Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Jul. 25, 2022 | |
Document Information [Line Items] | ||
Entity Registrant Name | CEREVEL THERAPEUTICS HOLDINGS, INC. | |
Entity Central Index Key | 0001805387 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Shell Company | false | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 148,501,958 | |
Entity File Number | 001-39311 | |
Entity Tax Identification Number | 85-3911080 | |
Entity Address, Address Line One | 222 Jacobs Street | |
Entity Address, Address Line Two | Suite 200 | |
Entity Address, City or Town | Cambridge | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02141 | |
City Area Code | 844 | |
Local Phone Number | 304-2048 | |
Entity Interactive Data Current | Yes | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Common Stock [Member] | ||
Document Information [Line Items] | ||
Title of 12(b) Security | Common stock, par value $0.0001 per share | |
Trading Symbol | CERE | |
Security Exchange Name | NASDAQ |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 138,218 | $ 193,018 |
Marketable securities | 392,990 | 372,670 |
Prepaid expenses and other current assets | 8,933 | 12,329 |
Total current assets | 540,141 | 578,017 |
Marketable securities | 52,269 | |
Property and equipment, net | 29,314 | 28,449 |
Operating lease assets | 22,573 | 23,251 |
Restricted cash | 1,867 | 4,200 |
Other long-term assets | 2,762 | 2,733 |
Total assets | 596,657 | 688,919 |
Current liabilities: | ||
Accounts payable | 11,008 | 11,298 |
Accrued expenses and other current liabilities | 43,063 | 28,803 |
Operating lease liabilities, current portion | 2,672 | 2,437 |
Total current liabilities | 56,743 | 42,538 |
Operating lease liabilities, net of current portion | 32,688 | 34,110 |
Financing liability, related party (Notes 5 and 6) | 27,205 | 16,770 |
Financing liability (Notes 5 and 6) | 27,205 | 16,770 |
Other long-term liabilities | 2 | 2 |
Total liabilities | 143,843 | 110,190 |
Commitments and contingencies (Notes 12 and 13) | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value: 10,000,000 shares authorized; no shares issued and outstanding as of June 30, 2022 and December 31, 2021 | ||
Common stock, $0.0001 par value: 500,000,000 shares authorized; 148,395,282 and 147,719,523 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively | 15 | 15 |
Additional paid-in capital | 1,219,820 | 1,195,944 |
Accumulated other comprehensive income (loss) | 7,988 | (986) |
Accumulated deficit | (775,009) | (616,244) |
Total stockholders’ equity | 452,814 | 578,729 |
Total liabilities and stockholders’ equity | $ 596,657 | $ 688,919 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 500,000,000 | 500,000,000 |
Common stock, shares issued | 148,395,282 | 147,719,523 |
Common stock, shares outstanding | 148,395,282 | 147,719,523 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Operating expenses: | ||||
Research and development | $ 72,539 | $ 37,294 | $ 127,562 | $ 73,855 |
General and administrative | 20,467 | 13,216 | 37,974 | 27,226 |
Total operating expenses | 93,006 | 50,510 | 165,536 | 101,081 |
Loss from operations | (93,006) | (50,510) | (165,536) | (101,081) |
Interest income, net | 667 | 10 | 962 | 25 |
Other income (expense), net | 1,868 | (2,739) | 5,809 | (3,164) |
Loss before income taxes | (90,471) | (53,239) | (158,765) | (104,220) |
Net loss | $ (90,471) | $ (53,239) | $ (158,765) | $ (104,220) |
Net loss per share, basic and diluted | $ (0.61) | $ (0.42) | $ (1.07) | $ (0.82) |
Weighted-average shares used in calculating net loss per share, basic and diluted | 148,295,716 | 127,482,127 | 148,141,180 | 127,354,540 |
Comprehensive loss: | ||||
Net loss | $ (90,471) | $ (53,239) | $ (158,765) | $ (104,220) |
Other comprehensive income (loss) | ||||
Changes in fair value attributable to instrument-specific credit risk | 9,554 | 10,830 | ||
Unrealized gains (losses) on securities available-for-sale | (232) | (1,856) | ||
Total other comprehensive income (loss) | 9,322 | 8,974 | ||
Comprehensive loss | $ (81,149) | $ (53,239) | $ (149,791) | $ (104,220) |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital | Accumulated other comprehensive income (loss) [Member] | Accumulated Deficit [Member] |
Beginning balance at Dec. 31, 2020 | $ 384,520 | $ 13 | $ 775,417 | $ (390,910) | |
Beginning balance (in shares) at Dec. 31, 2020 | 127,123,954 | ||||
Issuance of common stock under equity incentive plans related to vesting of RSUs, (in shares) | 14,270 | ||||
Issuance of common stock under equity incentive plans related to exercise of options | 742 | 742 | |||
Issuance of common stock under equity incentive plans related to exercise of options (in shares) | 186,892 | ||||
Reclassification of private placement warrants from equity to other long-term liabilities | (305) | (305) | |||
Equity-based compensation expense | 6,060 | 6,060 | |||
Net loss | (50,981) | (50,981) | |||
Ending balance at Mar. 31, 2021 | 340,036 | $ 13 | 781,914 | (441,891) | |
Ending balance (in shares) at Mar. 31, 2021 | 127,325,116 | ||||
Beginning balance at Dec. 31, 2020 | 384,520 | $ 13 | 775,417 | (390,910) | |
Beginning balance (in shares) at Dec. 31, 2020 | 127,123,954 | ||||
Net loss | (104,220) | ||||
Ending balance at Jun. 30, 2021 | 293,887 | $ 13 | 789,004 | (495,130) | |
Ending balance (in shares) at Jun. 30, 2021 | 127,584,659 | ||||
Beginning balance at Mar. 31, 2021 | 340,036 | $ 13 | 781,914 | (441,891) | |
Beginning balance (in shares) at Mar. 31, 2021 | 127,325,116 | ||||
Issuance of common stock under equity incentive plans related to vesting of RSUs, (in shares) | 14,270 | ||||
Issuance of common stock under equity incentive plans related to exercise of options | 1,394 | 1,394 | |||
Issuance of common stock under equity incentive plans related to exercise of options (in shares) | 204,684 | ||||
Issuance of common stock under equity incentive plans related to ESPP | 435 | 435 | |||
Issuance of common stock under equity incentive plans related to ESPP (in shares) | 40,589 | ||||
Equity-based compensation expense | 5,261 | 5,261 | |||
Net loss | (53,239) | (53,239) | |||
Ending balance at Jun. 30, 2021 | 293,887 | $ 13 | 789,004 | (495,130) | |
Ending balance (in shares) at Jun. 30, 2021 | 127,584,659 | ||||
Beginning balance at Dec. 31, 2021 | 578,729 | $ 15 | 1,195,944 | $ (986) | (616,244) |
Beginning balance (in shares) at Dec. 31, 2021 | 147,719,523 | ||||
Issuance of common stock under equity incentive plans related to vesting of RSUs, (in shares) | 14,270 | ||||
Issuance of common stock under equity incentive plans related to exercise of options | 2,854 | 2,854 | |||
Issuance of common stock under equity incentive plans related to exercise of options (in shares) | 449,005 | ||||
Equity-based compensation expense | 8,558 | 8,558 | |||
Other comprehensive income (loss) | (348) | (348) | |||
Net loss | (68,294) | (68,294) | |||
Ending balance at Mar. 31, 2022 | 521,499 | $ 15 | 1,207,356 | (1,334) | (684,538) |
Ending balance (in shares) at Mar. 31, 2022 | 148,182,798 | ||||
Beginning balance at Dec. 31, 2021 | 578,729 | $ 15 | 1,195,944 | (986) | (616,244) |
Beginning balance (in shares) at Dec. 31, 2021 | 147,719,523 | ||||
Other comprehensive income (loss) | 8,974 | ||||
Net loss | (158,765) | ||||
Ending balance at Jun. 30, 2022 | 452,814 | $ 15 | 1,219,820 | 7,988 | (775,009) |
Ending balance (in shares) at Jun. 30, 2022 | 148,395,282 | ||||
Beginning balance at Mar. 31, 2022 | 521,499 | $ 15 | 1,207,356 | (1,334) | (684,538) |
Beginning balance (in shares) at Mar. 31, 2022 | 148,182,798 | ||||
Issuance of common stock under equity incentive plans related to vesting of RSUs, (in shares) | 14,270 | ||||
Issuance of common stock under equity incentive plans related to exercise of options | 1,471 | 1,471 | |||
Issuance of common stock under equity incentive plans related to exercise of options (in shares) | 160,623 | ||||
Issuance of common stock under equity incentive plans related to ESPP | 845 | 845 | |||
Issuance of common stock under equity incentive plans related to ESPP (in shares) | 37,591 | ||||
Equity-based compensation expense | 10,148 | 10,148 | |||
Other comprehensive income (loss) | 9,322 | 9,322 | |||
Net loss | (90,471) | (90,471) | |||
Ending balance at Jun. 30, 2022 | $ 452,814 | $ 15 | $ 1,219,820 | $ 7,988 | $ (775,009) |
Ending balance (in shares) at Jun. 30, 2022 | 148,395,282 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (158,765) | $ (104,220) |
Adjustments to reconcile net loss to net cash flows used in operating activities: | ||
Depreciation and amortization | 2,341 | 664 |
Adjustments to operating lease expense | (495) | (400) |
Equity-based compensation | 18,706 | 11,321 |
Change in fair value of financing liabilities | (5,800) | 992 |
Change in fair value of private placement warrants | 2,171 | |
Amortization of premiums and accretion of discounts on marketable securities | 1,012 | |
Changes in operating assets and liabilities, net: | ||
Prepaid expenses and other current assets | 3,331 | 2,270 |
Other assets | (240) | (757) |
Accounts payable | 464 | 1,485 |
Accrued expenses and other liabilities | 14,142 | 1,325 |
Operating lease liability | 3,123 | |
Net cash flows used in operating activities | (125,304) | (82,026) |
Cash flows from investing activities: | ||
Purchases of marketable securities | (141,566) | |
Maturities and redemptions of marketable securities | 170,647 | |
Purchases of property and equipment | (3,329) | (8,243) |
Net cash flows provided by (used in) investing activities | 25,752 | (8,243) |
Cash flows from financing activities: | ||
Proceeds from the exercise of stock options and ESPP purchases | 5,170 | 2,571 |
Proceeds from financing liability, related party | 18,750 | 15,625 |
Proceeds from financing liability | 18,750 | 15,625 |
Deferred costs related to financing activities | (251) | (115) |
Net cash flows provided by financing activities | 42,419 | 33,706 |
Net decrease in cash, cash equivalents and restricted cash | (57,133) | (56,563) |
Cash, cash equivalents and restricted cash, beginning of the period | 197,218 | 387,823 |
Cash, cash equivalents and restricted cash, end of the period | 140,085 | 331,260 |
Reconciliation of cash, cash equivalents and restricted cash: | ||
Cash and cash equivalents | 138,218 | 327,060 |
Restricted cash | 1,867 | 4,200 |
Total cash, cash equivalents and restricted cash | 140,085 | 331,260 |
Supplemental cash flow disclosures from non-cash investing and financing activities: | ||
Fixed asset additions included in accounts payable and other current liabilities | $ 349 | 655 |
Unpaid offering costs included in accounts payable and other current liabilities | $ 520 |
Nature of Operations
Nature of Operations | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Operations | 1. Nature of Operations Unless the context otherwise requires, references in these notes to “Cerevel,” “the company,” “we,” “us” and “our” and any related terms are intended to mean Cerevel Therapeutics Holdings, Inc. and its consolidated subsidiaries. We are a clinical-stage biopharmaceutical company pursuing a targeted approach to neuroscience that combines a deep understanding of disease-related biology and neurocircuitry of the brain with advanced chemistry and central nervous system (CNS) target receptor selective pharmacology to discover and design new therapies. We seek to transform the lives of patients through the development of new therapies for neuroscience diseases, including schizophrenia, epilepsy and Parkinson’s disease. We are advancing our extensive and diverse pipeline with numerous clinical trials underway or planned, including three ongoing Phase 3 trials and an open-label extension trial for tavapadon in Parkinson's, two ongoing Phase 2 trials and a planned open-label extension trial for emraclidine in schizophrenia and an ongoing Phase 2 proof-of-concept trial with an open-label extension trial for darigabat in focal epilepsy. We have built a highly experienced team of senior leaders and neuroscience drug developers who combine a nimble, results-driven biotech mindset with the proven expertise of large pharmaceutical company experience and capabilities in drug discovery and development. Our portfolio of product candidates is based on a differentiated approach to addressing neuroscience diseases, which incorporates three key pillars: (1) targeted neurocircuitry, where we seek to unlock new treatment opportunities by precisely identifying and targeting the neurocircuit that underlies a given neuroscience disease, (2) targeted receptor subtype selectivity, where we selectively target the receptor subtype(s) related to the disease physiology to minimize undesirable off-target effects while maximizing activity and (3) differentiated pharmacology, where we design full and partial agonists, antagonists and allosteric modulators to precisely fine-tune the receptor pharmacology and neurocircuit activity to avoid over-activation or over-suppression of the endogenous physiologic range. In addition, our portfolio is supported by robust data packages and rigorous clinical trial execution designed to elucidate the key points of differentiation for our compounds. We believe that this science-driven approach is critical to achieving optimal therapeutic activity while minimizing unintended side effects of currently available therapies. For additional information on our formation, please read Note 1, Nature of Operations , to our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2021 (our Annual Report). |
Risks and Liquidity
Risks and Liquidity | 6 Months Ended |
Jun. 30, 2022 | |
Risks and Uncertainties [Abstract] | |
Risks and Liquidity | 2. Risks and Liquidity We are subject to risks and uncertainties common to clinical-stage companies in the biopharmaceutical industry. These risks include, but are not limited to, the introduction of new products, therapies, standards of care or new technological innovations, our ability to obtain and maintain adequate protection for our in-licensed technology, data or other intellectual property and proprietary rights and compliance with extensive government regulation and oversight. In addition, we are dependent upon the services of our employees, including key personnel, consultants, third-party contract research organizations and other third-party organizations. Our product candidates, currently under development or that we may develop, will require significant additional research and development efforts, including extensive clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance and reporting capabilities. There can be no assurance that our research and development activities will be successfully completed, that adequate protection for our licensed or developed technology will be obtained and maintained, that products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Our unaudited condensed consolidated financial statements have been prepared on the basis of continuity of operations, the realization of assets and the satisfaction of liabilities in the ordinary course of business. We have incurred significant operating losses since our inception and, as of June 30, 2022, had an accumulated deficit of $ 775.0 million and had not yet generated revenues. In addition, we anticipate that our expenses will increase significantly in connection with our ongoing activities to support our research, discovery and clinical development efforts and we expect to continue to incur significant expenses and operating losses for the foreseeable future. We have funded our operations primarily with the net proceeds received from the issuance of preferred stock and common stock, net proceeds from the consummation of our Business Combination (as defined in Note 14, Related Parties , to these unaudited condensed consolidated financial statements) and our Funding Agreements (as defined in Note 5, Financing Liabilities , to these unaudited condensed consolidated financial statements). We believe that our available cash, cash equivalent and marketable security resources as of June 30, 2022, will enable us to fund our operating expense and capital expenditure requirements through at least 12 months from the issuance date of these financial statements. Impact of the Ongoing COVID-19 Pandemic We are closely monitoring the impact of the ongoing COVID-19 pandemic on all aspects of our business, including how it has impacted and may continue to impact our operations and the operations of our suppliers, vendors and business partners. The extent to which COVID-19 impacts our business, results of operations and financial condition will depend on future developments, which, despite progress in vaccination efforts, are highly uncertain and cannot be predicted with confidence, including the duration of the pandemic, new information that may emerge concerning the severity of COVID-19, such as new variants, which may impact rates of infection and vaccination efforts, developments or perceptions regarding the safety of vaccines and the extent and effectiveness of actions to contain COVID-19 or treat its impact, including vaccination campaigns, COVID-19 treatments and lockdown measures, among others. We have not incurred any significant impairment losses in the carrying values of our assets as a result of the pandemic and we are not aware of any specific related event or circumstance that would require us to revise our estimates reflected in our unaudited condensed consolidated financial statements. Our estimates of the impact on our business may change based on new information that may emerge concerning COVID-19 and the actions to contain it or treat its impact and the economic impact on local, regional, national and international markets. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed consolidated financial statements include those of the company and its subsidiaries, Cerevel Therapeutics, Inc., Cerevel Therapeutics, LLC and Cerevel MA Securities Corp., after elimination of all intercompany accounts and transactions. The accompanying unaudited condensed consolidated financial statements and notes hereto have been prepared in conformity with the rules and regulations of the Securities and Exchange Commission (SEC) for interim financial reporting and, therefore, omit or condense certain footnotes and other information normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) as set forth in the Financial Accounting Standards Board’s (FASB) accounting standards codification. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Update (ASU) of the FASB. In the opinion of management, all adjustments necessary for a fair statement of the financial information, which are of a normal and recurring nature, have been made for the interim periods reported. Results of operations for the three and six months ended June 30, 2022 and 2021, are not necessarily indicative of the results for the entire fiscal year or any other period. The unaudited condensed consolidated financial statements for the three and six months ended June 30, 2022 and 2021, have been prepared on the same basis as and should be read in conjunction with our audited consolidated financial statements and notes included in our Annual Report. Use of Estimates The preparation of condensed consolidated financial statements in conformity with GAAP requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions made in the accompanying condensed consolidated financial statements include, but are not limited to, the fair value of our financing liabilities, the fair value of stock options, the accrual for research and development expense and the recoverability of our net deferred tax assets and the related valuation allowance. The impact on accounting estimates and judgments on our financial condition and results of operations due to COVID-19 may introduce additional uncertainties. We evaluate our estimates and assumptions on an ongoing basis using historical experience and other factors and adjust those estimates and assumptions when facts and circumstances change. Actual results could differ materially from those estimates. Restricted Cash In connection with our entering into the lease agreement for our headquarters in Cambridge, MA, in July 2019, we were required to provide a security deposit in the form of a letter of credit. We have classified this amount as restricted cash within our condensed consolidated balance sheets as of June 30, 2022 and December 31, 2021. For additional information related to our other significant accounting policies, please read Note 4, Summary of Significant Accounting Policies , to our audited consolidated financial statements included in our Annual Report. Recent Accounting Guidance From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and 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 our financial position or results of operations upon adoption. |
Pfizer License Agreement
Pfizer License Agreement | 6 Months Ended |
Jun. 30, 2022 | |
License Agreement [Abstract] | |
Pfizer License Agreement | 4. Pfizer License Agreement In August 2018, we entered into a license agreement with Pfizer (the Pfizer License Agreement) pursuant to which we were granted an exclusive, sublicensable, worldwide license under certain Pfizer patent rights, and a non-exclusive, sublicensable, worldwide license under certain Pfizer know-how to develop, manufacture and commercialize certain compounds and products, which currently constitute substantially all of our asset portfolio, in the field of treatment, prevention, diagnosis, control and maintenance of all diseases and disorders in humans, subject to the terms and conditions of the Pfizer License Agreement. Under the Pfizer License Agreement, we are solely responsible for the development, manufacture, regulatory approval and commercialization of compounds and products in the field and we will pay Pfizer tiered royalties on the aggregate net sales during each calendar year, determined on a product-by-product basis, with respect to products under the Pfizer License Agreement, and we may pay potential milestone payments to Pfizer, based on the successful achievement of certain regulatory and commercial milestones. To date, no regulatory or commercial approval milestone payments or royalty payments have been made or become due under this agreement. For additional information related to our Pfizer License Agreement, please read Note 6, Pfizer License Agreement, to our audited consolidated financial statements included in our Annual Report. |
Financing Liabilities
Financing Liabilities | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Financing Liabilities | 5. Financing Liabilities Funding Agreements In April 2021, we entered into a funding agreement with NovaQuest Co-Investment Fund XVI, L.P. (NovaQuest and the NovaQuest Funding Agreement) and a funding agreement with BC Pinnacle Holdings, LP (Bain, the Bain Funding Agreement and, together with the NovaQuest Funding Agreement, the Funding Agreements), pursuant to which NovaQuest and Bain will provide funding to support our development of tavapadon for the treatment of Parkinson’s disease. Under the terms of the Funding Agreements, we will receive up to $ 62.5 million in funding from each of NovaQuest and Bain, for a combined total of up to $ 125.0 million in funding (the Total Funding Commitment), of which approximately $ 31.1 million ( 25 % of the Total Funding Commitment, net of $ 0.2 million of fees incurred by Bain and NovaQuest) was received in April 2021, $ 37.5 million ( 30 % of the Total Funding Commitment) was received in April 2022, and approximately $ 31.3 million ( 25 % of the Total Funding Commitment) and $ 25.0 million ( 20 % of the Total Funding Commitment) are expected to be received on the second and third anniversaries of the effective date of the Funding Agreements, respectively, subject to certain customary funding conditions. In return , we agreed to pay to NovaQuest and Bain significant regulatory milestone, sales milestone and royalty payments upon approval of tavapadon by the FDA that collectively will not exceed $ 531.3 million. In addition, we have the option to satisfy our payment obligations to NovaQuest and Bain upon the earlier of FDA approval or May 1, 2025 , by paying an amount equal to the Total Funding Commitment multiplied by an initial factor of 3.00 x. This factor will increase ratably over time up to a maximum of 4.25 x, less amounts previously paid to NovaQuest and Bain. We determined that each funding agreement represents a financial instrument that is considered to be a debt host containing embedded redemption features due to certain contingencies related to repayment. We elected to account for the Funding Agreements in accordance with the fair value option as permitted under ASC 825, Financial Instruments . As of June 30, 2022 and December 31, 2021, the estimated fair value of the financing liability related to potential amounts payable to Bain under the Bain Funding Agreement, which is reflected within our condensed consolidated balance sheets as financing liability, related party, totaled $ 27.2 million and $ 16.8 million, respectively. As of June 30, 2022 and December 31, 2021, the estimated fair value of the financing liability related to potential amounts payable to NovaQuest under the NovaQuest Funding Agreement, which is reflected within our condensed consolidated balance sheets as financing liability, totaled $ 27.2 million and $ 16.8 million, respectively. During the three months ended June 30, 2022, we recognized gains of approximately $ 0.9 million and $ 0.9 million , respectively, as a component of other income (expense), net within our unaudited condensed consolidated statements of operations and comprehensive loss, reflecting the change in fair value of the financing liabilities associated with the Bain and NovaQuest Funding Agreements. Gains of $ 2.9 million and $ 2.9 million , respectively, were recognized as a component of other income (expense), net within our unaudited condensed consolidated statements of operations and comprehensive loss for the six months ended June 30, 2022. For the three months ended June 30, 2022, we recognized unrealized gains of approximately $ 4.8 million and $ 4.8 million , respectively, within other comprehensive income (loss) related to the change in fair value attributable to instrument-specific credit risk for the financing liabilities associated with the Bain and NovaQuest Funding Agreements. Unrealized gains of approximately $ 5.4 million and $ 5.4 million , respectively, were recognized within other comprehensive income (loss) related to the change in fair value attributable to instrument-specific credit risk for the six months ended June 30, 2022. Changes in fair value attributable to instrument-specific credit risk were derived by benchmarking against the prior period credit spread to isolate the impact directly associated with the change in the credit spread utilized between periods. For the period of initial recognition on April 12, 2021 through June 30, 2021 , losses of $ 0.5 million and $ 0.5 million, respectively, were recognized as a charge to other income (expense), net within our unaudited condensed consolidated statements of operations and comprehensive loss, reflecting the net change in fair value of the financing liabilities associated with the Bain and NovaQuest Funding Agreements. For the three and six months ended June 30, 2021 , no amounts were recognized within other comprehensive income (loss) due to a change fair value attributable to instrument-specific credit risk as such amounts were not material. For additional information related to our Funding Agreements, please read Note 8, Financing Liabilities , to our audited consolidated financial statements included in our Annual Report. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 6. Fair Value Measurements The tables below present information about our assets and liabilities that are measured and carried at fair value on a recurring basis and indicate the level within the fair value hierarchy we utilized to determine such fair values: As of June 30, 2022 (In thousands) Quoted Significant Significant Total Assets: Cash equivalents Money market funds $ 133,202 $ — $ — $ 133,202 Commercial paper — 4,999 — 4,999 Marketable securities (current) U.S. government treasuries 211,135 — — 211,135 Corporate debt securities — 8,958 — 8,958 Commercial paper — 172,897 — 172,897 Restricted cash Money market funds 1,867 — — 1,867 Total assets $ 346,204 $ 186,854 $ — $ 533,058 Liabilities: Financing liability, related party — — 27,205 27,205 Financing liability — — 27,205 27,205 Total liabilities $ — $ — $ 54,410 $ 54,410 As of December 31, 2021 (In thousands) Quoted Significant Significant Total Assets: Cash equivalents Money market funds $ 153,589 $ — $ — $ 153,589 Corporate debt securities — 1,431 — 1,431 Commercial paper — 37,998 — 37,998 Marketable securities (current) U.S. government treasuries 171,063 — — 171,063 Corporate debt securities — 20,452 — 20,452 Commercial paper — 181,155 — 181,155 Marketable securities (non-current) U.S. government treasuries 52,269 — — 52,269 Restricted cash Money market funds 4,200 — — 4,200 Total assets $ 381,121 $ 241,036 $ — $ 622,157 Liabilities: Financing liability, related party — — 16,770 16,770 Financing liability — — 16,770 16,770 Total liabilities $ — $ — $ 33,540 $ 33,540 There have been no impairments of our assets measured and carried at fair value during the six months ended June 30, 2022 . There have been no changes in valuation techniques, inputs utilized or transfers between fair measurement levels in the periods presented. The fair value of our Level 2 instruments were determined using third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly. We validate the prices provided by our third-party pricing services by understanding the models used, obtaining market values from other pricing sources and analyzing pricing data in certain instances. After completing our validation procedures, we did not adjust or override any fair value measurements provided by our pricing services as of June 30, 2022 and December 31, 2021. As of June 30, 2022, our financing liabilities represented our only Level 3 assets or liabilities carried at fair market value. Changes in the fair value remeasurement of our financing liabilities can result from changes in one or multiple inputs, including adjustments to discount rates, changes in the expected achievement or timing of any sales-based, development or regulatory milestones, changes in the amount or timing of expected net cash flows, changes in the probability of certain clinical events and changes in the assumed probability associated with regulatory approval. These fair value measurements represent Level 3 measurements as they are based on significant inputs not observable in the market. The carrying amounts reflected in our condensed consolidated balance sheets for our cash and cash equivalents, prepaid expenses and other current assets, accounts payable, accrued expenses and other current liabilities approximate fair value due to the short-term nature of these assets and liabilities. Marketable Securities The estimated fair value and amortized cost of our available-for-sale marketable debt securities, by contractual maturity and security type, are summarized as follows: As of June 30, 2022 (In thousands) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Due in one year or less U.S. government treasuries $ 212,366 $ 17 $ ( 1,248 ) $ 211,135 Corporate debt securities 9,004 — ( 46 ) 8,958 Commercial paper 173,675 12 ( 790 ) 172,897 Total marketable securities $ 395,045 $ 29 $ ( 2,084 ) $ 392,990 As of December 31, 2021 (In thousands) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Due in one year or less U.S. government treasuries $ 171,111 $ — $ ( 48 ) $ 171,063 Corporate debt securities 20,464 — ( 12 ) 20,452 Commercial paper 181,176 11 ( 32 ) 181,155 Due after one year through two years U.S. government treasuries 52,387 — ( 118 ) 52,269 Total marketable securities $ 425,138 $ 11 $ ( 210 ) $ 424,939 We had no realized gains or losses recognized on the sale or maturity of marketable securities during the six months ended June 30, 2022 and 2021. To date, we have not recognized any allowances for credit losses or impairments in relation to our available-for-sale marketable securities as these marketable securities are comprised of high credit quality, investment grade securities that we do not intend or expect to be required to sell prior to their anticipated recovery, and the decline in fair value of these securities is attributable to factors other than credit losses. None of the marketable securities presented in the previous tables have been in a continuous unrealized loss position for 12 months or longer. Based on our evaluation, we determined credit losses related to marketable securities were immaterial for the three and six months ended June 30, 2022. The weighted average maturity of our marketable securities as of June 30, 2022 and December 31, 2021 , was approximately five months and nine months , respectively. Financing Liabilities Upon execution of the Funding Agreements, we determined that the agreements qualified for election under the fair value option and initially measured the financial instruments at their issue-date estimated fair value. We revalue the related financial liabilities on a recurring basis at each reporting period. As of June 30, 2022, the financing liability, related party and financing liability totaled $ 27.2 million and $ 27.2 million , respectively. We determined their respective estimated fair values using a Monte Carlo simulation model under the income approach determined by using probability assessments of the expected future cash receipts and expected future cash payments and a discount rate of approximately 11.0 %. As of December 31, 2021 , we used a discount rate of approximately 9.0 %. The following table provides a rollforward of the liability associated with our financing liabilities: For the Six Months Ended (In thousands) 2022 Beginning liability balance $ 33,540 Funding commitment received 37,500 Change in fair value recognized in other expense (income), net ( 5,800 ) Change in fair value attributable to instrument-specific credit risk recognized in other comprehensive (income) loss ( 10,830 ) Ending liability balance $ 54,410 For additional information related to the fair value of our financing liability and financing liability, related party, please read Note 5, Financing Liabilities , to these unaudited condensed consolidated financial statements . |
Financial Statement Components
Financial Statement Components | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Financial Statement Components | 7. Financial Statement Components Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following: As of (In thousands) June 30, December 31, Prepaid clinical trial services $ 1,207 $ 2,038 Prepaid research and development expenses 1,438 2,074 Prepaid insurance 1,935 4,701 Other prepaid expenses 2,271 2,225 Interest receivable 981 729 Other 1,101 562 Prepaid expenses and other current assets $ 8,933 $ 12,329 Property and Equipment, Net Property and equipment, net consisted of the following: As of (In thousands) June 30, December 31, Computer equipment and software $ 996 $ 946 Furniture and fixtures 459 437 Laboratory equipment 9,001 5,617 Leasehold improvements 23,466 23,286 Construction in progress 199 729 Less: Accumulated depreciation ( 4,807 ) ( 2,566 ) Property and equipment, net $ 29,314 $ 28,449 Other Long-Term Assets Other long-term assets consisted of the following: As of (In thousands) June 30, December 31, Other prepaid expenses, net of current portion $ 1,737 $ 1,806 Deferred expenses associated with financing activities 465 485 Other 560 442 Other long-term assets $ 2,762 $ 2,733 As of June 30, 2022 and December 31, 2021, other prepaid expenses, net of current portion, primarily consisted of deposits paid under certain contract research organization agreements that will be held until the completion of the related clinical trials that are anticipated to end more than 12 months from the balance sheet date. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following: As of (In thousands) June 30, December 31, Accrued external research and development services $ 30,659 $ 16,097 Accrued compensation and personnel costs 8,272 10,827 Accrued property and equipment 311 109 Accrued professional fees and consulting services 2,931 1,270 Other 890 500 Accrued expenses and other current liabilities $ 43,063 $ 28,803 Other Income (Expense), net Other income (expense), net consisted of the following: For the Three Months Ended For the Six Months Ended (In thousands) 2022 2021 2022 2021 Gain (loss) on fair value remeasurement of financing liability, related party $ 930 $ ( 496 ) $ 2,900 $ ( 496 ) Gain (loss) on fair value remeasurement of financing liability 930 ( 496 ) 2,900 ( 496 ) Loss on fair value remeasurement of private placement warrants — ( 1,746 ) — ( 2,170 ) Other, net 8 ( 1 ) 9 ( 2 ) Other income (expense), net $ 1,868 $ ( 2,739 ) $ 5,809 $ ( 3,164 ) |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2022 | |
Equity [Abstract] | |
Stockholders' Equity | 8. Stockholders’ Equity Preferred Stock Pursuant to the terms of our certificate of incorporation, we have 10,000,000 authorized shares of preferred stock with a par value of $ 0.0001 per share. Our board of directors has the authority, without further action by our stockholders, to issue such shares of preferred stock in one or more series, to establish from time to time the number of shares to be included in each such series, and to fix the dividend, voting, and other rights, preferences and privileges of the shares. There were no issued and outstanding shares of preferred stock as of June 30, 2022 and December 31, 2021. Common Stock Pursuant to the terms of our certificate of incorporation, we have 500,000,000 authorized shares of common stock with a par value of $ 0.0001 per share. There were 148,395,282 and 147,719,523 shares of common stock issued and outstanding as of June 30, 2022 and December 31, 2021, respectively. Voting The holders of our common stock are entitled to one vote for each share of common stock held at all meetings of stockholders (and written actions in lieu of meetings), and there is no cumulative voting. Dividends Common stockholders are entitled to receive dividends whenever funds are legally available and when declared by the board of directors. No dividends have been declared to date. ATM Program On November 10, 2021, we entered into an open market sales agreement with Jefferies LLC, as sales agent, to provide for the issuance and sale of up to $ 250.0 million of our common stock from time-to-time in “at-the-market” offerings (the ATM Program). As of June 30, 2022 and December 31, 2021 , no sales had been made pursuant to the ATM Program. Private Placement Warrants We reclassified the fair value associated with the 166,333 outstanding private placement warrants from equity to other long-term liabilities in our unaudited condensed consolidated balance sheet as of March 31, 2021. Upon establishment of this liability, we reclassified approximately $ 0.3 million from additional paid-in capital and recognized a charge of approximately $ 0.4 million to other income (expense), net, resulting from the change in fair value of these warrants. We did no t recognize a liability in relation to our private placement warrants prior to March 31, 2021, as we previously determined that the fair value of these warrants was immaterial. For the three and six months ended June 30, 2021, we recognized net losses of $ 1.7 million and $ 2.2 million, respectively, as a component of other income (expense), net, related to the changes in fair value of our private placement warrants. No private placement warrants remained outstanding as of June 30, 2022 and December 31, 2021. For additional information on our private placement warrants, please read Note 12, Stockholders’ Equity , to our audited consolidated financial statements included in our Annual Report. |
Equity-Based Compensation
Equity-Based Compensation | 6 Months Ended |
Jun. 30, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Equity-Based Compensation | 9. Equity-Based Compensation Equity-based Compensation Expense The following table summarizes equity-based compensation expense included in our unaudited condensed consolidated statements of operations and comprehensive loss: For the Three Months Ended For the Six Months Ended (In thousands) 2022 2021 2022 2021 Research and development $ 4,802 $ 2,122 $ 8,808 $ 3,919 General and administrative 5,346 3,062 9,898 7,402 Total equity-based compensation expense included in total operating expense $ 10,148 $ 5,184 $ 18,706 $ 11,321 The following table summarizes equity-based compensation expense by award type included in our unaudited condensed consolidated statements of operations and comprehensive loss: For the Three Months Ended For the Six Months Ended (In thousands) 2022 2021 2022 2021 Stock options $ 9,943 $ 5,024 $ 18,302 $ 11,063 Restricted stock units 19 21 28 43 Employee stock purchase plan 186 139 376 215 Total equity-based compensation expense included in total operating expense $ 10,148 $ 5,184 $ 18,706 $ 11,321 Stock Options The following table summarizes our stock option activity for the six months ended June 30, 2022: Number of Weighted Weighted (in years) Aggregate (in thousands) Outstanding at December 31, 2021 16,066,064 $ 9.92 8.09 $ 362,250 Granted 2,726,531 $ 30.12 Exercised ( 609,628 ) $ 7.10 Forfeited, canceled or expired ( 240,072 ) $ 15.92 Outstanding at June 30, 2022 17,942,895 $ 13.01 7.98 $ 254,755 Options vested and expected to vest as of June 30, 2022 17,942,895 $ 13.01 7.98 $ 254,755 Options exercisable as of June 30, 2022 8,198,252 $ 7.43 7.16 $ 155,871 The aggregate intrinsic value represents the difference between the closing stock price of our common stock and the exercise price of in-the-money options. Our closing stock price as reported on the NASDAQ Stock Market on June 30, 2022 was $ 26.44 . As of June 30, 2022 , total unrecognized equity-based compensation expense relating to stock options was $ 113.1 million. This amount is expected to be recognized over a weighted average period of 3.1 years. Stock options granted during the six months ended June 30, 2022, include our annual long-term incentive awards, which were granted in February 2022. The weighted-average assumptions that we used to determine the fair value of stock options granted to employees and directors are summarized as follows: For the Six Months Ended 2022 2021 Risk free interest rate 2.04 % 0.76 % Expected term (in years) 6.04 6.04 Expected volatility 96.0 % 94.0 % Expected dividend yield 0.0 % 0.0 % Weighted-average grant date fair value $ 23.39 $ 9.87 |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 10. Net Loss Per Share The following table sets forth the computation of the basic and diluted net loss per share: For the Three Months Ended For the Six Months Ended (In thousands, except share amounts and per share data) 2022 2021 2022 2021 Numerator: Net loss $ ( 90,471 ) $ ( 53,239 ) $ ( 158,765 ) $ ( 104,220 ) Denominator: Weighted-average shares used in calculating net loss per share, basic and diluted 148,295,716 127,482,127 148,141,180 127,354,540 Net loss per share, basic and diluted $ ( 0.61 ) $ ( 0.42 ) $ ( 1.07 ) $ ( 0.82 ) Since we were in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share as the inclusion of all potential dilutive securities would have been anti-dilutive. The shares in the table below were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: As of June 30, June 30, Stock options outstanding 17,942,895 17,120,349 Restricted stock units outstanding 18,932 42,810 Warrants outstanding — 5,149,647 ESPP shares issuable — 8,187 Total 17,961,827 22,320,993 |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 11. Income Taxes For the three and six months ended June 30, 2022 and 2021 , we did no t record income tax benefits for net operating losses incurred or for the research and development tax credits generated in each period due to the uncertainty of realizing a benefit from those items. Our tax provision and the resulting effective tax rate for interim periods is determined based upon our estimated annual effective tax rate, adjusted for the effect of discrete items arising during the interim quarterly period. The impact of such inclusions could result in a higher or lower effective tax rate during a particular quarterly period, based upon the mix and timing of actual earnings or losses versus annual projections. In each quarterly period, we update our estimate of the annual effective tax rate, and if the estimated annual tax rate changes, a cumulative adjustment is made in that quarter. We have evaluated the positive and negative evidence bearing upon our ability to realize our deferred tax assets, which primarily consist of net operating loss carryforwards and research and development tax credits. We have considered our history of cumulative net losses, estimated future taxable income and prudent and feasible tax planning strategies and have concluded that it is more likely than not that we will not realize the benefits of our deferred tax assets. As a result, as of June 30, 2022 and December 31, 2021 , we have recorded a full valuation allowance against our net deferred tax assets. |
Legal Proceedings
Legal Proceedings | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Legal Proceedings | 12. Legal Proceedings We, from time to time, may be subject to various legal proceedings and claims that may arise in the ordinary course of business. We were not subject to any material legal proceedings as of June 30, 2022 , and, to the best of our knowledge, no material legal proceedings are currently pending or threatened. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 13. Commitments and Contingencies As of June 30, 2022, we have several ongoing clinical studies in various clinical trial stages. Our most significant contracts relate to agreements with contract research organizations (CROs) for clinical trials and preclinical studies and contract manufacturing organizations (CMOs) for the manufacturing of drug substance, which we enter into in the normal course of business. The contracts with CROs and CMOs are generally cancellable, with notice, at our option. Guarantees and Indemnification Obligations We enter into standard indemnification obligations in the ordinary course of business. Pursuant to these obligations, we indemnify and agree to reimburse the indemnified party for certain losses and costs incurred by the indemnified party. The term of these indemnification obligations is generally perpetual after execution of the agreement. In addition, we have entered into indemnification obligations with members of our board of directors and our executive officers that will require us, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or executive officers. The maximum potential amount of future payments we could be required to make under these indemnification agreements is unlimited. To date, we have no t incurred any losses or any material costs related to these indemnification obligations and no claims with respect thereto were outstanding. We do not believe that the outcome of any claims under indemnification arrangements will have a material effect on our financial position, results of operations and cash flows, and we have no t accrued any liabilities related to such obligations in our condensed consolidated financial statements as of June 30, 2022 and December 31, 2021 . |
Related Parties
Related Parties | 6 Months Ended |
Jun. 30, 2022 | |
Related Party Transactions [Abstract] | |
Related Parties | 14. Related Parties As of June 30, 2022 and December 31, 2021 , Pfizer held 27,349,211 shares of our common stock and had nominated two members to our board of directors. For information related to our license agreement with Pfizer, please read Note 4, Pfizer License Agreement , to these unaudited condensed consolidated financial statements. As of June 30, 2022 and December 31, 2021 , Bain Investor held 60,632,356 shares of our common stock and had nominated four members to our board of directors. Research Collaboration and License Agreement In June 2022, we entered into a research collaboration and license agreement with Pfizer, pursuant to which we will collaborate to identify, screen and evaluate compounds directed at certain targets for neuroscience diseases using Pfizer’s chemical library. Under the terms of the agreement, we will be required to reimburse Pfizer for certain research services and make a contingent development milestone payment and single-digit royalty payments on net sales of products containing one or more compounds derived from the collaboration. No amounts have been incurred under the agreement to date. Funding Agreement In April 2021, we entered into a funding agreement with Bain, pursuant to which Bain will provide up to $ 62.5 million in funding (the Bain Funding Commitment) to support our development of tavapadon for the treatment of Parkinson’s disease over four years , of which approximately $ 15.5 million ( 25 % of the Bain Funding Commitment, net of $ 0.1 million of fees incurred by Bain) was received in April 2021 and $ 18.75 million ( 30 % of the Bain Funding Commitment) was received in April 2022. For additional information related to our funding agreement with Bain, please read Note 5, Financing Liabilities , to these unaudited condensed consolidated financial statements . Management Agreement Following the closing of the business combination in October 2020 pursuant to which ARYA Sciences Acquisition Corp II (ARYA) acquired Cerevel Therapeutics, Inc., with Cerevel Therapeutics, Inc. becoming a wholly-owned subsidiary of ARYA and ARYA being renamed Cerevel Therapeutics Holdings, Inc. (the Business Combination), we entered into a management agreement with Bain Capital Private Equity, LP and Bain Capital Life Sciences, LP, providing for the expense reimbursement and indemnification of such entities. No amounts have been incurred under the management agreement to date. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | 15. Subsequent Events We have completed an evaluation of all subsequent events after the unaudited balance sheet date of June 30, 2022, through August 1, 2022, the issuance date of these financial statements, to ensure that these unaudited condensed consolidated financial statements include appropriate disclosure of material events both recognized in the unaudited condensed consolidated financial statements as of June 30, 2022 , and material events which occurred subsequently but were not recognized in the unaudited condensed consolidated financial statements. We have concluded that no such subsequent events have occurred that require disclosure. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements include those of the company and its subsidiaries, Cerevel Therapeutics, Inc., Cerevel Therapeutics, LLC and Cerevel MA Securities Corp., after elimination of all intercompany accounts and transactions. The accompanying unaudited condensed consolidated financial statements and notes hereto have been prepared in conformity with the rules and regulations of the Securities and Exchange Commission (SEC) for interim financial reporting and, therefore, omit or condense certain footnotes and other information normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) as set forth in the Financial Accounting Standards Board’s (FASB) accounting standards codification. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Update (ASU) of the FASB. In the opinion of management, all adjustments necessary for a fair statement of the financial information, which are of a normal and recurring nature, have been made for the interim periods reported. Results of operations for the three and six months ended June 30, 2022 and 2021, are not necessarily indicative of the results for the entire fiscal year or any other period. The unaudited condensed consolidated financial statements for the three and six months ended June 30, 2022 and 2021, have been prepared on the same basis as and should be read in conjunction with our audited consolidated financial statements and notes included in our Annual Report. |
Use of Estimates | Use of Estimates The preparation of condensed consolidated financial statements in conformity with GAAP requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions made in the accompanying condensed consolidated financial statements include, but are not limited to, the fair value of our financing liabilities, the fair value of stock options, the accrual for research and development expense and the recoverability of our net deferred tax assets and the related valuation allowance. The impact on accounting estimates and judgments on our financial condition and results of operations due to COVID-19 may introduce additional uncertainties. We evaluate our estimates and assumptions on an ongoing basis using historical experience and other factors and adjust those estimates and assumptions when facts and circumstances change. Actual results could differ materially from those estimates. |
Restricted Cash | Restricted Cash In connection with our entering into the lease agreement for our headquarters in Cambridge, MA, in July 2019, we were required to provide a security deposit in the form of a letter of credit. We have classified this amount as restricted cash within our condensed consolidated balance sheets as of June 30, 2022 and December 31, 2021. For additional information related to our other significant accounting policies, please read Note 4, Summary of Significant Accounting Policies , to our audited consolidated financial statements included in our Annual Report. |
Recent Accounting Guidance | Recent Accounting Guidance From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and 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 our financial position or results of operations upon adoption. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis | The tables below present information about our assets and liabilities that are measured and carried at fair value on a recurring basis and indicate the level within the fair value hierarchy we utilized to determine such fair values: As of June 30, 2022 (In thousands) Quoted Significant Significant Total Assets: Cash equivalents Money market funds $ 133,202 $ — $ — $ 133,202 Commercial paper — 4,999 — 4,999 Marketable securities (current) U.S. government treasuries 211,135 — — 211,135 Corporate debt securities — 8,958 — 8,958 Commercial paper — 172,897 — 172,897 Restricted cash Money market funds 1,867 — — 1,867 Total assets $ 346,204 $ 186,854 $ — $ 533,058 Liabilities: Financing liability, related party — — 27,205 27,205 Financing liability — — 27,205 27,205 Total liabilities $ — $ — $ 54,410 $ 54,410 As of December 31, 2021 (In thousands) Quoted Significant Significant Total Assets: Cash equivalents Money market funds $ 153,589 $ — $ — $ 153,589 Corporate debt securities — 1,431 — 1,431 Commercial paper — 37,998 — 37,998 Marketable securities (current) U.S. government treasuries 171,063 — — 171,063 Corporate debt securities — 20,452 — 20,452 Commercial paper — 181,155 — 181,155 Marketable securities (non-current) U.S. government treasuries 52,269 — — 52,269 Restricted cash Money market funds 4,200 — — 4,200 Total assets $ 381,121 $ 241,036 $ — $ 622,157 Liabilities: Financing liability, related party — — 16,770 16,770 Financing liability — — 16,770 16,770 Total liabilities $ — $ — $ 33,540 $ 33,540 |
Summary of Estimated Fair Value and Amortized Cost of Available-for-Sale Marketable Debt Securities | The estimated fair value and amortized cost of our available-for-sale marketable debt securities, by contractual maturity and security type, are summarized as follows: As of June 30, 2022 (In thousands) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Due in one year or less U.S. government treasuries $ 212,366 $ 17 $ ( 1,248 ) $ 211,135 Corporate debt securities 9,004 — ( 46 ) 8,958 Commercial paper 173,675 12 ( 790 ) 172,897 Total marketable securities $ 395,045 $ 29 $ ( 2,084 ) $ 392,990 As of December 31, 2021 (In thousands) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Due in one year or less U.S. government treasuries $ 171,111 $ — $ ( 48 ) $ 171,063 Corporate debt securities 20,464 — ( 12 ) 20,452 Commercial paper 181,176 11 ( 32 ) 181,155 Due after one year through two years U.S. government treasuries 52,387 — ( 118 ) 52,269 Total marketable securities $ 425,138 $ 11 $ ( 210 ) $ 424,939 |
Summary of Rollforward of the Liability Associated with Financing Liabilities | The following table provides a rollforward of the liability associated with our financing liabilities: For the Six Months Ended (In thousands) 2022 Beginning liability balance $ 33,540 Funding commitment received 37,500 Change in fair value recognized in other expense (income), net ( 5,800 ) Change in fair value attributable to instrument-specific credit risk recognized in other comprehensive (income) loss ( 10,830 ) Ending liability balance $ 54,410 |
Financial Statement Components
Financial Statement Components (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following: As of (In thousands) June 30, December 31, Prepaid clinical trial services $ 1,207 $ 2,038 Prepaid research and development expenses 1,438 2,074 Prepaid insurance 1,935 4,701 Other prepaid expenses 2,271 2,225 Interest receivable 981 729 Other 1,101 562 Prepaid expenses and other current assets $ 8,933 $ 12,329 |
Summary of Property and Equipment Net | Property and equipment, net consisted of the following: As of (In thousands) June 30, December 31, Computer equipment and software $ 996 $ 946 Furniture and fixtures 459 437 Laboratory equipment 9,001 5,617 Leasehold improvements 23,466 23,286 Construction in progress 199 729 Less: Accumulated depreciation ( 4,807 ) ( 2,566 ) Property and equipment, net $ 29,314 $ 28,449 |
Summary of Other Long-Term Assets | Other long-term assets consisted of the following: As of (In thousands) June 30, December 31, Other prepaid expenses, net of current portion $ 1,737 $ 1,806 Deferred expenses associated with financing activities 465 485 Other 560 442 Other long-term assets $ 2,762 $ 2,733 |
Summary of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following: As of (In thousands) June 30, December 31, Accrued external research and development services $ 30,659 $ 16,097 Accrued compensation and personnel costs 8,272 10,827 Accrued property and equipment 311 109 Accrued professional fees and consulting services 2,931 1,270 Other 890 500 Accrued expenses and other current liabilities $ 43,063 $ 28,803 |
Summary of Other Income (Expense), Net | Other income (expense), net consisted of the following: For the Three Months Ended For the Six Months Ended (In thousands) 2022 2021 2022 2021 Gain (loss) on fair value remeasurement of financing liability, related party $ 930 $ ( 496 ) $ 2,900 $ ( 496 ) Gain (loss) on fair value remeasurement of financing liability 930 ( 496 ) 2,900 ( 496 ) Loss on fair value remeasurement of private placement warrants — ( 1,746 ) — ( 2,170 ) Other, net 8 ( 1 ) 9 ( 2 ) Other income (expense), net $ 1,868 $ ( 2,739 ) $ 5,809 $ ( 3,164 ) |
Equity-Based Compensation (Tabl
Equity-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Equity-based Compensation Expense | The following table summarizes equity-based compensation expense included in our unaudited condensed consolidated statements of operations and comprehensive loss: For the Three Months Ended For the Six Months Ended (In thousands) 2022 2021 2022 2021 Research and development $ 4,802 $ 2,122 $ 8,808 $ 3,919 General and administrative 5,346 3,062 9,898 7,402 Total equity-based compensation expense included in total operating expense $ 10,148 $ 5,184 $ 18,706 $ 11,321 The following table summarizes equity-based compensation expense by award type included in our unaudited condensed consolidated statements of operations and comprehensive loss: For the Three Months Ended For the Six Months Ended (In thousands) 2022 2021 2022 2021 Stock options $ 9,943 $ 5,024 $ 18,302 $ 11,063 Restricted stock units 19 21 28 43 Employee stock purchase plan 186 139 376 215 Total equity-based compensation expense included in total operating expense $ 10,148 $ 5,184 $ 18,706 $ 11,321 |
Summary of Stock Options Activity | The following table summarizes our stock option activity for the six months ended June 30, 2022: Number of Weighted Weighted (in years) Aggregate (in thousands) Outstanding at December 31, 2021 16,066,064 $ 9.92 8.09 $ 362,250 Granted 2,726,531 $ 30.12 Exercised ( 609,628 ) $ 7.10 Forfeited, canceled or expired ( 240,072 ) $ 15.92 Outstanding at June 30, 2022 17,942,895 $ 13.01 7.98 $ 254,755 Options vested and expected to vest as of June 30, 2022 17,942,895 $ 13.01 7.98 $ 254,755 Options exercisable as of June 30, 2022 8,198,252 $ 7.43 7.16 $ 155,871 |
Summary of Weighted Average Assumptions Used to Determine Fair Value of Stock Options Granted to Employees and Directors | The weighted-average assumptions that we used to determine the fair value of stock options granted to employees and directors are summarized as follows: For the Six Months Ended 2022 2021 Risk free interest rate 2.04 % 0.76 % Expected term (in years) 6.04 6.04 Expected volatility 96.0 % 94.0 % Expected dividend yield 0.0 % 0.0 % Weighted-average grant date fair value $ 23.39 $ 9.87 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Net Loss Per Share | The following table sets forth the computation of the basic and diluted net loss per share: For the Three Months Ended For the Six Months Ended (In thousands, except share amounts and per share data) 2022 2021 2022 2021 Numerator: Net loss $ ( 90,471 ) $ ( 53,239 ) $ ( 158,765 ) $ ( 104,220 ) Denominator: Weighted-average shares used in calculating net loss per share, basic and diluted 148,295,716 127,482,127 148,141,180 127,354,540 Net loss per share, basic and diluted $ ( 0.61 ) $ ( 0.42 ) $ ( 1.07 ) $ ( 0.82 ) |
Potential Dilutive Securities Excluded From Calculation of Net Loss Per Share | The shares in the table below were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: As of June 30, June 30, Stock options outstanding 17,942,895 17,120,349 Restricted stock units outstanding 18,932 42,810 Warrants outstanding — 5,149,647 ESPP shares issuable — 8,187 Total 17,961,827 22,320,993 |
Risks and Liquidity - Additiona
Risks and Liquidity - Additional Information (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Risks and Uncertainties [Abstract] | ||
Accumulated deficit | $ 775,009 | $ 616,244 |
Pfizer License Agreement - Addi
Pfizer License Agreement - Additional Information (Details) - Pfizer License Agreement [Member] | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
License Agreement [Line Items] | |
Royalty payments | $ 0 |
Regulatory approval milestone payments | 0 |
Commercial approval milestone payments | $ 0 |
Financing Liabilities - Additio
Financing Liabilities - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
Apr. 30, 2022 | Apr. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Fair Value, Option, Quantitative Disclosures [Line Items] | ||||||||
Total funding received | $ 31,100,000 | |||||||
Percentage of funding received | 25% | |||||||
Funding expected to be received | $ 125,000,000 | |||||||
Financing liability, related party | $ 27,205,000 | $ 27,205,000 | $ 16,770,000 | |||||
Financing liability | 27,205,000 | 27,205,000 | 16,770,000 | |||||
Gains (losses) on change in fair value of financing liability, related party | 930,000 | $ (496,000) | $ (500,000) | 2,900,000 | $ (496,000) | |||
Change in fair value of financing liability | (5,800,000) | 992,000 | ||||||
Gains (losses) on change in fair value of financing liability | 930,000 | (496,000) | $ (500,000) | 2,900,000 | (496,000) | |||
Unrealized gains recognized within other comprehensive income related to change in instrument-specific credit risk | 9,554,000 | 10,830,000 | ||||||
First Anniversaries [Member] | ||||||||
Fair Value, Option, Quantitative Disclosures [Line Items] | ||||||||
Total funding received | $ 37,500,000 | |||||||
Percentage of funding received | 30% | |||||||
Second Anniversaries [Member] | ||||||||
Fair Value, Option, Quantitative Disclosures [Line Items] | ||||||||
Funding expected to be received | $ 31,300,000 | |||||||
Percentage of funding expected to be received | 25% | |||||||
Third Anniversaries [Member] | ||||||||
Fair Value, Option, Quantitative Disclosures [Line Items] | ||||||||
Funding expected to be received | $ 25,000,000 | |||||||
Percentage of funding expected to be received | 20% | |||||||
NovaQuest Funding Agreement [Member] | ||||||||
Fair Value, Option, Quantitative Disclosures [Line Items] | ||||||||
Funding expected to be received | $ 62,500,000 | |||||||
Financing liability | 27,200,000 | 27,200,000 | 16,800,000 | |||||
Unrealized gains recognized within other comprehensive income related to change in instrument-specific credit risk | 4,800,000 | 0 | 5,400,000 | 0 | ||||
Bain Funding Agreement [Member] | ||||||||
Fair Value, Option, Quantitative Disclosures [Line Items] | ||||||||
Total funding received | $ 18,750,000 | $ 15,500,000 | ||||||
Percentage of funding received | 30% | 25% | ||||||
Funding expected to be received | $ 62,500,000 | |||||||
Fees incurred | 100,000 | |||||||
Financing liability, related party | 27,200,000 | 27,200,000 | $ 16,800,000 | |||||
Unrealized gains recognized within other comprehensive income related to change in instrument-specific credit risk | $ 4,800,000 | $ 0 | $ 5,400,000 | $ 0 | ||||
NovaQuest and Bain Funding Agreements [Member] | ||||||||
Fair Value, Option, Quantitative Disclosures [Line Items] | ||||||||
Fees incurred | 200,000 | |||||||
Payable on funding agreement | $ 531,300,000 | |||||||
Contractual obligation description repayment timing | earlier of FDA approval or May 1, 2025 | |||||||
NovaQuest and Bain Funding Agreements [Member] | Minimum [Member] | ||||||||
Fair Value, Option, Quantitative Disclosures [Line Items] | ||||||||
Percentage of funding commitment | 300% | |||||||
NovaQuest and Bain Funding Agreements [Member] | Maximum [Member] | ||||||||
Fair Value, Option, Quantitative Disclosures [Line Items] | ||||||||
Percentage of funding commitment | 425% |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Assets: | ||
Marketable securities (current) | $ 392,990 | $ 372,670 |
Marketable securities (non-current) | 52,269 | |
Recurring [Member] | ||
Assets: | ||
Total Assets | 533,058 | 622,157 |
Liabilities: | ||
Total Liabilities | 54,410 | 33,540 |
Recurring [Member] | Money Market Funds [Member] | ||
Assets: | ||
Cash equivalents, fair value | 133,202 | 153,589 |
Recurring [Member] | US Treasury and Government [Member] | ||
Assets: | ||
Marketable securities (current) | 211,135 | 171,063 |
Marketable securities (non-current) | 52,269 | |
Recurring [Member] | Corporate Debt Securities [Member] | ||
Assets: | ||
Cash equivalents, fair value | 1,431 | |
Marketable securities (current) | 8,958 | 20,452 |
Recurring [Member] | Commercial Paper [Member] | ||
Assets: | ||
Cash equivalents, fair value | 4,999 | 37,998 |
Marketable securities (current) | 172,897 | 181,155 |
Recurring [Member] | Restricted Cash [Member] | ||
Assets: | ||
Total Assets | 1,867 | 4,200 |
Recurring [Member] | Financing Liability, Related Party [Member] | ||
Liabilities: | ||
Total Liabilities | 27,205 | 16,770 |
Recurring [Member] | Financing Liability [Member] | ||
Liabilities: | ||
Total Liabilities | 27,205 | 16,770 |
Recurring [Member] | Quoted Prices in Active Markets (Level 1) [Member] | ||
Assets: | ||
Total Assets | 346,204 | 381,121 |
Recurring [Member] | Quoted Prices in Active Markets (Level 1) [Member] | Money Market Funds [Member] | ||
Assets: | ||
Cash equivalents, fair value | 133,202 | 153,589 |
Recurring [Member] | Quoted Prices in Active Markets (Level 1) [Member] | US Treasury and Government [Member] | ||
Assets: | ||
Marketable securities (current) | 211,135 | 171,063 |
Marketable securities (non-current) | 52,269 | |
Recurring [Member] | Quoted Prices in Active Markets (Level 1) [Member] | Restricted Cash [Member] | ||
Assets: | ||
Total Assets | 1,867 | 4,200 |
Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | ||
Assets: | ||
Total Assets | 186,854 | 241,036 |
Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | Corporate Debt Securities [Member] | ||
Assets: | ||
Cash equivalents, fair value | 1,431 | |
Marketable securities (current) | 8,958 | 20,452 |
Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | Commercial Paper [Member] | ||
Assets: | ||
Cash equivalents, fair value | 4,999 | 37,998 |
Marketable securities (current) | 172,897 | 181,155 |
Recurring [Member] | Significant Unobservable Inputs (Level 3) [Member] | ||
Liabilities: | ||
Total Liabilities | 54,410 | 33,540 |
Recurring [Member] | Significant Unobservable Inputs (Level 3) [Member] | Financing Liability, Related Party [Member] | ||
Liabilities: | ||
Total Liabilities | 27,205 | 16,770 |
Recurring [Member] | Significant Unobservable Inputs (Level 3) [Member] | Financing Liability [Member] | ||
Liabilities: | ||
Total Liabilities | $ 27,205 | $ 16,770 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | |
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |||
Asset impairment Charges | $ 0 | ||
Gains or losses recognized on the sale or maturity of marketable securities | $ 0 | $ 0 | |
Marketable securities weighted average maturity term | 5 months | 9 months | |
Discount Rate [Member] | |||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |||
Financing liability, related party and financing liability measurement input | 0.110 | 0.090 | |
Recurring [Member] | |||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |||
Liabilities fair value | $ 54,410,000 | $ 33,540,000 | |
Recurring [Member] | Financing Liability, Related Party [Member] | |||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |||
Liabilities fair value | 27,200,000 | ||
Recurring [Member] | Financing Liability [Member] | |||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |||
Liabilities fair value | 27,200,000 | ||
Quoted Prices in Active Markets (Level 1) [Member] | Recurring [Member] | |||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |||
Transfers from Level 1 to Level 2 | 0 | 0 | |
Significant Other Observable Inputs (Level 2) [Member] | Recurring [Member] | |||
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |||
Transfers from Level 2 to Level 1 | $ 0 | $ 0 |
Fair Value Measurements - Sum_2
Fair Value Measurements - Summary of Estimated Fair Value and Amortized Cost of Available-for-Sale Marketable Debt Securities (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Available-for-sale marketable debt securities, Amortized Cost | $ 395,045 | $ 425,138 |
Available-for-sale marketable debt securities, Unrealized Gains | 29 | 11 |
Available-for-sale marketable debt securities, Unrealized Losses | (2,084) | (210) |
Available-for-sale marketable debt securities, Fair Value | 392,990 | 424,939 |
US Treasury and Government [Member] | Due in One Year or Less [Member] | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Available-for-sale marketable debt securities, Amortized Cost | 212,366 | 171,111 |
Available-for-sale marketable debt securities, Unrealized Gains | 17 | |
Available-for-sale marketable debt securities, Unrealized Losses | (1,248) | (48) |
Available-for-sale marketable debt securities, Fair Value | 211,135 | 171,063 |
US Treasury and Government [Member] | Due after One Year through Two Years [Member] | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Available-for-sale marketable debt securities, Amortized Cost | 52,387 | |
Available-for-sale marketable debt securities, Unrealized Losses | (118) | |
Available-for-sale marketable debt securities, Fair Value | 52,269 | |
Corporate Debt Securities [Member] | Due in One Year or Less [Member] | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Available-for-sale marketable debt securities, Amortized Cost | 9,004 | 20,464 |
Available-for-sale marketable debt securities, Unrealized Losses | (46) | (12) |
Available-for-sale marketable debt securities, Fair Value | 8,958 | 20,452 |
Commercial Paper [Member] | Due in One Year or Less [Member] | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Available-for-sale marketable debt securities, Amortized Cost | 173,675 | 181,176 |
Available-for-sale marketable debt securities, Unrealized Gains | 12 | 11 |
Available-for-sale marketable debt securities, Unrealized Losses | (790) | (32) |
Available-for-sale marketable debt securities, Fair Value | $ 172,897 | $ 181,155 |
Fair Value Measurements - Sum_3
Fair Value Measurements - Summary of Rollforward of the Liability Associated with Financing Liabilities (Details) - Fair Value, Inputs, Level 3 [Member] - Financing Liabilities [Member] $ in Thousands | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Beginning balance | $ 33,540 |
Funding commitment received | 37,500 |
Change in fair value recognized in other expense (income), net | (5,800) |
Change in fair value attributable to instrument-specific credit risk recognized in other comprehensive (income) loss | (10,830) |
Ending balance | $ 54,410 |
Financial Statement Component_2
Financial Statement Components - Summary of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid clinical trial services | $ 1,207 | $ 2,038 |
Prepaid research and development expenses | 1,438 | 2,074 |
Prepaid insurance | 1,935 | 4,701 |
Other prepaid expenses | 2,271 | 2,225 |
Interest receivable | 981 | 729 |
Other | 1,101 | 562 |
Prepaid expenses and other current assets | $ 8,933 | $ 12,329 |
Financial Statement Component_3
Financial Statement Components - Summary of Property and Equipment Net (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Property Plant And Equipment [Line Items] | ||
Less: Accumulated depreciation | $ (4,807) | $ (2,566) |
Property and equipment, net | 29,314 | 28,449 |
Computer Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | 996 | 946 |
Furniture and Fixtures [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | 459 | 437 |
Laboratory Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | 9,001 | 5,617 |
Leasehold Improvements [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | 23,466 | 23,286 |
Construction in-progress [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment | $ 199 | $ 729 |
Financial Statement Component_4
Financial Statement Components - Summary of Other Long-Term Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Assets [Abstract] | ||
Other prepaid expenses, net of current portion | $ 1,737 | $ 1,806 |
Deferred expenses associated with financing activities | 465 | 485 |
Other | 560 | 442 |
Other long-term assets | $ 2,762 | $ 2,733 |
Financial Statement Component_5
Financial Statement Components - Summary of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Accrued Liabilities and Other Liabilities [Abstract] | ||
Accrued external research and development services | $ 30,659 | $ 16,097 |
Accrued compensation and personnel costs | 8,272 | 10,827 |
Accrued property and equipment | 311 | 109 |
Accrued professional fees and consulting services | 2,931 | 1,270 |
Other | 890 | 500 |
Accrued expenses and other current liabilities | $ 43,063 | $ 28,803 |
Financial Statement Component_6
Financial Statement Components - Summary of Other Income (Expense), Net (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Other Nonoperating Income (Expense) [Abstract] | |||||
Gain (loss) on fair value remeasurement of financing liability, related party | $ 930 | $ (496) | $ (500) | $ 2,900 | $ (496) |
Gain (loss) on fair value remeasurement of financing liability | 930 | (496) | $ (500) | 2,900 | (496) |
Loss on fair value remeasurement of private placement warrants | (1,746) | (2,170) | |||
Other, net | 8 | (1) | 9 | (2) | |
Other income (expense), net | $ 1,868 | $ (2,739) | $ 5,809 | $ (3,164) |
Stockholders' Equity, Preferred
Stockholders' Equity, Preferred Stock and Common Stock (Details) - USD ($) | 6 Months Ended | 12 Months Ended | |
Nov. 10, 2021 | Jun. 30, 2022 | Dec. 31, 2021 | |
Stockholders' Equity [Abstract] | |||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | |
Preferred stock, par value | $ 0.0001 | $ 0.0001 | |
Preferred stock, shares issued | 0 | 0 | |
Preferred stock, shares outstanding | 0 | 0 | |
Common stock, shares authorized | 500,000,000 | 500,000,000 | |
Common stock, par value | $ 0.0001 | $ 0.0001 | |
Common stock, shares issued | 148,395,282 | 147,719,523 | |
Common stock, shares outstanding | 148,395,282 | 147,719,523 | |
Common stock, voting rights | one vote | ||
Dividends declared | $ 0 | ||
Issuance and sale of common stock | $ 0 | ||
ATM Program [Member] | |||
Stockholders' Equity [Abstract] | |||
Issuance and sale of common stock | $ 0 | ||
ATM Program [Member] | Maximum [Member] | |||
Stockholders' Equity [Abstract] | |||
Issuance and sale of common stock yet to issue | $ 250,000,000 |
Stockholders' Equity, Warrants
Stockholders' Equity, Warrants (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2021 | Jun. 30, 2021 | Jun. 30, 2022 | Dec. 31, 2021 | Mar. 31, 2021 | Mar. 30, 2021 | |
Warrants [Abstract] | ||||||
Net losses related to changes in fair value of private placement warrants | $ 1,746,000 | $ 2,170,000 | ||||
Private Placement Warrants [Member] | ||||||
Warrants [Abstract] | ||||||
Warrants outstanding (in shares) | 0 | 0 | ||||
Fair value of private placement warrants reclassified from equity to other long term liabilities | 166,333 | |||||
Fair value of warrants | $ 0 | |||||
Private Placement Warrants [Member] | Other Income (Expense) [Member] | ||||||
Warrants [Abstract] | ||||||
Fair value of warrants | $ 400,000 | |||||
Net losses related to changes in fair value of private placement warrants | $ 1,700,000 | $ 2,200,000 | ||||
Private Placement Warrants [Member] | Additional Paid-in Capital [Member] | ||||||
Warrants [Abstract] | ||||||
Fair value of warrants | $ 300,000 |
Equity-Based Compensation - Sum
Equity-Based Compensation - Summary of Equity-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total equity-based compensation expense included in total operating expense | $ 10,148 | $ 5,184 | $ 18,706 | $ 11,321 |
Research and Development [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total equity-based compensation expense included in total operating expense | 4,802 | 2,122 | 8,808 | 3,919 |
General and Administrative [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total equity-based compensation expense included in total operating expense | 5,346 | 3,062 | 9,898 | 7,402 |
Stock Options [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total equity-based compensation expense included in total operating expense | 9,943 | 5,024 | 18,302 | 11,063 |
Restricted Stock Units [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total equity-based compensation expense included in total operating expense | 19 | 21 | 28 | 43 |
Employee Stock Purchase Plan [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total equity-based compensation expense included in total operating expense | $ 186 | $ 139 | $ 376 | $ 215 |
Equity-Based Compensation - S_2
Equity-Based Compensation - Summary of Stock Options Activity (Details) - Stock Option [Member] $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | |
Number of Shares | ||
Outstanding, Beginning balance | shares | 16,066,064 | |
Granted | shares | 2,726,531 | |
Exercised | shares | (609,628) | |
Forfeited, canceled or expired | shares | (240,072) | |
Outstanding, Ending balance | shares | 17,942,895 | 16,066,064 |
Options vested and expected to vest | shares | 17,942,895 | |
Options exercisable | shares | 8,198,252 | |
Weighted Average Exercise Price | ||
Outstanding, Beginning balance | $ / shares | $ 9.92 | |
Granted | $ / shares | 30.12 | |
Exercised | $ / shares | 7.10 | |
Forfeited | $ / shares | 15.92 | |
Outstanding, Ending balance | $ / shares | 13.01 | $ 9.92 |
Options vested and expected to vest | $ / shares | 13.01 | |
Options Exercisable | $ / shares | $ 7.43 | |
Weighted Average Remaining Contractual Life (in years) | ||
Outstanding | 7 years 11 months 23 days | 8 years 1 month 2 days |
Options vested and expected to vest | 7 years 11 months 23 days | |
Options Exercisable | 7 years 1 month 28 days | |
Aggregate Intrinsic Value | ||
Outstanding | $ | $ 254,755 | $ 362,250 |
Options vested and expected to vest | $ | 254,755 | |
Options Exercisable | $ | $ 155,871 |
Equity-Based Compensation - Add
Equity-Based Compensation - Additional Information (Details) - Stock Options [Member] $ / shares in Units, $ in Millions | 6 Months Ended |
Jun. 30, 2022 USD ($) $ / shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Total unrecognized equity-based compensation expense | $ | $ 113.1 |
Equity-based compensation expense expected to be recognized over weighted average period | 3 years 1 month 6 days |
Nasdaq [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Closing stock price | $ / shares | $ 26.44 |
Equity-Based Compensation - S_3
Equity-Based Compensation - Summary of Weighted Average Assumptions Used to Determine Fair Value of Stock Options Granted to Employees and Directors (Details) - Stock Options [Member] - $ / shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk free interest rate | 2.04% | 0.76% |
Expected term (in years) | 6 years 14 days | 6 years 14 days |
Expected volatility | 96% | 94% |
Expected dividend yield | 0% | 0% |
Weighted-average grant date fair value | $ 23.39 | $ 9.87 |
Net Loss Per Share - Computatio
Net Loss Per Share - Computation of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Numerator: | ||||||
Net loss | $ (90,471) | $ (68,294) | $ (53,239) | $ (50,981) | $ (158,765) | $ (104,220) |
Denominator: | ||||||
Weighted-average shares used in calculating net loss per share, basic and diluted | 148,295,716 | 127,482,127 | 148,141,180 | 127,354,540 | ||
Net loss per share, basic and diluted | $ (0.61) | $ (0.42) | $ (1.07) | $ (0.82) |
Net Loss Per Share - Potential
Net Loss Per Share - Potential Dilutive Securities Excluded From Calculation of Net Loss Per Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potential dilutive securities excluded from calculation of net loss per share, total | 17,961,827 | 22,320,993 |
Stock Options Outstanding [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potential dilutive securities excluded from calculation of net loss per share, total | 17,942,895 | 17,120,349 |
Restricted Stock Units Outstanding [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potential dilutive securities excluded from calculation of net loss per share, total | 18,932 | 42,810 |
Warrant [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potential dilutive securities excluded from calculation of net loss per share, total | 5,149,647 | |
ESPP Shares Issuable [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potential dilutive securities excluded from calculation of net loss per share, total | 8,187 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Income Tax Disclosure [Abstract] | ||||
Income tax benefits related to net operating losses incurred or research and development tax credits | $ 0 | $ 0 | $ 0 | $ 0 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] | ||
Loss or material costs related to indemnification obligation | $ 0 | |
Claims outstanding | 0 | |
Liabilities related to obligation | $ 0 | $ 0 |
Related Parties (Details)
Related Parties (Details) | 1 Months Ended | 6 Months Ended | |||
Jun. 30, 2022 USD ($) Director shares | Apr. 30, 2022 USD ($) | Apr. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) Director shares | Dec. 31, 2021 Director shares | |
Related Party Transaction [Line Items] | |||||
Percentage of funding received | 25% | ||||
Funding expected to be received | $ 125,000,000 | ||||
Total funding received | $ 31,100,000 | ||||
Common stock, shares outstanding | shares | 148,395,282 | 148,395,282 | 147,719,523 | ||
Pfizer Inc [Member] | |||||
Related Party Transaction [Line Items] | |||||
Common stock, shares outstanding | shares | 27,349,211 | 27,349,211 | 27,349,211 | ||
Number of members nominated to board of directors | Director | 2 | 2 | 2 | ||
Bain Investor [Member] | |||||
Related Party Transaction [Line Items] | |||||
Common stock, shares outstanding | shares | 60,632,356 | 60,632,356 | 60,632,356 | ||
Number of members nominated to board of directors | Director | 4 | 4 | 4 | ||
Bain Funding Agreement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Percentage of funding received | 30% | 25% | |||
Period over which funding support received | 4 years | ||||
Fees incurred | $ 100,000 | ||||
Funding expected to be received | 62,500,000 | ||||
Total funding received | $ 18,750,000 | $ 15,500,000 | |||
Research Collaboration and License Agreement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Reimbursements for research services, contingent development milestone payment and single-digit royalty payments on net sales | $ 0 | ||||
Management Agreement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Management fee | $ 0 |