NeuroOne® Reports Second Quarter Fiscal Year 2025 Financial Results; Gross Margin Improves Significantly YoY to 55.6%
NeuroOne Medical Technologies (NASDAQ: NMTC) reported strong Q2 FY2025 financial results, with significant gross margin improvement to 55.6% from 28.3% YoY. Product revenue remained stable at $1.4M for Q2, while H1 FY2025 product revenue grew 98% to $4.7M. The company successfully filed an FDA submission for its OneRF® Trigeminal Nerve Ablation System ahead of schedule and completed an oversubscribed $8.2M capital raise in April 2025.
The company reaffirmed its FY2025 product revenue guidance of $8.0-10.0M, representing 132-190% growth YoY. NeuroOne strengthened its management team with key appointments and remains debt-free, with funding secured through FY2026. The first patient treated with OneRF Ablation System will reach one year of seizure freedom in June 2025, marking a significant milestone for the company's technology.
NeuroOne Medical Technologies (NASDAQ: NMTC) ha riportato solidi risultati finanziari per il secondo trimestre dell'anno fiscale 2025, con un notevole miglioramento del margine lordo, passato al 55,6% dal 28,3% dell'anno precedente. I ricavi da prodotti sono rimasti stabili a 1,4 milioni di dollari nel secondo trimestre, mentre i ricavi da prodotti nel primo semestre dell'anno fiscale 2025 sono cresciuti del 98%, raggiungendo 4,7 milioni di dollari. L'azienda ha presentato con successo, in anticipo rispetto ai tempi previsti, una domanda alla FDA per il suo OneRF® Trigeminal Nerve Ablation System e ha completato una raccolta fondi da 8,2 milioni di dollari, sottoscritta oltre le aspettative, nell'aprile 2025.
La società ha confermato le previsioni di ricavi da prodotti per l'anno fiscale 2025 tra 8,0 e 10,0 milioni di dollari, pari a una crescita del 132-190% anno su anno. NeuroOne ha rafforzato il suo team di gestione con nomine chiave e rimane senza debiti, con finanziamenti garantiti fino al 2026. Il primo paziente trattato con il sistema OneRF Ablation raggiungerà un anno di libertà dalle crisi epilettiche a giugno 2025, segnando un traguardo importante per la tecnologia dell'azienda.
NeuroOne Medical Technologies (NASDAQ: NMTC) reportó sólidos resultados financieros en el segundo trimestre del año fiscal 2025, con una mejora significativa en el margen bruto, que aumentó al 55.6% desde el 28.3% interanual. Los ingresos por productos se mantuvieron estables en 1.4 millones de dólares en el segundo trimestre, mientras que los ingresos por productos en el primer semestre del año fiscal 2025 crecieron un 98%, alcanzando 4.7 millones de dólares. La compañía presentó con éxito una solicitud ante la FDA para su OneRF® Trigeminal Nerve Ablation System antes de lo previsto y completó una ronda de financiación sobresuscrita de 8.2 millones de dólares en abril de 2025.
La empresa reafirmó su previsión de ingresos por productos para el año fiscal 2025 entre 8.0 y 10.0 millones de dólares, representando un crecimiento interanual del 132-190%. NeuroOne fortaleció su equipo directivo con nombramientos clave y sigue libre de deudas, con financiamiento asegurado hasta el 2026. El primer paciente tratado con el sistema OneRF Ablation cumplirá un año sin convulsiones en junio de 2025, marcando un hito importante para la tecnología de la compañía.
NeuroOne Medical Technologies (NASDAQ: NMTC)는 2025 회계연도 2분기 강력한 재무 실적을 보고했으며, 연간 대비 55.6%로 크게 개선된 총이익률을 기록했습니다(전년 대비 28.3%). 2분기 제품 매출은 140만 달러로 안정적이었으며, 2025 회계연도 상반기 제품 매출은 98% 증가한 470만 달러를 달성했습니다. 회사는 예정보다 앞서 OneRF® 삼차신경 절제 시스템에 대한 FDA 제출을 성공적으로 완료했으며, 2025년 4월에 820만 달러의 초과 청약 자본 조달을 마쳤습니다.
회사는 2025 회계연도 제품 매출 가이던스를 800만~1000만 달러로 재확인했으며, 이는 전년 대비 132~190% 성장에 해당합니다. NeuroOne은 주요 임원 임명을 통해 경영진을 강화했으며, 부채 없이 2026년까지 자금 조달을 확보한 상태입니다. OneRF 절제 시스템으로 치료받은 첫 환자는 2025년 6월에 발작 없는 1년을 맞이할 예정으로, 회사 기술에 중요한 이정표가 될 것입니다.
NeuroOne Medical Technologies (NASDAQ : NMTC) a publié de solides résultats financiers pour le deuxième trimestre de l'exercice 2025, avec une amélioration significative de la marge brute, passant à 55,6% contre 28,3% en glissement annuel. Les revenus produits sont restés stables à 1,4 million de dollars au deuxième trimestre, tandis que les revenus produits du premier semestre de l'exercice 2025 ont augmenté de 98% pour atteindre 4,7 millions de dollars. La société a déposé avec succès une demande auprès de la FDA pour son Système d'ablation du nerf trijumeau OneRF® avant la date prévue et a réalisé une levée de fonds de 8,2 millions de dollars, largement sursouscrite, en avril 2025.
L'entreprise a confirmé ses prévisions de revenus produits pour l'exercice 2025, comprises entre 8,0 et 10,0 millions de dollars, soit une croissance annuelle de 132 à 190%. NeuroOne a renforcé son équipe de direction avec des nominations clés et reste sans dette, avec un financement assuré jusqu'en 2026. Le premier patient traité avec le système d'ablation OneRF atteindra un an sans crise en juin 2025, marquant une étape importante pour la technologie de l'entreprise.
NeuroOne Medical Technologies (NASDAQ: NMTC) meldete starke Finanzergebnisse für das zweite Quartal des Geschäftsjahres 2025 mit einer deutlichen Verbesserung der Bruttomarge auf 55,6% gegenüber 28,3% im Vorjahresvergleich. Die Produktumsätze blieben im zweiten Quartal mit 1,4 Mio. USD stabil, während die Produktumsätze im ersten Halbjahr des Geschäftsjahres 2025 um 98 % auf 4,7 Mio. USD stiegen. Das Unternehmen reichte seine FDA-Zulassung für das OneRF® Trigeminal Nerve Ablation System vor dem Zeitplan erfolgreich ein und schloss im April 2025 eine überzeichnete Kapitalerhöhung in Höhe von 8,2 Mio. USD ab.
Das Unternehmen bestätigte seine Prognose für die Produktumsätze im Geschäftsjahr 2025 von 8,0 bis 10,0 Mio. USD, was einem Wachstum von 132-190 % gegenüber dem Vorjahr entspricht. NeuroOne verstärkte sein Managementteam durch wichtige Ernennungen und bleibt schuldenfrei, mit gesicherter Finanzierung bis zum Geschäftsjahr 2026. Der erste Patient, der mit dem OneRF Ablation System behandelt wurde, wird im Juni 2025 ein Jahr ohne Anfälle erreichen, was einen bedeutenden Meilenstein für die Technologie des Unternehmens darstellt.
- Gross margin improved significantly to 55.6% from 28.3% YoY
- H1 FY2025 product revenue grew 98% to $4.7M
- Secured $8.2M in oversubscribed capital raise, fully funded through FY2026
- Company is debt-free with strong revenue guidance of $8.0-10.0M for FY2025
- Early FDA submission for OneRF® Trigeminal Nerve Ablation System with potential revenue by late 2025
- First patient approaching one year of seizure freedom with OneRF Ablation System
- Q2 product revenue remained flat at $1.4M YoY
- Cash position decreased to $1.3M from $1.4M in September 2024
- Working capital declined to $2.0M from $2.4M in September 2024
Insights
NeuroOne's finances show positive trajectory with improved margins, $8.2M raise securing operations, and promising product pipeline including FDA submission.
NeuroOne's Q2 FY2025 results reveal impressive financial improvements alongside key operational milestones. The most striking financial metric is the dramatic improvement in gross margin to 55.6% compared to 28.3% in the same quarter last year - a critical indicator that the company is successfully scaling its manufacturing operations and improving unit economics.
While quarterly product revenue remained flat year-over-year at
On the operational front, NeuroOne's ahead-of-schedule FDA submission for the OneRF® Trigeminal Nerve Ablation System is particularly significant as this could create a new revenue stream by late 2025. The oversubscribed
Cost discipline is evident with six-month operating expenses decreasing
The company's maintained fiscal 2025 product revenue guidance of
NeuroOne's FDA submission for trigeminal nerve ablation and commercial progress with OneRF system show promising clinical and market potential.
NeuroOne's ahead-of-schedule FDA 510(k) submission for the OneRF® Trigeminal Nerve Ablation System represents a significant clinical advancement. Trigeminal neuralgia is a notoriously difficult-to-treat condition causing extreme facial pain, with conventional treatments often providing inadequate relief. The company's minimally invasive ablation approach could potentially provide an important alternative to more invasive surgical procedures or less effective pharmaceutical options.
The clinical validation of the OneRF® Ablation platform is particularly encouraging, with the first treated epilepsy patient approaching one year of seizure freedom in June 2025. This longitudinal outcome data is crucial for neurosurgical adoption, as durability of response is a primary concern for interventional epilepsy procedures. The company's planned post-market registry to collect outcomes data indicates a commitment to evidence-based medicine that will be critical for broader clinical acceptance.
NeuroOne's product pipeline demonstrates sophisticated understanding of neurosurgical needs across multiple applications. The spinal cord stimulation percutaneous paddle lead program addresses a significant limitation of current leads (migration and suboptimal coverage), while the sEEG-based drug delivery program could revolutionize targeted CNS therapeutics. These applications leverage the company's core technological platform while addressing distinct clinical needs.
The strategic addition of Dr. Parag Patil as Chief Medical Advisor significantly strengthens NeuroOne's clinical credibility. His expertise as a neurosurgeon will be invaluable for product development, clinician education, and FDA interactions. The ongoing training of Zimmer Biomet's team and exhibition at AANS are essential steps to drive adoption of these novel technologies among neurosurgeons who typically require substantial evidence and education before adopting new surgical tools.
Filed 510(k)Submission with FDA for OneRF® Trigeminal Nerve Ablation System to Treat Facial Pain Ahead of Schedule
Company Fully Funded Through at Least Fiscal Year 2026 Following Oversubscribed
EDEN PRAIRIE, Minn., May 13, 2025 (GLOBE NEWSWIRE) -- 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® Trigeminal Nerve Ablation System to treat facial pain, with a potential to generate revenues in late calendar year 2025 if cleared by the FDA.
- Completed an oversubscribed capital raise with institutional investors in April 2025 totaling
$8.2 million in net proceeds. The Company is debt free and anticipates being fully funded through at least fiscal year 2026. - The Company reaffirms its fiscal year 2025 guidance of product revenue, which excludes license revenue received of
$3.0 million , to range between$8.0 t o$10.0 million , representing an increase of between132% and190% when compared to product revenue of$3.5 million in fiscal year 2024. - Strengthening the Company’s management team with the hiring of Dr. Parag Patil, a renowned neurosurgeon as Chief Medical Advisor, effective May 12, 2025, and Emily Johns, a partner at Honigman LLP, as General Counsel and Secretary, effective June 1, 2025.
- Secured significant media interest, including recent features on Fox News 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
“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 of seizure freedom in June 2025.
- Completed initial training of Zimmer Biomet team at national sales meeting in February. We continue to work closely with Zimmer Biomet and our physician advisors on advanced training and education for this novel combination diagnostic and therapeutic procedure.
- Product exhibited by Zimmer Biomet at the American Association of Neurological 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 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 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 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 markets to-date, representing a potentially significant revenue opportunity.
Second Quarter Financial Results
Product revenue was
Product gross profit increased significantly to
Total operating expenses were
Net loss in the second quarter of fiscal 2025 improved to
As of March 31, 2025, the Company had cash and cash equivalents of
In the second quarter of fiscal 2025, the Company sold common stock under the ATM Program at an average price of
Full Fiscal Year 2025 Financial Guidance
The Company continues to expect product revenue for fiscal year 2025 to range between
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 Contact
MZ Group – MZ North America
NMTC@mzgroup.us
NeuroOne Medical Technologies Corporation
Balance Sheets
(unaudited)
| As of | ||||||||
| March 31, | September 30, | |||||||
| 2025 | 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, | — | — | ||||||
| Common stock, | 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 | ||||
NeuroOne Medical Technologies Corporation
Statements of Operations
(unaudited)
| For the Three Months Ended | For the 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 | ||||||||||||
FAQ
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When does NeuroOne expect potential FDA clearance for its OneRF Trigeminal Nerve Ablation System?
