ablation is a meaningful clinical advantage for patients with drug resistant epilepsy. "At the same time, we executed on the strategic priorities we laid out at the start of the year. We completed our stage 2 ISO 13485 audit, paving the way for international expansion. We regained Nasdaq compliance, restructured our capital base through the reverse stock split, and added a highly experienced executive, David Wambeke, as Chief Business Officer. Also, effective July 1, Christopher Volker will assume the role as our next Chief Financial Officer. Together, these moves will help lead our next phase of growth. "Looking ahead, the catalysts are clear: continued expansion of our OneRF Brain Ablation and Trigeminal Neuralgia Ablation Systems, commercial launch of our drug delivery system in the second half of fiscal 2026 for use in investigational clinical studies or animal studies, continued progress in basivertebral nerve ablation and spinal cord stimulation, and an expanding international footprint as we make progress towards ISO 13485 certification. We are well-positioned for the future and I'm proud of what this team has built," concluded Dave Rosa, CEO of NeuroOne. Operational Highlights and Updates OneRF(R) Trigeminal Nerve Ablation System: Successfully completed sixteen cases to-date using the OneRF Trigeminal Nerve Ablation System, with all patients reportedly pain free.* Company was highlighted in The Business Research Company 4/24/26 report, which stated that emerging growth patterns are driving expansion in the trigeminal neuralgia market (valued at $780 million) to stereotactic surgery using technology similar to the OneRF Trigeminal Neuralgia Ablation System. sEEG-Based Drug Delivery Program: Documentation and final device builds in process to ensure availability for use in investigational clinical studies or animals in second half of fiscal 2026. Working with the University of Minnesota to provide devices for animal and human IDE studies. Focused on glioblastomas (brain tumors), gene and cell-based therapies for brain related disorders. Evaluating distributors for commercial distribution. Basi-Vertebral Nerve Ablation Completed user requirements for the Basi-vertebral nerve ablation system. Strategy remains to leverage OneRF(R) generator, temperature probe, and ablation electrode while outsourcing access tools either through outside vendors or potential distribution partners. Pre-clinical testing initiated. OneRF(R) Ablation System in the Brain: Successfully completed stage 2 audit on ISO 13485 certification for Outside the U.S. ("OUS") distribution and remain bullish on certification in latter part of 2026. This will allow us to ship product outside the U.S. into geographies that recognize FDA clearance. Pipeline of centers waiting for hospital approval to begin trialing the system. Developing webinar to gain additional exposure with neurologists and neurosurgeons that will highlight clinical experience with the device along with patient interview. Reported clinical outcomes remain positive with respect to reduction or elimination in patient seizures. The OneRF brain ablation system was highlighted at Zimmer Biomet's booth at the recent AANS meeting in San Antonio, Texas as well as in presentations on the technology. Spinal Cord Stimulation (SCS) Percutaneous Paddle Lead Program: Concluded chronic animal study and will implement changes based on study results. System was displayed at the NANS annual meeting. Second Quarter Fiscal 2026 Financial Results 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 six 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 six months of fiscal 2026, compared to license revenue of $3.0 million in the first six months of fiscal 2025, which was derived from the expanded exclusive distribution agreement with Zimmer. 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 six 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 & Development (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 & Administrative (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 six 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 six months of fiscal 2026 were $2.9 million, compared to $2.7 million in the same period of fiscal 2025. SG&A expense in the first six 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 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 six 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 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 six months of fiscal 2025 reflected $3.0 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. The Company had no debt outstanding as of March 31, 2026. Conference Call and Webcast Management will host an investor conference call and webcast today, Tuesday, May 12, 2026, at 8:30 a.m. Eastern time to discuss the Company's fiscal second quarter 2026 financial results, provide a corporate update, and conclude with Q&A from telephone participants. To participate, please use the following information: Date: Tuesday, May 12, 2026 Time: 8:30 a.m. Eastern time U.S. Dial-In (Toll Free): 888-506-0062 International Dial-In: 973-528-0011 Participant Access Code: 224785 Webcast: https://www.webcaster5.com/Webcast/Page/2821/53948 Please join at least five minutes before the start of the call to ensure timely participation. A playback of the call will be available through Tuesday, May 26, 2026. To listen to the replay, please call 877-481-4010 within the United States or 919-882-2331 when calling internationally, using replay passcode 53948. A webcast replay will also be available using the webcast link above through Wednesday, May 12, 2027. About NeuroOne NeuroOne Medical Technologies Corporation is a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders. NeuroOne markets a minimally invasive and high-definition/high-precision electrode technology platform with four FDA-cleared product families: Evo(R) Cortical Electrodes, Evo(R) sEEG Electrodes, OneRF(R) Ablation System (for brain), and OneRF(R) Trigeminal Nerve Ablation System. These solutions offer the potential to reduce the number of hospitalizations and surgical procedures, lower costs, and improve patient outcomes by offering diagnostic and therapeutic functions. The Company is engaged in research and development for drug delivery, basivertebral nerve ablation and spinal cord stimulation programs. For more information, visit nmtc1.com. Forward Looking Statements This press release may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for statements of historical fact, any information contained in this press release may be a forward looking statement that reflects NeuroOne's current views about future events and are subject to known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward looking statements by the words or phrases "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "forecasts," "objective," "anticipate," "believe," "estimate," "predict," "project," "potential," "target," "seek," "contemplate," "continue, "focused on," "committed to" and "ongoing," or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward looking statements may include statements regarding the potential sales of the sEEG-Based Drug Delivery system in investigational clinical studies or animals in Q3 fiscal 2026, the collaborations with the University of Minnesota and other companies, our ability to obtain ISO 13485 or other regulatory approvals and expand internationally, the collection of accounts receivables, our ability to expand the sales of our OneRF Trigeminal Nerve Ablation System, our and the Company's ability to expand revenue. Although NeuroOne believes that we have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. Our actual future results may be materially different from what we expect due to factors largely outside our control, including risks related to whether the Company will continue to maintain compliance with all Nasdaq continued listing requirements, risks that our strategic partnerships may not facilitate the commercialization or market acceptance of our technology whether due to supply chain disruptions, labor shortages or otherwise risks that our technology will not perform as expected based on results of our pre-clinical and clinical trials risks related to uncertainties associated with the Company's capital requirements to achieve its business objectives and ability to raise additional funds: the risk that we may not be able to secure or retain coverage or adequate reimbursement for our technology uncertainties inherent in the development process of our technology risks related to changes in regulatory requirements or decisions of regulatory authorities that we may not have accurately estimated the size and growth potential of the markets for our technology risks related to clinical trial patient enrollment and the results of clinical trials that we may be unable to protect our intellectual property rights and other risks, uncertainties and assumptions, including those described under the heading "Risk Factors" in our filings with the Securities and Exchange Commission. These forward looking statements speak only as of the date of this press release and NeuroOne undertakes no obligation to revise or update any forward looking statements for any reason, even if new information becomes available in the future. Caution: Federal law restricts this device to sale by or on the order of a physician. * Disclaimer: This recounts several patients' experiences and may not be representative of all patient outcomes. IR Contact MZ Group – MZ North America [email protected] NeuroOne Medical Technologies Corporation Condensed Balance Sheets (Unaudited) NeuroOne Medical Technologies Corporation Condensed Statements of Operations (unaudited) View the original release on www.newmediawire.com