NeuroOne Medical Technologies Corporation (NMTC) Earnings

Management highlights

• Core Commercial Product Progress - OneRF brain ablation system achieved 72% year-over-year revenue growth in Q2 FY2026, with positive published clinical outcomes for epilepsy patients. The company is developing a clinician webinar to expand provider awareness, and completed the Stage 2 audit for ISO 13485 certification, which is on track for H2 2026 to enable international distribution. OneRF was highlighted at the American Association of Neurological Surgeons meeting via partner Zimmer Biomet. - OneRF trigeminal nerve ablation system, which received FDA 510(k) clearance and entered limited market release, has successfully completed 16 procedures to date with all patients reporting post-procedure pain relief. The device's single-placement design (with multiple electrode contacts) reduces patient discomfort and shortens procedure times compared to traditional systems. The trigeminal neuralgia treatment market is valued at approximately $780 million. • Pipeline Development Milestones - Drug delivery platform remains on track for commercial availability for investigational/animal studies in H2 FY2026. The company announced a research collaboration with University of Minnesota Medical School to evaluate next-generation epilepsy therapies using the platform, and is currently evaluating distributors for future commercialization. - Basivertebral nerve ablation system (for lower back pain) completed user design requirements and initiated preclinical testing in the quarter. The program leverages existing OneRF hardware and outsources access tools via vendors/partners. - Spinal cord stimulation percutaneous paddle lead program (for lower back pain) concluded chronic animal testing, identified performance enhancements to implement, and generated strong physician interest after being displayed at the North American Neuromodulation Society (NANS) meeting. • Corporate Updates - Appointed David Wambeke as Chief Business Officer to lead the drug delivery program, oversee investor relations, and support business development; Wambeke purchased 1 million pre-split common shares to signal confidence. - Regained compliance with NASDAQ's minimum bid price requirement following a 1-for-6 reverse stock split. - A new high net worth investor acquired approximately 7.4% of the company's outstanding common stock on the open market. - Announced a planned CFO transition: current CFO Ron McClurg will retire effective June 30, 2026, and remain as a senior advisor through year-end 2026. Current COO Chris Volker will assume the CFO role effective July 1, 2026.

Guidance

• Previously issued full-year FY2026 product revenue guidance of 10.5% growth remains unchanged. This guidance does not include any expected revenue contributions from the newly launched trigeminal nerve ablation system or the upcoming drug delivery platform. • Management does not expect material revenue contribution from the drug delivery platform in FY2026, as commercial availability will occur late in the fiscal year. Any contribution from the trigeminal nerve ablation system will depend on how quickly a broader commercial partnership agreement is finalized. • ISO 13485 certification, required to enable international commercial distribution, remains on track for completion in the latter part of 2026. • Drug delivery system commercial availability for investigational and animal studies remains on track for the second half of FY2026.

Segment performance

The only reported product segment is OneRF, which generated $2.4 million in product revenue in Q2 FY2026, representing 100% of total product revenue for the quarter. This reflects a 72% year-over-year increase from the $1.4 million in OneRF product revenue recorded in Q2 FY2025. For the 6 months ended March 31, 2026, total OneRF product revenue was $5.3 million, a 13% year-over-year increase from $4.7 million in the same prior-year period. Product gross profit for Q2 FY2026 was $1.3 million, equal to 53.8% of total product revenue, compared to $0.8 million (55.6% of product revenue) in Q2 FY2025. For the first 6 months of FY2026, product gross profit was $2.9 million (54.0% of product revenue), compared to $2.7 million (57.9% of product revenue) in the prior-year period. No separate revenue is reported for the company's pipeline segments (trigeminal nerve ablation, drug delivery, back pain management) as they are not yet commercially available for broad sale.

Risks & headwinds

• No specific operational failures were discussed during the call. The standard pre-call disclaimer notes that forward-looking statements involve inherent known and unknown risks and uncertainties that could cause actual future results to differ materially from management's current projections, and investors are referred to the company's SEC filings for full details of specific risk factors. • The company has a limited cash balance: as of March 31, 2026, cash and cash equivalents totaled $2.8 million, down from $6.6 million at the end of September 2025. While the company holds no debt, it may need to secure additional financing to fund ongoing operations and product development. • International commercial launch depends on successful completion of ISO 13485 certification and subsequent regulatory approval processes in target markets, which have uncertain timing and outcomes. • Revenue from new products is dependent on successful partnership negotiations, adoption by physicians, and favorable reimbursement conditions, all of which carry uncertainty.

Analyst Q&A

• Q: What work remains to complete the drug delivery platform, and why is the company pursuing a distributor model for commercialization? /

  A: The only remaining tasks are completion of sterilization testing and packaging validation, which takes approximately 3 months. Once finished, the product will be available for shipping for animal studies and approved human investigational device exemption studies. NeuroOne does not have an in-house direct sales force for this segment, so partnering with distributors that already serve the target market is the optimal initial commercialization strategy, particularly for animal research use. Multiple research institutions have already expressed interest in studying therapies on the platform.\n\nQ: How has the OneRF trigeminal nerve ablation commercial strategy evolved, and what procedural scheduling trends are being seen? / A: The commercial strategy has not changed: NeuroOne continues to target a future partnership for broader launch while opening new clinical centers on its own in the interim. Scheduling trends have held steady: trigeminal procedures are far easier to schedule in batches than brain ablation procedures, as no extended pre-procedure workup to identify seizure foci is required, and physicians can stack multiple cases in a single day.\n\nQ: What is the international commercialization strategy for OneRF following planned ISO certification, and are initial target markets identified? / A: NeuroOne plans to launch internationally with existing partner Zimmer Biomet, which holds distribution rights for certain geographies under their current agreement. For additional geographies where Zimmer does not have rights, NeuroOne will partner with other third-party distributors. The company is working with Zimmer to finalize the list of initial target markets, prioritizing countries that accept existing FDA clearance to avoid additional regulatory testing requirements, and expects to share more details next quarter.\n\nQ: How is NeuroOne driving physician adoption of the OneRF trigeminal nerve ablation system, and what is the timeline for the spinal cord stimulation paddle lead program? / A: NeuroOne primarily targets centers that already have an installed OneRF generator, and the same physicians that perform brain ablation procedures also perform trigeminal ablation. Adoption is driven by strong early clinical data (16 successful procedures, all patients pain-free post-treatment) and the device's clinical advantage over competitors: single probe placement with multiple contacts reduces patient discomfort and shortens procedure times. For the percutaneous paddle lead program, no public timeline has been set yet. The team is currently implementing performance enhancements identified in chronic animal testing, and a timeline will likely be shared within the next 1-2 quarters.