NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) announced its financial results for the fiscal third quarter ended June 30, 2026, revealing a 16% increase in product revenue to $2.0 million compared to $1.7 million in the same period last year. The company also reported record gross margins of 59.9%, up from 53.9% in the prior-year quarter, driven by a 29% increase in product gross profit to $1.2 million. This margin expansion reflects a more favorable sales mix toward higher-margin products.
Orders continued to outpace shipments, with the company receiving $2.7 million in new product orders during the quarter, a 43% year-over-year increase, and ending the quarter with a backlog of $1.7 million. For fiscal year 2026, NeuroOne has received product orders totaling $11.2 million, and management expects recognized revenue to range between $9.2 million and $10.5 million, depending on manufacturing completion and shipment timing. The company is working closely with manufacturing partners to maximize shipments and fulfill backlog.
Operationally, NeuroOne achieved ISO 13485:2016 certification in August 2026, ahead of schedule, which enables the company to commercialize its products internationally, subject to additional country-specific requirements. This certification is a significant milestone, signaling adherence to internationally recognized quality management standards and opening near-term commercial opportunities abroad.
The Journal of Neurosurgery published a study by Mayo Clinic in Jacksonville, Florida, evaluating the use of NeuroOne's OneRF Brain Ablation System in patients with implanted neuromodulation devices. The study concluded that these procedures can be performed without interfering with existing hardware, providing meaningful seizure reduction and expanding the pool of treatable patients.
NeuroOne's StereoCED drug delivery platform is expected to be available for animal research and FDA IDE-approved studies by the end of fiscal year 2026. The company released a white paper titled "StereoCED - A Scalable Platform for CNS Drug Delivery," highlighting its potential to reduce procedure time and address barriers to commercial delivery of brain therapeutics. This comes as the first potential blockbuster intraparenchymal brain-delivered therapy could receive FDA approval as early as 2027.
In collaboration with Mayo Clinic, NeuroOne will supply devices for a CURE Childhood Cancer-funded study evaluating a novel treatment for pediatric diffuse midline glioma (DMG), an aggressive childhood brain cancer. The study will utilize the StereoCED platform, which combines precision intracranial drug delivery with simultaneous neural recording. Additionally, NeuroOne is collaborating with the University of Minnesota to advance a study on next-generation epilepsy therapies using StereoCED for local drug delivery to specific brain regions, aiming to improve efficacy and reduce systemic toxicity.
The company is also advancing discussions with a tier-one potential strategic partner for the development and supply of access tools for its basivertebral nerve ablation system to treat lower back pain. Regulatory strategy for this system is complete, with an expected FDA 510(k) pathway.
Financially, NeuroOne reported a net loss of $2.0 million, or ($0.23) per basic share, for the third quarter, compared to a net loss of $1.5 million, or ($0.19) per basic share, in the prior-year quarter. Operating expenses increased to $3.6 million from $2.8 million, driven by higher selling, general and administrative costs and research and development expenses. The company had cash and cash equivalents of $2.0 million as of June 30, 2026, and raised $0.4 million during the quarter through its at-the-market offering program. Subsequent to quarter end, the company raised an additional $1.0 million through the ATM program.
Dave Rosa, CEO of NeuroOne, commented, "This quarter marked another period of revenue growth compared to 2025, with product revenue increasing 16% year-over-year to $2.0 million. Importantly, this growth is improving margins – product gross margins reached a record 59.9%. Even more encouraging is that new product orders of $2.7 million during the quarter meaningfully outpaced revenue recognized, growing our backlog to $1.7 million." He added, "Looking at the rest of the fiscal year, there's a lot to be excited about: the launch of our StereoCED drug delivery platform, continued growth of the OneRF Brain Ablation System, and planning for international expansion."
The company's recent inclusion in the Russell Microcap Index and the increased ownership by its lead investor to 12.5% further underscore its growth trajectory. NeuroOne continues to focus on transforming the surgical diagnosis and treatment of neurological disorders with its innovative technologies.
