Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): January 10, 2025

NeuroOne Medical Technologies Corporation

(Exact name of registrant as specified in its charter)

Delaware

001-40439

27-0863354

(State or other jurisdiction

of incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

7599 Anagram Dr., Eden Prairie, MN 55344

(Address of principal executive offices and zip code)

952-426-1383

(Registrant’s telephone number including area code)

(Registrant’s former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		NMTC		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging Growth Company ☐

If 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. ☐

Item 2.02 Results of Operations and Financial Condition.

On January 10, 2025, NeuroOne Medical Technologies Corporation (the “Company”) issued a press release announcing certain preliminary financial results, including unaudited revenue for the first fiscal quarter 2025 ended December 31, 2024. A copy of such press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. These preliminary estimates are not a comprehensive statement of the Company’s financial results for the quarter ended December 31, 2024 and have not been audited, reviewed, or compiled by its independent registered public accounting firm. The Company’s actual results may differ from these estimates due to the completion of the Company’s year-end closing and auditing procedures.

The foregoing information in this Item 2.02 (including the exhibit hereto) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

Item 7.01 Regulation FD Disclosure

On January 10, 2025, the Company posted an updated corporate presentation to its website at https://nmtc1.com/investors, which the Company may use from time to time in communications or conferences. A copy of the corporate presentation is attached as Exhibit 99.2 to this Current Report on Form 8-K.

The information in this Item 7.01 (including the exhibit hereto) is furnished pursuant to Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such a filing.

This Item 7.01 and Exhibit 99.2 hereto contain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements are based on current expectations and are not guarantees of future performance. Further, the forward-looking statements are subject to the limitations listed in Exhibit 99.2 and in the other reports of the Company filed with the Securities and Exchange Commission, including that actual events or results may differ materially from those in the forward-looking statements.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press release, dated January 10, 2025
99.2		Corporate Presentation, dated January 2025.
104		Cover Page Interactive Data File (embedded within Inline XBRL document).

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	NEUROONE MEDICAL TECHNOLOGIES CORPORATION
Dated: January 10, 2025
	By:	/s/ David Rosa
		David Rosa
		Chief Executive Officer

Exhibit 99.1

NeuroOne® Announces Preliminary Unaudited First Quarter Fiscal 2025 Revenue Increase to a Record $6.2 Million

First Quarter Fiscal 2025 Revenue Includes a One-Time Upfront Payment of $3.0 Million in Collaboration Revenue from Zimmer Biomet and $3.2M in Product Revenue

Management to Host Virtual Investor Webinar Today at 11:00 a.m. Eastern Time

EDEN PRAIRIE, Minn., January 10, 2025 -- 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 announced preliminary unaudited revenue for the fiscal first quarter ended December 31, 2024.

In the first quarter of fiscal 2025, the Company expects total revenue to increase to a record $6.2 million, compared to $1.0 million the first quarter of fiscal 2024. The first quarter of fiscal 2025 includes a one-time $3.0 million payment of collaboration revenue from the expanded distribution agreement with Zimmer Biomet for commercialization of the Company’s OneRF™ Ablation System, which was announced in October 2024 and is expected to be fully recognized in the first quarter of fiscal 2025. As previously announced, the agreement with Zimmer will provide NeuroOne with an additional milestone payment if certain performance criteria are achieved and is expected to generate meaningful revenue and expand product margins for the Company.

In addition to the collaboration revenue of $3.0 million, the Company expects product revenues to increase 227% to $3.2 million in the first quarter of fiscal 2025, compared to product revenue of $1.0 million in the first quarter of fiscal 2024. For the full year of fiscal 2025, the Company is reiterating guidance specific to product revenues, which exclude collaboration revenues, to range between $8.0 and $10.0 million, with product gross margin to range between 47% and 51%.

“Our expected record revenue in the first quarter of fiscal 2025 was driven by greater than expected product revenues as our partner built out inventory and started to implement both our products and technology with customers,” says Dave Rosa, Chief Executive Officer of NeuroOne. “As previously announced, our expanded exclusive distribution agreement with Zimmer Biomet included an upfront payment of $3.0 million, which we are recognizing in the first quarter of fiscal 2025.”

Complete financial results for the quarter are expected to be announced in February 2025. The selected unaudited results in this press release are preliminary and subject to the completion of accounting and interim review procedures and are therefore subject to adjustment. This preliminary financial information is the responsibility of management and has been prepared in good faith on a consistent basis with prior periods. As a result, prospective investors should exercise caution in relying on this information and should not draw any inferences from this information regarding the Company’s financial information that is not provided. This preliminary financial information should not be viewed as a substitute for full financial statements prepared in accordance with United States generally accepted accounting principles.

Virtual Investor Webinar

The Company will host a virtual investor webinar today to discuss its business operations and recent updates. Dave Rosa, Chief Executive Officer of NeuroOne, will provide an overview of the business model and discuss recent milestone achievements, including its recently expanded exclusive distribution agreement with Zimmer Biomet, one of the world’s largest medical device manufacturers.

The webcast will be accompanied by a presentation and followed by a question-and-answer session, which can be accessed via the webcast link or dial-in numbers below.

Date: Friday, January 10, 2025

Time: 11:00 a.m. Eastern Standard Time

U.S. Dial-In (Toll Free): 877-704-4453

International Dial-In: 201-389-0920

Webcast Link: NMTC Virtual Investor Webinar

Please join at least five minutes before the start of the call to ensure timely participation.

A playback of the call will be available through January 24, 2025. To listen, please call 844-512-2921 within the United States or 412-317-6671 when calling internationally, using replay passcode 13750530.

About NeuroOne

NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) is developing and commercializing minimally invasive and hi-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders that may improve patient outcomes and reduce procedural costs. The Company may also pursue applications for other areas such as depression, mood disorders, pain, incontinence, high blood pressure, and artificial intelligence. For more information, visit nmtc1.com.

Forward Looking Statements

This press release may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for statements of historical fact, any information contained in this press release may be a forward–looking statement that reflects NeuroOne’s current views about future events and are subject to 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. In some cases, you can identify forward–looking statements by the words or phrases “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “forecasts,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue, “focused on,” “committed to” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward–looking statements may include statements regarding fiscal year 2025 guidance, including expectations for significant product revenue growth and margin expansion, potential milestone payments, business strategy, market size, potential growth opportunities, future operations, future efficiencies, and other financial and operating information. Although NeuroOne believes that we have a reasonable basis for each forward-looking statement, 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. Our actual future results may be materially different from what we expect due to factors largely outside our control, including risks that our strategic partnerships may not facilitate the commercialization or market acceptance of our technology; whether due to supply chain disruptions, labor shortages or otherwise; risks that our technology will not perform as expected based on results of our pre-clinical and clinical trials; risks related to uncertainties associated with the Company’s capital requirements to achieve its business objectives and ability to raise additional funds; the risk that we may not be able to secure or retain coverage or adequate reimbursement for our technology; uncertainties inherent in the development process of our technology; risks related to changes in regulatory requirements or decisions of regulatory authorities; that we may not have accurately estimated the size and growth potential of the markets for our technology; risks relate to clinical trial patient enrollment and the results of clinical trials; that we may be unable to protect our intellectual property rights; and other risks, uncertainties and assumptions, including those described under the heading “Risk Factors” in our filings with the Securities and Exchange Commission. These forward–looking statements speak only as of the date of this press release and NeuroOne undertakes no obligation to revise or update any forward–looking statements for any reason, even if new information becomes available in the future.

Caution: Federal law restricts this device to sale by or on the order of a physician.

IR Contact

MZ Group – MZ North America

NMTC@mzgroup.us

Exhibit 99.2

Investor Presentation January 2025 NASDAQ: NMTC

2 Caution: Federal law restricts this device to sale by or on the order of a physician. Forward - Looking Statements This presentation contains forward - looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for statements of historical fact, any information contained in this presentation may be a forward – looking statement that reflects NeuroOne's current views about future events. In some cases, you can identify forward – looking statements by the words "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "upcoming," "target," "objective," "anticipate," "believe," "estimate," "predict," "project," "potential," "target," "seek," "contemplate," "continue" and "ongoing," or the negative of these terms, or other comparable terminology. Forward – looking statements may include statements regarding the fiscal 2025 guidance, the potential receipt of any revenue related to facial pain ablation, additional potential strategic partnerships, fiscal 2025 guidance, the potential receipt of any revenue related to facial pain ablation, additional potential strategic partnerships, the completion of drug delivery system in 2025, development of the Company's ablation electrode technology program, applications for, or receipt of, regulatory clearance, the timing and extent of product launch and commercialization of our technology, expected milestone payments, clinical and pre - clinical testing, what the future may hold for electrical stimulation and NeuroOne's potential role, business strategy, market size, potential growth opportunities, future operations, future efficiencies, and other financial and operating information. Our actual future results may be materially different from what we expect due to 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, including risks that the partnership with Zimmer Biomet may not facilitate the commercialization or market acceptance of our technology; risks that our sEEG electrodes may not be ready for commercialization in a timely manner or at all, whether due to supply chain disruptions and the impact of COVID - 19, or otherwise; risks that our technology will not perform as expected based on results of our pre - clinical and clinical trials; risks related to uncertainties associated with the Company's capital requirements to achieve its business objectives and ability to raise additional funds; the risk that the COVID - 19 pandemic will continue to adversely impact our business; the risk that we may not be able to secure or retain coverage or adequate reimbursement for our technology; uncertainties inherent in the development process of our technology; risks related to changes in regulatory requirements or decisions of regulatory authorities; that we may not have accurately estimated the size and growth potential of the markets for our technology; risks related to clinical trial patient enrollment and the results of clinical trials; that we may be unable to protect our intellectual property rights; and other risks, uncertainties and assumptions, including those described under the heading "Risk Factors" in our filings with the Securities and Exchange Commission. These forward – looking statements speak only as of the date of this presentation and NeuroOne undertakes no obligation to revise or update any forward – looking statements for any reason, even if new information becomes available in the future. This presentation also contains estimates and other statistical data made by independent parties and by us relating to market share and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of such products. NASDAQ: NMTC

NeuroOne is a medical technology company that is transforming the diagnosis and treatment of neurological disorders 3 FDA 510(k) cleared products for use in the brain, with the only FDA cleared product that uses the same sEEG electrode for both diagnostic and therapeutic applications. Additional submissions planned for 2025. Exclusive partnership with Zimmer Biomet, the global leader in robotic surgical technology, and the Mayo Clinic. Patented and disruptive technology unlocking multi - billion markets in neurology. NASDAQ: NMTC 3

Thin Film & Flexibility 4 NeuroOne’s next - generation electrode platform is highly disruptive and differentiated Multi - Purpose Device Since the 1950s, clinicians and researchers have used first generation electrodes for the recording and stimulation of brain tissue. NeuroOne’s multi - purpose electrodes are trying to reduce the number of surgeries, and hospitalizations while potentially improving efficacy. NASDAQ: NMTC

Mayo Clinic partnership • Mayo Clinic began testing technology in pre - clinical models and clinical research in 2015 • Mayo Clinic leading neurologist, Dr. Worrell, chairs the NeuroOne Scientific Advisory Board • First commercial human use of Evo® Cortical Electrodes performed at Mayo Clinic in November 2020 • Currently using our drug delivery system in pre - clinical studies Mayo Clinic board representation Current Investor 5 NASDAQ: NMTC

Zimmer Biomet partnership • Zimmer is a worldwide leader in robotic technology used in minimally invasive neurosurgeries • Evo® electrodes are complementary to Zimmer’s ROSA ONE ® robotic neurosurgery platform • Partnership initiated in 2020: $5.5 million total paid to NeuroOne under initial contract 6 NASDAQ: NMTC

7 Our electrode platform addresses a multi - billion $ and growing market needs¹ $100M Brain Ablation $500M+ Parkinson’s $3B Spinal Cord Stimulation (Back Pain) $100M Epilepsy (Diagnostic Only) $1B+ $1B+ $5B+ $10B+ $0 Drug Delivery $10B+ Actual Market Potential Market Size 1. Company data on file NASDAQ: NMTC

Technology platform 8 NASDAQ: NMTC

Product Portfolio Application Status Use Case Product Diagnostic Currently marketed by Zimmer Biomet Recording brain activity Placed on surface of brain Evo® Cortical Electrodes Diagnostic Currently marketed by Zimmer Biomet Recording brain activity Placed Deeper Into the Brain Evo® sEEG Electrodes Diagnostic & Therapeutic Currently marketed by Zimmer Biomet Ablating Brain Tissue using sEEGs Dedicated RF console OneRF TM Ablation System Diagnostic & Therapeutic In Development Chronic Recording & Stimulation For Peripheral, Spinal & Deep Brain Stim Thin - Film Implantable Electrodes Diagnostic & Therapeutic In Development Recording Brain Activity and Therapeutic Agent Delivery Drug Delivery System NASDAQ: NMTC 9

Thin - Film Evo® sEEG & Cortical Electrodes NASDAQ: NMTC 10

OneRF TM Ablation System Recently expanded Zimmer Biomet Partnership to distribute system NASDAQ: NMTC 11

Spinal Cord Percutaneous Paddle Lead NASDAQ: NMTC 12

sEEG - Based Drug Delivery System Designed to leverage our sEEG platform enabling drug delivery + brain activity recording NASDAQ: NMTC 13

Our management team Dave Rosa President & Chief Executive Officer Ron McClurg Chief Financial Officer Ron McClurg Chief Technology Officer Mark Christianson Co - Founder, Business Development Director, Medical Sales Liaison Hijaz Haris Vice - President of Marketing Camilo Diaz Botia Director of Electrode Development Chad Wilhelmy Vice President of Quality Control and Regulatory Affairs Scientific advisory board Greg Worrell MD PhD, Chairman of the Scientific Advisory Board Bob Gross MD, PhD Jamie Van Gompel MD Justin Williams PhD Greg Esper MD, MBA Kip Ludwig PhD Chris Volker Chief Operating Officer 14 NASDAQ: NMTC

• Decreasing burn rate in FY2024 • Expected FY2025 product revenue of $8 - $10M, an increase of 132% - 190% vs FY2024 • Expected FY2025 gross margin of 47% - 51% • More potential partnerships focused on pain management and drug delivery • Debt free balance sheet 15 Financial overview Highlights & Financial Catalysts Capital Position ($ in millions) $1.60 Cash (as of 9/30) $0 Debt $2.65 August 2024 pvt. placement $3.00 Upfront licensing fee payment $3.50 TTM revenue NASDAQ: NMTC

• Debt free balance sheet • Decreasing burn rate in FY2024 • FY2025 Guidance: • FY 2025 product revenue of $8.0 - $10.0M (132% - 190% increase vs. FY2024) • FY2025 product gross margin of 47% - 51% • New potential partnerships focused on pain management and drug delivery Financial overview Highlights & Financial Catalysts Capital Position ($ in millions) $1.60 Cash (as of 9/30/24) $0 Debt $2.65 August 2024 pvt. placement $3.00 Upfront licensing fee payment $3.50 TTM revenue NASDAQ: NMTC Fiscal Q1 2025 Revenue Expected to Increase to $6.2 Million (Preliminary, Unaudited) The selected unaudited results in this press release are preliminary and subject to the completion of accounting and interim review procedures and are therefore subject to adjustment 16

Upcoming potential catalysts 17 • Zimmer Biomet OneRF® Ablation System full launch • Potential revenue in calendar 2025 for facial pain ablation system • Electrode revenue expected to more than double in FY2025 • Non - dilutive licensing agreement for ablation system with Zimmer Biomet with future potential milestone payment • Potential strategic partnerships to leverage NeuroOne’s core technology for ablation and stimulation • Completion of drug delivery system in calendar 2025 followed by FDA 510(k) submission • Potential for strategic partnerships with pharma companies NASDAQ: NMTC

Key takeaways NASDAQ: NMTC 18

Thank you NASDAQ: NMTC Dave Rosa Chief Executive Officer ir@nmtc1.com

Cover	Jan. 10, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 10, 2025
Entity File Number	001-40439
Entity Registrant Name	NeuroOne Medical Technologies Corporation
Entity Central Index Key	0001500198
Entity Tax Identification Number	27-0863354
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	7599 Anagram Dr.
Entity Address, City or Town	Eden Prairie
Entity Address, State or Province	MN
Entity Address, Postal Zip Code	55344
City Area Code	952
Local Phone Number	426-1383
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	NMTC
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false