UNITED

STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

Form

10-K

(Mark

One)

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended September 30, 2024

☐

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)

(Address of principal executive offices) (Zip Code)

952-426-1383

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol Name of each exchange on which registered

Common Stock, $0.001 par value per share NMTC The Nasdaq Stock Market LLC

Securities

registered pursuant to Section 12(g) of the Act: None

Indicate

by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate

by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒

Indicate

by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange

Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)

has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate

by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule

405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant

was required to submit such files). Yes ☒ No ☐

Indicate

by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting

company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”

“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ Accelerated filer ☐

Non-accelerated filer ☒ Smaller reporting company ☒

Emerging growth company ☐

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate

by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness

of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered

public accounting firm that prepared or issued its audit report. ☐

securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registration

included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate

by check mark whether any of those error corrections are restatement that required a recovery analysis of incentive-based compensation

received by an of the registrant’s executive officers during the relevant recovery period pursuant to § 240.10D-1(b). ☐

Indicate

by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

As of March 28, 2024, the last business day of

the registrant’s most recently completed second fiscal quarter, the aggregate market value of shares of the registrant’s common

stock held by non-affiliates of the registrant based upon the March 28, 2024 price at which the common equity was last sold was $30.3

million. The number of outstanding shares of the registrant’s common stock as of December 13, 2024 was 30,841,830.

DOCUMENTS

INCORPORATED BY REFERENCE

Parts

of the Proxy Statement for the Registrant’s 2025 Annual Meeting of Stockholders to be filed subsequently are incorporated by reference

into Part III of this Annual Report on Form 10-K.

NeuroOne

Medical Technologies Corporation

FORM 10-K

FOR

THE FISCAL YEAR ENDED SEPTEMBER 30, 2024

TABLE

OF CONTENTS

Page

PART I. 1

ITEM 1. BUSINESS 1

ITEM 1A. RISK FACTORS 27

ITEM 1B. UNRESOLVED STAFF COMMENTS 57

ITEM 1C. CYBERSECURITY 57

ITEM 2. PROPERTIES 57

ITEM 3. LEGAL PROCEEDINGS 57

ITEM 4. MINE SAFETY DISCLOSURES 57

ITEM 6. [RESERVED] 58

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 70

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA F-1

ITEM 9A. CONTROLS AND PROCEDURES 71

ITEM 9B. OTHER INFORMATION 72

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 72

PART III 73

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 73

ITEM 11. EXECUTIVE COMPENSATION 73

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 73

ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 74

SIGNATURES 78

NeuroOne

Medical Technologies Corporation

FORM

10-K

SPECIAL

NOTE REGARDING FORWARD-LOOKING STATEMENTS

Unless

the context requires otherwise, references in this Annual Report on Form 10-K (this “Annual Report” or “Report”)

to “we,” “us,” “the Company” and “our” refer to NeuroOne Medical Technologies Corporation

(the “Company”).

This

Annual Report contains forward-looking statements that involve substantial risks and uncertainties. The forward-looking statements are

contained principally in the sections entitled “Risk Factors,” “Management’s Discussion and Analysis of Financial

Condition and Results of Operations” and “Business,” but are also contained elsewhere in this Annual Report. In some

cases, you can identify forward-looking statements by the words “may,” “might,” “will,” “could,”

“would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,”

“believe,” “estimate,” “predict,” “project,” “potential,” “target,”

“seek,” “contemplate,” “continue” and “ongoing,” or the negative of these terms, or other

comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties

and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from

the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each

forward-looking statement contained in this Annual Report, we caution you that these statements are based on a combination of facts and

factors currently known by us and our expectations of the future, about which we cannot be certain. Forward-looking statements include

statements about:

● our ability to maintain regulatory clearance of our products and technology;

● our ability to successfully commercialize our technology in the United States;

● our ability to achieve or sustain profitability;

● our ability to raise additional capital and to fund our operations;

● our ability to develop future generations of our products and technology;

● our future development priorities;

● our ability to comply with applicable regulatory requirements;

NeuroOne

Medical Technologies Corporation

FORM

10-K

● our ability to maintain our intellectual property position;

Forward-looking

statements are based on management’s current expectations, estimates, forecasts and projections about our business and the industry

in which we operate, and management’s beliefs and assumptions are not guarantees of future performance or development and involve

known and unknown risks, uncertainties and other factors that are in some cases beyond our control. You should refer to the “Risk

Factors” section of this Annual Report for a discussion of important factors that may cause our actual results to differ materially

from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking

statements in this Annual Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the

inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these

statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time

frame, or at all.

These

forward-looking statements speak only as of the date of this Annual Report. Except as required by law, we assume no obligation to update

or revise these forward-looking statements for any reason, even if new information becomes available in the future. You should, however,

review the factors and risks and other information we describe in the reports we will file from time to time with the Securities and

Exchange Commission (the “SEC”) after the date of this Annual Report.

iii

NeuroOne

Medical Technologies Corporation

FORM

10-K

PART

ITEM

1. BUSINESS

Overview

are a medical technology company focused on (i) diagnostic, ablation and deep brain stimulation technology for brain related conditions

such as epilepsy and Parkinson’s disease; (ii) ablation and stimulation for pain management throughout the body; and (iii) drug

delivery including diagnostic and stimulation capabilities.

are developing and commercializing thin film electrode technology for continuous electroencephalogram (“cEEG”) and stereoelectrocencephalography

(“sEEG”), spinal cord stimulation, brain stimulation, drug delivery and ablation solutions for patients suffering from epilepsy,

Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other pain-related neurological

disorders. The Company is also developing the capability to use its sEEG electrode technology to deliver drugs or gene therapy while

being able to record brain activity before, during, and after delivery. Additionally, we are investigating the potential applications

of its technology associated with artificial intelligence.

have received 510(k) clearance for three of our devices from the Food and Drug Administration (“FDA”), including: (i) our

Evo cortical electrode technology for recording, monitoring, and stimulating brain tissue for up to 30 days, (ii) our Evo sEEG electrode

technology for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring,

and stimulation of electrical signals at the subsurface level of the brain, and (iii) our OneRF ablation system for creation of radiofrequency

lesions in nervous tissue for functional neurosurgical procedures. We have a distribution agreement with Zimmer, Inc. (“Zimmer”)

providing Zimmer with a license to commercialize and distribute these three products in the brain. The Company’s other products

and indications are still under development.

Products

are focused on developing thin film electrode technology for continuous electroencephalogram (“cEEG”) and stereoelectroencephalography

(“sEEG”) recording. These cortical sheet and depth electrode technologies are crucial for diagnosing neurological disorders

such as epilepsy, Parkinson’s disease, dystonia, essential tremors, and other related conditions.

Diagnostic,

ablation and deep brain stimulation technology for brain related conditions such as epilepsy and Parkinson’s disease

NeuroOne

Medical Technologies Corporation

FORM

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Drug

delivery including diagnostic and stimulation capabilities

Ablation

and stimulation for pain management throughout the body

completed an initial animal implant of novel thin film paddle leads for SCS, intended for treating chronic back pain. Our SCS system

utilizes thin-film paddle leads to deliver precise electrical stimulation to the spinal cord, blocking pain signals and providing relief

to patients with FBSS. During the second fiscal quarter of 2023, we achieved a significant milestone with the initial animal implant

of these novel leads. Additionally, we are developing a percutaneous delivery system for paddle leads, which has shown promising results

in bench testing.

Furthermore,

we are pursuing the development of “all-in-one solutions”. We intend to expand our product offerings to include less

invasive means and all-in-one solutions, thus providing both patients and physicians better options to treat epilepsy, Parkinson’s

disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other pain-related neurological disorders.

believe that most of our future product development initiatives will involve unique and transformational next generation technology that

should drive further appeal of our products with both physicians and patients.

Our

Market Opportunity

Epilepsy

Market

expect to initially target the diagnosis and treatment of epilepsy. Epilepsy can be caused by a variety of conditions that affect a person’s

brain, some of which are: stroke, brain tumor, traumatic brain injury and central nervous system infections. According to the Centers

for Disease Control and Prevention (the “CDC”) and Citizens United for Research in Epilepsy (“CURE”), there are

approximately 3,000,000 patients annually suffering with epilepsy in the United States, with an additional 200,000 diagnosed every year.

The CDC and CURE also estimate that epilepsy costs the United States $15.5 billion per year. Approximately 30-40% of these patients are

not receptive to pharmaceutical treatment and therefore are appropriate for surgical treatment of this disorder. In addition to poor

quality of life, epilepsy also is associated with fairly high mortality rates. Sudden Unexpected Death in Epilepsy has an annual incidence

of approximately 1/1000 in epilepsy patients. Despite the large market opportunity, it is estimated that there are only less than 5,000

epilepsy surgeries performed each year in the United States.1

These

numbers represent an underpenetrated market due to the invasiveness of diagnostic procedures. After the diagnostic procedure, a second

therapeutic procedure is required and at times even a third surgery if the seizures persist. We believe patients are unwilling to proceed

due to the long diagnostic and treatment procedure times (one to four weeks in the hospital after a potential craniotomy for diagnosis).

As detailed above, after the diagnosis is completed, if successful, the patient must undergo an additional procedure to have the affected

area of brain tissue ablated or removed. The average cost for the diagnostic technology per procedure could be >$10,000, with ablation

devices costing >$15,000. We believe our technology, once developed, will offer an all-in-one solution with diagnostic and therapeutic

capabilities.

NeuroOne

Medical Technologies Corporation

FORM

10-K

Many

leading neurologists believe that the limits of today’s current technologies are the reason the exact affected area of the brain

causing epileptic seizures is not well-determined. We believe our technology provides a number of advantages over other commercially

available technologies, including the following:

Parkinson’s

Disease

The

Parkinson’s Disease Foundation estimates that as many as 1,000,000 patients in the United States live with Parkinson’s disease

with an additional 60,000 patients diagnosed per year. Over 10,000,000 patients worldwide are living with Parkinson’s disease.

There have not been any drugs introduced that have been effective at treating all patients with Parkinson’s disease. The average

onset is over 60 years old, but some people have been diagnosed as young as 40 years old. Parkinson’s is a disorder of the central

nervous system caused by loss of brain cells throughout various regions of the brain.

Today’s

primary treatment for Parkinson’s disease involves medications that have not proven to be curative but rather ease symptoms. One

of the potential treatments for Parkinson’s patients is DBS. According to the Michael J. Fox Parkinson’s Disease Research

Foundation website, patients that seem to do best with DBS are those that have had the disease for at least four years and have benefited

from taking medications prescribed to control the disease. In addition, DBS seems to help with reducing the issues with motor functions

such as tremors, stiffness and slowness but not for balance issues.

Essential

Tremors

Essential

tremors are thought to be due to electrical irregularities in the brain that send abnormal signals to the muscles. It is a progressive

condition that worsens over time and is linked to genetic disorders that typically appear in people who are over 40. Essential tremors

usually occur alone and without any other neurological symptoms or signs. The tremors usually occur when the hands are raised and primarily

affect the hands. Muscles in the trunk, face and neck may also experience symptoms. Sometimes misdiagnosed as Parkinson’s disease,

essential tremors are an involuntary rhythmic shaking of the hands that is not present at rest. It is apparent during activities such

as drinking, writing and eating. Symptoms can worsen due to stress, anxiety, smoking, caffeine, fatigue, etc. Genetics Home Reference

estimates that as many as 10,000,000 people in the United States are affected by the disease. Treatments for the disease include medical

therapy and DBS. DBS, which unlike other therapies, is reversible and programmable, helping to adjust the settings to maximize patient

benefit. Similar to Parkinson’s disease, the ability to detect this irregular brain activity before it causes a tremor is highly

desirable.

Dystonia

is a neurological condition recognized as a motion disorder that involves over activity of a variety of different muscles simultaneously

that work against each other. It presents itself in a variety of symptoms but typically involves repetitive, patterned and often twisting

involuntary muscle contractions resembling tremors. According to the Dystonia Medical Research Foundation, over 300,000 people are affected

in the United States and Canada alone. Dystonia is the third most common problem seen in movement disorder clinics. Because it has many

different manifestations, it is often misdiagnosed. In addition, similar to Parkinson’s disease, there are no specific tests that

can positively diagnose dystonia. A doctor typically will evaluate patient and family history, potentially do genetic testing, electroencephalogram

(“EEG”) testing, blood and urine tests. There are several treatment options (including medication and Botox) for patients

depending on the type of dystonia. DBS may be also an alternative for certain patient sub-types.

NeuroOne

Medical Technologies Corporation

FORM 10-K

Spinal

Cord Stimulation

Chronic

back pain is one of the most prevalent chronic conditions in the world. According to the CDC, “in 2016, an estimated 20.4% of U.S.

adults had chronic pain and 8.0% of U.S. adults had high-impact chronic pain. Chronic pain has been linked to numerous physical and mental

conditions and contributes to high health care costs and lost productivity”. FBSS is one of leading causes for chronic lower back/leg

pain due to one or more failed back surgeries. Typically, it is related to patients that suffer with pain after surgery of the lumbar

spine for degenerative disc disease. Re-operations are usually not recommended for these patients due to low success rates. These patients

experience greater levels of pain, a lower quality of life, varying levels of disability and higher rate of unemployment. Spinal cord

stimulation works by placing an electrode(s) in a targeted area of the spine which is then connected to an implantable pulse generator

that sends electrical stimulation to the electrode to block the pain signals from reaching the brain. The global market for SCS is substantial,

with an estimated value of approximately $2.5 to $3 billion.

The

back pain market includes the following indications: FBSS, Ischemic Limb Pain, and Complex Regional Pain Syndrome. Over half of this

market is comprised of patients with FBSS. Studies have indicated a benefit for some patients suffering from chronic back and lower limb

pain when they have been treated with electrical stimulation. Prior to the patient receiving an implant, they undergo a trial period

that allows them to determine if they are receiving relief from the therapy while preventing a surgery to implant the pulse generator

that provides the stimulation. If the trial period is successful, then the device is implanted in a follow-up procedure.

Artificial

Intelligence

The

brain consists of approximately 100 billion nerve cells, which are small wires that pass electrical signals to control all of its functions.

There have been a number of successful clinical trials in which small metal wires, known as electrodes, are implanted in the brain to

correct nerve damage using wireless communication between implanted wires to simulate functional nerve cells. In addition to correcting

damaged nerve cells, certain scientists have theorized that if millions of wires could be implanted in the brain, these electrodes could

present an opportunity to use artificial intelligence to create infrared sight, increase hearing or perfect memory recall. However, there

currently is no commercially available manufacturing platform capable of making thousands of wires that can be placed within or on the

brain and work reliably for the lifetime of a subject, and are soft enough to match the tissue of the brain, that avoid damage to the

brain.

Limitations

of Other Currently Available Therapies

There

are a limited number of currently available products for diagnosis and treatment for people with neurological disorders such as epilepsy.

Although the currently available systems provide diagnosis and treatment for patients, they have certain inherent limitations and shortcomings

that we believe limit their use and validate the need for improved technology in the market. These limitations include:

NeuroOne

Medical Technologies Corporation

FORM 10-K

Our

Solution

a result of the inherent limitations and inconvenience of existing systems, we believe that there is a significant unmet need among people

with neurological disorders for cortical strip, grid and depth electrodes that provide diagnostic capabilities through cEEG and sEEG

recording in addition to therapeutic modalities, such as brain stimulation and ablation, offered as an all-in-one product. In comparison

to other currently available technologies, we are continuing to develop applications of our strip, grid and depth electrodes with the

goal of providing the following expected advantages:

NeuroOne

Medical Technologies Corporation

FORM 10-K

Our

Strategy

Our

goal is to be the global leader in cEEG and sEEG recording, monitoring, deep brain and peripheral stimulation and ablation, owning the

procedure from diagnosis through treatment. The key elements of our strategy include:

NeuroOne

Medical Technologies Corporation

FORM 10-K

Our

Technology

Epilepsy

Mapping and Monitoring

Epileptic

seizures occur when the neurons in the brain miscommunicate. This miscommunication typically results in involuntary muscle seizure activities

and/or periods of perceptual disconnect where the individual appears frozen. Modern medical science has advanced the treatment of epileptic

seizures by mapping the electrical communication activity of neurons and understanding their special orientation in the brain. This mapping

is accomplished by access to the cranium (through a craniotomy) and placing conductive contacts on the brain directly. The craniotomy

procedure is very invasive, traumatic to the surrounding tissue, results in high patient down time, and increases the risk of infection.

seek to leverage scale-able technology and produce ultra-thin, or paper-thin electrodes that allow for high-resolution and high-definition

recordings, which would improve mapping resolution and signal acquisition. If the Company is able to leverage scale-able technology,

it would mean that our technology would be able to incorporate smaller electrodes and thereby increase the number of electrodes on a

given surface area. We expect that this would increase the imaging resolution so that brain activity is displayed in greater definition.

We also believe that the electrodes’ unique thinness and flexibility will provide a less invasive approach to electrode placement.

The electrodes would be able to be placed through a small quarter size hole instead of by an invasive full craniotomy procedure.

The

images under “Cortical Electrode,” from bottom to top, are images of our cortical electrode strip, our grid electrode, and

the placement of the grid electrode on the brain, respectively. The images under “High Density Interconnect” are both images

of our product that connects our electrodes to the head box, which is a piece of hardware that connects to electrodes to acquire, amplify,

display, store and archive electrophysiological signals, and is integrated as part of our manufactured electrode product. The images

under “Head Box” and “Signal Monitoring and Mapping” are images of the device which processes information received

through the high density interconnect, and a sample output of data acquisition, respectively, neither of which is one of the Company’s

products.

NeuroOne

Medical Technologies Corporation

FORM 10-K

Our

technology consists of three primary types of cortical electrodes: grid electrodes, strip electrodes and dual-sided electrodes. These

electrodes have a patented design that utilizes proprietary processing and materials technology, which we believe will allow the electrodes

to have improved features over the current industry standard recording electrodes.

What

sets our technology apart from others is the integration of state of the art design leveraging the latest in flexible printed circuit

technology. We believe our patented designs will provide the surgeon a higher tactile perspective on electrode placement allowing for

ultra-precise neuron recording. We expect the benefits of our electrode designs to include the ability to detect better defined margins

between healthy tissue and resect-able tissue, less immune-response from the brain and surrounding tissue, better signal acquisition

due to superior conformability of the electrode over the brain, improved flexibility that physicians have requested, which we expect

will enable a minimally invasive approach and the electrodes unique thinness that is unmatched by current products being used.

The

Future of Neurology Mapping with NeuroOne

seek to develop superior “scale-able” technology for future product system iterations in higher density contact placement.

This will open the doors to other brain related disease recording procedures by providing high fidelity, more accurate diagnostic capabilities

and also the ability to provide an all-in-one therapy capable of diagnosis, ablation and/or stimulation. Beyond the brain, we believe

our technology under development has applications in other neurological signal recording disease states related to voluntary or involuntary

motor neuron abnormalities, understanding sensory neuro behavior (pain), limb prosthetics and degenerative muscle disease.

Clinical

Development and Regulatory Pathway

Clinical

Experience, Future Development and Clinical Trial Plans

Our

sEEG Evo cortical electrode technology has received 510(k) clearance from the FDA in November 2019 for recording, monitoring, and stimulating

brain tissue for less than 30 days on the surface of the brain. Our Evo sEEG electrode technology has received FDA 510(k) clearance from

the FDA for use (less than 30 days) with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation

of electrical signals at the subsurface level of the brain. On December 6, 2023, we received 510(k) FDA clearance to market our OneRF

Ablation System for creation of radiofrequency lesion in nervous tissue for functional neurosurgical procedures. Our other products have

not received any clearance for commercialization by any U.S. or foreign regulatory body. In the future, we are planning on submitting

additional 510(k) clearance with the FDA for other ablation applications, as well as for neurological drug delivery.

date, the Company has performed a number of bench top (which includes feasibility testing) and pre-clinical tests (which include animal

testing of device placement, ergonomics, performance, ease of use, and other tests required by FDA regulations). As described in “Government

Regulation” below, the Company will be required to perform additional testing of its technology in connection with seeking additional

regulatory clearances or approvals.

intend to expand our product offerings to include less invasive means and all-in-one solutions, thus providing both patients and physicians

better options to treat epilepsy, Parkinson’s disease, dystonia, essential tremors, drug delivery, chronic pain due to failed back

surgeries and other pain-related neurological disorders. While we expect to make modifications to our initial system, we believe that

most of our future product development initiatives will involve unique and transformational next generation technology that should drive

further appeal of our products with both physicians and patients.

are utilizing a number of resources to develop these technologies as well as have hired additional employees with expertise in the respective

areas. We license three critical patents from Wisconsin Alumni Research Foundation (“WARF”) that are the foundation of the

technology and we are developing and intend to commercialize and benefit from the thin film technology know-how of Mayo Clinic doctors

through our license and development agreement. WARF, Mayo Clinic (cortical electrodes) and Cleveland Clinic (sEEG electrodes) have been

responsible for all pre-clinical studies of our technology under development to date. See “WARF License” and “Mayo

Foundation for Medical Education and Research License and Development Agreement” below. We announced in December 2020 that Mayo

Clinic doctors used our technology in the first human commercial application of our Evo cortical electrode technology to perform recording,

functional mapping and stimulation of the brain on a human patient. In July 2022, we announced the first clinical case using the Evo

sEEG electrode was performed by Dr. Robert Gross at Emory University. Dr. Gross selected the Evo sEEG electrode for intraoperative brain

mapping at the subsurface level of the brain.

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Medical Technologies Corporation

FORM 10-K

launched OneRF, demonstrating combined diagnostic and therapeutic technology for brain applications. We have also performed bedside ablations,

which can offer savings in operating room time and additional hospitalizations.

the first half of 2025, we expect to submit a 510(k) clearance with the FDA for an additional applications leveraging our RF generator

for brain ablations.

are also developing a device for brain monitoring and drug delivery capabilities using the same product. We have performed bench top

and animal experiments and successfully confirmed the proof of concept for this technology, which could be used to deliver drugs, genes,

or cell-based therapies to the brain. We are pursuing a 510(k) clearance with the FDA for brain cancer.

Below

we have summarized, for each component of our technology, the current stage of development or commercial production, the pre-clinical

testing done to date by WARF, the Cleveland Clinic or Mayo Clinic on such component, if any, our plans for further testing or clinical

trials and our expectations regarding the requirements for regulatory clearance or approval and timing of regulatory submissions.

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Technologies Corporation

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Collaborations

and Partnerships

Mayo

Clinic and University of Wisconsin-Madison Studies

Our

cortical technology for the diagnosis of epilepsy has been tested by doctors at Mayo Clinic in multiple pre-clinical tests conducted

from 2012 to 2017. In pre-clinical models, doctors examined the biological impact on mammalian brains. Polyimide substrate electrodes

(NeuroOne technology) were implanted on the pig’s brain for one week alongside standard competitive electrodes. The tissue underneath

the two types of electrodes was removed, fixed, stained, and examined for immunological responses. The results of a histological (evaluation

of brain tissue under a microscope) analysis showed reduced immunological reaction to prolonged polyimide substrate implants (NeuroOne

technology) compared to standard silicone substrate clinical electrodes. Electrophysiological recordings showed data obtained from polyimide

electrodes which demonstrated the feasibility of high fidelity multi-scale electrophysiology while also displaying easier deployment

of polyimide electrodes (NeuroOne technology) through minimally invasive burr holes.

Additionally,

doctors implanted our polyimide thin film electrodes on five human patients who were undergoing surgery to remove brain tissue for drug

resistant epilepsy. Electrophysiological recordings from the polyimide thin film technology displayed in each of these patients demonstrated

micro-seizure activity due to the high fidelity multi-scale electrophysiology. In December 2020, we announced the first human commercial

use of our Evo cortical electrode to perform recording, functional mapping and stimulation of the brain. In the procedure, performed

at the Mayo Clinic, our electrodes were used to record evidence of pre-seizure activity which may be critical in developing treatments

to prevent the onset of seizures.

Conclusions

reached by the physicians at Mayo Clinic were that thin, flexible polyimide electrodes (NeuroOne technology) provided recordings similar

to standard clinical electrodes with reduced immunological response. In addition, Mayo Clinic physicians observed that the flexibility

of polyimide electrodes may reduce pain and swelling associated with implantation of the device, and the single wire exiting the skull

may reduce infection risk. The ability to record micro-seizure and single neuron brain activity may also provide additional useful clinical

data. Combined, these properties suggest that the replacement of current competitive silicone electrodes with polyimide substrate electrodes

(NeuroOne technology) for recording brain activity for epilepsy could provide enhanced clinical value with reduced cost, reduced infection

risk, and improved patient comfort.

addition, our thin film cortical implant technology has been tested by researchers at the University of Wisconsin-Madison in multiple

pre-clinical animal studies conducted from 2006 to 2016, which included mice, rats and primates. In these studies, our technology was

able to record brain activity from different areas of the brain, was implanted in a minimally invasive fashion, electrically provided

brain stimulation and tissue ablation, and had increased flexibility compared to existing commercially available technology, which allowed

the grids to conform more easily to the brain surface (and may have reduced pain and swelling, compared to less flexible devices).

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Medical Technologies Corporation

FORM 10-K

WARF

License

January 2020, we entered into an Amended and Restated Exclusive Start-Up Company License Agreement, dated as of January 21, 2020, as

amended on June 15, 2020 (the “WARF License”) with WARF, which amended and restated in full the Original WARF License. Pursuant

to the WARF License, WARF has granted to us an exclusive license to make, use and sell, in the United States only, products that employ

certain licensed patents for a neural probe array or thin-film micro electrode array and method. We have agreed to pay WARF a royalty

equal to a single-digit percentage of our product sales pursuant to the WARF License, with a minimum annual royalty payment of $50,000

for calendar year 2020, $100,000 for calendar year 2021 and $150,000 for calendar year 2022 and each calendar year thereafter that the

WARF License is in effect. The minimum annual royalty payment for calendar year 2020 in the amount of $50,000 was paid in January 2021.

If we or any of our sublicensees contest the validity of any licensed patent, the royalty rate will be doubled during the pendency of

such contest and, if the contested patent is found to be valid and would be infringed by us if not for the WARF License, the royalty

rate will be tripled for the remaining term of the WARF License.

ARF

may terminate this license on 30 days’ written notice, if we default on the payments of amounts due to WARF or fail to timely submit

development reports, actively pursue our development plan or breach any other covenant in the WARF License and fail to remedy such default

in 90 days or in the event of certain bankruptcy events involving us. WARF may also terminate the WARF License (i) on 90 days’

notice if we had failed to have commercial sales of one or more FDA-approved products under the WARF License by June 30, 2021 or (ii)

if, after royalties earned on sales begin to be paid, such earned royalties cease for more than four calendar quarters. The first commercial

sale occurred on December 7, 2020, prior to the June 30, 2021 deadline. The WARF License otherwise expires by its terms on the date that

no valid claims on the patents licensed thereunder remain. We expect the latest expiration of a licensed patent to occur in 2030.

addition, WARF reserves the right to grant non-profit research institutions and government agencies non-exclusive licenses to practice

and use the inventions of the licensed patents for non-commercial research purposes, and we grant WARF a non-exclusive, sub licensable,

royalty-free right and license for non-commercial research purposes to use improvements to the licensed patents. In the event that we

discontinue use or commercialization of the licensed patents or improvements thereon, we must grant WARF an option to obtain a non-exclusive,

sub-licensable, royalty-bearing license to use the improvements for commercial purposes.

See

“Risk Factors-Risks Related to Our Business-We depend on intellectual property licensed from WARF for our technology, including

our technology under development, and the termination of this license would harm our business” for additional information regarding

the WARF License.

Mayo

Foundation for Medical Education and Research License and Development Agreement

May 2017, we entered into an Amended and Restated License and Development Agreement, dated as of May 25, 2017 (the “Mayo Development

Agreement”), with Mayo Foundation for Medical Education and Research (“Mayo”) to license worldwide (i) certain know

how for the development and commercialization of products, methods and processes related to flexible circuit thin film technology for

the recording of tissue and (ii) the products developed therefrom, and to partner with Mayo to assist the Company in the investigation,

research application, development and improvement of such technology. Mayo has agreed to assist us by providing access to certain individuals

at Mayo (the “Mayo Principal Investigators”), in developing our cortical thin film flexible circuit technology, including

prototype development, animal testing, protocol development for human and animal use, abstract development and presentation and access

to and license of any intellectual property that the Mayo Principal Investigators develop relating to the procedure.

have agreed to pay Mayo a royalty equal to a single-digit percentage of our product sales pursuant to the Mayo Development Agreement.

Mayo may purchase any developed products licensed under the Mayo Development Agreement at the best price offered by us to the end user

in the prior year. The Mayo Development Agreement generally will expire in October 2034, unless the Mayo know-how and improvements under

the Mayo Development Agreement remain in use, and the Mayo Development Agreement may be terminated by Mayo for cause or under certain

circumstances.

NeuroOne

Medical Technologies Corporation

FORM 10-K

For

additional information regarding the Mayo Development Agreement, see “Risk Factors-Risks Related to Our Business-We depend on our

partnership with Mayo to license certain know how for the development and commercialization of our technology. Termination of this partnership

would harm our business, and even if this partnership continues, it may not be successful.”

Commercialization,

Sales and Marketing

Zimmer

Distribution Agreement

Based

on the size and maturity of the U.S. market and our initial commercial focus, on July 20, 2020, we entered into an exclusive development

and distribution agreement (the “Original Distribution Agreement”) with Zimmer, pursuant to which we granted Zimmer exclusive

global rights to distribute NeuroOne’s strip and grid cortical electrodes (the “Strip/Grid Products”) and electrode

cable assembly products (the “Electrode Cable Assembly Products”), including to approximately 188 Level 4 epilepsy centers.

Additionally, we granted Zimmer the exclusive right and license to distribute certain depth electrodes developed by the Company (the

“sEEG Products”). The parties have agreed to collaborate with respect to development activities under the Distribution Agreement

through a joint development committee composed of an equal number of representatives of Zimmer and the Company.

Pursuant

to the Distribution Agreement, Zimmer made an upfront payment of $2.0 million to the Company in August 2020.

August 2022, we entered into an amendment to the Distribution Agreement with Zimmer that provided us with a $3.5 million accelerated

payment relating to certain milestone events. In addition, Zimmer received a Warrant to purchase 350,000 shares of our common stock,

$0.001 par value, with an exercise price of $3.00 per share.

October 2024, we amended and restated our development and distribution agreement with Zimmer to grant exclusive right and license to

distribute also our OneRF Ablation System (the “OneRF Products”) for an upfront fee of $3 million dollars and up to an additional

$1 million dollars upon achievement of certain net sales milestone by Zimmer (as amended, the “Zimmer Distribution Agreement”).

Under

the terms of the Distribution Agreement, we are responsible for all costs and expenses related to developing the Strip/Grid Products,

the Electrode Cable Assembly Products, the sEEG Products and the OneRF Products (collectively the “Products”), and Zimmer

is responsible for all costs and expenses related to the commercialization of the Products. In addition to the Distribution Agreement,

Zimmer and the Company have entered into a Manufacturing and Supply Agreement (the “MS Agreement”) and a supplier quality

agreement (the “Quality Agreement”) with respect to the manufacturing and supply of the Products.

Except

as otherwise provided in the Zimmer Distribution Agreement, we are responsible for performing all development activities, including non-clinical

and clinical studies directed at obtaining regulatory approval of each Product. Zimmer has agreed to use commercially reasonable efforts

to promote, market and sell each Product following the “Product Availability Date” (as defined in the Zimmer Distribution

Agreement) for such Products.

The

Zimmer Distribution Agreement will expire on September 30, 2034, unless terminated earlier pursuant to its terms. Either party may terminate

the Amended and Restated Distribution Agreement (x) with written notice for the other party’s material breach following a cure

period or (y) if the other party becomes subject to certain insolvency proceedings. In addition, Zimmer may terminate the Zimmer Distribution

Agreement for any reason with 90 days’ written notice, and we may terminate the Zimmer Distribution Agreement if Zimmer acquires

or directly or indirectly owns a controlling interest in certain competitors of the Company. Both Zimmer and the Company have agreed

to indemnify the other party against certain losses and expenses relating to the development or commercialization of a product by the

indemnifying party, the negligence or willful misconduct of the indemnifying party or its directors, officers, employees or agents or

a breach of the indemnifying party’s representations, warranties or covenants.

NeuroOne

Medical Technologies Corporation

FORM 10-K

will investigate markets outside of the U.S. with the assistance of Zimmer and formulate a plan to enter those markets with the support

of Zimmer.

For

more information regarding the Zimmer Distribution Agreement, see “Management’s Discussion and Analysis of Financial Condition

and Results of Operations-Financial Overview-Collaborations Revenue” and “Note 7-Zimmer Distribution Agreement” included

in “Item 8-Financial Statements and Supplementary Data” in this Report.

Financing

Debt

Facility Agreement

August 2, 2024, we entered into a loan and security agreement (the “Debt Facility Agreement”) with Growth Opportunity Funding,

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