Item 9A. Controls and Procedures
Item
9A. Controls and Procedures.
Disclosure
Controls and Procedures
We
maintain disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e) under the Exchange Act) that are designed to
ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is (1) recorded, processed,
summarized, and reported within the time periods specified in the SEC’s rules and forms and (2) accumulated and communicated to
our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions
regarding required disclosure.
As
of December 31, 2023, our management, with the participation of our principal executive officer and principal financial officer, evaluated
the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Annual Report on Form 10-K. Our
management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance
of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible
controls and procedures. Our principal executive officer and principal financial officer have concluded based upon the evaluation described
above that, as of December 31, 2023, our disclosure controls and procedures were effective at the reasonable assurance level.
We
continue to review and document our disclosure controls and procedures, including our internal controls and procedures for financial
reporting, and may from time to time make changes aimed at enhancing their effectiveness and to ensure that our systems evolve with our
business.
Management’s
Annual Report on Internal Control Over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over
financial reporting is a process designed under the supervision and with the participation of our management, including our Chief Executive
Officer and Chief Financial Officer, to provide reasonable assurance regarding the reliability of financial reporting and the preparation
of financial statements for external purposes in accordance with accounting principles generally accepted in the United States of America.
As
of December 31, 2023, our management assessed the effectiveness of our internal control over financial reporting using the criteria set
forth by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO, in Internal Control-Integrated Framework (2013).
Based on this assessment, management, under the supervision and with the participation of our Chief Executive Officer and Chief Financial
Officer, concluded that, as of December 31, 2023, our internal control over financial reporting was effective based on those criteria.
Changes
in Internal Control Over Financial Reporting
An
evaluation was performed under the supervision and with the participation of our management, including our Chief Executive Officer and
Chief Financial Officer, of any changes in our internal control over financial reporting that occurred during our last fiscal quarter
that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. That evaluation
did not identify any change in our internal control over financial reporting, as such term is defined in Rules 13a-15 and 15(d)-15 promulgated
under the Exchange Act, that occurred during our latest fiscal quarter and that has materially affected, or is reasonably likely to materially
affect, our internal control over financial reporting.
Item
9B. Other Information.
(a) There is no information that was required to be disclosed
in a report on Form 8-K during the fourth quarter of 2023 but was not reported.
(b) In the quarter ended December 31, 2023, none of our directors
or officers (as defined in Rule 16a-1(f) of the Exchange Act) adopted or terminated a plan for the purchase or sale of our securities
intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or a non-Rule 10b5-1 trading arrangement for the purchase or
sale of our securities, within the meaning of Item 408 of Regulation S-K.
Item
9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
None.
96
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 “Information Regarding the Board of Directors and Corporate Governance” in our definitive Proxy Statement for our 2023
Annual Meeting of Stockholders to be filed with the SEC on or before April 29, 2024 (our “ Proxy Statement ”)
and is incorporated in this report 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://www.protaratx.com under the Corporate Governance section of our Investors 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, the name of such person who is granted
the waiver and the date of the waiver. Stockholders may request a free copy of the Code of Business Conduct and Ethics by emailing info@protaratx.com.
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 in this report 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 in this report by reference.
Information
regarding our equity compensation plans will be set forth in the section headed “ Executive Compensation ” in our Proxy
Statement and is incorporated in this report 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 in this report 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 in this report by reference.
97
PART
IV
Item
15. Exhibits and Financial Statement Schedules.
(a)
Documents filed as part of this report.
1.
The following financial statements of Protara Therapeutics, Inc. and Report of Ernst & Young LLP, Independent Register Public Accounting
Firm, are included in this report:
Page Number
Report of Independent Registered Public Accounting Firm (PCAOB ID:42)
71
Consolidated Balance Sheets
72
Consolidated Statements of Operations and Comprehensive Loss
73
Consolidated Statements of Changes in Stockholders’ Equity
74
Consolidated Statements of Cash Flows
75
Notes to Consolidated Financial Statements
76
2.
List of financial statement schedules:
All
schedules have been omitted because they are not applicable or the required information is shown in the financial statements or notes
thereto.
3.
List of Exhibits required by Item 601 of Regulation S-K. See part (b) below.
(b)
Exhibits.
Exhibit
No.
Description
2.1
Agreement
and Plan of Merger and Reorganization, dated September 23, 2019, by and among the Registrant, ArTara Therapeutics, Inc. and REM 1
Acquisition, Inc. (filed as Exhibit 2.1 to the Registrant’s Current Report on Form 8-K as filed on September 24, 2019, and
incorporated herein by reference).
2.2
Amendment
No. 1 to Agreement and Plan of Merger and Reorganization, dated November 19, 2019, by and among the Registrant, ArTara Therapeutics,
Inc. and REM 1 Acquisition, Inc. (filed as Exhibit 2.2 to the Registrant’s Registration Statement on Amendment No. 2 to Form
S-4 as filed on December 4, 2019, and incorporated herein by reference).
3.1
Sixth
Amended and Restated Certificate of Incorporation of the Company (incorporated by reference to Exhibit 3.1 to the Company’s
Current Report on Form 8-K filed on October 27, 2014).
3.2
Certificate
of Amendment to the Sixth Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Registrant’s
Current Report on Form 8-K, filed with the SEC on January 10, 2020).
3.3
Second
Certificate of Amendment to the Sixth Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.3
to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on May 13, 2020).
3.4
Certificate
of Designation of Preferences, Rights and Limitations of Series 1 Convertible Preferred Stock (incorporated by reference to Exhibit
3.2 to the Registrant’s Current Report on Form 8-K, filed with the SEC on January 10, 2020).
3.5
Certificate
of Amendment to the Certificate of Designation of Preferences, Rights and Limitations of Series 1 Convertible Non-Voting Preferred
Stock (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on September
23, 2020).
3.6
Composite
Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.6 to the Company’s
Annual Report on Form 10-K, filed with the SEC on March 8, 2023).
3.7
Second
Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 of Current Report on Form 8-K, filed on August 3, 2017).
4.1
Form
of Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed
with the SEC on January 10, 2020).
4.2
Description
of securities registered under Section 12 of the Exchange Act of 1934 (incorporated by reference to Exhibit 4.2 of the Registrant’s
Annual Report on Form 10-K, filed with the SEC on March 11, 2021).
4.3
Registration
Rights Agreement, dated as of September 23, 2019, by and among the Registrant and the institutional investors named therein (incorporated
by reference to Exhibit 10.5 to the Registrant’s Current Report on Form 8-K, filed with the SEC on September 24, 2019).
10.1†
2006
Equity Incentive Plan, as amended and restated August 21, 2014 (incorporated by reference to Exhibit 10.1 to Amendment No. 1 to the
Company’s Registration Statement on Form S-1 filed on October 7, 2014 (File No. 333-198777)).
10.2†
Form
of Stock Option Grant Notice and Stock Option Agreement under the Company’s 2006 Equity Incentive Plan, as amended (incorporated
by reference to Exhibit 10.16 to the Company’s Registration Statement on Form S-1 filed on September 16, 2014).
98
10.3
Assignment
of Rights/License Agreement, effective as of February 4, 2002, by and between Johns Hopkins University and F. Nicholas Franano (incorporated
by reference to Exhibit 10.11 to the Company’s Registration Statement on Form S-1 filed on September 16, 2014).
10.4
Letter
Agreement, dated January 12, 2009, by and between F. Nicholas Franano and the Company (as successor-in-interest to Proteon Therapeutics,
L.L.C.) (incorporated by reference to Exhibit 10.14 to the Company’s Registration Statement on Form S-1 filed on September
16, 2014).
10.5†
2014
Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.25 to Amendment No. 1 to the Company’s Registration Statement
on Form S-1 filed on October 7, 2014).
10.6**
Subscription
Agreement, dated September 23, 2019, by and among the Registrant and the institutional investors named therein (incorporated by reference
to Exhibit 10.4 to the Registrant’s Current Report on Form 8-K, filed with the SEC on September 24, 2019).
10.7**
First
Amendment to Subscription Agreement, dated November 19, 2019, by and among the Registrant and the institutional investors named therein
(incorporated by reference to Exhibit 99.12 to the Registrant’s Registration Statement on Form S-4).
10.8†
Amended
and Restated 2014 Equity Incentive Plan of the Registrant (incorporated by reference to Exhibit 10.1 to the Registrant’s Current
Report on Form 8-K, filed on January 10, 2020).
10.9†
Forms
of Stock Option Agreement, Option Exercise, Restricted Stock Unit Grant and Restricted Stock Unit Agreement under the Amended and
Restated 2014 Equity Incentive Plan of the Registrant, as amended (incorporated by reference to Exhibit 10.25 to the Registrant’s
Annual Report on Form 10-K on form 10-K for the fiscal year ended December 31, 2019 filed on March 20, 2020).
10.10†
2017
Equity Incentive Plan of ArTara Subsidiary, Inc. (incorporated by reference to Exhibit 10.11 to the Registrant’s Current Report
on Form 8-K, filed with the SEC on January 10, 2020).
10.11†
Inducement
Plan of the Registrant (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed with
the SEC on March 30, 2020).
10.12†
Form
of Stock Option Grant Notice and Stock Option Agreement under the Inducement Plan of the Registrant (incorporated by reference to
Exhibit 10.2 to the Registrant’s Current Report on Form 8-K, filed with the SEC on March 30, 2020).
10.13†
Forms
of Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement under the Inducement Plan of the Registrant (incorporated
by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K, filed with the SEC on March 30, 2020).
10.14†
Executive
Employment Agreement, dated as of November 5, 2019, as amended on December 4, 2019, by and between ArTara Subsidiary, Inc. and Jesse
Shefferman. (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K, filed with the SEC on
January 10, 2020).
10.15†
Executive
Employment Agreement, dated as of December 17, 2019, by and between ArTara Subsidiary, Inc. and Jacqueline Zummo, Ph.D., MPH, MBA.
(incorporated by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K, filed with the SEC on January 10,
2020).
10.16†
Executive
Employment Agreement, effective as of January 10, 2022, by and between the Registrant and Jathin Bandari, M.D. (incorporated by reference
to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on May 5, 2022).
10.17†
Amended
and Restated Executive Employment Agreement, entered into as of June 1, 2023, by and between the Registrant and Patrick Fabbio
(incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 10-Q, filed with the SEC on August 3,
2023).
10.18††
Choline
License Agreement, by and between ArTara Subsidiary, Inc. and Alan L. Buchman, M.D. dated as of September 27, 2017. (incorporated
by reference to Exhibit 10.4 to the Registrant’s Current Report on Form 8-K, filed with the SEC on January 10, 2020).
10.19††
Sponsored
Research and License Agreement, by and between ArTara Subsidiary, Inc. and The University of Iowa dated as of November 28, 2018.
(incorporated by reference to Exhibit 10.5 to the Registrant’s Current Report on Form 8-K, filed with the SEC on January 10,
2020).
10.20††
License
Agreement, by and between ArTara Subsidiary, Inc. and The Feinstein Institute for Medical Research dated as of December 22, 2017.
(incorporated by reference to Exhibit 10.6 to the Registrant’s Current Report on Form 8-K, filed with the SEC on January 10,
2020).
99
10.21
††
Agreement,
by and between ArTara Subsidiary, Inc. and Chugai Pharmaceutical Co., Ltd. dated as of June 17, 2019. (incorporated by reference
to Exhibit 10.7 to the Registrant’s Current Report on Form 8-K, filed with the SEC on January 10, 2020).
10.22
††
Amendment
to Agreement, by and between Chugai Pharmaceutical Co., Ltd. and the Registrant, dated as of July 14, 2020 and effective as of June
30, 2020 (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on
November 12, 2020).
10.23
†
Form
of Indemnity Agreement between the Registrant and each of its directors and officers. (incorporated by reference to Exhibit 10.8
to the Registrant’s Current Report on Form 8-K, filed with the SEC on January 10, 2020).
10.24
†
Restated
Non-Employee Director Compensation Policy (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form
10-Q, filed with the SEC on May 5, 2022).
10.25
†† **
Lease
by and between 345 PAS HOLDING LLC, and the Registrant, dated as of December 7, 2020. (incorporated by reference to Exhibit 10.25
to the Registrant’s Annual Report on Form 10-K, filed with the SEC on March 11, 2021)
21.1
+
List of Subsidiaries.
23.1
+
Consent of Ernst & Young LLP, independent registered public accounting firm.
24.1
+
Power of Attorney (Included in signature pages)
31.1
+
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2
+
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1
+
Principal Executive Officer Certification and Principal Financial Officer Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
97.1 +
Executive Compensation Clawback Policy.
101
*
Interactive Data Files Pursuant to Rule 405 of Regulation S-T: (i)
the Consolidated Balance Sheets as of December 31, 2023 and 2022; (ii) the Consolidated Statements of Operations for the years ended December
31, 2023 and 2022; (iii) the Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the years ended December 31,
2023 and 2022; (iv) the Consolidated Statements of Cash Flows for the years ended December 31, 2023 and 2022; and (v) the notes to the
Consolidated Financial Statements.
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
Cover
Page Interactive Data File (embedded within the Inline XBRL document)
+
Filed
herewith.
**
Schedules
have been omitted pursuant to Item 601(b)(2) of Regulation S-K. A copy of any omitted schedules will be furnished to the SEC upon
request.
†
Indicates
management contract or compensatory plan or arrangement.
††
Certain
portions of this exhibit (indicated by “[***]”) have been omitted as the Registrant has determined (i) the omitted information
is not material and (ii) the omitted information is of the type the Registrant customarily and actually treats as private or confidential.
Item
16. Form 10-K Summary.
None.
100
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities and Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned, thereunto duly authorized.
Protara
Therapeutics, Inc.
Date:
March 13, 2024
/s/
JESSE SHEFFERMAN
Jesse
Shefferman
President
and Chief Executive Officer
(on
behalf of the registrant and as the registrant’s Principal Executive Officer)
Date:
March 13, 2024
/s/
PATRICK FABBIO
Patrick
Fabbio
Chief
Financial Officer
(on
behalf of the registrant and as the registrant’s Principal Financial Officer)
KNOW
ALL PERSONS BY THESE PRESENTS, that each individual whose signature appears below constitutes and appoints Jesse Shefferman and Patrick
Fabbio his or her true and lawful attorney-in-fact and agent with full power of substitution, for him or her and in his or her name,
place and stead, in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same,
with all exhibits thereto and all 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 or she might or could do in person, hereby ratifying and confirming
all that said attorney-in-fact and agent, or his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant
to the requirements of the Securities and Exchange Act of 1934, this 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/
JESSE SHEFFERMAN
President
and Chief Executive Officer and Director
March
13, 2024
Jesse
Shefferman
(Principal
Executive Officer)
/s/
PATRICK FABBIO
Chief
Financial Officer
March
13, 2024
Patrick
Fabbio
(Principal
Financial Officer)
/s/
HANNAH FRY
Vice
President, Controller
March
13, 2024
Hannah
Fry
(Principal
Accounting Officer)
/s/
LUKE BESHAR
Chairman
of the Board of Directors
March
13, 2024
Luke
Beshar
/s/
BARRY FLANNELLY, PHARM.D.
Director
March
13, 2024
Barry
Flannelly, Pharm.D.
101
/s/
ROGER GARCEAU, M.D.
Director
March
13, 2024
Roger
Garceau, M.D.
/s/
JANE HUANG, M.D.
Director
March
13, 2024
Jane
Huang, M.D.
/s/
RICHARD LEVY, M.D.
Director
March
13, 2024
Richard
Levy, M.D.
/s/
GREGORY P. SARGEN
Director
March
13, 2024
Gregory
P. Sargen
/s/
CYNTHIA SMITH
Director
March
13, 2024
Cynthia
Smith
/s/
MICHAEL SOLOMON, PH.D.
Director
March
13, 2024
Michael
Solomon, Ph.D.
102