false 0001500198 0001500198 2023-12-14 2023-12-14 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

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): December 14, 2023

 

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 December 14, 2023, NeuroOne Medical Technologies Corporation (the “Company”) issued a press release announcing its financial results for the fiscal quarter and fiscal year ended September 30, 2023. A copy of this press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

In accordance with General Instruction B.2. of Form 8-K, the information in this Item 2.02, and Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
99.1   Press Release, dated December 14, 2023
104   Cover Page Interactive Data File (embedded with Inline XBRL document).

 

1

 

 

SIGNATURES

 

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

 

  NEUROONE MEDICAL TECHNOLOGIES CORPORATION
Dated: December 14, 2023    
  By: /s/ David Rosa
    David Rosa
    Chief Executive Officer

 

 

2

 

 

Exhibit 99.1

 

NeuroOne® Reports Fiscal Fourth Quarter and Full Fiscal Year 2023 Financial Results and Provides Corporate Update

 

EDEN PRAIRIE, Minn., December 14, 2023 (GlobeNewswire) -- 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 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 also 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

 

2

 

 

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.

 

3

 

 

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.

 

About NeuroOne

 

NeuroOne Medical Technologies Corporation is a developmental stage company committed to providing 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,” “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 the development of the Company’s electrode technology program, applications for, or receipt of, regulatory clearance, the timing and extent of product launch and commercialization of our technology, receipt of revenues from sale of the sEEG electrodes, timing and success of any clinical and pre-clinical testing, the timing and extent of product launch and commercialization of our OneRF Ablation System, the potential capabilities of our OneRF Ablation System, SCS and drug delivery programs, 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 the partnership with Zimmer Biomet 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.

 

Contact:

 

800-631-4030

 

ir@nmtc1.com

 

4

 

 

NeuroOne Medical Technologies Corporation

Balance Sheets

(unaudited)

 

   As of September 30, 
   2023   2022 
Assets        
Current assets:        
Cash and cash equivalents  $5,322,493   $8,160,329 
Short-term investments       2,981,010 
Accounts receivable       33,237 
Inventory   1,726,686    704,538 
Prepaid expenses   263,746    296,649 
Total current assets   7,312,925    12,175,763 
Intangible assets, net   89,577    111,892 
Right-of-use asset   169,059    181,355 
Property and equipment, net   525,753    353,599 
Total assets  $8,097,314   $12,822,609 
           
Liabilities and Stockholders’ Equity          
Current liabilities:          
Accounts payable  $685,104   $927,662 
Accrued expenses and other liabilities   1,107,522    715,839 
Deferred revenue       1,455,188 
Total current liabilities   1,792,626    3,098,689 
Operating lease liability, long term   55,284    119,556 
Total liabilities   1,847,910    3,218,245 
           
Commitments and contingencies (Note 4)          
           
Stockholders’ equity:          
Preferred stock, $0.001 par value; 10,000,000 shares authorized as of September 30, 2023 and 2022; no shares issued or outstanding as of September 30, 2023 and 2022.        
Common stock, $0.001 par value; 100,000,000 shares authorized as of September 30, 2023 and 2022; 23,928,945 and 16,216,540 shares issued and outstanding as of September 30, 2023 and 2022, respectively.   23,929    16,217 
Additional paid–in capital   68,911,778    60,414,959 
Accumulated deficit   (62,686,303)   (50,826,812)
Total stockholders’ equity   6,249,404    9,604,364 
Total liabilities and stockholders’ equity  $8,097,314   $12,822,609 

 

5

 

 

NeuroOne Medical Technologies Corporation

Statements of Operations

(unaudited)

 

   Years ended
September 30,
 
   2023   2022 
Product revenue  $1,952,441   $171,169 
Cost of product revenue   1,495,924    241,963 
Product gross profit (loss)   456,517    (70,794)
Collaboration revenue   1,455,188    1,948,872 
Operating expenses:          
Selling, general and administrative   6,926,269    6,979,416 
Research and development   6,940,686    4,929,427 
Total operating expenses   13,866,955    11,908,843 
Loss from operations   (11,955,250)   (10,030,765)
Other income, net   95,759    31,152 
Net loss  $(11,859,491)  $(9,999,613)
Net loss per share:          
Basic and diluted  $(0.65)  $(0.63)
Number of shares used in per share calculations:          
Basic and diluted   18,121,108    15,998,567 

 

 

6

 

v3.23.3
Cover
Dec. 14, 2023
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Dec. 14, 2023
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

NeuroOne Medical Technol... (NASDAQ:NMTC)
Historical Stock Chart
From Mar 2024 to Apr 2024 Click Here for more NeuroOne Medical Technol... Charts.
NeuroOne Medical Technol... (NASDAQ:NMTC)
Historical Stock Chart
From Apr 2023 to Apr 2024 Click Here for more NeuroOne Medical Technol... Charts.