Item 8. Financial Statements and Supplementary Data
Item
8. Financial Statements and Supplementary Data.
Protara
Therapeutics, Inc.
Index to Consolidated Financial Statements
Page No.
Protara Therapeutics, Inc. for the Years Ended December 31, 2023 and 2022
Report of Independent Registered Public Accounting Firm (PCAOB ID: 42 ) 71
Consolidated Balance Sheets as of December 31, 2023 and 2022 72
Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2023 and 2022 73
Consolidated Statements of Changes in Stockholders’ Equity for the Years Ended December 31, 2023 and 2022 74
Consolidated Statements of Cash Flows for the Years Ended December 31, 2023 and 2022 75
Notes to Consolidated Financial Statements 76
70
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, 2023 and 2022, the related consolidated
statements of operations and comprehensive loss, changes in stockholders’ equity and cash flows for each of the two years ended
December 31, 2023, 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,
2023 and 2022, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2023, 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 audits. 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 audits 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 the 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.
Clinical trial prepaid and accrued expenses
Description of the Matter
As discussed in Note 2 to the consolidated financial statements, depending
on the timing of payments to service providers, the Company records clinical trial prepaid or accrued expenses based on management’s
estimates of the work performed under the service agreements, milestones achieved and experience with similar contracts. Auditing
the Company’s accounting for clinical trial prepaid and accrued expenses is challenging due to the fact that information necessary
to estimate the clinical trial prepaid and accrued expenses is accumulated from multiple sources. The determination of the clinical trial
prepaid and accrued expenses when the Company has either not been invoiced or has not received information regarding actual costs incurred
requires evaluation of the extent of completion of the services.
How We Addressed the Matter in Our Audit
To test the clinical trial prepaid and accrued expenses, our audit procedures included, among others, i) confirming the completeness of the terms and conditions of certain significant service agreements directly with the vendor; ii) testing the completeness and accuracy of the Company’s clinical trial prepaid and accrued expense models through verification of significant inputs, such as costs incurred and invoices paid, to the terms and conditions of the underlying agreements; iii) meeting with clinical operations personnel outside of the accounting department to discuss the basis for assumptions used in estimating cost of services provided but not yet invoiced; and iv) performing a hindsight analysis of invoices received subsequent to the balance sheet date and comparing to the Company’s estimates.
/s/ Ernst & Young LLP
We
have served as the Company’s auditor since 2021
New
York, New York
March
13, 2024
71
Protara
Therapeutics, Inc.
Consolidated
Balance Sheets
(in
thousands, except share and per share data)
December 31,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$
39,586
$
24,127
Marketable debt securities
25,994
60,243
Prepaid expenses and other current assets
3,125
1,776
Total current assets
68,705
86,146
Restricted cash, non-current
745
745
Marketable debt securities, non-current
-
17,886
Property and equipment, net
1,296
1,592
Operating lease right-of-use asset
5,264
6,277
Other assets
2,944
644
Total assets
$
78,954
$
113,290
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
2,434
$
1,586
Accrued expenses
2,732
3,237
Operating lease liability
983
917
Total current liabilities
6,149
5,740
Operating lease liability, non-current
4,484
5,467
Total liabilities
10,633
11,207
Commitments and contingencies (Note 10)
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, 2023 and 2022, 7,991 and 8,027 shares issued and outstanding as of December 31, 2023 and 2022, respectively.
-
-
Common stock, $ 0.001 par value, authorized 100,000,000 shares:
Common stock, 11,364,903 and 11,267,389 shares issued and outstanding as of December 31, 2023 and 2022, respectively.
11
11
Additional paid in capital
268,725
262,724
Accumulated deficit
( 200,384
)
( 159,964
)
Accumulated other comprehensive income (loss)
( 31
)
( 688
)
Total stockholders’ equity
68,321
102,083
Total liabilities and stockholders’ equity
$
78,954
$
113,290
See
accompanying notes to consolidated financial statements.
72
Protara
Therapeutics, Inc.
Consolidated
Statements of Operations and Comprehensive Loss
(in
thousands, except share and per share data)
Years Ended December 31,
2023
2022
Operating expenses:
Research and development
$
24,989
$
16,808
General and administrative
18,624
20,737
Loss on impairment of goodwill
-
29,517
Total operating expenses
43,613
67,062
Loss from operations
( 43,613
)
( 67,062
)
Other income (expense), net:
Interest and investment income
3,193
1,110
Other income (expense), net
3,193
1,110
Net loss
( 40,420
)
( 65,952
)
Net loss per share attributable to common stockholders, basic and diluted
$
( 3.57
)
$
( 5.86
)
Weighted average shares outstanding, basic and diluted
11,331,338
11,259,615
Other comprehensive income (loss):
Net unrealized gain (loss) on marketable debt securities
657
( 477
)
Other comprehensive income (loss)
657
( 477
)
Comprehensive loss
$
( 39,763
)
$
( 66,429
)
See
accompanying notes to consolidated financial statements.
73
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
Income
Total
Stockholders’
Shares
Amount
Shares
Amount
Capital
Deficit
(Loss)
Equity
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
Unrealized (loss) gain on marketable debt securities
-
-
-
-
-
-
( 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
Settlement of restricted stock units
-
-
61,691
-
( 91 )
-
-
( 91 )
Stock-based compensation - restricted stock units
-
-
-
-
1,208
-
-
1,208
Stock-based compensation - stock options
-
-
-
-
4,884
-
-
4,884
Conversion of series 1 convertible preferred stock to common stock
( 36 )
-
35,823
-
-
-
-
-
Net unrealized (loss) gain on marketable debt securities
-
-
-
-
-
-
657
657
Net loss
-
-
-
-
-
( 40,420 )
-
( 40,420 )
Balance at December 31, 2023
7,991
$ -
11,364,903
$ 11
$ 268,725
$ ( 200,384 )
( 31 )
$ 68,321
See
accompanying notes to consolidated financial statements.
74
Protara
Therapeutics, Inc.
Consolidated
Statements of Cash Flows
(in
thousands)
Years Ended December 31,
2023
2022
Cash flows from operating activities:
Net loss
$ ( 40,420 )
$ ( 65,952 )
Adjustments to reconcile net loss to net cash used in operating activities:
Loss on impairment of goodwill
-
29,517
Stock based compensation
6,092
6,688
Operating lease right-of-use asset
1,013
1,366
Depreciation
341
248
Amortization of premium (Accretion of discount) on marketable debt securities
( 444 )
1,137
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
( 1,265 )
265
Other assets
( 2,300 )
222
Accounts payable
848
631
Accrued expenses
( 505 )
748
Operating lease liabilities
( 917 )
( 1,327 )
Net cash provided by (used in) operating activities
( 37,557 )
( 26,457 )
Cash flows from investing activities:
Purchase of marketable debt securities
( 12,186 )
( 43,550 )
Proceeds from maturity and redemption of marketable debt securities
65,338
58,620
Purchase of property and equipment
( 45 )
( 120 )
Net cash provided by (used in) investing activities
53,107
14,950
Cash flows from financing activities:
Repurchase of shares in connection with settlement of RSUs
( 91 )
( 90 )
Net cash provided by (used in) financing activities
( 91 )
( 90 )
Net increase (decrease) in cash and cash equivalents and restricted cash
15,459
( 11,597 )
Cash and cash equivalents and restricted cash - beginning of year
24,872
36,469
Cash and cash equivalents and restricted cash - end of year
$ 40,331
$ 24,872
Supplemental disclosure of cash flow information:
Cash paid for:
Interest
$ -
$ -
Income taxes
$ -
$ -
See
accompanying notes to consolidated financial statements.
75
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 non-muscle invasive bladder
cancer, or NMIBC, and lymphatic malformations, or LMs. The third program in the portfolio is Intravenous, or IV, Choline Chloride, an
investigational phospholipid substrate replacement therapy in development for patients receiving parenteral nutrition, or PN.
Liquidity and Capital Resources
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 12 months from the date of issuance of these consolidated financial statements.
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 research and development accruals as
well as 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.
76
Protara
Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per share data)
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.
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,
2023
2022
Cash and cash equivalents
$ 39,586
$ 24,127
Restricted cash, non-current
745
745
Total cash, cash equivalents and restricted cash shown in the consolidated statements of cash flows
$ 40,331
$ 24,872
Fair
Value Measurements
Accounting Standards Codification,
or 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:
●
Level
1 Quoted prices in active markets for identical assets or liabilities.
●
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.
●
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 earned on securities that are classified as
available-for-sale are included in interest and investment income.
The Company records investments
at fair value with unrealized gains and losses recorded as a component of other comprehensive income (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.
77
Protara
Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per share data)
The Company periodically evaluates the need for an allowance
for credit losses. This evaluation includes consideration of several qualitative and quantitative factors, including whether it plans
to sell the security, whether it is more likely than not it will be required to sell any marketable debt securities before recovery of
its amortized cost basis, and if the entity has the ability and intent to hold the security to maturity, and the portion of any unrealized
loss that is the result of a credit loss. Factors considered in making these evaluations include quoted market prices, recent financial
results, operating trends, and implied values from any recent transactions or offers of investee securities, credit quality of debt instrument
issuers, expected cash flows from securities, other publicly available information that may affect the value of the marketable debt security,
duration and severity of decline in value and the Company’s strategy and intentions for holding the marketable debt security.
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
3 - 5 years
Furniture,
fixtures and other
5 years
Laboratory
equipment
7 years
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, or 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.
78
Protara
Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per share data)
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, or 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.
Segment
Information
The Company identifies its
operating segments in accordance with Accounting Standards Codification 280, Segment Reporting, or 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
Goodwill
represented 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 was 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
was 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, the Company elected to forego the qualitative screen and performed a quantitative annual goodwill impairment test
for the reporting unit.
79
Protara
Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per share data)
As
of December 31, 2022, the Company’s stock price and market capitalization declined 60 % from December 31, 2021, which reflected
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, relied 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
its 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, resulting in full impairment of goodwill.
The
following table provides a roll forward of the Company’s goodwill and accumulated impairment losses:
Goodwill
Goodwill, gross amount as of January 1, 2022
$ 29,517
Loss on impairment
( 29,517 )
Goodwill as of December 31, 2022
$ -
Research
and Development
Research
and development expenses consist primarily of third-party costs incurred to develop drug candidates, personnel-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.
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,
or 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 in conjunction with known variable factors such as enrolled patients and site activity. The Company
monitors each of these factors and adjusts estimates accordingly.
80
Protara
Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per share data)
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, interest income related to cash, cash equivalents and restricted cash and dividend income related
to money market funds.
Stock-Based
Compensation
The Company’s stock-based
compensation programs include stock options, restricted stock units, or RSUs, and an employee stock purchase program, or 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 simplified method is used as the Company
does not have sufficient appropriate exercise data on which to base its own estimate. 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.
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.
81
Protara
Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per share data)
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
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. On January 1, 2023, the Company adopted ASU 2016-13, using a modified retrospective approach. The adoption of
this standard did not have an effect on the Company’s consolidated financial position, results of operations, or cash flows.
Recent
Accounting Pronouncements Not Yet Adopted
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.
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 12 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, 2023 and 2022 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.
82
Protara
Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per share data)
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, 2023
Level 1
Level 2
Level 3
Total
Cash equivalents:
Money market funds (a)
$ 39,031
$ -
$ -
$ 39,031
Restricted cash, non-current:
Money market funds (b)
745
-
-
745
Marketable debt securities:
Corporate bonds (c)
-
23,495
-
23,495
Agency
bonds (c)
-
2,499
-
2,499
Total
$ 39,776
$ 25,994
$ -
$ 65,770
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
(a) Money market funds and bonds 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) Bonds with original maturities greater than 90 days are included within Marketable debt 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.
Money market funds are classified
as Level 1 within the fair value hierarchy, because they are valued using quoted prices in active markets. Corporate and agency bonds
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.
83
Protara
Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per share data)
Non-Recurring
Fair Value Measurements
During
2022, the Company recorded a goodwill impairment loss of $ 29.5 million, refer to Note 2 for additional details on the impairment of goodwill.
In 2022, the fair value of the Company’s 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 were based on the Company’s most recent internal long-range forecast and budget and, for years
beyond the budget, the Company’s estimates, which were based, in part, on industry benchmarks and forecasted growth rates. The
discount rate used in the DCF analysis was intended to reflect the risks inherent in the expected future cash flows of the respective
programs within the Company’s portfolio. The inputs to the DCF model were Level 3 valuation inputs.
4.
Marketable Debt Securities
Marketable
debt securities, all of which were classified as available-for-sale, consist of the following as of:
December 31, 2023
Amortized
Cost
Unrealized
Gains
Unrealized
Losses
Estimated
Fair Value
Corporate bonds – presented in marketable debt securities
$ 23,525
$ -
$ ( 30 )
$ 23,495
Agency bonds – presented in marketable debt securities
2,500
-
( 1 )
2,499
Total
$ 26,025
$ -
$ ( 31 )
$ 25,994
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
The
amount of realized gains and losses reclassified into earnings for the years ended December 31, 2023 and December 31, 2022 was $ 0 and
$ 17 , respectively. These gains were included in investment income within the consolidated statements of operations and comprehensive
loss. There were no sales of securities in the periods presented.
The
Company has recorded the securities at fair value in its consolidated balance sheets and unrealized gains and losses are reported as
a component of accumulated other comprehensive income (loss). The amount of realized gains and losses reclassified into earnings are
based on the specific identification of the securities sold or securities that reached maturity date. The amount of realized gains and
losses reclassified into earnings have not been material to the Company’s consolidated statements of operations and comprehensive
income.
At
the time of purchase, the Company determines the appropriate classification of investments based upon its intent with regard to such
investments. 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
contractual maturities of all securities held at December 31, 2023 was 4 months or less. There were no sales of securities in the periods
presented.
84
Protara
Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per share data)
Credit Losses
Securities
with an amortized cost basis in excess of estimated fair value are assessed to determine what amount of the excess, if any, is caused
by expected credit losses. For the year ended December 31, 2023, it was determined that none of the unrealized loss is related to expected
credit losses as the Company has the ability and intent to hold all marketable securities that have been in a continuous loss position
until maturity or recovery. Further, the entire portfolio is held with investment grade high credit quality institutions. The Company
intends to continue investing only in such securities. Expected credit losses, if they existed, would be recognized in other income (expense),
net within the Company’s consolidated statement of operations and comprehensive income. The remaining unrealized losses, not related
to credit losses, net of taxes, are included in accumulated other comprehensive loss in stockholders’ equity within the Company’s
consolidated balance sheets.
Marketable
debt securities in a loss position consist of the following as of:
December 31, 2023
In Continuous Loss Position
Less Than 12 Months
In Continuous Loss Position
Greater Than 12 Months
Total
Estimated
Fair Value
Unrealized
Losses
Estimated
Fair Value
Unrealized
Losses
Estimated
Fair Value
Unrealized
Losses
December 31, 2023
Corporate bonds – presented in marketable debt securities
$ 19,498
$ ( 27 )
$ 3,997
$ ( 3 )
$ 23,495
$ ( 30 )
Agency bonds – presented in marketable debt securities
2,499
( 1 )
-
-
2,499
( 1 )
Total
$ 21,997
$ ( 28 )
$ 3,997
$ ( 3 )
$ 25,994
$ ( 31 )
Interest
and Investment Income
Interest
and investment income consists of the following for the year ended:
December 31,
2023
2022
Interest income
$ 2,727
$ 2,230
Accretion/(Amortization) of discount/premium, net
454
( 1,137 )
Dividend income
12
-
Realized gain/loss
-
17
Total interest and investment income
$ 3,193
$ 1,110
5.
Prepaid Expenses and Other Current Assets
Prepaid
expenses and other current assets consist of the following as of:
December 31,
2023
2022
Prepaid research and development
$ 1,957
$ 569
Prepaid insurance
659
288
Accrued interest on marketable debt securities
242
486
Other prepaid expenses
163
184
Prepaid software
67
122
Other current assets
37
127
Total
$ 3,125
$ 1,776
85
Protara
Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per share data)
6.
Property and Equipment, net
Property
and equipment, net consists of the following as of:
December 31,
2023
2022
Computer equipment
$ 247
$ 205
Furniture, fixtures and other
352
352
Laboratory equipment
913
866
Leasehold improvements
553
553
Property and equipment not yet placed into service
55
99
Total property and equipment
2,120
2,075
Less: Accumulated depreciation
( 824 )
( 483 )
Total property and equipment, net
$ 1,296
$ 1,592
Depreciation
expense was $ 341 and $ 247 for the years ended December 31, 2023 and 2022, respectively. During the year ended December 31, 2023, $ 204
and $ 137 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, 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. As of December 31, 2023 and 2022, 100 % of the Company’s total property and equipment, net was attributable to the United
States.
7.
Other Assets
Other
assets consists of the following as of:
December 31,
2023
2022
Prepaid research and development, non-current
$ 2,661
$ 84
Prepaid insurance, non-current
272
544
Other non-current assets
11
16
Total
$ 2,944
$ 644
8.
Accrued Expenses
Accrued
expenses consist of the following as of:
December 31,
2023
2022
Employee costs
$ 2,112
$ 2,543
Research and development
440
512
Other expenses
180
182
Total
$ 2,732
$ 3,237
9.
Leases
Operating
leases
In December 2020, the Company
entered into an agreement to lease approximately 10,300 square feet of office space in New York, New York, the 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.
86
Protara
Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per share data)
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, non-current, within the consolidated balance sheets.
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.
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 within the consolidated balance sheets. Cash paid for operating lease liabilities was $ 1,234 and $ 1,327
during the years ended December 31, 2023 and 2022, respectively.
The
components of lease expense were as follows:
For the year ended
December 31,
Lease expense
2023
2022
Operating lease expense
$ 1,423
$ 1,366
Short-term lease expense
-
3
Total
$ 1,423
$ 1,369
Variable
lease expense for the years ended December 31, 2023 and 2022, respectively was not material.
The
weighted average remaining lease term and the weighted average discount rate for operating leases were:
For the year ended
December 31,
2023
2022
Weighted-average discount rate
7.0 %
7.0 %
Weighted-average remaining lease term – operating lease (in months)
55
67
The
total remaining operating lease payments included in the measurement of lease liabilities on the Company’s consolidated balance
sheet as of December 31, 2023, was as follows:
For the year ending December 31:
Operating
Lease
Payments
2024
$ 1,327
2025
1,395
2026
1,429
2027
1,429
2028
718
Thereafter
87
Total future operating lease payments
6,385
Less: imputed interest
( 918 )
Present value of future minimum lease payments
$ 5,467
87
Protara
Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per share data)
10.
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, or the Choline License Agreement, with Alan L. Buchman, or 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.
Certain milestone and royalty
payments may also be payable to Dr. Buchman. Regardless of whether development or commercialization is undertaken by the Company under
the Choline License Agreement, during the term of the Choline License Agreement, the Company shall pay Dr. Buchman a minimum annual royalty
that ranges from $ 25 to $ 75 . The Company will also pay Dr. Buchman up to $ 775 in additional milestone payments upon the achievement of
various regulatory approval milestones. Further, the Company agreed to sales royalties described further in Item 1. Business .
During
the years ended December 31, 2023 and 2022, the Company recorded research and development expense of $ 27 and $ 2 , in connection with the
Choline License Agreement.
License
Agreement
On
December 22, 2017, the Company entered into an agreement, or the Feinstein Agreement, with The Feinstein Institute for Medical Research,
or 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, 2023 and 2022, the Company recorded research and development expense of $ 15 and $ 17 , 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, or 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.
88
Protara
Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per share data)
Pursuant
to the Iowa Agreement there were no research and development expenses recognized during the years ended December 31, 2023 and 2022.
Chugai
Agreement
On June 17, 2019, the Company
entered into an agreement, or the Chugai Pharmaceutical Agreement, with Chugai Pharmaceutical Co., LTD, or 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, or the New Product, which is comparable to the Chugai existing therapeutic product,
or 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, or 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, 2023 and 2022.
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.
11.
Stockholders’ Equity
Common
Stock
As
of December 31, 2023, the Company had 100,000,000 shares of common stock authorized for issuance, $ 0.001 par value per share, of which
11,364,903 and 11,267,389 shares were issued and outstanding as of December 31, 2023 and 2022, respectively.
The
holders of the Company’s common stock are entitled to one vote per share.
Preferred
Stock
As of December 31, 2023 and
2022, 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. As of December 31, 2023 and 2022, 7,991 and 8,027 shares were issued
and outstanding, respectively.
89
Protara
Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per share data)
Description
of Series 1 Convertible Preferred Stock
Each share of Series 1 Convertible
Preferred Stock is convertible into approximately 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.
During
August 2023, approximately 36 shares of Series 1 Convertible Preferred Stock were converted into 35,823 shares of common stock.
12.
Stock-Based Compensation
2020
Inducement Plan
On March 26, 2020, the Compensation
Committee of the Board of Directors, or the Compensation Committee, approved the ArTara Therapeutics, Inc. Inducement Plan, or 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, 2023, there were 409,000 shares of common stock subject to outstanding awards and 191,000 shares of common stock available
for future issuance under the 2020 Inducement Plan.
90
Protara
Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per share data)
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.
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, 2023, pursuant to the annual evergreen feature of the Amended and Restated 2014 Plan, as amended, the number of shares authorized
under the Amended and Restated 2014 Plan, as amended, was increased by 861,933 shares to 3,563,303 shares. As of December 31, 2023, there
were 2,883,056 shares of common stock subject to outstanding awards and 547,382 shares of common stock available for future issuance
under the Amended 2014 Plan.
On
January 1, 2024, pursuant to the annual evergreen feature of the Amended and Restated 2014 Plan, as amended, the number of shares authorized
under the Amended and Restated 2014 Plan, as amended, was increased by 911,380 shares to 4,474,683 shares.
2014
Employee Stock Purchase Plan
On October 3, 2014, the stockholders
approved the 2014 Employee Stock Purchase Plan, or 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, 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. As of December 31, 2023, the authorized number of shares under the 2014 ESPP is 39,087 and the number of shares
available for issuance is 39,087 . During the years ended December 31, 2023 and 2022, no shares were issued under the 2014 ESPP.
91
Protara
Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per share data)
On
January 1, 2024, pursuant to the increase per the 2014 ESPP, the number of shares authorized under the 2014 ESPP was increased by 7,025
shares to 46,112 shares.
Restricted
Stock Units
The
following table summarizes restricted stock unit activity:
Restricted
Stock Units
Weighted
Average Grant
Date Fair
Value
Non-vested at December 31, 2022
196,838
$ 12.49
Granted
165,100
3.02
Forfeited
( 30,731 )
4.35
Vested
( 94,528 )
12.16
Non-vested at December 31, 2023
236,679
$ 7.07
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,
2023, the unamortized value of RSUs was $ 569 . As of December 31, 2023, the weighted average remaining amortization period was 1.55 years.
As of December 31, 2023 and 2022, 289,500 and 289,500 RSUs, respectively, have vested that have not yet been settled into shares of the
Company’s common stock.
During
the year ended December 31, 2023, the Company issued 61,691 shares of the Company’s common stock from the net settlement of 94,528
RSUs. The Company paid $ 91 in connection with the net share settlement of these RSUs.
Stock
Options
The
Company determined the fair value of stock options granted utilizing the Black-Scholes valuation model and based upon the assumptions
as provided below:
For the Years Ended
December 31,
2023
2022
Exercise price
$ 1.20 - $ 3.91
$ 2.77 - $ 6.90
Dividend yield
0.00 %
0.00 %
Expected volatility
90.00 % - 98.00 %
92.00 % - 99.00 %
Risk-free interest rate
3.46 % - 4.73 %
1.46 % - 4.23 %
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, 2023:
Number of
Options
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term (years)
Aggregate
Intrinsic
Value (1)
Outstanding at December 31, 2022
1,828,329
$ 14.23
8.16
$ -
Granted
1,310,900
2.99
Exercised
-
-
Forfeited
( 157,523 )
6.83
Expired
( 81,501 )
15.94
Outstanding at December 31, 2023
2,900,205
$ 9.50
8.03
$ 20
Vested or expected to vest at December 31, 2023
2,900,205
$ 9.50
8.03
$ 20
Exercisable as of December, 31 2023
1,242,111
$ 15.48
7.08
$ -
(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, 2023. The intrinsic value of options exercised during the years ended December 31, 2023 and 2022 was $ 0 and no options were exercised.
92
Protara
Therapeutics, Inc.
Notes to Consolidated Financial Statements
(amounts in thousands, except share and per share data)
The
weighted average grant date fair value per share of the options granted during the years ended December 31, 2023 and 2022 was $ 2.36 and
$ 4.80 , respectively. As of December 31, 2023, there was approximately $ 5,699 of unrecognized share-based compensation for unvested stock
option grants which is expected to be recognized over a weighted average period of 2.59 years. The total unrecognized share-based compensation
cost will be adjusted for actual forfeitures as they occur.
Summary
of Stock-Based Compensation Expense
The
following tables summarize total stock-based compensation costs recognized:
For the Years Ended
December 31,
2023
2022
RSUs
$ 1,208
$ 1,272
Stock options
4,884
5,416
Total
$ 6,092
$ 6,688
Stock-based
compensation expense was reflected within the consolidated statements of operations and comprehensive loss:
For the Years Ended
December 31,
2023
2022
Research and development
$ 1,653
$ 1,511
General and administrative
4,439
5,177
Total
$ 6,092
$ 6,688
13.
Income Taxes
Federal
and State income tax expense is as follows:
For the Years Ended
December 31,
2023
2022
Current
Federal
$ -
$ -
State
-
-
Total current
-
-
Deferred
Federal
( 9,627 )
( 7,954 )
State
( 4,124 )
( 1,068 )
Total deferred
( 13,751 )
( 9,022 )
Change in valuation allowance
13,751
9,022
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.
93
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,
2023
2022
Deferred tax assets:
Net operating loss carry forwards
$ 30,731
$ 26,768
Capitalized research and development
9,611
3,418
Stock option expense
4,464
2,477
Research and development credits
4,824
3,710
Operating lease liability
1,485
1,481
RSU expense
2,723
2,199
Other
467
408
Total deferred tax assets
54,305
40,461
Valuation allowance
( 52,734 )
( 38,983 )
Deferred tax assets, net of valuation allowance
1,571
1,478
Deferred tax liabilities:
Operating right-of-use asset
( 1,430 )
( 1,456 )
Other
( 141 )
( 22 )
Total deferred tax liabilities
( 1,571 )
( 1,478 )
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,
2023
2022
U.S. federal statutory rate
( 21.0 )%
( 21.0 )%
State taxes, net of federal benefit
( 7.8 )%
( 2.2 )%
State rate change
( 4.0 )%
-
%
Research and development credits
( 2.4 )%
( 3.3 )%
True-up to prior years return
2.2 %
( 0.7 )%
Stock-based compensation
( 1.3 )%
0.1 %
Other
0.4 %
( 0.3 )%
Goodwill impairment
-
%
10.4 %
Change in valuation allowance
33.9 %
17.0 %
Effective tax rate
-
%
-
%
For the year ended December
31, 2023, 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 7.8 %, as well as state tax rate and apportionment changes of 4.0 %, which collectively
are offset by a valuation allowance 33.9 %. 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, 2023 and 2022 for U.S. federal and state income
tax reporting purposes, the Company has approximately $ 187,492 and $ 114,800 , respectively, of unused net operating losses, or NOLs, available
for carry forward to future years. As a result of the Tax Cuts and Jobs Act of 2017, or 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 $ 128,196 can be carried forward indefinitely. The New York state and city NOLs may be carried
forward through the year 2043 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.
94
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, 2023 and 2022, 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, 2023 and 2022, the Company has recorded a valuation allowance of $ 52.7
million and $ 39.0 million, respectively.
As of December 31, 2023 and
2022, 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.
14.
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,
or 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, 2023 and 2022, the Company recorded expense of $ 237 and $ 223 , respectively, representing employer contributions
under the 401(k) Plan.
15.
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,
2023
2022
Numerator:
Net loss attributable to common stockholders
$ ( 40,420 )
$ ( 65,952 )
Denominator:
Weighted-average common shares outstanding – basic and diluted
11,331,338
11,259,615
Net loss per share attributable to common stockholders, basic and diluted
$ ( 3.57 )
$ ( 5.86 )
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,
2023
2022
Stock options issued and outstanding
2,900,205
1,828,329
Restricted stock units issued and outstanding
526,179
486,338
Conversion of Series 1 Convertible Preferred Stock
7,993,217
8,029,039
Total potentially dilutive shares
11,419,601
10,343,706
95
Item
9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.
Not
Applicable.