Nkarta Inc
For the period ended Dec 31, 2023. Filed Mar 21, 2024.
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FY2023 · Filed Mar 21, 2024
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Notes to Financial Statements
Notes to the Financial Statements
- Description of Business
Description of the Business
Nkarta, Inc. ("Nkarta" or the "Company") was incorporated in the State of Delaware in July 2015. The Company is a biopharmaceutical company developing engineered natural killer ("NK") cells to treat cancer and autoimmune disease. The Company is focused on leveraging the natural potent power of NK cells to identify and kill abnormal cells and recruit adaptive immune effectors to generate responses that are specific and durable. Nkarta is combining its NK expansion platform technology with proprietary cell engineering technologies to generate an abundant supply of NK cells, engineer enhanced NK cell recognition of therapeutic targets, and improve persistence for sustained activity in the body. Nkarta’s goal is to develop off-the-shelf NK cell therapy product candidates to improve outcomes for patients. The Company’s operations are based in South San Francisco, California, and it operates in one segment.
Liquidity and Management Plans
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. Since inception, the Company has devoted substantially all of its efforts to organizing and staffing, business planning, raising capital, conducting preclinical studies and initiating clinical studies, and has not realized substantial revenues from its planned principal operations. In addition, the Company has a limited operating history, has incurred operating losses since inception and expects that it will continue to incur net losses into the foreseeable future as it continues its research and development activities. As of December 31, 2023, the Company had an accumulated deficit of $435.4 million and cash, cash equivalents, restricted cash and short-term investments of $250.9 million.
Management plans to continue to incur substantial costs in order to conduct research and development activities for which additional capital will be needed. The Company intends to raise such capital through debt or equity financings or other arrangements to fund operations. Management believes that the Company’s current cash, cash equivalents, restricted cash and investments will provide sufficient funds to enable the Company to meet its obligations for at least twelve months from the filing date of this report.
- Basis of Presentation and Significant Accounting Policies
Basis of Presentation
The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principle ("U.S. GAAP").
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the Company’s financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to preclinical studies and clinical trial accruals, fair value of assets and liabilities, impairment of assets, leases, share-based compensation and income taxes. Management bases its estimates on historical experience, knowledge of current events and actions it may undertake in the future that management believes to be reasonable under the circumstances. Actual results may differ from these estimates and assumptions.
Concentration of Credit Risk
Financial instruments, which potentially subject the Company to concentration of credit risk, consist primarily of cash, cash equivalents and investments. The Company maintains cash, cash equivalents and investments with various high credit quality and are invested through banks and other financial institutions in the United States. Such deposits may be in excess of federally insured limits. Management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. The Company has not experienced any losses on deposits since inception.
Comprehensive Loss
Comprehensive loss consists of net loss and unrealized gains or losses on investments. The Company displays comprehensive loss and its components as part of the statements of operations and comprehensive loss.
Fair Value of Financial Instruments
The accounting guidance defines fair value, establishes a consistent framework for measuring fair value, and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as an exit price representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
Level 1: Observable inputs such as quoted prices in active markets;
Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and
Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.
The carrying amounts of prepaid expenses and other current assets, accounts payable, accrued liabilities and other current liabilities are reasonable estimates of their fair value due to the short-term nature of these accounts.
Cash, Cash Equivalents, Short-term Investments and Restricted Cash
Cash and Cash Equivalents
The Company considers all highly liquid investments with insignificant interest rate risk and an original maturity of three months or less at the date of purchase to be cash equivalents. Cash includes demand deposits held in readily available checking accounts at a federally insured financial institution. Cash equivalents consist of money market funds.
Short-term Investments
Short-term investments consist of corporate debt securities, commercial paper and Government securities, classified as available-for-sale securities and have maturities of greater than three months but less than one year. The Company has classified its available-for-sale investment securities as current assets on the balance sheets because these are considered highly liquid securities and are available for use in current operations. The Company carries these securities at fair value, and reports unrealized gains and losses as a separate component of accumulated other comprehensive income (loss). The cost of debt securities is adjusted for amortization of purchase premiums and accretion of discounts to maturity. Such amortization and accretion is included in interest income in the statements of operations and comprehensive loss. Realized gains and losses on sales of securities are determined using the specific identification method and recorded in other income, net in the statement of operations and comprehensive loss. We review our portfolio of available-for-sale securities, using both quantitative and qualitative factors, to determine if declines in fair value below amortized cost have resulted from a credit-related loss or other factors. If the decline in fair value is due to credit-related factors, we recognize a loss in the statement of operations, whereas if the decline in fair value is not due to credit-related factors, we recognize the loss in comprehensive loss.
Restricted Cash
The Company is required to maintain letters of credit related to its office and lab space leases in South San Francisco. This cash is the collateral for those letters of credit and per the terms of the leases, must remain in place untilone to two months after the termination of the leases. As the remaining terms of the leases as of December 31, 2023 is greater than one year, the related restricted cash has been classified as non-current.
Property and Equipment, Net
Property and equipment, which consist of leasehold improvements, furniture and fixtures, research equipment, computers and software and construction-in-progress are stated at cost less accumulated depreciation. Depreciation and amortization is calculated using the straight-line method over the estimated useful lives of the assets, which ranges from three tofive years. Leasehold improvements are amortized over the remaining life of the lease at the time the asset is placed into service.
Impairment of Long-Lived Assets
The carrying value of long-lived assets, including property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the asset may not be recoverable. An impairment loss is recognized when the total of estimated future undiscounted cash flows, expected to result from the use of the asset and its eventual disposition, are less than its carrying amount. Impairment, if any, would be assessed using discounted cash flows or other appropriate measures of fair value. See Note 6 for additional information on the long-lived asset impairment expense recognized for the year ended December 31, 2023.
Collaborative Arrangements
The Company analyzes its collaboration arrangements to assess whether they are within the scope of Accounting Standards Codification ("ASC") Topic 808, Collaborative Arrangements ("ASC 808"), to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards that are dependent on the commercial success of such activities. To the extent the arrangement is within the scope of ASC 808, the Company assesses whether aspects of the arrangement between the Company and its collaboration partner are within the scope of other accounting literature, including ASC Topic 606, Revenue from Contracts with Customers ("ASC 606"). If it is concluded that some or all aspects of the arrangement represent a transaction with a customer, the Company will account for those aspects of the arrangement within the scope of ASC 606.
ASC 808 provides guidance for the presentation and disclosure of transactions in collaborative arrangements, but it does not provide recognition or measurement guidance. Therefore, if the Company concludes a counterparty to a transaction is not a customer or otherwise not within the scope of ASC 606, the Company considers the guidance in other accounting literature as applicable or by analogy to account for such transaction. The classification of transactions under the Company’s arrangements is determined based on the nature and contractual terms of the arrangement along with the nature of the operations of the participants.
Research and Development Costs
Research and development costs are expensed as incurred. Research and development costs consist primarily of salaries and other benefits of research and development personnel, including associated share-based compensation, costs related to research activities, preclinical studies, clinical trial, drug manufacturing and allocated overhead and facility-related expenses. The Company accounts for non-refundable advance payments for goods or services that will be used in future research and development activities as expenses when the goods have been received or when the service has been performed rather than when the payment is made.
Clinical trial costs are a component of research and development expenses. The Company expenses costs for its clinical trial activities performed by third parties, including clinical research organizations and other service providers, as they are incurred, based upon estimates of the work completed over the life of the individual study in accordance with associated agreements. The Company uses information it receives from internal personnel and outside service providers to estimate the clinical trial costs incurred.
Commitments
The Company recognizes a liability with regard to loss contingencies when it believes it is probable a liability has occurred and the amount can be reasonably estimated. If some amount within a range of loss appears at the time to be a better estimate than any other amount within the range, the Company accrues that amount. When no amount within the range is a better estimate than any other amount the Company accrues the minimum amount in the range. There have beenno such liabilities recorded by the Company as of December 31, 2023 and 2022.
Leases
At the commencement date of a lease, the Company recognizes lease liabilities which represent its obligation to make lease payments, and right-of-use assets ("ROU assets") which represent its right to use the underlying asset during the lease term. The lease liability is measured at the present value of lease payments over the lease term. As the Company’s leases typically do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at the lease commencement date. The ROU asset is measured at cost, which includes the initial measurement of the lease liability and initial direct costs incurred by the Company and excludes lease incentives. ROU assets are recorded in operating lease ROU assets and lease liabilities are recorded in operating lease liabilities, current and noncurrent in the balance sheets. We have elected the practical expedient to account for the lease and non-lease components, such as common area maintenance charges, as a single lease component for our facilities leases, and elected the short-term lease recognition exemption for our short-term leases, under which we do not recognize lease liabilities and right-of-use assets for leases with an original term of twelve months or less.
Lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Operating lease expense is recognized on a straight-line basis over the lease term. The Company does not recognize lease liabilities and ROU assets for short-term leases with terms of twelve months or less.
Share-Based Compensation
Share-based compensation expense represents the cost of the grant-date fair value of employee, officer, director, and non-employee stock option, employee stock purchase plan, and restricted stock unit grants, estimated in accordance with the applicable accounting guidance, recognized using the straight-line method over the vesting period for service-based options, employee stock purchase plan rights and restricted stock units and using the graded vesting method for performance-based options. The vesting period generally approximates the expected service period of the awards. Forfeitures are recognized and accounted for as they occur.
The fair value of stock options and employee stock purchase plan rights are estimated using a Black-Scholes option pricing model on the date of grant. This method requires certain assumptions be used as inputs, such as the fair value of the underlying common stock, expected term of the option before exercise, expected volatility of the Company’s common stock, expected dividend yield, and a risk-free interest rate. Options granted during the year have a maximum contractual term often years. The Company has limited historical stock option activity and therefore estimates the expected term of stock options granted using the simplified method, which represents the average of the contractual term of the stock option and its weighted-average vesting period. The expected term of the employee stock purchase plan rights equals the six-month look-back period. Since inception and prior to 2023, the expected volatility was based upon the historical volatility of a number of publicly traded companies in similar stages of clinical development. For grants during 2023, the expected volatility was determined by using a blended approach of the Company's historical stock price volatility and the historical stock price volatility for a select group of other publicly traded companies in the same industry. The Company has historically not declared or paid any dividends and does not currently expect to do so in the foreseeable future. The risk-free interest rates used are based on the U.S. Department of Treasury ("U.S. Treasury") yield in effect at the time of grant for zero-coupon U.S. Treasury notes with maturities approximately equal to the expected term of the stock options. The fair value of restricted stock units is based on the closing price of the Company's common stock as reported on The Nasdaq Global Select Market on the date of grant.
Income Taxes
Income taxes have been accounted for using the asset and liability method. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates applicable to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance against deferred tax assets is recorded if, based upon the weight of all available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.
Segment Reporting
The Company’s chief operating decision maker, its President and Chief Executive Officer, manages its operations and business asone operating segment for the purposes of allocating resources, makes operating decisions and evaluates financial performance. No product revenue has been generated since inception and all assets are held in the United States.
Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration of potential dilutive securities. Diluted net loss per share is computed by dividing the net loss by the sum of the weighted average number of common shares plus the potential dilutive effects of potential dilutive securities outstanding during the period. Potential dilutive securities are excluded from diluted earnings or loss per share if the effect of such inclusion is antidilutive. The Company’s potentially dilutive securities, which include unvested common stock, unvested restricted stock options, and outstanding stock options under the Company’s equity incentive plans, have been excluded from the computation of diluted net loss per share as they would be anti-dilutive to the net loss per share. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position.
Recent Accounting Pronouncements
In November 2023, the Financial Accounting Standard Board ("FASB") issued Accounting Standards Update ("ASU") No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires disclosure of incremental segment information on an interim and annual basis. This ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal periods beginning after December 15, 2024, and requires retrospective application to all prior periods presented in the financial statements. The Company is currently evaluating the impact of the guidance on the financial statements and disclosures.
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures ("ASU 2023-09"). ASU 2023-09 is intended to enhance the transparency and decision usefulness of income tax disclosures. The amendments in ASU 2023-09 address investor requests for enhanced income tax information primarily through changes to the rate reconciliation and income taxes paid information. ASU 2023-09 will be effective for us in the annual period beginning January 1, 2025, though early adoption is permitted. The Company is currently evaluating the presentational effect that ASU 2023-09 will have on its financial statements.
There were no other significant updates to the recently issued accounting standards other than as disclosed herewith. Although there are several other new accounting pronouncements issued or proposed by the FASB, the Company does not believe any of those accounting pronouncements have had or will have a material impact on its financial position or operating results.
- Net Loss Per Share
The following tables summarize the computation of the basic and diluted net loss per share (in thousands except share and per share data):
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Numerator: | ||
| Net loss | $(117,501) | $(113,837) |
| Denominator: | ||
| Weighted average common shares outstanding | 49,014,357 | 43,635,044 |
| Less: weighted average unvested common stock issued upon early exercise of common stock options | (57) | (3,322) |
| Weighted average shares used to compute net loss per share, basic and diluted | 49,014,300 | 43,631,722 |
| Net loss per share, basic and diluted | $(2.40) | $(2.61) |
The following table summarizes the outstanding potentially dilutive securities that have been excluded in the calculation of diluted net loss per share because their inclusion would be anti-dilutive:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Common stock options | 6,716,526 | 5,519,275 |
| Restricted stock units | 594,768 | 356,728 |
| Unvested common stock upon early exercise of common stock options | — | 508 |
| 7,311,294 | 5,876,511 | |
- Fair Value of Financial Instruments
The following tables summarize the fair value of the Company’s financial instruments (in thousands):
| Fair Value Measurements Using | ||||
|---|---|---|---|---|
| December 31,2023 | Quoted Pricesin Active Markets forIdentical Assets(Level 1) | Significant OtherObservable Inputs(Level 2) | Significant Unobservable Inputs(Level 3) | |
| Assets: | ||||
| Cash equivalents: | ||||
| Money market funds | $30,751 | $30,751 | $— | $— |
| Short-term investments: | ||||
| Corporate debt securities | $40,609 | $— | $40,609 | $— |
| Commercial paper | 38,197 | — | 38,197 | — |
| Government securities | 138,343 | — | 138,343 | — |
| Total short-term investments | $217,149 | $— | $217,149 | $— |
| Total | $247,900 | $30,751 | $217,149 | $— |
| Fair Value Measurements Using | ||||
|---|---|---|---|---|
| December 31,2022 | Quoted Pricesin Active Markets forIdentical Assets(Level 1) | Significant OtherObservable Inputs(Level 2) | Significant Unobservable Inputs(Level 3) | |
| Assets: | ||||
| Cash equivalents: | ||||
| Money market funds | $36,494 | $36,494 | $— | $— |
| Short-term investments: | ||||
| Corporate debt securities | $88,681 | $— | $88,681 | $— |
| Commercial paper | 65,409 | — | 65,409 | |
| U.S. Government securities | 160,559 | — | 160,559 | — |
| Total short-term investments | $314,649 | $— | $314,649 | $— |
| Total | $351,143 | $36,494 | $314,649 | $— |
Cash Equivalents and Short-Term Investments
Financial assets measured at fair value on a recurring basis consist of the Company’s cash equivalents and short-term investments. Cash equivalents consisted of money market funds and short-term investments consisted of commercial paper, corporate debt securities and Government securities. The Company obtains pricing information from its investment manager and generally determines the fair value of investment securities using standard observable inputs, including reported trades, broker/dealer quotes, and bids and/or offers.
Investments are classified as Level 1 within the fair value hierarchy if their quoted prices are available in active markets for identical securities. Investments in money market funds of $30.8 million and $36.5 million included in cash equivalents as of December 31, 2023 and 2022, respectively, were classified as Level 1 instruments.
Investments in corporate debt securities, commercial paper and Government securities included in short-term investments are valued using Level 2 inputs. Level 2 securities are initially valued at the transaction price and subsequently valued and reported upon utilizing inputs other than quoted prices that are observable either directly or indirectly, such as quotes from third-party pricing vendors. Fair values determined by Level 2 inputs, which utilize data points that are observable such as quoted prices, interest rates and yield curves, require the exercise of judgment and use of estimates, that if changed, could significantly affect the Company’s financial position and results of operations.
The following tables summarize the Company’s short-term investments as of December 31, 2023 and 2022 (in thousands):
| Maturity(in years) | AmortizedCost | UnrealizedLosses | UnrealizedGains | EstimatedFair Value | |
|---|---|---|---|---|---|
| Corporate debt securities | 1 year or less | $40,602 | $(11) | $18 | $40,609 |
| Commercial paper | 1 year or less | 38,198 | (2) | 1 | 38,197 |
| Government securities | 1 year or less | 138,341 | (56) | 58 | 138,343 |
| Total | $217,141 | $(69) | $77 | $217,149 |
| Maturity(in years) | AmortizedCost | UnrealizedLosses | UnrealizedGains | EstimatedFair Value | |
|---|---|---|---|---|---|
| Corporate debt securities | 1 year or less | $88,995 | $(320) | $6 | $88,681 |
| Commercial paper | 1 year or less | 65,532 | (123) | — | 65,409 |
| U.S. Government securities | 1 year or less | 160,801 | (319) | 77 | 160,559 |
| Total | $315,328 | $(762) | $83 | $314,649 |
The Company considers whether unrealized losses have resulted from a credit loss or other factors. The unrealized losses on the Company’s available-for-sale securities as of December 31, 2023 and 2022 were caused by fluctuations in market value and interest rates as a result of the economic environment and not credit risk. The Company concluded that an allowance for credit losses was unnecessary as of December 31, 2023 and 2022. It is neither management’s intention to sell nor is it more likely than not that the Company will be required to sell these investments prior to recovery of their cost basis or recovery of fair value, except for investments totaling $27.0 million that were sold with a realized loss of $0.2 million in December 2022 and $67.6 million that were sold with a realized loss of $0.3 million in January 2023. The Company recorded this $0.3 million as an impairment loss for the year ended December 31, 2022. Unrealized gains and losses are included in accumulated other comprehensive income (loss). Realized gains and losses on sales of available-for-sale investments are computed based upon specific identification of the initial cost adjusted for any other-than-temporary declines in fair value that were recorded in earnings.
The Company excludes accrued interest from both the fair value and the amortized cost basis of the available-for-sale debt securities for the purposes of identifying and measuring an impairment and to not measure an allowance for expected credit losses for accrued interest receivables. Accrued interest receivable is written off through net realized investment gains (losses) at the time the issuer of the bond defaults or is expected to default on payment. It is the Company's policy to present the accrued interest receivable balanceas part of prepaid expenses and other current assets in the balance sheets. Accrued interest receivable related to short-term investments was $1.2 million and $0.8 million as of December 31, 2023 and 2022, respectively.
- Balance Sheet Components
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets are comprised of the following (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Prepaid expenses | $3,263 | $5,616 |
| Other current assets | 1,619 | 2,929 |
| Total prepaid expenses and other current assets | $4,882 | $8,545 |
Property and Equipment, Net
Property and equipment, net is comprised of the following (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Leasehold improvements | $66,618 | $4,402 |
| Furniture and fixtures | 745 | 645 |
| Research equipment | 14,298 | 12,900 |
| Computers and software | 404 | 130 |
| Construction-in-progress | 8,954 | 49,655 |
| Total property and equipment, gross | 91,019 | 67,732 |
| Less accumulated depreciation and amortization | (11,693) | (5,824) |
| Total property and equipment, net | $79,326 | $61,908 |
Depreciation and amortization expense were $5.9 million and $2.6 million for the years ended December 31, 2023 and 2022, respectively.
Accrued and Other Current Liabilities
Accrued and other current liabilities are comprised of the following (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Accrued compensation | $6,722 | $6,691 |
| Accrued research and development costs | 5,845 | 3,486 |
| Accrued property and equipment | 174 | 5,001 |
| Other accrued and current liabilities | 855 | 858 |
| Total accrued and other liabilities | $13,596 | $16,036 |
- Leases
The Company has operating leases for its current corporate offices, laboratory space, manufacturing facility, and dedicated space in a vivarium in South San Francisco, California.
The components of lease expense were as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Operating lease expense | $10,900 | $11,220 |
| Variable lease expense (1) | 1,018 | 462 |
| Short-term lease expense | 18 | 45 |
| Total lease expense | $11,936 | $11,727 |
(1) Variable lease expense for the periods presented primarily included common area maintenance charges.
Supplemental information related to operating leases were as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Cash paid for amounts included in the measurement of lease liabilities | ||
| Operating cash flows used for operating leases | $11,540 | $6,887 |
The weighted-average remaining lease term was 9.8 years for the corporate office and laboratory space leases as of December 31, 2023. The corporate office lease includes an option to renew for an additional seven years. However, the renewal option was not included in the lease term for calculating the lease liability, as the renewal option allows the Company to maintain operational flexibility, and the Company was not reasonably certain that it would exercise the renewal option at the time of the lease commencement. The weighted-average discount rate was 9.8% as of December 31, 2023.
There were none and $0.4 million in ROU assets obtained in exchange for operating lease liabilities resulting from new leases and from modifications of existing leases, respectively, for the year ended December 31, 2023.
Maturities of operating lease liabilities under existing operating leases as of December 31, 2023 were as follows (in thousands):
| Year ending December 31, | Amount |
|---|---|
| 2024 | $12,818 |
| 2025 | 13,027 |
| 2026 | 13,462 |
| 2027 | 13,912 |
| 2028 | 14,378 |
| 2029 and thereafter | 72,876 |
| Total undiscounted future minimum lease payments | 140,473 |
| Less imputed interest | (52,134) |
| Total operating lease liabilities | $88,339 |
| Operating lease liabilities: | |
| Current | 6,069 |
| Non-current | 82,270 |
| Total lease liability | $88,339 |
In May 2018, the Company entered into a lease agreement for its corporate office and laboratory space located in South San Francisco, California with an expiration date in May 2025 (the"Initial Lease Agreement"). In April 2019, the Company executed the first amendment to the Initial Lease Agreement for additional corporate space, laboratory space and manufacturing capabilities andan extension to the lease term through April 2026.
In May 2020, the Company signed a second amendment to the Initial Lease Agreement. The amended lease provides for aneight-year non-cancelable lease of additional office and laboratory space in the same building. The lease amendment for additional office and laboratory space provided for abatement of rent during the first three months of the lease and contains rent escalations during the term of the lease. The lease for this additional space commenced in January 2021 and expires in January 2029. The lease amendment also includes an extension of the lease term for the existing office and laboratory space beginning on May 1, 2020 and expiring in January 2029. The amendment to the Initial Lease Agreement also includes anoption to extend the lease for an additional seven-year term.
In January 2021, the Company signed a third amendment to the Initial Lease Agreement which provides for the lease of additional space in the same building. The lease amendment for this additional space commenced in April 2021 and expires in March 2024.
In October 2021, the Company signed a fourth amendment to the Initial Lease Agreement which provides for the lease of additional space in the same building. The lease for additional office and laboratory space provides for abatement of rent during the first two months of the lease and contains rent escalations during the term of the lease. The lease amendment of this additional space commenced in April 2022 and expires in January 2029. The lease amendment also includes this additional space in the Company’soption to extend the amended Initial Lease Agreement for an additional seven-year term. The other terms of the Initial Lease Agreement, as amended, remain unchanged.
In July 2021, the Company entered into a lease agreement for corporate office, manufacturing and laboratory space located in South San Francisco, California with an expiration date approximately twelve years after the lease's legal commencement date (the"Additional Lease Agreement"). The lease for this additional space and the Company's obligation to pay rent commenced in January 2022. In addition to base rent, the Company is responsible for payment of direct expenses, which include operating, insurance and tax expenses. The lease also provides for certain tenant improvement allowances ("TIA") of up to approximately $25.2 million for tenant improvements and certain infrastructure upgrades in connection with the initial buildout of the premises, approximately $4.4 million ("Optional TIA") of which, if utilized, would need to be repaid by the Company over the lease term. In 2021, the Company delivered a security deposit in the form of a letter of credit of $1.6 million to the Landlord in connection with the Additional Lease Agreement.
In November 2021, the Company entered into an amendment to the Additional Lease Agreement. The lease amendment expressly includes manufacturing as a permitted use at the facility, clarifies that Silicon Valley Bank ("SVB") is an acceptable bank for purposes of issuing a letter of credit under the lease, revises the letter of credit transferability terms and replaces the form of letter of credit attached to the lease.
In August 2022, the Company entered into fifth amendment to the Initial Lease Agreement and a second amendment to the Additional Lease Agreement for its existing facilities in South San Francisco, California. The fifth amendment to the Initial Lease Agreement includes an extension of the lease term for certain of the Company's existing facilities through July 31, 2030. The second amendment to the Additional Lease Agreement provides for approximately $15.0 million of additional tenant improvement allowances, in addition to the tenant improvement allowances of $25.2 million included in the original Additional Lease Agreement, and increases the base rent payments over the existing term of the lease.
In March 2023, the Company held $2.7 million in collateral money market accounts supporting letters of credit issued by SVB to the landlord in connection with the Initial Lease Agreement and Additional Lease Agreement. In April 2023, the Company replaced the $2.7 million in letters of credit issued by SVB with letters of credit in the same amount from a different financial institution, and the Company entered into a third amendment to the Additional Lease Agreement. The lease amendment clarifies the form of letter of credit.
In June 2023, the Company entered into a fourth amendment to the Additional Lease Agreement. The lease amendment confirms that the Company utilized the $4.4 million Optional TIA and began repaying the Optional TIA in July 2023. The other terms of the Additional Lease Agreement, as amended, remain unchanged.
The Company tests long-lived assets for recoverability whenever events or changes in circumstances suggest that the carrying value of an asset or group of assets may not be recoverable. Beginning in the second quarter of 2023, the Company started to market for sublease portions of the Company's leased corporate office space in South San Francisco. As a result of these plans, the Company reviewed these spaces for impairment. As part of the impairment evaluation of the spaces being marketed for sublease, the Company compared the estimated undiscounted income for the marketed sublease spaces to the net book value of the related long-term assets, which include ROU assets and certain property, plant and equipment, primarily for leasehold improvements (collectively, "Sublease Asset Group"). The Company estimated potential sublease income using market participant assumptions, which the Company evaluated based on current real estate trends and market conditions. For the Sublease Asset Group, the Company determined that the respective ROU assets had net carrying values that exceeded their estimated undiscounted future cash flows. Accordingly, the Company then estimated the fair value of the Sublease Asset Group based on its discounted cash flows using the estimated borrowing rate of a market participant subtenant which we estimated to be 8%. The carrying value of the Sublease Asset Group exceeded its fair values and, as a result, the Company recorded an ROU asset impairment of $4.1 million for the year ended December 31, 2023. The impairment is recorded within general and administrative expenses in the statements of operations and comprehensive loss.
- Commitments and Contingencies
Guarantee Agreement
The Company has agreements whereby it indemnifies its officers and directors for certain events or occurrences while the officer or director is, or was, serving at the Company’s request in such capacity. The term of the indemnification period is for the officer’s or director’s lifetime. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is unlimited; however, the Company has a director and officer insurance policy that limits its exposure and enables the Company to recover a portion of any future amounts under certain circumstances and subject to deductibles and exclusions. The Company hadno liabilities recorded for these agreements as of December 31, 2023 and 2022.
Letters of Credit
The Company has $2.7 million in letter of credit agreements with a financial institution that are used as collateral for the Company’s corporate headquarters’ operating leases. The letters of credit automatically renew annually without amendment unless cancelled by the financial institutions within 30 to 60 days of the annual expiration date. The letters of credit are presented as restricted cash in the balance sheet.
Purchase Commitments
The Company enters into contracts in the normal course of business for clinical trials, preclinical studies, manufacturing and other services and products for operating purposes. These contracts generally provide for termination following a certain period after notice and therefore the Company believes that non-cancelable obligations under these agreements are not material.
- Collaboration and License Agreements
CRISPR Collaboration Agreement
On May 5, 2021, the Company entered into the CRISPR Agreement with CRISPR to co-develop and co-commercialize an allogeneic, off-the-shelf CAR NK product candidate targeting the CD70 tumor antigen and an allogeneic, off-the-shelf product candidate that comprises both engineered NK cells and engineered T cells. In May 2022, the CRISPR Agreement was amended to revise the transfer of materials and nomination provisions. In March 2023, the CRISPR Agreement was further amended to permit Nkarta's advancement of CRISPR-licensed product candidates targeting a specified tumor antigen(the "Specified TA") and incorporate associated development and regulatory approval milestones and sales based royalties. In addition, the Company has received licenses from CRISPR forfour CRISPR-Cas9 gene editing targets and will receive a license from CRISPR for up toone more CRISPR-Cas9 gene editing target that can be engineered into an unlimited number of its own NK cell products. CRISPR also has an option to co-develop and co-commercialize a future CAR NK program.
Under the terms of the CRISPR Agreement, the Company and CRISPR share equally in all research and development costs and potential profits worldwide related to the NKX070 product candidate, NK+T product candidate, and the potential future CAR NK program. For the NK+T program, CRISPR is responsible for gene-editing activities and T cell related activities, and Nkarta is responsible for NK cell related activities. The related impact of the cost sharing associated with the research and development activities is included in research and development expense on the statements of operations and comprehensive loss. Expenses related to services performed by the Company are classified as research and development expense. Payments received from CRISPR for partial reimbursement of expenses are recorded as a reduction of research and development expense. Reduction of research and development expense resulting from partial reimbursement from CRISPR was $1.6 million and $4.2 million for the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023 and 2022, the Company had a $0.2 million receivable and $1.3 million receivable, respectively, under the research cost sharing provision, which is included as part of prepaid expenses and other current assets in the balance sheet.
For each non-collaboration product candidate incorporating a genome editing target licensed from CRISPR (a "CRISPR-Licensed Product Candidate"), other than those targeting the Specified TA, the Company would retain worldwide rights and may be required to make potential future payments based on the achievement of development and regulatory approval milestones totaling less than mid-twenty million dollars, as well as tiered royalties up to the mid-single digits on net product sales of such product candidate. For each CRISPR-Licensed Product Candidate targeting the Specified TA, the Company would retain worldwide rights and may be required to make potential future payments based on the achievement of development and regulatory approval milestones totaling less than high-forty million dollars, as well as tiered royalties up to the mid-single digits on net product sales of such product candidate. As of December 31, 2023, the Company hasnot paid any amountsnor are any amounts owed by the Company under the CRISPR Agreement, and no milestones have been achieved.
MaxCyte License Agreement
On October 26, 2021, the Company entered into a license agreement (the "MaxCyte Agreement") with MaxCyte, Inc. ("MaxCyte") to obtain non-exclusive clinical and commercial rights to use MaxCyte's cell loading technology to develop and commercialize in up to ten licensed products.
In connection with the MaxCyte Agreement, the Company must pay to MaxCyte annual research license fees and commercialization license fees, ranging from $0.1 million to $0.3 million, for each instrument licensed by the Company. Further, the Company could be required to make milestone payments to MaxCyte upon completion of certain regulatory and commercial milestones related to the clinical development and commercialization of certain of the Company’s licensed products. The aggregate potential milestone payments range from $10 million to $13 million per licensed product. Additionally, the Company may be required to make net sales milestone payments totaling between $61.9 million to $116.8 million per licensed product. As of December 31, 2023, no milestones have been achieved.
University of Singapore and St. Jude Children’s License Agreement
In August 2016, the National University of Singapore ("NUS") and St. Jude Children’s Research Hospital ("St. Jude") and the Company entered into a license agreement under which NUS and St. Jude (the "Licensors") granted the Company an exclusive, royalty-bearing, worldwide license to its patent rights related to a method for expanding natural killer cells; a chimeric receptor with NKG2D specificity; and a method for supporting autonomous natural killer cell function ("NUS and St. Jude License Agreement"). The NUS and St. Jude License Agreement provides the Company with the rights to grant and authorize sublicenses to make, have made, use, sell, offer for sale and import products and otherwise exploit the patent rights.
As consideration for the license, the Company made an upfront payment of $31,800 and issued NUS 250,000 shares of the Company’s common stock. The Company determined that the upfront payment (SGD 42,750) and value of the common stock issued ($2,500 based on fair value at time of issuance) as part of the license agreement would be expensed upon execution of the contract as the license was acquired for research and development purposes which does not have alternative future uses, and the underlying technology has not reached technological feasibility, hence the Company expensed these costs during 2016.
In addition, the Company is required to pay an annual license maintenance fee of SGD 25,000, increasing to SGD 50,000 after year two of the agreement. Further, the Company could be required to make milestone payments to the Licensors upon completion of certain regulatory and commercial milestones related to the clinical development and commercialization of certain of the Company’s product candidates. The aggregate potential milestone payments are approximately SGD 5 million. The Company has also agreed to pay the Licensors royalties of 2.5% of net sales of products sold by the Company or through a sublicense. Additionally, the Company agreed to pay the Licensors a tiered percentage of sublicensing income (ranging from 7.5% to 20%) based on the timing of capital raised and stage of clinical trials. The NUS and St. Jude License Agreement also includes certain performance objectives which obligate the Company to meet various milestones related to the clinical development and commercialization of certain of the Company’s product candidates over time for up to 120 months after the effective date of the NUS and St. Jude License Agreement.
The Company recorded $37,000 license maintenance fees included as part of research and development expenses for each of the years ended December 31, 2023 and 2022.
- Employee Benefits
On January 1, 2018, the Company adopted a defined contribution 401(k) plan that is available to eligible employees. Under the terms of the plan, employees may make voluntary contributions as a percent of compensation, limited to the maximum amount allowable under federal tax regulations. As part of the plan, the Company elected to make non-matching contributions via mandatory 3% of compensation safe harbor nonelective contributions. The Company recognized $1.0 million and $0.8 million for expense related to the nonelective 401(k) contributions for the years ended December 31, 2023 and 2022, respectively.
- Stockholders’ Equity
Under the Amended and Restated Certificate of Incorporation dated July 14, 2020, the Company had a total of 100,000,000 authorized shares of common stock with a par value of $0.0001 per share and 54,350,179 authorized shares of preferred stock with a par value of $0.0001 per share.
Common Stock
On August 12, 2021, the Company filed a Registration Statement on Form S-3 (the "2021 Shelf Registration Statement"), covering the offer and sale from time to time, pursuant to Rule 415 of the Securities Act of 1933, as amended (the "Securities Act"), of up to $500.0 million in aggregate offering price of shares of the Company’s common stock, shares of the Company’s preferred stock, debt securities, warrants, and rights and units. The 2021 Shelf Registration Statement was declared effective by the Securities and Exchange Commission (the "SEC") on September 2, 2021 and included a prospectus covering the offer and sale from time to time of up to $150.0 million in aggregate offering price of shares of the Company’s common stock through an “at-the-market” equity offering program (the "ATM Offering Program") with Cowen and Company, LLC, as sales agent. As of December 31, 2022, the Company has issued and sold 113,213 shares of its common stock pursuant to the ATM Offering Program, resulting in net proceeds of approximately $1.6 million, after deducting offering expenses.
On April 28, 2022, the Company issued and sold 15,333,334 shares of its common stock in an underwritten public offering, including 2,000,000 shares associated with the full exercise of the underwriters’ option to purchase additional shares, at a price to the public of $15.00 per share. The total net proceeds to the Company from the offering were approximately $215.3 million, after deducting underwriting discounts and commissions and offering expenses. The shares were issued pursuant to the Company’s 2021 Shelf Registration Statement.
On March 17, 2023, the Company filed the Registration Statement on Form S-3, as amended by the Form S-3/A filed on April 24, 2023 (the "2023 Shelf Registration Statement"), covering the offer and sale from time to time, pursuant to Rule 415 of the Securities Act, of up to $350.0 million in aggregate offering price of shares of the Company's common stock, shares of the Company's preferred stock, debt securities, warrants, rights and/or units (including up to $120.0 million in aggregate offering price of shares of its common stock, shares of its preferred stock, debt securities, warrants, rights and/or units registered on the 2021 Registration Statement that have not yet been sold). The 2023 Shelf Registration Statement was declared effective by the SEC on May 5, 2023.
- Share-Based Compensation
Equity Incentive Plan
2015 Equity Incentive Plan
The Company granted options under its 2015 Equity Incentive Plan (the "2015 Plan"). The 2015 Plan allowed for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock unit awards and other stock awards, although only stock options were awarded under the 2015 Plan. Awards could be made to officers, directors, employees, non-employee directors, and consultants of the Company. In connection with the Board of Directors’ and stockholders’ approval of the 2020 Plan, the 2015 Plan was terminated as to future awards and any options then outstanding under the 2015 Plan remained outstanding and effective. As of December 31, 2023, there were an aggregate of 1,177,232 shares of common stock issuable upon the exercise of outstanding options issued under the 2015 Plan.
2020 Performance Incentive Plan
The Company’s 2020 Performance Incentive Plan (the "2020 Plan") which was adopted by the Company’s board of directors in June 2020 and approved by the Company’s stockholders in July 2020, became effective upon the consummation of the IPO in July 2020. The 2020 Plan allows for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, stock bonuses, restricted stock, stock units and other forms of awards including cash awards to its officers, directors, employees, consultants and advisors.
Asof December 31, 2023, a total of 8,388,917 shares of the Company’s common stock were authorized for issuance with respect to awards granted under the 2020 Plan (this number of shares gives effect to the annual increases in the 2020 Plan share limit, as described in the next sentence). The share limit will automatically increase on the first trading day in January of each year by an amount equal to the lesser of (1)5% of the total number of outstanding shares of the Company’s common stock on the last trading day in December in the prior year, or (2) such lesser number as determined by the Company’s board of directors. Any shares subject to awards granted under the 2020 Plan or the 2015 Plan that are not paid, delivered or exercised before they expire or are canceled or terminated, or otherwise fail to vest, as well as shares used to pay the purchase or exercise price of such awards or related tax withholding obligations, will become available for new award grants under the 2020 Plan. A total of 2,645,312 shares was available for issuance under the 2020 Plan as of December 31, 2023.
The following table summarizes the stock option activity during the year ended December 31, 2023 (in thousands, except number ofshares, exercise prices and contractual term):
| Number of shares | Weighted-averageexercise price | Weighted-averageremaining contractualterm (in years) | Aggregate Intrinsic Value | |
|---|---|---|---|---|
| Outstanding at December 31, 2022 | 5,519,275 | $17.17 | 8.1 | $2,915 |
| Granted | 2,412,028 | 4.39 | ||
| Exercised | (49,871) | 3.22 | ||
| Forfeited | (1,164,906) | 15.44 | ||
| Outstanding at December 31, 2023 | 6,716,526 | $12.99 | 7.5 | $8,279 |
| Exercisable at December 31, 2023 | 3,550,191 | $16.20 | 6.4 | $3,361 |
| Vested and expected to vest at December 31, 2023 | 6,716,526 | $12.99 | 7.5 | $8,279 |
The aggregate intrinsic value represents the difference between the exercise price of stock options and the quoted closing market price of the Company’s common stock on the applicable date for all in-the-money stock options.
Additional information related to the Company’s stock options is summarized below (in thousands, except per share amounts):
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Weighted-average grant-date fair value of stock option grants per share | $3.36 | $8.60 |
| Intrinsic value of options exercised | $39 | $4,268 |
The following table summarizes the restricted stock unit activity during the year ended December 31, 2023:
| Number of shares | Weighted-averagegrant date fair value per share | Weighted-averageremainingcontractualterm(in years) | |
|---|---|---|---|
| Outstanding at December 31, 2022 | 356,728 | $12.66 | 1.7 |
| Granted | 503,639 | 5.57 | |
| Forfeited | (177,056) | 7.62 | |
| Vested | (88,543) | 12.66 | |
| Outstanding at December 31, 2023 | 594,768 | $8.16 | 1.4 |
The weighted-average grant-date fair values of restricted stock units granted during the years ended December 31, 2023 and 2022 were $5.57 and $12.62, respectively. The fair value ofrestricted stock units that vested in the year ended December 31, 2023 totaled $0.4 million. There were no RSUs that vested in the year ended December 31, 2022.
Employee Stock Purchase Plan
The Company’s 2020 Employee Stock Purchase Plan (the "ESPP"), which was adopted by the Company’s board of directors in June 2020 and approved by the Company’s stockholders in July 2020, became effective upon the consummation of the IPO. The ESPP allows eligible employees to purchase shares of the Company’s common stock at a discount through payroll deductions of up to 15% of their eligible compensation, subject to any plan limitations. The ESPP provides forsix-month offering periods, and at the end of each offering period, employees are able to purchase shares at 85% of the lower of the fair market value of the Company’s common stock on the first trading day of the offering period or on the last trading day of the offering period. During 2023 and 2022,164,567 and 61,754 shares were issued under the ESPP resulting in aggregate cash proceeds of $0.5 million and $0.4 million, respectively. As of December 31, 2023,1,214,986 shares remained available for issuance under the ESPP (after giving effect to share purchases made under the ESPP through and including the ESPP offering period that ended on November 30, 2023).
Common Stock Reserved for Future Issuance
As of December 31, 2023, the Company had reserved the following shares of common stock for future issuance:
| Common stock options and restricted stock units granted and outstanding | 7,311,294 |
|---|---|
| Reserved for future equity award grants | 2,645,312 |
| Reserved for future ESPP issuances | 1,214,986 |
Share-Based Compensation Expense
Share-based compensation expense for the years ended December 31, 2023 and 2022 were as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Research and development | $8,025 | $7,326 |
| General and administrative | 9,174 | 9,530 |
| Total share-based compensation expense | $17,199 | $16,856 |
The total unrecognized compensation cost related to stock options was $19.5 million, which is expected to be recognized over a weighted-average remaining service period of 2.6 years as of December 31, 2023. The total unrecognized compensation cost related to restricted stock units was $3.7 million, which is expected to be recognized over a weighted-average remaining service period of 2.8 years as of December 31, 2023.
Fair Value Disclosures
The fair value of stock options was estimated on the date of grant using the quoted market price for the Company’s common stock on the applicable grant date and the Black-Scholes option pricing model with the following range of assumptions:
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Options | ||
| Risk-free interest rate | 3.5% - 4.9% | 1.6% - 4.2% |
| Expected volatility | 90.0% - 101.8% | 75.7% - 78.9% |
| Expected term (in years) | 5.5 - 6.1 | 5.5 - 6.1 |
| Expected dividend yield | — | — |
| ESPP | ||
| Risk-free interest rate | 4.7% - 5.4% | 1.6% - 4.7% |
| Expected volatility | 63.8% - 152.7% | 63.8% - 151.9% |
| Expected term (in years) | 0.5 | 0.5 |
| Expected dividend yield | — | — |
The Company recognizes compensation costs related to stock options granted to employees and nonemployees based on the estimated fair value of the awards on the date of grant, net of forfeitures. The Company generally recognizes grant-date fair value of stock options granted to employees and non-employee service providers on a straight-line basis over the requisite service period, which is generally the vesting term of the respective awards. The Company determines the fair value of stock options with a service and performance condition, or performance-based options as described above. The Company accounts for the impact of forfeitures as they occur. The determination of the fair value of share-based payment awards utilizing the Black-Scholes option-pricing model is affected by the Company’s stock price and a number of assumptions, including expected volatility, expected life, risk-free interest rate and expected dividends.
Expected term. The Company opted to use the “simplified method” for estimating the expected term of employee options, whereby the expected term equals the average of the vesting term and the original contractual term of the option (generally 10 years). The expected term of the employee stock purchase plan rights equals the six-month look-back period.
Expected volatility. Due to the Company’s limited operating history and a lack of company specific historical and implied volatility data, since inception and prior to 2023, the Company based its estimate of expected volatility on an average of the historical volatilities of the common stock of comparable publicly traded biopharmaceutical companies over a period equal to the expected term of the stock option grants. For the grants during 2023, the expected volatility was determined by using a blended approach of the Company’s historical stock price volatility and the historical stock price volatility for a select group of other publicly traded companies in the same industry. The comparable companies were chosen based on their similar size, stage in the life cycle, and financial leverage to the Company.
Risk-free interest rate. The risk-free rate assumption is based on the U.S. Treasury instruments with maturities similar to the expected term of the stock options.
Expected dividend yield. The Company hasnot issued any dividends and donot expect to issue dividends over the life of the options, as a result the estimated dividend yield iszero.
- Income Taxes
Due to the Company’s net losses for the years ended December 31, 2023 and 2022, and since the Company has a full valuation allowance against deferred tax assets, there wasno tax provision or benefit for income taxes recorded in the years presented other than minimum amounts required for state tax purposes.
A reconciliation on income taxes to the amount computed by applying the statutory federal income tax rate to the net loss is summarized as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Income tax benefit at statutory rates | $(24,675) | $(23,906) |
| State income tax, net of federal benefit | (1,438) | (1,566) |
| Permanent items | 1,656 | 1,891 |
| Research and development credits | (6,170) | (3,426) |
| Change in valuation allowance | 30,627 | 27,007 |
| Income tax expense | $— | $— |
Significant components of the Company’s deferred tax assets are shown below (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Deferred tax assets: | ||
| Net operating loss carry forwards | $43,491 | $36,732 |
| Depreciation and amortization | 334 | 316 |
| Research and development credits | 19,782 | 11,999 |
| Share-based compensation | 4,668 | 3,552 |
| Accrued expenses | 1,402 | 1,367 |
| Lease liability | 18,551 | 19,062 |
| Other, net | 49 | 35 |
| Section 174 Capitalized R&D | 30,147 | 17,352 |
| Total deferred tax assets | 118,424 | 90,415 |
| Valuation allowance for deferred tax assets | (102,169) | (71,368) |
| Deferred tax assets, net of valuation allowance | 16,255 | 19,047 |
| Deferred tax liabilities: | ||
| ROU asset | (8,404) | (18,089) |
| Depreciation and amortization | (7,851) | (958) |
| Net deferred tax assets | $— | $— |
The Company has a net operating loss and has provided a valuation allowance against net deferred tax assets due to uncertainties regarding the Company’s ability to realize these assets. The valuation allowance increased by $30.6 million and $27.0 million as of December 31, 2023 and 2022, respectively.
In assessing the realizability of deferred tax assets, the Company considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which the temporary differences representing net future deductible amounts become deductible. Due to the Company’s history of losses, and lack of other positive evidence, the Company has determined that it is more likely than not that its net deferred tax assets will not be realized, and therefore, the net deferred tax assets are substantially offset by a valuation allowance as of December 31, 2023 and 2022. The deferred tax assets were primarily comprised of federal and state tax net operating losses and tax credit carryforwards.
As of December 31, 2023, the Company had net operating loss ("NOL") carryforwards of approximately $185.5 million and $65.1 million, available to reduce future taxable income, if any, for federal and California state income tax purposes, respectively. Of the $185.5 million federal NOL carryforwards, $0.2 million, $1.7 million, and $1.3 million will begin expiring in 2035,2036, and 2037, respectively, if not utilized, while $182.2 million can be carried forward indefinitely. The state NOL carryforwards will begin expiring in 2036, if not utilized.
The Company also had federal and state research and development credit carry forwards of approximately $17.4 million and $7.4 million, respectively, as of December 31, 2023. The federal credits will begin expiring in 2035 if not utilized. The California credits have no expiration date.
Utilization of the NOL and research and development credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that may have occurred or that could occur in the future, as required by Section 382 of the Internal Revenue Code of 1986, as amended (the "Code"), as well as similar state provisions. The future utilization of the Company’s NOL and tax credit carryforwards to offset future taxable income may be subject to a substantial annual limitation as a result of changes in ownership by stockholders that hold 5% or more of the Company’s common stock. An assessment of such ownership changes under Section 382 was not completed through December 31, 2019. To the extent that an assessment is completed in the future, the Company’s ability to utilize tax attributes could be restricted on a year-by-year basis and certain attributes could expire before they are utilized. The Company will examine the impact of any potential ownership changes in the future.
The Company has not been audited by the Internal Revenue Service or any state income or franchise tax agency. As of December 31, 2023, its federal and state returns for the years ended 2015 through the current period are still open to examination. In addition, all of the net operating losses and research and development credit carryforwards that may be used in future years are still subject to inquiry given that the statute of limitation for these items would begin in the year of the utilization. The balance of gross unrecognized tax benefits as of December 31, 2023 and 2022 was approximately $3.7 million and $2.3 million, respectively, all of which would affect the Company’s income tax expense if recognized, before consideration of the Company’s valuation allowance. The Company does not expect its unrecognized tax benefits to change significantly over the next 12 months. The Company recognizes interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense. There wasno interest and penalties for the years ended December 31, 2023 and 2022. The Company files income tax returns in the United States federal jurisdiction and various state jurisdictions and is not currently under examination by any taxing authority for any open tax year. Due to net operating loss carryforwards, all years remain open for income tax examination. To the extent the Company has tax attribute carryforwards, the tax years in which the attribute was generated may still be adjusted upon examination by the IRS or state tax authorities to the extent utilized in a future period. No federal or state tax audits are currently in process.
The following table summarizes the changes in the Company’s gross unrecognized tax benefits (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Balance at the beginning of the year | $2,339 | $1,359 |
| Increases (decreases) related to tax positions taken in prior years | 102 | (43) |
| Increases related to tax positions taken in current year | 1,297 | 1,023 |
| Balance at the end of the year | $3,738 | $2,339 |
- Reduction in Force
On October 16, 2023, the Company committed to cost saving measures, including a reduction in force (the "Reduction") that resulted in a reduction of 18 positions, representing approximately 10% of the Company’s workforce. The Company undertook the Reduction to decrease its costs and create a more streamlined organization to support its operations through multiple clinical data updates.
In connection with the Reduction, the Company incurred $1.2 million in costs, consisting primarily of cash severance costs and transition support services for impacted employees, which the Company recognized in the fourth quarter of 2023 in general and administrative operating expenses in the statement of operations. As of December 31, 2023, $0.8 million was paid out and $0.4 million was recorded under other accrued and other current liabilities.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.