Q3 2026 Neuroone Medical Technologies Corp Earnings Call

Speaker #1: Good day, ladies and gentlemen. And welcome to the NEUROONE MEDICAL TECHNOLOGIES Corp Q4 F2026 financial results conference call. Today's call will be conducted by the companies' chief executive officer, Dave Rosa, Chris Volker, the companies' chief financial officer, and Dave Wambeck, the company's chief business officer.

Operator: Good day, ladies and gentlemen, and welcome to the NeuroOne Medical Technologies Corporation's Q3 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 David Wambeke, 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 US 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.

Operator: Good day, ladies and gentlemen, and welcome to the NeuroOne Medical Technologies Corporation's Q3 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 Wambeke, 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 US 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.

Speaker #1: 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, events, trends, and performance, including our 2026 guidance, which are based on management's beliefs and assumptions as of today's call.

Speaker #1: 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.

Speaker #1: See NEUROONE's financial results press release and SEC filings for information regarding specific risks and uncertainties that could cause actual results to differ. Accept as required by law, NEUROONE undertakes no obligation to update such forward-looking statements.

Operator: 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.

Operator: 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.

Speaker #1: With that, I will turn the call over to Mr. Dave Rosa, CEO of NEUROONE. Sir, please go ahead.

Speaker #2: 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.

Dave Rosa: Thank you, operator, and thank you to everyone for joining us today. I would like to welcome you to our Q3 fiscal 2026 financial results conference call. Before I begin, I want to first welcome both Chris Voelker, the company's Chief Financial Officer, and David Wambeke, 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 Q3 of fiscal 2026 grew 16% year over year to $2 million, compared to $1.7 million in Q3 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.

Dave Rosa: Thank you, Operator, and thank you to everyone for joining us today. I would like to welcome you to our Q3 fiscal 2026 financial results conference call. Before I begin, I want to first welcome both Chris Voelker, the company's Chief Financial Officer, and David Wambeke, 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 Q3 of fiscal 2026 grew 16% year over year to $2 million, compared to $1.7 million in Q3 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.

Speaker #2: Before I begin, I want to first welcome both Chris Volker, the company's Chief Financial Officer, and David Wambeck, the company's Chief Business Officer, as both will be presenting for the first time in their respective roles.

Speaker #2: Now, let's get started with a brief financial summary of the quarter. Product revenue for the 1RF 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.

Speaker #2: 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 and $10.5 million, depending on the timing of shipment of those orders.

Dave Rosa: Recognized revenue for the fiscal year is expected to be between $9.2 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 Q4 calendar 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.

Dave Rosa: Recognized revenue for the fiscal year is expected to be between $9.2 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 Q4 calendar 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.

Speaker #2: We are working closely with our suppliers to expedite manufacturing, and order to address any remaining backlog by the end of the fourth calendar quarter of 2026.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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.

Dave Rosa: 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 Nerve 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.

Dave Rosa: 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 Nerve 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.

Speaker #2: I am very proud to announce that we received our certification recently, which now provides the opportunity to enter international markets with our 1RF Brain Ablation System, 1RF Trigeminal Neuralgia Ablation System, and EVO Cortical and SEEG Diagnostic Product Lines.

Speaker #2: We will be working closely with our distribution partners, Zimmer Biomet, to start the process to enter geographies that optimize their existing customer relationships and with a focus on countries that have favorable that remain exclusive to NEUROONE, we will explore independent partnerships.

Speaker #2: 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.

Dave Rosa: 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 have 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 product 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 "Stereo-electroencephalography-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.

Dave Rosa: 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 have 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 product 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 "Stereo-electroencephalography-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.

Speaker #2: Now, let's discuss the exciting progress we've made with our product portfolio. Regarding our 1RF Brain Ablation System, as I mentioned earlier, we experienced 16% year-over-year revenue growth for the quarter, while purchase orders for our product showed growth of 43% year-over-year.

Speaker #2: 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 1RF Brain Ablation System in patients who have implanted neuromodulation devices.

Speaker #2: 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.

Dave Rosa: 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.

Dave Rosa: 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.

Speaker #2: 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.

Speaker #2: Regarding our 1RF 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 1RF Trigeminal Nerve Ablation System was featured in a television interview on Cleveland 19 News, an affiliate of the CBS television network.

Speaker #2: 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.

Dave Rosa: 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. The US 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.

Dave Rosa: 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. The US 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.

Speaker #2: 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 and enhanced patient comfort while also having the potential to significantly reduce procedure times.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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 Wambeck to provide an update on our drug delivery system which we have named Stereo CED.

Dave Rosa: Now I am turning the call over to David Wambeck to provide an update on our drug delivery system, which we have named StereoCED.

Dave Rosa: Now I am turning the call over to David Wambeck to provide an update on our drug delivery system, which we have named StereoCED.

Speaker #3: Thanks, David. 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.

David Wambeke: 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 eight 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.

Dave Wambeke: 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 eight 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.

Speaker #3: 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.

Speaker #3: 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?

Speaker #3: 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.

Speaker #3: We believe those workflow challenges matter even more at commercial scale. That's exactly the future Stereo CED is designed for. Our robotic-assisted platform is intended to leverage neurosurgical equipment and workflows already established in leading hospitals.

David Wambeke: 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 would 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 three-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 USD 2 billion, but also highlight the commercial risk associated with a complex workflow and lengthy procedures that can take 8 to 12 hours.

Dave Wambeke: 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 would 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 three-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 USD 2 billion, but also highlight the commercial risk associated with a complex workflow and lengthy procedures that can take 8 to 12 hours.

Speaker #3: 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.

Speaker #3: Before discussing our progress, I'd like to highlight an important industry milestone. In June, the FDA reversed its earlier position allowing Unicure to submit an accelerated approval BLA or biologics license agreement for AMT130 in Huntington's disease based on its existing three-year clinical data.

Speaker #3: If approved, AMT130 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.

David Wambeke: 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 have 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 pre-clinical front, we have also made excellent progress. We have 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.

Dave Wambeke: 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 have 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 pre-clinical front, we have also made excellent progress. We have 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.

Speaker #3: publish a white paper highlighting the potential scalability of our Stereo CED platform. We anticipate that it will be ready for investigational human clinical studies by the end of September and possibly sooner for animal We were pleased to recently research.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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 non-human primate study later this year.

David Wambeke: In parallel, we are expanding our academic collaborations and expect our first device sales to a pharmaceutical company for a non-human primate study later this year. In closing, I believe we are 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 will now turn the call back over to Dave.

Dave Wambeke: In parallel, we are expanding our academic collaborations and expect our first device sales to a pharmaceutical company for a non-human primate study later this year. In closing, I believe we are 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 will now turn the call back over to Dave.

Speaker #3: 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.

Speaker #3: I'll now turn the call back over to David.

Speaker #2: Thanks, David. Before I provide an update on our BVNA or Basic Vertebral Nerve Ablation System for back pain, I just want to reiterate what I said last quarter with the hiring of David Wambeck.

Dave 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 Wambeke. 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 pre-clinical 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 reconfirmed that it is likely a 510(k) submission.

Dave 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 Wambeke. 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 pre-clinical 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 reconfirmed that it is likely a 510(k) submission.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: Our strategy remains to leverage our existing 1RF generator, temperature accessory, and ablation electrode while outsourcing access tools either through outside vendors or potential distribution partners.

Speaker #2: 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 1RF trigeminal nerve ablation system was approximately four months.

Dave Rosa: You may remember that the total time it took to gain clearance for our OneRF Trigeminal Nerve Ablation System was approximately four 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 Voelker to provide a review of our Q3 fiscal 2026 financial results.

Dave Rosa: You may remember that the total time it took to gain clearance for our OneRF Trigeminal Nerve Ablation System was approximately four 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 Voelker to provide a review of our Q3 fiscal 2026 financial results.

Speaker #2: Which is lightning speed in medical regulatory submissions. While there are no guarantees, we have experienced success with both of our 510(k) case submissions to the FDA and expect to submit this for FDA clearance in the second half of calendar 2027.

Speaker #2: 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.

Speaker #2: We believe these goals will also enhance shareholder value and appreciate the support we have received during the volatility in the world today. I would now like to turn the call over to Chris Volcker to provide a review of our third quarter fiscal 2026 financial results.

Speaker #4: 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.

Chris Volker: Thanks, Dave. Product revenue was $2.0 million in the Q3 of fiscal 2026, a 16% increase compared to product revenue of $1.7 million in the Q3 of fiscal 2025. The increase was driven by higher sales of OneRF products. The company received $2.7 million of 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 30 June 2026. Product gross profit was $1.2 million, or 59.9% of product revenue in the Q3 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.

Chris Volker: Thanks, Dave. Product revenue was $2.0 million in the Q3 of fiscal 2026, a 16% increase compared to product revenue of $1.7 million in the Q3 of fiscal 2025. The increase was driven by higher sales of OneRF products. The company received $2.7 million of 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 30 June 2026. Product gross profit was $1.2 million, or 59.9% of product revenue in the Q3 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.

Speaker #4: The increase was driven by higher sales of 1RF products. The company received $2.7 million of new product orders during the quarter, representing 43% year-over-year growth.

Speaker #4: 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.

Speaker #4: 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.

Chris Volker: Total operating expenses were $3.6 million in the Q3 of fiscal 2026, compared to $2.8 million in the same quarter of the prior year. Research and development expense in the Q3 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 Q3 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 Q3 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.

Chris Volker: Total operating expenses were $3.6 million in the Q3 of fiscal 2026, compared to $2.8 million in the same quarter of the prior year. Research and development expense in the Q3 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 Q3 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 Q3 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.

Speaker #4: 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.

Speaker #4: 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 an increase being driven by increased headcount and sales and marketing costs.

Speaker #4: 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.

Speaker #4: 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.

Chris Volker: The net loss in the Q3 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 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 16 April 2026. As of 30 June 2026, the company had cash and cash equivalents of $2.0 million, compared to $6.6 million as of 30 September 2025. The company also had $1.1 million in accounts receivable as of 30 June 2026, which should be converted to cash in the Q4 of fiscal 2026 based on normal collection patterns. During the Q3 of fiscal 2026, the company raised $0.4 million through its at-the-market offering program.

Chris Volker: The net loss in the Q3 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 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 16 April 2026. As of 30 June 2026, the company had cash and cash equivalents of $2.0 million, compared to $6.6 million as of 30 September 2025. The company also had $1.1 million in accounts receivable as of 30 June 2026, which should be converted to cash in the Q4 of fiscal 2026 based on normal collection patterns. During the Q3 of fiscal 2026, the company raised $0.4 million through its at-the-market offering program.

Speaker #4: 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.

Speaker #4: 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.

Speaker #4: 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 $400,000 $346 shares under the ATM program representing the second time in calendar 2026 the ATM was utilized.

Chris Volker: Subsequent to quarter end, on 13 July 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 30 June 2026, compared to working capital of $7.9 million as of 30 September 2025. NeuroOne had no debt outstanding as of 30 June 2026. I will now turn the call back to Dave for his closing remarks.

Chris Volker: Subsequent to quarter end, on 13 July 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 30 June 2026, compared to working capital of $7.9 million as of 30 September 2025. NeuroOne had no debt outstanding as of 30 June 2026. I will now turn the call back to Dave for his closing remarks.

Speaker #4: 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.

Speaker #4: NEUROONE had no debt outstanding as of June 30, 2026. I'll now turn the call back to Dave for his closing remarks.

Speaker #2: 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 to 59.9%, and received product orders of $2.7 million, representing an increase of 43%.

Dave 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 Nerve Ablation Systems in the US 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.

Dave 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 Nerve Ablation Systems in the US 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.

Speaker #2: Received ISO 13485 clearance paving the way for international revenue growth with selected by prestigious teaching institutions for upcoming animal and human studies and identified potential partners to accelerate the development of our BVNA system.

Speaker #2: Moving forward, the catalyst include continued commercial expansion of the 1RF brain ablation system and 1RF trigeminal neuralgia ablation systems in the US and internationally.

Speaker #2: 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.

Speaker #2: With that operator at this time, we can open up the call for questions.

Dave Rosa: With that, operator, at this time, we can open up the call for questions.

Dave Rosa: With that, operator, at this time, we can open up the call for questions.

Speaker #5: Thank you. Ladies and gentlemen, at this time, we'll be conducting our question and answer session. If you would like to ask a question, please press star one on your telephone keypad.

Operator: Thank you. Ladies and gentlemen, at this time, we will be conducting our question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue, and you may press star two if you wish to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Thank you. Our first question today is coming from Jeffrey Cohen with Ladenburg Thalmann. Your line is live.

Operator: Thank you. Ladies and gentlemen, at this time, we will be conducting our question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue, and you may press star two if you wish to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Thank you. Our first question today is coming from Jeffrey Cohen with Ladenburg Thalmann. Your line is live.

Speaker #5: A confirmation tone will indicate your line is in the question queue. You may press star two if you wish to remove your question from the queue.

Speaker #5: For participants using speaker equipment, they may be necessary to pick up your handset before pressing the star keys. One moment, please, while we pull for questions.

Speaker #5: Thank you. Our first question today is coming from Jeffrey Kohn with Ladenberg Thelman. Your line is live.

Jeffrey S. Cohen: Hey, good morning, and thank you for taking our questions. I guess, Percy, can we talk about that study at University of Minnesota for epilepsy? Could you give us a sense of, is that focal or general epilepsy that is being studied, and what the size of the study is, and what you would anticipate from a timeline perspective?

Jeffrey Cohen: Hey, good morning, and thank you for taking our questions. I guess, Percy, can we talk about that study at University of Minnesota for epilepsy? Could you give us a sense of, is that focal or general epilepsy that is being studied, and what the size of the study is, and what you would anticipate from a timeline perspective?

Speaker #6: Hey, good morning, and thank you for taking our questions. I guess, Mercy, can we talk about that study at the University of Minnesota for epilepsy?

Speaker #6: 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?

Speaker #3: Yeah. 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.

Dave Rosa: Yeah. Thanks for attending today, Jeff. Good to talk to you again. 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 have developed, and that will happen literally, expectedly, most likely in the next quarter. Then once they have been able to successfully complete the testing, and assuming that it is showing any efficacy, then they would look to go to phase I, where they would then start testing it in patients. But the preclinical work is going to be happening very shortly.

Dave Rosa: Yeah. Thanks for attending today, Jeff. Good to talk to you again. 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 have developed, and that will happen literally, expectedly, most likely in the next quarter. Then once they have been able to successfully complete the testing, and assuming that it is showing any efficacy, then they would look to go to phase I, where they would then start testing it in patients. But the preclinical work is going to be happening very shortly.

Speaker #3: 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 one where they would then start testing it in patients.

Speaker #3: But the preclinical work is going to be happening very shortly.

Speaker #6: 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?

Jeffrey S. Cohen: Okay. Got it. Then give us a sense of your supplier and backlog into Q4. Is it related to components, or it is related to labor? Then give us a sense of the second site that has come online. Do you expect to catch up with all the backlog during Q4 and balance of the year? Also, could you talk about some of the ex-US discussions you are having as far as distribution, at least in the case of OneRF?

Jeffrey Cohen: Okay. Got it. Then give us a sense of your supplier and backlog into Q4. Is it related to components, or it is related to labor? Then give us a sense of the second site that has come online. Do you expect to catch up with all the backlog during Q4 and balance of the year? Also, could you talk about some of the ex-US discussions you are having as far as distribution, at least in the case of OneRF?

Speaker #6: And then give us a sense of the second site that's come online. Will 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 XUS discussions you're having as far as distribution at least in the case of 1RF?

Dave Rosa: I could not hear the last part of what you said, but let me take the first big question, and then whatever I do not answer, just let me know. The supplier situation is the company has lead times, and the lead times can take as long as 6 months. So there is an ordering process that is 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.

Dave Rosa: I could not hear the last part of what you said, but let me take the first big question, and then whatever I do not answer, just let me know. The supplier situation is the company has lead times, and the lead times can take as long as 6 months. So there is an ordering process that is 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.

Speaker #3: I couldn't hear the last part of what you said. But let me take the first big question, and then for whatever I don't answer, just let me know.

Speaker #3: So the supplier situation is we the company has lead times and the lead times are roughly can take as long as six months. So there is an ordering process that's in place with Zimmer Biomed today where they give us orders in advance so that we can manufacture the product and then ship it to them on time.

Speaker #3: But we basically build the 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, so 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 timeframe is limited.

Dave Rosa: What happens is that if there is 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 timeframe is limited based on the way the ordering is done now. We have experienced less of that in the past, I would say more of that this year. There are a few ways of dealing with this. One is you carry inventory and work with your partner to make sure that it is 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 is what we are working on now. That is what we expect to go online in the first part of 2027.

Dave Rosa: What happens is that if there is 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 timeframe is limited based on the way the ordering is done now. We have experienced less of that in the past, I would say more of that this year. There are a few ways of dealing with this. One is you carry inventory and work with your partner to make sure that it is 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 is what we are working on now. That is what we expect to go online in the first part of 2027.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: So we're going through all the work to do that. And if you've got two facilities, capable of manufacturing product in the second one, is actually much larger than the one we use now.

Dave Rosa: We are going through all the work to do that, and if you have 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, would the company consider placing a one-time order for that difference? Then what happens if you do that is your gross margins obviously are impacted, and you are not able to take advantage of the economies of scale. We try to place big orders in, which has worked very well for us from a margin perspective. It makes it much more difficult if we are making small changes here and there. It is just not as efficient. What was the other question that I may not have answered?

Dave Rosa: We are going through all the work to do that, and if you have 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, would the company consider placing a one-time order for that difference? Then what happens if you do that is your gross margins obviously are impacted, and you are not able to take advantage of the economies of scale. We try to place big orders in, which has worked very well for us from a margin perspective. It makes it much more difficult if we are making small changes here and there. It is just not as efficient. What was the other question that I may not have answered?

Speaker #3: 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 one-time order for that difference?

Speaker #3: 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.

Speaker #3: So we try to place big orders in, which is 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.

Speaker #3: It's just not as efficient. So what was the other question that I may not have answered?

Speaker #6: Yeah. So could you talk about the ISO certification of the second site and maybe give us a sense of some OUS potential opportunities for 1RF as far as distributors and territories?

Jeffrey S. Cohen: 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?

Jeffrey Cohen: 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?

Speaker #3: Yeah. So the ISO certification is kind of like your 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.

Dave Rosa: Yeah. The ISO certification is kind of like your 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 have got to be able to provide also data. Depending upon which area you are going to, there is 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 are assessing which ones they want to go to first. And again, the idea is how can we hit the ground running?

Dave Rosa: Yeah. The ISO certification is kind of like your 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 have got to be able to provide also data. Depending upon which area you are going to, there is 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 are assessing which ones they want to go to first. And again, the idea is how can we hit the ground running?

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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.

Dave Rosa: You really have to work on your targets, everything from where you can go today to start planning on how you get to Europe as well. There are 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. If you are able to use some existing data, you may be able to even shorten that timeline. That is all in process. Now that is the geographies that Zimmer has, but there are others that they do not have, and those are the areas where we are assessing are the economics in those geographies, do they make sense? Are there distributors that we could utilize to commercialize the products there? That is all in process.

Dave Rosa: You really have to work on your targets, everything from where you can go today to start planning on how you get to Europe as well. There are 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. If you are able to use some existing data, you may be able to even shorten that timeline. That is all in process. Now that is the geographies that Zimmer has, but there are others that they do not have, and those are the areas where we are assessing are the economics in those geographies, do they make sense? Are there distributors that we could utilize to commercialize the products there? That is all in process.

Speaker #3: And there are ways of even addressing the clinical data. We just released, obviously, information on the study that was done at the Mayo Clinic in Jacksonville.

Speaker #3: 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 timeline.

Speaker #3: 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?

Speaker #3: Do they make sense? Are there distributors that we could 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.

Dave Rosa: I do not expect that we will have a firm answer on that until probably next quarter when we have had time to sit down with Zimmer and go through this. Excuse me.

Dave Rosa: I do not expect that we will have a firm answer on that until probably next quarter when we have had time to sit down with Zimmer and go through this. Excuse me.

Speaker #3: Excuse me.

Speaker #6: Okay. Perfect. Thanks for taking our questions.

Jeffrey S. Cohen: Okay. Perfect. Thanks for taking our questions.

Jeffrey Cohen: Okay. Perfect. Thanks for taking our questions.

Speaker #2: Thank you. Our next question is coming from Justin Walsh with Jones Trading. Your line is live.

Operator: Thank you. Our next question is coming from Justin Walsh with JonesTrading. Your line is live.

Operator: Thank you. Our next question is coming from Justin Walsh with JonesTrading. Your line is live.

Speaker #7: Hi, thanks for taking the question. I was wondering if you could provide some 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 do you think it has to be adopted as a standard for an approved agent?

Justin Walsh: Hi. Thanks for taking the question. I was wondering if you could provide some additional color on how you view the StereoCED opportunity. Do you think it is 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?

Justin Walsh: Hi. Thanks for taking the question. I was wondering if you could provide some additional color on how you view the StereoCED opportunity. Do you think it is 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?

Dave Rosa: That is a good question. The answer is no. I think it could be used in both the clinical stage, well, actually the preclinical stage, which is what we are seeing now with the University of Minnesota, as well as the clinical stage, and then obviously the commercialization piece as well. We really feel there are 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. 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 have completed their phase I, they are happy with the results, they are not going to make any changes. No company would be interested in introducing a new technology, even if it is a delivery device, into a phase II.

Dave Rosa: That is a good question. The answer is no. I think it could be used in both the clinical stage, well, actually the preclinical stage, which is what we are seeing now with the University of Minnesota, as well as the clinical stage, and then obviously the commercialization piece as well. We really feel there are 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.

Speaker #3: 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 the University of Minnesota.

Speaker #3: 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.

Speaker #3: 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 one, 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 two.

Dave Rosa: 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 have completed their phase I, they are happy with the results, they are not going to make any changes. No company would be interested in introducing a new technology, even if it is a delivery device, into a phase II.

Dave Rosa: You can never really predict what might happen. Just as a way for them to mitigate any risk, if they start with a particular technology, unless there are issues with their clinical data or with that technology, they are 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.

Dave Rosa: You can never really predict what might happen. Just as a way for them to mitigate any risk, if they start with a particular technology, unless there are issues with their clinical data or with that technology, they are 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.

Speaker #3: 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 are issues with their clinical data or with that technology—they're likely to stay with that through clearance.

Speaker #3: 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.

Speaker #2: Thank you. Our next question is coming from Jeremy Perlman with Maxim Group. Your line is live.

Operator: Thank you. Our next question is coming from Jeremy Pearlman with Maxim Group. Your line is live.

Operator: Thank you. Our next question is coming from Jeremy Pearlman with Maxim Group. Your line is live.

Speaker #7: Okay, good morning. Thank you for taking the questions. Firstly, related to trigeminal, I mean, again, maybe I'm just—correct me if I'm not reading between the lines correctly.

Jeremy Pearlman: Okay, good morning. Thank you for taking the question. Firstly, related to trigeminal, just correct me if I am not reading between the lines correctly. You said you are going to leverage existing personnel that you have on staff and then other distributors for that product. Does that mean that Zimmer is not interested in adding that or mending that onto their agreement, or maybe I am just misinterpreting that?

Jeremy Pearlman: Okay, good morning. Thank you for taking the question. Firstly, related to trigeminal, just correct me if I am not reading between the lines correctly. You said you are going to leverage existing personnel that you have on staff and then other distributors for that product. Does that mean that Zimmer is not interested in adding that or mending that onto their agreement, or maybe I am just misinterpreting that?

Speaker #7: 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 interested in adding that or amending that onto their agreement, or maybe I'm just misinterpreting that?

Speaker #3: Yeah, 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 of the strategics that we've spoken to, you always think that it should take a lot less time, but there are other factors that may be going on—not even in our company, but with the potential partner—that may delay those things.

Dave Rosa: Well, that may be what it sounds like, but it is not the case at all. When you look at discussions that we have had in the past with any of the strategics that we have spoken to, you always think that it should take a lot less time, but there are other factors that may be going on in, not even our company, the potential partner that may delay those things. I think at some point, we as a company have to say, "Look, we need to move forward. We cannot 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 has delayed us with trigeminal is this backlog that we are dealing with the brain ablation devices. So we have really prioritized the units that go to Zimmer, because that is, today, the larger opportunity.

Dave Rosa: Well, that may be what it sounds like, but it is not the case at all. When you look at discussions that we have had in the past with any of the strategics that we have spoken to, you always think that it should take a lot less time, but there are other factors that may be going on in, not even our company, the potential partner that may delay those things. I think at some point, we as a company have to say, "Look, we need to move forward. We cannot sit and wait to conclude these discussions."

Speaker #3: So, I think at some point 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.

Dave Rosa: But it does not mean that there is no interest. There is interest on their end. Some of what has delayed us with trigeminal is this backlog that we are dealing with the brain ablation devices. So we have really prioritized the units that go to Zimmer, because that is, today, the larger opportunity.

Speaker #3: 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.

Speaker #3: 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.

Dave Rosa: But as we make progress on that, we will start to get more devices for trigeminal sales. And 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 do not want to do when you are trying to address demand from another area, and that is your biggest source of revenue. You do not want to shortchange that by an opportunity that, while compelling, is smaller. So we have not opened up additional centers, but we will be beyond this quarter. So it has not been, I would say, a major issue for us to address because we were not able to really do much given the backlog that we experienced on the other side. So short answer, they are definitely interested.

Dave Rosa: But as we make progress on that, we will start to get more devices for trigeminal sales. And 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 do not want to do when you are trying to address demand from another area, and that is your biggest source of revenue. You do not want to shortchange that by an opportunity that, while compelling, is smaller. So we have not opened up additional centers, but we will be beyond this quarter. So it has not been, I would say, a major issue for us to address because we were not able to really do much given the backlog that we experienced on the other side. So short answer, they are definitely interested.

Speaker #3: And 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.

Speaker #3: And 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.

Speaker #3: So we haven't opened up additional centers, but we will be beyond this quarter. So it hasn't been a 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.

Speaker #3: 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.

Dave Rosa: It does not mean that it will not happen, but we are going to move forward, and if there is an opportunity, then great.

Dave Rosa: It does not mean that it will not happen, but we are going to move forward, and if there is an opportunity, then great.

Speaker #7: 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 the press release, you put out this morning, you said I think it was between 9.2 and 10.5.

Jeremy Pearlman: Okay, understood. Lastly, in the past you have guided towards revenue of at least $10.5 million. I know there has been some manufacturing delays, and in the press release you put out this morning, you said, I think it was between what, $9.2 million and $10.5 million. Is that just basically you will 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 is baked into that range? Thanks.

Jeremy Pearlman: Okay, understood. Lastly, in the past you have guided towards revenue of at least $10.5 million. I know there has been some manufacturing delays, and in the press release you put out this morning, you said, I think it was between what, $9.2 million and $10.5 million. Is that just basically you will 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 is baked into that range? Thanks.

Speaker #7: Does 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?

Speaker #7: Thanks.

Speaker #3: 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.

Dave Rosa: No, it is manufacturing. It is 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 is more reasonable, more conservative is that range, but it is completely dependent on everything from the vendors being able to deliver what they say they deliver, with some risks that we have built into that. From an order standpoint, the number that if we were able to meet the manufacturing, would have been almost or around $11.2 million.

Dave Rosa: No, it is manufacturing. It is 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 is more reasonable, more conservative is that range, but it is completely dependent on everything from the vendors being able to deliver what they say they deliver, with some risks that we have built into that. From an order standpoint, the number that if we were able to meet the manufacturing, would have been almost or around $11.2 million.

Speaker #3: 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 or around 11.2 million.

Speaker #7: Okay. Understood. Great. And then just last question from us. And maybe, I mean, you might not have this I know Zimmer is the one who's pushing the 1RF 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?

Jeremy Pearlman: Okay, understood. Great. Just the last question from us. Maybe you might not have this. I know Zimmer Biomet is the one who is pushing the OneRF ablation device, but is there any data or maybe KPIs you have regarding new accounts versus utilization in preexisting accounts, how that is going, growth within those accounts? You can share anything on that front.

Jeremy Pearlman: Okay, understood. Great. Just the last question from us. Maybe you might not have this. I know Zimmer Biomet is the one who is pushing the OneRF ablation device, but is there any data or maybe KPIs you have regarding new accounts versus utilization in preexisting accounts, how that is going, growth within those accounts? You can share anything on that front.

Speaker #7: You can share anything about that.

Dave Rosa: Yeah, contractually, we do not have the right to get that information. We have asked for more detailed information. Zimmer Biomet, and it is not just Zimmer Biomet, it is other companies as well, they like to keep that close to the vest. Other companies, you would not see them reporting on an area like this either. Zimmer Biomet does it because they do not want their competitors to really know what is going on. In anecdotal discussions, their feedback is they are continuing to gain additional traction. As far as giving you hard numbers, I do not have that.

Dave Rosa: Yeah, contractually, we do not have the right to get that information. We have asked for more detailed information. Zimmer Biomet, and it is not just Zimmer Biomet, it is other companies as well, they like to keep that close to the vest. Other companies, you would not see them reporting on an area like this either. Zimmer Biomet does it because they do not want their competitors to really know what is going on. In anecdotal discussions, their feedback is they are continuing to gain additional traction. As far as giving you hard numbers, I do not have that.

Speaker #3: Yeah. 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.

Speaker #3: 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.

Speaker #3: And Zimmer does it because they don't want their competitors to really know what's going on. But an anecdotal discussions, their feedback is they're continuing to gain additional traction.

Speaker #3: But as far as giving you hard numbers I don't have that.

Speaker #7: Okay. Understood. Thank you for taking my questions. Have a nice day.

Jeremy Pearlman: Okay, understood. Thank you for taking my questions. Have a nice day.

Jeremy Pearlman: Okay, understood. Thank you for taking my questions. Have a nice day.

Speaker #3: Sure. Thank you.

Dave Rosa: Sure. Thank you.

Dave Rosa: Sure. Thank you.

Speaker #2: Thank you. That appears to be the last question at this time, so I'd like to turn the call back over to Mr. Rosa.

Operator: Thank you. That appears to be the last question at this time. I would like to turn the call back over to Mr. Rosa.

Operator: Thank you. That appears to be the last question at this time. I would like to turn the call back over to Mr. Rosa.

Speaker #3: 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.

Dave Rosa: I just want to thank everyone again for attending the call today. 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 would be more than happy to follow up.

Dave Rosa: I just want to thank everyone again for attending the call today. 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 would be more than happy to follow up.

Speaker #3: If we were unable to answer any of your questions today, please reach out to our investor relations firm, the MZ Group, and they would be more than happy to follow up.

Speaker #2: 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.

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.

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.

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Q3 2026 Neuroone Medical Technologies Corp Earnings Call

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NMTC

Neuroone Medical

Earnings

Q3 2026 Neuroone Medical Technologies Corp Earnings Call

NMTC

Thursday, August 13th, 2026 at 12:30 PM

Transcript

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