NeuroOne Reports Fiscal Q3 2026 Results: Revenue Up 16%, Backlog Grows, and Drug Delivery Platform Nears Launch

NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) reported financial results for the third quarter of fiscal year 2026, showing a 16% year-over-year increase in product revenue to $2.0 million. The company also announced that product orders outpaced shipments, resulting in a backlog of $1.7 million as of June 30, 2026. This demand signals growing adoption of its neuromodulation and ablation technologies.

The company achieved a record product gross margin of 59.9%, up from 53.9% in the same quarter last year, driven by a 29% increase in product gross profit to $1.2 million. This margin expansion reflects a more favorable sales mix and operational efficiencies. Net loss for the quarter was $2.0 million, 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 period. As of June 30, 2026, cash and cash equivalents totaled $2.0 million, with no debt outstanding.

Operationally, NeuroOne received ISO 13485:2016 certification, a key milestone for international commercialization. The certification, received ahead of schedule, allows the company to pursue opportunities in global markets. Additionally, a study published in the Journal of Neurosurgery by Mayo Clinic in Jacksonville evaluated the OneRF® Brain Ablation System in patients with implanted neuromodulation devices, concluding that the procedure can be performed safely and effectively, expanding the treatable patient population.

The company expects its StereoCED™ drug delivery platform to be available for animal research and FDA IDE approved studies by the end of fiscal year 2026. This platform leverages robotic stereotactic systems to deliver therapeutics directly to the brain, potentially reducing procedure time and addressing barriers to commercial delivery of brain therapies. The timing is significant as the first potential blockbuster intraparenchymal brain-delivered therapy could receive FDA approval as early as 2027.

NeuroOne has also expanded collaborations with Mayo Clinic and the University of Minnesota. With Mayo Clinic, the company will support a CURE Childhood Cancer-funded study for pediatric diffuse midline glioma, a highly aggressive brain cancer. With the University of Minnesota, NeuroOne will advance a study on next-generation epilepsy therapies using its drug delivery platform. These collaborations highlight the platform’s potential in treating difficult neurological conditions.

In the basivertebral nerve ablation program, the company is in advanced discussions with a tier-one strategic partner to develop and supply access tools for the system, which targets lower back pain. The regulatory strategy is complete, with an expected FDA 510(k) pathway. Additionally, the OneRF® Trigeminal Nerve Ablation System is gaining interest, with new center evaluations and distributor interviews underway.

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.”

Looking ahead, NeuroOne has received product orders for fiscal year 2026 totaling $11.2 million, and expects recognized revenue to range from $9.2 million to $10.5 million, depending on manufacturing and shipment timing. The company is working closely with manufacturing partners to maximize shipments. Subsequent to quarter end, the lead investor increased its ownership from 7.4% to 12.5%, reflecting confidence in the company’s trajectory.

With the ISO certification, international expansion is planned, and the company is strategically positioned to capitalize on its innovative technologies. The addition to the Russell Microcap Index also enhances its visibility among investors. NeuroOne continues to focus on advancing its pipeline and expanding its commercial footprint, driven by its mission to improve outcomes for patients with neurological disorders.

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