Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Oct. 31, 2021 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2021 | |
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 $.001 | |
Trading Symbol | CLDX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 46,663,872 | |
Entity Central Index Key | 0000744218 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false | |
Document Quarterly Report | true |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 72,184 | $ 43,836 |
Marketable securities | 350,905 | 150,586 |
Accounts and other receivables | 197 | 1,802 |
Prepaid and other current assets | 3,269 | 1,619 |
Total current assets | 426,555 | 197,843 |
Property and equipment, net | 3,342 | 3,815 |
Operating lease right-of-use assets, net | 3,016 | 3,449 |
Intangible assets, net | 27,190 | 30,690 |
Other assets | 98 | 41 |
Total assets | 460,201 | 235,838 |
Current liabilities: | ||
Accounts payable | 836 | 1,048 |
Accrued expenses | 10,253 | 8,459 |
Current portion of operating lease liabilities | 1,366 | 1,327 |
Current portion of other long-term liabilities | 1,721 | 3,372 |
Total current liabilities | 14,176 | 14,206 |
Long-term portion of operating lease liabilities | 1,713 | 2,154 |
Other long-term liabilities | 7,600 | 10,121 |
Total liabilities | 23,489 | 26,481 |
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, 2021 and December 31, 2020 | ||
Common stock, $.001 par value; 297,000,000 shares authorized; 46,663,340 and 39,603,771 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively | 47 | 40 |
Additional paid-in capital | 1,557,576 | 1,279,824 |
Accumulated other comprehensive income | 2,548 | 2,589 |
Accumulated deficit | (1,123,459) | (1,073,096) |
Total stockholders' equity | 436,712 | 209,357 |
Total liabilities and stockholders' equity | $ 460,201 | $ 235,838 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
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 | 46,663,340 | 39,603,771 |
Common Stock, Shares Outstanding | 46,663,340 | 39,603,771 |
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, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenues: | ||||
Total revenues | $ 153 | $ 668 | $ 4,317 | $ 3,633 |
Operating expenses: | ||||
Research and development | 13,557 | 10,708 | 38,633 | 32,109 |
General and administrative | 5,821 | 3,640 | 14,247 | 10,833 |
Intangible asset impairment | 3,500 | 3,500 | 3,500 | |
(Gain) loss on fair value remeasurement of contingent consideration | (1,901) | 662 | (1,160) | (4,236) |
Total operating expenses | 20,977 | 15,010 | 55,220 | 42,206 |
Operating loss | (20,824) | (14,342) | (50,903) | (38,573) |
Investment and other income, net | 145 | 118 | 313 | 465 |
Net loss before income tax benefit | (20,679) | (14,224) | (50,590) | (38,108) |
Income tax benefit | 227 | 227 | 228 | |
Net loss | $ (20,452) | $ (14,224) | $ (50,363) | $ (37,880) |
Basic and diluted net loss per common share | $ (0.45) | $ (0.36) | $ (1.21) | $ (1.44) |
Shares used in calculating basic and diluted net loss per share | 45,453 | 39,278 | 41,582 | 26,303 |
Comprehensive loss: | ||||
Net loss | $ (20,452) | $ (14,224) | $ (50,363) | $ (37,880) |
Other comprehensive income (loss): | ||||
Unrealized (loss) gain on marketable securities | (44) | 14 | (41) | (11) |
Comprehensive loss | (20,496) | (14,210) | (50,404) | (37,891) |
Product development and licensing agreements | ||||
Revenues: | ||||
Total revenues | 12 | 29 | 2,297 | |
Contracts and grants | ||||
Revenues: | ||||
Total revenues | $ 153 | $ 656 | $ 4,288 | $ 1,336 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (50,363) | $ (37,880) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 2,291 | 3,174 |
Amortization and premium of marketable securities, net | (3,407) | (422) |
Gain on sale or disposal of assets | (23) | (29) |
Intangible Asset Impairment | 3,500 | 3,500 |
Gain on fair value remeasurement of contingent consideration | (1,160) | (4,236) |
Non-Cash Income Tax Benefit | (227) | (228) |
Stock-based compensation expense | 5,813 | 2,658 |
Changes in operating assets and liabilities: | ||
Accounts and other receivables | 1,549 | 177 |
Prepaid and other current assets | (2,261) | (1,280) |
Accounts payable and accrued expenses | 1,757 | 864 |
Other liabilities | (3,855) | (1,491) |
Net cash used in operating activities | (46,386) | (35,193) |
Cash flows from investing activities: | ||
Sales and maturities of marketable securities | 129,000 | 55,600 |
Purchases of marketable securities | (325,342) | (183,394) |
Acquisition of property and equipment | (895) | (1,305) |
Proceeds from sale or disposal of assets | 25 | 29 |
Net cash used in investing activities | (197,212) | (129,070) |
Cash flows from financing activities: | ||
Net proceeds from stock issuances | 269,893 | 170,964 |
Proceeds from issuance of stock from employee benefit plans | 2,053 | 218 |
Issuance of Term Loan | 2,962 | |
Payment of Term Loan | (2,962) | |
Net cash provided by financing activities | 271,946 | 171,182 |
Net increase in cash and cash equivalents | 28,348 | 6,919 |
Cash and cash equivalents at beginning of period | 43,836 | 11,232 |
Cash and cash equivalents at end of period | 72,184 | 18,151 |
Non-cash investing activities | ||
Accrued construction in progress | $ 46 | $ 63 |
Basis of Presentation
Basis of Presentation | 9 Months Ended |
Sep. 30, 2021 | |
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, 2020, which are included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 29, 2021. 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, 2021. At September 30, 2021, the Company had cash, cash equivalents and marketable securities of $423.1 million. The Company has had recurring losses and incurred a loss of $50.4 million for the nine months ended September 30, 2021. Net cash used in operations for the nine months ended September 30, 2021 was $46.4 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 contingent milestones from the acquisition of Kolltan Pharmaceuticals, Inc. (“Kolltan”), in the event that the Company achieves the drug candidate 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. The COVID-19 pandemic continues to have a major impact in the US and around the world. The availability of vaccines holds promise for the future, though new variants of the virus and potential waning immunity from vaccines may result in continued impact from this pandemic in the future, including supply chain and work force issues which could adversely impact our operations. To date, the Company has 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, 2021. |
Significant Accounting Policies
Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
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, 2021 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, 2020. 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. We are currently evaluating the potential impact that this standard may have on the Company’s consolidated financial statements and related disclosures. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2021 | |
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, 2021 Level 1 Level 2 Level 3 (In thousands) Assets: Money market funds and cash equivalents $ 66,929 — $ 66,929 — Marketable securities 350,905 — 350,905 — $ 417,834 — $ 417,834 — Liabilities: Kolltan acquisition contingent consideration $ 7,107 — — $ 7,107 $ 7,107 — — $ 7,107 As of December 31, 2020 Level 1 Level 2 Level 3 (In thousands) Assets: Money market funds and cash equivalents $ 35,066 — $ 35,066 — Marketable securities 150,586 — 150,586 — $ 185,652 — $ 185,652 — Liabilities: Kolltan acquisition contingent consideration $ 8,267 — — $ 8,267 $ 8,267 — — $ 8,267 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, 2021 (in thousands): Other Liabilities: Contingent Consideration Balance at December 31, 2020 $ 8,267 Fair value adjustments included in operating expenses (1,160) Balance at September 30, 2021 $ 7,107 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 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. As of September 30, 2021, the weighted average probability of success used in calculating the fair value of contingent consideration was 48.0% (with a range of 5.1% to 68.6%), the weighted average discount rate was 5.6% ( with a range of 5.1% to 6.7%) and the weighted average amount of time until the conditions of the milestone payments are met was 4 years. Weighted averages are calculated based on the relative fair value of our contingent consideration obligations. During the three and nine months ended September 30, 2021, the Company recorded a $ 1.9 1.2 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, 2021 | |
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, 2021 Marketable securities U.S. government and municipal obligations Maturing in one year or less $ 24,291 $ 5 $ — $ 24,296 Maturing after one year through three years 75,314 2 (17) 75,299 Total U.S. government and municipal obligations $ 99,605 $ 7 $ (17) $ 99,595 Corporate debt securities Maturing in one year or less $ 183,504 $ — $ (10) $ 183,494 Maturing after one year through three years 67,844 8 (36) 67,816 Total corporate debt securities $ 251,348 $ 8 $ (46) $ 251,310 Total marketable securities $ 350,953 $ 15 $ (63) $ 350,905 Gross Unrealized Amortized Fair Cost Gains Losses Value (In thousands) December 31, 2020 Marketable securities U.S. government and municipal obligations Maturing in one year or less $ 40,328 $ 3 $ (2) $ 40,329 Maturing after one year through three years — — — — Total U.S. government and municipal obligations $ 40,328 $ 3 $ (2) $ 40,329 Corporate debt securities Maturing in one year or less $ 110,265 $ 2 $ (10) $ 110,257 Maturing after one year through three years — — — — Total corporate debt securities $ 110,265 $ 2 $ (10) $ 110,257 Total marketable securities $ 150,593 $ 5 $ (12) $ 150,586 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, 2021 and December 31, 2020. 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 $0.8 million and $0.2 million in accrued interest at September 30, 2021 and December 31, 2020, respectively. |
Intangible Assets
Intangible Assets | 9 Months Ended |
Sep. 30, 2021 | |
Intangible Assets | |
Intangible Assets | (5) Intangible Assets At September 30, 2021 and December 31, 2020, the carrying value of the Company’s indefinite-lived intangible assets was $27.2 million and $30.7 million, respectively. Indefinite-lived intangible assets consist of acquired IPR&D related to the development of the anti-KIT program (including CDX-0159) and the TAM program, a broad antibody discovery effort to generate antibodies that modulate the TAM family of RTKs, comprised of Tyro3, AxL and MerTK. CDX-0159 is in Phase 1 development and the TAM program is in preclinical development. As of September 30, 2021, none of the Company’s IPR&D assets had reached technological feasibility nor did any 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 fourth quarter of 2020, the Company decided that although it had developed promising data for the AxL target within the TAM program, it would focus its efforts on out-licensing opportunities for its TAM program. As a result, the Company evaluated the TAM program IPR&D asset for potential impairment due to the change in projected development and regulatory timelines related to the program and recorded a non-cash partial impairment charge of $14.5 million for the fourth quarter of 2020. During the third quarter of 2021, the Company evaluated its out-licensing progress since December 31, 2020 and the status and expectation for the TAM program. Despite the Company’s efforts to out-license, there was a lack of interest in the program from third parties. Therefore, the Company evaluated the TAM program IPR&D asset for potential impairment using a discounted cash flow fair value model and concluded that the TAM IPR&D asset was fully impaired. A non-cash impairment charge of $3.5 million was recorded for the three months ended September 30, 2021. As a result of the discontinuation of the CDX-3379 program in the second quarter of 2020, the Company concluded that the CDX-3379 IPR&D asset was fully impaired and a non-cash impairment charge of $3.5 million was recorded in the second quarter of 2020. 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, 2021 | |
Other Long-Term Liabilities | |
Other Long-Term Liabilities | (6) Other Long-Term Liabilities Other long-term liabilities include the following: September 30, December 31, 2021 2020 (In thousands) Net deferred tax liabilities related to IPR&D (Note 11) $ 1,613 $ 1,840 Contingent milestones (Note 3) 7,107 8,267 Deferred revenue (Note 10) 601 3,386 Total 9,321 13,493 Less current portion (1,721) (3,372) Long-term portion $ 7,600 $ 10,121 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2021 | |
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, 2021, the Company had $50.0 million remaining in aggregate gross offering price available under the Company’s November 2020 prospectus. 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. The changes in Stockholders’ Equity during the three and nine months ended September 30, 2021 and 2020 are summarized below: 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 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, 2019 16,972,077 $ 17 $ 1,104,706 $ 2,619 $ (1,013,316) $ 94,026 Shares issued under stock option and employee stock purchase plans 12,573 — 24 — — 24 Shares issued in connection with at the market agreement 746,152 1 1,613 — — 1,614 Stock-based compensation — — 686 — — 686 Unrealized loss on marketable securities — — — (22) — (22) Net loss — — — — (12,625) (12,625) Consolidated balance at March 31, 2020 17,730,802 $ 18 $ 1,107,029 $ 2,597 $ (1,025,941) $ 83,703 Shares issued in connection with at the market agreement 5,978,452 6 23,686 — — 23,692 Shares issued in underwritten offering, net 15,384,614 15 141,346 — — 141,361 Stock-based compensation — — 722 — — 722 Unrealized loss on marketable securities — — — (3) — (3) Net loss — — — — (11,031) (11,031) Consolidated balance at June 30, 2020 39,093,868 $ 39 $ 1,272,783 $ 2,594 $ (1,036,972) $ 238,444 Shares issued under stock option and employee stock purchase plans 68,204 — 194 — — 194 Shares issued in connection with at the market agreement 400,400 1 4,296 — — 4,297 Stock-based compensation — — 1,250 — — 1,250 Unrealized gain on marketable securities — — — 14 — 14 Net loss — — — — (14,224) (14,224) Consolidated balance at September 30, 2020 39,562,472 $ 40 $ 1,278,523 $ 2,608 $ (1,051,196) $ 229,975 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2021 | |
Stock-Based Compensation | |
Stock-Based Compensation | (8) Stock-Based Compensation A summary of stock option activity for the nine months ended September 30, 2021 is as follows: Weighted Weighted Average Average Exercise Remaining Price Contractual Shares Per Share Term (In Years) Options outstanding at December 31, 2020 3,042,229 $ 28.93 8.2 Granted 1,350,210 $ 28.16 Exercised (192,464) $ 9.53 Canceled (70,349) $ 35.62 Options outstanding at September 30, 2021 4,129,626 $ 29.46 8.2 Options vested and expected to vest at September 30, 2021 3,982,965 $ 29.81 8.2 Options exercisable at September 30, 2021 1,387,147 $ 51.75 6.7 Shares available for grant under the 2021 Plan 3,319,116 The weighted average grant-date fair value of stock options granted during the three and nine months ended September 30, 2021 was $41.34 and $21.86, respectively. The aggregate intrinsic value of stock options vested and expected to vest at September 30, 2021 was $140.6 million. The aggregate intrinsic value of stock options exercisable at September 30, 2021 was $47.3 million. As of September 30, 2021, total compensation cost related to non-vested employee, consultant and non-employee director stock options not yet recognized was approximately $33.7 million, net of estimated forfeitures, which is expected to be recognized as expense over a weighted average period of 2.9 years. Stock-based compensation expense for the three and nine months ended September 30, 2021 and 2020 was recorded as follows: Three months ended September 30, Nine months ended September 30, 2021 2020 2021 2020 (In thousands) (In thousands) Research and development $ 1,504 $ 642 $ 2,927 $ 1,294 General and administrative 1,525 608 2,886 1,364 Total stock-based compensation expense $ 3,029 $ 1,250 $ 5,813 $ 2,658 The fair values of employee, consultant and non-employee director stock options granted during the three and nine months ended September 30, 2021 and 2020 were valued using the Black-Scholes option pricing model with the following assumptions: Three months ended September 30, Nine months ended September 30, 2021 2020 2021 2020 Expected stock price volatility 98% 98% 97 – 98% 91 – 98% Expected option term 6.0 Years 6.0 Years 6.0 Years 6.0 Years Risk-free interest rate 1.1 – 1.2% 0.5% 0.8 – 1.3% 0.5 – 0.6% Expected dividend yield None None None None |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Income | 9 Months Ended |
Sep. 30, 2021 | |
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, 2021 are summarized below: Unrealized Loss on Marketable Foreign Securities Currency Items Total (In thousands) Balance at December 31, 2020 $ (7) $ 2,596 $ 2,589 Other comprehensive loss (41) — (41) Balance at September 30, 2021 $ (48) $ 2,596 $ 2,548 No amounts were reclassified out of accumulated other comprehensive income during the nine months ended September 30, 2021. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2021 | |
Revenue | |
Revenue | (10) Revenue Product Development and Licensing Revenue The Company’s agreement with Rockefeller University, as amended (the “Rockefeller Agreement”), provides for the Company to perform manufacturing and development services for Rockefeller University for their portfolio of antibodies against HIV. This portfolio was licensed to Gilead Sciences in January 2020 from Rockefeller University (“Rockefeller Transaction”). Pursuant to the Rockefeller Agreement, the Company received an upfront payment of $1.8 million as a result of the Rockefeller Transaction which was recorded to revenue during the first quarter of 2020. The Company is eligible to receive additional payments from Rockefeller University if this portfolio progresses through clinical and commercial development. 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 $0.1 million and $4.0 million in revenue under these agreements during the three and nine months ended September 30, 2021, respectively, and $0.3 million and $0.9 million during the three and nine months ended September 30, 2020, 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 and $0.3 million in grant revenue under the award during the three and nine months ended September 30, 2021, respectively, and $0.3 million during the three and nine months ended September 30, 2020. Contract Assets and Liabilities At September 30, 2021 and December 31, 2020, the Company’s right to consideration under all contracts was considered unconditional, and as such, there were no recorded contract assets. At September 30, 2021, the Company had $0.6 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, 2020, the Company had $3.4 million in contract liabilities recorded. Revenue recognized from contract liabilities as of December 31, 2020 during the three and nine months ended September 30, 2021 was $0.0 million and $3.4 million, respectively. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2021 | |
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, 2021 and December 31, 2020. The net deferred tax liability of $1.6 million and $1.8 million at September 30, 2021 and December 31, 2020, respectively, relates to the temporary differences associated with the IPR&D intangible assets acquired in previous business combinations and is not deductible for tax purposes. A $0.2 million non-cash income tax benefit was recorded during the third quarter of 2021 and a $0.9 million non-cash income tax benefit was recorded during the fourth quarter of 2020 related to impairments of the TAM program IPR&D asset. A $0.2 million non-cash income tax benefit was recorded during the second quarter of 2020 related to the impairment of the CDX-3379 IPR&D asset. 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, 2021 | |
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, 2021 2020 Stock Options 4,129,626 3,074,832 Restricted Stock — — 4,129,626 3,074,832 |
Kolltan Acquisition
Kolltan Acquisition | 9 Months Ended |
Sep. 30, 2021 | |
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. The payment of Kolltan Milestones , if any, may be made, at Celldex’s sole election, in cash, in shares of Celldex’s common stock or a combination of both, subject to provisions of the Agreement and Plan of Merger, dated November 1, 2016 (the “Merger Agreement”). Certain Kolltan Milestones related to the METRIC clinical study, TAM partnership closing within two years of the acquisition, CDX-3379 and CDX-0158 have been abandoned and, because of this, as of September 30, 2021, the Company believes that the adjusted amount we may be required to pay for future consideration is up to $107.5 million contingent upon the achievement of the Kolltan Milestones. In October 2019, the Company received a letter from Shareholder Representative Services LLC (“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. The Company disagrees with their objection and believes their objection to be without merit. 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. Specifically, Celldex sought the entry of an order declaring that: (i) Celldex’s determination to discontinue the development of CDX-0158 (formerly known as KTN0158) was proper and valid under the Merger Agreement; (ii) the Milestone Abandonment Notice dated December 5, 2018 from Celldex was valid and effective under the Merger Agreement and that the “Successful Completion of Phase I Clinical Trial for KTN0158” Milestone has not been achieved and has properly been abandoned; and (iii) under the Merger Agreement, the CDX-0159 program is not a program that results in milestone payments under the Merger Agreement. In SRS’ responsive Answer and Verified Counterclaim, SRS made claims of breach of contract with respect to the Merger Agreement, breach of implied covenant of good faith and fair dealing, declaratory relief, and unjust enrichment regarding abandonment of the CDX-0158 milestones, based in part on SRS’ assertion that the CDX-0159 program is in essence an extension of the CDX-0158 (formerly KTN0158) program. The parties entered into non-binding mediation in May 2021 following SRS’s approach to Celldex about its interest in settlement or mediation discussions, but those discussions did not result in a resolution of the dispute. The case remains ongoing and we are currently unable to predict or estimate the outcome of this matter. The case is currently scheduled for trial in June 2022. Following the Company’s discontinuation of the CDX-3379 program, the Company sent a milestone abandonment notice to SRS with respect to Kolltan Milestones related to the CDX-3379 program. In October 2020, the Company received notice that SRS has objected to that notice, seeking further information from the Company, which was provided pursuant to the terms of the Merger Agreement. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
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. We are currently evaluating the potential impact that this standard may have on the Company’s consolidated financial statements and related disclosures. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Measurements | |
Schedule of financial assets and liabilities subject to fair value measurements | As of September 30, 2021 Level 1 Level 2 Level 3 (In thousands) Assets: Money market funds and cash equivalents $ 66,929 — $ 66,929 — Marketable securities 350,905 — 350,905 — $ 417,834 — $ 417,834 — Liabilities: Kolltan acquisition contingent consideration $ 7,107 — — $ 7,107 $ 7,107 — — $ 7,107 As of December 31, 2020 Level 1 Level 2 Level 3 (In thousands) Assets: Money market funds and cash equivalents $ 35,066 — $ 35,066 — Marketable securities 150,586 — 150,586 — $ 185,652 — $ 185,652 — Liabilities: Kolltan acquisition contingent consideration $ 8,267 — — $ 8,267 $ 8,267 — — $ 8,267 |
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, 2021 (in thousands): Other Liabilities: Contingent Consideration Balance at December 31, 2020 $ 8,267 Fair value adjustments included in operating expenses (1,160) Balance at September 30, 2021 $ 7,107 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Marketable Securities | |
Schedule of marketable debt securities, classified as available-for-sale | Gross Unrealized Amortized Fair Cost Gains Losses Value (In thousands) September 30, 2021 Marketable securities U.S. government and municipal obligations Maturing in one year or less $ 24,291 $ 5 $ — $ 24,296 Maturing after one year through three years 75,314 2 (17) 75,299 Total U.S. government and municipal obligations $ 99,605 $ 7 $ (17) $ 99,595 Corporate debt securities Maturing in one year or less $ 183,504 $ — $ (10) $ 183,494 Maturing after one year through three years 67,844 8 (36) 67,816 Total corporate debt securities $ 251,348 $ 8 $ (46) $ 251,310 Total marketable securities $ 350,953 $ 15 $ (63) $ 350,905 Gross Unrealized Amortized Fair Cost Gains Losses Value (In thousands) December 31, 2020 Marketable securities U.S. government and municipal obligations Maturing in one year or less $ 40,328 $ 3 $ (2) $ 40,329 Maturing after one year through three years — — — — Total U.S. government and municipal obligations $ 40,328 $ 3 $ (2) $ 40,329 Corporate debt securities Maturing in one year or less $ 110,265 $ 2 $ (10) $ 110,257 Maturing after one year through three years — — — — Total corporate debt securities $ 110,265 $ 2 $ (10) $ 110,257 Total marketable securities $ 150,593 $ 5 $ (12) $ 150,586 |
Other Long-Term Liabilities (Ta
Other Long-Term Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Other Long-Term Liabilities | |
Schedule of other long-term liabilities | September 30, December 31, 2021 2020 (In thousands) Net deferred tax liabilities related to IPR&D (Note 11) $ 1,613 $ 1,840 Contingent milestones (Note 3) 7,107 8,267 Deferred revenue (Note 10) 601 3,386 Total 9,321 13,493 Less current portion (1,721) (3,372) Long-term portion $ 7,600 $ 10,121 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
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 (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 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, 2019 16,972,077 $ 17 $ 1,104,706 $ 2,619 $ (1,013,316) $ 94,026 Shares issued under stock option and employee stock purchase plans 12,573 — 24 — — 24 Shares issued in connection with at the market agreement 746,152 1 1,613 — — 1,614 Stock-based compensation — — 686 — — 686 Unrealized loss on marketable securities — — — (22) — (22) Net loss — — — — (12,625) (12,625) Consolidated balance at March 31, 2020 17,730,802 $ 18 $ 1,107,029 $ 2,597 $ (1,025,941) $ 83,703 Shares issued in connection with at the market agreement 5,978,452 6 23,686 — — 23,692 Shares issued in underwritten offering, net 15,384,614 15 141,346 — — 141,361 Stock-based compensation — — 722 — — 722 Unrealized loss on marketable securities — — — (3) — (3) Net loss — — — — (11,031) (11,031) Consolidated balance at June 30, 2020 39,093,868 $ 39 $ 1,272,783 $ 2,594 $ (1,036,972) $ 238,444 Shares issued under stock option and employee stock purchase plans 68,204 — 194 — — 194 Shares issued in connection with at the market agreement 400,400 1 4,296 — — 4,297 Stock-based compensation — — 1,250 — — 1,250 Unrealized gain on marketable securities — — — 14 — 14 Net loss — — — — (14,224) (14,224) Consolidated balance at September 30, 2020 39,562,472 $ 40 $ 1,278,523 $ 2,608 $ (1,051,196) $ 229,975 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
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, 2020 3,042,229 $ 28.93 8.2 Granted 1,350,210 $ 28.16 Exercised (192,464) $ 9.53 Canceled (70,349) $ 35.62 Options outstanding at September 30, 2021 4,129,626 $ 29.46 8.2 Options vested and expected to vest at September 30, 2021 3,982,965 $ 29.81 8.2 Options exercisable at September 30, 2021 1,387,147 $ 51.75 6.7 Shares available for grant under the 2021 Plan 3,319,116 |
Schedule of stock-based compensation expense | Three months ended September 30, Nine months ended September 30, 2021 2020 2021 2020 (In thousands) (In thousands) Research and development $ 1,504 $ 642 $ 2,927 $ 1,294 General and administrative 1,525 608 2,886 1,364 Total stock-based compensation expense $ 3,029 $ 1,250 $ 5,813 $ 2,658 |
Schedule of assumptions used for the fair value of employee stock options granted | Three months ended September 30, Nine months ended September 30, 2021 2020 2021 2020 Expected stock price volatility 98% 98% 97 – 98% 91 – 98% Expected option term 6.0 Years 6.0 Years 6.0 Years 6.0 Years Risk-free interest rate 1.1 – 1.2% 0.5% 0.8 – 1.3% 0.5 – 0.6% Expected dividend yield None None None None |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Income (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
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, 2020 $ (7) $ 2,596 $ 2,589 Other comprehensive loss (41) — (41) Balance at September 30, 2021 $ (48) $ 2,596 $ 2,548 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
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, 2021 2020 Stock Options 4,129,626 3,074,832 Restricted Stock — — 4,129,626 3,074,832 |
Basis of Presentation (Details)
Basis of Presentation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||||||
Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Unusual Risk or Uncertainty [Line Items] | |||||||||
Cash, cash equivalents and marketable securities | $ 423,100 | $ 423,100 | |||||||
Net loss | (20,452) | $ (13,373) | $ (16,538) | $ (14,224) | $ (11,031) | $ (12,625) | (50,363) | $ (37,880) | |
Net cash used in operations | (46,386) | (35,193) | |||||||
Indefinite-lived intangible assets | 27,200 | 27,200 | $ 30,700 | ||||||
Intangible asset impairment | $ 3,500 | 3,500 | $ 3,500 | ||||||
COVID-19 | |||||||||
Unusual Risk or Uncertainty [Line Items] | |||||||||
Intangible asset impairment | $ 27,200 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Liabilities: | ||
Kolltan acquisition contingent consideration | $ 7,107 | $ 8,267 |
Fair value | Level 3 | ||
Liabilities: | ||
Kolltan acquisition contingent consideration | 7,107 | 8,267 |
Fair Value Measurements. | Level 2 | ||
Assets: | ||
Money market funds and cash equivalents | 66,929 | 35,066 |
Marketable securities | 350,905 | 150,586 |
Total financial assets at fair value | 417,834 | 185,652 |
Fair Value Measurements. | Level 3 | ||
Liabilities: | ||
Kolltan acquisition contingent consideration | 7,107 | 8,267 |
Total financial liabilities at fair value | 7,107 | 8,267 |
Fair Value Measurements. | Fair value | ||
Assets: | ||
Money market funds and cash equivalents | 66,929 | 35,066 |
Marketable securities | 350,905 | 150,586 |
Total financial assets at fair value | 417,834 | 185,652 |
Liabilities: | ||
Kolltan acquisition contingent consideration | 7,107 | 8,267 |
Total financial liabilities at fair value | $ 7,107 | $ 8,267 |
Fair Value Measurements - Conti
Fair Value Measurements - Contingent Consideration Liabilities (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Contingent consideration liabilities measured at fair value | |
Balance at beginning of period | $ 8,267 |
Balance at end of period | 7,107 |
Fair value | Level 3 | |
Contingent consideration liabilities measured at fair value | |
Balance at beginning of period | 8,267 |
Fair value adjustments included in operating expenses | (1,160) |
Balance at end of period | $ 7,107 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional information (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | |
Fair value measurements | ||||
Gain on Fair Value Remeasurement of Contingent Consideration | $ 1,901 | $ (662) | $ 1,160 | $ 4,236 |
Discount rate | Weighted average | ||||
Fair value measurements | ||||
Measurement input | 5.6 | 5.6 | ||
Discount rate | Minimum | ||||
Fair value measurements | ||||
Measurement input | 5.1 | 5.1 | ||
Discount rate | Maximum | ||||
Fair value measurements | ||||
Measurement input | 6.7 | 6.7 | ||
Time until the conditions of the milestone payments are met | ||||
Fair value measurements | ||||
Measurement input | 4 | 4 | ||
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 | |||
Fair value | Weighted average | ||||
Fair value measurements | ||||
Measurement input | 48 | 48 | ||
Fair value | Minimum | ||||
Fair value measurements | ||||
Measurement input | 5.1 | 5.1 | ||
Fair value | Maximum | ||||
Fair value measurements | ||||
Measurement input | 68.6 | 68.6 |
Marketable Securities (Details)
Marketable Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Amortized Cost | ||
Amortized Cost | $ 350,953 | $ 150,593 |
Gross Unrealized Gains | ||
Gross Unrealized Gains | 15 | 5 |
Gross Unrealized Losses | ||
Gross Unrealized Losses | (63) | (12) |
Fair Value | ||
Fair Value | 350,905 | 150,586 |
U.S. government and municipal obligations | ||
Amortized Cost | ||
Maturing in one year or less | 24,291 | 40,328 |
Maturing after one year through three years | 75,314 | |
Amortized Cost | 99,605 | 40,328 |
Gross Unrealized Gains | ||
Maturing in one year or less | 5 | 3 |
Maturing after one year through three years | 2 | |
Gross Unrealized Gains | 7 | 3 |
Gross Unrealized Losses | ||
Maturing in one year or less | (2) | |
Maturing after one year through three years | (17) | |
Gross Unrealized Losses | (17) | (2) |
Fair Value | ||
Maturing in one year or less | 24,296 | 40,329 |
Maturing after one year through three years | 75,299 | |
Fair Value | 99,595 | 40,329 |
Corporate debt securities | ||
Amortized Cost | ||
Maturing in one year or less | 183,504 | 110,265 |
Maturing after one year through three years | 67,844 | |
Amortized Cost | 251,348 | 110,265 |
Gross Unrealized Gains | ||
Maturing in one year or less | 2 | |
Maturing after one year through three years | 8 | |
Gross Unrealized Gains | 8 | 2 |
Gross Unrealized Losses | ||
Maturing in one year or less | (10) | (10) |
Maturing after one year through three years | (36) | |
Gross Unrealized Losses | (46) | (10) |
Fair Value | ||
Maturing in one year or less | 183,494 | 110,257 |
Maturing after one year through three years | 67,816 | |
Fair Value | $ 251,310 | $ 110,257 |
Marketable Securities - Additio
Marketable Securities - Additional Information (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Marketable Securities | ||
Number of investment-grade securities in unrealized loss position over 12 months | $ 0 | $ 0 |
Accrued interest | $ 800 | $ 200 |
Intangible Assets - Intangible
Intangible Assets - Intangible Assets, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Intangible assets | |||||
Indefinite-lived intangible assets | $ 27,200 | $ 30,700 | $ 27,200 | ||
Intangible Asset Impairment | 3,500 | $ 3,500 | $ 3,500 | ||
IPR&D | |||||
Intangible assets | |||||
Intangible Asset Impairment | $ 3,500 | $ 14,500 | $ 3,500 |
Other Long-Term Liabilities (De
Other Long-Term Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Other Long-Term Liabilities | ||
Net deferred tax liabilities related to IPR&D (Note 11) | $ 1,613 | $ 1,840 |
Contingent milestones (Note 3) | 7,107 | 8,267 |
Deferred revenue (Note 10) | 601 | 3,386 |
Total | 9,321 | 13,493 |
Less current portion | (1,721) | (3,372) |
Long-term portion | $ 7,600 | $ 10,121 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
Jul. 31, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Common Stock | |||||||||
Balance | $ 182,282 | $ 182,282 | $ 194,166 | $ 209,357 | $ 238,444 | $ 83,703 | $ 94,026 | $ 209,357 | $ 94,026 |
Balance (in shares) | 39,603,771 | 39,603,771 | |||||||
Shares issued under stock option and employee stock purchase plans | 2,004 | $ 74 | 194 | 24 | |||||
Shares issued under stock option and employee stock purchase plans | (25) | ||||||||
Shares issued in connection with at the market agreement | 4,297 | 23,692 | 1,614 | ||||||
Shares issued in underwritten offering, net | 269,893 | 141,361 | |||||||
Stock-based compensation | 3,029 | 1,509 | 1,275 | 1,250 | 722 | 686 | |||
Unrealized (loss) gain on marketable securities | (44) | 5 | (2) | 14 | (3) | (22) | $ (41) | (11) | |
Net loss | (20,452) | (13,373) | (16,538) | (14,224) | (11,031) | (12,625) | (50,363) | (37,880) | |
Balance | $ 436,712 | 182,282 | 194,166 | 229,975 | 238,444 | 83,703 | $ 436,712 | 229,975 | |
Balance (in shares) | 46,663,340 | 46,663,340 | |||||||
Aggregate gross offering price available | $ 50,000 | $ 50,000 | |||||||
Net proceeds from sale of common stock | 269,893 | 170,964 | |||||||
Underwritten Public Offering | |||||||||
Common Stock | |||||||||
Common stock issued (in shares) | 6,845,238 | ||||||||
Net proceeds from sale of common stock | $ 269,900 | ||||||||
Common Stock | |||||||||
Common Stock | |||||||||
Balance | $ 40 | $ 40 | $ 40 | $ 40 | $ 39 | $ 18 | $ 17 | $ 40 | $ 17 |
Balance (in shares) | 39,616,696 | 39,616,696 | 39,614,638 | 39,603,771 | 39,093,868 | 17,730,802 | 16,972,077 | 39,603,771 | 16,972,077 |
Shares issued under stock option and employee stock purchase plans (in shares) | 201,406 | 10,867 | 68,204 | 12,573 | |||||
Shares issued under stock option and employee stock purchase plans (in shares) | 2,058 | ||||||||
Shares issued in connection with at the market agreement | $ 1 | $ 6 | $ 1 | ||||||
Shares issued in connection with at the market agreement (in shares) | 400,400 | 5,978,452 | 746,152 | ||||||
Shares issued in underwritten offering, net | $ 7 | $ 15 | |||||||
Shares issued in underwritten offering, net (in shares) | 6,845,238 | 15,384,614 | |||||||
Balance | $ 47 | $ 40 | $ 40 | $ 40 | $ 39 | $ 18 | $ 47 | $ 40 | |
Balance (in shares) | 46,663,340 | 39,616,696 | 39,614,638 | 39,562,472 | 39,093,868 | 17,730,802 | 46,663,340 | 39,562,472 | |
Additional Paid-In Capital | |||||||||
Common Stock | |||||||||
Balance | $ 1,282,657 | $ 1,282,657 | $ 1,281,173 | $ 1,279,824 | $ 1,272,783 | $ 1,107,029 | $ 1,104,706 | $ 1,279,824 | $ 1,104,706 |
Shares issued under stock option and employee stock purchase plans | 2,004 | 74 | 194 | 24 | |||||
Shares issued under stock option and employee stock purchase plans | (25) | ||||||||
Shares issued in connection with at the market agreement | 4,296 | 23,686 | 1,613 | ||||||
Shares issued in underwritten offering, net | 269,886 | 141,346 | |||||||
Stock-based compensation | 3,029 | 1,509 | 1,275 | 1,250 | 722 | 686 | |||
Balance | 1,557,576 | 1,282,657 | 1,281,173 | 1,278,523 | 1,272,783 | 1,107,029 | 1,557,576 | 1,278,523 | |
Accumulated Other Comprehensive Income | |||||||||
Common Stock | |||||||||
Balance | 2,592 | 2,592 | 2,587 | 2,589 | 2,594 | 2,597 | 2,619 | 2,589 | 2,619 |
Unrealized (loss) gain on marketable securities | (44) | 5 | (2) | 14 | (3) | (22) | |||
Balance | 2,548 | 2,592 | 2,587 | 2,608 | 2,594 | 2,597 | 2,548 | 2,608 | |
Accumulated Deficit | |||||||||
Common Stock | |||||||||
Balance | $ (1,103,007) | (1,103,007) | (1,089,634) | (1,073,096) | (1,036,972) | (1,025,941) | (1,013,316) | (1,073,096) | (1,013,316) |
Net loss | (20,452) | (13,373) | (16,538) | (14,224) | (11,031) | (12,625) | |||
Balance | $ (1,123,459) | $ (1,103,007) | $ (1,089,634) | $ (1,051,196) | $ (1,036,972) | $ (1,025,941) | $ (1,123,459) | $ (1,051,196) |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Option Activity (Details) - Stock Options - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Shares | ||
Options outstanding at beginning of the period (in shares) | 3,042,229 | |
Granted (in shares) | 1,350,210 | |
Exercised (in shares) | (192,464) | |
Canceled (in shares) | (70,349) | |
Options outstanding at the end of the period (in shares) | 4,129,626 | 3,042,229 |
Options vested and expected to vest at the end of the period (in shares) | 3,982,965 | |
Options exercisable at the end of the period (in shares) | 1,387,147 | |
Shares available for grant under the 2021 Plan | 3,319,116 | |
Weighted Average Exercise Price Per Share | ||
Options outstanding at beginning of the period (in dollars per share) | $ 28.93 | |
Granted (in dollars per share) | 28.16 | |
Exercised (in dollars per share) | 9.53 | |
Canceled (in dollars per share) | 35.62 | |
Options outstanding at the end of the period (in dollars per share) | 29.46 | $ 28.93 |
Options vested and expected to Vest at the end of the period (in dollars per share) | 29.81 | |
Options exercisable at the end of the period (in dollars per share) | $ 51.75 | |
Weighted Average Remaining Contractual Term (In Years) | ||
Options outstanding at the end of the period | 8 years 2 months 12 days | 8 years 2 months 12 days |
Options vested and expected to vest at the end of the period | 8 years 2 months 12 days | |
Options exercisable at the end of the period | 6 years 8 months 12 days |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Stock-based compensation expense | ||||
Stock-based compensation expense | $ 3,029 | $ 1,250 | $ 5,813 | $ 2,658 |
Research and development | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | 1,504 | 642 | 2,927 | 1,294 |
General and administrative | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | $ 1,525 | $ 608 | $ 2,886 | $ 1,364 |
Stock-Based Compensation - Valu
Stock-Based Compensation - Valuation (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Black-Scholes option with following assumptions: | ||||
Expected stock price volatility (as a percent) | 98.00% | 98.00% | ||
Expected stock price volatility, minimum (as a percent) | 97.00% | 91.00% | ||
Expected stock price volatility, maximum (as a percent) | 98.00% | 98.00% | ||
Expected option term | 6 years | 6 years | 6 years | 6 years |
Risk-free interest rate (as a percent) | 0.50% | |||
Risk-free interest rate, minimum (as a percent) | 1.10% | 0.80% | 0.50% | |
Risk-free interest rate, maximum (as a percent) | 1.20% | 1.30% | 0.60% | |
Expected dividend yield (as a percent) | 0.00% | 0.00% | 0.00% | 0.00% |
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, 2021USD ($)$ / shares | Sep. 30, 2021USD ($)$ / shares | |
Additional information | ||
Weighted average grant-date fair value (in dollars per share) | $ / shares | $ 41.34 | $ 21.86 |
Intrinsic value of options vested and expected to vest | $ 140.6 | $ 140.6 |
Intrinsic value of options exercisable | 47.3 | 47.3 |
Compensation cost not yet recognized | $ 33.7 | $ 33.7 |
Weighted average period compensation cost is expected to be recognized (in years) | 2 years 10 months 24 days |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive Income (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Accumulated Other Comprehensive Income | |
Balance | $ 209,357 |
Balance | 436,712 |
Amounts reclassified from AOCI | 0 |
Unrealized Loss on Marketable Securities | |
Accumulated Other Comprehensive Income | |
Balance | (7) |
Other comprehensive loss | (41) |
Balance | (48) |
Foreign Currency Items | |
Accumulated Other Comprehensive Income | |
Balance | 2,596 |
Balance | 2,596 |
Accumulated Other Comprehensive Income | |
Accumulated Other Comprehensive Income | |
Balance | 2,589 |
Other comprehensive loss | (41) |
Balance | $ 2,548 |
Revenue (Details)
Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2021 | Sep. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Revenue | ||||||
Revenue, contract liabilities | $ 0 | $ 3,400 | ||||
Revenues | 153 | $ 668 | 4,317 | $ 3,633 | ||
Contract assets | 0 | 0 | $ 0 | |||
Contract liability | 601 | 601 | $ 3,386 | |||
Product development and licensing agreements | ||||||
Revenue | ||||||
Revenues | 12 | 29 | 2,297 | |||
Contracts and grants | ||||||
Revenue | ||||||
Revenues | 153 | 656 | 4,288 | 1,336 | ||
Rockefeller | Product development and licensing agreements | ||||||
Revenue | ||||||
Revenue, contract liabilities | $ 1,800 | |||||
Rockefeller University and Duke University | Contracts and grants | ||||||
Revenue | ||||||
Revenues | 100 | 300 | 4,000 | 900 | ||
National Institute of Health | ||||||
Revenue | ||||||
Revenues | $ 0 | $ 300 | $ 300 | $ 300 |
Income Taxes - Summary of Defer
Income Taxes - Summary of Deferred tax assets and liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Gross deferred tax liabilities | |||||
Net deferred tax liability | $ 1,613 | $ 1,840 | $ 1,613 | ||
Principal components of the deferred tax assets and liabilities | |||||
Income Tax Benefit | $ (227) | $ 900 | $ (200) | $ (227) | $ (228) |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - shares | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
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 | 4,129,626 | 3,074,832 |
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 | 4,129,626 | 3,074,832 |
Kolltan Acquisition (Details)
Kolltan Acquisition (Details) - Kolltan - USD ($) $ in Millions | Nov. 29, 2016 | Sep. 30, 2021 |
Kolltan Acquisition | ||
Shares issued as part of consideration (in shares) | 1,217,200 | |
Potential milestone payments | $ 107.5 | |
Specified development, regulatory approvals or sales-based milestones | ||
Kolltan Acquisition | ||
Potential milestone payments | $ 172.5 |