NeuroOne Medical Technologies Corporation Q4 FY2025 earnings call

• Fiscal year 2025 was the most successful year in company history with record product sales growth, reduced operating expenses, improved gross margins, and a $8.2 million capital raise.
• Received FDA 510(k) clearance for the OneRF trigeminal nerve ablation system, advanced spinal cord stimulation electrode development for lower back pain, and initiated basivertebral nerve ablation program.
• Reported sales of first preclinical drug delivery devices to a large pharma company, strengthened infrastructure with senior hires, initiated ISO 13485 certification process, and bolstered IP portfolio with multiple patent allowances.
• In Q4 2025, product revenue up 907% to $2.7 million, gross margins at 55.8%, operating expenses reduced by 2%.
• Drug delivery program gaining physician interest, pain management platforms with two active programs, and trade show participation with technology presentations.

In the fourth quarter of fiscal 2025, product revenue increased 907% to $2.7 million compared to $0.3 million in the fourth quarter of fiscal 2024. For the full fiscal year 2025, product revenue rose 163% to $9.1 million from $3.5 million in fiscal 2024. License revenue in fiscal 2025 was $3 million, which was not present in 2024. Product gross profit in Q4 2025 was $1.5 million, or 55.8% of revenue, compared to $0.1 million, or 51.8% of revenue in Q4 2024. For the full fiscal year 2025, product gross profit was $5.1 million, or 56.5% of revenue, versus $1.1 million, or 31.3% of revenue in fiscal 2024. Total operating expenses in Q4 2025 decreased 2% to $2.9 million from $3.0 million in the prior year. For the full fiscal year 2025, total operating expenses decreased 5% to $12.4 million from $13.0 million in fiscal 2024.

• Plan to provide fiscal 2026 financial guidance once final forecast from distribution partner Zimmer Biomet is received.
• NASDAQ granted 180-day extension until May 4, 2026, to regain compliance with minimum bid price rule for NASDAQ Capital Market listing.

• Forward-looking statements involve known and unknown risks, uncertainties, and factors that could cause actual results to differ from projections. Specific risks detailed in SEC filings, though not extensively discussed in the call beyond general forward-looking statement disclaimer.

Q: Destiny on for Jeff asked about face pain procedures, if more would be done prior to year-end and feasibility of stacked procedures.

A: Dave Rosa said there are 3 other centers with planned cases, some waiting for ancillary equipment, but more cases likely this month; both initial cases were back-to-back and feasible moving forward.

Q: Destiny on for Jeff asked about drug delivery orders from large pharma, visibility, and expansion.

A: Dave Rosa said midyear should see additional preclinical testing unit shipments, focusing on manufacturing validation for midyear preclinical device shipping.

Q: Destiny on for Jeff asked about epilepsy registry timing.

A: Dave Rosa said protocol makes sense, but sites have internal processes taking months to longer, expecting Q2 for paperwork and site sign-offs after AES meeting in December.

Q: Destiny on for Jeff asked about patient awareness strategies for 2026.

A: Dave Rosa said partnering with Cure and Epilepsy Foundation, using stories like a professional pianist who resumed career after procedure to increase visibility.

Q: Anthony Vendetti asked about Zimmer Biomet distribution agreement expansion, lower back pain development programs.

A: Dave Rosa explained lower back pain has two programs: paddle electrode program partnering with larger companies to piggyback on PMA, and basivertebral nerve ablation system leveraging brain ablation generator; Zimmer Biomet not involved in current back pain strategic discussions as they divested spine business.

Q: Anthony Vendetti asked about navigating reimbursement challenges.

A: Dave Rosa said brain ablation has cost advantages with bedside procedures avoiding operating room costs, neurosurgeons seeing value, and reimbursement codes not being a hindrance to adoption so far.