NEUROONE MEDICAL TECHNOLOGIES Corp

DEF 14A 1 def14a0124_neuroone.htm PROXY STATEMENT

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

SCHEDULE 14A

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Proxy Statement Pursuant to Section 14(a)

of the Securities Exchange Act of 1934

(Amendment No.______)

Check the appropriate box:

NeuroOne Medical Technologies Corporation

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January 29, 2024

Dear Valued Shareholders,

We would like to extend a warm welcome to you to attend our 2024 annual meeting of stockholders, to be held at 7599 Anagram Dr., Eden Prairie, MN 55344, on March 14, 2024 at 9:00 a.m. local time.

Fiscal 2023 was a transformational year for NeuroOne in advancing our platform technology, including cortical strip and grid and sEEG electrodes for both diagnostic and therapeutic applications. We are well positioned as we enter 2024 to capitalize on key near-term and longer-term opportunities.

NeuroOne’s robust product portfolio has recently expanded beyond our two families of diagnostic products, the Evo® Cortical Electrode and the Evo® sEEG Depth Electrode systems, to now include our first combination diagnostic and therapeutic product offering, the OneRF® Ablation System. We believe this system, with combination diagnostic and therapeutic functionality, has the capability to create a paradigm shift in neurological surgical procedures. During fiscal 2023, we also made significant progress with our product development programs for drug delivery and spinal cord stimulation, as well as progress in assessing additional market opportunities for our platform technology.

The purpose of this letter is to share with you the key highlights from the past year, as well as to highlight several exciting catalysts for NeuroOne in fiscal year 2024.

Fiscal Year 2023 and Subsequent Highlights

• U.S. Food and Drug Administration (FDA) clearance and commercial launch of our Evo® sEEG Electrodes. Following FDA 510(k) clearance in October 2022, we initiated the commercial launch of our diagnostic Evo® sEEG (stereoelectroencephalography) electrodes with our distribution partner Zimmer Biomet in May 2023. The initial limited launch was well received by customers, prompting the Company and Zimmer Biomet to expand the launch to new accounts. This represents the second NeuroOne product family to be commercialized following our line of Evo® cortical electrodes. The Evo® sEEG product portfolio is marketed for temporary (less than 30 days) diagnostic use for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain. Engineered for accuracy, the Evo® sEEG electrodes enhance physicians’ ability to precisely identify the problematic brain tissue which is triggering the patient’s seizures. This diagnostic information is then used by the neurosurgeon to guide therapies in an effort to reduce or eliminate the patient’s seizures. The worldwide market for our diagnostic electrodes is currently estimated to be over $100 million USD.

• FDA clearance of our OneRF® Ablation System, the first and only FDA-cleared sEEG-RF system representing NeuroOne’s first FDA-cleared therapeutic device. We submitted a 510(k) application for the OneRF® Ablation System in June 2023 and received FDA clearance in December 2023. This represents the third NeuroOne product family to receive FDA clearance. Our team’s achievement in reaching this milestone was the culmination of years of perseverance, and we could not be more excited given this was a goal of the Company when we incorporated in 2017. Designed to both record brain activity and ablate nervous tissue with temperature control using our same Evo® sEEG electrode, the OneRF® Ablation System offers the potential for a safer and less expensive combination diagnostic and therapeutic electrode platform technology. Intended to improve patient outcomes, reduce follow up procedures and reduce

overall costs, this system is our first approved therapeutic device, representing the next major phase in our Company’s development, and is the first and only radiofrequency combination ablation system cleared by the FDA for use in the brain. We estimate the current brain ablation market to be at least $100 million worldwide and growing rapidly, with the potential to grow multifold based on large addressable patient populations with unmet clinical needs. We also will explore other potential markets outside of the brain that could benefit from nervous tissue ablation.

• Significant progress in the development of our drug delivery system. Our drug delivery device is designed to leverage our sEEG electrode platform to monitor neural activity before, during and for up to 30 days following delivery of therapeutic agents such as pharmaceuticals, gene therapy and stem cell therapy. Our drug delivery device would be a first-of-kind device that can deliver therapeutic or diagnostic agents to the brain via the lumen of our sEEG electrodes while also having the capability to stimulate and record before, during and after the application, thereby measuring the impact to the brain. We also believe this system to be useful during the development of these pharmacologic therapies. Key milestones completed include: i) feasibility bench top testing, ii) feasibility animal study with sEEG recordings and drug delivery, iii) initiated discussions with potential strategic partners, and iv) we received a patent for our drug delivery system. Given the large patient populations for broader neurologic disorders, we believe drug delivery represents a very large market opportunity with unmet needs, including for clinical research, which can be addressed with our sEEG electrode technology.

• Continued development of percutaneous electrodes for chronic spinal cord stimulation. Our initial target market for this chronic implant platform technology is the spinal cord stimulation market which is estimated to be a $3 billion market opportunity worldwide. We are designing our percutaneous (non-surgical placement) electrode platform to enable expanded tissue coverage while requiring equivalent or less battery energy as compared to standard electrodes placed percutaneously. Key milestones completed include: i) bench testing of percutaneous delivery system for paddle leads, ii) cadaver study with three physicians to assess feasibility of the percutaneous method in humans, iii) multiple acute animal implants to study thin-film lead placement in the epidural space and electrode/tissue interface in the short term,

iv) sub-chronic (28-day) animal implants without any adverse events or neurological complications, followed by histological evaluation of the implanted tissue, and v) and we filed non-provisional patents for a conformable thin-film paddle lead and for the percutaneous implantation method.

• Several NeuroOne scientific publications and presentations completed in addition to Evo® electrode family being exhibited at key congresses. Our technology and data were presented to the scientific and clinical community at several U.S. and global meetings including the American Epilepsy Society, the Congress of Neurosurgical Surgeons, the International Brain Stimulation Conference, the Neurological Disorders Summit, the North American Neuromodulation Society, and the Society of Neuroscience. We also exhibited our Evo® electrode product family with Zimmer Biomet at the annual meetings for the American Association of Neurosurgeons, the American Epilepsy Society and the Congress of Neurological Surgeons.

• Strengthened the Company’s financial profile and secured capital resources to support upcoming commercial and product development catalysts. Driven by the commercial launch of our Evo® sEEG electrodes, Product Revenue increased from $171,169 in fiscal year 2022 to $1,952,441 in fiscal year 2023. In July 2023, we completed an underwritten public offering of common stock, with net proceeds of $5.2 million. In addition, the Company sold common stock under the ATM program at an average price of $1.77 per share, from which we received net proceeds of $2.5 million during fiscal year 2023. Subsequent to our fiscal year end, the Company sold additional shares under the ATM program at an average price of $1.46 per share and received net proceeds of $2.8 million. With the pending commercial launch of our OneRF® Ablation System, we are poised to further strengthen our financial profile in fiscal year 2024.

Fiscal Year 2024 Potential Catalysts

• Growth in Evo® sEEG Electrodes utilization. The limited launch of our Evo® sEEG electrodes was initiated less than nine months ago and we anticipate continued growth in new accounts and utilization in 2024. We are working closely with Zimmer Biomet on a steady cadence of training sales reps and physicians and opening new accounts.

• Commercial launch of OneRF® Ablation System. We expect to commercially launch the OneRF® Ablation System either directly or with a strategic partner in the first half of calendar 2024. In addition to having a first-to-market opportunity with our therapeutic ablation system, we anticipate that the launch of the OneRF® Ablation System will also accelerate utilization of Evo® sEEG electrodes for diagnostic purposes.

• Secure drug delivery strategic partnerships. We are actively exploring strategic partnerships to leverage our platform technology to deliver therapeutic agents in the brain during clinical studies and research. We believe the opportunity exists to secure partnerships in fiscal 2024 with companies engaged in clinical studies of therapeutic and diagnostic agents (pharmaceuticals, gene therapies and stem cell therapies) in the brain that would benefit from the ability to monitor brain activity pre-delivery, during delivery and post-delivery of agents. In fiscal 2024, we plan to complete device qualification for our drug delivery device to be used in clinical studies and research.

• Advance Spinal cord stimulation (SCS) electrode development. In fiscal 2024, we plan to complete design verification of our spinal cord stimulation product and explore potential strategic partnership opportunities.

• Exploration of new indications. We believe there are additional applications in neurology as well as potential applications in cardiovascular, orthopedic, and pain-related indications that could benefit from our high-fidelity, thin-film electrode technology platform that can provide recording and/or stimulation and/or ablation capabilities. We will selectively identify additional applications to pursue either directly or via strategic partnerships.

In closing, fiscal 2023 was a transformational year for NeuroOne, including commercialization of our full diagnostic electrode portfolio, regulatory approval of our first combination diagnostic and therapeutic system, continued advances with our product pipeline, and we completed financings to achieve our objectives. As we enter fiscal 2024, we are well positioned to continue executing meaningful advances with our platform electrode technology. Our focus remains on developing innovative solutions for patients suffering from epilepsy and other neurological disorders.

On behalf of our Board of Directors and employees, we thank you for your continued support of NeuroOne and wish you and your family a wonderful 2024.

Sincerely,

President and Chief Executive Officer

NeuroOne Medical Technologies Corporation

NOTICE OF 2024 ANNUAL

MEETING OF STOCKHOLDERS

• We currently intend to hold the Annual Meeting in person. However, in the event we determine it is not possible or advisable to hold the Annual Meeting in person, we will publicly announce alternative arrangements for the Annual Meeting as promptly as practicable before the Annual Meeting. Please monitor our website atwww.nmtc1.com for updated information.

Sincerely,

President and Chief Executive Officer

Eden Prairie, Minnesota

January 29, 2024

NEUROONE MEDICAL TECHNOLOGIES CORPORATION

PROXY STATEMENT FOR 2024 ANNUAL MEETING OF STOCKHOLDERS