Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2023 | May 01, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-38311 | |
Entity Registrant Name | Denali Therapeutics Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 46-3872213 | |
Entity Address, Address Line One | 161 Oyster Point Blvd | |
Entity Address, City or Town | South San Francisco | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94080 | |
City Area Code | 650 | |
Local Phone Number | 866-8548 | |
Title of 12(b) Security | Common Stock, par value $0.01 per share | |
Trading Symbol | DNLI | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding (shares) | 136,888,912 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false | |
Entity Central Index Key | 0001714899 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 68,131 | $ 218,044 |
Short-term marketable securities | 1,220,322 | 1,118,171 |
Prepaid expenses and other current assets | 36,709 | 36,104 |
Total current assets | 1,325,162 | 1,372,319 |
Property and equipment, net | 42,117 | 44,087 |
Operating lease right-of-use assets | 28,049 | 30,437 |
Other non-current assets | 14,016 | 13,399 |
Total assets | 1,409,344 | 1,460,242 |
Current liabilities: | ||
Accrued clinical and other research & development costs | 47,571 | 16,297 |
Accrued manufacturing costs | 19,959 | 22,307 |
Other accrued costs and current liabilities | 9,136 | 3,682 |
Accrued compensation | 7,365 | 17,087 |
Operating lease liabilities, current | 6,539 | 7,318 |
Related-party contract liability, current | 289,757 | 290,053 |
Total current liabilities | 391,080 | 363,922 |
Related-party contract liability, less current portion | 633 | 479 |
Operating lease liabilities, less current portion | 50,546 | 53,032 |
Other non-current liabilities | 379 | 379 |
Total liabilities | 442,638 | 417,812 |
Commitments and contingencies (Note 7) | ||
Stockholders' equity: | ||
Convertible preferred stock, $0.01 par value; 40,000,000 shares authorized as of March 31, 2023 and December 31, 2022; 0 shares issued and outstanding as of March 31, 2023 and December 31, 2022 | 0 | 0 |
Common stock, $0.01 par value; 400,000,000 shares authorized as of March 31, 2023 and December 31, 2022; 136,741,627 shares and 135,965,918 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively | 1,694 | 1,686 |
Additional paid-in capital | 2,048,297 | 2,018,617 |
Accumulated other comprehensive loss | (2,517) | (6,886) |
Accumulated deficit | (1,080,768) | (970,987) |
Total stockholders' equity | 966,706 | 1,042,430 |
Total liabilities and stockholders’ equity | 1,409,344 | 1,460,242 |
Nonrelated Party | ||
Current liabilities: | ||
Accounts payable | 2,215 | 2,790 |
Related Party | ||
Current liabilities: | ||
Accounts payable | $ 8,538 | $ 4,388 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Convertible preferred stock, par value (usd per share) | $ 0.01 | $ 0.01 |
Convertible preferred stock, shares authorized (in shares) | 40,000,000 | 40,000,000 |
Convertible preferred stock, shares issued (in shares) | 0 | 0 |
Convertible preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (usd per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 400,000,000 | 400,000,000 |
Common stock, shares issued (in shares) | 136,741,627 | 135,965,918 |
Common stock, shares outstanding (in shares) | 136,741,627 | 135,965,918 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | ||
Collaboration revenue: | |||
Collaboration revenue from customers | [1] | $ 35,141 | $ 42,141 |
Total collaboration revenue | 35,141 | 42,141 | |
Operating expenses: | |||
Research and development | [2] | 128,816 | 86,098 |
General and administrative | 27,140 | 22,541 | |
Total operating expenses | 155,956 | 108,639 | |
Loss from operations | (120,815) | (66,498) | |
Interest and other income, net | 11,034 | 1,278 | |
Net loss | (109,781) | (65,220) | |
Other comprehensive income (loss): | |||
Net unrealized gain (loss) on marketable securities, net of tax | 4,369 | (6,752) | |
Comprehensive loss | $ (105,412) | $ (71,972) | |
Net loss per share, basic (usd per share) | $ (0.80) | $ (0.53) | |
Net loss per share, diluted (usd per share) | $ (0.80) | $ (0.53) | |
Weighted average number of shares outstanding, basic (in shares) | 136,524,528 | 122,673,935 | |
Weighted average number of shares outstanding, diluted (in shares) | 136,524,528 | 122,673,935 | |
[1]Includes related-party collaboration revenue from a customer of $0.1 million and $2.2 million for the three months ended March 31, 2023 and 2022, respectively.[2]Includes expenses for cost sharing payments due to a related party of $4.2 million and $2.7 million for the three months ended March 31, 2023 and 2022, respectively. |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | ||
Collaboration revenue from customers | [1] | $ 35,141 | $ 42,141 |
Research and development expense due to cost share payments to related party | [2] | 128,816 | 86,098 |
Related Party | |||
Collaboration revenue from customers | 100 | 2,200 | |
Research and development expense due to cost share payments to related party | $ 4,200 | $ 2,700 | |
[1]Includes related-party collaboration revenue from a customer of $0.1 million and $2.2 million for the three months ended March 31, 2023 and 2022, respectively.[2]Includes expenses for cost sharing payments due to a related party of $4.2 million and $2.7 million for the three months ended March 31, 2023 and 2022, respectively. |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2021 | 122,283,305 | ||||
Beginning balance at Dec. 31, 2021 | $ 962,291 | $ 1,548 | $ 1,608,238 | $ (2,499) | $ (644,996) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuances under equity incentive plans (in shares) | 151,419 | ||||
Issuances under equity incentive plans | 1,463 | $ 2 | 1,461 | ||
Vesting of restricted stock units (in shares) | 423,184 | ||||
Vesting of restricted stock units | 0 | $ 4 | (4) | ||
Stock-based compensation | 26,145 | 26,145 | |||
Net loss | (65,220) | (65,220) | |||
Other comprehensive gain (loss) | (6,752) | (6,752) | |||
Ending balance (in shares) at Mar. 31, 2022 | 122,857,908 | ||||
Ending balance at Mar. 31, 2022 | $ 917,927 | $ 1,554 | 1,635,840 | (9,251) | (710,216) |
Beginning balance (in shares) at Dec. 31, 2022 | 135,965,918 | 135,965,918 | |||
Beginning balance at Dec. 31, 2022 | $ 1,042,430 | $ 1,686 | 2,018,617 | (6,886) | (970,987) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuances under equity incentive plans (in shares) | 204,308 | ||||
Issuances under equity incentive plans | 1,604 | $ 2 | 1,602 | ||
Vesting of restricted stock units (in shares) | 571,401 | ||||
Vesting of restricted stock units | 0 | $ 6 | (6) | ||
Stock-based compensation | 28,084 | 28,084 | |||
Net loss | (109,781) | (109,781) | |||
Other comprehensive gain (loss) | $ 4,369 | 4,369 | |||
Ending balance (in shares) at Mar. 31, 2023 | 136,741,627 | 136,741,627 | |||
Ending balance at Mar. 31, 2023 | $ 966,706 | $ 1,694 | $ 2,048,297 | $ (2,517) | $ (1,080,768) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating activities | ||
Net loss | $ (109,781) | $ (65,220) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 10,047 | 2,079 |
Stock–based compensation expense | 28,084 | 26,145 |
Net amortization of premiums and (discounts) on marketable securities | (7,853) | 1,627 |
Non-cash adjustment to operating lease expense | (877) | (783) |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (1,789) | 1,242 |
Accounts payable | 3,698 | 1,248 |
Accruals and other current liabilities | 19,810 | (8,306) |
Contract liabilities | 0 | (27,915) |
Related-party contract liability | (141) | (2,226) |
Net cash used in operating activities | (58,802) | (72,109) |
Investing activities | ||
Purchases of marketable securities | (523,714) | (364,337) |
Purchases of property and equipment | (2,786) | (4,041) |
Maturities and sales of marketable securities | 433,785 | 250,500 |
Net cash used in investing activities | (92,715) | (117,878) |
Financing activities | ||
Proceeds from exercise of awards under equity incentive plans | 1,604 | 1,463 |
Net cash provided by financing activities | 1,604 | 1,463 |
Net decrease in cash, cash equivalents and restricted cash | (149,913) | (188,524) |
Cash, cash equivalents and restricted cash at beginning of period | 219,544 | 294,977 |
Cash, cash equivalents and restricted cash at end of period | 69,631 | 106,453 |
Supplemental disclosures of cash flow information | ||
Cash paid during the period for income taxes | 4 | 0 |
Property and equipment purchases accrued but not yet paid | $ 6,075 | $ 114 |
Significant Accounting Policies
Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | Significant Accounting Policies Organization and Description of Business Denali Therapeutics Inc. ("Denali" or the “Company”) is a biopharmaceutical company, incorporated in Delaware, that discovers and develops therapeutics to defeat neurodegenerative diseases. The Company is headquartered in South San Francisco, California. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of the Securities and Exchange Commission ("SEC") Regulation S-X for interim financial information. These unaudited condensed consolidated financial statements and notes should be read in conjunction with the audited consolidated financial statements and notes thereto contained in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on February 27, 2023 (the "2022 Annual Report on Form 10-K"). The Condensed Consolidated Balance Sheet as of December 31, 2022 was derived from the audited annual consolidated financial statements as of and for the period then ended. Certain information and footnote disclosures typically included in the Company's annual consolidated financial statements have been condensed or omitted. The accompanying unaudited condensed consolidated financial statements reflect all adjustments that, in the opinion of management, are necessary for a fair statement of the results of the interim periods presented. All such adjustments are of a normal recurring nature except for the impacts of adopting new accounting standards, if any, discussed below. These interim financial results are not necessarily indicative of results expected for the full fiscal year or for any subsequent interim period. During the three months ended March 31, 2023 there were no material changes to the Company's significant accounting and financial reporting policies from those reflected in the 2022 Annual Report on Form 10-K. For further information with regard to the Company’s Significant Accounting Policies, please refer to Note 1, "Significant Accounting Policies," to the Company’s Consolidated Financial Statements included in the 2022 Annual Report on Form 10-K. Principles of Consolidation These unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. For the Company and its subsidiaries, the functional currency has been determined to be U.S. dollars. Monetary assets and liabilities denominated in foreign currency are remeasured at period-end exchange rates, non-monetary assets and liabilities denominated in foreign currencies are remeasured at historical rates, and transactions in foreign currencies are remeasured at average exchange rates. Foreign currency gains and losses resulting from remeasurement are recognized in interest and other income, net in the Condensed Consolidated Statements of Operations and Comprehensive Loss. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make certain estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, as well as the reported amounts of expenses during the reporting period. Actual results could differ from those estimates, and such differences could be material to the Condensed Consolidated Balance Sheets and Statements of Operations and Comprehensive Loss. Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, and marketable securities. Substantially all of the Company’s cash and cash equivalents are deposited in accounts with financial institutions that management believes are of high credit quality. Such deposits have and will continue to exceed federally insured limits. The Company maintains its cash with accredited financial institutions and accordingly, such funds are subject to minimal credit risk. The Company’s investment policy limits investments to certain types of securities issued by the U.S. government and its agencies, as well as institutions with investment-grade credit ratings and places restrictions on maturities and concentration by type and issuer. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash, cash equivalents and marketable securities and issuers of marketable securities to the extent recorded on the Condensed Consolidated Balance Sheets. As of March 31, 2023 and December 31, 2022, the Company had no off-balance sheet concentrations of credit risk. The Company is subject to a number of risks similar to other clinical-stage biopharmaceutical companies, including, but not limited to, the need to obtain adequate additional funding, possible failure of current or future preclinical testing or clinical trials, its reliance on third parties to conduct its clinical trials, the need to obtain regulatory and marketing approvals for its product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of the Company’s product candidates, its right to develop and commercialize its product candidates pursuant to the terms and conditions of the licenses granted to the Company, protection of proprietary technology, the ability to make milestone, royalty or other payments due under any license or collaboration agreements, and the need to secure and maintain adequate manufacturing arrangements with third parties. If the Company does not successfully commercialize or partner any of its product candidates, it will be unable to generate product revenue or achieve profitability. Further, the company is also subject to broad market risks and uncertainties resulting from recent events, such as bank failures or instability in the financial services sector, the COVID-19 pandemic, the Russian invasion of Ukraine, inflation, rising interest rates, and recession risks as well as supply chain and labor shortages. Segments The Company has one operating segment. The Company’s chief operating decision maker, its Chief Executive Officer, manages the Company’s operations on a consolidated basis for the purposes of allocating resources. Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with original maturities of 90 days or less at the date of purchase to be cash and cash equivalents. Cash equivalents are reported at fair value. Cash, cash equivalents, and restricted cash reported within the Condensed Consolidated Statements of Cash Flows is composed of cash and cash equivalents reported in the Condensed Consolidated Balance Sheets and $1.5 million of restricted cash for the letter of credit for the Company’s headquarters building lease which is included within other non-current assets in the Condensed Consolidated Balance Sheets. Marketable Securities The Company generally invests its excess cash in money market funds and investment grade short to intermediate-term fixed income securities. Such investments are included in cash and cash equivalents, short-term marketable securities, or long-term marketable securities on the Condensed Consolidated Balance Sheets, are considered available-for-sale, and reported at fair value with net unrealized gains and losses included as a component of stockholders’ equity. The Company classifies investments in securities with remaining maturities of less than one year, or where its intent is to use the investments to fund current operations or to make them available for current operations, as short-term investments. The Company classifies investments in securities with remaining maturities of over one year as long-term investments, unless intended to fund current operations. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest and other income, net in the Condensed Consolidated Statements of Operations and Comprehensive Loss. Realized gains and losses and declines in value determined to be due to credit losses on marketable securities, if any, are included in interest and other income, net. The Company periodically evaluates the need for an allowance for credit losses. This evaluation includes consideration of several qualitative and quantitative factors, including whether it has plans to sell the security, whether it is more likely than not it will be required to sell any marketable securities before recovery of its amortized cost basis, and if the entity has the ability and intent to hold the security to maturity, and the portion of any unrealized loss that is the result of a credit loss. Factors considered in making these evaluations include quoted market prices, recent financial results and operating trends, implied values from any recent transactions or offers of investee securities, credit quality of debt instrument issuers, expected cash flows from securities, other publicly available information that may affect the value of the marketable security, duration and severity of the decline in value, and the Company's strategy and intentions for holding the marketable security. Accounts Receivable Accounts receivable are included within prepaid expenses and other current assets on the Condensed Consolidated Balance Sheets. The accounts receivable balance represents amounts receivable from the Company's collaboration partners, excluding related parties, net of an allowance for credit losses, if required. Leases The Company leases real estate, and certain equipment for use in its operations. A determination is made as to whether an arrangement is a lease at inception. Right-of-use (“ROU”) assets and operating lease liabilities are recognized for identified operating leases in the Condensed Consolidated Balance Sheets. The changes in operating lease ROU assets and operating lease liabilities are presented net within non-cash adjustment to operating lease expense in the Condensed Consolidated Statements of Cash Flows. ROU assets represent the Company’s right to use the underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments due over the lease term, with the ROU assets adjusted for lease incentives received. When determining the present value of lease payments, the Company uses its incremental borrowing rate on the date of lease commencement, or the rate implicit in the lease, if known. The Company does not assume renewals in its determination of the lease term unless the renewals are deemed by management to be reasonably certain at lease inception. Leases with an initial term of twelve months or less are not recorded on the balance sheet, unless they include an option to purchase the underlying asset that the Company is reasonably certain to exercise. The Company recognizes lease expenses on a straight-line basis over the lease term. The Company has leases with lease and non-lease components, which the Company has elected to account for as a single lease component. Revenue Recognition License, Option and Collaboration Revenue The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC 808, Collaborative Arrangements (“ASC 808”) to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities. This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement. For collaboration arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 808 and those that are more reflective of a vendor-customer relationship and, therefore, within the scope of Topic 606. For elements of collaboration arrangements that are accounted for pursuant to ASC 808, an appropriate recognition method is determined and applied consistently, generally by analogy to Topic 606. The accounting treatment pursuant to Topic 606 is outlined below. The terms of license, option and collaboration agreements entered into typically include payment of one or more of the following: non-refundable, up-front license fees; option exercise fees; development, regulatory and commercial milestone payments; payments for manufacturing supply and research and development services and royalties on net sales of licensed products. Each of these payments results in license, collaboration and other revenue, except for revenues from royalties on net sales of licensed products, which are classified as royalty revenue. The core principle of Topic 606 is to recognize revenue when promised goods or services are transferred to customers in an amount that reflects the consideration that is expected to be received in exchange for those goods or services. The Company may also receive reimbursement or make payments to a collaboration partner to satisfy cost sharing requirements. These payments are accounted for pursuant to ASC 808 and are recorded as an offset or increase to research and development expenses, respectively. In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under each of its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. Amounts received prior to satisfying the revenue recognition criteria are recorded as contract liabilities in the Company’s Condensed Consolidated Balance Sheets. If the related performance obligation is expected to be satisfied within the next twelve months this will be classified in current liabilities. Amounts recognized as revenue prior to the Company having an unconditional right (other than a right that is conditioned only on the passage of time) to receipt are recorded as contract assets in the Company's Condensed Consolidated Balance Sheets. If the Company expects to have an unconditional right to receive the consideration in the next twelve months, this will be classified in current assets. A net contract asset or liability is presented for each contract with a customer. At contract inception, the Company assesses the goods or services promised in a contract with a customer and identifies those distinct goods and services that represent a performance obligation. A promised good or service may not be identified as a performance obligation if it is immaterial in the context of the contract with the customer, if it is not separately identifiable from other promises in the contract (either because it is not capable of being separated or because it is not separable in the context of the contract), or if the promised good or service does not provide the customer with a material right. The Company considers the terms of the contract to determine the transaction price. The transaction price is the amount of consideration to which the Company expects to be entitled in exchange for transferring promised goods or services to a customer. The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. Variable consideration will only be included in the transaction price when it is not considered constrained, which is when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. If it is determined that multiple performance obligations exist, the transaction price is allocated at the inception of the agreement to all identified performance obligations based on the relative standalone selling prices ("SSP"). The relative SSP for each deliverable is estimated using external sourced evidence if it is available. If external sourced evidence is not available, the Company uses its best estimate of the SSP for the deliverable. Revenue is recognized when, or as, the Company satisfies a performance obligation by transferring a promised good or service to a customer. An asset is transferred when, or as, the customer obtains control of that asset, which for a service is considered to be as the services are received and used. The Company recognizes revenue over time by measuring the progress toward complete satisfaction of the relevant performance obligation using an appropriate input or output method based on the nature of the service promised to the customer. After contract inception, the transaction price is reassessed at every period end and updated for changes such as resolution of uncertain events. Any change in the transaction price is allocated to the performance obligations on the same basis as at contract inception, or to a single performance obligation as applicable. Management may be required to exercise considerable judgment in estimating revenue to be recognized. Judgment is required in identifying performance obligations, estimating the transaction price, estimating the SSP of identified performance obligations, which may include forecasted revenue, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success, and estimating the progress towards satisfaction of performance obligations. Comprehensive Loss Comprehensive loss is composed of net loss and certain changes in stockholders’ equity that are excluded from net loss, primarily unrealized gains or losses on the Company’s marketable securities. Net Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are antidilutive given the net loss for each period presented. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements Assets and liabilities measured at fair value at each balance sheet date are as follows (in thousands): March 31, 2023 Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 38,170 $ — $ — $ 38,170 Short-term marketable securities: U.S. government treasuries 1,093,118 — — 1,093,118 U.S. government agency securities — 26,471 — 26,471 Corporate debt securities — 47,315 — 47,315 Commercial paper — 53,418 — 53,418 Total $ 1,131,288 $ 127,204 $ — $ 1,258,492 December 31, 2022 Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 105,340 $ — $ — $ 105,340 U.S. government treasuries 43,781 — — 43,781 Commercial paper — 9,948 — 9,948 Short-term marketable securities: U.S. government treasuries 1,003,504 — — 1,003,504 U.S. government agency securities — 16,861 — 16,861 Corporate debt securities — 54,215 — 54,215 Commercial paper — 43,591 — 43,591 Total $ 1,152,625 $ 124,615 $ — $ 1,277,240 The carrying amounts of cost sharing reimbursements due to related party, prepaid expenses and other current assets, accounts payable, and accrued liabilities approximate their fair values due to their short-term maturities. The Company’s Level 2 securities are valued 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. The Company has not transferred any assets or liabilities between the fair value measurement levels. |
Marketable Securities
Marketable Securities | 3 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | Marketable Securities All marketable securities were considered available-for-sale at March 31, 2023 and December 31, 2022. On a recurring basis, the Company records its marketable securities at fair value using Level 1 or Level 2 inputs as discussed in Note 2, "Fair Value Measurements". The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s marketable securities by major security type at each balance sheet date are summarized in the tables below (in thousands): March 31, 2023 Amortized Cost Unrealized Holding Gains Unrealized Holding Losses Aggregate Fair Value Short-term marketable securities: U.S. government treasuries (1) $ 1,095,241 $ 280 $ (2,403) $ 1,093,118 U.S. government agency securities 26,419 52 — 26,471 Corporate debt securities (2) 47,410 — (95) 47,315 Commercial paper 53,418 — — 53,418 Total $ 1,222,488 $ 332 $ (2,498) $ 1,220,322 __________________________________________________ (1) Unrealized holding losses on 40 securities with an aggregate fair value of $570.5 million. (2) Unrealized holding losses on 13 securities with an aggregate fair value of $47.3 million. December 31, 2022 Amortized Cost Unrealized Holding Gains Unrealized Holding Losses Aggregate Fair Value Short-term marketable securities: U.S. government treasuries (1) $ 1,009,733 $ 58 $ (6,287) $ 1,003,504 U.S. government agency securities 16,823 38 — 16,861 Corporate debt securities (2) 54,571 — (356) 54,215 Commercial paper 43,591 — — 43,591 Total $ 1,124,718 $ 96 $ (6,643) $ 1,118,171 __________________________________________________ (1) Unrealized holding losses on 51 securities with an aggregate fair value of $683.4 million. (2) Unrealized holding losses on 16 securities with an aggregate fair value of $54.2 million. As of March 31, 2023 and December 31, 2022, a majority of the Company's marketable securities were in an unrealized loss position. The Company has not recognized an allowance for credit losses as of March 31, 2023 or December 31, 2022. The Company determined that it had the ability and intent to hold all marketable securities that have been in a continuous loss position until maturity or recovery. Further, a majority of these marketable securities are held in U.S. government securities, and the remainder were initially, and continue to be, held with investment grade, high credit quality institutions. All marketable securities with unrealized losses as of each balance sheet date have been in a loss position for less than twelve months or the loss is not material. As of March 31, 2023, all of the Company’s marketable securities have an effective maturity of less than one year. |
Acquisition
Acquisition | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Acquisition | AcquisitionIn August 2016, the Company entered into a License and Collaboration Agreement (“F-star Collaboration Agreement”) with F-star Gamma Limited (“F-star Gamma”), F-star Biotechnologische Forschungs-und Entwicklungsges M.B.H ("F-star GmbH") and F-star Biotechnology Limited ("F-star Ltd") (collectively, “F-star”) to leverage F-star’s modular antibody technology and the Company’s expertise in the development of therapies for neurodegenerative diseases. In May 2018, the Company exercised the pre-negotiated option agreement (the "Option Agreement") under the F-star Collaboration Agreement and entered into a Share Purchase Agreement (the “Purchase Agreement”) with the shareholders of F-star Gamma and Shareholder Representative Services LLC, pursuant to which the Company acquired all of the outstanding shares of F-star Gamma (the “Acquisition”). The details of the Acquisition are further described in Note 4, "Acquisition", to the consolidated financial statements in the Company's 2022 Annual Report on Form 10-K.As of March 31, 2023, the Company had paid consideration of $19.8 million in the aggregate consisting of up-front and preclinical contingent consideration, all of which was recorded as research and development expense as incurred. An additional contingent consideration payment of $30.0 million was triggered in March 2023 upon the achievement of a specified clinical milestone in the ETV:IDS program, and recognized as research and development expense in the Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) for the three months ended March 31, 2023, and is recorded in accrued clinical and other research and development costs on the Condensed Consolidated Balance Sheet as of March 31, 2023. This payment fully satisfies the Company's clinical contingent consideration obligations under the Purchase Agreement. There was no contingent consideration expense recognized for the three months ended March 31, 2022. |
Collaboration Agreements
Collaboration Agreements | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaboration Agreements | Collaboration Agreements Biogen In August 2020, the Company entered into a binding Provisional Collaboration and License Agreement (“Provisional Biogen Collaboration Agreement”) with Biogen Inc.’s subsidiaries, Biogen MA Inc. (“BIMA”) and Biogen International GmbH (“BIG”) (BIMA and BIG, collectively, “Biogen”), which expired in October 2020 upon the execution of a Definitive LRRK2 Collaboration and License Agreement (“LRRK2 Agreement”) with Biogen on October 4, 2020 and a Right of First Negotiation, Option and License Agreement (the “ROFN and Option Agreement”) on October 6, 2020 (collectively, the "Biogen Collaboration Agreement"). The details of the Provisional Biogen Collaboration Agreement and the Biogen Collaboration Agreement and the payments the Company has received, and is entitled to receive, are further described in Note 5, "Collaboration Agreements", to the consolidated financial statements in the 2022 Annual Report on Form 10-K. During the first quarter of 2023, there were no changes to the terms of the Biogen Collaboration Agreement, and no change in the transaction price during the three months ended March 31, 2023. In April 2023, Biogen exercised its option to license Denali's ATV:Abeta program, triggering a $5.0 million option fee payment, which is expected to be received in May 2023. A related-party contract liability of $290.4 million and $290.5 million was recorded on the Condensed Consolidated Balance Sheets as of March 31, 2023 and December 31, 2022, respectively. Approximately $288.9 million of this contract liability relates to the revenue allocated to the material right for the ATV:Abeta option under the ROFN and Option Agreement, which was exercised in April 2023. The remaining $1.5 million of this contract liability relates to the portion of the Option Research Services performance obligation for the second option program yet to be satisfied, with such amount to be recognized over the estimated period of the services, which is expected to be more than one year. The Company recorded $4.2 million and $2.7 million of cost sharing payments to Biogen for LRRK2 development activities in research and development expenses in the Condensed Consolidated Statement of Operations and Comprehensive Loss for the three months ended March 31, 2023 and 2022, respectively. C ost sharing payments due to related party of $8.5 million and $4.4 million were recorded on the Condensed Consolidated Balance Sheets as of March 31, 2023 and December 31, 2022 , respectively. Sanofi In October 2018, the Company entered into a Collaboration and License Agreement ("Sanofi Collaboration Agreement") with Genzyme Corporation, a wholly owned subsidiary of Sanofi S.A. ("Sanofi"). The details of the Sanofi Collaboration Agreement and the payments the Company has received, and is entitled to receive, are further described in Note 5, "Collaboration Agreements", to the consolidated financial statements in the Company's 2022 Annual Report on Form 10-K. The Company has no remaining performance obligations under the Sanofi Collaboration Agreement, and therefore no contract liability remains on the Condensed Consolidated Balance Sheets as of March 31, 2023 or December 31, 2022 . During the first quarter of 2023, there were no changes to the terms of the Sanofi Collaboration Agreement, and the transaction price increased by $25.0 million due to a milestone payment triggered and received in January 2023 upon the commencement of dosing in a Phase 2 study of SAR443820/DNL788 in individuals with multiple sclerosis. This milestone was recognized in collaboration revenue from customers in the Condensed Consolidated Statement of Operations and Comprehensive Loss for the three months ended March 31, 2023 since the associated performance obligation had been satisfied. As of March 31, 2023, the Company had earned milestone payments of $100.0 million and had not recorded any product sales under the Sanofi Collaboration Agreement. Takeda PTV:PGRN and ATV:TREM2 Collaboration Agreements In January 2018, the Company entered into a Collaboration and Option Agreement ("Takeda Collaboration Agreement") with Takeda Pharmaceutical Company Limited ("Takeda"). The details of the Takeda Collaboration Agreement are further described in Note 5, "Collaboration Agreements", to the consolidated financial statements in the Company's 2022 Annual Report on Form 10-K. There are no remaining performance obligations or potential payments remaining under the initial Takeda Collaboration Agreement. The opt-in by Takeda on the PTV:PGRN and ATV:TREM2 programs represented two new contracts with a customer for accounting purposes (the "PTV:PGRN Collaboration Agreement" and the "ATV:TREM2 Collaboration Agreement"), both of which became effective in December 2021. The details of the PTV:PGRN Collaboration Agreement and the ATV:TREM2 Collaboration Agreement are further described in Note 5, "Collaboration Agreements", to the consolidated financial statements in the Company's 2022 Annual Report on Form 10-K. During the three months ended March 31, 2023, there were no changes to the terms of the ATV:TREM2 or PTV:PGRN Collaboration Agreements, and an increase in the transaction price in the PTV:PGRN Collaboration Agreement of $10.0 million upon achievement of a specified clinical milestone in the Phase 1/2 clinical of DNL593 in patients with FTD-GRN. This milestone was recognized in collaboration revenue from customers in the Condensed Consolidated Statement of Operations and Comprehensive Loss for the three months ended March 31, 2023 since the associated performance obligation has been satisfied, and was included as a receivable within prepaid expenses and other current assets on the Condensed Consolidated Balance Sheet as of March 31, 2023. The Company recorded $1.5 million and $2.9 million of cost sharing reimbursements for PTV:PGRN, and $1.7 million and $2.1 million of cost sharing reimbursements for ATV:TREM2 Development Activities, for the three months ended March 31, 2023 and 2022, respectively, as offsets to research and development expenses in the Condensed Consolidated Statement of Operations and Comprehensive Loss. Cost sharing reimbursements of $3.2 million and $8.9 million are recorded as receivables within prepaid expenses and other current assets on the Condensed Consolidated Balance Sheets as of March 31, 2023 and December 31, 2022, respectively. As of March 31, 2023, the Company had earned $10.0 million in option fee payments and $10.0 million in milestone payments from Takeda under the combined PTV:PGRN and ATV:TREM2 Collaboration Agreements, and had not recorded any product sales under either agreement. Collaboration Revenue Revenue disaggregated by collaboration agreement and performance obligation is as follows (in thousands): Three Months Ended March 31, 2023 2022 Takeda Collaboration Agreement: Takeda Collaboration Agreement Services (1) $ — $ 39,916 PTV:PGRN Collaboration Agreement 10,000 — Total Takeda Collaboration Revenue 10,000 39,916 Sanofi Collaboration Agreement CNS Program License 25,000 — Total Sanofi Collaboration Revenue 25,000 — Biogen Collaboration Agreement Option Research Services (2) 141 2,225 Total Biogen Collaboration Revenue 141 2,225 Total Collaboration Revenue $ 35,141 $ 42,141 _________________________________________________ (1) Revenue of $27.9 million for the three months ended March 31, 2022 was included in the contract liability balance at the beginning of the period. |
License Agreements
License Agreements | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License Agreements | License Agreements Genentech In June 2016, the Company entered into an Exclusive License Agreement with Genentech, Inc. (“Genentech License Agreement”). The details of the Genentech License Agreement are further described in Note 6, "License Agreements", to the consolidated financial statements in the Company's 2022 Annual Report on Form 10-K. No expenses were recorded under the Genentech License Agreement for the three months ended March 31, 2023 or 2022. To date, the Company has made payments to Genentech of $25.0 million in the aggregate, including an upfront fee, a technology transfer fee and three clinical milestone payments, with $18.8 million of the payments recorded as research and development expense as incurred, net of cost sharing reimbursements from Biogen. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Lease Obligations In May 2018, the Company entered into an operating lease for its corporate headquarters in South San Francisco (the "Headquarters Lease"), as further described in Note 8, "Commitments and Contingencies," to the consolidated financial statements in the Company's 2022 Annual Report on Form 10-K. In August 2021, the Company entered into an operating lease for laboratory, office and warehouse premises in Salt Lake City, Utah (the “SLC Lease”) . In March 2023, the Company terminated the SLC Lease, which resulted in the recognition of $7.9 million of accelerated depreciation on leasehold improvements in the three months ended March 31, 2023 . The SLC Lease had not commenced for accounting purposes, and as such, no lease liability or ROU asset was recorded on the Condensed Consolidated Balance Sheet, and no operating lease expense was recorded associated with this lease. In April 2023, the Company entered into a new operating lease in Salt Lake City for a 59,336 square foot laboratory, office and warehouse premises with a contractual term of approximately 15.0 years upon commencement, and future undiscounted lease payments of approximately $13.4 million. Management exercised judgment in applying the requirements of ASC 842, including the determination as to whether certain contracts contain a lease and for leases identified under the standard, the discount rate used to determine the measurement of the lease liability. The discount rates of our operating leases are an approximation of the Company's incremental borrowing rate and are dependent upon the term and economics of the agreement. To estimate the incremental borrowing rate, management considers observable debt yields of comparable market instruments, as well as benchmarks within the lease agreement that may be indicative of the rate implicit in the lease. There were no changes to the terms of the leases recognized under ASC 842 during three months ended March 31, 2023. Operating lease costs, including variable costs, recognized under ASC 842 were $2.9 million and $2.8 million for three months ended March 31, 2023 and 2022, respectively. The following table contains a summary of other information pertaining to the Company’s operating lease for the periods presented (in thousands): Three Months Ended March 31, 2023 2022 Cash paid for amounts included in measurement of lease liabilities $ 2,996 $ 2,618 As of March 31, 2023 2022 Weighted average remaining lease term 6.1 years 7.1 years Weighted average discount rate 9.0 % 9.0 % The following table reconciles the undiscounted cash flows for the next five years and total of the remaining years to the operating lease liabilities recorded in the Condensed Consolidated Balance Sheet as of March 31, 2023 (in thousands): Year Ended December 31: 2023 (nine months) 8,348 2024 11,417 2025 11,793 2026 12,182 2027 12,584 Thereafter 17,382 Total undiscounted lease payments 73,706 Present value adjustment (16,621) Net operating lease liabilities $ 57,085 Indemnification In the ordinary course of business, the Company may provide indemnifications of varying scope and terms to vendors, lessors, business partners, board members, officers, and other parties with respect to certain matters, including, but not limited to, losses arising out of breach of such agreements, services to be provided by the Company, negligence or willful misconduct of the Company, violations of law by the Company, or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with directors and certain officers and employees that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors, officers or employees. No demands have been made upon the Company to provide indemnification under such agreements, and thus, there are no claims that the Company is aware of that could have a material effect on the Company’s Condensed Consolidated Balance Sheets, Condensed Consolidated Statements of Operations and Comprehensive Loss, or Condensed Consolidated Statements of Cash Flows. Commitments Effective September 2017, the Company entered into a Development and Manufacturing Services Agreement as amended (“DMSA”) with Lonza Sales AG (“Lonza”) for the development and manufacture of biologic products. Under the DMSA, the Company will execute purchase orders based on project plans authorizing Lonza to provide development and manufacturing services with respect to certain of the Company's antibody and enzyme products, and will pay for the services provided and batches delivered in accordance with the DMSA and project plan. Unless earlier terminated, the DMSA will expire when all development and manufacturing services are completed, which is expected to be by November 2029. As of March 31, 2023 and December 31, 2022, the Company had total non-cancellable purchase commitments under the DMSA of $39.6 million and $32.3 million, respectively. During the three months ended March 31, 2023 and 2022, the Company incurred costs of $5.2 million and $10.0 million, respectively, and made payments of $3.8 million and $8.7 million, respectively, for the development and manufacturing services rendered under the DMSA. In the normal course of business, the Company enters into other firm purchase commitments primarily related to research and development activities. The Company had contractual obligations under certain clinical and manufacturing agreements other than the DMSA of $46.9 million and $9.6 million, as of March 31, 2023 and December 31, 2022, respectively, with certain amounts subject to cost sharing with Takeda. Contingencies From time to time, the Company may be involved in lawsuits, arbitration, claims, investigations and proceedings consisting of intellectual property, employment and other matters which arise in the ordinary course of business. The Company records accruals for loss contingencies to the extent that the Company concludes that it is probable that a liability has been incurred and the amount of the related loss can be reasonably estimated. |
Stock-Based Awards
Stock-Based Awards | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Awards | Stock-Based Awards The Company has issued stock-based awards from various equity incentive and stock purchase plans, as more fully described in Note 9, "Stock-Based Awards" to the consolidated financial statements in the Company's 2022 Annual Report on Form 10-K. Stock Option Activity The following table summarizes stock option activity for the three months ended March 31, 2023: Number of Options Weighted-Average Exercise Price Balance at December 31, 2022 14,673,717 $ 27.03 Granted 2,977,841 27.66 Exercised (204,308) 7.85 Forfeited (194,300) 39.71 Balance at March 31, 2023 17,252,950 $ 27.22 Vested and expected to vest at March 31, 2023 16,443,079 $ 28.53 Exercisable at March 31, 2023 10,535,232 $ 23.63 The estimated fair value of stock options granted to employees were calculated using the Black-Scholes option-pricing model using the following assumptions: Three Months Ended March 31, 2023 2022 Expected term (in years) 6.08 6.08 Volatility 69.1% - 69.6% 65.5% - 66.1% Risk-free interest rate 3.6% - 4.2% 1.5% - 1.8% Dividend yield — — Restricted Stock Activity The following table summarizes restricted stock unit ("RSU") activity for the three months ended March 31, 2023: Number of RSU shares Weighted-Average Fair Value at Date of Grant per Share Unvested at December 31, 2022 3,330,654 $ 41.39 Granted 1,321,680 27.66 Vested and released (571,401) 44.35 Forfeited (133,150) 36.79 Unvested and expected to vest at March 31, 2023 3,947,783 $ 36.52 Stock-Based Compensation Expense The Company’s results of operations include expenses relating to stock-based compensation as follows (in thousands): Three Months Ended March 31, 2023 2022 Research and development $ 16,784 $ 15,556 General and administrative 11,300 10,589 Total $ 28,084 $ 26,145 |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Net Loss Per Share Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share for all periods as the inclusion of all potential shares of common stock outstanding would have been anti-dilutive. Potentially dilutive securities, including all options issued and outstanding, ESPP shares issuable, and restricted shares subject to future vesting, that were not included in the diluted per share calculations for all periods presented because they would be anti-dilutive totaled approximately 21.4 million and 18.4 million shares as of March 31, 2023 and March 31, 2022, respectively. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Organization and Description of Business | Organization and Description of Business Denali Therapeutics Inc. ("Denali" or the “Company”) is a biopharmaceutical company, incorporated in Delaware, that discovers and develops therapeutics to defeat neurodegenerative diseases. The Company is headquartered in South San Francisco, California. |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of the Securities and Exchange Commission ("SEC") Regulation S-X for interim financial information. These unaudited condensed consolidated financial statements and notes should be read in conjunction with the audited consolidated financial statements and notes thereto contained in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on February 27, 2023 (the "2022 Annual Report on Form 10-K"). The Condensed Consolidated Balance Sheet as of December 31, 2022 was derived from the audited annual consolidated financial statements as of and for the period then ended. Certain information and footnote disclosures typically included in the Company's annual consolidated financial statements have been condensed or omitted. The accompanying unaudited condensed consolidated financial statements reflect all adjustments that, in the opinion of management, are necessary for a fair statement of the results of the interim periods presented. All such adjustments are of a normal recurring nature except for the impacts of adopting new accounting standards, if any, discussed below. These interim financial results are not necessarily indicative of results expected for the full fiscal year or for any subsequent interim period. |
Principles of Consolidation | Principles of Consolidation These unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. For the Company and its subsidiaries, the functional currency has been determined to be U.S. dollars. Monetary assets and liabilities denominated in foreign currency are remeasured at period-end exchange rates, non-monetary assets and liabilities denominated in foreign currencies are remeasured at historical rates, and transactions in foreign currencies are remeasured at average exchange rates. Foreign currency gains and losses resulting from remeasurement are recognized in interest and other income, net in the Condensed Consolidated Statements of Operations and Comprehensive Loss. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make certain estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, as well as the reported amounts of expenses during the reporting period. Actual results could differ from those estimates, and such differences could be material to the Condensed Consolidated Balance Sheets and Statements of Operations and Comprehensive Loss. |
Concentration of Credit Risk and Other Risks and Uncertainties | Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, and marketable securities. Substantially all of the Company’s cash and cash equivalents are deposited in accounts with financial institutions that management believes are of high credit quality. Such deposits have and will continue to exceed federally insured limits. The Company maintains its cash with accredited financial institutions and accordingly, such funds are subject to minimal credit risk. The Company’s investment policy limits investments to certain types of securities issued by the U.S. government and its agencies, as well as institutions with investment-grade credit ratings and places restrictions on maturities and concentration by type and issuer. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash, cash equivalents and marketable securities and issuers of marketable securities to the extent recorded on the Condensed Consolidated Balance Sheets. As of March 31, 2023 and December 31, 2022, the Company had no off-balance sheet concentrations of credit risk. The Company is subject to a number of risks similar to other clinical-stage biopharmaceutical companies, including, but not limited to, the need to obtain adequate additional funding, possible failure of current or future preclinical testing or clinical trials, its reliance on third parties to conduct its clinical trials, the need to obtain regulatory and marketing approvals for its product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of the Company’s product candidates, its right to develop and commercialize its product candidates pursuant to the terms and conditions of the licenses granted to the Company, protection of proprietary technology, the ability to make milestone, royalty or other payments due under any license or collaboration agreements, and the need to secure and maintain adequate manufacturing arrangements with third parties. If the Company does not successfully commercialize or partner any of its product candidates, it will be unable to generate product revenue or achieve profitability. Further, the company is also subject to broad market risks and uncertainties resulting from recent events, such as bank failures or instability in the financial services sector, the COVID-19 pandemic, the Russian invasion of Ukraine, inflation, rising interest rates, and recession risks as well as supply chain and labor shortages. |
Segments | Segments The Company has one operating segment. The Company’s chief operating decision maker, its Chief Executive Officer, manages the Company’s operations on a consolidated basis for the purposes of allocating resources. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with original maturities of 90 days or less at the date of purchase to be cash and cash equivalents. Cash equivalents are reported at fair value. |
Marketable Securities | Marketable Securities The Company generally invests its excess cash in money market funds and investment grade short to intermediate-term fixed income securities. Such investments are included in cash and cash equivalents, short-term marketable securities, or long-term marketable securities on the Condensed Consolidated Balance Sheets, are considered available-for-sale, and reported at fair value with net unrealized gains and losses included as a component of stockholders’ equity. The Company classifies investments in securities with remaining maturities of less than one year, or where its intent is to use the investments to fund current operations or to make them available for current operations, as short-term investments. The Company classifies investments in securities with remaining maturities of over one year as long-term investments, unless intended to fund current operations. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest and other income, net in the Condensed Consolidated Statements of Operations and Comprehensive Loss. Realized gains and losses and declines in value determined to be due to credit losses on marketable securities, if any, are included in interest and other income, net. The Company periodically evaluates the need for an allowance for credit losses. This evaluation includes consideration of several qualitative and quantitative factors, including whether it has plans to sell the security, whether it is more likely than not it will be required to sell any marketable securities before recovery of its amortized cost basis, and if the entity has the ability and intent to hold the security to maturity, and the portion of any unrealized loss that is the result of a credit loss. Factors considered in making these evaluations include quoted market prices, recent financial results and operating trends, implied values from any recent transactions or offers of investee securities, credit quality of debt instrument issuers, expected cash flows from securities, other publicly available information that may affect the value of the marketable security, duration and severity of the decline in value, and the Company's strategy and intentions for holding the marketable security. |
Accounts Receivable | Accounts Receivable Accounts receivable are included within prepaid expenses and other current assets on the Condensed Consolidated Balance Sheets. The accounts receivable balance represents amounts receivable from the Company's collaboration partners, excluding related parties, net of an allowance for credit losses, if required. |
Leases | Leases The Company leases real estate, and certain equipment for use in its operations. A determination is made as to whether an arrangement is a lease at inception. Right-of-use (“ROU”) assets and operating lease liabilities are recognized for identified operating leases in the Condensed Consolidated Balance Sheets. The changes in operating lease ROU assets and operating lease liabilities are presented net within non-cash adjustment to operating lease expense in the Condensed Consolidated Statements of Cash Flows. |
Revenue Recognition | Revenue Recognition License, Option and Collaboration Revenue The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC 808, Collaborative Arrangements (“ASC 808”) to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities. This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement. For collaboration arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 808 and those that are more reflective of a vendor-customer relationship and, therefore, within the scope of Topic 606. For elements of collaboration arrangements that are accounted for pursuant to ASC 808, an appropriate recognition method is determined and applied consistently, generally by analogy to Topic 606. The accounting treatment pursuant to Topic 606 is outlined below. The terms of license, option and collaboration agreements entered into typically include payment of one or more of the following: non-refundable, up-front license fees; option exercise fees; development, regulatory and commercial milestone payments; payments for manufacturing supply and research and development services and royalties on net sales of licensed products. Each of these payments results in license, collaboration and other revenue, except for revenues from royalties on net sales of licensed products, which are classified as royalty revenue. The core principle of Topic 606 is to recognize revenue when promised goods or services are transferred to customers in an amount that reflects the consideration that is expected to be received in exchange for those goods or services. The Company may also receive reimbursement or make payments to a collaboration partner to satisfy cost sharing requirements. These payments are accounted for pursuant to ASC 808 and are recorded as an offset or increase to research and development expenses, respectively. In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under each of its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. Amounts received prior to satisfying the revenue recognition criteria are recorded as contract liabilities in the Company’s Condensed Consolidated Balance Sheets. If the related performance obligation is expected to be satisfied within the next twelve months this will be classified in current liabilities. Amounts recognized as revenue prior to the Company having an unconditional right (other than a right that is conditioned only on the passage of time) to receipt are recorded as contract assets in the Company's Condensed Consolidated Balance Sheets. If the Company expects to have an unconditional right to receive the consideration in the next twelve months, this will be classified in current assets. A net contract asset or liability is presented for each contract with a customer. At contract inception, the Company assesses the goods or services promised in a contract with a customer and identifies those distinct goods and services that represent a performance obligation. A promised good or service may not be identified as a performance obligation if it is immaterial in the context of the contract with the customer, if it is not separately identifiable from other promises in the contract (either because it is not capable of being separated or because it is not separable in the context of the contract), or if the promised good or service does not provide the customer with a material right. The Company considers the terms of the contract to determine the transaction price. The transaction price is the amount of consideration to which the Company expects to be entitled in exchange for transferring promised goods or services to a customer. The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. Variable consideration will only be included in the transaction price when it is not considered constrained, which is when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. If it is determined that multiple performance obligations exist, the transaction price is allocated at the inception of the agreement to all identified performance obligations based on the relative standalone selling prices ("SSP"). The relative SSP for each deliverable is estimated using external sourced evidence if it is available. If external sourced evidence is not available, the Company uses its best estimate of the SSP for the deliverable. Revenue is recognized when, or as, the Company satisfies a performance obligation by transferring a promised good or service to a customer. An asset is transferred when, or as, the customer obtains control of that asset, which for a service is considered to be as the services are received and used. The Company recognizes revenue over time by measuring the progress toward complete satisfaction of the relevant performance obligation using an appropriate input or output method based on the nature of the service promised to the customer. After contract inception, the transaction price is reassessed at every period end and updated for changes such as resolution of uncertain events. Any change in the transaction price is allocated to the performance obligations on the same basis as at contract inception, or to a single performance obligation as applicable. Management may be required to exercise considerable judgment in estimating revenue to be recognized. Judgment is required in identifying performance obligations, estimating the transaction price, estimating the SSP of identified performance obligations, which may include forecasted revenue, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success, and estimating the progress towards satisfaction of performance obligations. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is composed of net loss and certain changes in stockholders’ equity that are excluded from net loss, primarily unrealized gains or losses on the Company’s marketable securities. |
Net Loss per Share | Net Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are antidilutive given the net loss for each period presented. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets and Liabilities Measured at Fair Value | Assets and liabilities measured at fair value at each balance sheet date are as follows (in thousands): March 31, 2023 Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 38,170 $ — $ — $ 38,170 Short-term marketable securities: U.S. government treasuries 1,093,118 — — 1,093,118 U.S. government agency securities — 26,471 — 26,471 Corporate debt securities — 47,315 — 47,315 Commercial paper — 53,418 — 53,418 Total $ 1,131,288 $ 127,204 $ — $ 1,258,492 December 31, 2022 Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 105,340 $ — $ — $ 105,340 U.S. government treasuries 43,781 — — 43,781 Commercial paper — 9,948 — 9,948 Short-term marketable securities: U.S. government treasuries 1,003,504 — — 1,003,504 U.S. government agency securities — 16,861 — 16,861 Corporate debt securities — 54,215 — 54,215 Commercial paper — 43,591 — 43,591 Total $ 1,152,625 $ 124,615 $ — $ 1,277,240 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Available for Sale Securities | The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s marketable securities by major security type at each balance sheet date are summarized in the tables below (in thousands): March 31, 2023 Amortized Cost Unrealized Holding Gains Unrealized Holding Losses Aggregate Fair Value Short-term marketable securities: U.S. government treasuries (1) $ 1,095,241 $ 280 $ (2,403) $ 1,093,118 U.S. government agency securities 26,419 52 — 26,471 Corporate debt securities (2) 47,410 — (95) 47,315 Commercial paper 53,418 — — 53,418 Total $ 1,222,488 $ 332 $ (2,498) $ 1,220,322 __________________________________________________ (1) Unrealized holding losses on 40 securities with an aggregate fair value of $570.5 million. (2) Unrealized holding losses on 13 securities with an aggregate fair value of $47.3 million. December 31, 2022 Amortized Cost Unrealized Holding Gains Unrealized Holding Losses Aggregate Fair Value Short-term marketable securities: U.S. government treasuries (1) $ 1,009,733 $ 58 $ (6,287) $ 1,003,504 U.S. government agency securities 16,823 38 — 16,861 Corporate debt securities (2) 54,571 — (356) 54,215 Commercial paper 43,591 — — 43,591 Total $ 1,124,718 $ 96 $ (6,643) $ 1,118,171 __________________________________________________ (1) Unrealized holding losses on 51 securities with an aggregate fair value of $683.4 million. (2) Unrealized holding losses on 16 securities with an aggregate fair value of $54.2 million. |
Collaboration Agreements (Table
Collaboration Agreements (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Collaboration Revenue | Revenue disaggregated by collaboration agreement and performance obligation is as follows (in thousands): Three Months Ended March 31, 2023 2022 Takeda Collaboration Agreement: Takeda Collaboration Agreement Services (1) $ — $ 39,916 PTV:PGRN Collaboration Agreement 10,000 — Total Takeda Collaboration Revenue 10,000 39,916 Sanofi Collaboration Agreement CNS Program License 25,000 — Total Sanofi Collaboration Revenue 25,000 — Biogen Collaboration Agreement Option Research Services (2) 141 2,225 Total Biogen Collaboration Revenue 141 2,225 Total Collaboration Revenue $ 35,141 $ 42,141 _________________________________________________ (1) Revenue of $27.9 million for the three months ended March 31, 2022 was included in the contract liability balance at the beginning of the period. |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Supplemental Information for Lease Amounts Recognized | The following table contains a summary of other information pertaining to the Company’s operating lease for the periods presented (in thousands): Three Months Ended March 31, 2023 2022 Cash paid for amounts included in measurement of lease liabilities $ 2,996 $ 2,618 As of March 31, 2023 2022 Weighted average remaining lease term 6.1 years 7.1 years Weighted average discount rate 9.0 % 9.0 % |
Summary of Future Minimum Lease Commitments | The following table reconciles the undiscounted cash flows for the next five years and total of the remaining years to the operating lease liabilities recorded in the Condensed Consolidated Balance Sheet as of March 31, 2023 (in thousands): Year Ended December 31: 2023 (nine months) 8,348 2024 11,417 2025 11,793 2026 12,182 2027 12,584 Thereafter 17,382 Total undiscounted lease payments 73,706 Present value adjustment (16,621) Net operating lease liabilities $ 57,085 |
Stock-Based Awards (Tables)
Stock-Based Awards (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Stock Option Activity | The following table summarizes stock option activity for the three months ended March 31, 2023: Number of Options Weighted-Average Exercise Price Balance at December 31, 2022 14,673,717 $ 27.03 Granted 2,977,841 27.66 Exercised (204,308) 7.85 Forfeited (194,300) 39.71 Balance at March 31, 2023 17,252,950 $ 27.22 Vested and expected to vest at March 31, 2023 16,443,079 $ 28.53 Exercisable at March 31, 2023 10,535,232 $ 23.63 |
Summary of Assumptions Used for Estimating the Fair Value of Stock Granted | The estimated fair value of stock options granted to employees were calculated using the Black-Scholes option-pricing model using the following assumptions: Three Months Ended March 31, 2023 2022 Expected term (in years) 6.08 6.08 Volatility 69.1% - 69.6% 65.5% - 66.1% Risk-free interest rate 3.6% - 4.2% 1.5% - 1.8% Dividend yield — — |
Summary of Restricted Stock Activity | The following table summarizes restricted stock unit ("RSU") activity for the three months ended March 31, 2023: Number of RSU shares Weighted-Average Fair Value at Date of Grant per Share Unvested at December 31, 2022 3,330,654 $ 41.39 Granted 1,321,680 27.66 Vested and released (571,401) 44.35 Forfeited (133,150) 36.79 Unvested and expected to vest at March 31, 2023 3,947,783 $ 36.52 |
Summary of Stock-Based Compensation Expense | The Company’s results of operations include expenses relating to stock-based compensation as follows (in thousands): Three Months Ended March 31, 2023 2022 Research and development $ 16,784 $ 15,556 General and administrative 11,300 10,589 Total $ 28,084 $ 26,145 |
Significant Accounting Polici_3
Significant Accounting Policies - Narrative (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2023 USD ($) segment | |
Accounting Policies [Abstract] | |
Number of operating segments | segment | 1 |
Restricted cash | $ | $ 1.5 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Assets and Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Assets: | ||
Total | $ 1,258,492 | $ 1,277,240 |
U.S. government treasuries | ||
Assets: | ||
Short-term marketable securities, fair value | 1,093,118 | 1,003,504 |
U.S. government agency securities | ||
Assets: | ||
Short-term marketable securities, fair value | 26,471 | 16,861 |
Corporate debt securities | ||
Assets: | ||
Short-term marketable securities, fair value | 47,315 | 54,215 |
Commercial paper | ||
Assets: | ||
Short-term marketable securities, fair value | 53,418 | 43,591 |
Money market funds | ||
Assets: | ||
Cash equivalents | 38,170 | 105,340 |
U.S. government treasuries | ||
Assets: | ||
Cash equivalents | 43,781 | |
Commercial paper | ||
Assets: | ||
Cash equivalents | 9,948 | |
Level 1 | ||
Assets: | ||
Total | 1,131,288 | 1,152,625 |
Level 1 | U.S. government treasuries | ||
Assets: | ||
Short-term marketable securities, fair value | 1,093,118 | 1,003,504 |
Level 1 | U.S. government agency securities | ||
Assets: | ||
Short-term marketable securities, fair value | 0 | 0 |
Level 1 | Corporate debt securities | ||
Assets: | ||
Short-term marketable securities, fair value | 0 | 0 |
Level 1 | Commercial paper | ||
Assets: | ||
Short-term marketable securities, fair value | 0 | 0 |
Level 1 | Money market funds | ||
Assets: | ||
Cash equivalents | 38,170 | 105,340 |
Level 1 | U.S. government treasuries | ||
Assets: | ||
Cash equivalents | 43,781 | |
Level 1 | Commercial paper | ||
Assets: | ||
Cash equivalents | 0 | |
Level 2 | ||
Assets: | ||
Total | 127,204 | 124,615 |
Level 2 | U.S. government treasuries | ||
Assets: | ||
Short-term marketable securities, fair value | 0 | 0 |
Level 2 | U.S. government agency securities | ||
Assets: | ||
Short-term marketable securities, fair value | 26,471 | 16,861 |
Level 2 | Corporate debt securities | ||
Assets: | ||
Short-term marketable securities, fair value | 47,315 | 54,215 |
Level 2 | Commercial paper | ||
Assets: | ||
Short-term marketable securities, fair value | 53,418 | 43,591 |
Level 2 | Money market funds | ||
Assets: | ||
Cash equivalents | 0 | 0 |
Level 2 | U.S. government treasuries | ||
Assets: | ||
Cash equivalents | 0 | |
Level 2 | Commercial paper | ||
Assets: | ||
Cash equivalents | 9,948 | |
Level 3 | ||
Assets: | ||
Total | 0 | 0 |
Level 3 | U.S. government treasuries | ||
Assets: | ||
Short-term marketable securities, fair value | 0 | 0 |
Level 3 | U.S. government agency securities | ||
Assets: | ||
Short-term marketable securities, fair value | 0 | 0 |
Level 3 | Corporate debt securities | ||
Assets: | ||
Short-term marketable securities, fair value | 0 | 0 |
Level 3 | Commercial paper | ||
Assets: | ||
Short-term marketable securities, fair value | 0 | 0 |
Level 3 | Money market funds | ||
Assets: | ||
Cash equivalents | $ 0 | 0 |
Level 3 | U.S. government treasuries | ||
Assets: | ||
Cash equivalents | 0 | |
Level 3 | Commercial paper | ||
Assets: | ||
Cash equivalents | $ 0 |
Marketable Securities - Summary
Marketable Securities - Summary of Available for Sale Securities (Details) $ in Thousands | Mar. 31, 2023 USD ($) security | Dec. 31, 2022 USD ($) security |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 1,222,488 | $ 1,124,718 |
Unrealized Holding Gains | 332 | 96 |
Unrealized Holding Losses | (2,498) | (6,643) |
Aggregate Fair Value | $ 1,220,322 | $ 1,118,171 |
U.S. government treasuries | ||
Debt Securities, Available-for-sale [Line Items] | ||
Number of securities held in unrealized holding loss positions, short-term | security | 40 | 51 |
Aggregate fair value, unrealized holding loss position, short-term | $ 570,500 | $ 683,400 |
U.S. government treasuries | Short-term marketable securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 1,095,241 | 1,009,733 |
Unrealized Holding Gains | 280 | 58 |
Unrealized Holding Losses | (2,403) | (6,287) |
Aggregate Fair Value | 1,093,118 | 1,003,504 |
U.S. government agency securities | Short-term marketable securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 26,419 | 16,823 |
Unrealized Holding Gains | 52 | 38 |
Unrealized Holding Losses | 0 | 0 |
Aggregate Fair Value | $ 26,471 | $ 16,861 |
Corporate debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Number of securities held in unrealized holding loss positions, short-term | security | 13 | 16 |
Aggregate fair value, unrealized holding loss position, short-term | $ 47,300 | $ 54,200 |
Corporate debt securities | Short-term marketable securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 47,410 | 54,571 |
Unrealized Holding Gains | 0 | 0 |
Unrealized Holding Losses | (95) | (356) |
Aggregate Fair Value | 47,315 | 54,215 |
Commercial paper | Short-term marketable securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 53,418 | 43,591 |
Unrealized Holding Gains | 0 | 0 |
Unrealized Holding Losses | 0 | 0 |
Aggregate Fair Value | $ 53,418 | $ 43,591 |
Marketable Securities - Narrati
Marketable Securities - Narrative (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Investments, Debt and Equity Securities [Abstract] | ||
Allowance for credit losses | $ 0 | $ 0 |
Effective maturity (less than) | 1 year |
Acquisition - Narrative (Detail
Acquisition - Narrative (Details) - USD ($) | 3 Months Ended | 80 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2023 | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Research and development | [1] | $ 128,816,000 | $ 86,098,000 | |
Collaborative Arrangement with F-Star and Acquisition of F-Star Gamma | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Research and development | $ 19,800,000 | |||
Contingent consideration recognized | $ 0 | |||
Collaborative Arrangement with F-Star and Acquisition of F-Star Gamma | Contingent Payments Upon Achievement of Specialized Clinical Milestone | Accrued Clinical And Other Research And Development Costs, Current | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Research and development | $ 30,000,000 | |||
[1]Includes expenses for cost sharing payments due to a related party of $4.2 million and $2.7 million for the three months ended March 31, 2023 and 2022, respectively. |
Collaboration Agreements - Biog
Collaboration Agreements - Biogen (Details) | 1 Months Ended | 3 Months Ended | |||
Apr. 30, 2023 USD ($) | Mar. 31, 2023 USD ($) milestone | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Research and development expense due to cost share payments to related party | [1] | $ 128,816,000 | $ 86,098,000 | ||
Collaboration revenue from customers | [2] | 35,141,000 | 42,141,000 | ||
Related Party | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Research and development expense due to cost share payments to related party | 4,200,000 | 2,700,000 | |||
Accounts payable | 8,538,000 | $ 4,388,000 | |||
Collaboration revenue from customers | 100,000 | 2,200,000 | |||
Biogen | Related Party | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Contract liability | 290,400,000 | 290,500,000 | |||
Biogen Collaborative Arrangement | Biogen | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Transaction price, increase (decrease) | $ 0 | ||||
Number of milestones achieved | milestone | 0 | ||||
Biogen Collaborative Arrangement | Biogen | Related Party | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Research and development expense due to cost share payments to related party | $ 4,200,000 | $ 2,700,000 | |||
Accounts payable | 8,500,000 | $ 4,400,000 | |||
Biogen Collaborative Arrangement | Biogen | Option Research Services | Related Party | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Contract liability | $ 1,500,000 | ||||
Performance obligation, period (more than one) | one year | ||||
Biogen Collaborative Arrangement | Biogen | Product | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Collaboration revenue from customers | $ 0 | ||||
ROFN and Option Agreement | Biogen | Material Right For An Option | Related Party | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Contract liability | $ 288,900,000 | ||||
Collaborative Arrangement, ATV:Abeta | Biogen | Related Party | Subsequent Event | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Option fee, receivable | $ 5,000,000 | ||||
[1]Includes expenses for cost sharing payments due to a related party of $4.2 million and $2.7 million for the three months ended March 31, 2023 and 2022, respectively.[2]Includes related-party collaboration revenue from a customer of $0.1 million and $2.2 million for the three months ended March 31, 2023 and 2022, respectively. |
Collaboration Agreements - Sano
Collaboration Agreements - Sanofi (Details) - USD ($) | 3 Months Ended | 54 Months Ended | |||
Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2023 | Dec. 31, 2022 | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Collaboration revenue from customers | [1] | $ 35,141,000 | $ 42,141,000 | ||
Sanofi | Collaborative Arrangement | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Contract liability | 0 | $ 0 | $ 0 | ||
Transaction price, increase (decrease) | $ 25,000,000 | ||||
Sanofi | Collaborative Arrangement | Milestone Triggered | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Collaboration revenue from customers | 100,000,000 | ||||
Sanofi | Collaborative Arrangement | Product | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Collaboration revenue from customers | $ 0 | ||||
[1]Includes related-party collaboration revenue from a customer of $0.1 million and $2.2 million for the three months ended March 31, 2023 and 2022, respectively. |
Collaboration Agreements - Take
Collaboration Agreements - Takeda (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 63 Months Ended | |||
Dec. 31, 2021 contract | Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | Mar. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Collaboration revenue from customers | [1] | $ 35,141 | $ 42,141 | |||
Takeda Pharmaceutical Company Limited | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Receivable | 3,200 | $ 3,200 | $ 8,900 | |||
Collaborative Arrangement, PTV:PGRN and ATV:TREM2 | Takeda Pharmaceutical Company Limited | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Number of new contracts | contract | 2 | |||||
Collaborative Arrangement, PTV:PGRN and ATV:TREM2 | Takeda Pharmaceutical Company Limited | Option Fee Payment | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Collaboration revenue from customers | 10,000 | |||||
Collaborative Arrangement, PTV:PGRN and ATV:TREM2 | Takeda Pharmaceutical Company Limited | Milestone Payment | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Collaboration revenue from customers | 10,000 | |||||
Collaborative Arrangement, PTV:PGRN and ATV:TREM2 | Takeda Pharmaceutical Company Limited | Product | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Collaboration revenue from customers | 0 | |||||
Collaborative Arrangement, PTV:PGRN | Takeda Pharmaceutical Company Limited | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Transaction price, increase (decrease) | 10,000 | |||||
Receivable recorded upon achievement of milestone | 10,000 | $ 10,000 | ||||
Offset to research and development expense, cost reimbursement | 1,500 | 2,900 | ||||
Collaborative Arrangement, ATV:TREM2 | Takeda Pharmaceutical Company Limited | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Offset to research and development expense, cost reimbursement | $ 1,700 | $ 2,100 | ||||
[1]Includes related-party collaboration revenue from a customer of $0.1 million and $2.2 million for the three months ended March 31, 2023 and 2022, respectively. |
Collaboration Agreements - Summ
Collaboration Agreements - Summary of Collaboration Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Collaborative revenue, revenue from contract with customer | [1] | $ 35,141 | $ 42,141 |
Total Collaboration Revenue | 35,141 | 42,141 | |
Takeda Collaboration Agreement | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Total Collaboration Revenue | 10,000 | 39,916 | |
Revenue recognized included in the contract liability balance at the beginning of the period | 27,900 | ||
Takeda Collaboration Agreement | Collaboration Agreement Services | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Collaborative revenue, revenue from contract with customer | 0 | 39,916 | |
Takeda Collaboration Agreement | PTV:PGRN Collaboration Agreement | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Collaborative revenue, revenue from contract with customer | 10,000 | 0 | |
Sanofi Collaboration Agreement | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Total Collaboration Revenue | 25,000 | 0 | |
Sanofi Collaboration Agreement | CNS Program License | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Collaborative revenue, revenue from contract with customer | 25,000 | 0 | |
Biogen | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Total Collaboration Revenue | 141 | 2,225 | |
Biogen | Option Research Services | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Collaborative revenue, revenue from contract with customer | $ 141 | $ 2,225 | |
[1]Includes related-party collaboration revenue from a customer of $0.1 million and $2.2 million for the three months ended March 31, 2023 and 2022, respectively. |
License Agreements - Narrative
License Agreements - Narrative (Details) $ in Thousands | 3 Months Ended | 82 Months Ended | ||
Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | Mar. 31, 2023 USD ($) payment | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Research and development | [1] | $ 128,816 | $ 86,098 | |
License Agreement | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Research and development | $ 18,800 | |||
Genentech Inc | Collaborative Arrangement | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Research and development | $ 0 | $ 0 | ||
Genentech Inc | License Agreement | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Clinical milestone payments | payment | 3 | |||
Genentech Inc | License Agreement | Research and development | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Aggregate payments | $ 25,000 | |||
[1]Includes expenses for cost sharing payments due to a related party of $4.2 million and $2.7 million for the three months ended March 31, 2023 and 2022, respectively. |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) | 3 Months Ended | |||
Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | Apr. 30, 2023 USD ($) ft² | Dec. 31, 2022 USD ($) | |
Loss Contingencies [Line Items] | ||||
Operating lease cost | $ 2,900,000 | $ 2,800,000 | ||
DMSA, Non-Cancellable | ||||
Loss Contingencies [Line Items] | ||||
Purchase commitments | 39,600,000 | $ 32,300,000 | ||
DMSA | ||||
Loss Contingencies [Line Items] | ||||
Costs incurred | 5,200,000 | 10,000,000 | ||
Payments for development and manufacturing services | 3,800,000 | $ 8,700,000 | ||
Other than DMSA | ||||
Loss Contingencies [Line Items] | ||||
Purchase commitments | 46,900,000 | $ 9,600,000 | ||
Building | SLC Lease | ||||
Loss Contingencies [Line Items] | ||||
Lease not yet commenced, lease liability | 0 | |||
Lease not yet commenced, ROU asset | 0 | |||
Lease not yet commenced, operating lease expense | 0 | |||
Building | SLC Lease | Operating Lease, 9.3 Year Lease Agreement, Terminated | ||||
Loss Contingencies [Line Items] | ||||
Accelerated depreciation on leasehold improvements in relation to SLC Lease termination | $ 7,900,000 | |||
Laboratory, Office, and Warehouse | New SLC Operating Lease | Subsequent Event | Operating Lease, 15 Year Lease Agreement | ||||
Loss Contingencies [Line Items] | ||||
Lease not yet commenced, area under lease | ft² | 59,336 | |||
Lease not yet commenced, period | 15 years | |||
Lease not yet commenced, undiscounted lease payments | $ 13,400,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Summary of Supplemental Lease Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Cash paid for amounts included in measurement of lease liabilities | $ 2,996 | $ 2,618 |
Weighted average remaining lease term | 6 years 1 month 6 days | 7 years 1 month 6 days |
Weighted average discount rate | 9% | 9% |
Commitments and Contingencies_3
Commitments and Contingencies - Summary of Company's Future Minimum Lease Commitments (Details) $ in Thousands | Mar. 31, 2023 USD ($) |
Operating Lease Liabilities, Payments Due [Abstract] | |
2023 (nine months) | $ 8,348 |
2024 | 11,417 |
2025 | 11,793 |
2026 | 12,182 |
2027 | 12,584 |
Thereafter | 17,382 |
Total undiscounted lease payments | 73,706 |
Present value adjustment | (16,621) |
Net operating lease liabilities | $ 57,085 |
Stock-Based Awards - Summary of
Stock-Based Awards - Summary of Stock Option Activity (Details) | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Number of Options | |
Beginning balance (in shares) | shares | 14,673,717 |
Granted (in shares) | shares | 2,977,841 |
Exercised (in shares) | shares | (204,308) |
Forfeited (in shares) | shares | (194,300) |
Ending balance (in shares) | shares | 17,252,950 |
Vested and expected to vest (in shares) | shares | 16,443,079 |
Exercisable (in shares) | shares | 10,535,232 |
Weighted-Average Exercise Price | |
Beginning balance (usd per share) | $ / shares | $ 27.03 |
Granted (usd per share) | $ / shares | 27.66 |
Exercised (usd per share) | $ / shares | 7.85 |
Forfeited (usd per share) | $ / shares | 39.71 |
Ending balance (usd per share) | $ / shares | 27.22 |
Vested and expected to vest (usd per share) | $ / shares | 28.53 |
Exercisable (usd per share) | $ / shares | $ 23.63 |
Stock-Based Awards - Summary _2
Stock-Based Awards - Summary of Assumptions Used for Estimating the Fair Value of Stock Options Granted (Details) - Stock Options | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 years 29 days | 6 years 29 days |
Volatility, minimum | 69.10% | 65.50% |
Volatility, maximum | 69.60% | 66.10% |
Risk-free interest rate, minimum | 3.60% | 1.50% |
Risk-free interest rate, maximum | 4.20% | 1.80% |
Dividend yield | 0% | 0% |
Stock-Based Awards - Summary _3
Stock-Based Awards - Summary of Restricted Stock Activity (Details) - Restricted Stock Units (RSUs) | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Number of RSU shares | |
Unvested at December 31, 2022 (in shares) | shares | 3,330,654 |
Granted (in shares) | shares | 1,321,680 |
Vested and released (in shares) | shares | (571,401) |
Forfeited (in shares) | shares | (133,150) |
Unvested at March 31, 2023 (in shares) | shares | 3,947,783 |
Expected to vest at March 31, 2023 (in shares) | shares | 3,947,783 |
Weighted-Average Fair Value at Date of Grant per Share | |
Unvested at December 31, 2022 (usd per share) | $ / shares | $ 41.39 |
Granted (usd per share) | $ / shares | 27.66 |
Vested and released (usd per share) | $ / shares | 44.35 |
Forfeited (usd per share) | $ / shares | 36.79 |
Unvested at March 31, 2023 (usd per share) | $ / shares | 36.52 |
Expected to vest at March 31, 2023 (usd per share) | $ / shares | $ 36.52 |
Stock-Based Awards - Summary _4
Stock-Based Awards - Summary of Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total | $ 28,084 | $ 26,145 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total | 16,784 | 15,556 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total | $ 11,300 | $ 10,589 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Dilutive Securities Not Included in Diluted Per Share Calculations (Details) - shares shares in Millions | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Earnings Per Share [Abstract] | ||
Antidilutive securities, excluded (in shares) | 21.4 | 18.4 |