NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) reported financial results for the third quarter of fiscal year 2026, ended June 30, 2026. The company posted product revenue of $2.0 million, a 16% increase year-over-year, and product gross margins expanded to 59.9%, a record high for the company. Notably, new product orders reached $2.7 million during the quarter, outpacing recognized revenue and contributing to a backlog of $1.7 million.
The company has received product orders totaling $11.2 million for fiscal year 2026, with recognized revenue expected to range from $9.2 million to $10.5 million, depending on manufacturing and shipment timing. NeuroOne is working closely with its manufacturing partners to maximize shipments and reduce backlog. The strong order flow underscores sustained demand for its OneRF® ablation systems.
In addition to financial performance, NeuroOne achieved a significant regulatory milestone by receiving ISO 13485:2016 certification ahead of schedule. This certification enables the company to commercialize its products internationally, opening up new market opportunities. The company is now planning targeted international expansion, which could provide a substantial growth avenue in the near term.
On the clinical front, the Journal of Neurosurgery published an article by the Mayo Clinic in Jacksonville, Florida, evaluating NeuroOne's OneRF® Brain Ablation System in patients with implanted neuromodulation devices. The study concluded that the procedures may be performed safely without interfering with existing hardware and provided meaningful seizure reduction. This expands the potential patient pool to include those with existing implants, broadening the market for the system.
NeuroOne also provided updates on its StereoCED™ drug delivery platform, which 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 highlighting the platform's potential to significantly reduce procedure time and address key barriers to scalable commercial delivery of brain therapeutics. This comes at a pivotal time as the first potential blockbuster intraparenchymal brain-delivered therapy could receive FDA approval as early as 2027.
The company has expanded its drug delivery collaborations, including a partnership with Mayo Clinic to support a CURE Childhood Cancer funded research program for pediatric diffuse midline glioma (DMG), and with the University of Minnesota to study next-generation epilepsy therapies using the StereoCED™ platform. These collaborations validate the platform's potential and could lead to new therapeutic applications.
Additionally, NeuroOne is advancing discussions with a tier-one potential strategic partner for its basivertebral nerve ablation system, targeting lower back pain. The company has completed its regulatory strategy and expects to pursue an FDA 510(k) pathway. This program represents another growth opportunity for the company.
"This quarter marked another period of revenue growth compared to 2025, with product revenue increasing 16% year-over-year to $2.0 million," said Dave Rosa, CEO of NeuroOne. "Importantly, this growth is improving margins – product gross margins reached a record 59.9%, driven by a 29% increase in product gross profit to $1.2 million compared to the prior year period. Even more encouraging is that new product orders of $2.7 million during the quarter meaningfully outpaced revenue recognized during the quarter, growing our backlog to $1.7 million."
Looking ahead, the company has several catalysts, including the launch of the StereoCED™ platform, continued growth of the OneRF® Brain Ablation System, onboarding independent distributor reps for the OneRF® Trigeminal Nerve Ablation System, selecting a partner for the basivertebral nerve ablation access tools, and planning for international expansion. These initiatives are expected to drive revenue growth and expand the company's market presence.
Financially, NeuroOne reported a net loss of $2.0 million for the quarter, or $0.23 per basic share, 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. As of June 30, 2026, the company had cash and cash equivalents of $2.0 million and working capital of $3.7 million, with no debt outstanding.
Subsequent to quarter-end, the lead investor increased its ownership from 7.4% to 12.5%, and the company raised an additional $1.0 million through its at-the-market offering program. These actions provide additional capital to support ongoing operations and growth initiatives.
Overall, NeuroOne's fiscal Q3 2026 results demonstrate solid revenue growth, improved profitability, and significant strategic progress. The company is well-positioned to capitalize on upcoming catalysts, including the launch of its drug delivery platform and international expansion, which could drive long-term shareholder value.
