8-K
NEUROONE MEDICAL TECHNOLOGIES Corp (NMTC)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the SecuritiesExchange Act of 1934
Date of Report (Date of Earliest Event Reported): May 13, 2025
NeuroOne Medical Technologies Corporation
(Exact name of registrant as specified in its charter)
| Delaware | 001-40439 | 27-0863354 |
|---|---|---|
| (State or other jurisdiction<br><br> <br>of incorporation) | (Commission File Number) | (IRS Employer<br><br>Identification No.) |
7599 Anagram Dr., Eden Prairie, MN 55344
(Address of principal executive offices and zip code)
952-426-1383
(Registrant’s telephone number including area code)
(Registrant’s former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value $0.001 per share | NMTC | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging Growth Company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 13, 2025, NeuroOne Medical Technologies Corporation (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended March 31, 2025. A copy of this press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K (this “Current Report”) and is incorporated herein by reference.
Item 7.01 Regulation FD Disclosure
On May 13, 2025, the Company posted an updated corporate presentation to its website at https://nmtc1.com/investors, which the Company may use from time to time in communications or conferences. A copy of the corporate presentation is attached as Exhibit 99.2 to this Current Report.
This Current Report and Exhibit 99.2 hereto contain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements are based on current expectations and are not guarantees of future performance. Further, the forward-looking statements are subject to the limitations listed in Exhibit 99.2 and in the other reports of the Company filed with the Securities and Exchange Commission, including that actual events or results may differ materially from those in the forward-looking statements.
In accordance with General Instruction B.2. of Form 8-K, the information contained in Item 2.02 and this Item 7.01 of this Current Report, including Exhibits 99.1 and 99.2 hereto, is furnished pursuant to Items 2.02 and 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing. The Company’s submission of this Current Report shall not be deemed an admission as to the materiality of any information required to be disclosed solely to satisfy the requirements of Regulation FD.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description |
|---|---|
| 99.1 | Press Release, dated May 13, 2025. |
| 99.2 | Corporate Presentation, dated May 2025. |
| 104 | Cover Page Interactive Data File (embedded with Inline XBRL document). |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| NOONE MEDICAL TECHNOLOGIES CORPORATION | |
|---|---|
| Dated: May 13, 2025 | By: |
All values are in Euros.
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Exhibit 99.1
NeuroOne^®^Reports Second Quarter Fiscal Year 2025 Financial Results; Gross Margin Improves Significantly YoY to 55.6%
Filed 510(k)Submission with FDA for OneRF^®^Trigeminal Nerve Ablation System to Treat Facial Pain Ahead of Schedule
Company Fully FundedThrough at Least Fiscal Year 2026 Following Oversubscribed $8.2 Million Capital Raise
EDEN PRAIRIE, Minn., May 13, 2025 -- 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 for the second quarter of fiscal year 2025 ended March 31, 2025.
Recent Company Highlights
| ● | Successfully filed FDA submission ahead of schedule for the OneRF^®^<br>Trigeminal Nerve Ablation System to treat facial pain, with a potential to generate revenues in late calendar year 2025 if cleared by<br>the FDA. |
|---|---|
| ● | Completed an oversubscribed capital raise with institutional investors in<br>April 2025 totaling $8.2 million in net proceeds. The Company is debt free and anticipates being fully funded through at least fiscal<br>year 2026. |
| --- | --- |
| ● | The Company reaffirms its fiscal year 2025 guidance of product revenue, which<br>excludes license revenue received of $3.0 million, to range between $8.0 to $10.0 million, representing an increase of between 132% and<br>190% when compared to product revenue of $3.5 million in fiscal year 2024. |
| --- | --- |
| ● | Strengthening the Company’s management team with the hiring of Dr.<br>Parag Patil, a renowned neurosurgeon as Chief Medical Advisor, effective May 12, 2025, and Emily Johns, a partner at Honigman LLP, as<br>General Counsel and Secretary, effective June 1, 2025. |
| --- | --- |
| ● | Secured significant media interest, including recent features on Fox News<br>and Good Morning America. |
| --- | --- |
Management Commentary
“The second quarter of fiscal 2025 was highlighted by our significant operational progress with our commercial OneRF^®^ Ablation System technology platform, which is increasingly being validated as a versatile and scalable platform across multiple applications,” said Dave Rosa, CEO of NeuroOne. “Not only did we continue to have clinical success with patients who are remaining seizure free after being treated with our system, but we also successfully filed our 510(k) submission to the FDA for the OneRF^®^ Trigeminal Nerve Ablation System to treat facial pain well ahead of schedule.
“We believe there is a potential to generate revenues from trigeminal nerve ablation as soon as late calendar year 2025 if cleared by the FDA. Building upon this momentum, we are in discussions with a number of top-tier strategic partners for other applications leveraging our patented OneRF^®^ System, including spinal cord nerve ablation and spinal cord stimulation for back pain management, and the sEEG-Based drug delivery program.
“To execute on these opportunities, we successfully completed an oversubscribed capital raise with institutional investors totaling $8.2 million in net proceeds, which we believe will fully fund us through at least the end of fiscal year 2026, based on Zimmer making the minimum purchase requirements set forth in our expanded agreement. In fact, if we achieve some of the key milestones currently in progress, this capital could bring us to cash flow breakeven and support our long-term growth plans with no need for additional dilutive financing.”
“Today, we stand as a larger, more mature company than ever before as we focus on significantly ramping revenues and expanding our product margins. We have a world class strategic partner, the necessary capital to execute on our strategic growth initiatives and several upcoming milestones that present significant opportunities to grow shareholder value,” concluded Rosa.
Operational Updates
OneRF^®^ Ablation System:
| ● | The first patient treated with our OneRF Ablation System will reach one year<br>of seizure freedom in June 2025. |
|---|---|
| ● | Completed initial training of Zimmer Biomet team at national sales meeting<br>in February. We continue to work closely with Zimmer Biomet and our physician advisors on advanced training and education for this novel<br>combination diagnostic and therapeutic procedure. |
| --- | --- |
| ● | Product exhibited by Zimmer Biomet at the American Association of Neurological<br>Surgeons (AANS) in April. |
| --- | --- |
| ● | Planning post-market registry to collect outcomes data. |
| --- | --- |
Trigeminal Nerve Ablation System:
| ● | Filed 510(k) submission with the FDA in April 2025, ahead of schedule. |
|---|---|
| ● | Subject to 510(k) clearance by the FDA, Trigeminal Nerve Ablation System<br>could contribute to revenue in late calendar year 2025. |
| --- | --- |
Spinal Cord Stimulation (SCS) Percutaneous Paddle Lead Program:
| ● | Finalized protocol for chronic animal study. |
|---|---|
| ● | Continuing discussions with potential strategic partners to further develop<br>and commercialize our Percutaneous Paddle Lead. |
| --- | --- |
sEEG-Based Drug Delivery Program:
| ● | Presentation at the Neurological Disorders Summit in Germany in April. |
|---|---|
| ● | Continuing discussions with potential strategic partners. |
| --- | --- |
Outside the U.S. (OUS) Distribution
| ● | Initiating process to secure ISO13485 certification, which is required to<br>commercialize outside of the United States in addition to requirements for OUS regulatory approvals. |
|---|---|
| ● | The Company has not sold or commercialized any products in international<br>markets to-date, representing a potentially significant revenue opportunity. |
| --- | --- |
Second Quarter Financial Results
Product revenue was $1.4 million in the second quarter of fiscal 2025, compared to product revenue of $1.4 million in the same quarter of the prior year. For the first six months of fiscal 2025, product revenue increased 98% to $4.7 million, compared to $2.4 million for the same period in fiscal 2024. The Company also had license revenue of $3.0 million in the first six months of fiscal 2025 which is not included in product revenue, compared to no license revenue in the first six months of fiscal 2024. License revenue in fiscal 2025 was derived from the expanded exclusive distribution agreement with Zimmer.
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Product gross profit increased significantly to $0.8 million, or 55.6% of revenue, in the second quarter of fiscal 2025, compared to product gross profit of $0.4 million, or 28.3% of revenue in the same quarter of the prior year. For the first six months of fiscal 2025, product gross profit increased significantly to $2.7 million, or 57.9% of revenue, compared to product gross profit of $0.7 million, or 27.9% of revenue in the first six months of fiscal 2024.
Total operating expenses were $3.5 million in the second quarter of fiscal 2025, compared to $3.3 million in the same quarter of the prior year. R&D expense in the second quarter of fiscal 2025 was $1.5 million, compared with $1.3 million in the same quarter of the prior year. SG&A expense in the second quarter of fiscal 2025 was $1.9 million, compared to $2.0 million in the same quarter of the prior year. For the first six months of fiscal 2025, total operating expenses decreased 4% to $6.7 million, compared to $6.9 million in the same period of fiscal 2024. R&D expense in the first six months of fiscal 2025 decreased 3% to $2.7 million, compared to $2.8 million in the same period of fiscal 2024. SG&A expense in the first six months of fiscal 2025 decreased 5% to $4.0 million, compared to $4.2 million in the prior year period.
Net loss in the second quarter of fiscal 2025 improved to $2.3 million, or ($0.07) per share, compared to a net loss of $2.9 million, or $(0.11) per share, in the same quarter of the prior year. Net loss for the first six months of fiscal 2025 improved significantly to $0.5 million, or $(0.02) per share, compared with $6.2 million, or $(0.25) per share, in the same period of fiscal 2024.
As of March 31, 2025, the Company had cash and cash equivalents of $1.3 million, compared to $1.4 million as of September 30, 2024. The Company had working capital of $2.0 million as of March 31, 2025, compared to working capital of $2.4 million as of September 30, 2024. The Company had no debt outstanding as of March 31, 2025.
In the second quarter of fiscal 2025, the Company sold common stock under the ATM Program at an average price of $1.16 per share, from which the Company received net proceeds of $0.3 million. In April 2025, the Company completed an oversubscribed capital raise with institutional investors totaling $8.2 million in net proceeds and eliminated all availability under the ATM program.
Full Fiscal Year 2025 Financial Guidance
The Company continues to expect product revenue for fiscal year 2025 to range between $8.0 million and $10.0 million, representing an increase of between 132% and 190% when compared to product revenue of $3.5 million in fiscal year 2024. The Company continues to expect product gross margin in fiscal year 2025 to range between 47% and 51%, compared to product gross margin of 31% in fiscal year 2024.
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Conference Call and Webcast
Management will host an investor conference call and webcast today, Tuesday, May 13, 2025, at 8:30 a.m. Eastern time to discuss the Company’s second quarter fiscal year 2025 financial results, provide a corporate update, and conclude with Q&A from telephone participants. To participate, please use the following information:
Date: Tuesday, May 13, 2025
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: 655933
Webcast: 2Q25 Webcast Link
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 27, 2025. To listen, please call 877-481-4010 within the United States or 919-882-2331 when calling internationally, using replay passcode 52404. A webcast replay will also be available using the webcast link above through May 27, 2025.
About NeuroOne
NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) is developing and commercializing minimally invasive and hi-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders that may improve patient outcomes and reduce procedural costs. The Company may also pursue applications for other areas such as depression, mood disorders, pain, incontinence, high blood pressure, and artificial intelligence. 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 addition the Company’s ability to be fully-funded through 2026; the fact that the first patient treated with our OneRF Ablation System will reach one year of seizure freedom in June 2025; the continued development of the Company’s electrode technology program (including its drug delivery program and spinal cord stimulation program); the ability to achieve cash-flow break-even without additional dilutive financing;, fiscal year 2025 guidance, including expectations for significant product revenue growth and margin expansion, the potential to receive FDA clearance for our trigeminal nerve ablation program, the potential to receive any revenues from our trigeminal nerve ablation program, business strategy, market size, potential growth opportunities, future operations, future efficiencies, and other financial and operating information. 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 relate 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.
IR ContactMZ Group – MZ North America
NMTC@mzgroup.us
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NeuroOne Medical Technologies Corporation
Balance Sheets
(unaudited)
| September 30, | |||||
| 2024 | |||||
| Assets | |||||
| Current assets: | |||||
| Cash and cash equivalents | 1,320,251 | $ | 1,460,042 | ||
| Accounts receivable | 318,780 | 176,636 | |||
| Inventory | 1,834,607 | 2,635,153 | |||
| Deferred offering costs | 72,377 | 142,633 | |||
| Prepaid expenses | 208,067 | 216,461 | |||
| Total current assets | 3,754,082 | 4,630,925 | |||
| Intangible assets, net | 56,104 | 67,262 | |||
| Right-of-use asset | 311,652 | 254,910 | |||
| Property and equipment, net | 334,853 | 416,843 | |||
| Total assets | 4,456,691 | $ | 5,369,940 | ||
| Liabilities and Stockholders’ Equity | |||||
| Current liabilities: | |||||
| Accounts payable | 910,754 | $ | 1,029,206 | ||
| Accrued expenses and other liabilities | 852,587 | 1,184,014 | |||
| Total current liabilities | 1,763,341 | 2,213,220 | |||
| Warrant liability | 1,360,519 | 2,140,315 | |||
| Operating lease liability, long term | 206,973 | 194,392 | |||
| Total liabilities | 3,330,833 | 4,547,927 | |||
| Commitments and contingencies (Note 4) | |||||
| Stockholders’ equity: | |||||
| Preferred stock, 0.001 par value; 10,000,000 shares authorized; no shares issued or outstanding. | — | — | |||
| Common stock, 0.001 par value; 100,000,000 shares authorized; 31,385,526 and 30,816,499 shares issued and outstanding as of March 31, 2025 and September 30, 2024, respectively. | 31,385 | 30,816 | |||
| Additional paid–in capital | 76,584,171 | 75,795,610 | |||
| Accumulated deficit | (75,489,698 | ) | (75,004,413 | ) | |
| Total stockholders’ equity | 1,125,858 | 822,013 | |||
| Total liabilities and stockholders’ equity | 4,456,691 | $ | 5,369,940 |
All values are in US Dollars.
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NeuroOne Medical Technologies Corporation
Statements of Operations
(unaudited)
| For the<br> Three Months Ended | For the<br> Six Months Ended | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| March 31, | March 31, | |||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||
| Product revenue | $ | 1,386,550 | $ | 1,377,294 | $ | 4,660,717 | $ | 2,354,943 | ||||
| Cost of product revenue | 615,489 | 986,875 | 1,962,767 | 1,698,210 | ||||||||
| Product gross profit | 771,061 | 390,419 | 2,697,950 | 656,733 | ||||||||
| License revenue | — | — | 3,000,000 | — | ||||||||
| Operating expenses: | ||||||||||||
| Selling, general and administrative | 1,940,414 | 2,002,949 | 3,983,868 | 4,176,421 | ||||||||
| Research and development | 1,510,663 | 1,273,568 | 2,682,891 | 2,756,885 | ||||||||
| Total operating expenses | 3,451,077 | 3,276,517 | 6,666,759 | 6,933,306 | ||||||||
| Loss from operations | (2,680,016 | ) | (2,886,098 | ) | (968,809 | ) | (6,276,573 | ) | ||||
| Fair value change in warrant liability | 390,351 | — | 779,796 | — | ||||||||
| Financing costs | — | — | (324,738 | ) | — | |||||||
| Other income, net | 19,058 | 31,008 | 28,466 | 76,583 | ||||||||
| Loss before income taxes | (2,270,607 | ) | (2,855,090 | ) | (485,285 | ) | (6,199,990 | ) | ||||
| Provision for income taxes | — | — | — | — | ||||||||
| Net loss | $ | (2,270,607 | ) | $ | (2,855,090 | ) | $ | (485,285 | ) | $ | (6,199,990 | ) |
| Net loss per share: | ||||||||||||
| Basic and diluted | $ | (0.07 | ) | $ | (0.11 | ) | $ | (0.02 | ) | $ | (0.25 | ) |
| Number of shares used in per share calculations: | ||||||||||||
| Basic and diluted | 31,111,786 | 25,910,478 | 30,973,149 | 24,947,813 |
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Exhibit 99.2
Corporate Presentation April 2025 NASDAQ: NMTC
2 This presentation contains forward - looking statements within the meaning of Section 27A of the Securities Act of 1933, as amende d, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for statements of historical fact, any information contained in this presentation may be a forward – look ing statement that reflects NeuroOne's current views about future events. In some cases, you can identify forward – looking statements by the words "may," "might," "will," "could," "w ould," "should," "expect," "intend," "plan," "upcoming," "target," "objective," "anticipate," "believe," "estimate," "predict," "project," "potential," "target," "seek," "contemplate ," "continue" and "ongoing," or the negative of these terms, or other comparable terminology. Forward – looking statements may include statements regarding the fiscal 2025 guidance, the potentia l receipt of approval of and the receipt of any revenue related to facial pain ablation, additional potential strategic partnerships, development of the Company's ablation e lec trode technology program, applications for, or receipt of, regulatory clearance, the timing and extent of product launch and commercialization of our technology, expected milestone pay men ts, clinical and pre - clinical testing, what the future may hold for electrical stimulation and NeuroOne's potential role, business strategy, market size, potential growth opportunities, future operations, future efficiencies, and o th er financial and operating information. Our actual future results may be materially different from what we expect due to known and unknown ri sks, 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, including risks that the partnership with Zimmer Biomet may not facilitate the commercialization or market acceptance of our technology ; r isks that our sEEG electrodes may not be ready for commercialization in a timely manner or at all, whether due to supply chain disruptions or otherwise; risks that our technolo gy 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 it s b usiness 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 s ize 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 i nte llectual property rights; and other risks, uncertainties and assumptions, including those described under the heading "Risk Factors" in our filings with the Securities and Exchange Commi ssi on. These forward – looking statements speak only as of the date of this presentation and NeuroOne undertakes no obligation to revise or update any forward – looking statements for any reason, even if new information becomes ava ilable in the future. This presentation also contains estimates and other statistical data made by independent parties and by us relating to market sh are and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use shou ld not be construed as an endorsement of such products. Caution: Federal law restricts this device to sale by or on the order of a physician. Forward - Looking Statements NASDAQ: NMTC
3 NeuroOne is a medical technology company that is transforming the diagnosis and treatment of neurological disorders FDA - Cleared 3 FDA 510(k) cleared products for use in the brain, with the only FDA cleared product that uses the same sEEG electrode for both diagnostic and therapeutic applications. 510(k) submission for the OneRF ® Trigeminal Nerve Ablation System. Patented Technology Exclusive Partnerships Exclusive partnership with Zimmer Biomet, the global leader in robotic surgical technology, and the Mayo Clinic. Patented and disruptive technology unlocking multi - billion markets in neurology. NASDAQ: NMTC
4 Thin Film & Flexibility • Highly flexible design provides new options for surgical placement and potentially smaller borings/incisions • Lower inflammation compared to bulkier electrodes • Enables pairing of diagnostic and therapeutic procedures using the same sEEG • First 510(k) cleared device using the previously implanted sEEG electrode to diagnosis and then create radiofrequency lesions in the brain. NeuroOne’s next - generation electrode platform is highly disruptive and differentiated Multi - Function Device Since the 1950s, clinicians and researchers have used first generation electrodes for the recording and stimulation of brain tissue. NeuroOne’s multi - purpose electrodes a re trying to reduce the number of surgeries, and hospitalizations while potentially improving efficacy. NASDAQ: NMTC
5 Mayo Clinic Partnership • Mayo Clinic began testing technology in pre - clinical models and clinical research in 2015 • Mayo Clinic leading neurologist, Dr. Worrell, chairs the NeuroOne Scientific Advisory Board • First commercial human use of Evo ® Cortical Electrodes performed at Mayo Clinic in November 2020 • Currently using our drug delivery system in pre - clinical studies Mayo Clinic Board Representation Greg Worrell MD, PhD, Chairman of the Scientific Advisory Board World renowned neurologist at Mayo Clinic. Recognized by the American Epilepsy Society (AES), the American Academy of Neurolo gy (AAN), the American Neurological Association (ANA), and the Citizens United in Research for Epilepsy (CURE) Foundation for his contr ibu tions to the field of epilepsy research. Dr. Worrell is a frequent keynote speaker at neurology conferences and has published 90 papers. Jamie Van Gompel , MD Neurosurgeon practicing at Mayo Clinic, specializing in epilepsy surgery utilizing minimally invasive techniques. Since 2008, Dr . Van Gompel has authored or co - authored 87 papers on clinical outcome projects centered on neurological conditions. Dr. Van Gompel works collaboratively with colleagues from Mayo Clinic’s Epilepsy and Neurophysiology lab, engaging in clinical work relative to brain stimulation as a viable restorative therapy for epilepsy over current treatment methodologies. Current Investor NASDAQ: NMTC
6 Zimmer Biomet Partnership Recently expanded partnership to include distribution rights for NeuroOne’s OneRF ® Ablation System • $3 million licensing fee • Distribution rights in US and select OUS countries • Expected to boost NeuroOne revenue growth and profitability • Zimmer is a worldwide leader in robotic technology used in minimally invasive neurosurgeries • Evo ® electrodes are complementary to Zimmer’s ROSA ONE ® robotic neurosurgery platform • Partnership initiated in 2020: $5.5 million total paid to NeuroOne under initial contract NASDAQ: NMTC
7 Brain Ablation Parkinson’s Epilepsy (Diagnostic Only) Spinal Cord Stimulation (Back Pain) Our electrode platform addresses multi - billion $ and growing market needs¹ $100M $500M+ $1B+ $3B $100M $5B+ $10B+ $1B+ Drug Delivery $0 $10B+ Actual Market Potential Market Size 1. Company data on file NASDAQ: NMTC
8 Technology Platform NASDAQ: NMTC
9 Product Portfolio Application Status Use Case Product Diagnostic Currently marketed by Zimmer Biomet Recording brain activity Placed on surface of brain Evo® Cortical Electrodes Diagnostic Currently marketed by Zimmer Biomet Recording brain activity Placed Deeper Into the Brain Evo® sEEG Electrodes Diagnostic & Therapeutic Currently marketed by Zimmer Biomet Ablating Brain Tissue using sEEGs Dedicated RF console OneRF® Ablation System for Brain Therapeutic In Development (recently submitted to the FDA) Ablating Trigeminal Nerve Tissue using Dedicated TNRF Probe and RF Console OneRF® Ablation System for Facial Pain Diagnostic & Therapeutic In Development Chronic Recording & Stimulation For Peripheral, Spinal & Deep Brain Stim Thin - Film Implantable Electrodes Diagnostic & Therapeutic In Development Recording Brain Activity and Therapeutic Agent Delivery Drug Delivery System NASDAQ: NMTC
10 Summary • Increased signal clarity /reduced noise design • Cortical device thinner & lighter than competitive devices • sEEG - Better tactile feedback during brain tissue insertion • Both product lines are distributed by Zimmer Biomet Thin - Film Evo® sEEG & Cortical Electrodes Applications • Epilepsy surgery for brain mapping • Brain tumor mapping $100M Market Size 1 FDA 510(k) Clearance Use: Diagnostic NASDAQ: NMTC
11 OneRF ® Ablation System for Brain FDA 510(k) Clearance Summary • One procedure for diagnostic and therapeutic expected to save time, money and to improve patient outcomes • Temperature - guided ablation provides additional safety measure • Designed to reduce number of procedures and hospitalizations • Uses well established RF energy to ablate tissue • New ICD - 10 - PCS code for OneRF procedure effective October 1, 2024 Recently expanded Zimmer Biomet Partnership to distribute system Capital Equipment Single - Use RF Procedure sEEG Use: Diagnostic/Therapeutic NASDAQ: NMTC
12 OneRF ® Ablation System for Facial Pain (Trigeminal Neuralgia - TN) FDA 510(k) Submitted Summary • Legacy TN RF ablation has proven clinical efficacy with established reimbursement • OneRF introduces the first multi - contact probe for TN ablation • This enables stimulation and ablation in target anatomy in same cannula/probe insertion • May lead to fewer anesthesia cycles, more efficient procedure and more comfortable procedure for the patient • This probe is paired with modern RF generator custom built to work with these probes Capital Equipment Single Use: RF Accessories Single Use: TNRF Probe & Cannula Use: Therapeutic NASDAQ: NMTC In development, recently filed 510(k) submission with the FDA
13 Spinal Cord Percutaneous Paddle Lead Summary • Percutaneously placed paddle electrodes for spinal cord stimulation • Able to stimulate broadly and precisely target tissue • Successfully completed initial testing for durability and stimulation for 5 - year use for recording and stimulation • Advisory Board of leading anesthesiologists & neurosurgeons • Initiating discussions with potential strategic partners to fund further development and commercialization Current Solutions Most procedures use small percutaneous cylindrical electrodes that have limited stimulation coverage and high battery usage NeuroOne’s Solution Provides greater stimulation coverage with expected reduced battery usage $3B+ Global Market NASDAQ: NMTC
14 sEEG - Based Drug Delivery System Designed to leverage our sEEG platform enabling drug delivery + brain activity recording Pre - Drug Delivery Record Brain Activity with sEEG Electrode(s) Drug Delivery Via Cannula Inserted Through sEEG Electrode(s) Post - Drug Delivery Record Brain Activity with sEEG Electrode(s) Summary • Ability to record brain activity pre - , during, and post - drug delivery • Leverages small diameter and design of our current sEEG products • Open platform - does not require investment in proprietary software, infusion or navigation systems • Status: Currently in development - completed in vivo feasibility testing study and drug absorption testing • Does not require MRI for placement NASDAQ: NMTC
15 Our Management Team Dave Rosa President & Chief Executive Officer Ron McClurg Chief Financial Officer Steve Mertens Chief Technology Officer Mark Christianson Co - Founder, Business Development Director, Medical Sales Liaison Hijaz Haris Vice - President of Marketing Camilo Diaz Botia Director of Electrode Development Scientific Advisory Board Greg Worrell MD PhD, Chairman of the Scientific Advisory Board Bob Gross MD, PhD Jamie Van Gompel MD Justin Williams PhD Greg Esper MD, MBA Kip Ludwig PhD Chris Volker Chief Operating Officer NASDAQ: NMTC Evan Goulet Senior Director of Quality Assurance & Regulatory Affairs
16 Financial Overview • Debt free balance sheet • Decreasing burn rate in FY2025 • FY2025 Guidance: • FY 2025 product revenue of $8.0 - $10.0M (132% - 190% increase vs. FY2024) • FY2025 product gross margin of 47% - 51% • New potential partnerships focused on pain management and drug delivery Highlights & Financial Catalysts Capital Position ($ in millions) $9.4 Cash (as of 4/30/25) $0.0 Debt $3.0 Upfront Licensing Fee Payment $5.8 TTM Revenue (excludes license payment) NASDAQ: NMTC • I ncludes a one - time $3.0 million in license revenue from expanded distribution agreement with Zimmer Biomet • Includes p roduct revenues of $4.66 million (98% increase compared to $2.35 million in fiscal 2024) Fiscal 1H YTD 2025 Revenue Increased to $7.66 Million in Total
17 Upcoming Potential Catalysts • Zimmer Biomet OneRF ® Ablation System full launch • OneRF ® Trigeminal Nerve Ablation System FDA submission completed in April 2025 o Potential revenue in calendar 2025 for facial pain ablation system • Electrode revenue expected to more than double in FY2025 • Non - dilutive licensing agreement for ablation system with Zimmer Biomet • Potential strategic partnerships with NeuroOne’s core technology for ablation and stimulation • Completion of drug delivery system in calendar 2025 • Potential for strategic partnerships with pharma companies NASDAQ: NMTC
18 Key Takeaways Our platform technology of thin film electrode products improve outcomes for patients suffering from neurological disorders The only company with a single device that can perform multiple diagnostic & therapeutic functions such as recording, ablation and stimulation using the same electrode Successfully achieved 510(k) FDA clearance for 3 product families; 510(k) FDA submission for the OneRF ® Trigeminal Nerve Ablation System Targeting multi - billion markets for neurological diseases (i.e. epilepsy, Parkinson's disease), pain management (i.e. back pain) & drug delivery World - class partnerships with the Mayo Clinic and Zimmer Biomet NASDAQ: NMTC
Thank you Dave Rosa Chief Executive Officer NASDAQ: NMTC ir@nmtc1.com