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):
September 18, 2019
NeuroOne
Medical Technologies Corporation
(Exact name of registrant as specified in
its charter)
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Delaware
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000-54716
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27-0863354
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(State or other jurisdiction of
incorporation)
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(Commission File Number)
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(IRS Employer
Identification No.)
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10901 Red Circle Dr., Suite 150, Minnetonka,
MN 55343
(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:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which
registered
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N/A
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N/A
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N/A
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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 1.01 Entry into a Material Definitive
Agreement.
As previously disclosed, on October 1, 2014, NeuroOne Medical
Technologies Corporation (the “Company”) entered into an Exclusive Start-Up Company License Agreement
with Wisconsin Alumni Research Foundation (“WARF”), as amended on February 22, 2017 and March 30, 2019
(the “Original WARF License”).
Under the Original WARF License, WARF had a termination right
upon 90 days’ notice if NeuroOne failed to have commercial sales of one or more FDA-approved products by September 30, 2019
(“WARF Termination Option Date”). On September 18, 2019, WARF and the Company entered into an amendment
(the “Amendment”) to the Original WARF License extending the WARF Termination Option Date to March 31,
2020.
The foregoing summary does not purport to be complete and is
qualified in its entirety by reference to the Amendment, which is attached as Exhibit 10.1 hereto and incorporated herein by reference.
Item 7.01. Regulation FD Disclosure.
On September 23, 2019, the Company issued a press release reporting
the first sale of its sEEG depth electrode. The sEEG depth electrode has not yet received FDA approval, and the sale was for non-human
research purposes. The press release is furnished as Exhibit 99.1 and incorporated by reference herein.
The information in this Item 7.01, including
Exhibit 99.1 attached hereto, is being furnished, shall not be deemed “filed” for any purpose, and shall not be deemed
incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as
amended, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
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.
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NEUROONE MEDICAL TECHNOLOGIES
CORPORATION
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Dated: September 23, 2019
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By:
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/s/ David Rosa
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David Rosa
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Chief Executive Officer
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Exhibit 10.1
Agreement No. 14-00333C
AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT
This Amendment to Exclusive Start-Up Company
License Agreement (“Amendment”) is made effective the 18th day of September 2019, by and between the Wisconsin Alumni
Research Foundation (“WARF”), a nonstock, nonprofit Wisconsin corporation, and NeuroOne, Inc. (“Licensee”),
a corporation a Delaware corporation.
WITNESSETH
WHEREAS, WARF and Licensee entered
into an Exclusive Start-Up Company License Agreement (Agreement No. 14-00333) made effective October 1, 2014, as amended on February
22, 2017 (Agreement No. 14-00333A), and amended on March 30, 2019 (Agreement No. 14-00333B) (the “Agreement”);
WHEREAS, the Agreement obligates
the Licensee to meet Date of First Commercial Sale by September 30, 2019;
WHEREAS, the Parties would each like
to amend the Agreement to extend the date by which WARF may terminate the Agreement if the Date of First Commercial Sale has not
been met.
NOW THEREFORE, in consideration of
the mutual covenants and agreements set forth below and in the Agreement, the parties covenant and agree as follows:
1. Section
7E is hereby deleted and replaced with the following:
“E. WARF may terminate this Agreement
by giving Licensee at least ninety (90) days’ written notice if the Date of First Commercial Sale does not occur by March
31, 2020.”
2. Capitalized
terms used herein and not otherwise defined shall have the meaning set forth in the Agreement. Except as otherwise provided in
this Amendment, all terms and conditions previously set forth in the Agreement shall remain in effect as set forth therein. In
the event that this Amendment and the Agreement are inconsistent, the terms and provisions of this Amendment shall supersede the
terms and provisions of the Agreement, but only to the extent necessary to satisfy the purpose of this Amendment. Each party hereto
represents to the other that it has the full authority to execute, deliver and perform this Amendment in accordance with its terms.
The persons signing on behalf of WARF and Licensee hereby warrant and represent that they have authority to execute this Amendment
on behalf of the party for whom they have signed.
IN WITNESS WHEREOF, the parties hereto
have duly executed this Amendment on the dates indicated below.
WISCONSIN ALUMNI RESEARCH FOUNDATON
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By:
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/s/ Leigh
Cagan
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Date: 9/18/2019
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Leigh Cagan, Chief Technology
Commercialization
Officer
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NEUROONE, INC.
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By:
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/s/ Dave Rosa
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Date: 9/18/2019
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Dave Rosa, Chief Executive Officer
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14-00333C NeuroOne, Inc.
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Page 1 of 1
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Wisconsin
Alumni Research Foundaton
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Exhibit 99.1
NeuroOne™ Medical
Technologies Corporation Announces First Sale of sEEG Depth Electrode
Company’s sEEG Electrode will be used
for non-human research purposes by the Cleveland Clinic Foundation
MINNETONKA, MN / ACCESSWIRE /
September 23, 2019 / NeuroOne Medical Technologies Corporation (OTCQB: NMTC), a
medical device company focused on the development and commercialization of thin film electrode technology for recording
brain activity, stimulation and ablation solutions for patients suffering from Epilepsy, Parkinson’s Disease, and back
pain, today announced its first product sale to the Cleveland Clinic for non-human research applications. The NeuroOne
sEEG combination depth and ablation electrode is not currently cleared or approved for human use in the United States
or internationally and has not yet been reviewed by FDA nor any international regulatory bodies.
The
device is intended to be used to perform recording of brain activity up to 30 days, short term brain tissue stimulation and offer
radio frequency tissue ablation properties all within the same device.
“This
is a very exciting day for everyone associated with NeuroOne Medical Technologies Corporation,” stated Dave Rosa, NeuroOne’s
President and CEO. “Although the device is not yet FDA cleared for sale for human use in the United States, we are honored
to have the Cleveland Clinic purchase the device for pre-clinical research and development purposes. We believe that this is the
first of many more exciting milestones the Company will achieve in the future.”
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, Essential Tremors and other
related neurological disorders that may improve patient outcomes and reduce procedural costs.
Forward Looking Statement
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 presentation may be a forward-looking
statement that reflects the Company’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 “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. Forward-looking statements may include statements regarding the Company’s
regulatory submissions, potential regulatory approval, commercialization of the technology, business strategy, market size, potential
growth opportunities, plans for product applications and product development, future operations, future efficiencies, and other
financial and operating information. Although the Company 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 our ability to raise additional funds, uncertainties inherent in the development
process of our technology, changes in regulatory requirements or decisions of regulatory authorities, the size and growth potential
of the markets for our technology, our ability to serve those markets, the rate and degree of market acceptance of our products,
clinical trial patient enrollment, the results of clinical trials, future competition, the actions of third-party clinical research
organizations, suppliers and manufacturers, our ability 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 the Company undertakes
no obligation to revise or update any forward-looking statements for any reason, even if new information becomes available in the
future.
Investor Relations Contact:
Leah Noaeill
Sr. Director of Marketing
NeuroOne Medical Technologies Corporation
leahn@neurooneinc.com