NeuroOne Reports Second Quarter Fiscal Year 2022 Financial Results and Provides Corporate Update

NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) ("NeuroOne" or the "Company"), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announces its operating results for the second quarter of fiscal year 2022 ended March 31, 2022.

• Evo® sEEG electrode first commercial order is in inventory and ready to ship pending FDA clearance for less than 30 day duration of use.  The Evo sEEG electrode was already 510(k) cleared for temporary (less than 24 hours) use.
• Filed appeal with the FDA regarding their decision related to the Company`s request for clearance for less than 30 day use of NeuroOne`s Evo® sEEG Electrode. Appeal meeting between NeuroOne and the FDA was held on April 14^th, 2022.
• Participated in Zimmer Biomet`s physician advisory board meeting with prominent neurosurgeons to perform usability testing of Evo sEEG implant accessories.
• Initiated the process to qualify a second source to manufacture electrodes for Evo® Cortical and sEEG product lines to increase manufacturing capacity and reduce supply risk for both product lines.
• Initiated cost reduction program for cable assembly.
• Exhibited our Evo Cortical electrode product family at the University of Minnesota Neuromodulation Symposium and presented at the Gordon Research Conference 2022 Neuroelectronic Interfaces Meeting.
• Announced positive five-year bench top results in stimulation testing of electrodes designed for use in spinal cord stimulation for patients suffering with chronic back pain.
• Completed prototypes for RF ablation system as well as planning phase with our hardware partner RBC Medical Systems which remains on schedule to submit to FDA in the first quarter of calendar year 2023 for commercial clearance.
• Appointed Maria Vomero, PhD., a prominent scientist and expert in thin film electrode technology to drive the Company`s spinal cord stimulation program, further strengthening the development team.
• NeuroOne featured on "The Claman Countdown," an American financial program airing on the Fox Business Network.
• Presented at the 34^th Annual Roth Capital Partners Conference and the Oppenheimer 32^nd Annual Virtual Healthcare Conference.

Dave Rosa, CEO of NeuroOne commented, "In September 2021, NeuroOne received FDA 510(k) clearance for our Evo sEEG product line for less than 24 hour use.  Although the FDA did not provide clearance for longer term use for our sEEG product line, the Company remains confident that the product met ISO 10993 "Biological Evaluation of Medical Devices - Part 12 and Part 18" requirements for biocompatibility which was the basis of the Company appealing the FDA decision. We appreciated the FDA`s willingness to hear our appeal which occurred on April 14^th, 2022. We continue to remain ready to fulfill our initial stocking order to Zimmer Biomet upon an FDA clearance for less than 30 day use.  Additionally, the development of our RF ablation electrode and hardware remains on schedule as we expect to complete system prototypes by the end of the third calendar quarter of 2022. We are still targeting submitting for 510(k) clearance for RF ablation in early calendar year 2023. Cost reduction programs are underway for our cable assembly line, next generation connector and validation of a new electrode supplier in order to ensure the ability to meet supply requirements to Zimmer Biomet. Our team remains enthusiastic and determined as we make progress across a number of key commercial and product development objectives for 2022."

• Evo sEEG Depth Diagnostic Electrode
• FDA decision on Company`s appeal regarding the FDA`s denial for clearance of the Evo sEEG product line for less than 30 day use.
• Qualification of second source for manufacturing of the Evo Cortical and sEEG electrode product lines.
• Completion of validation of new cable assembly providing significant cost reduction for the specific component.
• Completion of design verification to extend the shelf life for cortical electrode product line to 3 years and sEEG product line to 2 years.
• RF Ablation system
• Generator prototype expected by the end of the third calendar quarter of 2022.
• Completion of additional feasibility testing planned on sEEG RF probe, temperature accessory, and RF connection box expected in September 2022.
• Submit 510(k) application to the FDA in early calendar year 2023.
• Completion of physician advisory board for spinal cord stimulation program.
• Partner with research organization to develop electrode for new clinical indication.
• Chronic Use Electrode
• Report additional accelerated aging test results for chronic stimulation electrodes.

Product revenue was $37,000 in the second quarter of fiscal 2022, compared to product revenue of $18,000 in the second quarter of fiscal 2021.  Collaboration revenue was delayed in the second quarter of fiscal 2022 due to the FDA decision, compared to collaboration revenue of $20,000 in the second quarter of fiscal 2021. Collaboration revenue was derived from the Zimmer Development Agreement and represented the portion of the upfront initial development fee payment eligible for revenue recognition as of March 31, 2022.

Total operating expenses in the second quarter of fiscal 2022 were $3.0 million, compared with $2.4 million in the same period of the prior year.  R&D expense in the second quarter was $1.8 million, compared with $1.3 million in the same period of fiscal 2021.  SG&A expense in the second quarter of fiscal 2022 was $1.2 million, compared with $1.1 million in the prior year period.

Net loss was $3.1 million for the second quarter of fiscal 2022, compared to a net loss of $2.4 million in the second quarter of fiscal 2021. 

As of March 31, 2022, the Company had cash of $12.9 million, compared to $16.2 million at December 31, 2021 and $6.9 million at September 30, 2021, our fiscal year end.