Release Date: December 17, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• NeuroOne Medical Technologies Corp (NASDAQ:NMTC) successfully achieved 510(k) clearance from the FDA for their OneRF Ablation System, marking it as the first and only FDA-cleared system for both electrical activity reporting and nervous tissue ablation.
• The company secured a strategic partnership with Zimmer Biomet, providing a broad distribution network in the US and certain international geographies.
• NeuroOne received a $3 million upfront license payment from Zimmer Biomet, with potential for additional milestone payments, strengthening their financial position.
• The company projects significant revenue growth for fiscal year 2025, with expected revenue between $8 million and $10 million, representing a 132% to 190% increase over 2024.
• NeuroOne is expanding its product applications, targeting additional indications such as RF ablation for facial pain and potentially lower back and knee pain, which could contribute to future revenue growth.

Negative Points

• Product revenue in the fourth quarter of fiscal 2024 decreased to $0.3 million from $0.7 million in the prior year due to the cancellation of a Zimmer Biomet purchase order.
• The company reported a net loss of $3.3 million for the fourth quarter of fiscal 2024, slightly higher than the $3.1 million net loss in the same period of the prior year.
• Cash and cash equivalents decreased significantly to $1.5 million as of September 30, 2024, from $5.3 million the previous year, indicating potential liquidity concerns.
• Working capital also decreased to $2.4 million as of September 30, 2024, compared to $5.5 million the previous year, which may impact operational flexibility.
• Despite the progress, the company remains non-compliant with Nasdaq's minimum bid price requirement, which could pose a risk to its stock listing.

Q & A Highlights

• Warning! GuruFocus has detected 2 Warning Signs with NMTC.

Q: Can you elaborate on the significance of the FDA clearance for the OneRF Ablation System? A: David Rosa, CEO: The OneRF Ablation System is the first and only FDA-cleared device intended for both reporting electrical activity and ablation of nervous tissue using the same device. This clearance, along with our strategic partnership with Zimmer Biomet, positions us strongly in the market and provides a broad distribution network in the US and certain international geographies.

Q: What are the expected financial impacts of the Zimmer Biomet partnership? A: David Rosa, CEO: We received an upfront license payment of USD3 million and anticipate additional milestone payments. The partnership is expected to boost sales and improve profitability, with projected revenue growth of 132% to 190% in fiscal year 2025.

Q: How is the OneRF Ablation System performing in clinical settings? A: David Rosa, CEO: The system has been used in 12 patients, with all experiencing either seizure freedom or significant reduction in seizure occurrence. We've completed over 150 RF ablations across five centers, and interest from epilepsy centers has doubled since last quarter.

Q: What are the future plans for expanding the OneRF Ablation System's applications? A: David Rosa, CEO: We are pursuing additional applications outside the brain, such as for trigeminal neuralgia. We plan to submit a 510(k) application to the FDA in the first half of 2025, potentially contributing to revenue that year.

Q: Can you provide an update on the financial performance for fiscal year 2024? A: Ronald McClurg, CFO: Product revenue increased by 77% to USD3.5 million compared to the previous year. Operating expenses decreased by 6%, and we completed a USD2.65 million private placement. We expect significant revenue growth and margin improvement in fiscal year 2025.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.