Item 9A. Controls and Procedures
Item
9A. Controls and Procedures
Disclosure
Controls and Procedures
We
maintain “disclosure controls and procedures,” as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange
Act, that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange
Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and that such information
is accumulated and communicated to our management, including our principal executive officer and our principal financial officer, to
allow timely decisions regarding required disclosure.
The
design of any disclosure controls and procedures also is based in part upon 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.
As
of December 31, 2022, an evaluation was conducted under the supervision and with the participation of our management, including our Chief
Executive Officer and Chief Financial Officer, of the effectiveness of our disclosure controls and procedures. Based on this evaluation,
such officers have concluded that our disclosure controls and procedures are effective as of December 31, 2022.
Management’s
Report on Internal Control over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting for our Company, as such
term is defined in Rule 13a-15(f) under the Exchange Act. Our management conducted an evaluation, with the participation of our principal
executive officer and principal financial officer, of the effectiveness of our internal control over financial reporting as of December
31, 2022, based on the criteria set forth in the 2013 Internal Control—Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission. Based on this evaluation, our management concluded that our internal control over financial
reporting was effective as of December 31, 2022.
This
report does not include an attestation report of our independent registered public accounting firm regarding our internal control over
financial reporting, in accordance with applicable SEC rules that permit us to provide only management’s report in this report.
Changes
in Internal Control over Financial Reporting
There
has not been any change in our internal control over financial reporting (as defined in Rules 13a-15(f) under the Exchange Act) that
occurred during the quarter ended December 31, 2022 that has materially affected, or is reasonably likely to materially affect, our internal
control over financial reporting.
79
Inherent
Limitations on Effectiveness of Controls
Our
management, including our principal executive officer and principal financial officer, do not expect that our disclosure controls or
our internal control over financial reporting will 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.
These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because
of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people,
or by management override of the controls. 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. Projections of any evaluation of controls effectiveness to future periods are subject to risks. Over time, controls may become
inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures.
Item
9B. Other Information
Not
applicable
PART
III
Item
10. Directors, Executive Officers and Corporate Governance
The
information required by this item and not set forth below will be set forth in the section headed “ Election of Directors”
and “ Executive Officers ” in our Proxy Statement for our 2023 Annual Meeting of Stockholders (“Proxy Statement”),
to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2022, and is incorporated herein by reference.
We
have adopted a code of ethics for directors, officers (including our principal executive officer, principal financial officer and principal
accounting officer) and employees, known as the Code of Business Conduct and Ethics. The Code of Business Conduct and Ethics is available
on our website at http://ir.etonpharma.com under the Corporate Governance section of our Investor Relations page. We will
promptly disclose on our website (i) the nature of any amendment to the policy that applies to our principal executive officer, principal
financial officer, principal accounting officer or controller, or persons performing similar functions and (ii) the nature of any waiver,
including an implicit waiver, from a provision of the policy that is granted to one of these specified individuals that is required to
be disclosed pursuant to SEC rules and regulations, the name of such person who is granted the waiver and the date of the waiver.
Item
11. Executive Compensation
The
information required by this item will be set forth in the section headed “ Executive Compensation ” in our Proxy Statement
and is incorporated herein by reference.
Item
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The
information required by this item will be set forth in the section headed “ Security Ownership of Certain Beneficial Owners and
Management ” in our Proxy Statement and is incorporated herein by reference.
The
information required by Item 201(d) of Regulation S-K will be set forth in the section headed “ Executive Compensation”
in our Proxy Statement and is incorporated herein by reference.
Item
13. Certain Relationships and Related Transactions, and Director Independence
The
information required by this item will be set forth in the section headed “ Transactions With Related Persons ” in our
Proxy Statement and is incorporated herein by reference.
Item
14. Principal Accountant Fees and Services
The
information required by this item will be set forth in the section headed “ Ratification of Selection of Independent Registered
Public Accounting Firm ” in our Proxy Statement and is incorporated herein by reference.
80
PART
IV
Item
15. Exhibits, Financial Statement Schedules
(1)
Index to Financial Statements
The
following financial statements of Eton Pharmaceuticals, Inc. and the Report of the Independent Registered Public Accounting Firm are
included in Part II, Item 8 of this Annual Report on Form 10-K:
Report of Independent Registered Public Accounting Firm
54
Balance Sheets as of December 31, 2022 and 2021
56
Statements of Operations for the years ended December 31, 2022, 2021 and 2020
57
Statements of Stockholders’ Equity (Deficit) for the years ended December 31, 2022, 2021 and 2020
58
Statements of Cash Flows for the years ended December 31, 2022, 2021 and 2020
59
Notes to the Financial Statements
60
(2)
Financial Statement Schedules
Financial
statement schedules have been omitted in this report because they are not applicable, not required under the instructions, or the information
requested is set forth in the financial statements or related notes thereto.
(3)
Exhibits
The
following exhibits have been filed or are being filed herewith and are numbered in accordance with Item 601 of Regulation S-K:
EXHIBIT
INDEX
Exhibit
No.
Description
3.1
Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed November 20, 2018).
3.2
Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K, filed November 20, 2018).
4.1
Specimen Certificate representing shares of common stock of Registrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-226774), originally filed August 10, 2018).
4.2
Form of Underwriter’s Warrant (incorporated by reference to Exhibit 4.4 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-226774), originally filed August 10, 2018).
81
Exhibit
No.
Description
4.3
Warrant dated November 13, 2019 issued to SWK Holdings LLC. (incorporated by reference to Exhibit 4.5 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2019 filed March 5, 2020).
10.1
Registration Rights Agreement dated June 19, 2017 by and among the Registrant and certain of its stockholders (incorporated by reference to Exhibit 10.2 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-226774), originally filed August 10, 2018).
10.2†
Asset Purchase Agreement (DS-200) dated June 23, 2017 between Selenix, LLC and the Registrant (incorporated by reference to Exhibit 10.5 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-226774), originally filed August 10, 2018).
10.3
Amended and Restated Agreement relating to sales and marketing dated February 18, 2019 between the Registrant and Eyemax, LLC (incorporated by reference to Exhibit 10.6 to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2019)
10.4†
Sales/Marketing Agreement (DS-300) dated November 17, 2017 by and among AL Pharma, Inc., SCS National, LLC, Dry Creek Project, LLC and the Registrant (incorporated by reference to Exhibit 10.9 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-226774), originally filed August 10, 2018).
10.5+
Offer Letter Agreement by and between the Registrant and Sean E. Brynjelsen, dated as of May 17, 2017 (incorporated by reference to Exhibit 10.12 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-226774), originally filed August 10, 2018).
10.6+
Offer
Letter Agreement by and between the Registrant and James Gruber, dated as of March 25, 2022.
10.7+
2018 Equity Incentive Plan as amended December 2020 (incorporated by reference to Exhibit 10.11 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2020 filed on March 16, 2021).
82
Exhibit
No.
Description
10.8+
2018 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.17 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-226774), originally filed August 10, 2018).
10.9
Amendment No. 1 dated August 29, 2018 to Sales/Marketing Agreement (DS-300) dated November 17, 2017 between AL Pharma, Inc. and the Registrant (incorporated by reference to Exhibit 10.18 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-226774), originally filed August 10, 2018).
10.10
Credit
Agreement dated as of November 13, 2019, by and among the Company and SWK Funding LLC (incorporated by reference to Exhibit 10.14 to
the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2019 filed March 5, 2020) (as amended on April 5, 2022 and such amendment is incorporated by reference to exhibit 10.1 to the Registrant’s quarterly report
on Form 10-Q for the quarter ended March 31, 2022).
23.1
Consent of KMJ Corbin & Company LLP, Independent Registered Public Accounting Firm.
24.1
Power of Attorney. Reference is made to the signature page hereto.
31.1
Certification of President and Chief Executive Officer (Principal Executive Officer), pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2
Certification of Chief Financial Officer (Principal Financial and Accounting Officer), pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 .
32.1*
Certifications of President and Chief Executive Officer (Principal Executive Officer) and Chief Financial Officer (Principal Financial and Accounting Officer), pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101
The
following financial information from the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, formatted
in Extensible Business Reporting Language (XBRL): (i) the Balance Sheets, (ii) the Statements of Operations, (iii) the Statement
of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit), (iv) the Statements of Cash Flows and (v) Notes
to Financial Statements.
†
Confidential
treatment has been granted with respect to certain portions of this exhibit. Omitted portions have been filed separately with the
SEC.
+
Indicates
management compensatory plan, contract or arrangement.
*
These
certifications are being furnished solely to accompany this Annual Report pursuant to 18 U.S.C. Section 1350, and are not being filed
for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and are not to be incorporated by reference into any
filing of the Registrant, whether made before or after the date hereof, regardless of any general incorporation language in such
filing.
83
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Annual Report to be signed
on its behalf by the undersigned thereunto duly authorized.
ETON
PHARMACEUTICALS, INC.
March
16, 2023
By:
/s/
Sean E. Brynjelsen
Sean
E. Brynjelsen
President
and Chief Executive Officer
(Principal
Executive Officer)
By:
/s/
James Gruber
James
Gruber
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
84
POWER
OF ATTORNEY
Each
person whose signature appears below constitutes and appoints each of Sean Brynjelsen and James Gruber, his or her true and lawful
attorney-in-fact and agent, each with full power of substitution and resubstitution, severally, for him or her and in his or her
name, place and stead, in any and all capacities, to sign this Annual Report on Form 10-K of Eton Pharmaceuticals, Inc., and any or
all amendments thereto, and to file the same, with all exhibits thereto and other documents in connection therewith, with the
Securities and Exchange Commission, granting unto said attorney-in-fact and agent, full power and authority to do and perform each
and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he
might or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agent or his substitute or
substitutes, may lawfully do or cause to be done by virtue hereof. This power of attorney may be executed in
counterparts.
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Annual Report to be signed
on its behalf by the undersigned thereunto duly authorized.
Signature
Title
Date
/s/
Sean E. Brynjelsen
President,
Chief Executive Officer, and Director
March
16, 2023
Sean
E. Brynjelsen
(Principal
Executive Officer)
/s/
James Gruber
Chief
Financial Officer, Treasurer and Secretary
March
16, 2023
James
Gruber
(Principal
Financial and Accounting Officer)
/s/
Jennifer M. Adams
Director
March
16, 2023
Jennifer
M. Adams
/s/
Charles J. Casamento
Director
March
16, 2023
Charles
J. Casamento
/s/
Paul V. Maier
Director
March
16, 2023
Paul
V. Maier
/s/
Norbert G. Riedel, Ph.D.
Director
March
16, 2023
Norbert
G. Riedel, Ph.D.
85
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.