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Celldex Therapeutics Inc

For the period ended Dec 31, 2023. Filed Feb 26, 2024.

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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2023 · Filed Feb 26, 2024

CLDX$30.65-1.9%Stored close · as of Nov 10, 2026

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Item 8. Financial Statements and Supplementary Data

Report of Independent Registered Public Accounting Firm

To the Board of Directors and Stockholders of Celldex Therapeutics, Inc.

Opinions on the Financial Statements and Internal Control over Financial Reporting

We have audited the accompanying consolidated balance sheets of Celldex Therapeutics, Inc. and its subsidiary (the “Company”) as of December 31, 2023 and 2022, and the related consolidated statements of operations and comprehensive loss, of stockholders’ equity and of cash flows for each of the three years in the period ended December 31, 2023, including the related notes (collectively referred to as the “consolidated financial statements”). We also have audited the Company’s internal control over financial reporting as of December 31, 2023, based on criteria established inInternal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2023 in conformity with accounting principles generally accepted in the United States of America. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2023, based on criteria established inInternal Control - Integrated Framework (2013) issued by the COSO.

Basis for Opinions

The Company’s management is responsible for these consolidated financial statements, for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in Management’s Annual Report on Internal Control over Financial Reporting appearing under Item 9A. Our responsibility is to express opinions on the Company’s consolidated financial statements and on the Company’s internal control over financial reporting 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 audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud, and whether effective internal control over financial reporting was maintained in all material respects.

Our audits of the consolidated financial statements included performing procedures to assess the risks of material misstatement of the consolidated 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 consolidated 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 consolidated financial statements. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.

Definition and Limitations of Internal Control over Financial Reporting

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Critical Audit Matters

The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters 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 accounts or disclosures to which it relates.

Research and Development Expenses and Accruals Related to Clinical Research Organization and Contract Manufacturing Organization Activities

As described in Notes 2 and 9 to the consolidated financial statements, research and development costs, including internal and contract research costs, are expensed as incurred. Research and development expenses consist mainly of clinical trial costs and manufacturing of clinical material, toxicology and other preclinical studies, personnel costs, depreciation, license fees and funding of outside contracted research. Clinical trial expenses include expenses associated with clinical research organization, or CRO, services. Contract manufacturing expenses include expenses associated with contract manufacturing organization, or CMO, services. The invoicing from CROs and CMOs for services rendered can lag several months. Management accrues the cost of services rendered in connection with CRO and CMO activities based on their estimate of costs incurred. Management maintains regular communication with their CROs and CMOs to assess the reasonableness of its estimates. Research and development expenses for the year ended December 31, 2023 were $118 million, a portion of which related to CRO and CMO activities. Within accrued expenses, total accrued research and development contract costs as of December 31, 2023 amounted to $10.9 million, a majority of which related to CRO and CMO activities.

The principal consideration for our determination that performing procedures relating to research and development expenses and accruals related to CRO and CMO activities is a critical audit matter is a high degree of auditor effort in performing procedures related to the Company’s research and development expenses and accruals.

Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to management’s estimated research and development accruals, including those related to CRO and CMO activities. These procedures also included, among others (i) testing management’s process for developing the estimate of research and development accruals related to CROs and CMOs, (ii) evaluating the appropriateness of the methods used by management to develop the estimate, (iii) testing, on a sample basis, the completeness and accuracy of costs incurred for services that have been performed and for which the Company has been invoiced by comparing amounts to CRO and CMO contracts and invoices, and evaluating the reasonableness of the cost incurred for the services for which the Company has not yet been invoiced by comparing estimated amounts to information received from the CROs and CMOs, and (iv) testing, on a sample basis, classification of research and development expenses.

/s/ PricewaterhouseCoopers LLP

Boston, Massachusetts

February 26, 2024

We have served as the Company’s auditor since 2008.

CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share amounts)

​​​​​​​
​December 31, 2023December 31, 2022
Assets​​​​​​
Current assets:​​​​​​
Cash and cash equivalents​$34,814​$29,429
Marketable securities​​388,784​​275,523
Accounts and other receivables​​2,628​​347
Prepaid and other current assets​​5,467​​12,394
Total current assets​​431,693​​317,693
Property and equipment, net​​4,060​​3,747
Operating lease right-of-use assets, net​​2,577​​4,001
Intangible assets​​27,190​​27,190
Other assets​​107​​104
Total assets​$465,627​$352,735
Liabilities and stockholders’ equity​​​​​​
Current liabilities:​​​​​​
Accounts payable​$3,494​$3,340
Accrued expenses​​22,029​​12,835
Current portion of operating lease liabilities​​1,614​​1,445
Current portion of long-term liabilities​​3,988​​990
Total current liabilities​​31,125​​18,610
Long-term portion of operating lease liabilities​​928​​2,588
Other long-term liabilities​​4,403​​5,333
Total liabilities​​36,456​​26,531
Commitments and contingent liabilities (Note 14)​​​​​​
Stockholders’ equity:​​​​​​
Convertible preferred stock, $.01 par value; 3,000,000 shares authorized; no shares issued and outstanding at December 31, 2023 and 2022​​—​​—
Common stock, $.001 par value; 297,000,000 shares authorized; 55,883,377 and 47,200,695 shares issued and outstanding at December 31, 2023 and 2022, respectively​​56​​47
Additional paid-in capital​​1,823,168​​1,580,829
Accumulated other comprehensive income​​3,308​​1,260
Accumulated deficit​​(1,397,361)​​(1,255,932)
Total stockholders’ equity​​429,171​​326,204
Total liabilities and stockholders’ equity​$465,627​$352,735

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except per share amounts)

​​​​​​​​​​
​ · Year Ended · Year Ended · Year Ended
​ · ​ · December 31, 2023 · ​ · December 31, 2022 · ​ · December 31, 2021
Revenues:​​​​​​​​​
Product development and licensing agreements​$278​$56​$31
Contracts and grants​​6,605​​2,301​​4,620
Total revenues​​6,883​​2,357​​4,651
Operating expenses:​​​​​​​​​
Research and development​​118,011​​82,258​​53,311
General and administrative​​30,914​​27,195​​20,488
Intangible asset impairment​​—​​—​​3,500
Gain on fair value remeasurement of contingent consideration​​—​​(6,862)​​(1,405)
Litigation settlement related loss​​12,500​​15,000​​—
Total operating expenses​​161,425​​117,591​​75,894
Operating loss​​(154,542)​​(115,234)​​(71,243)
Investment and other income, net​​13,113​​2,909​​505
Net loss before income tax benefit​$(141,429)​$(112,325)​$(70,738)
Income tax benefit​​—​​—​​227
Net loss​$(141,429)​$(112,325)​$(70,511)
Basic and diluted net loss per common share​$(2.92)​$(2.40)​$(1.64)
Shares used in calculating basic and diluted net loss per share​​48,449​​46,888​​42,870
Comprehensive loss:​​​​​​​​​
Net loss​$(141,429)​$(112,325)​$(70,511)
Other comprehensive income (loss):​​​​​​​​​
Unrealized gain (loss) on marketable securities​​2,048​​(634)​​(695)
Comprehensive loss​$(139,381)​$(112,959)​$(71,206)

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In thousands, except share amounts)

​​​​​​​​​​​​​​​​​​
​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · Accumulated · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · Common · ​ · Common · ​ · Additional · ​ · Other · ​ · ​ · ​ · ​ · Total
​ · ​ · Stock · ​ · Stock Par · ​ · Paid-In · ​ · Comprehensive · ​ · Accumulated · ​ · Stockholders’
​ · Shares · Value · Capital · Income · Deficit · Equity
Balance at December 31, 202039,603,771​$40​$1,279,824​$2,589​$(1,073,096)​$209,357
Shares issued under stock option and employee stock purchase plans​281,189​​—​​2,479​​—​​—​​2,479
Shares issued in underwritten offering, net​6,845,238​​7​​269,886​​—​​—​​269,893
Stock-based compensation—​​—​​8,953​​—​​—​​8,953
Unrealized loss on marketable securities—​​—​​—​​(695)​​—​​(695)
Net loss—​​—​​—​​—​​(70,511)​​(70,511)
Balance at December 31, 202146,730,198​$47​$1,561,142​$1,894​$(1,143,607)​$419,476
Shares issued under stock option and employee stock purchase plans​470,497​​—​​4,076​​—​​—​​4,076
Stock-based compensation​—​​—​​15,611​​—​​—​​15,611
Unrealized loss on marketable securities​—​​—​​—​​(634)​​—​​(634)
Net loss​—​​—​​—​​—​​(112,325)​​(112,325)
Balance at December 31, 2022​47,200,695​$47​$1,580,829​$1,260​$(1,255,932)​$326,204
Shares issued under stock option and employee stock purchase plans​143,932​​—​​2,236​​—​​—​​2,236
Shares issued in underwritten offering, net​8,538,750​​9​​216,213​​—​​—​​216,222
Stock-based compensation​—​​—​​23,890​​—​​—​​23,890
Unrealized gain on marketable securities​—​​—​​—​​2,048​​—​​2,048
Net loss​—​​—​​—​​—​​(141,429)​​(141,429)
Balance at December 31, 2023​55,883,377​$56​$1,823,168​$3,308​$(1,397,361)​$429,171

CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

​​​​​​​​​​
​ · Year Ended · Year Ended · Year Ended
​ · ​ · December 31, 2023 · ​ · December 31, 2022 · ​ · December 31, 2021
Cash flows from operating activities:​​​​​​​​​
Net loss​$(141,429)​$(112,325)​$(70,511)
Adjustments to reconcile net loss to net cash used in operating activities:​​​​​​​​​
Depreciation and amortization​​3,008​​2,896​​3,068
Amortization and premium of marketable securities, net​​(6,222)​​844​​(3,209)
Loss (gain) on sale or disposal of assets​​—​​2​​(24)
Intangible asset impairment​​—​​—​​3,500
Gain on fair value remeasurement of contingent consideration​​—​​(6,862)​​(1,405)
Non-cash income tax benefit​​—​​—​​(227)
Stock-based compensation expense​​23,890​​15,611​​8,953
Changes in operating assets and liabilities:​​​​​​​​​
Accounts and other receivables​​(2,281)​​(175)​​1,574
Prepaid and other current assets​​5,900​​(9,572)​​(1,871)
Other assets​​(3)​​—​​(5)
Accounts payable and accrued expenses​​9,384​​3,123​​3,653
Other liabilities​​462​​2,726​​(4,405)
Net cash used in operating activities​​(107,291)​​(103,732)​​(60,909)
Cash flows from investing activities:​​​​​​​​​
Sales and maturities of marketable securities​​320,597​​280,666​​174,947
Purchases of marketable securities​​(424,561)​​(188,965)​​(389,881)
Acquisition of property and equipment​​(1,818)​​(1,828)​​(1,249)
Proceeds from sale or disposal of assets​​—​​69​​27
Net cash (used in) provided by investing activities​​(105,782)​​89,942​​(216,156)
Cash flows from financing activities:​​​​​​​​​
Net proceeds from stock issuances​​216,222​​—​​269,893
Proceeds from issuance of stock from employee benefit plans​​2,236​​4,076​​2,479
Net cash provided by financing activities​​218,458​​4,076​​272,372
Net increase (decrease) in cash and cash equivalents​​5,385​​(9,714)​​(4,693)
Cash and cash equivalents at beginning of period​​29,429​​39,143​​43,836
Cash and cash equivalents at end of period​$34,814​$29,429​$39,143
Non-cash investing activities​​​​​​​​​
Accrued construction in progress​$77​$113​$289

NOTES TO FINANCIAL STATEMENTS

(1) Nature of Business and Overview

Celldex Therapeutics, Inc. (the “Company” or “Celldex”) is a biopharmaceutical company dedicated to developing therapeutic monoclonal and bispecific antibodies that address diseases for which available treatments are inadequate. The Company is primarily focusing its efforts and resources on the continued research and development of barzolvolimab (also referred to as CDX-0159) and CDX-585.

At December 31, 2023, the Company had cash, cash equivalents and marketable securities of $423.6 million. The Company has had recurring losses and incurred a loss of $141.4 million for the year ended December 31, 2023. Net cash used in operations for the year ended December 31, 2023 was $107.3 million. The Company believes that the cash, cash equivalents and marketable securities at the filing date of this Form 10-K will be sufficient to meet estimated working capital requirements and fund planned operations for at least the next twelve months from the date of issuance of these financial statements.

During the next twelve months and beyond, the Company may take further steps to raise additional capital to meet its long-term liquidity needs including, but not limited to, one or more of the following: the licensing of drug candidates with existing or new collaborative partners, possible business combinations, issuance of debt, or the issuance of common stock or other securities via private placements or public offerings. Although the Company has been successful in raising capital in the past, there can be no assurance that additional financing will be available on acceptable terms, if at all, and the Company’s negotiating position in capital-raising efforts may worsen as existing resources are used. There is also no assurance that the Company will be able to enter into further collaborative relationships. Additional equity financings may be dilutive to the Company’s stockholders; debt financing, if available, may involve significant cash payment obligations and covenants that restrict the Company’s ability to operate as a business; and licensing or strategic collaborations may result in royalties or other terms which reduce the Company’s economic potential from products under development. The Company’s ability to continue funding its planned operations beyond twelve months from the issuance date is also dependent on the timing and manner of payment of amounts due under the Settlement Agreement with Shareholder Representative Services LLC (“SRS”) (refer to Note 17), in the event that the Company achieves the milestone related to that payment. The Company, at its option, may decide to pay that milestone payment in cash, shares of its common stock or a combination thereof. If the Company is unable to raise the funds necessary to meet its long-term liquidity needs, it may have to delay or discontinue the development of one or more programs, discontinue or delay ongoing or anticipated clinical trials, discontinue or delay our commercial manufacturing efforts, discontinue or delay our efforts to expand into additional indications for our drug product candidates, license out programs earlier than expected, raise funds at a significant discount or on other unfavorable terms, if at all, or sell all or a part of the Company.

(2) Summary of Significant Accounting Policies

Basis of Presentation

The balance sheets and statements of operations and comprehensive loss, stockholders’ equity, and cash flows, are consolidated for the years ended December 31, 2023, 2022 and 2021. These consolidated financial statements reflect the operations of the Company and its wholly-owned subsidiary. All intercompany balances and transactions have been eliminated in consolidation. The Company operates inone segment, which is the business of development, manufacturing and commercialization of novel therapeutics for human health care.

Use of Estimates

The preparation of the financial statements in conformity with accounting principles generally accepted in the United States of America (U.S. GAAP) requires management to make estimates and use assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the dates of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

Cash and Cash Equivalents

The Company considers all highly liquid investments purchased with a maturity date of 90 days or less at the date of purchase to be cash equivalents. Cash equivalents consist principally of money market funds and debt securities.

Marketable Securities

The Company invests its excess cash balances in marketable securities, including municipal bond securities, U.S. government agency securities, and highly rated corporate bonds. The Company classifies all of its marketable securities as current assets on the balance sheets because they are available-for-sale and available to fund current operations. Marketable securities are stated at fair value with unrealized gains and losses included as a component of accumulated other comprehensive income (loss), which is a separate component of stockholders’ equity. Each reporting period, the Company evaluates its investment portfolio to determine if any security is impaired and if an allowance for credit losses should be recorded. As part of this evaluation, the Company considers whether it has the ability and intent to hold the investment until recovery of its amortized cost basis and whether the decline in fair value is due to any credit related factors. If an impairment is the result of a credit loss, the Company recognizes an allowance for credit losses. Realized gains and losses are determined on the specific identification method and are included in investment and other income, net.

Concentration of Credit Risk and of Significant Customers and Suppliers

Financial instruments that potentially subject the Company to concentrations of credit risk primarily consist of cash, cash equivalents, marketable securities and accounts receivable. The Company invests its cash, cash equivalents and marketable securities in debt instruments and interest-bearing accounts at major financial institutions in excess of insured limits. The Company mitigates credit risk by limiting the investment type and maturity to securities that preserve capital, maintain liquidity and have a high credit quality. The Company has not historically experienced credit losses from its accounts receivable and therefore has not established an allowance for doubtful accounts.

Revenue from Rockefeller University represented 95% and 75% of total Company revenue for the years ended December 31, 2023 and 2022, respectively. Revenue from Rockefeller University and Gilead Sciences represented 88% of total Company revenue for the year ended December 31, 2021.

The Company relies on contract manufacturing organizations (CMO) to manufacture drug substance and drug product as well as for future commercial supplies. The Company also relies on CMOs for supply of raw materials as well as filling, packaging, storing and shipping our drug products.

Fair Value Measurements

The Company has certain assets and liabilities that are measured at fair value in the financial statements. The Company seeks to maximize the use of observable inputs (market data obtained from sources independent from the Company) and to minimize the use of unobservable inputs (the Company’s assumptions about how market participants would price assets and liabilities) when measuring the fair value of its assets and liabilities. These assets and liabilities are classified into one of three levels of the following fair value hierarchy as defined by U.S. GAAP:

Level 1: Observable inputs such as quoted prices in active markets for identical assets or liabilities. An active market for an asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis.

Level 2: Observable inputs other than Level 1 prices, such as quoted prices in active markets for similar assets or liabilities and quoted prices for identical assets or liabilities in markets that are not active.

Level 3: Unobservable inputs based on the Company’s assessment of the assumptions that market participants would use in pricing the asset or liability.

Property and Equipment

Property and equipment are stated at cost and depreciated over the estimated useful lives of the related assets using the straight-line method. Laboratory equipment and office furniture and equipment are depreciated over five years, and computer equipment is depreciated over three years. Manufacturing equipment is depreciated over seven toten years. Leasehold improvements are amortized over the shorter of the estimated useful life or the non-cancelable term of the related lease, including any renewals that are reasonably assured of occurring. Property and equipment under construction is classified as construction in progress and is depreciated or amortized only after the asset is placed in service. Expenditures for maintenance and repairs are charged to expense whereas the costs of significant improvements which extend the life of the underlying asset are capitalized. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are eliminated and any resulting gain or loss is reflected in the Company’s statements of operations and comprehensive loss.

The treatment of costs to construct property and equipment depends on the nature of the costs and the stage of construction. Costs incurred in the project planning, design, construction and installation phases are capitalized as part of the cost of the asset. The Company stops capitalizing these costs when the asset is substantially complete and ready for its intended use. For manufacturing property and equipment, the Company also capitalizes the cost of validating these assets for the underlying manufacturing process. The Company completes the capitalization of validation costs when the asset is substantially complete and ready for its intended use. Costs capitalized include incremental labor and fringe benefits, and direct consultancy services.

Leases

The Company has operating leases of office, manufacturing and laboratory space, which have remaining lease terms ofone totwo years and may includeone or more options to renewor terminate early.

The Company determines if an arrangement contains a lease at inception. Operating lease right-of-use assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. Certain adjustments to the right-of-use asset may be required for items such as prepaid or accrued lease payments, initial direct costs paid or incentives received. The Company’s leases do not contain an implicit rate, and therefore the Company uses an estimated incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments. Options to extend or terminate the lease are reflected in the calculation when it is reasonably certain that the option will be exercised. The Company has elected to account for lease and non-lease components as a single lease component, however non-lease components that are variable, such as common area maintenance and utilities, are generally paid separately from rent based on actual costs incurred and therefore are not included in the right-of-use asset and operating lease liability and are reflected as an expense in the period incurred. Leases with an initial term of 12 months or less are not recorded on the balance sheet.

Contingent Consideration

The Company records contingent consideration resulting from a business combination at its fair value on the acquisition date. The Company determines the fair value of the contingent consideration based primarily on the (i) timing and probability of success of clinical events or regulatory approvals; (ii) timing and probability of success of meeting clinical and commercial milestones; and (iii) discount rates. The Company’s contingent consideration liabilities arose in connection with its acquisition of Kolltan. On a quarterly basis, the Company revalues these obligations and records increases or decreases in their fair value as an adjustment to operating earnings. Changes to contingent consideration obligations can result from adjustments to discount rates, accretion of the discount rates due to the passage of time, changes in the Company’s estimates of the likelihood or timing of achieving development or commercial milestones, changes in the probability of certain clinical events or changes in the assumed probability associated with regulatory approval. The assumptions related to determining the value of contingent consideration include a significant amount of judgment, and any changes in the underlying estimates could have a material impact on the amount of contingent consideration adjustment recorded in any given period.

Intangible Assets

IPR&D assets acquired in a business combination initially are recorded at fair value and accounted for as indefinite-lived intangible assets. The valuation model used to measure the fair value of the Company’s IPR&D assets was primarily a discounted cash flow approach. The assumptions used in determining the fair value of the Company’s IPR&D assets include (i) probability of success; (ii) probability of partnership; (iii) partnership milestones; and (iv) discount rate. These assets are capitalized on the Company’s

balance sheets until either the project underlying them is completed or the assets become impaired. If a project is completed, the carrying value of the related intangible asset is amortized over the remaining estimated life of the asset beginning in the period in which the project is completed. If a project becomes impaired or is abandoned, the carrying value of the related intangible asset is written down to its fair value and an impairment charge is taken in the period in which the impairment occurs.

Each IPR&D asset is assessed for impairment at least annually or when impairment indicators are present. The Company has the option to assess qualitative factors to determine if it is more likely than not that the IPR&D asset is impaired and whether it is necessary to perform a quantitative impairment test.

Impairment of Intangible and Long-Lived Assets

The Company evaluates the recoverability of its long-lived assets, including property and equipment, right-of-use assets, and intangible assets when circumstances indicate that an event of impairment may have occurred. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written-down to their estimated fair values.

Revenue Recognition

Revenues are recognized when performance obligations under agreements or contracts are satisfied, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those services.

The Company determines revenue recognition through the following steps:

●Identification of the contract, or contracts, with a customer;
●Identification of the performance obligations in the contract;
●Determination of the transaction price;
●Allocation of the transaction price to the performance obligations in the contract; and
●Recognition of revenue when, or as, the Company satisfies a performance obligation.

Revenue for the Company is derived from product development agreements with collaborative partners for the research and development of therapeutic drug candidates. The terms of the agreements may include nonrefundable signing and licensing fees, funding for research, development and manufacturing, milestone payments and royalties on any product sales derived from collaborations. The Company assesses the multiple obligations typically within product development contracts to determine the distinct performance obligations and how to allocate the arrangement consideration to each distinct performance obligation. Under product development agreements, revenue is generally recognized using a cost-to-cost measure of progress. Revenue is recognized based on the costs incurred to date as a percentage of the total estimated costs to fulfill the contract. Incurred cost represents work performed, which corresponds with, and thereby best depicts, the transfer of control to the customer. Due to the nature of the work performed in these arrangements, the estimation of cost at completion is complex, subject to many variables, such as expected clinical trial costs, and requires significant judgements. Circumstances can arise that change original estimates of costs or progress toward completion. Any revisions to estimates are reflected in revenue on a cumulative catch-up basis in the period in which the change in circumstances became known.

Revenue for the Company is also derived from manufacturing and research and development arrangements. The Company owns and operates a cGMP manufacturing facility in Fall River, Massachusetts, to produce drug substance for its current and planned early-stage clinical trials. In order to utilize excess capacity, the Company has, from time to time, entered into contract manufacturing and research and development arrangements in which services are provided on a time-and-material basis or at a negotiated fixed price. Revenue from time-and-material contracts is generally recognized on an output basis as labor hours and/or direct expenses are incurred. Under fixed-price contracts, revenue is generally recognized on an output basis as progress is made toward completion of the performance obligations using surveys of performance completed to date.

Contract Assets and Liabilities

The Company classifies the right to consideration in exchange for products or services transferred to a client as either a receivable or a contract asset. A receivable is a right to consideration that is unconditional as compared to a contract asset which is a right to consideration that is conditional upon factors other than the passage of time.

The Company’s contract liabilities result from arrangements where the Company has received payment in advance of performance under the contract. These amounts are included as deferred revenue within current portion of long-term liabilities on the consolidated balance sheets.

Research and Development Expenses

Research and development costs, including internal and contract research costs, are expensed as incurred. Research and development expenses consist mainly of clinical trial costs, manufacturing of clinical material, toxicology and other preclinical studies, personnel costs, depreciation, license fees and funding of outside contracted research.

Clinical trial expenses include expenses associated with clinical research organization, or CRO, services. Contract manufacturing expenses include expenses associated with contract manufacturing organization, or CMO, services. The invoicing from CROs and CMOs for services rendered can lag several months. The Company accrues the cost of services rendered in connection with CRO and CMO activities based on our estimate of costs incurred. The Company maintains regular communication with our CROs and CMOs to assess the reasonableness of its estimates. Differences between actual expenses and estimated expenses recorded have not been material and are adjusted for in the period in which they become known.

Patent Costs

Patent costs are expensed to general and administrative expense as incurred. Certain patent costs are reimbursed by the Company’s product development and licensing partners. Any reimbursed patent costs are recorded as product development and licensing agreement revenues in the Company’s consolidated financial statements.

Stock-Based Compensation

The Company records stock-based compensation expense for all stock-based awards made to employees, consultants and non-employee directors based on the estimated fair values of the stock-based awards expected to vest at the grant date and adjusts, if necessary, to reflect actual forfeitures. Compensation expense for all stock-based awards is recognized using the straight-line method over the term of vesting or performance.

Foreign Currency Translation

Net unrealized gains and losses resulting from foreign currency translation are included in accumulated other comprehensive income. At December 31, 2023 and 2022, accumulated other comprehensive income includes a net unrealized gain related to foreign currency translation of $2.6 million.

Income Taxes

The Company uses the asset and liability method to account for income taxes, including the recognition of deferred tax assets and deferred tax liabilities for the anticipated future tax consequences attributable to differences between financial statement amounts and their respective tax basis. Quarterly, the Company reviews its deferred tax assets for recovery. A valuation allowance is established when the Company believes that it is more likely than not that its deferred tax assets will not be realized. Changes in valuation allowances from period to period are included in the Company’s tax provision in the period of change.

The Company records uncertain tax positions in the financial statements only if it is more likely than not that the uncertain tax position will be sustained upon examination by the taxing authorities. The Company records interest and penalties related to uncertain tax positions in income tax expense.

Comprehensive Loss

Comprehensive loss is comprised of net loss and certain changes in stockholders’ equity that are excluded from net loss. The Company includes foreign currency translation adjustments and unrealized gains and losses on marketable securities in other comprehensive loss. The statements of operations and comprehensive loss reflect total comprehensive loss for the years ended December 31, 2023, 2022 and 2021.

Net Loss Per Share

Basic net loss per common share is based upon the weighted-average number of common shares outstanding during the period, excluding restricted stock that has been issued but is not yet vested. Diluted net loss per common share is based upon the weighted-average number of common shares outstanding during the period plus additional weighted-average potentially dilutive common shares outstanding during the period when the effect is dilutive. In periods in which the Company reports a net loss, there is no difference between basic and diluted net loss per share because dilutive shares of common stock are not assumed to have been issued as their effect is anti-dilutive. The potentially dilutive common shares that have not been included in the net loss per common share calculations because the effect would have been anti-dilutive are as follows:

​​​​​​​
​ · ​ · Year Ended December 31,
​ · 2023 · 2022 · 2021
Stock options​6,378,924​5,085,662​4,077,667

Newly-Adopted Accounting Pronouncements

On January 1, 2023, the Company adopted ASU 2016-13: Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The guidance requires that credit losses be reported using an expected losses model rather than the incurred losses model and establishes additional disclosure requirements related to credit risks. For available-for-sale debt securities with unrealized losses, the standard requires allowances to be recorded instead of reducing the amortized cost of the investment. The adoption of this guidance did not have a material impact on the Company’s consolidated financial statements and related disclosures.

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that are adopted by the Company as of the specified effective date. The Company has reviewed recently issued accounting pronouncements and concluded they are either not applicable to the business or not expected to have a material impact on the Company’s consolidated financial statements as a result of future adoption.

(3) Accumulated Other Comprehensive Income

The changes in accumulated other comprehensive income, which is reported as a component of stockholders’ equity, for the year ended December 31, 2023 are summarized below:

​​​​​​​​​​
​ · Unrealized · ​ · ​ · ​ · ​
​ · ​ · Gain (Loss) on · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · Marketable · ​ · Foreign · ​ · ​ · ​
​ · ​ · Securities · ​ · Currency Items · ​ · Total
​ · ​ · (In thousands)
Balance at December 31, 2022​$(1,336)​$2,596​$1,260
Other comprehensive gain​​2,048​​—​​2,048
Balance at December 31, 2023​$712​$2,596​$3,308

No amounts were reclassified out of accumulated other comprehensive income during the years ended December 31, 2023, 2022 and 2021.

(4) Fair Value Measurements

The following tables set forth the Company’s financial assets and liabilities subject to fair value measurements:

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · As of · ​ · ​ · ​ · ​ · ​
​ · ​ · December 31, 2023 · ​ · Level 1 · ​ · Level 2 · ​ · Level 3
​ · ​ · (In thousands)
Assets: · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
Money market funds and cash equivalents​$19,803—​$19,803​—
Marketable securities​​388,784—​​388,784​—
​​$408,587​—​$408,587​​—
​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · As of · ​ · ​ · ​ · ​ · ​
​ · ​ · December 31, 2022 · ​ · Level 1 · ​ · Level 2 · ​ · Level 3
​ · ​ · (In thousands)
Assets: · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
Money market funds and cash equivalents​$16,813—​$16,813​—
Marketable securities​​275,523—​​275,523​—
​​$292,336​—​$292,336​​—

The Company’s financial assets consist mainly of cash equivalents and marketable securities and are classified as Level 2 within the valuation hierarchy. The Company values its marketable securities utilizing independent pricing services which normally derive security prices from recently reported trades for identical or similar securities, making adjustments based on significant observable transactions. At each balance sheet date, observable market inputs may include trade information, broker or dealer quotes, bids, offers or a combination of these data sources.

Contingent consideration liabilities measured at fair value using Level 3 inputs were $0.0 million as of December 31, 2023 and December 31, 2022. The valuation technique used to measure fair value of the Company’s Level 3 liabilities, which consist of contingent consideration related to the acquisition of Kolltan Pharmaceuticals, Inc. (“Kolltan”) in 2016, is primarily an income approach. The significant unobservable inputs used in the fair value measurement of the contingent consideration are estimates including probability of success, discount rates and amount of time until the conditions of the milestone payment are met.

During the year ended December 31, 2022, the Company recorded a $6.9 million gain on fair value remeasurement of contingent consideration primarily due to the Company’s decision to deprioritize the CDX-1140 program. The assumptions related to determining the value of contingent consideration include a significant amount of judgment, and any changes in the underlying estimates could have a material impact on the amount of contingent consideration adjustment recorded in any given period.

The Company did not have any transfers of assets or liabilities between the fair value measurement classifications during the years ended December 31, 2023 and 2022.

(5) Marketable Securities

The following is a summary of marketable debt securities, classified as available-for-sale:

​​​​​​​​​​​​​
​ · ​ · ​ · Gross · Gross · ​ · ​
​ · ​ · Amortized · ​ · Unrealized · ​ · Unrealized · ​ · Fair
​ · ​ · Cost · ​ · Gains · ​ · Losses · ​ · Value
​​(In thousands)
December 31, 2023​​​​​​​​​​​​
Marketable securities​​​​​​​​​​​​
U.S. government and municipal obligations​​​​​​​​​​​​
Maturing in one year or less​$132,459​$143​$(53)​$132,549
Maturing after one year through three years​​26,009​​77​​—​​26,086
Total U.S. government and municipal obligations​$158,468​$220​$(53)​$158,635
Corporate debt securities​​​​​​​​​​​​
Maturing in one year or less​$183,625​$300​$(10)​$183,915
Maturing after one year through three years​​45,977​​257​​—​​46,234
Total corporate debt securities​$229,602​$557​$(10)​$230,149
Total marketable securities​$388,070​$777​$(63)​$388,784
December 31, 2022​​​​​​​​​​​​
Marketable securities​​​​​​​​​​​​
U.S. government and municipal obligations​​​​​​​​​​​​
Maturing in one year or less​$97,246​$5​$(369)​$96,882
Maturing after one year through three years​​—​​—​​—​​—
Total U.S. government and municipal obligations​$97,246​$5​$(369)​$96,882
Corporate debt securities​​​​​​​​​​​​
Maturing in one year or less​$179,613​$—​$(972)​$178,641
Maturing after one year through three years​​—​​—​​—​​—
Total corporate debt securities​$179,613​$—​$(972)​$178,641
Total marketable securities​$276,859​$5​$(1,341)​$275,523

The Company holds investment grade marketable securities. Unrealized losses are generally attributable to changes in interest rates. The aggregate fair value of marketable securities held by the Company in an unrealized loss position as of December 31, 2023 and December 31, 2022 was $80.4 million and $133.9 million, respectively. The Company has the intent and ability to hold its marketable securities until recovery and has determined that there has beenno material change to the Company’s credit risk. As a result, the Company determined it did not hold any investments with a credit loss at December 31, 2023.

Marketable securities include $1.9 million and $0.8 million in accrued interest at December 31, 2023 and December 31, 2022, respectively.

(6) Property and Equipment, Net

Property and Equipment, net includes the following:

​ · ​ · ​ · ​ · ​ · ​ · ​
​ · December 31, · December 31,
​​2023​2022
​ · ​ · (In thousands)
Laboratory equipment​$9,848​$9,250
Manufacturing equipment​2,419​2,558
Office furniture and equipment​3,738​3,454
Leasehold improvements​9,653​9,613
Construction in progress​787​498
Total property and equipment​26,445​25,373
Less: accumulated depreciation and amortization​(22,385)​(21,626)
Property and equipment, net​$4,060​$3,747

Depreciation and amortization expense related to property and equipment was $1.5 million, $1.4 million and $1.6 million for the years ended December 31, 2023, 2022 and 2021, respectively.

(7) Leases

The Company has operating leases of office, manufacturing and laboratory space, which have remaining lease terms ofone totwo years and may includeone or more options to renew.

During the years ended December 31, 2023, 2022 and 2021, the Company recorded right of use assets andlease liabilities of $0.1 million, $2.5 million and $1.0 million related to new leases and lease extensions, respectively.

Operating lease expense was $1.9 million, $1.9 million and $1.9 million for years ended December 31, 2023, 2022 and 2021, respectively. Variable lease expense was $0.8 million, $0.8 million and $0.7 million for years ended December 31, 2023, 2022 and 2021, respectively. Cash paid for amounts included in the measurement of operating lease liabilities was $2.0 million, $1.9 million and $1.8 million for the years ended December 31, 2023, 2022 and 2021, respectively. As of December 31, 2023, the weighted-average remaining lease term was 2 years and the weighted-average discount rate was 10.0%, compared to a weighted-average remaining lease term of 2 years and weighted average discount rate of 10.0% as of December 31, 2022.

Future minimum lease payments under non-cancellable leases as of December 31, 2023 were as follows:

​ · ​ · ​ · ​
2024$1,788
2025​949
Total lease payments​2,737
Less imputed interest​(195)
Present value of operating lease liabilities​$2,542

(8) Intangible Assets

At December 31, 2023 and 2022, the carrying value of the Company’s indefinite-lived intangible assets was $27.2 million. Indefinite-lived intangible assets consist of acquired in-process research and development (“IPR&D”) related to the development of the anti-KIT program (including barzolvolimab). Barzolvolimab is in Phase 2 development. As of December 31, 2023, the IPR&D asset related to the anti-KIT program had not reached technological feasibility nor did the asset have alternative future uses.

The Company performs an impairment test on IPR&D assets at least annually, or more frequently if events or changes in circumstances indicate that IPR&D assets may be impaired. During the third quarter of 2021, the Company evaluated its TAM program IPR&D asset for potential impairment as a result of a lack of interest in the program from third parties. The Company concluded that the TAM program IPR&D asset was fully impaired, and a non-cash impairment charge of $3.5 million was recorded in the third quarter of 2021.

The Company performed its annual impairment test of the IPR&D asset related to the development of the anti-KIT program (including barzolvolimab) during the fourth quarter of 2023 and concluded that the IPR&D asset was not impaired. Due to the nature of IPR&D projects, the Company may experience future delays or failures to obtain regulatory approvals to conduct clinical trials, failures of such clinical trials or other failures to achieve a commercially viable product, and as a result, may recognize further impairment losses in the future.

(9) Accrued Expenses

Accrued expenses include the following:

​​​​​​​
​ · December 31, · December 31,
​ · ​ · 2023 · ​ · 2022
​ · ​ · (In thousands)
Accrued payroll and employee benefits​$9,348​$7,526
Accrued research and development contract costs​​10,864​​4,223
Accrued professional fees​​1,439​​766
Other accrued expenses​​378​​320
​​$22,029​$12,835

(10) Other Long-Term Liabilities

Other long-term liabilities include the following:

​​​​​​​
​ · December 31, · December 31,
​ · ​ · 2023 · ​ · 2022
​ · ​ · (In thousands)
Net deferred tax liabilities related to IPR&D (Note 15)​$1,613​$1,613
Deferred income from sale of tax benefits​​3,720​​4,650
Deferred revenue (Note 13)​​3,058​​60
Total​​8,391​​6,323
Less current portion​​(3,988)​​(990)
Long-term portion​$4,403​$5,333

In March 2022, the Company received approval from the New Jersey Economic Development Authority and agreed to sell New Jersey tax benefits of $5.0 million to an independent third party for $4.7 million. Under the agreement, the Company must maintain a base of operations in New Jersey forfive years or the tax benefits must be paid back on a pro-rata basis based on the number of years completed. The Company recognized $0.9 million in other income related to the sale of these tax benefits during the year ended December 31, 2023.

(11) Stockholders’ Equity

Common Stock

In November 2023, the Company filed an automatic shelf registration statement with the SEC to register for sale any combination of the types of securities described in the shelf registration statement.

On February 26, 2024, the Company entered into a controlled equity offering sales agreement with Cantor Fitzgerald & Co. (“Cantor”) to allow the Company to issue and sell shares of its common stock having an aggregate offering price of up to $300.0 million from time to time through Cantor, acting as agent. On February 26, 2024, the Company terminated its sales agreement dated May 19, 2016 with Cantor.

In November 2023, the Company issued 8,538,750 shares of its common stock in an underwritten public offering resulting in net proceeds to the Company of $216.2 million, after deducting underwriting fees and offering expenses.

In July 2021, the Company issued 6,845,238 shares of its common stock in an underwritten public offering resulting in net proceeds to the Company of $269.9 million, after deducting underwriting fees and offering expenses.

Convertible Preferred Stock

At December 31, 2023, the Company had authorized 3,000,000 shares of preferred stock all of which have been designated Class C Preferred Stock including 350,000 shares which have been designated Series C-1 Junior Participating Cumulative Preferred Stock (the “Series C-1 Preferred Stock”). No shares of Series C-1 Preferred Stock were outstanding at December 31, 2023 or 2022.

(12) Stock-Based Compensation

The Company has the following stock-based compensation plans: the 2004 Employee Stock Purchase Plan (the “2004 ESPP Plan”), the 2008 Stock Option and Incentive Plan (the “2008 Plan”) and the 2021 Omnibus Equity Incentive Plan (the “2021 Plan”). There areno shares available for future grant under the 2008 Plan. Outstanding options under the 2008 Plan will be rolled into the 2021 Plan if canceled.

Employee Stock Purchase Plan

At December 31, 2023, a total of 276,666 shares of common stock are reserved for issuance under the 2004 ESPP Plan. Under the 2004 ESPP Plan, each participating employee may purchase shares of common stock through payroll deductions at a purchase price equal to 85% of the lower of the fair market value of the common stock at either the beginning of the offering period or the applicable exercise date. During the years ended December 31, 2023, 2022 and 2021, the Company issued 12,729,12,243 and 21,867 shares under the 2004 ESPP Plan, respectively. At December 31, 2023,163,503 shares were available for issuance under the 2004 ESPP Plan.

Employee Stock Option Plan

The 2021 Plan permits the granting of incentive stock options (intended to qualify as such under Section 422A of the Internal Revenue Code of 1986, as amended), non-qualified stock options, stock appreciation rights, performance share units, restricted stock and other awards of restricted stock in lieu of cash bonuses to employees, consultants and non-employee directors.

The 2021 Plan allows for grants of new awards until April 19, 2031. As of December 31, 2023, there were 2,055,002 shares outstanding under the 2008 Plan that will be rolled into the 2021 Plan if canceled. The Company’s Board of Directors determines the term of each option, option price, and number of shares for which each option is granted and the rate at which each option vests. Options generally vest over a period not to exceed four years. The term of each option cannot exceedten years (five years for options granted to holders of more than 10% of the voting stock of the Company), and the exercise price of stock options cannot be less than the fair market value of the common stock at the date of grant (110% of fair market value for incentive stock options granted to holders of more than 10% of the voting stock of the Company). Vesting of all employee and non-employee director stock option awards may accelerate upon a change in control as defined in the 2021 Plan.

A summary of stock option activity for the year ended December 31, 2023 is as follows:

​​​​​​​​
​ · ​ · Weighted · Weighted
​ · ​ · ​ · ​ · Average · ​ · Average
​ · ​ · ​ · ​ · Exercise · ​ · Remaining
​ · ​ · ​ · ​ · Price · ​ · Contractual
​ · ​ · Shares · ​ · Per Share · ​ · Term (In Years)
Options outstanding at December 31, 2022​5,085,662​$29.26​7.9
Granted​1,612,175​$36.58​—
Exercised​(131,203)​$14.92​—
Canceled​(187,710)​$87.30​—
Options outstanding at December 31, 2023​6,378,924​$29.69​7.5
Options vested and expected to vest at December 31, 2023​6,264,180​$29.67​7.5
Options exercisable at December 31, 2023​3,261,890​$29.21​6.4
Shares available for grant under the 2021 Plan​1,013,503​​—​—

The total intrinsic value of stock options exercised during the years ended December 31, 2023, 2022 and 2021 was $2.7 million, $12.8 million and $9.4 million, respectively. The weighted average grant-date fair value of stock options granted during the years

ended December 31, 2023, 2022 and 2021 was $28.15, $17.60 and $22.16, respectively. The total fair value of stock options vested during the years ended December 31, 2023, 2022 and 2021 was $20.4 million, $15.6 million and $5.9 million, respectively.

The aggregate intrinsic value of stock options outstanding at December 31, 2023 was $98.6 million. The aggregate intrinsic value of stock options vested and expected to vest at December 31, 2023 was $97.6 million. The aggregate intrinsic value of stock options exercisable at December 31, 2023 was $68.9 million. As of December 31, 2023, total compensation cost related to non-vested employee and non-employee director stock options not yet recognized was approximately $61.9 million, net of estimated forfeitures, which is expected to be recognized as expense over a weighted average period of 2.6 years.

Valuation and Expenses Information

Stock-based compensation expense for the years ended December 31, 2023, 2022 and 2021 was recorded as follows:

​​​​​​​​​​
​ · 2023 · 2022 · 2021
​ · ​ · (In thousands)
Research and development​$11,948​$8,082​$4,525
General and administrative​​11,942​​7,529​​4,428
Total stock-based compensation expense​$23,890​$15,611​$8,953

The fair values of employee and director stock options granted during the years ended December 31, 2023, 2022 and 2021 were valued using the Black-Scholes option pricing model with the following assumptions:

​​​​​​​
​ · 2023 · 2022 · 2021
Expected stock price volatility​92%​90 - 97%​97 - 98%
Expected option term​6.0 Years​6.0 Years​6.0 Years
Risk-free interest rate​3.5 - 4.7%​1.7 - 4.2%​0.8 - 1.4%
Expected dividend yield​None​None​None

The Company estimates expected term based on historical exercise patterns. The Company uses its historical stock price volatility consistent with the expected term of grant as the basis for its expected volatility assumption. The risk-free interest rate is based upon the yield of U.S. Treasury securities consistent with the expected term of the option. The dividend yield assumption is based on the Company’s history ofzero dividend payouts and expectation thatno dividends will be paid in the foreseeable future.

(13) Revenue

Contract and Grants Revenue

The Company has entered into the Rockefeller Agreement and an agreement with Gilead Sciences pursuant to which the Company performs manufacturing and research and development services on a time-and-materials basis or at a negotiated fixed price. The Company recognized $6.6 million, $1.8 million and $4.1 million in revenue under these agreements during the years ended December 31, 2023, 2022 and 2021, respectively.

During the third quarter of 2020, the Company was awarded a Small Business Innovation Research (“SBIR”) grant from the National Institutes of Health (NIH) to support the Company’s CDX-1140 and CDX-301 programs. The Company recognized $0.0 million, $0.5 million and $0.4 million in grant revenue under the award during the years ended December 31, 2023, 2022 and 2021, respectively.

Contract Assets and Liabilities

At December 31, 2023 and 2022, the Company’s right to consideration under all contracts was considered unconditional, and as such, there wereno recorded contract assets. At December 31, 2023, the Company had $3.1 million in contract liabilities recorded, which is expected to be recognized during the next 12 months as manufacturing and research and development services are performed. At December 31, 2022, the Company had $0.1 million in contract liabilities recorded. Revenue recognized from contract liabilities as of December 31, 2022 during the year ended December 31, 2023 was $0.1 million.

(14) Collaboration Agreements

The Company has entered into license agreements whereby the Company has received licenses or options to license technology, specified patents and/or patent applications. These license and collaboration agreements generally provide for royalty payments equal to specified percentages of product sales, annual license maintenance fees, continuing patent prosecution costs and potential future milestone payments to third parties upon the achievement of certain development, regulatory and/or commercial milestones. Nonrefundable license fee expense of $0.3 million, $0.1 million and $0.1 million was recorded to research and development expense for the years ended December 31, 2023, 2022 and 2021, respectively.

Yale University (Yale)

Under a license agreement with Yale, the Company may be required to make a one-time payment to Yale of $3.0 million with respect to barzolvolimab upon achievement of a specified commercial milestone. In addition, the Company may be required to pay a low single-digit royalty on annual worldwide net sales of barzolvolimab. Unless earlier terminated by us or Yale, the Yale license agreement is due to expire no later than May 2038 but may expire earlier on a country-by-country basis under specified circumstances.

(15) Income Taxes

The components of income tax benefit (provision) are as follows:

​​​​​​​​​​
​ · ​ · Year Ended December 31,
​ · 2023 · 2022 · 2021
​ · ​ · (In thousands)
Income tax benefit (provision):​​​​​​​​​
Federal​$36,067​$17,484​$18,513
State​​13,691​​9,606​​7,082
Expiration of NOLs and R&D credit​​(15,141)​​(16,862)​​(14,210)
​​​34,617​​10,228​​11,385
Deferred tax valuation allowance​​(34,617)​​(10,228)​​(11,158)
​​$—​$—​$227

A reconciliation between the amount of reported income tax and the amount computed using the U.S. statutory rate is as follows:

​​​​​​​​​​
​ · 2023 · 2022 · 2021
​ · ​ · (In thousands)
Pre-tax loss​$(141,429)​$(112,325)​$(70,738)
Loss at statutory rates​​(29,700)​​(23,588)​​(14,855)
Research and development credits​​(5,237)​​(3,876)​​(2,422)
State taxes​​(13,691)​​(9,606)​​(7,082)
Other​​(1,130)​​11,421​​(941)
Change in fair value remeasurement of contingent consideration​​—​​(1,441)​​(295)
Expiration of NOLs and R&D credit​​15,141​​16,862​​14,210
Change in valuation allowance​​34,617​​10,228​​11,158
Income tax (benefit) provision​$—​$—​$(227)

Deferred tax assets and liabilities are recognized based on temporary differences between the financial reporting and tax basis of assets and liabilities using future expected enacted rates. The principal components of the deferred tax assets and liabilities at December 31, 2023 and 2022 are as follows:

​​​​​​​
​ · December 31, · December 31,
​ · ​ · 2023 · ​ · 2022
​​(In thousands)
Gross deferred tax assets​​​​​​
Net operating loss carryforwards​$197,618​$188,255
Tax credit carryforwards​​56,830​​50,688
Deferred research and development expenses​​82,077​​67,494
Stock-based compensation​​14,671​​9,993
Fixed assets​​1,019​​1,193
Accrued expenses and other​​398​​373
​​​352,613​​317,996
Gross deferred tax liabilities​​​​​​
IPR&D intangibles​​(6,840)​​(6,840)
Total deferred tax assets and liabilities​​345,773​​311,156
Valuation allowance​​(347,386)​​(312,769)
Net deferred tax liability​$(1,613)​$(1,613)

The Company has evaluated the positive and negative evidence bearing upon the realizability of its net deferred tax assets and considered its history of losses, ultimately concluding that it is “more likely than not” that the Company will not recognize the benefits of federal, state and foreign deferred tax assets and, as such, has maintained a full valuation allowance on its deferred tax assets.

In response to COVID-19, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was enacted on March 27, 2020. Among other provisions, the CARES Act included (i) the ability to use net operating losses to offset income without the 80% taxable income limitation enacted as part of the Tax Cuts and Jobs Act (“TCJA”) for net operating losses incurred in the 2018, 2019 or 2020 tax years; and (ii) the ability to claim a current deduction for interest expense up to 50% of adjusted taxable income for the 2019 and 2020 tax years (rather than 30% of adjusted taxable income pursuant to the TCJA). We do not expect that any of the provisions of the CARES Act will result in a material impact to the financial statements.

The net deferred tax liability of $1.6 million at December 31, 2023 and 2022, relates to the temporary differences associated with the IPR&D intangible assets acquired in previous business combinations and are not deductible for tax purposes. The Company recorded an income tax benefit of $0.2 million during the year ended December 31, 2021 due to a decrease in deferred tax liabilities resulting from the impairment of the TAM program IPR&D asset in the third quarter of 2021.

As of December 31, 2023, the Company had federal and state net operating loss carryforwards of $618.4 million and $1.0 billion, respectively, which may be available to offset certain future income tax liabilities and begin to expire in 2024 and 2029, respectively. Of the federal net operating loss carryforwards of $618.4 million, approximately $442.2 million are from 2018 through 2023 and haveno expiration date. As of December 31, 2023, the Company also had federal and state research and development tax credit carryforwards of $46.7 million and $12.9 million, respectively, which may be available to offset future income tax liabilities and begin to expire in 2023 and 2022, respectively.

Utilization of the net operating loss carryforwards and research and credit carryforwards may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986, or Section 382, due to ownership changes that occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50% over a three-year period. The Company has estimated the amounts of net operating loss and research and development tax credit carryforwards which will expire unutilized as a result of its estimated annual limitations under Section 382 and has excluded those amounts from the carryforward amounts disclosed above and in the deferred tax assets and liabilities table included in this footnote. The Company has concluded Section 382 studies through 2015 for Celldex generated NOLs.

As of December 31, 2023 and 2022, the Company did not have any unrecognized tax benefits.

Massachusetts, New Jersey, New York and Connecticut are the jurisdictions in which the Company primarily operates or has operated and has income tax nexus. The Company is not currently under examination by these or any other jurisdictions for any tax year. Generally, in U.S. federal and state taxing jurisdictions, all years which generated net operating losses and/or tax credit carryforwards remain subject to examination to the extent those carryforwards are utilized in a subsequent period.

(16) Retirement Savings Plan

The Company maintains a 401(k) Plan which is available to substantially all employees. Under the terms of the 401(k) Plan, participants may elect to contribute up to 60% of their compensation or the statutory prescribed limits. The Company may make 50% matching contributions on up to 4% of a participant’s annual salary. Benefit expense for the 401(k) Plan was $0.5 million, $0.4 million and $0.4 million for the years ended December 31, 2023, 2022 and 2021, respectively.

(17) Kolltan Acquisition

On November 29, 2016, the Company acquired all of the share and debt interests of Kolltan, a clinical-stage biopharmaceutical company, in exchange for 1,217,200 shares of the Company’s common stock plus contingent consideration in the form of development, regulatory approval and sales-based milestones (“Kolltan Milestones”) of up to $172.5 million payable in cash, in shares of Celldex’s common stock or a combination of both, in the sole discretion of Celldex and subject to provisions of the Agreement and Plan of Merger, dated November 1, 2016 (the “Merger Agreement”).

In October 2019, the Company received a letter from SRS, the hired representative of the former stockholders of Kolltan, notifying the Company that it objected to the Company’s characterization of the development, regulatory approval and sales-based Kolltan Milestones relating to CDX-0158 as having been abandoned and contending instead that the related milestone payments are due from Celldex to the Kolltan stockholder.

On August 18, 2020, Celldex filed a Verified Complaint in the Court of Chancery of the State of Delaware against SRS (acting in its capacity as the representative of the former stockholders of Kolltan pursuant to the Merger Agreement) seeking declaratory relief with respect to the rights and obligations of the parties relating to certain contingent milestone payments under the Merger Agreement relating to the discontinued CDX-0158 program (the “Litigation”).

On July 15, 2022, the Company entered into a definitive settlement agreement between the Company and SRS (the “Settlement Agreement”) and the Company and SRS jointly filed a Stipulation of Dismissal with prejudice relating to the Litigation on July 19, 2022.

Pursuant to the terms of the Settlement Agreement, all milestone payments provided for by the Merger Agreement were replaced in their entirety with the following payments, each of which is payable only once:

(i)The Company paid $15.0 million upon execution of the Settlement Agreement (the “Initial Payment”).
(ii)The Company paid $12.5 million upon the Successful Completion (as defined in the Settlement Agreement) of a Phase 2 Clinical Trial (as defined in the Merger Agreement) of barzolvolimab.
(iii)The Company shall pay $52.5 million upon the first United States Food and Drug Administration or European Medicines Agency, or, in each case, any successor organization, regulatory approval of a Surviving Company Product (as defined the Settlement Agreement).

The above payment obligations replace, in their entirety, the contingent consideration in the form of development, regulatory approval and sales-based milestones of up to $172.5 million contained in the Merger Agreement.

Under the Settlement Agreement, each of the Company and SRS provided broad mutual releases of all claims relating to or arising out of the Merger Agreement, including without limitation, all claims brought in the Litigation or that could have been brought in the Litigation.

The Company paid the Initial Payment in cash in July 2022. During the fourth quarter of 2023, the Company announced positive topline results from our Phase 2 clinical trial of barzolvolimab in patients with moderate to severe CSU, which satisfied the requirement of “successful completion” of a Phase 2 Clinical Trial of barzolvolimab such that the Company was obligated to make the applicable milestone payment under the Settlement Agreement with SRS in the amount of $12.5 million. During the fourth quarter of 2023, the Company paid the $12.5 million milestone in cash and recorded a litigation settlement related loss of $12.5 million.

A future milestone payment related to the barzolvolimab program, which was subject to the Litigation, will be recorded when and if payment becomes probable and reasonably estimable in accordance with the loss contingency model under ASC 450. A future milestone payment related to the remaining Surviving Company Products are measured at fair value (refer to Note 4). When and if the remaining payment described above becomes due, it shall be payable, at the Company’s sole election, in either cash or stock (as set forth in the Merger Agreement) or a combination thereof.

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