Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures
(as defined in Rule 13a-15(e) and 15d-15(e) under the Exchange Act) which are controls and other procedures that are designed to provide
reasonable assurance that that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded,
processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is
accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow
timely decisions regarding required disclosure.
As of September 30, 2022, our management, with
the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the design and operation
of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Disclosure controls and
procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in the reports
we file or submit under the Exchange Act is accumulated and communicated to management, including our Chief Executive Officer and Chief
Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. Based on this evaluation, our Chief Executive
Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level
as of September 30, 2022.
Management’s Annual Report on Internal
Control Over Financial Reporting
Our management is responsible for establishing
and maintaining adequate internal control over financial reporting to provide reasonable assurance regarding the reliability of our financial
reporting and the preparation of financial statements for external purposes in accordance with U.S. generally accepted accounting principles.
Internal control over financial reporting includes those policies and procedures that: (i) pertain to the maintenance of records that,
in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets; (ii) provide reasonable assurance
that transactions are recorded as necessary to permit preparation of financial statements in accordance with U.S. generally accepted accounting
principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and Board;
and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our
assets that could have a material effect on the financial statements.
Our management, including our Chief Executive
Officer and Chief Financial Officer, recognizes that our internal control over financial reporting cannot prevent or detect all errors
and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the
control system’s objectives will be met. The design of a control system must reflect the fact that there are resource constraints,
and the benefits of controls must be considered relative to their costs. Further, because of the inherent limitations in all control systems,
no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues
and instances of fraud, if any, have been detected. The design of any system of controls is based in part on certain assumptions about
the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential
future conditions.
Management, with the participation of the Chief
Executive Officer and Chief Financial Officer, assessed our internal control over financial reporting as of September 30, 2022, the end
of our fiscal year. Management based its assessment on criteria established in Internal Control-Integrated Framework (2013) issued by
the Committee of Sponsoring Organizations of the Treadway Commission. Based on that evaluation, management has concluded that the Company’s
internal control over financial reporting was effective as of September 30, 2022.
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Exemption from Attestation Report of Independent
Registered Public Accounting Firm
This Report does not include an attestation report
of our independent registered public accounting firm regarding internal control over financial reporting. Management’s report was
not subject to attestation by our independent registered public accounting firm pursuant to the rules of the SEC that permit us to
provide only Management’s Report because we are a non-accelerated filer.
Changes in Internal Control Over Financial
Reporting
No change in our system of internal control over
financial reporting occurred during the quarter ended September 30, 2022 that has materially affected, or is reasonably likely to materially
affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
“At the Market” Offering
On December 21, 2022, the Company entered into
a Capital on Demand™ Sales Agreement (the “Sales Agreement”) with JonesTrading Institutional Services LLC (“JonesTrading”)
pursuant to which the Company may sell from time to time, at its option, up to an aggregate of $9.0 million of shares of its common stock
through or to JonesTrading, as sales agent or principal. Sales of the Company’s Common Stock made pursuant to the Sales Agreement,
if any, will be made on the Nasdaq Capital Market under the Company’s Registration Statement on Form S-3 (File No. 333-256830),
in sales deemed to be “at the market offerings” as defined in Rule 415 promulgated under the Securities Act. JonesTrading
will use its commercially reasonable efforts to see the Common Stock from time to time, based upon the Company’s instructions (including
any price, time, or size limits or other customary parameters or conditions the Company may impose).
The Company is not obligated to make any sales
of Common Stock under the Sales Agreement, and the Company cannot provide any assurances that it will issue any shares pursuant to the
Sales Agreement. The offering of Common Stock pursuant to the Sales Agreement will terminate upon the earlier of (i) sale of all of the
shares of Common Stock subject to the Sales Agreement or (ii) termination of the Sales Agreement as permitted therein. The Company is
obligated to pay JonesTrading an aggregate sales agent commission of up to 3.0% of the gross proceeds of the sale price for Common Stock
sold under the Sales Agreement. The Company has also provided JonesTrading with customary indemnification rights and expense reimbursements
for up to $35,000 of expenses as well as ongoing diligence expenses.
The foregoing description of the Sales Agreement
is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which is filed herewith as
Exhibit 1.1 to this Current Report on Form 10-K.
The opinion of Honigman LLP relating to the shares
of Common Stock being offered is filed as Exhibit 5.1 to this Current Report on Form 10-K.
ITEM 9C. DISCLOSURE REGARDING
FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
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NeuroOne Medical Technologies Corporation
Form 10-K
PART III
ITEM 10. DIRECTORS, EXECUTIVE
OFFICERS AND CORPORATE GOVERNANCE
The information required by Item 10 is hereby
incorporated by reference to the sections of the 2023 Proxy Statement under the captions “Executive Compensation”, “Proposal
No. 1 – Election of Class III Directors,” and “Executive Officers,” and “Board and Committee Information.”
ITEM 11. EXECUTIVE COMPENSATION
The information required by Item 11 is hereby
incorporated by reference to the sections of the 2023 Proxy Statement under the captions “Executive Compensation” and “Proposal
No. 1 – Election of Class III Directors – Non-Employee Director Compensation.”
ITEM 12. SECURITY OWNERSHIP
OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The information required by Item 12 is hereby
incorporated by reference to the sections of the 2023 Proxy Statement under the captions “Security Ownership of Certain Beneficial
Owners and Management” and “Securities Authorized for Issuance under Equity Compensation Plan.”
ITEM 13. CERTAIN RELATIONSHIPS
AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required by Item 13 is hereby
incorporated by reference to the sections of the 2023 Proxy Statement under the captions “Certain Relationships and Related-Party
Transactions” and “Board and Committee Information.”
ITEM 14. PRINCIPAL ACCOUNTANT
FEES AND SERVICES
The information required by Item 14 is hereby
incorporated by reference to the sections of the 2023 Proxy Statement under the caption “Proposal No. 2 – Ratification of
Independent Registered Public Accounting Firm.”
75
NeuroOne Medical Technologies Corporation
Form 10-K
PART IV
ITEM 15. EXHIBITS AND FINANCIAL
STATEMENT SCHEDULES
(a) The following documents are filed as part of this Annual Report:
(1) Financial Statements: The financial statements filed as part of this Annual Report are listed in Part
II, Item 8.
(2) Financial Statement Schedules:
No financial statement schedules are
provided because the information called for is not required or is shown either in the financial statements or notes thereto.
(3) Exhibits: The exhibits incorporated by reference or filed as part of this Annual Report are listed in
the Index to Exhibits below.
Exhibit No.
Document
1.1*
Capital on Demand™ Sales Agreement, dated December 21, 2022 between NeuroOne Medical Technologies Corporation. and JonesTrading Institutional Services LLC
2.1 **
Agreement and Plan of Merger and Reorganization by and among NeuroOne Medical Technologies Corporation, OSOK Acquisition Company and NeuroOne, Inc. dated as of July 20, 2017 (incorporated by reference to Exhibit 2.1 on the Registrant’s Current Report on Form 8-K filed on July 20, 2017)
2.2
Plan of Conversion of NeuroOne Medical Technologies Corporation dated June 20, 2017 (incorporated by reference to Exhibit 2.1 on the Registrant’s Current Report on Form 8-K filed on June 29, 2017)
3.1
Certificate of Incorporation of NeuroOne Medical Technologies Corporation (incorporated by reference to Exhibit 3.4 on the Registrant’s Current Report on Form 8-K filed on June, 29, 2017)
3.2
Certificate of Amendment to Amended and Restated Certificate of Incorporation of NeuroOne Medical Technologies Corporation (incorporated by reference to Exhibit 3.1 on the Registrant’s Current Report on Form 8-K filed on March 31, 2021).
3.3
Bylaws of NeuroOne Medical Technologies Corporation (incorporated by reference to Exhibit 3.5 on the Registrant’s Current Report on Form 8-K filed on June 29, 2017)
4.1
Form of Common Stock Certificate (incorporated by reference to Exhibit 4.1 on the Registrant’s Current Report on Form 8-K filed on July 20, 2017)
4.2
Description of Securities (incorporated by reference to Exhibit 4.2 on the Registrant’s Annual Report on Form 10-K filed on December 20, 2019)
5.1*
Opinion of Honigman LLP
10.1 #
Amended and Restated Exclusive Start-up Company License Agreement effective January 21, 2020 by and between NeuroOne Medical Technologies Corporation and Wisconsin Alumni Research Foundation (incorporated by reference to Exhibit 10.1 on the Registrant’s Current Report on Form 8-K filed on January 24, 2020)
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NeuroOne Medical Technologies Corporation
Form 10-K
10.2 ##
Mayo Foundation for Medical Education and Research Amended and Restated License and Development Agreement by and between Mayo Foundation for Medical Education and Research, and NeuroOne LLC dated as of May 25, 2017 (incorporated by reference to Exhibit 10.3 on the Registrant’s Current Report on Form 8-K filed on July 20, 2017)
10.3 +
2016 Equity Incentive Plan of NeuroOne, Inc. (incorporated by reference to Exhibit 10.11 on the Registrant’s Current Report on Form 8-K filed on July 20, 2017)
10.3.1 +
Form of Stock Option Award Agreement pursuant to 2016 Equity Incentive Plan of NeuroOne, Inc. (incorporated by reference to Exhibit 10.12 on the Registrant’s Current Report on Form 8-K filed on July 20, 2017)
10.4 +
2017 Equity Incentive Plan of the Company (incorporated by reference to Appendix G to Schedule 14C filed on April 20, 2017)
10.4.1 +
NeuroOne Medical Technologies Corporation 2017 Equity Incentive Plan Option Agreement (incorporated by reference to Exhibit 10.15 on the Registrant’s Current Report on Form 8-K filed on July 20, 2017)
10.4.2 +
NeuroOne Medical Technologies Corporation 2017 Equity Incentive Plan Restricted Stock Unit Agreement (incorporated by reference to Exhibit 10.16 on the Registrant’s Current Report on Form 8-K filed on July 20, 2017)
10.5 +
NeuroOne Medical Technologies Corporation 2021 Inducement Plan (incorporated by reference to Exhibit 10.1 on the Registrant’s Current Report on Form 8-K filed on October 4, 2021)
10.5.1 +
NeuroOne Medical Technologies Corporation 2021 Inducement Plan Form of Option Grant Agreement (incorporated by reference to Exhibit 10.2 on the Registrant’s Current Report on Form 8-K filed on October 4, 2021)
10.6 +
Offer Letter to Mark Christianson from NeuroOne, Inc. dated December 1, 2016 (incorporated by reference to Exhibit 10.18 on the Registrant’s Current Report on Form 8-K filed on July 20, 2017)
10.7 +
Form of Indemnification Agreement with the Company’s Officers and Directors (incorporated by reference to Exhibit E to Appendix B to Schedule 14C filed on April 20, 2017)
10.8 +
Employment Agreement by and between NeuroOne Medical Technologies Corporation and David A. Rosa dated August 4, 2017 (incorporated by reference to Exhibit 10.1 on the Registrant’s Current Report on Form 8-K filed on August 7, 2017)
10.9
Form of Amended and Restated Capital Stock Purchase Warrant issued pursuant to Amended and Restated Promissory Note and Warrant Subscription Agreement (incorporated by reference to Exhibit 4.2 on the Registrant’s Current Report on Form 8-K filed on December 20, 2017)
10.10 +
Non-Employee Director Compensation Policy (incorporated by reference to Exhibit 10.40 on the Registrant’s Annual Report on Form 10-K filed April 16, 2018)
10.11
Form of Warrant (incorporated by reference to Exhibit 4.1 on the Registrant’s Current Report on Form 8-K filed July 13, 2018)
10.12
Form of Registration Rights Agreement (incorporated by reference to Exhibit 10.2 on the Registrant’s Current Report on Form 8-K filed July 13, 2018)
10.13 +
Employee Proprietary Information, Inventions, Assignment and Non-Competition Agreement. (incorporated by reference to Exhibit 10.52 on the Registrant’s Annual Report on Form 10-KT filed on December 12, 2018)
77
NeuroOne Medical Technologies Corporation
Form 10-K
10.14
Form of Warrant (incorporated by reference to Exhibit 4.1 on the Registrant’s Current Report on Form 8-K filed on January 4, 2019)
10.15
Form of Registration Rights Agreement (incorporated by reference to Exhibit 10.2 on the Registrant’s Current Report on Form 8-K filed on January 4, 2019)
10.16 +
Offer Letter between Steve Mertens and NeuroOne Medical Technologies Corporation, effective April 1, 2019 (incorporated by reference to Exhibit 10.2 on the Registrant’s Quarterly Report on Form 10-Q filed on May 10, 2019)
10.17
Form of Conversion Warrant (incorporated by reference to Exhibit 4.2 on the Registrant’s Current Report on Form 8-K filed on March 6, 2019)
10.18
Form of Paulson Placement Agent Warrant (incorporated by reference to Exhibit 4.2 on the Registrant’s Current Report on Form 8-K filed on July 5, 2019)
10.19
Form of HRA Placement Agent Warrant (incorporated by reference to Exhibit 4.3 on the Registrant’s Current Report on Form 8-K filed on July 5, 2019)
10.20
Lease Agreement dated October 7, 2019, by and among NeuroOne Medical Technologies Corporation and Biynah Cleveland, LLC, BIP Cleveland, LLC, and Edenvale Investors (incorporated by reference to Exhibit 10.1 on the Registrant’s Current Report on Form 8-K filed on October 11, 2019)
10.21
Form of Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 on the Registrant’s Current Report on Form 8-K filed on October 29, 2019)
10.22
Form of Broker Warrant (incorporated by reference to Exhibit 4.1 on the Registrant’s Current Report on Form 8-K filed on January 24, 2020)
10.23
Form of Warrant (incorporated by reference to Exhibit 4.2 on the Registrant’s Current Report on Form 8-K filed on May 1, 2020)
10.24
Exclusive Development and Distribution Agreement dated as
of July 20, 2020 by and between the Company and Zimmer, Inc. (incorporated by reference to Exhibit 10.1 on the Registrant’s
Current Report on Form 8-K filed on July 22, 2020)
10.24.1
Amendment to Exclusive Development and Distribution Agreement by and between the Company and Zimmer, Inc. dated January 6, 2021 (incorporated by reference to Exhibit 10.39 on the Registrant’s Annual Report on Form 10-K filed on December 15, 2021)
10.24.2
Second Amendment to Exclusive Development and Distribution Agreement by and between the Company and Zimmer, Inc. dated June 28, 2022 (incorporated by reference to Exhibit 10.1 on the Registrant’s Quarterly Report on Form 10-Q filed on August 11, 2022)
10.24.3
Third Amendment to Exclusive Development and Distribution Agreement by and between the Company and Zimmer, Inc. dated August 2, 2022 (incorporated by reference to Exhibit 10.2 on the Registrant’s Quarterly Report on Form 10-Q filed on August 11, 2022)
10.25 +
Employment Offer Letter, dated as of January 1, 2021, by and between Ron McClurg and the Company (incorporated by reference to Exhibit 10.1 on the Registrant’s Current Report on Form 8-K filed on January 7, 2021)
10.26
Form of Warrant (incorporated by reference to Exhibit 4.1 on the Registrant’s Current Report on Form 8-K filed on January 15, 2021)
78
NeuroOne Medical Technologies Corporation
Form 10-K
10.27
Form of Common Stock and Warrant Purchase Agreement (incorporated by reference to Exhibit 10.1 on the Registrant’s Current Report on Form 8-K filed on January 15, 2021)
10.28
Underwriting Agreement, dated October 13, 2021, between NeuroOne Medical Technologies Corporation and Craig-Hallum Capital Group LLC (incorporated by reference to Exhibit 1.1 on the Registrant’s Current Report on Form 8-K filed on October 14, 2021)
10.29
Warrant to Purchase Common Stock (incorporated by reference to Exhibit 4.1 on the Registrant’s Quarterly Report on Form 10-Q filed on August 11, 2022)
21.1*
Subsidiaries of the Registrant
23.1*
Consent of Baker Tilly US, LLP
23.2*
Consent of Honigman LLP (included in Exhibit 5.1)
31.1
Certification of Principal Executive Officer Pursuant to Exchange Act Rule 13a-14(a) or 15d-14(a), as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2
Certification of Principal Financial Officer Pursuant to Exchange Act Rule 13a-14(a) or 15d-14(a), as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS
Inline XBRL Instance Document
101.SCH
Inline XBRL Taxonomy Extension Schema Document
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
104.1
104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
* Indicates filed herewith.
** Pursuant to Item 601(b)(2) of Regulation S-K, the Registrant
agrees to furnish supplementally a copy of any omitted schedule or exhibit to the Agreement and Plan of Merger to the Securities and
Exchange Commission upon request.
# Certain schedules and exhibits have been omitted pursuant
to Item 601(a)(5) of Regulation S-K. A copy of any omitted schedule and/or exhibit will be furnished to the SEC upon request. Certain
portions of the exhibits that are not material have been redacted pursuant to Item 601(b)(10)(iv) of Regulation S-K. Copies of the unredacted
exhibits will be furnished to the SEC upon request.
## Portions of this exhibit have been omitted pursuant to a
request for confidential treatment and have been separately filed with the Securities and Exchange Commission.
+ Indicates management contract or compensatory plan.
(b) The exhibits listed in Item 15(a)(3) are hereby filed with
this Annual Report.
(c) None.
ITEM 16. FORM 10-K SUMMARY
None.
79
NeuroOne Medical Technologies Corporation
Form 10-K
SIGNATURES
Pursuant to the requirements of Section 13 or
15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Annual Report to be signed on its behalf by the undersigned,
thereunto duly authorized.
Date: December 21, 2022
NEUROONE
MEDICAL TECHNOLOGIES
CORPORATION
By:
/s/
DAVID ROSA
David Rosa
Chief Executive Officer
Pursuant to the requirements of the Securities
Exchange Act of 1934, this Annual Report has been signed below by the following persons on behalf of the registrant and in the capacities
and on the dates indicated.
SIGNATURE
TITLE
DATE
/s/ DAVID ROSA
Chief Executive Officer and Director
December 21, 2022
David Rosa
(Principal Executive Officer)
/s/ RONALD MCCLURG
Chief Financial Officer
December 21, 2022
Ronald McClurg
(Principal Financial Officer and Principal Accounting Officer)
/s/ PAUL BUCKMAN
Chairman of the Board of Directors
December 21, 2022
Paul Buckman
/s/ EDWARD ANDRLE
Member of the Board of Directors
December 21, 2022
Edward Andrle
/s/ JEFFREY MATHIESEN
Member of the Board of Directors
December 21, 2022
Jeffrey Mathiesen
80