NeuroOne reports fiscal Q4 and full fiscal year 2023 financial results

NeuroOne Medical Technologies Corporation announces its operating results for the fiscal fourth quarter and full fiscal year ended September 30, 2023.

Fiscal fourth quarter 2023 and recent business updates
Financial highlights:

• Product revenue of $742,000 in Q4 2023, compared to $69,000 in Q4 2022
• Product revenue of $1,952,000 for FY 2023, compared to $171,000 for FY 2022
• Completed capital raise of $6M in July 2023 with net proceeds of $5.2M and raised an additional $2.5M using the ATM program at an average price of $1.77 per share

Evo^® sEEG:

• Zimmer Biomet expanded the launch to new centers as the sites receive internal approval to evaluate the Evo electrode product line
• Collected feedback remains positive
• Device sales and revenue ramp expected to continue quarter by quarter
• Completed additional sales training for Zimmer Biomet personnel

OneRF^™Ablation System:

• Received feedback from FDA on 510(k) submission in August 2023 and the Company responded to FDA questions in November 2023
• Received FDA clearance for OneRF Ablation System in December 2023
• Placed component orders for OneRF Ablation System for commercialization
• Presented poster on pre-clinical experience with the OneRF Ablation System at the Congress of Neurological Surgeons (CNS) Meeting in September 2023

Spinal Cord Stimulation Program:

• Completed test of an implantable pulse generator (IPG) to test electrode fluid ingress
• Successfully performed percutaneous placement of a 9mm paddle electrode in a human cadaver model with our physician advisory board
• Completed histological analysis of a 28-day implanted Company electrode

Drug Delivery Program:

• Defined product requirements for drug delivery system for both clinical and research use in the biotech and pharma industry
• Developed prototypes for future pre-clinical studies
• Initiated licensing discussion with gene therapy company for use in clinical studies
• Received patent for drug delivery system

Dave Rosa, CEO of NeuroOne, commented, “During and subsequent to our fiscal fourth quarter, the Company continued to execute at a high level on our strategic plan. We were proud to announce the FDA clearance of our OneRF Ablation System, the Company’s first device that has an indication for both recording electrical activity as well as ablation of nervous tissue and the first device with an FDA clearance. We believe this device has the capability to create a paradigm shift in neurosurgical procedures. We expect to commercially launch this product either directly or with a strategic partner in the first half of 2024. This represents the third FDA clearance in the Company’s history and a monumental achievement. In addition, Zimmer Biomet continues to expand the commercial launch of our Evo sEEG electrode as centers receive approval from their respective product committees to trial the technology. We continue to be bullish on the opportunity to deliver drugs or gene therapies and record the impact of these therapies using our sEEG electrode. We have already held discussions with a Company that has strong interest in using our electrode in their clinical trial to evaluate the performance of their therapy. The Company has made great strides in all areas, and I look forward to continuing to lead the Company as we execute our strategic plan.”

Upcoming targeted milestones
Evo sEEG:

• Complete full sales force training in early 2024
• Continued product roll-out to additional US centers

OneRF Ablation System:

• Develop commercialization plan for product launch
• Place stocking orders for system components
• Present at the Society of Neuroscience and American Epilepsy Society meetings

SCS Program:

• Complete animal protocol to evaluate stimulation and battery performance using the Company’s spinal cord stimulation electrode technology

Drug Delivery Program:

• Continue to gather product requirements for drug delivery system for both clinical and research use in the biotech and pharma industry
• Conduct large animal feasibility studies with drug delivery system into the brain
• Advance contract discussions with gene therapy company
• Investigate US regulatory pathway for device clearance

Fourth quarter and full fiscal year 2023 financial results
Product revenue was $742,000 in the fourth quarter of fiscal 2023 and $1,952,000 for the full fiscal year, compared to product revenue of $69,000 in the fourth quarter and $171,000 for the full year of fiscal 2022. The Company had no collaboration revenue in the fourth quarter of fiscal 2023 and $1,455,000 for the full year of fiscal 2023, compared to collaboration revenue of $1,942,000 in the fourth quarter and $1,949,000 for the full year of fiscal 2022. Collaboration revenue was derived from the Zimmer Development Agreement and represents the portion of the exclusivity and milestone fee payments eligible for revenue recognition during the respective periods.

Total operating expenses in the fourth quarter of fiscal 2023 were $3.4 million, compared with $3.3 million in the same period of the prior year. R&D expense in the fourth quarter of fiscal 2023 was $1.8 million compared with $1.4 million in the same period of fiscal 2022. SG&A expense in the fourth quarter of fiscal 2023 was $1.6 million compared with $1.9 million in the same period of the prior year.

Total operating expenses for the full fiscal year 2023 were $13.9 million, compared with $11.9 million in the prior fiscal year. R&D expense for the full fiscal year 2023 was $6.9 million compared with $4.9 million in fiscal 2022. SG&A expense for the full fiscal year 2023 was $6.9 million compared with $7.0 million in the same period of the prior year.

Net loss was $3.1 million for the fourth quarter of fiscal 2023, compared to a net loss of $1.4 million in the same period of the prior year. Net loss was $11.9 million for the full year fiscal 2023, compared to a net loss of $10.0 million in fiscal 2022.

On July 27, 2023, the Company completed an underwritten public offering of its common stock from which the Company received $5.2 million in net proceeds. In addition, the Company sold common stock under the ATM program at an average price of $1.77 per share, from which the Company received net proceeds of $2.5 million.

As of September 30, 2023, the Company had cash, cash equivalents, and short-term investments of $5.3 million, compared to $11.1 million as of September 30, 2022. The Company had working capital of $5.5 million as of September 30, 2023, compared to working capital of $9.1 million as of September 30, 2022.

The Company had no debt outstanding as of September 30, 2023.
MB Bureau