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, 2025,
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, 2025,
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, 2025,
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, 2025, 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.
114
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 2025 but was not reported.
(b) Insider trading arrangements
The following table provides information concerning Rule 10b5-1 trading arrangements (as defined in Item 408 of Regulation S-K under the Securities Exchange Act of 1934) adopted in the fourth quarter of 2025 by any director or any executive officer who is subject to the filing requirements of Section 16 of the Securities Exchange Act of 1934. These trading arrangements are intended to satisfy the affirmative defense of Rule 10b5-1(c). These trading arrangements permit transactions through and including the earlier to occur of (a) the completion of all purchases or sales or (b) the date listed in the table below. These trading arrangements, identified as “Rule 10b5-1 Trading Arrangements”, only permit transactions upon expiration of the applicable mandatory cooling-off period under Rule 10b5-1.
Name Title Adoption Date Duration Aggregate number
of shares of
common stock to be
purchased or sold
pursuant to the
trading arrangement
Jesse Shefferman President, Chief Executive Officer and Director December 25, 2025 March 25, 2026 –
September 24, 2026 69,448
Jacqueline Zummo Chief R&D Officer December 31, 2025 April 1, 2026 –
December 31, 2026 23,732
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent
Inspections.
Not applicable.
115
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 sections headed “ —Election of Directors ,” “ Information
Regarding Director Nominees and Current Directors ,” “ Information Regarding the Board of Directors and Corporate Governance ”
and “ Executive Officers ” in our definitive Proxy Statement for our 2026 Annual Meeting of Stockholders to be filed
with the SEC on or before April 30, 2026, or 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.
We have also adopted an Insider
Trading Policy that governs the purchase, sale and/or other dispositions of our securities by us and by our directors, officers and employees,
and that we believe is reasonably designed to promote compliance with insider trading laws, rules and regulations and applicable exchange
listing standards. A copy of our Insider Trading Policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K.
Item 11. Executive Compensation.
The information required
by this Item will be set forth in the sections headed “ Executive Compensation ” and “ Non-Employee Director
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.
116
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 Registered Public Accounting Firm, are included
in this report:
Page
Number
Report of Independent Registered Public Accounting Firm (PCAOB ID:42)
86
Consolidated Balance Sheets
87
Consolidated Statements of Operations and Comprehensive Loss
88
Consolidated Statements of Changes in Stockholders’ Equity
89
Consolidated Statements of Cash Flows
90
Notes to Consolidated Financial Statements
91
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).
117
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 to the Registrant’s 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†
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).
10.2+
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).
10.3+
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 as filed on December 5, 2019).
10.4*
Second Amendment to Subscription Agreement, dated December 17, 2025, by and among the Registrant and the institutional investors named therein.
10.5†
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).
10.6†
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, filed with the SEC on March 20, 2020).
10.7†
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).
10.8†
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).
10.9†
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).
10.10†
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).
10.11†
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).
10.12†
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).
10.13†
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).
10.14††
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).
10.15††
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).
118
10.16††
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).
10.17††
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).
10.18††
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).
10.19†
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).
10.20†
Non-Employee
Director Compensation Policy (incorporated by reference to Exhibit 10.7 to the Registrant’s Quarterly Report on Form 10-Q,
filed with the SEC on May 8, 2025).
10.21††+
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) .
10.22+
Subscription Agreement, dated April 5, 2024 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on April 5, 2024).
10.23
Form of Pre-Funded Common Stock Purchase Warrant (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K, filed with the SEC on April 5, 2024).
10.24
Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K, filed with the SEC on April 5, 2024).
10.25
Registration Rights Agreement, dated April 5, 2024 (incorporated by reference to Exhibit 10.4 to the Registrant’s Current Report on Form 8-K, filed with the SEC on April 5, 2024).
10.26†
2024 Equity Incentive Plan of the Registrant (incorporated by reference to Exhibit 99.1 to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on August 6, 2024).
10.27†
2024 Equity Incentive Plan, as Amended (incorporated by reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on August 11, 2025).
10.28†
2024 Employee Stock Purchase Plan of the Registrant (incorporated by reference to Exhibit 99.2 to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on August 6, 2024).
10.29†
Forms of Stock Option Agreement, Stock Option Grant Notice, Restricted Stock Unit Agreement and Restricted Stock Unit Grant Notice under the 2024 Equity Incentive Plan of the Registrant (incorporated by reference to Exhibit 99.3 to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on August 6, 2024).
10.30†
Separation and Consulting Agreement and Release, dated as of March 18, 2024, by and between the Company and Jathin Bandari, M.D. (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on March 18, 2024).
10.31†
Retention Bonus, effective as of January 25, 2024, by and between Registrant and Jacqueline Zummo, Ph.D, MPH, MBA (incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on May 2, 2024).
10.32
Form of Pre-Funded Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on December 11, 2024).
10.33
First Certificate of Amendment to Inducement Plan of the Registrant dated March 3, 2025 (incorporated by reference to Exhibit 10.36 to the Registrant’s Annual Report on Form 10-K, filed with the SEC on March 5, 2025).
10.34†
Executive Employment Agreement, effective as of April 15, 2025, by and between the Registrant and Leonardo Nicacio, M.D. (incorporated by reference to Exhibit 10.6 to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on May 8, 2025).
10.35†
Executive Employment Agreement, effective as of June 2, 2025, by and between the Registrant and William Conkling (incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on August 11, 2025).
19.1
Insider Trading Policy (incorporated by reference to Exhibit 19.1 to the Registrant’s Annual Report on Form 10-K, filed with the SEC on March 5, 2025).
21.1*
List of Subsidiaries.
23.1*
Consent of Ernst & Young LLP, independent registered public accounting firm.
119
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 (incorporated by reference to Exhibit 97.1 to the Registrant’s Annual Report on Form 10-K, filed with the SEC on March 13, 2024).
101*
Interactive Data Files Pursuant to Rule 405 of Regulation S-T: (i) the Consolidated Balance Sheets as of December 31, 2025 and 2024; (ii) the Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2025 and 2024; (iii) the Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2025 and 2024; (iv) the Consolidated Statements of Cash Flows for the years ended December 31, 2025 and 2024; 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.
**
Furnished 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.
120
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 10, 2026
/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 10, 2026
/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 10, 2026
Jesse Shefferman
(Principal Executive Officer)
/s/ PATRICK FABBIO
Chief Financial Officer
March 10, 2026
Patrick Fabbio
(Principal Financial Officer)
/s/ HANNAH FRY
Vice President, Controller
March 10, 2026
Hannah Fry
(Principal Accounting Officer)
/s/ LUKE BESHAR
Chairman of the Board of Directors
March 10, 2026
Luke Beshar
/s/ BARRY FLANNELLY, PHARM.D.
Director
March 10, 2026
Barry Flannelly, Pharm.D.
/s/ ROGER GARCEAU, M.D.
Director
March 10, 2026
Roger Garceau, M.D.
/s/ JANE HUANG, M.D.
Director
March 10, 2026
Jane Huang, M.D.
/s/ RICHARD LEVY,
M.D.
Director
March 10, 2026
Richard Levy, M.D.
/s/ GREGORY P.
SARGEN
Director
March 10, 2026
Gregory P. Sargen
/s/ CYNTHIA SMITH
Director
March 10, 2026
Cynthia Smith
/s/ MICHAEL SOLOMON,
PH.D.
Director
March 10, 2026
Michael Solomon, Ph.D.
121