NeuroOne Reports Fiscal Q3 2026 Results: Revenue Up 16%, Orders Surge, and Key Milestones Set Stage for Growth

NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) reported financial results for the third quarter of fiscal year 2026, showcasing a 16% year-over-year increase in product revenue to $2.0 million and a record gross margin of 59.9%. The company also received $2.7 million in new product orders during the quarter, significantly outpacing shipments and boosting backlog to $1.7 million. These results underscore the growing demand for NeuroOne's innovative neurological devices and the company's improving operational efficiency.

The company has now received $11.2 million in product orders for fiscal year 2026, with recognized revenue expected to range from $9.2 million to $10.5 million. This indicates robust market traction and a strong pipeline of orders, although manufacturing and shipment timing will influence final revenue figures. NeuroOne is actively collaborating with manufacturing partners to maximize shipments through the end of the fiscal year, aiming to convert as much of the backlog as possible.

A significant achievement in the quarter was the receipt of ISO 13485:2016 certification, which enables the company to commercialize its products internationally. This certification, received ahead of schedule, is a critical step for global expansion and opens up new market opportunities for NeuroOne's product portfolio. The company plans to selectively target international markets, leveraging this certification to drive revenue growth beyond domestic sales.

In the drug delivery segment, NeuroOne expects its StereoCED™ platform to be available for animal research and FDA IDE approved studies by the end of fiscal year 2026. The company recently 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, positioning NeuroOne to capitalize on this emerging market.

The company has also expanded its drug delivery collaborations with the Mayo Clinic and the University of Minnesota. The Mayo Clinic study, funded by CURE Childhood Cancer, will evaluate a novel treatment for pediatric diffuse midline glioma (DMG), a challenging brain cancer. The University of Minnesota study will test next-generation epilepsy therapies delivered locally into specific brain regions. These collaborations validate the versatility of the StereoCED™ platform and its potential to address various neurological conditions.

In the brain ablation space, NeuroOne’s OneRF® system received positive coverage in the Journal of Neurosurgery, with a study from the Mayo Clinic in Jacksonville, Florida concluding that the system can be used safely in patients with implanted neuromodulation devices. This expands the treatable patient population and could drive additional adoption of the technology. The company also expects to enroll the first patient in its post-market registry by the end of September, with five centers currently participating.

Financially, NeuroOne reported a net loss of $2.0 million for the quarter, compared to a net loss of $1.5 million in the prior-year period. The increase in net loss is attributed to higher operating expenses, particularly in selling, general, and administrative costs, which rose to $2.2 million from $1.6 million due to increased headcount, sales and marketing efforts, and professional fees. However, the company's cash position remains solid with $2.0 million in cash and cash equivalents as of June 30, 2026, and no debt outstanding.

Looking ahead, NeuroOne is focused on several key initiatives: launching the StereoCED™ drug delivery platform, expanding the OneRF® product line, onboarding independent distributor reps for the trigeminal nerve ablation system, selecting a partner for the basivertebral nerve ablation access tools, and planning for international expansion. These efforts are expected to drive growth and solidify the company's position in the neurological device market.

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%, 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."

The company's strategic progress is further underscored by its addition to the Russell Microcap Index in June 2026, reflecting increased investor confidence and market visibility. Additionally, a lead investor increased its ownership stake from 7.4% to 12.5% subsequent to quarter end, signaling strong belief in the company's future prospects.

With a robust pipeline, expanding clinical evidence, and a clear roadmap for international growth, NeuroOne is well-positioned to capitalize on the growing demand for minimally invasive neurological solutions. The company's focus on innovation and strategic partnerships is expected to drive long-term value for shareholders and, more importantly, improve outcomes for patients suffering from neurological disorders.