NEUROONE MEDICAL TECHNOLOGIES Corp Q4 FY2024 earnings call

• Achieved FDA 510(k) clearance for the OneRF Ablation System and secured a strategic partnership with Zimmer Biomet, including a $3 million upfront license payment.
• OneRF Ablation System is the first and only FDA cleared system for both reporting electrical activity and ablation of nervous tissue. Extended partnership with Zimmer Biomet provides broad distribution.
• 12 patients have had OneRF Ablation procedures, with all either seizure free or showing significant reduction in seizures. 24 epilepsy centers requested proposals, doubling from prior quarter.
• New ICD-10-PCS code for OneRF ablation procedure effective October 1, 2024, to support reimbursement.
• Pursuing additional RF Ablation applications, including trigeminal neuralgia, with plan to submit 510(k) to FDA in first-half 2025.
• Progress on spinal cord stimulation program with optimized percutaneous paddle lead and discussions with potential partners.
• Advancing sEEG based drug delivery program, preparing 510(k) application and developing miniaturized device.

Product revenue in the fourth quarter of fiscal 2024 was $1.3 million, compared to $1.7 million in the prior year fourth quarter. For fiscal year 2024, product revenue increased 77% to $3.5 million, up from $2 million in fiscal year 2023. Collaboration revenue in fiscal 2023 was $1.5 million from the Zimmer Development Agreement. Total operating expenses decreased 12% to $3 million in the fourth quarter of fiscal 2024 compared to $3.4 million in the prior year fourth quarter. For the full fiscal year 2024, total operating expenses decreased 6% to $13 million, down from $13.9 million in fiscal year 2023. R&D expense decreased 39% to $1.1 million in the fourth quarter of fiscal 2024 compared to $1.8 million in the prior year fourth quarter; for the full fiscal year 2024, R&D expense decreased by 27% to $5.1 million, down from $6.9 million in fiscal year 2023. SG&A expense was $1.8 million in the fourth quarter of fiscal 2024 compared to $1.6 million in the prior year fourth quarter; for fiscal year 2024, SG&A expense was $7.9 million, up from $6.9 million in fiscal year 2023. Net loss was $3.3 million for the fourth quarter of fiscal 2024 compared to $3.1 million in the prior year fourth quarter; for the full fiscal year 2024, net loss was $12.3 million, up from $11.9 million in fiscal year 2023. As of September 30, 2024, cash and cash equivalents were $1.5 million compared to $5.3 million as of September 30, 2023, and working capital was $2.4 million compared to $5.5 million as of September 30, 2023.

• Fiscal year 2025 revenue expected to be $8 million to $10 million, representing 132% to 190% growth over 2024.
• Gross margins for fiscal year 2025 projected to be between 47% and 51%, compared to 31% in 2024.

• Forward-looking statements involve known and unknown risks, uncertainties, and factors that could cause actual results to differ.
• NeuroOne intends to monitor closing bid price of common stock between now and January 7, 2025, to regain NASDAQ compliance.