NeuroOne Medical Technologies (US:NMTC)2023-08-14 23:26Financial Data and Key Metrics Changes - Product revenue for Q3 2023 was $630,000, a significant increase from $32,000 in Q3 2022, and for the first nine months of fiscal 2023, product revenue reached $1.2 million compared to $102,000 in the same period of fiscal 2022 [4][16] - Collaboration revenue for the first nine months of fiscal 2023 was $1.46 million, up from $6,000 in the same period of fiscal 2022, derived from the Zimmer Development Agreement [4] - Total operating expenses in Q3 2023 were $3.8 million, compared to $2.8 million in Q3 2022, with R&D expenses at $1.9 million and SG&A expenses also at $1.9 million [4][16] - The net loss for Q3 2023 was $3.5 million, compared to a net loss of $2.8 million in the prior year period, with a total net loss of $8.7 million for the first nine months of fiscal 2023 [16] Business Line Data and Key Metrics Changes - The company has made progress with the Evo sEEG electrode limited launch, completing the targeted number of cases and training Zimmer Biomet field sales personnel [3] - The OneRF ablation system has had a 510(k) application submitted to the FDA, with expectations for commercialization in the first half of 2024 [3] Market Data and Key Metrics Changes - The company has received its first order for calendar year 2024 product supply from Zimmer Biomet, indicating positive market reception [3] Company Strategy and Development Direction - The company is evaluating direct commercialization of its devices and has ongoing discussions with strategic organizations regarding licensing technology [14] - There is a focus on developing a spinal cord stimulation program to treat chronic back pain, with successful animal testing completed [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in addressing FDA's questions regarding the OneRF ablation system and remains optimistic about the commercialization timeline [10] - The company anticipates a reduction in operating cash burn as development costs decrease [4] Other Important Information - As of June 30, 2023, the company had cash and cash equivalents of $3.1 million, down from $8.1 million at the end of the previous fiscal year [16] - The company raised $5.2 million from a public offering and $2.5 million from an ATM program since January 2023 [16] Q&A Session Summary Question: Can you speak to the training that Zimmer has done in the field for the depth electrode alongside the ROSA robot? - Over half of Zimmer's sales force has been trained on the device, and the rollout to additional centers depends on hospital committee approvals [17] Question: How is Zimmer thinking about adding the ablation electrode to their portfolio? - There has been no pre-announcement on expected EVO sales for 2024, and the focus is on getting the device cleared through the FDA before determining the impact [19][24] Question: Can you expand on the FDA submission regarding labeling and additional information requests? - The company received fewer questions than in previous submissions, indicating a positive outlook on addressing the FDA's requests [10][26]