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, 2022,
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, 2022, 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, 2022,
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 (2017). 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, 2022, 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.
None.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent
Inspections.
None.
68
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 2022 Annual Meeting of Stockholders
to be filed with the SEC on or before May 2, 2023 (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.
69
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)
F-2
Consolidated Balance Sheets
F-3
Consolidated Statements of Operations and Comprehensive Loss
F-4
Consolidated Statements of Changes in Stockholders’ Equity
F-5
Consolidated Statements of Cash Flows
F-6
Notes to Consolidated Financial Statements
F-7
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
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).
70
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†+
Executive Employment Agreement, effective as of January 30, 2023 by and between the Registrant and Patrick Fabbio.
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).
71
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)
10.26 †
Consulting
Agreement, dated as of October 16, 2021, by and between the Company and Martín Sebastian Olivo, M.D. (incorporated by reference
to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on October 18, 2021).
10.27 †
Separation
Agreement and Release, dated as of October 15, 2021, by and between the Company and Martín Sebastian Olivo, M.D. (incorporated
by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K, filed with the SEC on October 18, 2021.
10.28†
Executive Employment Agreement, effective as of February 11, 2020 by and between the Registrant and Blaine Davis (incorporated by reference to Exhibit 10.30 to the Registrant’s Annual Report on Form 10-K, filed with the SEC on March 19, 2020).
10.29†
Separation Agreement and Release, dated as of June 20, 2022, by and between the Registrant and Blaine Davis (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on June 21, 2022).
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.
101 *
Interactive Data Files
Pursuant to Rule 405 of Regulation S-T: (i) the Consolidated Balance Sheets as of December 31, 2020 and 2019; (ii) the Consolidated
Statements of Operations for the years ended December 31, 2020 and 2019; (iii) the Consolidated Statements of Changes in Stockholders’
Equity (Deficit) for the years ended December 31, 2020 and 2019; (iv) the Consolidated Statements of Cash Flows for the years ended
December 31, 2020 and 2019; 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.
^
Certain exhibits and schedules
have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Registrant hereby undertakes to furnish supplementally a copy
of any omitted exhibit or schedule upon request by the SEC.
Item 16. Form 10-K Summary.
None.
72
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 8, 2023
/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 8, 2023
/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 8, 2023
Jesse
Shefferman
(Principal Executive Officer)
/s/
PATRICK FABBIO
Chief Financial Officer
March 8, 2023
Patrick Fabbio
(Principal Financial
Officer)
/s/ HANNAH FRY
Vice President, Controller
March 8, 2023
Hannah Fry
(Principal Accounting
Officer)
/s/
LUKE BESHAR
Chairman of the Board of
Directors
March 8, 2023
Luke Beshar
/s/
BARRY FLANNELLY, PHARM.D.
Director
March 8, 2023
Barry Flannelly, Pharm.D.
/s/
ROGER GARCEAU, M.D.
Director
March 8, 2023
Roger Garceau, M.D.
/s/
JANE HUANG, M.D.
Director
March 8, 2023
Jane Huang, M.D.
/s/ RICHARD
LEVY, M.D.
Director
March 8, 2023
Richard Levy, M.D.
/s/ GREGORY
P. SARGEN
Director
March 8, 2023
Gregory P. Sargen
/s/
CYNTHIA SMITH
Director
March 8, 2023
Cynthia Smith
/s/ MICHAEL
SOLOMON, PH.D.
Director
March 8, 2023
Michael Solomon, Ph.D.
73
Protara Therapeutics,
Inc.
Index to Consolidated Financial Statements
Protara Therapeutics, Inc. for the Years Ended December 31, 2022 and 2021 Page No.
Report of Independent Registered Public Accounting Firm (PCAOB ID: 42 ) F-2
Consolidated Balance Sheets as of December 31, 2022 and 2021 F-3
Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2022 and 2021 F-4
Consolidated Statements of Changes in Stockholders’ Equity for the Years Ended December 31, 2022 and 2021 F-5
Consolidated Statements of Cash Flows for the Years Ended December 31, 2022 and 2021 F-6
Notes to Consolidated Financial Statements F-7
F- 1
Report of Independent Registered Public Accounting
Firm
To the Stockholders and the Board of Directors of Protara Therapeutics,
Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated
balance sheets of Protara Therapeutics, Inc. (the “Company”) as of December 31, 2022 and 2021, the related consolidated statements
of operations and comprehensive loss, changes in stockholders’ deficit and cash flows for each of the two years ended December 31,
2022, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated
financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2022 and 2021,
and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2022, in conformity with
U.S. generally accepted accounting principles.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our
audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are
required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and
regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with
the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the
financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we
engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures
to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that
respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial
statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as
evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below
is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to
the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our
especially challenging, subjective or complex judgments. The communication of critical audit matter does not alter in any way our opinion
on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing
a separate opinion on the critical audit matter or on the account or disclosure to which it relates.
Valuation of Goodwill
Description of the Matter
As discussed in Note 2 to the consolidated financial
statements, goodwill is assessed annually for impairment as of December 31, or more frequently if an event occurs or circumstances change
that would indicate that it is more likely than not that the fair value of a reporting unit has declined below its carrying value. As
a result of the annual impairment test, the Company determined the estimated fair value of the reporting unit was less than the carrying
value and recorded a non-cash goodwill impairment expense in the statements of operations and comprehensive loss of $29.5 million.
Auditing the Company’s quantitative impairment
test for goodwill was especially complex and judgmental due to the significant estimation required in determining the fair value of the
reporting unit. In particular, the fair value estimate was sensitive to the significant assumptions that require judgment including the
amount and timing of expected future cash flows and the related discount rate. These assumptions are affected by such factors as expected
future market or economic conditions and clinical trial and regulatory events.
How We Addressed the Matter in Our Audit
To test the estimated fair value of the reporting unit, our audit procedures included, among others, assessing the valuation methodology, evaluating the significant assumptions used to develop the projected financial information, and testing the underlying data used by the Company in its analysis. For example, we compared the projected financial information developed by management to current industry benchmarks and economic trends and evaluated the expected impacts of the Company’s ongoing operating strategies to develop its portfolio of therapies on the significant assumptions. We performed sensitivity analyses of the significant assumptions to evaluate the change in the fair value of the reporting unit resulting from changes in the assumptions. We also considered the relationship between the fair value of the reporting unit to the market capitalization of the Company. In addition, we involved our internal valuation specialists to assist in evaluating the methodology and significant assumptions applied in developing the fair value estimate.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 2021.
New York, New York
March 8, 2023
F- 2
Protara Therapeutics, Inc.
Consolidated Balance Sheets
(in thousands, except share and per share data)
December 31,
2022
2021
Assets
Current assets:
Cash and cash equivalents
$ 24,127
$ 35,724
Marketable debt securities
60,243
55,505
Prepaid expenses and other current assets
1,776
1,883
Total current assets
86,146
93,112
Restricted cash, non-current
745
745
Marketable debt securities, non-current
17,886
39,467
Property and equipment, net
1,592
1,719
Operating lease right-of-use asset
6,277
7,171
Goodwill
-
29,517
Other assets
644
865
Total assets
$ 113,290
$ 172,596
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 1,586
$ 954
Accrued expenses
3,237
2,489
Operating lease liability
917
855
Total current liabilities
5,740
4,298
Operating lease liability, non-current
5,467
6,384
Total liabilities
11,207
10,682
Commitments and contingencies (Note 9)
Stockholders’ Equity
Preferred stock, $0.001 par value, authorized 10,000,000 shares:
Series 1 convertible preferred stock, 8,028 shares authorized at December 31, 2022 and 2021, respectively 8,027 shares issued and outstanding as of December 31, 2022 and 2021, respectively.
-
-
Common stock, $0.001 par value, authorized 100,000,000 shares:
Common stock, 11,267,389 and 11,235,731 shares issued and outstanding as of December 31, 2022 and 2021, respectively.
11
11
Additional paid in capital
262,724
256,126
Accumulated deficit
( 159,964 )
( 94,012 )
Accumulated other comprehensive income (loss)
( 688 )
( 211 )
Total stockholders’ equity
102,083
161,914
Total liabilities and stockholders’ equity
$ 113,290
$ 172,596
See accompanying notes to consolidated financial
statements.
F- 3
Protara Therapeutics, Inc.
Consolidated Statements of Operations
and Comprehensive Loss
(in thousands, except share and per
share data)
Years Ended December 31,
2022
2021
Operating expenses:
Research and development
$ 16,808
$ 21,088
General and administrative
20,737
26,401
Loss on impairment of goodwill
29,517
-
Total operating expenses
67,062
47,489
Loss from operations
( 67,062 )
( 47,489 )
Other income (expense), net
Interest and investment income
1,110
237
Other income (expense), net
1,110
237
Net loss
( 65,952 )
( 47,252 )
Net loss per share attributable to common stockholders, basic and diluted
$ ( 5.86 )
$ ( 4.21 )
Weighted average shares outstanding, basic and diluted
11,259,615
11,232,576
Other comprehensive income (loss):
Net unrealized (loss) gain on marketable debt securities
( 477 )
( 211 )
Other comprehensive income (loss)
( 477 )
( 211 )
Comprehensive Loss
$ ( 66,429 )
$ ( 47,463 )
See accompanying notes to consolidated financial
statements.
F- 4
Protara Therapeutics, Inc.
Consolidated Statements of Changes
in Stockholders’ Equity
(in thousands, except share and per
share data)
Series 1 Convertible
Preferred Stock
Common Stock
Additional
Paid-in
Accumulated
Accumulated
Other
Comprehensive
Total
Stockholders’
Shares
Amount
Shares
Amount
Capital
Deficit
Loss
Equity
Balance at December 31, 2020
8,027
$
-
11,211,840
$
11
$
245,992
$
( 46,760
)
$
-
$
199,243
Settlement of restricted stock units
-
-
23,891
-
( 228
)
-
-
( 228
)
Stock-based compensation - restricted stock units
-
-
-
-
4,520
-
-
4,520
Stock-based compensation - stock options
-
-
-
-
5,842
-
-
5,842
Other comprehensive loss
-
-
-
-
-
-
( 211
)
( 211
)
Net loss
-
-
-
-
-
( 47,252
)
-
( 47,252
)
Balance at December 31, 2021
8,027
$
-
11,235,731
$
11
$
256,126
$
( 94,012
)
$
( 211
)
$
161,914
Settlement of restricted stock units
-
-
31,658
-
( 90
)
-
-
( 90
)
Stock-based compensation - restricted stock units
-
-
-
-
1,273
-
-
1,273
Stock-based compensation - stock options
-
-
-
-
5,415
-
-
5,415
Other comprehensive loss
-
-
-
-
-
-
( 477
)
( 477
)
Net loss
-
-
-
-
-
( 65,952
)
-
( 65,952
)
Balance at December 31, 2022
8,027
$
-
11,267,389
$
11
$
262,724
$
( 159,964
)
$
( 688
)
$
102,083
See accompanying notes to consolidated financial
statements.
F- 5
Protara Therapeutics, Inc.
Consolidated Statements of Cash Flows
(in thousands)
Years Ended December 31,
2022
2021
Cash flows from operating activities:
Net loss
$ ( 65,952 )
$ ( 47,252 )
Adjustments to reconcile net loss to net cash used in operating activities:
Loss on impairment of goodwill
29,517
-
Stock based compensation
6,688
10,362
Operating lease right-of-use asset
1,366
1,050
Depreciation
248
117
Amortization of premium on marketable debt securities
1,137
1,737
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
265
( 418 )
Other assets
222
295
Accounts payable
631
40
Accrued expenses
748
576
Operating lease liabilities
( 1,327 )
( 1,009 )
Net cash used in operating activities
( 26,457 )
( 34,502 )
Cash flows from investing activities:
Purchase of marketable debt securities
( 43,550 )
( 124,748 )
Proceeds from maturity and redemption of marketable debt securities
58,620
27,150
Purchase of property and equipment
( 120 )
( 596 )
Net cash (used in)/provided by investing activities
14,950
( 98,194 )
Cash flows from financing activities:
Repurchase of shares in connection with settlement of RSUs
( 90 )
( 228 )
Net cash (used in)/provided by financing activities
( 90 )
( 228 )
Net (decrease)/increase in cash and cash equivalents and restricted cash
( 11,597 )
( 132,924 )
Cash and cash equivalents and restricted cash - beginning of year
36,469
169,393
Cash and cash equivalents and restricted cash - end of period
$ 24,872
$ 36,469
Supplemental disclosure of cash flow information:
Cash paid for:
Interest
$ -
$ -
Income Taxes
$ -
$ -
See accompanying notes to consolidated financial
statements.
F- 6
Protara Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per
share data)
1. Organization and Nature of the Business
Overview
Protara Therapeutics, Inc., and its consolidated
subsidiaries (“Protara” or the “Company”), is a clinical-stage biopharmaceutical company committed to advancing
transformative therapies for the treatment of cancer and rare diseases. Protara’s portfolio includes two development programs utilizing
TARA-002, an investigational cell therapy in development for the treatment of lymphatic malformations, or LMs and non-muscle invasive
bladder cancer, or NMIBC. The third program in the portfolio is Intravenous, or IV Choline Chloride, an investigational phospholipid
substrate replacement therapy initially in development for patients receiving parenteral nutrition, or PN who have intestinal failure
associated liver disease, or IFALD.
On January 9, 2020, privately-held ArTara Subsidiary,
Inc. (“Private ArTara”) and Protara Therapeutics, Inc. (formerly ArTara Therapeutics, Inc., formerly Proteon Therapeutics,
Inc.) completed the merger and reorganization (the “Merger”), in accordance with the terms of the Agreement and Plan of Merger
and Reorganization, dated September 23, 2019, (the “Merger Agreement”) by and among Protara Therapeutics, Inc., Private ArTara
and REM 1 Acquisition, Inc., a wholly owned subsidiary of Protara Therapeutics, Inc (“Merger Sub”). Thereupon, Merger Sub
merged with and into Private ArTara, with Private ArTara surviving as a wholly owned subsidiary of Protara Therapeutics, Inc. The Merger
was structured as a reverse merger and Private ArTara was determined to be the accounting acquirer based on the terms of the Merger and
other factors, and the post-merger company retained the name ArTara Therapeutics, Inc., which on May 11, 2020 was changed to Protara
Therapeutics, Inc.
In addition, concurrently with the execution of the Merger Agreement,
Protara issued a private placement, whereby all of the outstanding shares of Protara Therapeutics, Inc.’s Series A Preferred Stock
were converted into shares of Protara Therapeutics, Inc.’s common stock. Shares of the Company’s common stock commenced trading
on The Nasdaq Capital Market under the new name and ticker symbol “TARA” as of market open on January 10, 2020.
Liquidity, Capital Resources and Management Plans
The Company is in the business of developing
biopharmaceuticals and has no current or near-term revenues. The Company has incurred substantial clinical and other costs in its drug
development efforts. The Company will need to raise additional capital in order to fully realize management’s plans.
The Company believes that its current financial
resources are sufficient to satisfy the Company’s estimated liquidity needs for at least twelve months from the date of issuance
of these consolidated financial statements.
Impact of the COVID-19
Pandemic
As a result of the impacts of the COVID-19 pandemic,
the Company has experienced delays and may experience additional future delays that impact the business, research and development activities,
the healthcare systems in which the Company operates and the global economy as a whole. Due to the continued impact of the COVID-19 pandemic,
the Company is not able to estimate the ongoing effects on the Company’s results of operations, financial condition, or liquidity.
The Company will continue to monitor the impact of the COVID-19 pandemic and its related macroeconomic effects closely including whether
the effects would have a material impact on the Company’s operations, liquidity and capital resources.
F- 7
Protara Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per
share data)
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying consolidated financial statements
have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”
or “GAAP”).
Principles of Consolidation
The consolidated financial statements include
the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in the
accompanying consolidated financial statements.
Use of Estimates
The preparation of financial statements in conformity
with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses,
and related disclosure of contingent assets and liabilities at the date of the consolidated financial statements. Significant items subject
to such estimates include but are not limited to income taxes, the valuation of deferred tax assets, recoverability of goodwill, and
contingencies.
On an ongoing basis, the Company’s management
evaluates its estimates based on historical and anticipated results, trends, and various other assumptions believed to be reasonable. Actual
results could differ from those estimates. The results of any changes in accounting estimates are reflected in the financial statements
of the period in which the change becomes evident.
Reclassification
Certain amounts in prior periods related to the classification of accrued
expenses and income taxes have been reclassified to conform to current period presentation. These reclassifications to adjust prior period
presentation had no impact on consolidated statements of operations and comprehensive loss or consolidated statements of cash flows.
Cash, Cash Equivalents
and Restricted Cash
The Company considers all highly liquid instruments
with an original maturity of three months or less when acquired to be cash equivalents. Cash and cash equivalents are held in depository
and money market accounts and are reported at fair value. The Company’s restricted cash balances consist of cash deposits to collateralize
letter of credit obligations.
F- 8
Protara Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per
share data)
The following table provides a reconciliation
of cash, cash equivalents, and restricted cash in the consolidated balance sheets to the total amount shown in the consolidated statements
of cash flows:
December 31,
2022
2021
Cash and cash equivalents
$ 24,127
$ 35,724
Restricted cash, non-current
745
745
Total cash, cash equivalents and restricted cash shown in the consolidated statements of cash flows
$ 24,872
$ 36,469
Fair Value Measurements
Accounting Standards Codification (“ASC”)
Topic 820 “Fair Value Measurements” provides the framework for measuring fair value and establishes a fair value hierarchy
that prioritizes the inputs used in pricing the asset or liability. The hierarchy gives the highest priority to unadjusted quoted prices
in active markets for identical assets or liabilities (level 1 measurements) and the lowest priority to unobservable inputs (level 3
measurements).
Fair value is defined as the exchange price,
or an exit price, representing the amount that would be received upon the sale of an asset or payment to transfer a liability in an orderly
transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, the three-tier
fair value hierarchy is used to prioritize the inputs in measuring fair value as follows:
Ø
Level 1 Quoted prices in
active markets for identical assets or liabilities.
Ø
Level 2 Quoted prices for
similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are
not active, or other inputs that are observable, either directly or indirectly.
Ø
Level 3 Significant unobservable
inputs that cannot be corroborated by market data.
The carrying amounts of cash and cash equivalents,
prepaid expenses and accounts payable approximate their fair values due to the short-term nature of these instruments.
Marketable Debt Securities
The Company classifies investments in marketable
debt securities with remaining maturities when purchased of greater than three months as available-for-sale. Investments with a remaining
maturity date greater than one year are classified as non-current. The cost of securities sold is based on the specific identification
method. Interest and dividends earned on securities are classified as available-for-sale are included in investment income.
The Company records investments at fair value
with unrealized gains and losses recorded as a component of other comprehensive loss in the consolidated statements of operations and
comprehensive loss until realized. Realized gains and losses are reflected in interest and investment income in the consolidated statements
of operations and comprehensive loss and are determined using the specific identification method with transactions recorded on a settlement
date basis. Fair value is determined based on quoted market rates when observable or utilizing data points that are observable, such
as quoted prices, interest rates and yield curves. To determine whether an other-than-temporary impairment exists, the Company considers
whether it has the ability and intent to hold the investment until a market price recovery, and whether evidence indicating the recoverability
of the cost of the investment outweighs evidence to the contrary. The Company has the ability to hold such securities with an unrealized
loss until its forecasted recovery. The Company determined that there was no material change in the credit risk of these investments.
F- 9
Protara Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per
share data)
Concentrations of Credit Risk
Financial instruments, which potentially subject
the Company to concentrations of credit risk, consists principally of cash, cash equivalents, restricted cash, and marketable debt securities.
The Company currently invests its excess cash
primarily in money market funds and high quality, investment grade marketable debt securities of corporations. The Company has adopted
an investment policy that includes guidelines relative to credit quality, diversification and maturities to preserve principal and liquidity.
Property and Equipment,
net
Property and equipment, including leasehold improvements,
are recorded at cost less accumulated depreciation and amortization. Depreciation is computed using the straight-line method over the
estimated useful life of the asset. Depreciation begins at the time the asset is placed in service. Leasehold improvements are amortized
using the straight-line method over the shorter of the lease term or estimated useful life of the asset. Repairs and maintenance
costs are expensed as incurred, whereas major improvements are capitalized as additions to property and equipment.
The estimated useful lives for significant property
and equipment categories are as follows:
Asset
Classification
Estimated
Useful Life
Computer
equipment
5
Furniture,
fixtures and other
5
Laboratory
equipment
7
Leasehold
improvements
Shorter of the useful life of asset or the lease term
Leases
The Company enters into contracts in the normal
course of business and assesses whether any such contracts contain a lease. The Company determines if an arrangement is a lease at inception
if it conveys the right to control the identified asset for a period of time in exchange for consideration. Under ASC 842, lease expense
is recognized as a single lease cost on a straight-line basis over the lease term. The lease term consists of non-cancelable periods
and may include options to extend or terminate the lease term, when it is reasonably certain such options will be exercised.
Leases classified as operating leases are included
in operating lease right-of-use (“ROU”) assets, current operating lease liabilities and noncurrent operating lease liabilities
in our consolidated balance sheet. Finance leases are included in property and equipment and finance lease obligations, in our consolidated
balance sheet. ROU assets represent the right to use an underlying asset for the lease term. Lease liabilities represent the present
value of future lease payments, net of lease incentives, discounted using an incremental borrowing rate, which is a management estimate
based on the information available at the commencement date of a lease arrangement. ROU assets and lease liabilities are recognized at
the lease commencement date.
The Company has elected to account for the lease
and non-lease components for leases as a single component for classes of all underlying assets and allocate all the contract consideration
to the lease component only. Lease cost for operating leases is recognized on a straight-line basis over the lease term and is included
in operating expenses on the statements of operations and comprehensive loss. Variable lease payments are included in lease operating
expenses.
The Company recognizes costs associated with
lease arrangements having an initial term of 12 months or less (“short-term leases”) on a straight-line basis over the lease
term; such short-term leases are not recorded on the balance sheet.
Impairment of Long-Lived Assets
Long-lived assets are reviewed for impairment
whenever events or changes in circumstances indicate that the carrying amount of the asset or asset group may not be recoverable or that
the useful life is shorter than originally estimated. When such events occur, the Company compares the carrying amounts of the asset
or asset group to the undiscounted expected future cash flows. If this comparison indicates that the asset or asset group is impaired,
the amount of impairment is measured as the difference between the carrying value and fair value of the asset or asset group. If the
useful life is shorter than originally estimated, the Company will amortize the remaining carrying value over the new shorter useful
life. To date, no such impairment loss has been recognized.
F- 10
Protara Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per
share data)
Segment Information
The Company identifies its operating segments
in accordance with Accounting Standards Codification (“ASC”) 280, Segment Reporting (“ASC 280”). Operating segments
are defined as components of an enterprise about which separate discrete financial information is available for evaluation by the chief
operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company’s
chief operating decision maker, its Chief Executive Officer, manages the Company’s operations on a consolidated basis for the purposes
of allocating resources. Accordingly, the Company has determined it operates and manages its business in a single reportable operating
segment .
Goodwill
On January 9, 2020, in connection with the Merger,
the Company separately valued the assets and liabilities acquired, and then determined goodwill as the residual of the purchase price
less identified net assets, resulting in the initial recording of $ 29.5 million in goodwill.
Goodwill represents the excess of purchase price
over the fair value of identifiable net assets acquired in a business combination. Goodwill has an indefinite useful life. Goodwill is
assessed annually for impairment as of December 31, or more frequently if an event occurs or circumstances change that would indicate
that it is more likely than not that the fair value of a reporting unit or the fair value of an indefinite-lived intangible asset has
declined below its carrying value. In performing its annual goodwill impairment assessment, the Company has the option under GAAP to
qualitatively assess whether it is more likely than not that the fair value of a reporting unit is less than its carrying value; if the
conclusion of the qualitative assessment is that there are no indicators of impairment, the Company does not perform a quantitative assessment.
Otherwise, a quantitative assessment is performed and the fair value of the reporting unit is determined.
Goodwill is evaluated for impairment at the reporting
unit level, which is defined as an operating segment, or one level below an operating segment. The Company has determined that it operates
as one reporting unit and has selected December 31 as the date to perform its annual impairment test.
As of December 31, 2022 and 2021, the Company elected to forego the
qualitative screen and performed a quantitative annual goodwill impairment test for the reporting unit.
As of December 31, 2022, the Company’s stock price and market
capitalization declined 60 % from December 31, 2021, which reflects the overall decline of similar companies with less than $ 250 million
in market capitalizations, or microcap companies. The life sciences sector, which includes pre-commercialization and therefore net operating
loss generating companies, relies heavily on the capital markets to finance their operations and fund pre-clinical and clinical trials
for their existing development programs. As a result of a shift in risk appetite in the overall financial markets, the availability of
capital for life science sector companies decreased significantly in 2022. The challenging financing conditions had a negative impact
on stock prices and respective market capitalizations, particularly for microcap companies. The Company considered the heightened financing
risk that impacted the life sciences sector during 2022 to be one of the key macroeconomic factors that led to a sustained decrease in
the Company’s stock price and market capitalization leading up to its annual goodwill impairment assessment date in late 2022. Based
upon the results of our 2022 annual goodwill impairment test, the Company recorded a loss on impairment of goodwill of $ 29.5 million during
the year ended December 31, 2022.
The following table provides a roll forward of the Company’s
goodwill and accumulated impairment losses.
Goodwill
Goodwill, gross amount as of December 31, 2021
$ 29,517
Accumulated impairment loss, as of December 31, 2021
-
Goodwill as of December 31, 2021
29,517
Additions to goodwill
-
Loss on impairment
( 29,517 )
Goodwill as of December 31, 2022
$ -
Based upon the results of our annual goodwill impairment test, no adjustments
to the carrying value of goodwill were necessary during the year ended December 31, 2021.
Research and Development
Research and development expenses consist primarily
of third-party costs incurred to develop drug candidates, employee-related expenses, including salaries, benefits, travel and stock-based
compensation expense, depreciation and other allocated overhead costs, which include rent and maintenance of facilities and other supplies.
Research and development costs are expensed as incurred.
Before a compound receives regulatory approval,
the Company records upfront and milestone payments made to third parties under licensing arrangements as expense provided that there
is no alternative future use of the rights in other research and development projects.
Nonrefundable advance payments to vendors for
goods or services that will be used or received in future research and development activities are deferred and recognized as expense
in the period in which the related goods are delivered or services are performed. Where milestone payments are due to third parties under
research and development collaboration arrangements or other contractual agreements, the milestone payment obligations are expensed when
the milestone conditions are met and the amount of payment is reasonably estimable.
F- 11
Protara Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per
share data)
Once a compound receives regulatory approval,
the Company records any milestone payments in identifiable intangible assets, less accumulated amortization and, unless the
asset is determined to have an indefinite life, the Company amortizes the payments on a straight-line basis over the remaining agreement
term or the expected product life cycle, whichever is shorter.
Certain third-party costs are included as a component
of research and development expense. These expenses include fees paid to contract research organizations (“CROs”) and other
clinical trial costs, contractual services costs and costs for supply of its drug candidates. Depending upon the timing of payments to
the service providers, the Company recognizes prepaid expenses or accrued expenses related to these costs. These accrued or prepaid expenses
are based on management’s estimates of the work performed under service agreements, milestones achieved and experience with similar
contracts. The Company monitors each of these factors and adjusts estimates accordingly.
Patent Costs
All patent-related costs incurred in connection
with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure.
Amounts incurred are classified as general and administrative expenses.
Interest and Investment Income
Investment income consists primarily of interest
income, accretion income earned and amortization expense incurred and realized gains or losses related to our marketable debt securities
and interest income related to cash, cash equivalents and restricted cash.
Stock-Based Compensation
The Company’s stock-based compensation
programs include stock options, restricted stock units (“RSUs”), and an employee stock purchase program (“ESPP”).
The Company accounts for stock-based compensation using the fair value method.
The Company measures all stock options and other
stock-based awards granted to employees and directors based on the fair value on the date of the grant and recognizes compensation expense
of those awards over the requisite service period, which is generally the vesting period of the respective award. The Company recognizes
forfeitures at the time forfeitures occur.
The fair value of each option is estimated on
the date of grant using the Black-Scholes option-pricing model. Expected volatility for the Company’s common stock is determined
based on an average of the historical volatility of the Company and the historical volatility of a peer-group of similar public companies.
The expected term of options granted to employees is calculated using the simplified method, which represents the average of the contractual
term of the option and the weighted-average vesting period of the option. The assumed dividend yield is based upon the Company’s
expectation of not paying dividends in the foreseeable future. The risk-free interest rate is based upon the U.S. Treasury yield curve
commensurate with the expected term at the time of grant or remeasurement.
The stock-based compensation expense associated
with purchase rights under the ESPP is measured at fair-value using a Black-Scholes option-pricing model at commencement of each offering
period and recognized over that offering period. The Black-Scholes option pricing assumptions are similar to those used for stock options
with the exception of the expected term of purchase rights for the ESPP which is based on the duration of an offering period.
The fair values of RSUs are based on the fair
market value of the Company’s common stock on the date of the grant.
The RSUs are granted to directors pursuant to
the Company’s equity plan. Settlement for the RSUs is deferred until the earliest to occur of (i) the director’s termination
of service, (ii) death, (iii) disability or (iv) a change in control of the Company. In the event of a change in control of the Company,
the RSUs will vest in full.
The fair value of all stock-based awards is recognized
as stock-based compensation expense on a straight-line basis over the vesting period, which is typically one to four years for RSUs and
four years for stock options.
The Company classifies stock-based compensation
expense in its statement of operations and comprehensive loss in the same way the payroll costs or service payments are classified for
the related stock-based award recipients.
F- 12
Protara Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per
share data)
Income Taxes
Deferred tax assets and liabilities are recognized
for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets
and liabilities and their respective tax basis, operating loss and tax credit carryforwards. Deferred tax assets and liabilities are
measured using enacted tax rates in effect for the year in which those temporary differences are expected to be recovered or settled.
The measurement of net deferred tax assets is reduced by the amount of any tax benefit that, based on available evidence, is not expected
to be realized, and a corresponding valuation allowance is established. In making such a determination, the Company considers all available
positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income,
tax-planning strategies, and results of recent operations.
Tax benefits are recognized only for tax positions
that are more likely than not to be sustained upon examination by tax authorities. The amount recognized is measured as the largest amount
of benefit that is greater than 50 percent likely to be realized upon settlement. A liability for unrecognized tax benefits is recorded
for any tax benefits claimed in the Company’s tax returns that do not meet these recognition and measurement standards. The Company’s
policy is to record interest and penalties on uncertain tax positions as a component of income tax expense in the consolidated statement
of operations and comprehensive loss.
Net Loss Per Share Attributable to Common
Stockholders
Basic net loss per share is computed by dividing
the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period.
Diluted net loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares
of common stock outstanding during the period plus the common equivalent shares for the period including any dilutive effect from unvested
restricted common stock, outstanding stock options and potential shares issuable under the ESPP.
Recently Adopted Accounting Pronouncements
In August 2018, the Financial Accounting Standards
Board, or the FASB, issued ASU No. 2018-15, Intangibles – Goodwill and Other – Internal-Use Software
(Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a
Service Contract (“ASU 2018-15”). This ASU is designed to reduce complexity for accounting for costs of
implementing a cloud computing service arrangement. This standard aligns the accounting for implementation costs of hosting arrangements,
regardless of whether they convey a license to the hosted software. The standard became effective for the first interim period within
annual reporting periods beginning after December 15, 2020. On January 1, 2021, the Company adopted ASU 2018-15. The adoption of
this standard did not have a material effect on the Company’s financial position, results of operations, or cash flows.
In December 2019, the FASB issued ASU 2019-12,
Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”). The amendments in ASU 2019-12
remove certain exceptions to the general principles in Topic 740. The amendments also clarify and amend existing guidance to improve
consistent application. The amendments became effective for annual reporting periods beginning after December 15, 2020. On January 1,
2021, the Company adopted ASU 2019-12. The adoption of this standard did not have a material effect on the Company’s financial
position, results of operations, or cash flows.
Recent Accounting Pronouncements
Not Yet Adopted
In June 2016, the Financial Accounting Standards
Board, or the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Statements . The new standard requires that expected
credit losses relating to financial assets measured on an amortized cost basis and available-for-sale debt securities be recorded through
an allowance for credit losses. It also limits the amount of credit losses to be recognized for available-for-sale debt securities to
the amount by which carrying value exceeds fair value and also requires the reversal of previously recognized credit losses if fair value
increases. In November 2019, the FASB issued ASU 2019-10, Financial Instruments – Credit Losses (Topic 326), Derivatives and
Hedging (Topic 815), and Leases (Topic 842): Effective Dates , which amended the effective date for certain companies. The standard
is effective for public companies eligible to be smaller reporting companies for annual and interim periods beginning after December
15, 2022. Early adoption is available. The Company has evaluated the impact of the adoption of ASU 2016-13, and related updates, and
has determined that the impact will not be material to its consolidated financial statements and disclosures.
The Company has evaluated other recently issued
accounting pronouncements and has concluded that the impact of recently issued standards that are not yet effective will not have a material
impact on the Company’s financial position or results of operations upon adoption.
F- 13
Protara Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per
share data)
Subsequent Events
The Company evaluated subsequent events and transactions
that occurred after the balance sheet date up to the date that the financial statements were available to be issued. Other than as described
in Note 11 and, the Company did not identify any subsequent events that would have required adjustment or disclosure in the financial
statements.
3. Fair Value of Financial Instruments
The tables below present information about the
Company’s financial instruments that are measured at fair value on a recurring basis as of December 31, 2022 and 2021 and indicates
the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value, as described under Note 2,
Summary of Significant Accounting Policies.
The following tables present the Company’s
financial assets and liabilities that are measured and carried at fair value and indicate the level within the fair value hierarchy of
the valuation techniques it utilizes to determine such fair value:
December 31, 2022
Level 1
Level 2
Level 3
Total
Cash Equivalents
Money market funds (a)
$ 13,284
$ -
$ -
$ 13,284
Corporate bonds (a)
-
2,523
-
2,523
Restricted cash, non-current
Money market funds (b)
745
-
-
745
Marketable debt securities
Corporate bonds (c)
-
78,129
-
78,129
Total
$ 14,029
$ 80,652
$ -
$ 94,681
December 31, 2021
Level 1
Level 2
Level 3
Total
Cash Equivalents
Money market funds (a)
$ 26,323
$ -
$ -
$ 26,323
Restricted cash, non-current
Money market funds (b)
745
-
-
745
Marketable debt securities
Corporate bonds (c)
-
94,972
-
94,972
Total
$ 27,068
$ 94,972
$ -
$ 122,040
(a) Money market funds and corporate debt securities with original maturities of 90 days or less are included within Cash and cash equivalents in the Consolidated Balance Sheets.
(b) Restricted Money market funds are included within Restricted Cash, non-current in the Consolidated Balance Sheets.
(c) Corporate debt securities with original maturities greater than 90 days are included within Marketable securities in the Consolidated Balance Sheets and classified as current or noncurrent based upon whether the maturity of the financial asset is less than or greater than 12 months.
F- 14
Protara Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per
share data)
Money market funds are classified as Level 1
within the fair value hierarchy, because they are valued using quoted prices in active markets. Corporate debt securities classified
as Level 2 within the fair value hierarchy are valued on the basis of prices from an orderly transaction between market participants
provided by reputable dealers or pricing services. Prices of these securities are obtained through independent, third-party pricing services
and include market quotations that may include both observable and unobservable inputs. In determining the value of a particular investment,
pricing services may use certain information with respect to transactions in such investments, quotations from dealers, pricing matrices
and market transactions in comparable investments and various relationships between investments. There were no transfers of financial
instruments among Level 1, Level 2, and Level 3 during the period presented.
Cash equivalents, prepaid expenses and other
current assets, accounts payable and accrued expenses at December 31, 2022 and 2021 are carried at amounts that approximate fair value
due to their short-term maturities.
Non-Recurring Fair Value Measurements
During the fourth quarter of 2022, the Company recorded a goodwill
impairment loss of $ 29.5 million, refer to Note 2 for additional details on the impairment of goodwill. The fair value of our reporting
unit was determined using an income approach based on discounted cash flows, or DCF. Determining fair value using a DCF analysis requires
the exercise of significant judgment with respect to several assumptions and estimates, including the amount and timing of expected future
cash flows and appropriate discount rate to be applied. The expected cash flows used in the DCF analysis are based on our most recent
internal long-range forecast and budget and, for years beyond the budget, our estimates, which are based, in part, on industry benchmarks
and forecasted growth rates. The discount rate used in the DCF analysis is intended to reflect the risks inherent in the expected future
cash flows of the respective programs within our portfolio. The inputs to the DCF model are Level 3 valuation inputs.
4. Marketable Debt Securities
Marketable debt securities, all of which were
classified as available-for-sale, consist of the following:
December 31, 2022
Amortized
Cost
Unrealized
Gains
Unrealized
Losses
Estimated
Fair Value
Corporate bonds - presented in marketable debt securities
60,790
-
( 547 )
60,243
Corporate bonds - presented in marketable debt securities, non-current
18,027
-
( 141 )
17,886
Total
$ 78,817
$ -
$ ( 688 )
$ 78,129
December 31, 2021
Amortized
Cost
Unrealized
Gains
Unrealized
Losses
Estimated
Fair Value
Corporate bonds - presented in marketable debt securities
$ 55,548
$ -
$ ( 43 )
$ 55,505
Corporate bonds - presented in marketable debt securities, non-current
39,635
-
( 168 )
39,467
Total
$ 95,183
$ -
$ ( 211 )
$ 94,972
The amount of realized gains and losses reclassified
into earnings for the year ended December 31, 2022 was $ 17 included in investment income within the consolidated statements of operations
and comprehensive loss. There were no sales of securities in the periods presented.
F- 15
Protara Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per
share data)
The contractual maturities of all securities
held at December 31, 2022 was 16 months or less. Of the 34 securities in a loss position held by the Company, there were 16 securities
in a continuous unrealized loss position for greater than twelve months at December 31, 2022. The total unrealized loss related to these
securities was $ 358 and was not material. The Company has the ability to hold such securities with an unrealized loss until its forecasted
recovery. The Company determined that there was no material change in the credit risk of the above investments. No other than temporary impairment
loss has been recorded on the securities as of December 31, 2022, as the Company believes that any decrease in fair value of these securities
is temporary and the Company expects to recover at least up to the initial cost of the investment for these securities.
Interest and Investment Income
Interest and investment income consists of the following:
December 31,
2022
2021
Interest income
$ 2,230
$ 1,974
Accretion/(amortization) of discount/premium, net
( 1,137 )
( 1,737 )
Realized gain/(loss)
17
-
Total interest and investment income
$ 1,110
$ 237
5. Prepaid Expenses and Other Current Assets
Prepaid expenses and
other current assets consist of the following:
December 31,
2022
2021
Prepaid insurance
$ 288
$ 279
Prepaid research and development
569
684
Prepaid software
122
79
Accrued interest on marketable debt securities
486
634
Other prepaid expenses
184
173
Other current assets
127
34
Total
$ 1,776
$ 1,883
6. Property and Equipment, net
Property and equipment,
net consists of the following:
December 31,
2022
2021
Computer equipment
$ 205
$ 175
Furniture, fixtures and other
352
352
Laboratory equipment
866
591
Leasehold improvements
553
224
Property and equipment not yet placed into service
99
613
Total property and equipment
2,075
1,955
Less: Accumulated depreciation
( 483 )
( 236 )
Total property and equipment, net
$ 1,592
$ 1,719
Depreciation expense was $ 247 and $ 117 for the
years ended December 31, 2022 and 2021, respectively. During the year ended December 31, 2022, $ 137 and $ 110 was included in research
and development expense and general and administrative expense, respectively, within the consolidated statements of operations and comprehensive
loss. During the year ended December 31, 2021, $ 36 and $ 81 was included in research and development expense and general and administrative
expense, respectively, within the consolidated statements of operations and comprehensive loss. As of December 31, 2022 and 2021, 100 %
of the Company’s total property and equipment, net was attributable to the United States.
F- 16
Protara Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per
share data)
7. Accrued Expenses
Accrued expenses consist
of the following:
December 31,
2022
2021
Employee Costs
$ 2,543
$ 1,801
Research and development costs
512
437
Other expenses
182
251
Total
$ 3,237
$ 2,489
8. Leases
Operating leases
In December 2020, the Company entered into an
agreement to lease approximately 10.3 square feet of office space in New York, New York (“Office Lease”), which commenced
in April 2021. Annual rent is approximately $1,117. The Office Lease has a term of approximately seven years and contains provisions
for a free-rent period, annual rent increases and an allowance for tenant improvements. The Company has an option to extend the term
by five years, however, the Company determined at the lease commencement date that it was not reasonably certain to exercise the renewal
option and such renewal was excluded from the operating lease right-of-use, or ROU, asset and operating lease liability recorded for
this lease.
The Company is responsible for real estate taxes,
maintenance and other operating expenses applicable to the leased premises which are recognized as variable lease expense in the period
when incurred. In conjunction with the Office Lease, the Company established a letter of credit of approximately $ 745 secured by cash
balances included in restricted cash.
In June 2021, the Company amended the existing
agreement with its contract development and manufacturing organization, or CDMO, establishing a term of eight-years from the amendment
date. Prior to the amendment, the leased spaces met the short-term lease exception under a quarter-to quarter arrangement and were not
included in measurement of lease liabilities.
Leases classified as operating leases are included
in operating lease right-of-use, or ROU, assets, operating lease liabilities and operating lease liabilities, non-current, in the Company’s
consolidated balance sheets. The Office Lease and the CDMO leased spaces are included in operating lease ROU assets and operating lease
liabilities. Cash paid for operating lease liabilities was $ 1,327 and $ 1,009 during the years ended December 31, 2022 and 2021, respectively,
which is included in operating cash flows. The ROU asset obtained in exchange for operating lease liabilities related to the Office Lease
was $ 6,549 .
F- 17
Protara Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per
share data)
The components of lease expense were as follows:
For the year ended
December 31,
Lease expense
2022
2021
Operating lease expense
$ 1,366
$ 1,050
Short-term lease expense
3
102
Total
$ 1,369
$ 1,152
Variable lease expense for the years ended December
31, 2022 and 2021, respectively were not material.
The weighted
average remaining lease term and the weighted average discount rate for operating leases were:
For the year ended
December 31,
2022
2021
Weighted-average discount rate
7.0 %
7.0 %
Weighted-average remaining lease term – operating lease (in months)
67
79
The total remaining operating lease payments
included in the measurement of lease liabilities on the Company’s consolidated balance sheet as of December 31, 2022, was
as follows:
For the year ending December 31:
Operating Lease Payments
2023
$ 1,327
2024
1,327
2025
1,395
2026
1,429
2027
1,429
Thereafter
805
Total future operating lease payments
7,712
Less: imputed interest
( 1,328 )
Present value of future minimum lease payments
$ 6,384
9. Commitments and Contingencies
Employment Agreements
Executive Employment Agreements
The Company’s executive officers have entered into at-will employment
agreements.
Collaborations and License Agreements
Choline License Agreement
On September 27, 2017, the Company entered into
a license agreement (the “Choline License Agreement”) with Alan L. Buchman (“Dr. Buchman”). Pursuant to the Choline
License Agreement, the Company received from Dr. Buchman the license rights in and to the “Licensed Orphan Designations”,
the “Licensed IND”, “Existing Study Data” and the “Licensed Know-How” for one or more of the licensed
indications.
During the years ended December 31, 2022 and
2021, the Company recorded research and development expense of $ 2 and $ 0 , in connection with the Choline License Agreement.
F- 18
Protara Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per
share data)
License Agreement
On December 22, 2017, the Company entered into
an agreement (the “Feinstein Agreement”) with The Feinstein Institute for Medical Research (the “Feinstein Institute”),
a not-for-profit corporation with 50 research labs and 2,500 clinical research studies. Pursuant to the Feinstein Agreement, the Company
acquired an exclusive license relating to treatment of fatty liver diseases in humans for which Choline may be an effective therapeutic.
In consideration for the rights and license granted, the Feinstein Institute would receive a royalty of one percent (1%) of the first
one hundred million dollars ($100,000) of net sales of IV Choline Chloride and a royalty of one and one-half percent (1.5%) of all net
sales thereafter. In addition, the Company would pay the Feinstein Institute twelve and one-half percent (12.5%) of net proceeds resulting
from agreements entered within 2 years from the effective date, and seven and one-half percent (7.5%) of net proceeds resulting from
agreements entered into thereafter. Pursuant to the Feinstein Agreement additional payments would be due to the Feinstein Institute for
license maintenance payments and for meeting milestone events. Pursuant to the Feinstein Agreement, upon the achievement of certain future
new drug application milestones, the Company would be obligated to remit an aggregate of $275.
During the years ended December 31, 2022 and
2021, the Company recorded research and development expense of $ 17 and $ 15 , respectively, in connection with the Feinstein Agreement.
Sponsored Research and License Agreement
On November 28, 2018, the Company entered into a sponsored research
and license agreement (the “Iowa Agreement”) with the University of Iowa. Pursuant to the Iowa Agreement, the University of
Iowa, which is engaged in clinical research to improve the diagnosis and treatment of lymphangioma using a pharmaceutical product (OK-432),
would assist the Company in collecting case reports, forms, source data, and safety data available to the University of Iowa in support
of the development of the Company’s proprietary Streptococcus Pyogenes investigational product, TARA-002 for the LMs indication.
During the term of the services, the Company would generally pay the University of Iowa thirty thousand dollars ($30) per year to fund
the project, plus additional amounts upon the realization of certain milestones. More specifically, upon forty-five (45) days of an approval
of TARA-002 by the FDA, the Company would pay up to $1,750 to the University of Iowa for meeting these milestones. Furthermore, the Company
would pay the University of Iowa royalties of up to 1.75% for net sales ranging from $0 - $25,000, 2.25% for net sales ranging from $25,000
to $50,000, and 2.50% for net sales in excess of $50,000. Pursuant to the Iowa Agreement, the University of Iowa would be entitled to
additional payments for the Company achieving annual net sales of product according to the milestones. For annual net sales of product
up to $25,000: $62; for annual net sales of product of up to $50,000: $62; and for annual net sales of product of up to $100,000: $125.
Pursuant to the Iowa Agreement there were no
research and development expenses recognized during the years ended December 31, 2022 and 2021.
Chugai Agreement
On June 17, 2019, the Company entered into
an agreement (the “Chugai Pharmaceutical Agreement”) with Chugai Pharmaceutical Co., LTD (“Chugai”), a drug
manufacturing firm with offices and operations in Japan. Pursuant to the Chugai Pharmaceutical Agreement, Chugai would help the
Company in its goals to develop and commercialize a therapeutic product (the “New Product”) which is comparable to the
Chugai existing therapeutic product (the “Existing Product”). In addition, the Company would be entitled to the use of
Chugai materials and technical support as necessary. On July 14, 2020, the Company and Chugai entered into an amendment (the
“Chugai Amendment”) to the Chugai Pharmaceutical Agreement, with an effective date of June 30, 2020. The Chugai
Amendment extended the date through which Chugai will exclusively provide the Existing Product and materials to the Company from
June 30, 2020 to June 30, 2021, extended the date through which Chugai will not provide materials or technical support to any
third-party for the purpose of development and commercialization in a given area from the fifth anniversary to the eleventh
anniversary of the original effective date, and provides for further such extensions on the occurrence of certain events and
milestones. The amendment further provides that, in addition to the designated fee provided upon the initial indication approval in
the Chugai Pharmaceutical Agreement, the Company will pay Chugai a designated fee for each additional indication approval. The
Company is obligated to Chugai for certain payments upon the completion of agreed upon milestones. As consideration for
Chugai’s performance under the Chugai Pharmaceutical Agreement, the Company agreed to pay Chugai a payment in the low,
single-digit millions related to such initial indication approval, which payment will be made in two installments with an initial
payment in July 2020, and the remaining majority of the payment payable upon FDA approval of the New Product.
Pursuant to the agreement there were no research
and development expenses recognized during the years ended December 31, 2022 and 2021.
F- 19
Protara Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per
share data)
Contingencies
From time to time, the Company may be subject
to various legal proceedings and claims that arise in the ordinary course of its business activities. Management is of the opinion that
the ultimate outcome of these matters would not have a material adverse impact on the financial position of the Company or the results
of its operations.
In the normal course of business, the Company
enters into contracts in which it makes representations and warranties regarding the performance of its services and that its services
will not infringe on third-party intellectual rights. There have been no significant events related to such representations and warranties
in which the Company believes the outcome could result in losses or penalties in the future.
10. Stockholders’ Equity
Common Stock
As of December 31, 2022, the Company had 100,000,000
shares of common stock authorized for issuance, $ 0.001 par value per share, of which 11,267,389 and 11,235,731 shares were issued and
outstanding as of December 31, 2022 and 2021, respectively.
The holders of the Company’s common stock
are entitled to one vote per share.
Preferred Stock
In connection with the Preferred Offering (defined
below) on September 22, 2020, the Company filed a Certificate of Amendment to the Certificate of Designation of Preferences, Rights and
Limitations of Series 1 Convertible Preferred Stock of the Company (the “Amendment”) with the State of Delaware to increase
the authorized number of shares of the Company’s Series 1 Convertible Preferred Stock that may be issued from 3,880 to 8,028 . The
Amendment was approved by a committee of the Company’s Board of Directors and the requisite holders of outstanding shares of Series
1 Convertible Preferred Stock. No approval of the holders of the Company’s common stock was required to effectuate the Amendment.
As of December 31, 2022 and 2021, the Company
had 10,000,000 shares of preferred stock authorized for issuance, $ 0.001 par value per share of which 8,028 shares of Series 1 Convertible
Preferred Stock are authorized for issuance and 8,027 shares were issued and outstanding, respectively.
Description of Series 1 Convertible Preferred
Stock
Each share of Series 1 Convertible Preferred
Stock is convertible into 1,000 shares of the Company’s common stock, at a conversion price initially equal to approximately $ 7.01
per common share, subject to adjustment for any stock splits, stock dividends and similar events, at any time at the option of the holder,
provided that any conversion of Series 1 Convertible Preferred Stock by a holder into shares of the Company’s common stock would
be prohibited if, as a result of such conversion, the holder, together with its affiliates and any other person or entity whose beneficial
ownership of the Company’s common stock would be aggregated with such holder’s for purposes of Section 13(d) of the Securities
Exchange Act of 1934, as amended, would beneficially own more than 9.99 % of the total number of shares of the Company’s common
stock issued and outstanding after giving effect to such conversion. Upon written notice to the Company, the holder may from time to
time increase or decrease such limitation to any other percentage not in excess of 19.99 % specified in such notice. In addition, upon
the occurrence of certain transactions that involve the merger or consolidation of the Company, an exchange or tender offer, a sale of
all or substantially all of the assets of the Company or a reclassification of its Common Stock, each share of Series 1 Convertible Preferred
Stock will be convertible into the kind and amount of securities, cash and/or other property that the holder of a number of shares of
Common Stock issuable upon conversion of one share of Series 1 Convertible Preferred Stock would receive in connection with such transaction.
The terms of the Series 1 Convertible Preferred
Stock provide that, in the event of a fundamental transaction (as such term is described in the certificate of designation of preferences,
rights and limitations of series 1 convertible non-voting preferred stock), each share of Series 1 Convertible Preferred Stock outstanding
will thereafter be convertible into the kind and amount of securities, cash and/or other property which a holder of the number of shares
of Common Stock of the Company issuable upon conversion of one share of Series 1 Convertible Preferred Stock immediately prior to such
fundamental transaction would have been entitled to receive pursuant to such fundamental transaction, provided that, if the value of
the aggregate of such securities, cash and/or other property the which the holder of one share of Series 1 Convertible Preferred Stock
would be entitled to upon conversion thereof would be less than the stated value, then each outstanding share of Series 1 Convertible
Preferred Stock will instead be convertible into such kind of securities, cash and/or other property with an aggregate value equal to
the stated value.
Each share of Series 1 Convertible Preferred
Stock is entitled to a preference of $ 10.00 per share upon liquidation of the Company, and thereafter will share ratably in any distributions
or payments on an as-converted basis with the holders of Common Stock.
The holders of Series 1 Convertible Preferred
Stock are not entitled to vote.
F- 20
Protara Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per
share data)
Underwritten Public Offering
On September 24, 2020, pursuant to an underwriting
agreement dated September 22, 2020, the Company issued and sold in an underwritten public offering (the “Common Offering”)
an aggregate of 4,600,000 shares of its common stock at an offering price of $ 16.87 per share, for gross and net proceeds of approximately
$ 77.6 million and $ 73.6 million, respectively. The underwriters were granted an option to purchase up to 690,000 additional shares of
the Company’s common stock at the public offering price, less the underwriting discount. On October 6, 2020, the underwriters exercised
their overallotment option in full, purchasing an additional 690,000 shares, resulting in the receipt of gross and net proceeds of $ 11.6
million and $ 11.1 million, respectively.
On September 24, 2020, pursuant to an underwriting
agreement (dated September 22, 2020), the Company issued and sold in an underwritten public offering (the “Preferred Offering”)
an aggregate of 4,148 shares of its Series 1 Convertible Preferred Stock at an offering price of $ 16,873.54 per share, for gross and
net proceeds of approximately $ 70.0 million and $ 66.3 million, respectively.
11. Stock-Based Compensation
2020 Inducement Plan
On March 26, 2020, the Compensation Committee
of the Board of Directors (the “Compensation Committee”) approved the ArTara Therapeutics, Inc. Inducement Plan (the “2020
Inducement Plan”) in order to award nonstatutory stock options, restricted stock awards, restricted stock unit awards and other
stock-based awards to persons not previously an employee or director of the Company, or following a bona fide period of non-employment,
as an inducement material to such persons entering into employment with the Company.
The 2020 Inducement Plan provides for a total
of 600,000 shares for the issuance of the Company’s common stock. The Compensation Committee also adopted a form of stock option
grant notice and stock option agreement and forms of restricted stock unit grant notice and restricted stock unit agreement for use with
the Inducement Plan.
As of December 31, 2022, 446,639 shares remain
available to be issued under the 2020 Inducement Plan.
2017 Equity Incentive
Plan
On August 10, 2017, Private ArTara, (a predecessor
of the Company), its Board of Directors and its stockholders approved the ArTara Therapeutics, Inc. 2017 Equity Incentive Plan to enable
Private ArTara and its affiliates to recruit and retain highly qualified personnel and to incentivize personnel for productivity and
growth.
The 2017 Equity Incentive Plan provided for the
grant of a total of 2,000,000 shares for the issuance of stock options, stock appreciation rights, restricted stock and restricted stock
units to among others, members of the Board of Directors, employees, consultants and service providers to the Company and its affiliates.
As of January 9, 2020, in connection with the Merger, no additional awards will be made under the 2017 Equity Incentive Plan.
F- 21
Protara Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per
share data)
2014 Equity Incentive Plan
On October 3, 2014, the stockholders approved
the 2014 Equity Incentive Plan. On June 20, 2017, the Company’s Board of Directors amended the 2014 Equity Incentive Plan, or the
Amended and Restated 2014 Plan. On July 31, 2017, the stockholders approved this amendment. On January 1, 2020, Protara Therapeutics,
Inc. amended its Amended and Restated 2014 Equity Incentive Plan to increase the number of shares of stock available for issuance under
the 2014 Equity Incentive Plan to 1,048,300 shares and made conforming changes and updates pursuant to Section 162(m) of the Code.
The Amended and Restated 2014 Plan provides for
the grant of incentive and non-statutory stock options, stock appreciation rights, restricted stock and stock unit awards, performance
units, stock grants and qualified performance-based awards. The Amended and Restated 2014 Plan provides that the number of shares reserved
and available for issuance will automatically increase each January 1, by four percent of the Company’s common stock on the immediately
preceding December 31, adjusted for the number of shares of the Company’s common stock issuable upon conversion of any security
that the Company may issue that is convertible into or exchangeable for the Company’s common stock, or such lesser number of shares
as determined by the Company’s Board of Directors.
Terms of the stock awards, including vesting
requirements, are determined by the Board of Directors, subject to the provisions of the plans. Certain awards provide for accelerated
vesting if there is a change in control as defined in the plans.
On January 1, 2022, pursuant to the Amended 2014
Plan’s annual evergreen feature, the number of shares authorized under the Amended 2014 Plan was increased by 840,181 shares to
1,238,785 shares. As of December 31, 2022, 603,218 shares remain available to be issued under the Amended 2014 Plan.
On January 1, 2023, pursuant to the Amended 2014
Plan’s annual evergreen feature, the number of shares authorized under the Amended 2014 Plan was increased by 861,933 shares to
1,465,151 shares available to be issued.
2014 Employee Stock
Purchase Plan
On October 3, 2014, the stockholders approved
the 2014 Employee Stock Purchase Plan (the “2014 ESPP”). The 2014 ESPP initially authorized the issuance of up to 3,513 shares
of the Company’s common stock. The number of shares increases each January 1, commencing on January 1, 2015 and ending on (and
including) January 1, 2024, by an amount equal to the lesser of one percent of the outstanding shares as of the end of the immediately
preceding fiscal year, 7,025 shares or any lower amount determined by the Company’s Board of Directors prior to each such January
1st.
On January 1, 2022, pursuant to the increase
per the 2014 ESPP, the number of shares authorized under the 2014 ESPP was increased by 7,025 shares to 32,062 shares. As of December
31, 2022, the authorized number of shares under the 2014 ESPP is 32,062 and the number of shares available for issuance is 32,062 . During
the years ended December 31, 2022 and 2021, no shares were issued under the 2014 ESPP.
On January 1, 2023, pursuant to the increase
per the 2014 ESPP, the number of shares authorized under the 2014 ESPP was increased by 7,025 shares to 39,087 shares.
Restricted Stock Units
The following table summarizes restricted stock unit activity:
Restricted
Stock Units
Weighted
Average Grant
Date Fair Value
Non-vested 12/31/2021
96,201
$ 28.87
Granted
178,425
6.08
Forfeited
( 26,400 )
11.01
Vested
( 51,388 )
21.67
Non-vested 12/31/2022
196,838
$ 12.49
F- 22
Protara Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per
share data)
The fair value of RSUs is amortized on a straight-line
basis over the requisite service period of the respective awards. As of December 31, 2022, the unamortized value of RSUs was $ 1,412 .
As of December 31, 2022, the weighted average remaining amortization period was 1.53 years. As of December 31, 2022 and 2021, 289,500
and 286,918 RSUs, respectively, have vested that have not yet been settled into shares of the Company’s common stock.
During the year ended December 31, 2022, the Company issued 31,658
shares of the Company’s common stock from the net settlement of 48,806 RSUs. The Company paid $ 90 in connection with the net share
settlement of these RSUs.
Stock Options
The Company determined the fair value of stock
options granted based upon the assumptions as provided below.
For the Years Ended
December 31,
2022
2021
Exercise price
$ 2.77 - $ 6.90
$ 6.56 - $ 19.82
Dividend yield
0.00 %
0.00 %
Expected volatility
92.00 % - 99.00 %
89.00 % - 98.00 %
Risk-free interest rate
1.46 % - 4.23 %
0.45 % - 1.33 %
Expected life (in years)
5.27 - 6.08
5.27 - 6.08
The following table summarizes stock option activities
for the year ended December 31, 2022:
Number of
Options
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term (years)
Aggregate
Intrinsic
Value (1)
Outstanding 12/31/2021
1,356,639
$ 20.51
8.59
$ 1
Granted
844,400
6.13
-
-
Exercised
-
-
-
-
Forfeited
( 246,977 )
15.35
-
-
Expired
( 125,733 )
25.40
-
-
Outstanding at December 31, 2022
1,828,329
$ 14.23
8.16
$ -
Vested or expected to vest at December 31, 2022
1,828,329
$ 14.23
8.16
$ -
Exercisable as of December, 31 2022
755,234
$ 18.71
7.50
$ -
(1) Aggregate intrinsic
value represents the difference between the exercise price of the option and the closing market price of our common stock on December 31,
2022. The intrinsic value of options exercised during the years ended December 31, 2022 and 2021 was $0 as no options
were exercised.
The weighted average grant date fair value per
share of the options granted during the years ended December 31, 2022 and 2021 was $ 4.80 and $ 12.60 , respectively. As of December 31,
2022, there was approximately $ 8,333 of unrecognized share-based compensation for unvested stock option grants which is expected to be
recognized over a weighted average period of 2.50 years. The total unrecognized share-based compensation cost will be adjusted for actual
forfeitures as they occur.
F- 23
Protara Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per
share data)
Summary of Stock-Based Compensation Expense
The following tables summarize total stock-based compensation costs
recognized:
For the Years Ended
December 31,
2022
2021
RSUs
$ 1,272
$ 4,520
Stock options
5,416
5,842
Total
$ 6,688
$ 10,362
Stock-based compensation expense was reflected within the consolidated
statements of operations and comprehensive loss as:
For the Years Ended
December 31,
2022
2021
Research and development
$ 1,511
$ 1,409
General and administrative
5,177
8,953
Total
$ 6,688
$ 10,362
12. Income Taxes
Federal and State income tax expense is as follows:
For the Years Ended
December 31,
2022
2021
Current
Federal
$ -
$ -
State
-
-
Total current
-
-
Deferred
Federal
( 7,954 )
( 8,918 )
State
( 1,068 )
4,294 )
Total deferred
( 9,022 )
( 4,624 )
Change in valuation allowance
9,022
4,624
Total income tax expense (benefit)
$ -
$ -
Deferred income taxes, if applicable, are provided
for the differences between the basis of assets and liabilities for financial reporting and income tax purposes.
F- 24
Protara Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per
share data)
The tax effects of temporary differences that
give rise to significant portions of the deferred tax assets are as follows:
As of
December 31,
2022
2021
Deferred tax assets:
Net operating loss carry forwards
$ 26,768
$ 23,350
Capitalized research and development
3,418
-
Stock option expense
2,477
920
Research and development credits
3,710
1,551
Operating lease liability
1,481
1,564
RSU expense
2,199
1,960
Other
408
7
Total deferred tax assets
40,461
29,352
Valuation allowance
( 38,983 )
( 27,803 )
Deferred tax assets, net of valuation allowance
1,478
1,549
Deferred tax liabilities:
Operating right-of-use asset
( 1,456 )
( 1,549 )
Other
( 22 )
-
Total deferred tax liabilities
( 1,478 )
( 1,549 )
Deferred tax assets, net of valuation allowance and deferred tax liabilities
$ -
$ -
A reconciliation of the provision for income
taxes with the amounts computed by applying the statutory Federal income tax to income before provision for income taxes is as follows:
For the Years Ended
December 31,
2022
2021
U.S. federal statutory rate
( 21.0 )%
( 21.0 )%
State taxes, net of federal benefit
( 2.2 )%
( 0.6 )%
Research and development credits
( 3.3 )%
( 2.8 )%
True-up to prior years return
( 0.7 )%
8.2 %
Other
( 0.3 )%
0.6 %
State rate change
-
%
1.5 %
Stock-based compensation
0.1 %
1.2 %
Goodwill impairment
10.4 %
- %
Change in valuation allowance
17.0 %
12.9 %
Effective tax rate
-
%
-
%
For the year ended December 31, 2021, the Company’s effective
tax rate was 0%, which consisted principally of a federal rate of 21%, and the Company’s estimate of state taxes, net of federal
benefit, of 0.6%, offset by a valuation allowance 12.9% and true-up to the prior year’s tax return of 8.2%. For the year ended December
31, 2022, the Company’s effective tax rate was 0%, which consisted principally of a federal rate of 21%, the Company’s estimate
of state taxes, net of federal benefit, of 2.2%, research and development credits of 3.3% and a true-up to the prior year’s tax
return of 0.7%, offset by goodwill impairment of 10.4% and a valuation allowance 17.0%.
As of December 31, 2022 and 2021 for U.S. federal
and state income tax reporting purposes, the Company has approximately $ 114,800 and $ 100,200 , respectively, of unused net operating losses
(“NOLs”) available for carry forward to future years. As a result of the Tax Cuts and Jobs Act of 2017 (“TCJA”),
for U.S. income tax purposes, NOLs generated in tax years beginning before January 1, 2018 can still be carried forward for up to 20 years,
but net operating losses generated for tax years beginning after December 31, 2017 carryforward indefinitely and can be used to offset
taxable income. Of the total Federal NOL, $ 600 can be carried forward until 2037; and $ 114,200 can be carried forward indefinitely. The
New York state and city NOLs may be carried forward through the year 2042 and may be applied against future taxable income. Further, the
benefit from utilization of NOL carry forwards could be subject to limitations due to material ownership changes that could occur as the
Company continues to issue additional shares of common stock pursuant to its capital raising plans. Based on such limitations, the Company
has significant NOLs for which realization of tax benefits is uncertain. The Company has not performed a study to determine whether or
not there is such a limitation.
F- 25
Protara Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per
share data)
The Company remains subject to examination by
tax authorities for all tax years.
Based on a history of cumulative losses at the Company and the results
of operations for the years ended December 31, 2022 and 2021, the Company determined that it is more likely than not that it will not
realize benefits from the net deferred tax assets. The Company will not record income tax benefits in the financial statements until it
is determined that it is more likely than not that the Company will generate sufficient taxable income to realize the deferred income
tax assets. As a result of the analysis, the Company determined that a full valuation allowance against the deferred tax assets, net,
was required. As of December 31, 2022 and 2021, the Company has recorded a valuation allowance of $ 39.0 million and $ 27.8 million, respectively.
As of December 31, 2022 and 2021, management
does not believe that the Company has any material uncertain tax positions that would require it to measure and reflect the potential
lack of sustainability of a position on audit in its consolidated financial statements. The Company will continue to evaluate its uncertain
tax positions in future periods to determine if measurement and recognition in its financial statements is necessary. The Company does
not believe there will be any material changes in its unrecognized tax positions over the next year.
13. Employee Benefit Plan
The Company maintains a defined contribution
benefit plan under section 401(k) of the Internal Revenue Code covering substantially all qualified employees of the Company (the “401(k)
Plan”). Under the 401(k) Plan, the Company matches 100 % of employee contributions up to 4 % of employee compensation. For the years
ended December 31, 2022 and 2021, the Company recorded expense of $ 223 and $ 215 , respectively, representing employer contributions under
the 401(k) Plan.
14. Net Loss per Common Share
The following table sets forth the computation
of the net loss per share attributable to common stockholders, basic and diluted:
December 31,
2022
2021
Numerator:
Net loss attributable to common stockholders
$ 65,952
$ 47,252
Denominator:
Weighted-average common shares outstanding – basic and diluted
11,259,615
11,232,576
Net loss per share attributable to common stockholders, basic and diluted
$ ( 5.86 )
$ ( 4.21 )
Since the Company was in a net loss position
for all periods presented, net loss per share attributable to common stockholders was the same on a basic and diluted basis, as the inclusion
of all potential common equivalent shares outstanding would have been anti-dilutive. The Company excluded the following potential common
shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to
common stockholders for the periods indicated because including them would have had an anti-dilutive effect:
December 31,
2022
2021
Stock options issued and outstanding
1,828,329
1,356,639
Restricted stock units issued and outstanding
486,338
383,119
Conversion of Series 1 Convertible Preferred Stock
8,029,039
8,029,039
Total potentially dilutive shares
10,343,706
9,768,797
F-26