NeuroOne Medical Technologies Corporation

Ladies and gentlemen, thank you for standing by and welcome to the NeuroOne Medical Technologies Corporation first quarter fiscal year 2023 financial results conference call. Today's call will be conducted by the company's chief executive officer, Dave Rosa, and chief financial officer, Ron McClurg. Before I turn the call over to Mr. Rosa, I'd like to remind you that this conference call will include four linking statements within the meaning of U.S. federal securities laws with respect to future operations, financial results, events, trends, and performance, which are based on management's beliefs and assumptions as of today's call or other specified date. Four-licking statements may involve known and unknown risks, uncertainties, and other factors, which may cause actual results to differ materially from those expressed or implied by such statements. See NeuroOne's corporate update press release and SEC filings for information regarding specific risks and uncertainties that could cause actual results to differ. Except as required by law, we undertake no obligation to update such four-licking statements. With that said, I'll turn the call over to David Rosa, CEO of NeuroOne. Dave?

Thanks, Operator, and thanks, everyone, for your attendance today. During our first fiscal quarter, we achieved one of the most significant milestones in the company's history when we received FDA 510 clearance for the Evo SCEG electrode for less than 30 days use. Zimmer Biomet is still targeting the end of the first calendar quarter of 2023 to begin a limited commercial launch. We're particularly excited about the synergies that exist between using Zimmer's ROSA robotic platform with our Evo SCEG electrode. The company also shipped the initial Evo SCEG limited market release order to Zimmer Biomet during the first fiscal quarter and continue to manufacture product to meet additional orders for a future full product launch. We also made tremendous progress with our 1RF therapeutic ablation electrode system as we completed a successful animal feasibility study with Dr. Jamie Van Gompel at the Mayo Clinic in Rochester, Minnesota. The results confirm that the system is capable of both recording brain activity and ablating brain tissue using the same electrode. I am also pleased to report that we met our goal of completing the development of the system by the end of calendar year 2022. We are excited that the system is performing to our specifications and our final steps are to complete design validation testing. We also remain on target to submit a 510K application to the FDA early in the second calendar quarter of 2023. Now I'll discuss our efforts in developing electrodes that could be used for chronic stimulation and recording. Our focus remains on treating chronic back pain due to multiple failed back surgeries. Our goal is to offer a percutaneously placed paddle electrode that can be deployed in a comparable manner to existing percutaneous systems while offering an increased stimulation area, improved conformability, and lower energy requirements. We have already developed and tested percutaneous delivery system prototypes that have received positive feedback from key opinion leaders. The company also engaged in discussions with potential strategic partners and are exploring opportunities to expand our offerings to other markets. While there is nothing definitive yet regarding these discussions, I am pleased to see the level of interest in our technology. We are also continuing to explore the potential for our technology to offer the ability to deliver genes or drugs, as well as record the agent's impact to the patient. We expect to conduct preclinical feasibility studies to assess the device's potential but are enthusiastic based on physician feedback to date. The company was also active with poster presentations highlighting the EVO-SEG electrode performance at the following meetings, Congress of Neurological Surgeons, Society of Neuroscience, and the American Epilepsy Society. Our products were also displayed at the Zimmer Biomed booth at the CNS and AES meetings. We will continue to target key society meetings to present our data in an effort to increase our exposure. And relating to increased exposure, I also had the pleasure of being interviewed on the show, Mornings with Maria, during the quarter as well. In addition, the company was invited to ring the NASDAQ stock market closing bell to celebrate the FDA clearance milestone for the Evo SCEG technology. Thanks for your time and attention. I would like to now turn the call over to Ron McClurg for a more in-depth review of our fiscal first quarter financial results. Ron? Thank you, Dave.

Product revenue was $115,000 in the first quarter of fiscal 2023, compared to product revenue of 34,000 in the first quarter of fiscal 22. We had collaboration revenue of 1.46 million in the first quarter of fiscal 23, compared to collaboration revenue of $6,000 in the first quarter of fiscal 22. Collaboration revenue is derived from the Zimmer development agreement and represents the portion of the exclusivity licensing payment that is eligible for revenue recognition as of December 31st, 2022. Total operating expenses in the first quarter of fiscal 23 were 3.2 million compared with 2.8 million in the same period at the prior year. R&D expense in the first quarter was 1.6 million compared with 1.1 million in the same period of fiscal 2022. SG&A expense in the first quarter of fiscal 2023 was 1.66 million compared with 1.74 million in the prior year period. We had a net loss of 1.7 million or 11 cents per share for the first quarter of fiscal 23, compared to a net loss of 2.8 million or 18 cents a share in the first quarter of fiscal 22. As of December 31st of 22, the company had cash and short-term investments of 7.6 million compared to 11.1 million as of September 30th, 2022, our most recent fiscal year end. The company had no debt outstanding as of December 31st, 2022. That concludes my remarks. I'll now pass it back to the operator to open up the call for Q&A.