Financial 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]

Financial 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].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-40439 NeuroOne Medical Technologies Corporation (Exact name of Registrant as specified in its charter) (State or Ot ...

NeuroOne Medical Technologies Corporation (NASDAQ:NMTC) Q1 2023 Earnings Conference Call February 14, 2023 4:30 AM ET Company Participants Dave Rosa - President and CEO Ron McClurg - CFO Conference Call Participants Alex Nowak - Craig Hallum Capital Group Ben Haynor - Alliance Global Partners Operator 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 ...

Financial Performance - As of December 31, 2022, the company had an accumulated deficit of $52.6 million, primarily due to research and development expenses and interest expenses [122]. - The company recognized revenue of $1,455,188 during the three months ended December 31, 2022, related to the completion of the sEEG exclusivity maintenance milestone [139]. - Product revenue for the three months ended December 31, 2022, was approximately $114,579, compared to $33,748 for the same period in 2021, representing an increase of 80,831 [148]. - Collaborations revenue increased significantly to $1,455,188 for the three months ended December 31, 2022, from $6,374 in the prior year, marking an increase of 1,448,814 [148]. - The net loss for the three months ended December 31, 2022, was $1,732,769, a decrease of $1,074,706 compared to a net loss of $2,807,475 for the same period in 2021 [148]. - The net loss for the three months ended December 31, 2022, was $1.7 million, partially offset by approximately $0.3 million in non-cash expenses [173]. - The net decrease in cash for the three months ended December 31, 2022, was $3.5 million, contrasting with an increase of $9.3 million in the same period of 2021 [172]. Expenses and Cash Flow - The company expects to continue incurring significant expenses and increasing operating losses until a higher level of revenue from commercial sales is achieved [123]. - Research and development expenses rose to $1,563,496 for the three months ended December 31, 2022, up from $1,060,462 in the same period of 2021, reflecting an increase of $503,034 [153]. - Selling, general and administrative expenses remained stable at $1,663,737 for the three months ended December 31, 2022, compared to $1,742,141 in the prior year, showing a decrease of $78,404 [148]. - Net cash used in operating activities was $3.5 million for the three months ended December 31, 2022, compared to $2.7 million for the same period in 2021, indicating an increase in cash outflow [173][174]. - Net cash used in financing activities was $16,000 for the three months ended December 31, 2022, compared to net cash provided of $12.0 million in the same period of 2021 [178]. - The cash use from changes in operating assets and liabilities for Q4 2022 was primarily due to a decrease in deferred revenue and an increase in inventory purchases [173]. Development and Agreements - The company commenced commercial sales of cEEG strip/grid and electrode cable assembly products in the first quarter of fiscal year 2021, with sEEG depth electrode products launched in late calendar 2022 [120]. - The company entered into a development and distribution agreement with Zimmer, which included an upfront payment of $2.0 million and a subsequent payment of $3.5 million in August 2022 [134]. - The company is responsible for all development activities under the Zimmer Development Agreement, while Zimmer handles commercialization costs [132]. - The company is targeting the first quarter of 2023 for design verification of new hardware for its diagnostic and ablation depth electrode [119]. - The company anticipates generating additional revenue from the sale of products based on Evo cortical technology [127]. - The company has received FDA 510(k) clearance for its Evo cortical technology and Evo sEEG electrode technology, enhancing its product offerings [118][139]. Future Outlook and Concerns - The company anticipates significant increases in research and development expenses in the coming years to support the development of its cortical strip, grid electrode, and depth electrode technologies [144]. - The company has substantial doubt about its ability to continue as a going concern, necessitating additional funding through equity or debt financings [169]. - The company has been affected by global economic conditions, including the COVID-19 pandemic and increased inflation, which may impact future capital raising efforts [125][126]. - The company has entered into a Capital on Demand Sales Agreement allowing for an aggregate offering price of up to $14.5 million, with no issuances of securities having occurred to date [157]. Accounting and Financial Reporting - The financial statements are prepared in accordance with U.S. generally accepted accounting principles, requiring estimates and judgments that may affect reported amounts [179]. - The company continues to evaluate its accounting policies and practices in light of recent accounting pronouncements [185]. - The company incurred deferred issuance costs related to the ATM in Q4 2022 [178]. - The company has not experienced significant variable consideration adjustments related to product revenue to date [180].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-K (Mark One) (Address of principal executive offices) (Zip Code) ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ Commission file number 001-40439 NeuroOne Medical Technologies Corporation (Exact name of Registrant as specified in its charter) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fisca ...

NeuroOne Medical Technologies Corporation (NASDAQ:NMTC) Q4 2022 Results Conference Call December 13, 2022 4:30 PM ET Company Participants Dave Rosa - President and Chief Executive Officer Ron McClurg - Chief Financial Officer Operator Ladies and gentlemen, thank you for standing by. And welcome to the NeuroOne Medical Technologies Corporation Corporate Update Conference Call. Today's call will be conducted by the company's Chief Executive Officer, Dave Rosa; and Chief Financial Officer, Ron McClurg. Before ...

NeuroOne Medical Technologies Corporation (NASDAQ:NMTC) Q3 2022 Earnings Conference Call August 11, 2022 5:30 PM ET Company Participants Dave Rosa - President and Chief Executive Officer Ron McClurg - Chief Financial Officer Conference Call Participants Alexander Nowak - Craig-Hallum Capital Group Ben Haynor - Alliance Global Partners Operator Ladies and gentlemen, thank you for standing by. And welcome to the NeuroOne Medical Technologies Corporation Third Quarter of Fiscal Year 2022 Financial Results Conf ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-40439 NeuroOne Medical Technologies Corporation (Exact name of Registrant as specified in its charter) (State or Oth ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-40439 NeuroOne Medical Technologies Corporation (Exact name of Registrant as specified in its charter) Delaware 27- ...