NeuroOne Medical Technologies (US:NMTC)2023-08-14 20:06Financial Performance - As of June 30, 2023, the company had an accumulated deficit of $59.6 million, primarily due to research and development expenses and interest expenses [131]. - The company reported a net loss of $8.7 million for the nine months ended June 30, 2023, compared to a net loss of $8.6 million in the same period of 2022 [170]. - Product revenue for the three months ended June 30, 2023, was $629,906, a significant increase of $597,857 from $32,049 in the same period of 2022 [162]. - The gross profit for product revenue during the three months ended June 30, 2023, was $243,666, compared to a gross loss of $(6,413) in the same period of 2022, reflecting improved sales volume [165]. - Collaborations revenue increased to $1.5 million for the nine months ended June 30, 2023, from $6,374 in the same period of 2022, primarily due to the Zimmer Development Agreement [174]. - Research and development expenses rose to $5.2 million for the nine months ended June 30, 2023, compared to $3.5 million in the same period of 2022, an increase of $1.7 million attributed to development activities [176]. - Selling, general and administrative expenses were $5.3 million for the nine months ended June 30, 2023, up from $5.1 million in the same period of 2022, reflecting a $0.3 million increase [175]. Cash Flow and Liquidity - As of June 30, 2023, the company had cash and cash equivalents of approximately $3.1 million, indicating ongoing liquidity challenges [180]. - As of June 30, 2023, the company had cash and cash equivalents totaling approximately $3.1 million, raising substantial doubt about its ability to continue as a going concern [191]. - Net cash used in operating activities for the nine months ended June 30, 2023, was $10.0 million, compared to $8.5 million for the same period in 2022, reflecting an increase in cash outflow [195][196]. - The company reported net cash provided by financing activities of $2.2 million for the nine months ended June 30, 2023, a significant decrease from $12.0 million in the same period of 2022 [200]. - The net cash provided by investing activities was $2.7 million for the nine months ended June 30, 2023, primarily from maturities of short-term investments [198]. - The company expects to satisfy its short-term and long-term obligations through cash on hand and future equity and debt financings until it generates adequate revenue from commercial sales [189]. - The company may need to secure additional funding through collaborations or partnerships, as existing cash may not be sufficient to fund operations for the next twelve months [191]. Product Development and Commercialization - The company commenced commercial sales of cEEG strip/grid and electrode cable assembly products in the first quarter of fiscal year 2021, and sEEG depth electrode products in late calendar 2022 [129]. - The company announced the commercial launch of the Evo® sEEG electrode product line in May 2023, fulfilling eight shipments to distribution partner Zimmer Biomet [134]. - The company submitted a 510(k) application to the FDA for the OneRF ablation system in June 2023, following successful usability testing with 15 neurosurgeons [136]. - The company has entered into a development and distribution agreement with Zimmer, which includes an upfront exclusivity fee payment of $2.0 million and a subsequent payment of $3.5 million in August 2022 [149]. - The company completed design verification of new hardware for its diagnostic and ablation depth electrode in early Q2 2023 [128]. - The company is developing a spinal cord stimulation program, having completed an initial animal implant of novel thin film paddle leads during Q2 2023 [137]. - The company has received FDA 510(k) clearance for its Evo cortical technology for temporary use in recording, monitoring, and stimulating brain tissue [127]. - The company anticipates generating additional revenue from the sale of products based on Evo cortical technology [142]. - The company recognized revenue of $1.5 million for the sEEG exclusivity maintenance milestone during the nine months ended June 30, 2023, compared to $6,000 in the same period of 2022 [153]. - The company has received regulatory clearance to expand the use of its Evo sEEG electrode technology for up to 30 days, but significant commercial sales are expected to take time [190]. Future Outlook - The company expects to continue incurring significant expenses and increasing operating losses until it generates higher revenue from commercial sales [132]. - The company anticipates significant increases in selling, general and administrative expenses to support research and development and commercialization efforts [157]. - The development and commercialization of the company's technology are subject to numerous uncertainties, and it may use cash resources sooner than expected [192]. - The net cash used in operating activities was partially offset by non-cash stock-based compensation and other adjustments totaling approximately $1.0 million for the nine months ended June 30, 2023 [196].