Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Oct. 31, 2022 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 000-15006 | |
Entity Registrant Name | CELLDEX THERAPEUTICS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 13-3191702 | |
Entity Address, Address Line One | Perryville III Building | |
Entity Address, Address Line Two | 53 Frontage Road | |
Entity Address, Address Line Three | Suite 220 | |
Entity Address, City or Town | Hampton | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 08827 | |
City Area Code | 908 | |
Local Phone Number | 200-7500 | |
Title of 12(b) Security | Common Stock, par value $.001 | |
Trading Symbol | CLDX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 47,099,831 | |
Entity Central Index Key | 0000744218 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 18,583 | $ 39,143 |
Marketable securities | 304,888 | 369,107 |
Accounts and other receivables | 189 | 172 |
Prepaid and other current assets | 10,939 | 2,417 |
Total current assets | 334,599 | 410,839 |
Property and equipment, net | 3,753 | 3,551 |
Operating lease right-of-use assets, net | 3,580 | 2,970 |
Intangible assets, net | 27,190 | 27,190 |
Other assets | 104 | 104 |
Total assets | 369,226 | 444,654 |
Current liabilities: | ||
Accounts payable | 2,272 | 1,228 |
Accrued expenses | 11,425 | 12,000 |
Current portion of operating lease liabilities | 1,438 | 1,746 |
Current portion of other long-term liabilities | 1,152 | 1,554 |
Total current liabilities | 16,287 | 16,528 |
Long-term portion of operating lease liabilities | 2,190 | 1,296 |
Other long-term liabilities | 5,333 | 7,354 |
Total liabilities | 23,810 | 25,178 |
Commitments and contingent liabilities | ||
Stockholders' equity: | ||
Convertible preferred stock, $.01 par value; 3,000,000 shares authorized; no shares issued and outstanding at September 30, 2022 and December 31, 2021 | 0 | |
Common stock, $.001 par value; 297,000,000 shares authorized; [ ] and 46,730,198 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 47 | 47 |
Additional paid-in capital | 1,574,926 | 1,561,142 |
Accumulated other comprehensive income | (112) | 1,894 |
Accumulated deficit | (1,229,445) | (1,143,607) |
Total stockholders' equity | 345,416 | 419,476 |
Total liabilities and stockholders' equity | $ 369,226 | $ 444,654 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Convertible Preferred Stock, Par Value (in dollars per share) | $ 0.01 | $ 0.01 |
Convertible Preferred Stock, Shares Authorized | 3,000,000 | 3,000,000 |
Convertible Preferred Stock, Shares Issued | 0 | 0 |
Convertible Preferred Stock, Shares Outstanding | 0 | 0 |
Common Stock, Par Value (in dollars per share) | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized | 297,000,000 | 297,000,000 |
Common Stock, Shares Issued | 47,096,063 | 46,730,198 |
Common Stock, Shares Outstanding | 47,096,063 | 46,730,198 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenues: | ||||
Total revenues | $ 407 | $ 153 | $ 744 | $ 4,317 |
Operating expenses: | ||||
Research and development | 21,572 | 13,557 | 59,359 | 38,633 |
General and administrative | 6,531 | 5,821 | 20,596 | 14,247 |
Intangible asset impairment | 3,500 | 3,500 | ||
Gain on fair value remeasurement of contingent consideration | 0 | (1,901) | (6,862) | (1,160) |
Litigation settlement related loss | 15,000 | |||
Total operating expenses | 28,103 | 20,977 | 88,093 | 55,220 |
Operating loss | (27,696) | (20,824) | (87,349) | (50,903) |
Investment and other income, net | 912 | 145 | 1,511 | 313 |
Net loss before income tax benefit | (26,784) | (20,679) | (85,838) | (50,590) |
Income tax benefit | 227 | 227 | ||
Net loss | $ (26,784) | $ (20,452) | $ (85,838) | $ (50,363) |
Basic net loss per common share | $ (0.57) | $ (0.45) | $ (1.83) | $ (1.21) |
Diluted net loss per common share | $ (0.57) | $ (0.45) | $ (1.83) | $ (1.21) |
Shares used in calculating basic net loss per share | 46,916 | 45,453 | 46,806 | 41,582 |
Shares used in calculating diluted net loss per share | 46,916 | 45,453 | 46,806 | 41,582 |
Comprehensive loss: | ||||
Net loss | $ (26,784) | $ (20,452) | $ (85,838) | $ (50,363) |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on marketable securities | 305 | (44) | (2,006) | (41) |
Comprehensive loss | (26,479) | (20,496) | (87,844) | (50,404) |
Product development and licensing agreements | ||||
Revenues: | ||||
Total revenues | 30 | 29 | ||
Contracts and grants | ||||
Revenues: | ||||
Total revenues | $ 407 | $ 153 | $ 714 | $ 4,288 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities: | |||
Net loss | $ (20,452) | $ (85,838) | $ (50,363) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 2,223 | 2,291 | |
Amortization and premium of marketable securities, net | 1,366 | (3,407) | |
Loss (gain) on sale or disposal of assets | 1 | (23) | |
Intangible asset impairment | 3,500 | 3,500 | |
Gain on fair value remeasurement of contingent consideration | (1,901) | (6,862) | (1,160) |
Non-cash income tax benefit | (227) | (227) | |
Stock-based compensation expense | 11,103 | 5,813 | |
Changes in operating assets and liabilities: | |||
Accounts and other receivables | (17) | 1,549 | |
Prepaid and other current assets | (7,928) | (2,261) | |
Accounts payable and accrued expenses | 720 | 1,757 | |
Other liabilities | 3,262 | (3,855) | |
Net cash used in operating activities | (81,970) | (46,386) | |
Cash flows from investing activities: | |||
Sales and maturities of marketable securities | 192,866 | 129,000 | |
Purchases of marketable securities | (132,613) | (325,342) | |
Acquisition of property and equipment | (1,593) | (895) | |
Proceeds from sale or disposal of assets | 69 | 25 | |
Net cash provided by (used in) investing activities | 58,729 | (197,212) | |
Cash flows from financing activities: | |||
Net proceeds from stock issuances | 269,893 | ||
Proceeds from issuance of stock from employee benefit plans | 2,681 | 2,053 | |
Net cash provided by financing activities | 2,681 | 271,946 | |
Net (decrease) increase in cash and cash equivalents | (20,560) | 28,348 | |
Cash and cash equivalents at beginning of period | 39,143 | 43,836 | |
Cash and cash equivalents at end of period | $ 72,184 | 18,583 | 72,184 |
Non-cash investing activities | |||
Accrued construction in progress | $ 38 | $ 46 |
Basis of Presentation
Basis of Presentation | 9 Months Ended |
Sep. 30, 2022 | |
Basis of Presentation | |
Basis of Presentation | (1) Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared by Celldex Therapeutics, Inc. (the “Company” or “Celldex”) in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and reflect the operations of the Company and its wholly-owned subsidiary. All intercompany balances and transactions have been eliminated in consolidation. These interim financial statements do not include all the information and footnotes required by U.S. GAAP for annual financial statements and should be read in conjunction with the audited financial statements for the year ended December 31, 2021, which are included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2022. In the opinion of management, the interim financial statements reflect all normal recurring adjustments necessary to fairly state the Company’s financial position and results of operations for the interim periods presented. The year-end condensed balance sheet data presented for comparative purposes was derived from audited financial statements but does not include all disclosures required by U.S. GAAP. The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for any future interim period or the fiscal year ending December 31, 2022. At September 30, 2022, the Company had cash, cash equivalents and marketable securities of $323.5 million. The Company has had recurring losses and incurred a loss of $85.8 million for the nine months ended September 30, 2022. Net cash used in operations for the nine months ended September 30, 2022 was $82.0 million. The Company believes that the cash, cash equivalents and marketable securities at the filing date of this Form 10-Q 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 13), in the event that the Company achieves the milestones related to those payments. The Company, at its option, may decide to pay those milestone payments 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, 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. COVID-19 continues to have an impact in the US and around the world. To date, we have managed delays and disruptions without significant impact in planned and ongoing preclinical and clinical trials, manufacturing or shipping. Potential impacts to our business include delays in planned and ongoing preclinical and clinical trials including enrollment of patients, disruptions in time and resources provided by independent clinical investigators, contract research organizations, and other third-party service providers, temporary closures of our facilities, disruptions or restrictions on our employees’ ability to travel, and delays in manufacturing and/or shipments to and from third-party suppliers and contract manufacturers for APIs and drug product. Any prolonged negative impacts to our business could materially impact our operating results and could lead to impairments of our intangible in-process research and development (“IPR&D”) assets with a carrying value of $27.2 million at September 30, 2022. |
Significant Accounting Policies
Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Significant Accounting Policies | |
Significant Accounting Policies | (2) Significant Accounting Policies The significant accounting policies used in preparation of these condensed consolidated financial statements on Form 10-Q for the three and nine months ended September 30, 2022 are consistent with those discussed in Note 2 to the financial statements in our Annual Report on Form 10-K for the year ended December 31, 2021. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s consolidated financial statements upon adoption. In June 2016, the FASB issued guidance on the 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 that is currently used, and establishes additional disclosures related to credit risks. For available-for-sale debt securities with unrealized losses, the standard now requires allowances to be recorded instead of reducing the amortized cost of the investment. This standard will be effective for the Company on January 1, 2023. The adoption of this new guidance is not expected to have a material impact on the Company’s consolidated financial statements and related disclosures. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Measurements | |
Fair Value Measurements | (3) Fair Value Measurements The following tables set forth the Company’s financial assets and liabilities subject to fair value measurements: As of September 30, 2022 Level 1 Level 2 Level 3 (In thousands) Assets: Money market funds and cash equivalents $ 10,729 — $ 10,729 — Marketable securities 304,888 — 304,888 — $ 315,617 — $ 315,617 — Liabilities: Kolltan acquisition contingent consideration $ — — — $ — $ — — — $ — As of December 31, 2021 Level 1 Level 2 Level 3 (In thousands) Assets: Money market funds and cash equivalents $ 26,220 — $ 26,220 — Marketable securities 369,107 — 369,107 — $ 395,327 — $ 395,327 — Liabilities: Kolltan acquisition contingent consideration $ 6,862 — — $ 6,862 $ 6,862 — — $ 6,862 The Company’s financial assets consist mainly of money market funds, 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. The following table reflects the activity for the Company’s contingent consideration liabilities measured at fair value using Level 3 inputs for the nine months ended September 30, 2022 (in thousands): Other Liabilities: Contingent Consideration Balance at December 31, 2021 $ 6,862 Fair value adjustments included in operating expenses (6,862) Balance at September 30, 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, was 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 payments are met. During the three and nine months ended September 30, 2022, the Company recorded a $0.0 million and $6.9 million gain on fair value remeasurement of contingent consideration, respectively, primarily due to the Company’s decision to deprioritize the CDX-1140 program. During the three and nine months ended September 30, 2021, the Company recorded a $1.9 million and $1.2 million gain on fair value remeasurement of contingent consideration, respectively, primarily due to updated assumptions for the TAM program, changes in discount rates and the passage of time. The assumptions related to determining the fair 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 in or out of Level 3 assets liabilities during |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2022 | |
Marketable Securities | |
Marketable Securities | (4) Marketable Securities The following is a summary of marketable debt securities, classified as available-for-sale: Gross Unrealized Amortized Fair Cost Gains Losses Value (In thousands) September 30, 2022 Marketable securities U.S. government and municipal obligations Maturing in one year or less $ 132,422 $ — $ (1,042) $ 131,380 Maturing after one year through three years 3,912 — (71) 3,841 Total U.S. government and municipal obligations $ 136,334 $ — $ (1,113) $ 135,221 Corporate debt securities Maturing in one year or less $ 168,698 $ — $ (1,548) $ 167,150 Maturing after one year through three years 2,564 — (47) 2,517 Total corporate debt securities $ 171,262 $ — $ (1,595) $ 169,667 Total marketable securities $ 307,596 $ — $ (2,708) $ 304,888 Gross Unrealized Amortized Fair Cost Gains Losses Value (In thousands) December 31, 2021 Marketable securities U.S. government and municipal obligations Maturing in one year or less $ 80,674 $ — $ (133) $ 80,541 Maturing after one year through three years 51,319 — (184) 51,135 Total U.S. government and municipal obligations $ 131,993 $ — $ (317) $ 131,676 Corporate debt securities Maturing in one year or less $ 170,034 $ — $ (28) $ 170,006 Maturing after one year through three years 67,782 — (357) 67,425 Total corporate debt securities $ 237,816 $ — $ (385) $ 237,431 Total marketable securities $ 369,809 $ — $ (702) $ 369,107 The Company holds investment-grade marketable securities, and none were in a continuous unrealized loss position for more than twelve months as of September 30, 2022 and December 31, 2021. The unrealized losses are attributable to changes in interest rates and the Company does not believe any unrealized losses represent other-than-temporary impairments. Marketable securities include $0.7 million and $1.3 million in accrued interest at September 30, 2022 and December 31, 2021, respectively. |
Intangible Assets
Intangible Assets | 9 Months Ended |
Sep. 30, 2022 | |
Intangible Assets | |
Intangible Assets | (5) Intangible Assets At September 30, 2022 and December 31, 2021, the carrying value of the Company’s indefinite-lived intangible assets was $27.2 million. Indefinite-lived intangible assets consist of acquired IPR&D related to the development of the anti-KIT program, including barzolvolimab (also referred to as CDX-0159), which was recorded in connection with the Kolltan acquisition. Barzolvolimab is in Phase 2 development. As of September 30, 2022, 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. 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. |
Other Long-Term Liabilities
Other Long-Term Liabilities | 9 Months Ended |
Sep. 30, 2022 | |
Other Long-Term Liabilities | |
Other Long-Term Liabilities | (6) Other Long-Term Liabilities Other long-term liabilities include the following: September 30, December 31, 2022 2021 (In thousands) Net deferred tax liabilities related to IPR&D (Note 11) $ 1,613 $ 1,613 Deferred Income From Sale of Tax Benefits 4,650 — Contingent milestones (Note 3 and Note 13) — 6,862 Deferred revenue (Note 10) 222 433 Total 6,485 8,908 Less current portion (1,152) (1,554) Long-term portion $ 5,333 $ 7,354 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 for five years or the tax benefits must be paid back on a pro-rata basis based on the number of years completed. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2022 | |
Stockholders' Equity | |
Stockholders' Equity | (7) Stockholders’ Equity In May 2016, the Company entered into a controlled equity offering sales agreement (the “Cantor Agreement”) with Cantor Fitzgerald & Co. (“Cantor”) to allow the Company to issue and sell shares of its common stock from time to time through Cantor, acting as agent. At September 30, 2022, the Company had $50.0 million remaining in aggregate gross offering price available under the Company’s November 2020 prospectus. The changes in Stockholders’ Equity during the three and nine months ended September 30, 2022 and 2021 are summarized below: Accumulated Common Common Additional Other Total Stock Stock Par Paid-In Comprehensive Accumulated Stockholders’ Shares Value Capital Income Deficit Equity Consolidated balance at December 31, 2021 46,730,198 $ 47 $ 1,561,142 $ 1,894 $ (1,143,607) $ 419,476 Shares issued under stock option and employee stock purchase plans 24,150 — 304 — — 304 Stock-based compensation — — 3,153 — — 3,153 Unrealized loss on marketable securities — — — (1,782) — (1,782) Net loss — — — — (23,050) (23,050) Consolidated balance at March 31, 2022 46,754,348 $ 47 $ 1,564,599 $ 112 $ (1,166,657) $ 398,101 Shares issued under stock option and employee stock purchase plans 10,355 — 71 — — 71 Stock-based compensation — — 3,454 — — 3,454 Unrealized loss on marketable securities — — — (529) — (529) Net loss — — — — (36,004) (36,004) Consolidated balance at June 30, 2022 46,764,703 $ 47 $ 1,568,124 $ (417) $ (1,202,661) $ 365,093 Shares issued under stock option and employee stock purchase plans 331,360 — 2,306 — — 2,306 Stock-based compensation — — 4,496 — — 4,496 Unrealized gain on marketable securities — — — 305 — 305 Net loss — — — — (26,784) (26,784) Consolidated balance at September 30, 2022 47,096,063 $ 47 $ 1,574,926 $ (112) $ (1,229,445) $ 345,416 Accumulated Common Common Additional Other Total Stock Stock Par Paid-In Comprehensive Accumulated Stockholders’ Shares Value Capital Income Deficit Equity (In thousands, except share amounts) Consolidated balance at December 31, 2020 39,603,771 $ 40 $ 1,279,824 $ 2,589 $ (1,073,096) $ 209,357 Shares issued under stock option and employee stock purchase plans 10,867 — 74 — — 74 Stock-based compensation — — 1,275 — — 1,275 Unrealized loss on marketable securities — — — (2) — (2) Net loss — — — — (16,538) (16,538) Consolidated balance at March 31, 2021 39,614,638 $ 40 $ 1,281,173 $ 2,587 $ (1,089,634) $ 194,166 Shares issued under stock option and employee stock purchase plans 2,058 — (25) — — (25) Stock-based compensation — — 1,509 — — 1,509 Unrealized gain on marketable securities — — — 5 — 5 Net loss — — — — (13,373) (13,373) Consolidated balance at June 30, 2021 39,616,696 $ 40 $ 1,282,657 $ 2,592 $ (1,103,007) $ 182,282 Shares issued under stock option and employee stock purchase plans 201,406 — 2,004 — — 2,004 Shares issued in underwritten offering, net 6,845,238 7 269,886 — — 269,893 Stock-based compensation — — 3,029 — — 3,029 Unrealized loss on marketable securities — — — (44) — (44) Net loss — — — — (20,452) (20,452) Consolidated balance at September 30, 2021 46,663,340 $ 47 $ 1,557,576 $ 2,548 $ (1,123,459) $ 436,712 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Stock-Based Compensation | |
Stock-Based Compensation | (8) Stock-Based Compensation A summary of stock option activity for the nine months ended September 30, 2022 is as follows: Weighted Weighted Average Average Exercise Remaining Price Contractual Shares Per Share Term (In Years) Options outstanding at December 31, 2021 4,077,667 $ 30.02 8.0 Granted 1,584,900 $ 22.89 Exercised (353,622) $ 6.71 Canceled (118,974) $ 50.12 Options outstanding at September 30, 2022 5,189,971 $ 28.97 8.07 Options vested and expected to vest at September 30, 2022 5,031,072 $ 29.21 8.05 Options exercisable at September 30, 2022 1,985,506 $ 41.56 6.74 Shares available for grant under the 2021 Plan 1,838,291 The weighted average grant-date fair value of stock options granted during the three and nine months ended September 30, 2022 was $25.38 and $17.36, respectively. The aggregate intrinsic value of stock options vested and expected to vest at September 30, 2022 was $45.6 million. The aggregate intrinsic value of stock options exercisable at September 30, 2022 was $23.6 million. As of September 30, 2022, total compensation cost related to non-vested employee, consultant and non-employee director stock options not yet recognized was approximately $46.7 million, net of estimated forfeitures, which is expected to be recognized as expense over a weighted average period of 2.8 Stock-based compensation expense for the three and nine months ended September 30, 2022 and 2021 was recorded as follows: Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 (In thousands) (In thousands) Research and development $ 2,342 $ 1,504 $ 5,754 $ 2,927 General and administrative 2,154 1,525 5,349 2,886 Total stock-based compensation expense $ 4,496 $ 3,029 $ 11,103 $ 5,813 The fair values of employee, consultant and non-employee director stock options granted during the three and nine months ended September 30, 2022 and 2021 were valued using the Black-Scholes option pricing model with the following assumptions: Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 Expected stock price volatility 91% 98% 90 – 97% 97 – 98% Expected option term 6.0 Years 6.0 Years 6.0 Years 6.0 Years Risk-free interest rate 2.9 – 3.5% 1.1 – 1.2% 1.7 – 3.6% 0.8 – 1.3% Expected dividend yield None None None None |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Income | 9 Months Ended |
Sep. 30, 2022 | |
Accumulated Other Comprehensive Income | |
Accumulated Other Comprehensive Income | (9) Accumulated Other Comprehensive Income The changes in accumulated other comprehensive income, which is reported as a component of stockholders’ equity, for the nine months ended September 30, 2022 are summarized below: Unrealized Loss on Marketable Foreign Securities Currency Items Total (In thousands) Balance at December 31, 2021 $ (702) $ 2,596 $ 1,894 Other comprehensive loss (2,006) — (2,006) Balance at September 30, 2022 $ (2,708) $ 2,596 $ (112) No amounts were reclassified out of accumulated other comprehensive income during the nine months ended September 30, 2022. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2022 | |
Revenue. | |
Revenue | (10) Revenue Contract and Grants Revenue The Company has entered into agreements with Rockefeller University and 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 $0.0 million and $0.2 million in revenue under these agreements during the three and nine months ended September 30, 2022, respectively, and $0.1 million and $4.0 million during the three and nine months ended September 30, 2021, respectively. Contract Assets and Liabilities At September 30, 2022 and December 31, 2021, the Company’s right to consideration under all contracts was considered unconditional, and as such, there were no recorded contract assets. At September 30, 2022, the Company had $0.2 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, 2021, the Company had $0.4 million in contract liabilities recorded. Revenue recognized from contract liabilities as of December 31, 2021 during the three and nine months ended September 30, 2022 was $0.2 million and $0.4 million, respectively. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2022 | |
Income Taxes | |
Income Taxes | (11) Income Taxes 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 as of September 30, 2022 and December 31, 2021. The net deferred tax liability of $1.6 million at September 30, 2022 and December 31, 2021 relates to the temporary differences associated with the IPR&D intangible assets acquired in previous business combinations and is not deductible for tax purposes. 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. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2022 | |
Net Loss Per Share | |
Net Loss Per Share | (12) 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: Nine Months Ended September 30, 2022 2021 Stock Options 5,189,971 4,129,626 Restricted Stock — — 5,189,971 4,129,626 |
Kolltan Acquisition
Kolltan Acquisition | 9 Months Ended |
Sep. 30, 2022 | |
Kolltan Acquisition | |
Kolltan Acquisition | (13) 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 June 20, 2022, the Company entered into a binding settlement term sheet (the “Term Sheet”) with SRS, related to the Litigation, which, upon execution of a definitive settlement agreement and the payment of the Initial Payment (as defined below), would result in the joint dismissal, with prejudice, of all claims and counterclaims in the Litigation. The definitive settlement agreement between the Company and SRS was executed on July 15, 2022 (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 Term Sheet and the Settlement Agreement, all milestone payments provided for by the Merger Agreement are 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 shall pay $15.0 million upon the Successful Completion (as defined in the Term Sheet) of a Phase 2 Clinical Trial (as defined in the Merger Agreement) of CDX-0159, subject to the $2.5 million contractual credit as set forth in the Merger Agreement. (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 Term Sheet). 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 during the three months ended September 30, 2022. Any future milestone payments related to the CDX-0159 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. Milestones related to the remaining Surviving Company Products are measured at fair value (refer to Note 3). When and if any of the remaining payments described above become due, they 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. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Significant Accounting Policies | |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s consolidated financial statements upon adoption. In June 2016, the FASB issued guidance on the 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 that is currently used, and establishes additional disclosures related to credit risks. For available-for-sale debt securities with unrealized losses, the standard now requires allowances to be recorded instead of reducing the amortized cost of the investment. This standard will be effective for the Company on January 1, 2023. The adoption of this new guidance is not expected to have a material impact on the Company’s consolidated financial statements and related disclosures. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Measurements | |
Schedule of financial assets and liabilities subject to fair value measurements | As of September 30, 2022 Level 1 Level 2 Level 3 (In thousands) Assets: Money market funds and cash equivalents $ 10,729 — $ 10,729 — Marketable securities 304,888 — 304,888 — $ 315,617 — $ 315,617 — Liabilities: Kolltan acquisition contingent consideration $ — — — $ — $ — — — $ — As of December 31, 2021 Level 1 Level 2 Level 3 (In thousands) Assets: Money market funds and cash equivalents $ 26,220 — $ 26,220 — Marketable securities 369,107 — 369,107 — $ 395,327 — $ 395,327 — Liabilities: Kolltan acquisition contingent consideration $ 6,862 — — $ 6,862 $ 6,862 — — $ 6,862 |
Schedule of the contingent consideration liabilities measured at fair value using Level 3 inputs | The following table reflects the activity for the Company’s contingent consideration liabilities measured at fair value using Level 3 inputs for the nine months ended September 30, 2022 (in thousands): Other Liabilities: Contingent Consideration Balance at December 31, 2021 $ 6,862 Fair value adjustments included in operating expenses (6,862) Balance at September 30, 2022 $ — |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Marketable Securities | |
Schedule of marketable debt securities, classified as available-for-sale | Gross Unrealized Amortized Fair Cost Gains Losses Value (In thousands) September 30, 2022 Marketable securities U.S. government and municipal obligations Maturing in one year or less $ 132,422 $ — $ (1,042) $ 131,380 Maturing after one year through three years 3,912 — (71) 3,841 Total U.S. government and municipal obligations $ 136,334 $ — $ (1,113) $ 135,221 Corporate debt securities Maturing in one year or less $ 168,698 $ — $ (1,548) $ 167,150 Maturing after one year through three years 2,564 — (47) 2,517 Total corporate debt securities $ 171,262 $ — $ (1,595) $ 169,667 Total marketable securities $ 307,596 $ — $ (2,708) $ 304,888 Gross Unrealized Amortized Fair Cost Gains Losses Value (In thousands) December 31, 2021 Marketable securities U.S. government and municipal obligations Maturing in one year or less $ 80,674 $ — $ (133) $ 80,541 Maturing after one year through three years 51,319 — (184) 51,135 Total U.S. government and municipal obligations $ 131,993 $ — $ (317) $ 131,676 Corporate debt securities Maturing in one year or less $ 170,034 $ — $ (28) $ 170,006 Maturing after one year through three years 67,782 — (357) 67,425 Total corporate debt securities $ 237,816 $ — $ (385) $ 237,431 Total marketable securities $ 369,809 $ — $ (702) $ 369,107 |
Other Long-Term Liabilities (Ta
Other Long-Term Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Other Long-Term Liabilities | |
Schedule of other long-term liabilities | September 30, December 31, 2022 2021 (In thousands) Net deferred tax liabilities related to IPR&D (Note 11) $ 1,613 $ 1,613 Deferred Income From Sale of Tax Benefits 4,650 — Contingent milestones (Note 3 and Note 13) — 6,862 Deferred revenue (Note 10) 222 433 Total 6,485 8,908 Less current portion (1,152) (1,554) Long-term portion $ 5,333 $ 7,354 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Stockholders' Equity | |
Schedule of Shareholder's equity | Accumulated Common Common Additional Other Total Stock Stock Par Paid-In Comprehensive Accumulated Stockholders’ Shares Value Capital Income Deficit Equity Consolidated balance at December 31, 2021 46,730,198 $ 47 $ 1,561,142 $ 1,894 $ (1,143,607) $ 419,476 Shares issued under stock option and employee stock purchase plans 24,150 — 304 — — 304 Stock-based compensation — — 3,153 — — 3,153 Unrealized loss on marketable securities — — — (1,782) — (1,782) Net loss — — — — (23,050) (23,050) Consolidated balance at March 31, 2022 46,754,348 $ 47 $ 1,564,599 $ 112 $ (1,166,657) $ 398,101 Shares issued under stock option and employee stock purchase plans 10,355 — 71 — — 71 Stock-based compensation — — 3,454 — — 3,454 Unrealized loss on marketable securities — — — (529) — (529) Net loss — — — — (36,004) (36,004) Consolidated balance at June 30, 2022 46,764,703 $ 47 $ 1,568,124 $ (417) $ (1,202,661) $ 365,093 Shares issued under stock option and employee stock purchase plans 331,360 — 2,306 — — 2,306 Stock-based compensation — — 4,496 — — 4,496 Unrealized gain on marketable securities — — — 305 — 305 Net loss — — — — (26,784) (26,784) Consolidated balance at September 30, 2022 47,096,063 $ 47 $ 1,574,926 $ (112) $ (1,229,445) $ 345,416 Accumulated Common Common Additional Other Total Stock Stock Par Paid-In Comprehensive Accumulated Stockholders’ Shares Value Capital Income Deficit Equity (In thousands, except share amounts) Consolidated balance at December 31, 2020 39,603,771 $ 40 $ 1,279,824 $ 2,589 $ (1,073,096) $ 209,357 Shares issued under stock option and employee stock purchase plans 10,867 — 74 — — 74 Stock-based compensation — — 1,275 — — 1,275 Unrealized loss on marketable securities — — — (2) — (2) Net loss — — — — (16,538) (16,538) Consolidated balance at March 31, 2021 39,614,638 $ 40 $ 1,281,173 $ 2,587 $ (1,089,634) $ 194,166 Shares issued under stock option and employee stock purchase plans 2,058 — (25) — — (25) Stock-based compensation — — 1,509 — — 1,509 Unrealized gain on marketable securities — — — 5 — 5 Net loss — — — — (13,373) (13,373) Consolidated balance at June 30, 2021 39,616,696 $ 40 $ 1,282,657 $ 2,592 $ (1,103,007) $ 182,282 Shares issued under stock option and employee stock purchase plans 201,406 — 2,004 — — 2,004 Shares issued in underwritten offering, net 6,845,238 7 269,886 — — 269,893 Stock-based compensation — — 3,029 — — 3,029 Unrealized loss on marketable securities — — — (44) — (44) Net loss — — — — (20,452) (20,452) Consolidated balance at September 30, 2021 46,663,340 $ 47 $ 1,557,576 $ 2,548 $ (1,123,459) $ 436,712 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Stock-Based Compensation | |
Schedule of stock option activity | Weighted Weighted Average Average Exercise Remaining Price Contractual Shares Per Share Term (In Years) Options outstanding at December 31, 2021 4,077,667 $ 30.02 8.0 Granted 1,584,900 $ 22.89 Exercised (353,622) $ 6.71 Canceled (118,974) $ 50.12 Options outstanding at September 30, 2022 5,189,971 $ 28.97 8.07 Options vested and expected to vest at September 30, 2022 5,031,072 $ 29.21 8.05 Options exercisable at September 30, 2022 1,985,506 $ 41.56 6.74 Shares available for grant under the 2021 Plan 1,838,291 |
Schedule of stock-based compensation expense | Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 (In thousands) (In thousands) Research and development $ 2,342 $ 1,504 $ 5,754 $ 2,927 General and administrative 2,154 1,525 5,349 2,886 Total stock-based compensation expense $ 4,496 $ 3,029 $ 11,103 $ 5,813 |
Schedule of assumptions used for the fair value of employee stock options granted | Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 Expected stock price volatility 91% 98% 90 – 97% 97 – 98% Expected option term 6.0 Years 6.0 Years 6.0 Years 6.0 Years Risk-free interest rate 2.9 – 3.5% 1.1 – 1.2% 1.7 – 3.6% 0.8 – 1.3% Expected dividend yield None None None None |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Income (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Accumulated Other Comprehensive Income | |
Schedule of changes in accumulated other comprehensive income | Unrealized Loss on Marketable Foreign Securities Currency Items Total (In thousands) Balance at December 31, 2021 $ (702) $ 2,596 $ 1,894 Other comprehensive loss (2,006) — (2,006) Balance at September 30, 2022 $ (2,708) $ 2,596 $ (112) |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Net Loss Per Share | |
Schedule of 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 | Nine Months Ended September 30, 2022 2021 Stock Options 5,189,971 4,129,626 Restricted Stock — — 5,189,971 4,129,626 |
Basis of Presentation (Details)
Basis of Presentation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Basis of Presentation | |||||||||
Cash, cash equivalents and marketable securities | $ 323,500 | $ 323,500 | |||||||
Net loss | (26,784) | $ (36,004) | $ (23,050) | $ (20,452) | $ (13,373) | $ (16,538) | (85,838) | $ (50,363) | |
Net cash used in operations | (81,970) | $ (46,386) | |||||||
Indefinite-lived intangible assets | $ 27,200 | $ 27,200 | $ 27,200 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Liabilities: | ||
Kolltan acquisition contingent consideration | $ 6,862 | |
Fair value | Level 3 | ||
Liabilities: | ||
Kolltan acquisition contingent consideration | $ 0 | 6,862 |
Fair Value Measurements. | Level 1 | ||
Liabilities: | ||
Kolltan acquisition contingent consideration | 0 | |
Total financial liabilities at fair value | 0 | |
Fair Value Measurements. | Level 2 | ||
Assets: | ||
Money market funds and cash equivalents | 10,729 | 26,220 |
Marketable securities | 304,888 | 369,107 |
Total financial assets at fair value | 315,617 | 395,327 |
Liabilities: | ||
Kolltan acquisition contingent consideration | 0 | |
Total financial liabilities at fair value | 0 | |
Fair Value Measurements. | Level 3 | ||
Liabilities: | ||
Kolltan acquisition contingent consideration | 0 | 6,862 |
Total financial liabilities at fair value | 0 | 6,862 |
Fair Value Measurements. | Fair value | ||
Assets: | ||
Money market funds and cash equivalents | 10,729 | 26,220 |
Marketable securities | 304,888 | 369,107 |
Total financial assets at fair value | 315,617 | 395,327 |
Liabilities: | ||
Kolltan acquisition contingent consideration | 0 | 6,862 |
Total financial liabilities at fair value | $ 0 | $ 6,862 |
Fair Value Measurements - Conti
Fair Value Measurements - Contingent Consideration Liabilities (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Contingent consideration liabilities measured at fair value | |
Balance at beginning of period | $ 6,862 |
Fair value | Level 3 | |
Contingent consideration liabilities measured at fair value | |
Balance at beginning of period | 6,862 |
Fair value adjustments included in operating expenses | (6,862) |
Balance at end of period | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Fair value measurements | ||||
Gain on Fair Value Remeasurement of Contingent Consideration | $ 0 | $ 1,901 | $ 6,862 | $ 1,160 |
Fair value | ||||
Fair value measurements | ||||
Asset transfer out of level 3 | 0 | |||
Asset transfer into level 3 | 0 | |||
Liabilities transfers out of level 3 | $ 0 |
Marketable Securities (Details)
Marketable Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Amortized Cost | ||
Amortized Cost | $ 307,596 | $ 369,809 |
Gross Unrealized Gains | ||
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | ||
Gross Unrealized Losses | (2,708) | (702) |
Fair Value | ||
Fair Value | 304,888 | 369,107 |
U.S. government and municipal obligations | ||
Amortized Cost | ||
Maturing in one year or less | 132,422 | 80,674 |
Maturing after one year through three years | 3,912 | 51,319 |
Amortized Cost | 136,334 | 131,993 |
Gross Unrealized Gains | ||
Maturing in one year or less | 0 | |
Maturing after one year through three years | 0 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | ||
Maturing in one year or less | (1,042) | (133) |
Maturing after one year through three years | (71) | (184) |
Gross Unrealized Losses | (1,113) | (317) |
Fair Value | ||
Maturing in one year or less | 131,380 | 80,541 |
Maturing after one year through three years | 3,841 | 51,135 |
Fair Value | 135,221 | 131,676 |
Corporate debt securities | ||
Amortized Cost | ||
Maturing in one year or less | 168,698 | 170,034 |
Maturing after one year through three years | 2,564 | 67,782 |
Amortized Cost | 171,262 | 237,816 |
Gross Unrealized Gains | ||
Maturing in one year or less | 0 | |
Maturing after one year through three years | 0 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | ||
Maturing in one year or less | (1,548) | (28) |
Maturing after one year through three years | (47) | (357) |
Gross Unrealized Losses | (1,595) | (385) |
Fair Value | ||
Maturing in one year or less | 167,150 | 170,006 |
Maturing after one year through three years | 2,517 | 67,425 |
Fair Value | $ 169,667 | $ 237,431 |
Marketable Securities - Additio
Marketable Securities - Additional Information (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Marketable Securities | ||
Number of investment-grade securities in unrealized loss position over 12 months | $ 0 | $ 0 |
Accrued interest | $ 700 | $ 1,300 |
Intangible Assets (Details)
Intangible Assets (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2021 | Sep. 30, 2022 | Dec. 31, 2021 | |
Intangible Assets | ||||
Indefinite-lived intangible assets | $ 27,200 | $ 27,200 | ||
Intangible asset impairment | $ 3,500 | $ 3,500 |
Other Long-Term Liabilities (De
Other Long-Term Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Other Long-Term Liabilities | ||
Net deferred tax liabilities related to IPR&D (Note 11) | $ 1,613 | $ 1,613 |
Deferred Income From Sale of Tax Benefits | 4,650 | |
Contingent milestones (Note 3 and Note 13) | 6,862 | |
Deferred revenue (Note 10) | 222 | 433 |
Total | 6,485 | 8,908 |
Less current portion | (1,152) | (1,554) |
Long-term portion | $ 5,333 | $ 7,354 |
Other Long-Term Liabilities- Ne
Other Long-Term Liabilities- New Jersey tax benefits (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Interest and Other Income | $ 912 | $ 145 | $ 1,511 | $ 313 | |
New Jersey tax benefits | |||||
Amount of tax benefit | $ 5,000 | ||||
Proceeds from sale of tax credits | $ 4,700 | ||||
Base of operations requirement (in years) | 5 years |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Common Stock | ||||||||
Balance, beginning | $ 365,093 | $ 398,101 | $ 419,476 | $ 182,282 | $ 194,166 | $ 209,357 | $ 419,476 | $ 209,357 |
Balance (in shares) | 46,730,198 | 46,730,198 | ||||||
Shares issued under stock option and employee stock purchase plans | 2,306 | 71 | $ 304 | 2,004 | 74 | |||
Shares issued under stock option and employee stock purchase plans | (25) | |||||||
Shares issued in underwritten offering, net | 269,893 | |||||||
Stock-based compensation | 4,496 | 3,454 | 3,153 | 3,029 | 1,509 | 1,275 | ||
Unrealized gain (loss) on marketable securities | 305 | (529) | (1,782) | (44) | 5 | (2) | $ (2,006) | (41) |
Net loss | (26,784) | (36,004) | (23,050) | (20,452) | (13,373) | (16,538) | (85,838) | (50,363) |
Balance, ending | $ 345,416 | 365,093 | 398,101 | 436,712 | 182,282 | 194,166 | $ 345,416 | 436,712 |
Balance (in shares) | 47,096,063 | 47,096,063 | ||||||
Aggregate gross offering price available | $ 50,000 | $ 50,000 | ||||||
Common Stock | ||||||||
Common Stock | ||||||||
Balance, beginning | $ 47 | $ 47 | $ 47 | $ 40 | $ 40 | $ 40 | $ 47 | $ 40 |
Balance (in shares) | 46,764,703 | 46,754,348 | 46,730,198 | 39,616,696 | 39,614,638 | 39,603,771 | 46,730,198 | 39,603,771 |
Shares issued under stock option and employee stock purchase plans (in shares) | 331,360 | 10,355 | 24,150 | 201,406 | 2,058 | 10,867 | ||
Shares issued in underwritten offering, net | $ 7 | |||||||
Shares issued in underwritten offering, net (in shares) | 6,845,238 | |||||||
Balance, ending | $ 47 | $ 47 | $ 47 | $ 47 | $ 40 | $ 40 | $ 47 | $ 47 |
Balance (in shares) | 47,096,063 | 46,764,703 | 46,754,348 | 46,663,340 | 39,616,696 | 39,614,638 | 47,096,063 | 46,663,340 |
Additional Paid-In Capital | ||||||||
Common Stock | ||||||||
Balance, beginning | $ 1,568,124 | $ 1,564,599 | $ 1,561,142 | $ 1,282,657 | $ 1,281,173 | $ 1,279,824 | $ 1,561,142 | $ 1,279,824 |
Shares issued under stock option and employee stock purchase plans | 2,306 | 71 | 304 | 2,004 | 74 | |||
Shares issued under stock option and employee stock purchase plans | (25) | |||||||
Shares issued in underwritten offering, net | 269,886 | |||||||
Stock-based compensation | 4,496 | 3,454 | 3,153 | 3,029 | 1,509 | 1,275 | ||
Balance, ending | 1,574,926 | 1,568,124 | 1,564,599 | 1,557,576 | 1,282,657 | 1,281,173 | 1,574,926 | 1,557,576 |
Accumulated Other Comprehensive Income. | ||||||||
Common Stock | ||||||||
Balance, beginning | (417) | 112 | 1,894 | 2,592 | 2,587 | 2,589 | 1,894 | 2,589 |
Unrealized gain (loss) on marketable securities | 305 | (529) | (1,782) | (44) | 5 | (2) | ||
Balance, ending | (112) | (417) | 112 | 2,548 | 2,592 | 2,587 | (112) | 2,548 |
Accumulated Deficit | ||||||||
Common Stock | ||||||||
Balance, beginning | (1,202,661) | (1,166,657) | (1,143,607) | (1,103,007) | (1,089,634) | (1,073,096) | (1,143,607) | (1,073,096) |
Net loss | (26,784) | (36,004) | (23,050) | (20,452) | (13,373) | (16,538) | ||
Balance, ending | $ (1,229,445) | $ (1,202,661) | $ (1,166,657) | $ (1,123,459) | $ (1,103,007) | $ (1,089,634) | $ (1,229,445) | $ (1,123,459) |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Option Activity (Details) - Stock Options - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Shares | ||
Options outstanding at beginning of the period (in shares) | 4,077,667 | |
Granted (in shares) | 1,584,900 | |
Exercised (in shares) | (353,622) | |
Canceled (in shares) | (118,974) | |
Options outstanding at the end of the period (in shares) | 5,189,971 | 4,077,667 |
Options vested and expected to vest at the end of the period (in shares) | 5,031,072 | |
Options exercisable at the end of the period (in shares) | 1,985,506 | |
Shares available for grant under the 2021 Plan | 1,838,291 | |
Weighted Average Exercise Price Per Share | ||
Options outstanding at beginning of the period (in dollars per share) | $ 30.02 | |
Granted (in dollars per share) | 22.89 | |
Exercised (in dollars per share) | 6.71 | |
Canceled (in dollars per share) | 50.12 | |
Options outstanding at the end of the period (in dollars per share) | 28.97 | $ 30.02 |
Options vested and expected to Vest at the end of the period (in dollars per share) | 29.21 | |
Options exercisable at the end of the period (in dollars per share) | $ 41.56 | |
Weighted Average Remaining Contractual Term (In Years) | ||
Options outstanding at the end of the period | 8 years 25 days | 8 years |
Options vested and expected to vest at the end of the period | 8 years 18 days | |
Options exercisable at the end of the period | 6 years 8 months 26 days |
Stock-Based Compensation - Empl
Stock-Based Compensation - Employee Stock Option and Incentive Plan Activity Additional Information (Details) $ / shares in Units, $ in Millions | 3 Months Ended | 9 Months Ended |
Sep. 30, 2022 USD ($) $ / shares | Sep. 30, 2022 USD ($) $ / shares | |
Additional information | ||
Weighted average grant-date fair value (in dollars per share) | $ / shares | $ 25.38 | $ 17.36 |
Intrinsic value of options vested and expected to vest | $ 45.6 | $ 45.6 |
Intrinsic value of options exercisable | 23.6 | 23.6 |
Compensation cost not yet recognized | $ 46.7 | $ 46.7 |
Weighted average period compensation cost is expected to be recognized (in years) | 0 years |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Stock-based compensation expense | ||||
Total stock-based compensation expense | $ 4,496 | $ 3,029 | $ 11,103 | $ 5,813 |
Research and development | ||||
Stock-based compensation expense | ||||
Total stock-based compensation expense | 2,342 | 1,504 | 5,754 | 2,927 |
General and administrative | ||||
Stock-based compensation expense | ||||
Total stock-based compensation expense | $ 2,154 | $ 1,525 | $ 5,349 | $ 2,886 |
Stock-Based Compensation - Valu
Stock-Based Compensation - Valuation (Details) - Stock Options | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Black-Scholes option with following assumptions: | ||||
Expected stock price volatility (as a percent) | 91% | 98% | ||
Expected stock price volatility, minimum (as a percent) | 98% | 90% | 97% | |
Expected stock price volatility, maximum (as a percent) | 97% | 98% | ||
Expected option term | 6 years | 6 years | 6 years | 6 years |
Risk-free interest rate, minimum (as a percent) | 2.90% | 1.10% | 1.70% | 0.80% |
Risk-free interest rate, maximum (as a percent) | 3.50% | 1.20% | 3.60% | 1.30% |
Expected dividend yield (as a percent) | 0% | 0% | 0% | 0% |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive Income (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Accumulated Other Comprehensive Income | |
Balance, beginning | $ 419,476 |
Balance, ending | 345,416 |
Amounts reclassified from AOCI | 0 |
Unrealized Loss on Marketable Securities | |
Accumulated Other Comprehensive Income | |
Balance, beginning | (702) |
Other comprehensive loss | (2,006) |
Balance, ending | (2,708) |
Foreign Currency Items | |
Accumulated Other Comprehensive Income | |
Balance, beginning | 2,596 |
Balance, ending | 2,596 |
Accumulated Other Comprehensive Income. | |
Accumulated Other Comprehensive Income | |
Balance, beginning | 1,894 |
Other comprehensive loss | (2,006) |
Balance, ending | $ (112) |
Revenue (Details)
Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Revenue | |||||
Revenues | $ 407 | $ 153 | $ 744 | $ 4,317 | |
Contract assets | 0 | 0 | $ 0 | ||
Contract liability | 222 | 222 | $ 433 | ||
Revenue, contract liabilities | 200 | 400 | |||
Contracts and grants | |||||
Revenue | |||||
Revenues | 407 | 153 | 714 | 4,288 | |
Rockefeller University And Gilead Sciences | Contracts and grants | |||||
Revenue | |||||
Revenues | $ 0 | $ 100 | $ 200 | $ 4,000 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Income Taxes | ||
Net deferred tax liability | $ 1,613 | $ 1,613 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Anti-dilutive securities | ||
Potentially dilutive common shares not been included in net loss per common share calculations because the effect would have been anti-dilutive | 5,189,971 | 4,129,626 |
Stock Options | ||
Anti-dilutive securities | ||
Potentially dilutive common shares not been included in net loss per common share calculations because the effect would have been anti-dilutive | 5,189,971 | 4,129,626 |
Kolltan Acquisition (Details)
Kolltan Acquisition (Details) - USD ($) $ in Millions | Jun. 20, 2022 | Nov. 29, 2016 |
Kolltan Acquisition | ||
Execution of the settlement agreement | $ 15 | |
European medicines agency | ||
Kolltan Acquisition | ||
Business contingent amount payable | 52.5 | |
Clinical Trial | ||
Kolltan Acquisition | ||
Execution of the settlement agreement | 15 | |
Contractual credit merger agreement | 2.5 | |
Specified development, regulatory approvals or sales-based milestones | ||
Kolltan Acquisition | ||
Business contingent amount payable | $ 172.5 | |
Kolltan | ||
Kolltan Acquisition | ||
Shares issued as part of consideration (in shares) | 1,217,200 | |
Kolltan | Specified development, regulatory approvals or sales-based milestones | ||
Kolltan Acquisition | ||
Potential milestone payments | $ 172.5 |