Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2023 | Oct. 30, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-38853 | |
Entity Registrant Name | NGM BIOPHARMACEUTICALS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 26-1679911 | |
Entity Address, Address Line One | 333 Oyster Point Boulevard | |
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 | 243-5555 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | NGM | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 82,715,507 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001426332 | |
Current Fiscal Year End Date | --12-31 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | [1] |
Current assets: | |||
Cash and cash equivalents | $ 51,476 | $ 73,456 | |
Short-term marketable securities | 114,569 | 198,036 | |
Prepaid expenses and other current assets | 7,994 | 9,787 | |
Restricted cash | 2,999 | 0 | |
Total current assets | 177,038 | 288,859 | |
Property and equipment, net | 7,281 | 8,496 | |
Operating lease right-of-use asset | 538 | 2,096 | |
Restricted cash | 2,455 | 3,954 | |
Other non-current assets | 4,838 | 3,997 | |
Total assets | 192,150 | 307,402 | |
Current liabilities: | |||
Accounts payable | 4,690 | 8,453 | |
Accrued liabilities | 16,167 | 33,638 | |
Operating lease liability, current | 1,381 | 5,385 | |
Contract liabilities | 107 | 366 | |
Total current liabilities | 22,345 | 47,842 | |
Total liabilities | 22,345 | 47,842 | |
Commitments and contingencies (Note 6) | |||
Stockholders' equity: | |||
Preferred stock, $0.001 par value; 10,000 shares authorized; no shares issued or outstanding as of September 30, 2023 and December 31, 2022, respectively | 0 | 0 | |
Common stock, $0.001 par value; 400,000 shares authorized; 82,716 and 81,885 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | 83 | 82 | |
Additional paid-in capital | 866,138 | 841,413 | |
Accumulated other comprehensive loss | (78) | (302) | |
Accumulated deficit | (696,338) | (581,633) | |
Total stockholders' equity | 169,805 | 259,560 | |
Total liabilities and stockholders' equity | 192,150 | 307,402 | |
Related party | |||
Current assets: | |||
Related party receivable from collaboration | $ 0 | $ 7,580 | |
[1]The condensed consolidated balance sheet as of December 31, 2022 has been derived from the audited financial statements as of that date. |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 400,000,000 | 400,000,000 |
Common stock, shares issued (in shares) | 82,716,000 | 81,885,000 |
Common stock, shares outstanding (in shares) | 82,716,000 | 81,885,000 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Statement [Abstract] | ||||
Related party revenue | $ 582 | $ 7,911 | $ 4,252 | $ 37,152 |
Operating expenses: | ||||
Research and development | 22,942 | 46,106 | 96,150 | 134,345 |
General and administrative | 8,671 | 10,109 | 29,902 | 30,759 |
Total operating expenses | 31,613 | 56,215 | 126,052 | 165,104 |
Loss from operations | (31,031) | (48,304) | (121,800) | (127,952) |
Interest income, net | 2,249 | 965 | 7,281 | 1,684 |
Other (expense) income, net | (15) | 78 | (186) | 38 |
Net loss | $ (28,797) | $ (47,261) | $ (114,705) | $ (126,230) |
Net loss per share, basic (in dollars per share) | $ (0.35) | $ (0.59) | $ (1.39) | $ (1.59) |
Net loss per share, diluted (in dollars per share) | $ (0.35) | $ (0.59) | $ (1.39) | $ (1.59) |
Weighted average shares used to compute net loss per share, basic (in shares) | 82,707 | 80,623 | 82,393 | 79,331 |
Weighted average shares used to compute net loss per share, diluted (in shares) | 82,707 | 80,623 | 82,393 | 79,331 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (28,797) | $ (47,261) | $ (114,705) | $ (126,230) |
Other comprehensive gain (loss), net of tax: | ||||
Net unrealized gain (loss) on available-for-sale marketable securities | 71 | 162 | 224 | (786) |
Total comprehensive loss | $ (28,726) | $ (47,099) | $ (114,481) | $ (127,016) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Other Comprehensive Loss | Accumulated Deficit | |
Beginning balance (in shares) at Dec. 31, 2021 | 77,962,000 | |||||
Beginning balance at Dec. 31, 2021 | $ 335,647 | $ 78 | $ 754,664 | $ (129) | $ (418,966) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock upon exercise of stock options (in shares) | 125,000 | |||||
Issuance of common stock upon exercise of stock options | 668 | 668 | ||||
Stock-based compensation expense | 7,820 | 7,820 | ||||
Comprehensive gain (loss) | (548) | (548) | ||||
Net loss | (32,450) | (32,450) | ||||
Ending balance (in shares) at Mar. 31, 2022 | 78,087,000 | |||||
Ending balance at Mar. 31, 2022 | 311,137 | $ 78 | 763,152 | (677) | (451,416) | |
Beginning balance (in shares) at Dec. 31, 2021 | 77,962,000 | |||||
Beginning balance at Dec. 31, 2021 | 335,647 | $ 78 | 754,664 | (129) | (418,966) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Comprehensive gain (loss) | (786) | |||||
Net loss | (126,230) | |||||
Ending balance (in shares) at Sep. 30, 2022 | 81,714,000 | |||||
Ending balance at Sep. 30, 2022 | 285,889 | $ 82 | 831,918 | (915) | (545,196) | |
Beginning balance (in shares) at Mar. 31, 2022 | 78,087,000 | |||||
Beginning balance at Mar. 31, 2022 | 311,137 | $ 78 | 763,152 | (677) | (451,416) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock under Open Market Sale Agreement, net of issuance costs (in shares) | 1,144,000 | |||||
Issuance of common stock under Open Market Sale Agreement, net of issuance costs | 17,403 | $ 1 | 17,402 | |||
Issuance of common stock under employee stock purchase plan (in shares) | 121,000 | |||||
Issuance of common stock under employee stock purchase plan | 1,228 | 1,228 | ||||
Issuance of common stock upon exercise of stock options (in shares) | 103,000 | |||||
Issuance of common stock upon exercise of stock options | 993 | 993 | ||||
Issuance of common stock to participants in 401(k) Plan (in shares) | 8,000 | |||||
Issuance of common stock to participants in 401(k) plan | 137 | 137 | ||||
Stock-based compensation expense | 8,102 | 8,102 | ||||
Comprehensive gain (loss) | (400) | (400) | ||||
Net loss | (46,519) | (46,519) | ||||
Ending balance (in shares) at Jun. 30, 2022 | 79,463,000 | |||||
Ending balance at Jun. 30, 2022 | 292,081 | $ 79 | 791,014 | (1,077) | (497,935) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock under Open Market Sale Agreement, net of issuance costs (in shares) | 2,102,000 | |||||
Issuance of common stock under Open Market Sale Agreement, net of issuance costs | 32,043 | $ 2 | 32,041 | |||
Issuance of common stock upon exercise of stock options (in shares) | 149,000 | |||||
Issuance of common stock upon exercise of stock options | 1,175 | $ 1 | 1,174 | |||
Stock-based compensation expense | 7,689 | 7,689 | ||||
Comprehensive gain (loss) | 162 | 162 | ||||
Net loss | (47,261) | (47,261) | ||||
Ending balance (in shares) at Sep. 30, 2022 | 81,714,000 | |||||
Ending balance at Sep. 30, 2022 | $ 285,889 | $ 82 | 831,918 | (915) | (545,196) | |
Beginning balance (in shares) at Dec. 31, 2022 | 81,885,000 | 81,885,000 | ||||
Beginning balance at Dec. 31, 2022 | $ 259,560 | [1] | $ 82 | 841,413 | (302) | (581,633) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock upon exercise of stock options (in shares) | 171,000 | |||||
Issuance of common stock upon exercise of stock options | 279 | 279 | ||||
Stock-based compensation expense | 8,537 | 8,537 | ||||
Comprehensive gain (loss) | 205 | 205 | ||||
Net loss | (47,647) | (47,647) | ||||
Ending balance (in shares) at Mar. 31, 2023 | 82,056,000 | |||||
Ending balance at Mar. 31, 2023 | $ 220,934 | $ 82 | 850,229 | (97) | (629,280) | |
Beginning balance (in shares) at Dec. 31, 2022 | 81,885,000 | 81,885,000 | ||||
Beginning balance at Dec. 31, 2022 | $ 259,560 | [1] | $ 82 | 841,413 | (302) | (581,633) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock upon exercise of stock options (in shares) | 351,000 | |||||
Comprehensive gain (loss) | $ 224 | |||||
Net loss | $ (114,705) | |||||
Ending balance (in shares) at Sep. 30, 2023 | 82,716,000 | 82,715,000 | ||||
Ending balance at Sep. 30, 2023 | $ 169,805 | $ 83 | 866,138 | (78) | (696,338) | |
Beginning balance (in shares) at Mar. 31, 2023 | 82,056,000 | |||||
Beginning balance at Mar. 31, 2023 | 220,934 | $ 82 | 850,229 | (97) | (629,280) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock under employee stock purchase plan (in shares) | 352,000 | |||||
Issuance of common stock under employee stock purchase plan | 996 | $ 1 | 995 | |||
Issuance of common stock upon exercise of stock options (in shares) | 180,000 | |||||
Issuance of common stock upon exercise of stock options | 389 | 389 | ||||
Issuance of common stock to participants in 401(k) Plan (in shares) | 127,000 | |||||
Issuance of common stock to participants in 401(k) plan | 639 | 639 | ||||
Stock-based compensation expense | 7,476 | 7,476 | ||||
Comprehensive gain (loss) | (52) | (52) | ||||
Net loss | (38,261) | (38,261) | ||||
Ending balance (in shares) at Jun. 30, 2023 | 82,715,000 | |||||
Ending balance at Jun. 30, 2023 | 192,121 | $ 83 | 859,728 | (149) | (667,541) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock-based compensation expense | 6,410 | 6,410 | ||||
Comprehensive gain (loss) | 71 | 71 | ||||
Net loss | $ (28,797) | (28,797) | ||||
Ending balance (in shares) at Sep. 30, 2023 | 82,716,000 | 82,715,000 | ||||
Ending balance at Sep. 30, 2023 | $ 169,805 | $ 83 | $ 866,138 | $ (78) | $ (696,338) | |
[1]The condensed consolidated balance sheet as of December 31, 2022 has been derived from the audited financial statements as of that date. |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Operating activities | ||
Net loss | $ (114,705) | $ (126,230) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 22,423 | 23,611 |
Depreciation | 1,703 | 3,421 |
(Accretion of discount) amortization of premium on marketable securities | (4,468) | 920 |
Non-cash lease expense | 1,558 | 1,449 |
Other non-cash expenses | 1,069 | 475 |
Changes in operating assets and liabilities: | ||
Related party receivable from collaboration | 7,580 | 565 |
Prepaid expenses and other assets | 952 | (892) |
Accounts payable | (3,187) | (1,681) |
Accrued and other liabilities | (17,901) | (1,092) |
Operating lease liability | (4,004) | (3,774) |
Contract liabilities | (259) | (10,807) |
Net cash used in operating activities | (109,239) | (114,035) |
Investing activities | ||
Proceeds from maturities of marketable securities | 159,970 | 186,537 |
Purchase of marketable securities | (71,811) | (172,486) |
Purchases of property and equipment | (1,064) | (1,417) |
Net cash provided by investing activities | 87,095 | 12,634 |
Financing activities | ||
Proceeds from employee stock purchase plan | 996 | 1,228 |
Proceeds from exercise of stock options | 668 | 2,836 |
Proceeds from Open Market Sale Agreement, net | 0 | 49,446 |
Net cash provided by financing activities | 1,664 | 53,510 |
Net decrease in cash, cash equivalents and restricted cash | (20,480) | (47,891) |
Cash, cash equivalents and restricted cash, at beginning of period | 77,410 | 153,294 |
Cash, cash equivalents and restricted cash, at end of period | 56,930 | 105,403 |
Supplemental disclosures of non-cash investing and financing activities: | ||
Property and equipment purchases not yet paid | $ 40 | $ 256 |
Organization and Description of
Organization and Description of Business | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | Organization and Description of Business NGM Biopharmaceuticals, Inc. and its wholly-owned subsidiary, NGM Biopharmaceuticals Australia Pty Ltd., or NGM Australia, collectively referred to as the Company, is a biopharmaceutical company focused on discovering and developing novel, potentially life-changing medicines based on scientific understanding of key biological pathways underlying grievous diseases with critical unmet or underserved patient need. The Company's portfolio of product candidates range from early discovery to Phase 2b development. The Company was incorporated in Delaware in December 2007 and commenced operations in 2008. The Company's headquarters are located at 333 Oyster Point Blvd., South San Francisco, California 94080. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or U.S. GAAP, and Regulation S-X for interim consolidated financial statements. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the U.S Securities and Exchange Commission, or SEC, on February 28, 2023. These unaudited condensed consolidated financial statements reflect all adjustments that management believes are necessary for a fair presentation of the periods presented. All such adjustments are of a normal recurring nature and are not necessarily indicative of results expected for the full fiscal year ending December 31, 2023, or for any subsequent interim period. These unaudited condensed consolidated financial statements include the consolidated accounts of NGM Biopharmaceuticals, Inc. and its wholly-owned foreign subsidiary, NGM Australia. All intercompany balances and transactions have been eliminated upon consolidation. Use of Estimates The preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make judgments, assumptions and estimates that affect the reported amounts of assets, liabilities, revenues and expenses. Specific accounts that require management estimates include, but are not limited to, stock-based compensation expense, contract manufacturing accruals, clinical trial accruals and revenue recognition in accordance with Accounting Standards Update, or ASU, 2014-09, Revenue from Contracts with Customers (Topic 606), or ASC 606. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results could differ materially from those estimates, and to the extent that there are differences between management's estimates and actual results, the Company's future financial statement presentation, financial condition, results of operations and cash flows may be affected. Sources and Uses of Liquidity Since inception, the Company has incurred net losses and negative cash flow from operations. During the three and nine months ended September 30, 2023, net losses were $28.8 million and $114.7 million, respectively. As of September 30, 2023, the Company had an accumulated deficit of $696.3 million. The Company expects its accumulated deficit will continue to increase over time and does not expect to experience positive cash flows from operations in the near future. As of September 30, 2023, the Company had $166.0 million of cash, cash equivalents and short-term marketable securities. In June 2020, the Company entered into an Open Market Sale Agreement SM , or the Sales Agreement, with Jefferies LLC, or Jefferies, pursuant to which the Company could sell, from time to time, through or to Jefferies, up to an aggregate of $150.0 million of the Company’s common stock. On June 7, 2023, the Company entered into Amendment No. 1, or the Amendment, to the Sales Agreement, and the Sales Agreement as amended is referred to as the Amended Sales Agreement. In connection with the Amendment, the Company filed a new shelf registration statement on Form S-3 which the SEC declared effective on August 4, 2023. The Amended Sales Agreement provides for the issuance and sales of shares of the Company's common stock having an aggregate offering price of up to $100.0 million through or to Jefferies. As of September 30, 2023, up to $100.0 million of the Company's common stock remained available to be sold under the Amended Sales Agreement, subject to conditions specified in the Amended Sales Agreement. The Company believes its existing cash, cash equivalents and short-term marketable securities will be sufficient to fund its operations for a period of at least one year from the issuance of these unaudited condensed consolidated financial statements. To fully implement the Company’s business plan and fund its operations, the Company needs to raise significant additional capital through public or private equity or debt offerings (which may include potential net proceeds from future sales of the Company's common stock, if any, under the Amended Sales Agreement), collaboration, out-licensing, partnership or other business development arrangements, or a combination of the foregoing. None may be possible and, as a result, the Company may need to significantly delay, scale back or discontinue development of or abandon some or all of its product candidates, or scale back or discontinue the Company's discovery research efforts, any of which could have a material adverse effect on the Company's business, operating results and prospects, or the Company may be required to cease operations altogether. Fair Value of Financial Instruments The carrying amounts of cash and cash equivalents, the related party receivable from collaboration and other current assets and liabilities approximate their respective fair values due to their short-term nature. Cash and Cash Equivalents Cash and cash equivalents are stated at fair value. Cash equivalents are securities with an original maturity of three months or less at the time of purchase. The Company limits its credit risk associated with cash and cash equivalents by investing in highly rated money market funds and placing its cash with banks it believes are highly creditworthy in amounts that may at times exceed Federal Deposit Insurance Corporation, or FDIC, limits. As of September 30, 2023 and December 31, 2022, cash and cash equivalents consisted of bank deposits and investments in money market funds. The Company’s bank deposits as of September 30, 2023 and December 31, 2022 included certain amounts over the FDIC limits. Marketable Securities The appropriate classification of the Company’s marketable securities is determined at the time of purchase and such designations are re-evaluated at each balance sheet date. All of the Company’s securities are considered as available-for-sale and carried at estimated fair values and reported in cash equivalents and short-term marketable securities. Unrealized gains and losses on available-for-sale securities are excluded from net loss and reported in accumulated other comprehensive loss as a separate component of stockholders’ equity. Interest income, net, includes interest, amortization of purchase premiums and accretion of purchase discounts, realized gains and losses on sales of securities and other-than-temporary declines in the fair value of securities, if any. The cost of securities sold is based on the specific identification method. The Company’s investments are regularly reviewed for any impairments in fair value. This review includes the consideration of the cause of the impairment, including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and duration of the unrealized losses, whether the Company has the intent to sell the securities and whether it is more likely than not that the Company will be required to sell the securities before the recovery of their amortized cost basis. When the Company determines that the investment is impaired, the Company reduces the carrying value of the security it holds and records a loss for the amount of such decline. As of September 30, 2023, the Company did not record any impairments related to its securities. Restricted Cash The Company’s restricted cash balances represent collateral required under the Company’s facility lease agreements. Collateral that will not be returned to the Company within twelve months from the date of these condensed consolidated financial statements is classified as a non-current asset. Concentration of Credit and Other Risks Cash, cash equivalents and marketable securities from the Company’s available-for-sale and marketable securities portfolio potentially subject the Company to concentrations of credit risk. The Company is invested in money market funds and marketable securities through custodial relationships with major United States, or U.S., banks. Under its investment policy, the Company limits amounts invested in such securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. Related party receivables from collaboration and partnering arrangements are typically unsecured. Accordingly, the Company may be exposed to credit risk generally associated with its current amended and restated research collaboration, product development and license agreement, or the Amended Collaboration Agreement, with Merck Sharp & Dohme LLC, or Merck, and any future collaboration or partnering arrangements with other potential future partners. To date, the Company has not experienced any losses related to these receivables. 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. Although the Company expects to have an unconditional right to receive such amounts, the Company may be exposed to the risk of not receiving the recorded amounts under its current collaboration agreement with Merck and any future collaboration or partnering arrangements with other potential future partners. To date, the Company has not experienced any losses related to contract assets. Merck accounted for 100% of the Company’s revenue for the three and nine months ended September 30, 2023 and 2022. Property and Equipment, Net Property and equipment are recorded at cost and consist of computer equipment, laboratory equipment and office furniture and leasehold improvements. Maintenance and repairs, and training on the use of equipment, are expensed as incurred. Costs that improve assets or extend their economic lives are capitalized. Depreciation is recognized using the straight-line method based on an estimated useful life of the asset, which is as follows: Computer equipment 3 years Laboratory equipment and office furniture 3 years Leasehold improvement Shorter of life of asset or lease term Leases The Company determines if an arrangement is a lease at inception. Lease assets represent the Company's right to use an underlying asset for the lease term and lease liabilities represent the Company's obligation to make lease payments arising from the lease. Lease liabilities are measured at the lease commencement date as the present value of future minimum lease payments over the term of the lease. Lease assets are measured as the lease liability plus initial direct costs and prepaid lease payments less lease incentives. In measuring the present value of the future minimum lease payments, the Company generally uses its incremental borrowing rate. The lease term is the noncancelable period of the lease and includes options to extend or terminate the lease when it is reasonably certain that an option will be exercised. Leases with terms of 12 months or less are not recorded on the Company's balance sheet. Lease expense is recognized on a straight-line basis over the lease terms, or in some cases, the useful life of the underlying asset. The Company accounts for the lease and non-lease components as a single lease component. The Company’s lease agreement for its corporate office space and facilities is classified as an operating lease. Impairment of Long-Lived Assets Long-lived assets, such as property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated undiscounted future cash flows, an impairment charge is recognized as the amount by which the carrying amount of the asset exceeds the estimated fair value of the asset. As of September 30, 2023 and December 31, 2022, no revision to the remaining useful lives or write-down of long-lived assets was required. Income Taxes Income taxes are accounted for under the liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to the differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and the operating loss and tax credit carryforwards. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. Deferred tax assets and liabilities are measured at the balance sheet date using the enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the period such tax rate changes are enacted. The net deferred tax assets have been fully offset by a valuation allowance. Revenue Recognition Under ASC 606, the Company estimates each arrangement’s total transaction price, which includes unconstrained variable consideration, and the recognition of that transaction price based on a cost-based input method that requires estimates to determine, at each reporting period, the percentage of completion based on the estimated total effort required to complete the project and the total transaction price. The unconstrained variable consideration amount included in the transaction price represents an amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. The Company applies the following five-step revenue recognition model outlined in ASC 606 to adhere to this core principle: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the Company satisfies a performance obligation. All of the Company’s revenue to date has been generated from its collaboration agreements, primarily its collaboration agreement with Merck. The terms of these agreements generally require the Company to provide (i) license options for its compounds, (ii) research and development, or R&D, services and (iii) non-mandatory services in connection with participation in research or steering committees. Payments received under these arrangements may include non-refundable upfront license fees, partial or complete reimbursement of R&D costs, contingent consideration payments based on the achievement of defined collaboration objectives and royalties on sales of commercialized products. In some agreements, the collaboration partner is solely responsible for meeting defined objectives that trigger contingent or royalty payments. Often the partner only pursues such objectives subsequent to exercising an optional license on compounds identified as a result of the R&D services performed under the collaboration agreement. The Company assesses whether the promises in its arrangements, including any options provided to the partner, are considered distinct performance obligations that should be accounted for separately. Judgment is required to determine whether the license to a compound is distinct from R&D services or participation in research or steering committees, as well as whether options create material rights in the contract. In situations when a contract includes distinct R&D services that are substantially the same and have the same pattern of transfer to the customer over time, they are recognized as a series of distinct services. The transaction price in each arrangement is generally comprised of a non-refundable upfront fee and unconstrained variable consideration related to the performance of R&D services. The unconstrained variable consideration amount included in the transaction price represents an amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. The Company typically submits a budget for the R&D services to the partner in advance of performing the services. The transaction price is allocated to the identified performance obligations based on the standalone selling price, or SSP, of each distinct performance obligation. Judgment is required to determine the SSP. In instances where the SSP is not directly observable, such as when a license or service is not sold separately, SSP is determined using information that may include market conditions and other observable inputs. The Company utilizes judgment to assess the nature of its performance obligations to determine whether they are satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress toward completion. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. The Company’s collaboration agreements may include contingent payments related to specified development and regulatory milestones or contingent payments for royalties based on sales of a commercialized product. Milestones can be achieved for such activities in connection with progress in clinical trials, regulatory filings in various geographical markets and marketing approvals from health authorities. Sales-based royalties are generally related to the volume of annual sales of a commercialized product. At the inception of each agreement that includes such payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price by using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s or its partner’s control, such as those related to regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation based on a relative SSP basis. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of each such milestone and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Pursuant to the guidance in ASC 606, sales-based royalties are not included in the transaction price. Instead, royalties are recognized at the later of when the performance obligation is satisfied or partially satisfied, or when the sale that gives rise to the royalty occurs. Contract modifications, defined as changes in the scope or price (or both) of a contract that are approved by the parties to the contract, such as a contract amendment, exist when the parties to a contract approve a modification that either creates new, or changes existing, enforceable rights and obligations of the parties to the contract. Depending on facts and circumstances, the Company accounts for a contract modification as one of the following: (i) a separate contract; (ii) a termination of the existing contract and a creation of a new contract; or (iii) a combination of the preceding treatments. A contract modification is accounted for as a separate contract if the scope of the contract increases because of the addition of promised services that are distinct and if the price of the contract increases by an amount of consideration that reflects the Company’s standalone selling prices of the additional promised services. When a contract modification is not considered a separate contract and the remaining services are distinct from the services transferred on or before the date of the contract modification, the Company accounts for the contract modification as a termination of the existing contract and a creation of a new contract. When a contract modification is not considered a separate contract and the remaining services are not distinct, the Company accounts for the contract modification as an add-on to the existing contract and as an adjustment to revenue on a cumulative catch-up basis. Research and Development R&D costs are expensed as incurred. R&D expenses primarily include salaries and benefits for medical, clinical, quality, preclinical, manufacturing and research personnel, costs related to research activities, preclinical studies, clinical trials, drug manufacturing expenses and allocated overhead and facility occupancy costs. The Company accounts for non-refundable advance payments for goods or services that will be used in future R&D activities as expenses when the goods have been received or when the service has been performed rather than when the payment is made. Clinical trial costs are a component of R&D expenses. The Company accrues estimated costs for its clinical trial activities performed by third parties, including clinical research organizations, or CROs, and other service providers based upon estimates of the proportion of work completed over the life of the individual clinical trial and patient enrollment rates in accordance with associated agreements. The Company's estimates are determined through detailed discussions with internal personnel and its service providers as to the progress of each clinical trial and by reviewing contracts, vendor agreements and purchase orders for previously agreed-upon rates and fees to be paid for such services. Stock-Based Compensation The Company’s stock-based compensation programs include stock option and restricted stock unit, or RSU, grants, as well as shares issued under its 2019 Employee Stock Purchase Plan, or ESPP. Grants are awarded to employees, directors and non-employees. The Company measures stock-based compensation expense for all stock-based awards at the grant date based on the fair value measurement of the award. The expense is recorded on a straight-line basis over the requisite service period, which is generally the vesting period, for the entire award. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures materially differ from estimates. The Company calculates the fair value measurement of stock options using the Black-Scholes option-pricing model. 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, net of taxes, on the Company’s marketable securities. Net Loss per Share Basic net loss per share is calculated by dividing net loss by the weighted average number of shares outstanding during the period, less shares subject to repurchase and excludes any dilutive effects of stock-based options and awards. Diluted net income per share is computed by giving effect to all potentially dilutive shares, including common stock issuable upon exercise of stock options and the assumed vesting of outstanding RSUs. However, where there is a diluted net loss per share, no adjustment is made for potentially issuable shares since their effect would be anti-dilutive. In this case, diluted net loss per share is equal to basic net loss per share. Net loss per share was computed as follows (in thousands, except per share amounts): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Numerator: Net loss $ (28,797) $ (47,261) $ (114,705) $ (126,230) Denominator: Weighted average number of shares used in calculating net loss per share—basic and diluted 82,707 80,623 82,393 79,331 Net loss per share—basic and diluted $ (0.35) $ (0.59) $ (1.39) $ (1.59) Potentially dilutive securities that were not included in the diluted per share calculations because they would be anti-dilutive were as follows (in thousands): For the Three and Nine Months Ended 2023 2022 Options to purchase common stock 13,254 13,223 Shares committed under the ESPP 971 472 RSUs 708 — Total 14,933 13,695 Segment and Geographical Information The Company operates in one business segment. Substantially all of the Company’s long-lived assets, primarily comprised of property and equipment, are based in the United States. For the three and nine months ended September 30, 2023 and 2022, the Company’s revenues were entirely within the United States based upon the location of the Company and Merck. Recent Accounting Pronouncements New accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s results of operations and financial position upon adoption. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements Cash equivalents and marketable securities are classified as available-for-sale securities and consisted of the following (in thousands): Amortized Gross Gross Fair As of September 30, 2023 U.S. treasury securities $ 54,548 $ 1 $ (33) $ 54,516 Money market funds 45,245 — — 45,245 Commercial paper 21,914 — — 21,914 U.S. government agency securities 20,916 1 (4) 20,913 Corporate and agency bonds 17,269 — (43) 17,226 Totals $ 159,892 $ 2 $ (80) $ 159,814 Classified as: Cash and cash equivalents $ 45,245 Short-term marketable securities (amortized cost of $114,647) 114,569 Total $ 159,814 Amortized Gross Gross Fair As of December 31, 2022 U.S. treasury securities $ 89,039 $ 7 $ (160) $ 88,886 Money market funds 62,844 — — 62,844 Corporate and agency bonds 46,300 — (200) 46,100 Commercial paper 42,746 — — 42,746 U.S. government agency securities 20,253 51 — $ 20,304 Totals $ 261,182 $ 58 $ (360) $ 260,880 Classified as: Cash and cash equivalents $ 62,844 Short-term marketable securities (amortized cost of $198,338) 198,036 Total $ 260,880 The cash and cash equivalents amount in the table above excludes cash on deposit with banks of $6.2 million and $10.6 million as of September 30, 2023 and December 31, 2022, respectively. To date, the Company has not recorded any impairment charges against the market value of its marketable securities. In determining whether an investment is impaired, the Company considers various factors including the length of time and extent to which the market value has been less than cost, the financial condition and near-term prospects of the issuer and the Company’s intent and ability to retain its investment in the issuer for a period of time sufficient to allow for any anticipated recovery in market value. As of September 30, 2023 and December 31, 2022, all of the Company’s marketable securities had remaining contractual maturities of less than one year. As of September 30, 2023, the Company had twelve marketable securities in an unrealized loss position compared to 19 marketable securities in an unrealized loss position as of December 31, 2022. Marketable securities that were in unrealized loss positions as of September 30, 2023 and December 31, 2022 had been in an unrealized loss position for less than twelve months. The Company does not need to, nor does it intend to, sell marketable securities that are in an unrealized loss position, and it is highly unlikely that the Company will be required to sell the investments before recovery of their amortized cost basis, which may be maturity. Assets and Liabilities Measured at Fair Value on a Recurring Basis The following table summarizes, by major security type, the Company's available-for-sale securities that were measured at fair value on a recurring basis and were categorized using the fair value hierarchy (in thousands): Fair Value Measurements As of September 30, 2023 Level 1 Level 2 Level 3 Total Assets: U.S. treasury securities $ 54,516 $ — $ — $ 54,516 Money market funds 45,245 — — 45,245 Commercial paper — 21,914 — 21,914 U.S. government agency securities — 20,913 — 20,913 Corporate and agency bonds — 17,226 — 17,226 Totals $ 99,761 $ 60,053 $ — $ 159,814 Fair Value Measurements As of December 31, 2022 Level 1 Level 2 Level 3 Total Assets: U.S. treasury securities $ 88,886 $ — $ — $ 88,886 Money market funds 62,844 — — 62,844 Corporate and agency bonds — 46,100 — 46,100 Commercial paper — 42,746 — 42,746 U.S. government agency securities — 20,304 — 20,304 Totals $ 151,730 $ 109,150 $ — $ 260,880 The Company estimates the fair values of investments in commercial paper, corporate and agency bond securities and U.S. government agency securities using Level 2 inputs by taking into consideration valuations obtained from third-party pricing services. There were no transfers of assets or liabilities between the fair value measurement levels during the nine months ended September 30, 2023 and year ended December 31, 2022. |
Balance Sheet Components
Balance Sheet Components | 9 Months Ended |
Sep. 30, 2023 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Components | Balance Sheet Components Cash, Cash Equivalents and Restricted Cash A reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets to the amount reported within the condensed consolidated statements of cash flows is as follows (in thousands): September 30, December 31, Cash and cash equivalents $ 51,476 $ 73,456 Restricted cash 5,454 3,954 Total cash, cash equivalents and restricted cash $ 56,930 $ 77,410 Property and Equipment Property and equipment consisted of the following (in thousands): September 30, December 31, Leasehold improvements $ 25,801 $ 25,866 Laboratory equipment and office furniture 23,979 23,807 Computer equipment 1,433 1,433 Construction-in-progress 391 284 Total property and equipment, gross 51,604 51,390 Less: accumulated depreciation and amortization (44,323) (42,894) Total property and equipment, net $ 7,281 $ 8,496 Depreciation expense was $0.5 million and $1.7 million for the three and nine months ended September 30, 2023, respectively, compared to $0.6 million and $3.4 million for the same periods in 2022. Accrued Liabilities Accrued liabilities consisted of the following (in thousands): September 30, December 31, Clinical trials and research and development costs $ 6,462 $ 14,597 Personnel-related costs 6,251 9,181 Accrued expenses 2,674 3,834 Manufacturing costs 780 6,026 Total accrued liabilities $ 16,167 $ 33,638 |
Research Collaboration and Lice
Research Collaboration and License Agreements | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Research Collaboration and License Agreements | Research Collaboration and License Agreements Merck In 2015, the Company entered into a research collaboration, product development and license agreement with Merck, which, together with amendments made prior to June 30, 2021, is referred to as the Original Collaboration Agreement, covering the discovery, development and commercialization of novel therapies across a range of therapeutic areas, including a broad, multi-year drug discovery and early development program that was financially supported by Merck, and scientifically directed by the Company with input from Merck. The original research phase of the collaboration was for five years and was extended by Merck for an additional two years through March 2022. As part of that extension, Merck agreed to continue to fund up to $75.0 million of the Company's R&D efforts each year consistent with the initial five-year research term and, in lieu of a $20.0 million extension fee payable to the Company, Merck agreed to make additional payments totaling up to $20.0 million in support of the Company's R&D activities during 2021 through the first quarter of 2022. On June 30, 2021, the Company entered into an amended and restated research collaboration, product development and license agreement with Merck, or the Amended Collaboration Agreement, replacing the Original Collaboration Agreement and extending the research phase of the collaboration generally through March 31, 2024, with possible extensions for each of the various programs to allow the Company or Merck to complete ongoing development, but with a narrower scope than in the Original Collaboration Agreement. Under the Amended Collaboration Agreement, the collaboration was focused primarily on the identification, research and development of collaboration compounds directed to targets of interest to Merck in the fields of ophthalmology and cardiovascular or metabolic, or CVM, disease, including heart failure. The collaboration scope also included certain laboratory testing and other activities on compounds that are directed to one of up to two undisclosed targets outside of the fields of ophthalmology and CVM disease, or the Lab Programs. Currently, the only ongoing research activities to be funded under the Amended Collaboration Agreement are certain CVM-related activities. The research phase for the CVM-related continuing programs will continue until March 31, 2024, unless the parties mutually agree to extend the research phase to March 31, 2026, in which case Merck would provide up to a total of $20.0 million in research funding during those additional two years. The Company does not expect the research phase to be extended. Remaining activities under the Lab Programs were substantially completed in the first quarter of 2023. The ophthalmology compounds in the collaboration under the Amended Collaboration Agreement initially included NGM621 (and its related compounds) and compounds directed against two other undisclosed ophthalmology targets (and their related compounds). Merck had a one-time option to license NGM621, its related compounds and the ophthalmology bundle upon completion of the Phase 2 CATALINA trial. In December 2022, Merck notified the Company that it would not exercise its option to license NGM621 and its related compounds, nor would Merck exercise the related ophthalmology bundle option; accordingly, these options expired unexercised in January 2023 and the programs are now wholly-owned by the Company. Further, Merck did not elect for the Company to continue to conduct R&D during an extended or tail period on any compounds from the Company's other ophthalmology programs that were subject to the collaboration. Because Merck did not exercise its ophthalmology license options or make an R&D tail period election, the programs are now wholly-owned by the Company and the Company does not have any funding from Merck to pursue such ophthalmology programs. Pursuant to the Amended Collaboration Agreement, the Company gained the right, in its sole discretion, to independently research, develop and commercialize the collaboration compounds known as NGM120, NGM707, NGM831 and NGM438, their related compounds and all other preclinical and research assets that the Company researched or developed under the Original Collaboration Agreement but that were not included within the R&D scope of the continuing collaboration, which are referred to as the released NGM compounds. Merck retained the right to receive royalties at low single-digit rates on the sales of any released NGM compounds that receive regulatory approval and, if the Company decides during a certain time period to engage in a formal partnering process for a released NGM compound or negotiations regarding a license or asset sale of a released NGM compound, the Company is obligated to notify Merck, provide Merck with certain information and engage in good faith, non-exclusive negotiations with respect to such released NGM compound with Merck at Merck’s request. Under the Amended Collaboration Agreement, Merck continued to have a Merck license option, as it did under the Original Agreement, to each continuing collaboration compound that is identified, researched and developed under the Amended Collaboration Agreement and reaches the specified option exercise point for such continuing collaboration compound as described below, and to its related compounds (each such continuing collaboration compound and its related compounds are referred to generally as a continuing program). In addition, under the terms of the Amended Collaboration Agreement, new CVM-related programs may be added to the continuing collaboration if recommended by the Company and selected by Merck, and Merck would have a Merck license option to such CVM-related continuing program. We do not expect any new CVM-related programs to be added to the collaboration. The Merck license option exercise point for a continuing collaboration compound from the CVM-related continuing programs or the Lab Programs will be the designation by Merck of such continuing collaboration compound as a research program development candidate that Merck intends to progress into preclinical development. Under the Amended Collaboration Agreement, if Merck exercises the Merck license option for a continuing collaboration compound from a CVM-related continuing program or the Lab Programs, Merck will pay the Company a $6.0 million option exercise fee at the time of selection to progress such licensed continuing collaboration compound or any of its related compounds into preclinical development and an additional $10.0 million milestone payment if such continuing collaboration compounds or one of its related compounds subsequently completes a human proof-of-concept trial. Merck will be responsible, at its own cost, for any further development and commercialization activities for continuing collaboration compounds within any such licensed continuing program. In March 2022, the Company and Merck entered into a letter agreement, or the Letter Agreement, regarding NGM621 manufacturing activities that the Company undertook with the intention of avoiding a significant delay between the completion of the CATALINA trial and the start of any Phase 3 clinical trial for NGM621. The Company concluded that the Amended Collaboration Agreement is a separate arrangement containing a three-year performance obligation to provide distinct R&D services in accordance with ASC 606. The total transaction price under the Amended Collaboration Agreement is $118.8 million which includes $86.0 million in research funding for the four calendar quarters that ended on March 31, 2022, $15.0 million in research funding for the ophthalmology and CVM-related continuing programs and the Lab Programs during the remaining two years of the research phase after March 2022, $13.1 million in estimated NGM621 reimbursable expenses and costs during the remaining two years of the research phase after March 2022 and $4.75 million for reimbursable amounts paid in 2022 to a third-party manufacturer in accordance with the terms of the Letter Agreement. The Company will continue to re-evaluate the transaction price as uncertain events are resolved or other changes in circumstances occur. The Company continues performing its R&D services in the area of both the continuing collaboration compounds and the released NGM compounds and has one performance obligation across all continuing programs. The Company will continue to use the cost-based input method to calculate the amount of revenue to recognize as services are being rendered from April 1, 2021 through March 31, 2024. For the period that started on October 1, 2023 and ends on March 31, 2024, the Company expects Merck will provide minimal funding for the ongoing CVM-related activities and this amount is included in the transaction price. The Company considered whether the Merck license option created material rights in the contract and concluded that the fee attached to the exercise of such option approximated the SSP of the promised goods or services included in the option. Therefore, the Company concluded that such option did not give rise to a material right, was not a performance obligation in the Amended Collaboration Agreement and, if and when exercised, would be accounted for as separate arrangements under ASC 606. Merck owned approximately 16% of the Company's outstanding shares as of September 30, 2023. Summary of Related Party Revenue The Company recognized revenue from its collaboration and license agreements as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Related party revenue $ 582 $ 7,911 $ 4,252 $ 37,152 For the three and nine months ended September 30, 2023, the Company recognized collaboration and license revenue primarily related to reimbursable R&D activities associated with the performance obligation under the Amended Collaboration Agreement under which Merck is providing significantly less annual R&D funding than it had provided through March 31, 2022. Revenue recognized related to the reimbursable R&D activities was recognized using the cost-based input model related to R&D activities. Related Party Contract Assets and Liabilities Amounts recognized as revenue prior to the Company having an unconditional right (or 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, the contract asset will be classified in current assets. As of September 30, 2023 and December 31, 2022, the Company did not have a related party contract asset. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Operating Leases and Lease Guarantee In December 2015, the Company entered into an operating lease agreement, or the 333 Oyster Point lease agreement, for its corporate office space and facilities at 333 Oyster Point Blvd., South San Francisco, California, or the 333 Oyster Point facility, for approximately 122,000 square feet that expires in December 2023. The 333 Oyster Point lease agreement provided a tenant improvement allowance of $15.2 million that the Company used in 2016 towards $22.3 million in total leasehold improvements that are amortized over the lease term of seven years. As of September 30, 2023, restricted cash in current assets on the Company's condensed consolidated balance sheets included a letter of credit in the amount of $1.5 million required under the 333 Oyster Point lease agreement. As of September 30, 2023, the remaining lease term for the 333 Oyster Point lease agreement was three months and the discount rate used to determine the Company's operating lease liability was 2.85%. Cash payments included in the measurement of the lease liabilities totaled $4.1 million and $4.0 million in the nine-month periods ended September 30, 2023 and 2022, respectively. During the three and nine months ended September 30, 2023 and September 30, 2022, the components of lease costs, which were included in general and administrative expenses on the Company's condensed consolidated statements of operations, were as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Operating lease costs $ 541 $ 541 $ 1,624 $ 1,624 Variable lease costs (1) 338 314 1,067 962 Total lease cost $ 879 $ 855 $ 2,691 $ 2,586 _____________ (1) Variable lease costs include certain additional charges for operating costs, including insurance, maintenance, taxes and other costs incurred, which are billed based on both usage and as a percentage of the Company’s share of total square footage. As of September 30, 2023, the maturities of the Company’s operating lease liabilities and future minimum lease payments were as follows (in thousands): Total undiscounted lease payments for the remainder of the year ending December 31, 2023 $ 1,384 Less: present value adjustment (3) Present value of lease liabilities $ 1,381 In July 2022, the Company entered into an operating lease agreement, or the 2024 Lease Agreement, for its corporate office space and facilities at 333 Oyster Point Blvd., South San Francisco, California, which the Company currently occupies pursuant to the 333 Oyster Point lease agreement that expires on December 31, 2023. Pursuant to the 2024 Lease Agreement, the lease term with the new landlord begins on January 1, 2024 (the lease commencement date) and expires on December 31, 2033, and the Company will pay an initial monthly base rent of approximately $0.9 million for the first year, which is subject to increase at an annual rate of 3.5% each year thereafter, plus certain operating and tax expenses. Base rent during the initial ten-year term of the 2024 Lease Agreement will total $124.1 million. The 2024 Lease Agreement provides a tenant improvement allowance of approximately $4.9 million. The Company has an option to extend the 2024 Lease Agreement for a period of either eight years or ten years after the initial term. In July 2022, pursuant to the 2024 Lease Agreement, the Company provided the landlord with a letter of credit in the amount of $2.5 million that was reported as restricted cash in non-current assets on the Company's condensed consolidated balance sheets as of September 30, 2023 and December 31, 2022. Indemnification In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and may provide for indemnification of the counterparty. The Company’s exposure under these agreements is unknown because it involves claims that may be made against it in the future but have not yet been made. In accordance with the Company’s amended and restated certificate of incorporation and its amended and restated bylaws, the Company has indemnification obligations to its officers and directors, subject to some limits, with respect to their service in such capacities. The Company has also entered into indemnification agreements with its directors and certain of its officers. To date, the Company has not been subject to any claims, and it maintains director and officer insurance that may enable it to recover a portion of any amounts paid for future potential claims. The Company’s exposure under these agreements is unknown because it involves claims that may be made against it in the future but have not yet been made. The Company believes that the fair value of these indemnification obligations is minimal and, accordingly, it has not recognized any liabilities relating to these obligations for any period presented. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation Stock Option Activity The following is a summary of the activity under the Company's equity incentive plans: Outstanding Options Weighted Aggregate Number of Weighted Balances at December 31, 2022 14,215 $ 14.74 6.89 $ 1,749 Options granted 5,161 4.26 Options exercised (351) 1.90 Options forfeited (2,602) 11.40 Options expired (3,169) 13.20 Balances at September 30, 2023 13,254 $ 12.03 7.37 $ — Vested and expected to vest at September 30, 2023 12,863 $ 12.12 7.32 $ — Exercisable at September 30, 2023 7,042 $ 14.73 5.93 $ — The aggregate intrinsic values of options outstanding, vested and expected to vest, and exercisable were calculated as the difference between the exercise price of the options and the estimated fair value of the Company’s common stock. As of September 30, 2023, the Company's outstanding options had no intrinsic value because the estimated fair value of the Company's common stock was less than the exercise price of the options outstanding. The weighted-average grant date fair value of stock options granted during the nine months ended September 30, 2023 was $3.09 per share. Employee Stock Purchase Plan Under the ESPP, eligible employees are granted the right to purchase shares of the Company's common stock through payroll deductions that cannot exceed 15% of each employee’s salary. The ESPP provides for a 24-month offering period, which includes four six-month purchase periods. At the end of each purchase period, eligible employees are permitted to purchase shares of common stock at the lower of 85% of fair market value at the beginning of the offering period or fair market value at the end of the purchase period. The ESPP is considered a compensatory plan. As of September 30, 2023, 1,087,768 shares of common stock had been purchased under the ESPP. Restricted Stock Units During the three and nine months ended September 30, 2023, the Company granted 1.0 million RSUs covering an equal number of shares of the Company's common stock to employees with a weighted-average grant date fair value of $4.36 per RSU. The fair value of RSUs is determined on the date of grant based on the market price of the Company's common stock as of that date. The fair value of the RSUs is recognized as an expense ratably over the vesting period of four years. No shares underlying the RSUs have vested or been released and 0.3 million shares have been forfeited as of September 30, 2023. Stock-Based Compensation Expense Stock-based compensation expense was calculated based on awards previously granted to employees, directors and non-employees that are ultimately expected to vest and was reduced for estimated forfeitures. Stock-based compensation expense was allocated as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Research and development $ 2,743 $ 4,182 $ 11,143 $ 12,804 General and administrative 3,667 3,507 11,280 10,807 Total stock-based compensation expense $ 6,410 $ 7,689 $ 22,423 $ 23,611 Stock-based compensation expense for the nine months ended September 30, 2023 included $0.7 million in restructuring charges. See Note 9 for information regarding the Company's workforce reduction in the second quarter of 2023. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income TaxesSince inception, the Company has incurred net losses, and the Company expects to record a net loss for the year ending December 31, 2023. Additionally, the Company’s net deferred tax assets have been fully offset by a valuation allowance. Therefore, the Company did not record a tax provision for income taxes for the three and nine months ended September 30, 2023 and 2022. |
Workforce Reduction
Workforce Reduction | 9 Months Ended |
Sep. 30, 2023 | |
Restructuring and Related Activities [Abstract] | |
Workforce Reduction | Workforce Reduction During the second quarter of 2023, the Company announced and substantially completed a restructuring of the Company's workforce pursuant to which the Company’s workforce was reduced by 74 people, or approximately 33% of the Company’s existing headcount as of April 3, 2023. The Company incurred approximately $4.9 million in restructuring charges in connection with the restructuring, consisting of (i) approximately $4.2 million in cash-based expenses related to employee severance and notice period payments, benefits and related costs, and (ii) approximately $0.7 million in non-cash stock-based compensation expense related to the vesting of share-based awards. The restructuring charges are included in the Company's condensed consolidated statements of income for the nine months ended September 30, 2023 as follows (in thousands): Nine Months Ended Research and development $ 3,811 General and administrative 1,105 Total restructuring expense $ 4,916 All restructuring charges were incurred in the second quarter of 2023, and cash payments were substantially completed by the end of the second quarter of 2023. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Event | Subsequent EventOn October 17, 2023, the Company's Compensation Committee, or the Committee, of the Board of Directors, or the Board, approved an option repricing program, or the repricing program, which will be effective on the second business day following the filing of this Quarterly Report on Form 10-Q, or the Effective Date. The repricing program generally applies to options to purchase shares of the Company’s common stock that: (i) were granted under the Company’s equity incentive plans; (ii) as of the Effective Date, are held by the Company’s then-current employees (subject to the retention requirements below); and (iii) have an exercise price per share greater than $5.00. Such options, subject to the retention requirements below, are referred to as the Eligible Options. The Eligible Options include options held by certain of the Company's executive officers, but exclude options held by Siobhan Nolan Mangini who is stepping down as Chief Financial Officer on November 3, 2023 and is stepping down as President on December 1, 2023. Options held by non-employee members of the Board are not eligible for the repricing program. As of the Effective Date, the Eligible Options will be immediately repriced such that the exercise price per share for such options will be reduced to the closing price of the Company’s common stock on the Effective Date, subject to certain retention requirements outlined below. If an employee exercises Eligible Options in advance of the end of the retention period as described below, the employee will be required to pay a premium exercise price equal to the original exercise price per share of the Eligible Options. The Eligible Options that were previously incentive stock options will be amended to become nonstatutory stock options on or following the Effective Date. There will be no changes to the number of shares underlying the Eligible Options or to the vesting schedules or expiration dates of the Eligible Options. In order to exercise the Eligible Options at the reduced exercise price, holders of the Eligible Options are required to remain in service with the Company through the end of the relevant retention period. The retention period begins on the Effective Date and ends on the earliest of the following: (i) the date 12 months (or, in the case of the Eligible Options held by the Company's Chief Executive Officer that are unvested as of the Effective Date, 18 months) following the Effective Date; (ii) a Change in Control (as defined in the applicable equity incentive plan) if the Eligible Options are not assumed or continued by the successor or acquiror entity (or its parent company) in such Change in Control or substituted for a similar award of the successor or acquiror entity (or its parent company); and (iii) the optionholder’s termination of Continuous Service (as defined in the applicable equity incentive plan) (a) due to such individual’s death or disability, (b) by the Company (or successor entity in a Change in Control) other than for Cause (as defined in the applicable equity incentive plan) or (c) due to such optionholder’s resignation on or following a Change in Control under certain circumstances. The total number of shares underlying all Eligible Options is 7,037,470 shares. The Company is in the process of determining the incremental compensation expense associated with the repricing program. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Pay vs Performance Disclosure | ||||||||
Net loss | $ (28,797) | $ (38,261) | $ (47,647) | $ (47,261) | $ (46,519) | $ (32,450) | $ (114,705) | $ (126,230) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Sep. 30, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation and Principles of Consolidation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or U.S. GAAP, and Regulation S-X for interim consolidated financial statements. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the U.S Securities and Exchange Commission, or SEC, on February 28, 2023. These unaudited condensed consolidated financial statements reflect all adjustments that management believes are necessary for a fair presentation of the periods presented. All such adjustments are of a normal recurring nature and are not necessarily indicative of results expected for the full fiscal year ending December 31, 2023, or for any subsequent interim period. |
Principles of Consolidation | These unaudited condensed consolidated financial statements include the consolidated accounts of NGM Biopharmaceuticals, Inc. and its wholly-owned foreign subsidiary, NGM Australia. All intercompany balances and transactions have been eliminated upon consolidation. |
Use of Estimates | Use of EstimatesThe preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make judgments, assumptions and estimates that affect the reported amounts of assets, liabilities, revenues and expenses. Specific accounts that require management estimates include, but are not limited to, stock-based compensation expense, contract manufacturing accruals, clinical trial accruals and revenue recognition in accordance with Accounting Standards Update, or ASU, 2014-09, Revenue from Contracts with Customers (Topic 606), or ASC 606. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results could differ materially from those estimates, and to the extent that there are differences between management's estimates and actual results, the Company's future financial statement presentation, financial condition, results of operations and cash flows may be affected. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amounts of cash and cash equivalents, the related party receivable from collaboration and other current assets and liabilities approximate their respective fair values due to their short-term nature. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents are stated at fair value. Cash equivalents are securities with an original maturity of three months or less at the time of purchase. The Company limits its credit risk associated with cash and cash equivalents by investing in highly rated money market funds and placing its cash with banks it believes are highly creditworthy in amounts that may at times exceed Federal Deposit Insurance Corporation, or FDIC, limits. As of September 30, 2023 and December 31, 2022, cash and cash equivalents consisted of bank deposits and investments in money market funds. The Company’s bank deposits as of September 30, 2023 and December 31, 2022 included certain amounts over the FDIC limits. |
Marketable Securities | Marketable Securities The appropriate classification of the Company’s marketable securities is determined at the time of purchase and such designations are re-evaluated at each balance sheet date. All of the Company’s securities are considered as available-for-sale and carried at estimated fair values and reported in cash equivalents and short-term marketable securities. Unrealized gains and losses on available-for-sale securities are excluded from net loss and reported in accumulated other comprehensive loss as a separate component of stockholders’ equity. Interest income, net, includes interest, amortization of purchase premiums and accretion of purchase discounts, realized gains and losses on sales of securities and other-than-temporary declines in the fair value of securities, if any. The cost of securities sold is based on the specific identification method. The Company’s investments are regularly reviewed for any impairments in fair value. This review includes the consideration of the cause of the impairment, including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and duration of the unrealized losses, whether the Company has the intent to sell the securities and whether it is more likely than not that the Company will be required to sell the securities before the recovery of their amortized cost basis. When the Company determines that the investment is impaired, the Company reduces the carrying value of the security it holds and records a loss for the amount of such decline. As of September 30, 2023, the Company did not record any impairments related to its securities. |
Restricted Cash | Restricted Cash The Company’s restricted cash balances represent collateral required under the Company’s facility lease agreements. Collateral that will not be returned to the Company within twelve months from the date of these condensed consolidated financial statements is classified as a non-current asset. |
Concentration of Credit and Other Risks | Concentration of Credit and Other Risks Cash, cash equivalents and marketable securities from the Company’s available-for-sale and marketable securities portfolio potentially subject the Company to concentrations of credit risk. The Company is invested in money market funds and marketable securities through custodial relationships with major United States, or U.S., banks. Under its investment policy, the Company limits amounts invested in such securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. Related party receivables from collaboration and partnering arrangements are typically unsecured. Accordingly, the Company may be exposed to credit risk generally associated with its current amended and restated research collaboration, product development and license agreement, or the Amended Collaboration Agreement, with Merck Sharp & Dohme LLC, or Merck, and any future collaboration or partnering arrangements with other potential future partners. To date, the Company has not experienced any losses related to these receivables. 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. Although the Company expects to have an unconditional right to receive such amounts, the Company may be exposed to the risk of not receiving the recorded amounts under its current collaboration agreement with Merck and any future collaboration or partnering arrangements with other potential future partners. To date, the Company has not experienced any losses related to contract assets. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment are recorded at cost and consist of computer equipment, laboratory equipment and office furniture and leasehold improvements. Maintenance and repairs, and training on the use of equipment, are expensed as incurred. Costs that improve assets or extend their economic lives are capitalized. Depreciation is recognized using the straight-line method based on an estimated useful life of the asset, which is as follows: Computer equipment 3 years Laboratory equipment and office furniture 3 years Leasehold improvement Shorter of life of asset or lease term |
Leases | Leases The Company determines if an arrangement is a lease at inception. Lease assets represent the Company's right to use an underlying asset for the lease term and lease liabilities represent the Company's obligation to make lease payments arising from the lease. Lease liabilities are measured at the lease commencement date as the present value of future minimum lease payments over the term of the lease. Lease assets are measured as the lease liability plus initial direct costs and prepaid lease payments less lease incentives. In measuring the present value of the future minimum lease payments, the Company generally uses its incremental borrowing rate. The lease term is the noncancelable period of the lease and includes options to extend or terminate the lease when it is reasonably certain that an option will be exercised. Leases with terms of 12 months or less are not recorded on the Company's balance sheet. Lease expense is recognized on a straight-line basis over the lease terms, or in some cases, the useful life of the underlying asset. The Company accounts for the lease and non-lease components as a single lease component. The Company’s lease agreement for its corporate office space and facilities is classified as an operating lease. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Long-lived assets, such as property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds |
Income Taxes | Income Taxes Income taxes are accounted for under the liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to the differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and the operating loss and tax credit carryforwards. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. Deferred tax assets and liabilities are measured at the balance sheet date using the enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the period such tax rate changes are enacted. The net deferred tax assets have been fully offset by a valuation allowance. |
Revenue Recognition | Revenue Recognition Under ASC 606, the Company estimates each arrangement’s total transaction price, which includes unconstrained variable consideration, and the recognition of that transaction price based on a cost-based input method that requires estimates to determine, at each reporting period, the percentage of completion based on the estimated total effort required to complete the project and the total transaction price. The unconstrained variable consideration amount included in the transaction price represents an amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. The Company applies the following five-step revenue recognition model outlined in ASC 606 to adhere to this core principle: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the Company satisfies a performance obligation. All of the Company’s revenue to date has been generated from its collaboration agreements, primarily its collaboration agreement with Merck. The terms of these agreements generally require the Company to provide (i) license options for its compounds, (ii) research and development, or R&D, services and (iii) non-mandatory services in connection with participation in research or steering committees. Payments received under these arrangements may include non-refundable upfront license fees, partial or complete reimbursement of R&D costs, contingent consideration payments based on the achievement of defined collaboration objectives and royalties on sales of commercialized products. In some agreements, the collaboration partner is solely responsible for meeting defined objectives that trigger contingent or royalty payments. Often the partner only pursues such objectives subsequent to exercising an optional license on compounds identified as a result of the R&D services performed under the collaboration agreement. The Company assesses whether the promises in its arrangements, including any options provided to the partner, are considered distinct performance obligations that should be accounted for separately. Judgment is required to determine whether the license to a compound is distinct from R&D services or participation in research or steering committees, as well as whether options create material rights in the contract. In situations when a contract includes distinct R&D services that are substantially the same and have the same pattern of transfer to the customer over time, they are recognized as a series of distinct services. The transaction price in each arrangement is generally comprised of a non-refundable upfront fee and unconstrained variable consideration related to the performance of R&D services. The unconstrained variable consideration amount included in the transaction price represents an amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. The Company typically submits a budget for the R&D services to the partner in advance of performing the services. The transaction price is allocated to the identified performance obligations based on the standalone selling price, or SSP, of each distinct performance obligation. Judgment is required to determine the SSP. In instances where the SSP is not directly observable, such as when a license or service is not sold separately, SSP is determined using information that may include market conditions and other observable inputs. The Company utilizes judgment to assess the nature of its performance obligations to determine whether they are satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress toward completion. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. The Company’s collaboration agreements may include contingent payments related to specified development and regulatory milestones or contingent payments for royalties based on sales of a commercialized product. Milestones can be achieved for such activities in connection with progress in clinical trials, regulatory filings in various geographical markets and marketing approvals from health authorities. Sales-based royalties are generally related to the volume of annual sales of a commercialized product. At the inception of each agreement that includes such payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price by using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s or its partner’s control, such as those related to regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation based on a relative SSP basis. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of each such milestone and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Pursuant to the guidance in ASC 606, sales-based royalties are not included in the transaction price. Instead, royalties are recognized at the later of when the performance obligation is satisfied or partially satisfied, or when the sale that gives rise to the royalty occurs. Contract modifications, defined as changes in the scope or price (or both) of a contract that are approved by the parties to the contract, such as a contract amendment, exist when the parties to a contract approve a modification that either creates new, or changes existing, enforceable rights and obligations of the parties to the contract. Depending on facts and circumstances, the Company accounts for a contract modification as one of the following: (i) a separate contract; (ii) a termination of the existing contract and a creation of a new contract; or (iii) a combination of the preceding treatments. A contract modification is accounted for as a separate contract if the scope of the contract increases because of the addition of promised services that are distinct and if the price of the contract increases by an amount of consideration that reflects the Company’s standalone selling prices of the additional promised services. When a contract modification is not considered a separate contract and the remaining services are distinct from the services transferred on or before the date of the contract modification, the Company accounts for the contract modification as a termination of the existing contract and a creation of a new contract. When a contract modification is not considered a separate contract and the remaining services are not distinct, the Company accounts for the contract modification as an add-on to the existing contract and as an adjustment to revenue on a cumulative catch-up basis. |
Research and Development | Research and Development R&D costs are expensed as incurred. R&D expenses primarily include salaries and benefits for medical, clinical, quality, preclinical, manufacturing and research personnel, costs related to research activities, preclinical studies, clinical trials, drug manufacturing expenses and allocated overhead and facility occupancy costs. The Company accounts for non-refundable advance payments for goods or services that will be used in future R&D activities as expenses when the goods have been received or when the service has been performed rather than when the payment is made. Clinical trial costs are a component of R&D expenses. The Company accrues estimated costs for its clinical trial activities performed by third parties, including clinical research organizations, or CROs, and other service providers based upon estimates of the proportion of work completed over the life of the individual clinical trial and patient enrollment rates in accordance with associated agreements. The Company's estimates are determined through detailed discussions with internal personnel and its service providers as to the progress of each clinical trial and by reviewing contracts, vendor agreements and purchase orders for previously agreed-upon rates and fees to be paid for such services. |
Stock-Based Compensation | Stock-Based Compensation The Company’s stock-based compensation programs include stock option and restricted stock unit, or RSU, grants, as well as shares issued under its 2019 Employee Stock Purchase Plan, or ESPP. Grants are awarded to employees, directors and non-employees. The Company measures stock-based compensation expense for all stock-based awards at the grant date based on the fair value measurement of the award. The expense is recorded on a straight-line basis over the requisite service period, which is generally the vesting period, for the entire award. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures materially differ from estimates. The Company calculates the fair value measurement of stock options using the Black-Scholes option-pricing model. |
Comprehensive Loss | Comprehensive LossComprehensive loss is composed of net loss and certain changes in stockholders’ equity that are excluded from net loss, primarily unrealized gains or losses, net of taxes, on the Company’s marketable securities. |
Net Loss per Share | Net Loss per Share Basic net loss per share is calculated by dividing net loss by the weighted average number of shares outstanding during the period, less shares subject to repurchase and excludes any dilutive effects of stock-based options and awards. Diluted net income per share is computed by giving effect to all potentially dilutive shares, including common stock issuable upon exercise of stock options and the assumed vesting of outstanding RSUs. However, where there is a diluted net loss per share, no adjustment is made for potentially issuable shares since their effect would be anti-dilutive. In this case, diluted net loss per share is equal to basic net loss per share. |
Segment and Geographical Information | Segment and Geographical Information The Company operates in one business segment. Substantially all of the Company’s long-lived assets, primarily comprised of property and equipment, are based in the United States. For the three and nine months ended September 30, 2023 and 2022, the Company’s revenues were entirely within the United States based upon the location of the Company and Merck. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements New accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s results of operations and financial position upon adoption. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Estimated Useful Life of Asset | Costs that improve assets or extend their economic lives are capitalized. Depreciation is recognized using the straight-line method based on an estimated useful life of the asset, which is as follows: Computer equipment 3 years Laboratory equipment and office furniture 3 years Leasehold improvement Shorter of life of asset or lease term |
Schedule of Computation of Net Loss Per Common Share | Net loss per share was computed as follows (in thousands, except per share amounts): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Numerator: Net loss $ (28,797) $ (47,261) $ (114,705) $ (126,230) Denominator: Weighted average number of shares used in calculating net loss per share—basic and diluted 82,707 80,623 82,393 79,331 Net loss per share—basic and diluted $ (0.35) $ (0.59) $ (1.39) $ (1.59) |
Schedule of Potentially Dilutive Securities Not Included in the Diluted Net Loss Per Share Calculations | Potentially dilutive securities that were not included in the diluted per share calculations because they would be anti-dilutive were as follows (in thousands): For the Three and Nine Months Ended 2023 2022 Options to purchase common stock 13,254 13,223 Shares committed under the ESPP 971 472 RSUs 708 — Total 14,933 13,695 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Cash and Cash Equivalents and Marketable Securities Classified as Available-for-sale Securities | Cash equivalents and marketable securities are classified as available-for-sale securities and consisted of the following (in thousands): Amortized Gross Gross Fair As of September 30, 2023 U.S. treasury securities $ 54,548 $ 1 $ (33) $ 54,516 Money market funds 45,245 — — 45,245 Commercial paper 21,914 — — 21,914 U.S. government agency securities 20,916 1 (4) 20,913 Corporate and agency bonds 17,269 — (43) 17,226 Totals $ 159,892 $ 2 $ (80) $ 159,814 Classified as: Cash and cash equivalents $ 45,245 Short-term marketable securities (amortized cost of $114,647) 114,569 Total $ 159,814 Amortized Gross Gross Fair As of December 31, 2022 U.S. treasury securities $ 89,039 $ 7 $ (160) $ 88,886 Money market funds 62,844 — — 62,844 Corporate and agency bonds 46,300 — (200) 46,100 Commercial paper 42,746 — — 42,746 U.S. government agency securities 20,253 51 — $ 20,304 Totals $ 261,182 $ 58 $ (360) $ 260,880 Classified as: Cash and cash equivalents $ 62,844 Short-term marketable securities (amortized cost of $198,338) 198,036 Total $ 260,880 |
Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis | The following table summarizes, by major security type, the Company's available-for-sale securities that were measured at fair value on a recurring basis and were categorized using the fair value hierarchy (in thousands): Fair Value Measurements As of September 30, 2023 Level 1 Level 2 Level 3 Total Assets: U.S. treasury securities $ 54,516 $ — $ — $ 54,516 Money market funds 45,245 — — 45,245 Commercial paper — 21,914 — 21,914 U.S. government agency securities — 20,913 — 20,913 Corporate and agency bonds — 17,226 — 17,226 Totals $ 99,761 $ 60,053 $ — $ 159,814 Fair Value Measurements As of December 31, 2022 Level 1 Level 2 Level 3 Total Assets: U.S. treasury securities $ 88,886 $ — $ — $ 88,886 Money market funds 62,844 — — 62,844 Corporate and agency bonds — 46,100 — 46,100 Commercial paper — 42,746 — 42,746 U.S. government agency securities — 20,304 — 20,304 Totals $ 151,730 $ 109,150 $ — $ 260,880 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Reconciliation of Cash, Cash Equivalent | A reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets to the amount reported within the condensed consolidated statements of cash flows is as follows (in thousands): September 30, December 31, Cash and cash equivalents $ 51,476 $ 73,456 Restricted cash 5,454 3,954 Total cash, cash equivalents and restricted cash $ 56,930 $ 77,410 |
Schedule of Reconciliation of Restricted Cash | A reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets to the amount reported within the condensed consolidated statements of cash flows is as follows (in thousands): September 30, December 31, Cash and cash equivalents $ 51,476 $ 73,456 Restricted cash 5,454 3,954 Total cash, cash equivalents and restricted cash $ 56,930 $ 77,410 |
Schedule of Property and Equipment | Property and equipment consisted of the following (in thousands): September 30, December 31, Leasehold improvements $ 25,801 $ 25,866 Laboratory equipment and office furniture 23,979 23,807 Computer equipment 1,433 1,433 Construction-in-progress 391 284 Total property and equipment, gross 51,604 51,390 Less: accumulated depreciation and amortization (44,323) (42,894) Total property and equipment, net $ 7,281 $ 8,496 |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): September 30, December 31, Clinical trials and research and development costs $ 6,462 $ 14,597 Personnel-related costs 6,251 9,181 Accrued expenses 2,674 3,834 Manufacturing costs 780 6,026 Total accrued liabilities $ 16,167 $ 33,638 |
Research Collaboration and Li_2
Research Collaboration and License Agreements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule Of Recognized Revenue From Collaboration And License Arrangements Table | The Company recognized revenue from its collaboration and license agreements as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Related party revenue $ 582 $ 7,911 $ 4,252 $ 37,152 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Components of Lease Costs | During the three and nine months ended September 30, 2023 and September 30, 2022, the components of lease costs, which were included in general and administrative expenses on the Company's condensed consolidated statements of operations, were as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Operating lease costs $ 541 $ 541 $ 1,624 $ 1,624 Variable lease costs (1) 338 314 1,067 962 Total lease cost $ 879 $ 855 $ 2,691 $ 2,586 _____________ (1) Variable lease costs include certain additional charges for operating costs, including insurance, maintenance, taxes and other costs incurred, which are billed based on both usage and as a percentage of the Company’s share of total square footage. |
Schedule of Lessee, Operating Lease, Liability, Maturity | As of September 30, 2023, the maturities of the Company’s operating lease liabilities and future minimum lease payments were as follows (in thousands): Total undiscounted lease payments for the remainder of the year ending December 31, 2023 $ 1,384 Less: present value adjustment (3) Present value of lease liabilities $ 1,381 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Schedule of Activity under 2008 Plan and 2018 Plan | The following is a summary of the activity under the Company's equity incentive plans: Outstanding Options Weighted Aggregate Number of Weighted Balances at December 31, 2022 14,215 $ 14.74 6.89 $ 1,749 Options granted 5,161 4.26 Options exercised (351) 1.90 Options forfeited (2,602) 11.40 Options expired (3,169) 13.20 Balances at September 30, 2023 13,254 $ 12.03 7.37 $ — Vested and expected to vest at September 30, 2023 12,863 $ 12.12 7.32 $ — Exercisable at September 30, 2023 7,042 $ 14.73 5.93 $ — |
Schedule of Stock Based Compensation Expense | Stock-based compensation expense was allocated as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Research and development $ 2,743 $ 4,182 $ 11,143 $ 12,804 General and administrative 3,667 3,507 11,280 10,807 Total stock-based compensation expense $ 6,410 $ 7,689 $ 22,423 $ 23,611 |
Workforce Reduction (Tables)
Workforce Reduction (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Restructuring and Related Activities [Abstract] | |
Schedule of Restructuring Charges | The restructuring charges are included in the Company's condensed consolidated statements of income for the nine months ended September 30, 2023 as follows (in thousands): Nine Months Ended Research and development $ 3,811 General and administrative 1,105 Total restructuring expense $ 4,916 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Narrative (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||||
Jun. 30, 2023 USD ($) | Sep. 30, 2023 USD ($) | Jun. 30, 2023 USD ($) | Mar. 31, 2023 USD ($) | Sep. 30, 2022 USD ($) | Jun. 30, 2022 USD ($) | Mar. 31, 2022 USD ($) | Sep. 30, 2023 USD ($) segment | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | [1] | Jun. 30, 2020 USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
Net loss | $ 28,797,000 | $ 38,261,000 | $ 47,647,000 | $ 47,261,000 | $ 46,519,000 | $ 32,450,000 | $ 114,705,000 | $ 126,230,000 | ||||
Retained Earnings (Accumulated Deficit) | 696,338,000 | 696,338,000 | $ 581,633,000 | |||||||||
Cash, cash equivalents and marketable securities | $ 166,000,000 | 166,000,000 | ||||||||||
Common stock remaining to be sold under open market sales agreement | $ 150,000,000 | |||||||||||
Sale of common stock, aggregate price | $ 100,000,000 | |||||||||||
Impairment related to other-than-temporary declines in fair value of securities | $ 0 | |||||||||||
Number of operating business segment | segment | 1 | |||||||||||
Merck | Revenue | Customer Concentration Risk | ||||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
Concentration risk, percentage | 100% | 100% | 100% | 100% | ||||||||
Maximum | ||||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
Common stock remaining to be sold under open market sales agreement | $ 100,000,000 | $ 100,000,000 | ||||||||||
[1]The condensed consolidated balance sheet as of December 31, 2022 has been derived from the audited financial statements as of that date. |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Estimated Useful Life of Asset (Details) | Sep. 30, 2023 |
Computer equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life of asset (in years) | 3 years |
Laboratory equipment and office furniture | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life of asset (in years) | 3 years |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Computation of Net Loss Per Common Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Numerator: | ||||||||
Net loss | $ (28,797) | $ (38,261) | $ (47,647) | $ (47,261) | $ (46,519) | $ (32,450) | $ (114,705) | $ (126,230) |
Denominator: | ||||||||
Weighted average number of shares used in computing net loss per share, basic (in shares) | 82,707 | 80,623 | 82,393 | 79,331 | ||||
Weighted average number of shares used in computing net loss per share, diluted (in shares) | 82,707 | 80,623 | 82,393 | 79,331 | ||||
Net loss per share, basic (in dollars per share) | $ (0.35) | $ (0.59) | $ (1.39) | $ (1.59) | ||||
Net loss per share, diluted (in dollars per share) | $ (0.35) | $ (0.59) | $ (1.39) | $ (1.59) |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Potentially Dilutive Securities Not Included in the Diluted Net Loss Per Share Calculations (Details) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Potentially dilutive securities not included in calculations of diluted per share (in shares) | 14,933 | 13,695 | 14,933 | 13,695 |
Options to purchase common stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Potentially dilutive securities not included in calculations of diluted per share (in shares) | 13,254 | 13,223 | 13,254 | 13,223 |
Shares committed under the ESPP | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Potentially dilutive securities not included in calculations of diluted per share (in shares) | 971 | 472 | 971 | 472 |
RSUs | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Potentially dilutive securities not included in calculations of diluted per share (in shares) | 708 | 0 | 708 | 0 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Cash and Cash Equivalents and Marketable Securities Classified as Available-for-sale Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 159,892 | $ 261,182 |
Gross Unrealized Gain | 2 | 58 |
Gross Unrealized Loss | (80) | (360) |
Fair Value | 159,814 | 260,880 |
Cash and cash equivalents | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | 45,245 | 62,844 |
Short-term Marketable Securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 114,647 | 198,338 |
Fair Value | 114,569 | 198,036 |
U.S. treasury securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 54,548 | 89,039 |
Gross Unrealized Gain | 1 | 7 |
Gross Unrealized Loss | (33) | (160) |
Fair Value | 54,516 | 88,886 |
Money market funds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 45,245 | 62,844 |
Gross Unrealized Gain | 0 | 0 |
Gross Unrealized Loss | 0 | 0 |
Fair Value | 45,245 | 62,844 |
Corporate and agency bonds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 17,269 | 46,300 |
Gross Unrealized Gain | 0 | 0 |
Gross Unrealized Loss | (43) | (200) |
Fair Value | 17,226 | 46,100 |
Commercial paper | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 21,914 | 42,746 |
Gross Unrealized Gain | 0 | 0 |
Gross Unrealized Loss | 0 | 0 |
Fair Value | 21,914 | 42,746 |
U.S. government agency securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 20,916 | 20,253 |
Gross Unrealized Gain | 1 | 51 |
Gross Unrealized Loss | (4) | 0 |
Fair Value | $ 20,913 | $ 20,304 |
Fair Value Measurements - Narra
Fair Value Measurements - Narrative (Details) $ in Millions | Sep. 30, 2023 USD ($) security | Dec. 31, 2022 USD ($) security |
Fair Value Disclosures [Abstract] | ||
Cash on deposit with banks | $ | $ 6.2 | $ 10.6 |
Number of marketable securities in unrealized loss positions less than 12 months | security | 12 | 19 |
Fair Value Measurements - Sch_2
Fair Value Measurements - Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Fair Value Measurements, Recurring - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Assets: | ||
Fair value of financial assets | $ 159,814 | $ 260,880 |
Level 1 | ||
Assets: | ||
Fair value of financial assets | 99,761 | 151,730 |
Level 2 | ||
Assets: | ||
Fair value of financial assets | 60,053 | 109,150 |
Level 3 | ||
Assets: | ||
Fair value of financial assets | 0 | 0 |
U.S. treasury securities | ||
Assets: | ||
Fair value of financial assets | 54,516 | 88,886 |
U.S. treasury securities | Level 1 | ||
Assets: | ||
Fair value of financial assets | 54,516 | 88,886 |
U.S. treasury securities | Level 2 | ||
Assets: | ||
Fair value of financial assets | 0 | 0 |
U.S. treasury securities | Level 3 | ||
Assets: | ||
Fair value of financial assets | 0 | 0 |
Money market funds | ||
Assets: | ||
Fair value of financial assets | 45,245 | 62,844 |
Money market funds | Level 1 | ||
Assets: | ||
Fair value of financial assets | 45,245 | 62,844 |
Money market funds | Level 2 | ||
Assets: | ||
Fair value of financial assets | 0 | 0 |
Money market funds | Level 3 | ||
Assets: | ||
Fair value of financial assets | 0 | 0 |
Commercial paper | ||
Assets: | ||
Fair value of financial assets | 21,914 | 42,746 |
Commercial paper | Level 1 | ||
Assets: | ||
Fair value of financial assets | 0 | 0 |
Commercial paper | Level 2 | ||
Assets: | ||
Fair value of financial assets | 21,914 | 42,746 |
Commercial paper | Level 3 | ||
Assets: | ||
Fair value of financial assets | 0 | 0 |
U.S. government agency securities | ||
Assets: | ||
Fair value of financial assets | 20,913 | 20,304 |
U.S. government agency securities | Level 1 | ||
Assets: | ||
Fair value of financial assets | 0 | 0 |
U.S. government agency securities | Level 2 | ||
Assets: | ||
Fair value of financial assets | 20,913 | 20,304 |
U.S. government agency securities | Level 3 | ||
Assets: | ||
Fair value of financial assets | 0 | 0 |
Corporate and agency bonds | ||
Assets: | ||
Fair value of financial assets | 17,226 | 46,100 |
Corporate and agency bonds | Level 1 | ||
Assets: | ||
Fair value of financial assets | 0 | 0 |
Corporate and agency bonds | Level 2 | ||
Assets: | ||
Fair value of financial assets | 17,226 | 46,100 |
Corporate and agency bonds | Level 3 | ||
Assets: | ||
Fair value of financial assets | $ 0 | $ 0 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Reconciliation of Cash, Cash Equivalent and Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 | |
Balance Sheet Related Disclosures [Abstract] | |||||
Cash and cash equivalents | $ 51,476 | $ 73,456 | [1] | ||
Restricted cash | 5,454 | 3,954 | |||
Total cash, cash equivalents and restricted cash | $ 56,930 | $ 77,410 | $ 105,403 | $ 153,294 | |
[1]The condensed consolidated balance sheet as of December 31, 2022 has been derived from the audited financial statements as of that date. |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment [Line Items] | |||
Total property and equipment, gross | $ 51,604 | $ 51,390 | |
Less: accumulated depreciation and amortization | (44,323) | (42,894) | |
Total property and equipment, net | 7,281 | 8,496 | [1] |
Leasehold improvements | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment, gross | 25,801 | 25,866 | |
Laboratory equipment and office furniture | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment, gross | 23,979 | 23,807 | |
Computer equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment, gross | 1,433 | 1,433 | |
Construction-in-progress | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment, gross | $ 391 | $ 284 | |
[1]The condensed consolidated balance sheet as of December 31, 2022 has been derived from the audited financial statements as of that date. |
Balance Sheet Components - Narr
Balance Sheet Components - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | ||||
Depreciation expense | $ 500 | $ 600 | $ 1,703 | $ 3,421 |
Balance Sheet Components - Sc_3
Balance Sheet Components - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |||
Clinical trials and research and development costs | $ 6,462 | $ 14,597 | |
Personnel-related costs | 6,251 | 9,181 | |
Accrued expenses | 2,674 | 3,834 | |
Manufacturing costs | 780 | 6,026 | |
Total accrued liabilities | $ 16,167 | $ 33,638 | [1] |
[1]The condensed consolidated balance sheet as of December 31, 2022 has been derived from the audited financial statements as of that date. |
Research Collaboration and Li_3
Research Collaboration and License Agreements - Narrative (Details) - USD ($) | 9 Months Ended | 12 Months Ended | 15 Months Ended | 24 Months Ended | |||
Sep. 30, 2023 | Mar. 31, 2022 | Dec. 31, 2015 | Mar. 31, 2022 | Mar. 31, 2024 | Dec. 31, 2022 | ||
Collaborative Arrangement [Line Items] | |||||||
Amount of additional fund received for research activities | $ 20,000,000 | ||||||
Contract liabilities | $ 107,000 | $ 366,000 | [1] | ||||
Research Collaboration and License Agreements | |||||||
Collaborative Arrangement [Line Items] | |||||||
Related party contract asset | 0 | 0 | |||||
Contract liabilities | 100,000 | 400,000 | |||||
Proof-Of-Concept Trial, CVM Research | |||||||
Collaborative Arrangement [Line Items] | |||||||
Milestone payment for potential achievement of certain clinical development events | 10,000,000 | ||||||
Merck Amended Agreement | Proof-Of-Concept Trial, CVM Research | |||||||
Collaborative Arrangement [Line Items] | |||||||
Option exercise fee | $ 6,000,000 | ||||||
Merck Sharp & Dohme Corp | |||||||
Collaborative Arrangement [Line Items] | |||||||
Percent of stock owned by counterparty | 16% | ||||||
Merck Sharp & Dohme Corp | Merck Original Agreement | |||||||
Collaborative Arrangement [Line Items] | |||||||
Performance of R&D services period | 5 years | ||||||
Additional term | 2 years | ||||||
Amount of fund received for research activities | $ 75,000,000 | ||||||
Research collaboration and license agreements extension fee | $ 20,000,000 | $ 20,000,000 | |||||
Merck Sharp & Dohme Corp | Merck Amended Agreement | |||||||
Collaborative Arrangement [Line Items] | |||||||
Amount of fund received for research activities | $ 86,000,000 | ||||||
Amount of additional fund received for research activities | $ 15,000,000 | ||||||
Remaining extension term | 2 years | ||||||
Research and development performance obligation period | 3 years | ||||||
Transaction price for the two-year performance obligation | $ 118,800,000 | ||||||
Due from related party | $ 4,750,000 | ||||||
Merck Sharp & Dohme Corp | Merck Amended Agreement | Forecast | |||||||
Collaborative Arrangement [Line Items] | |||||||
Reimbursable expense | $ 13,100,000 | ||||||
[1]The condensed consolidated balance sheet as of December 31, 2022 has been derived from the audited financial statements as of that date. |
Research Collaboration and Li_4
Research Collaboration and License Agreements - Schedule of Recognized Revenue from Collaboration and License Agreements (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Collaborative Arrangement [Line Items] | ||||
Related party revenue | $ 582 | $ 7,911 | $ 4,252 | $ 37,152 |
Merck Sharp & Dohme Corp | Collaboration Agreement | ||||
Collaborative Arrangement [Line Items] | ||||
Related party revenue | $ 582 | $ 7,911 | $ 4,252 | $ 37,152 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) ft² in Thousands, $ in Thousands | 1 Months Ended | 9 Months Ended | ||||
Jul. 31, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | [1] | Dec. 31, 2015 USD ($) ft² | |
Operating Leased Assets [Line Items] | ||||||
Total leasehold improvements | $ 7,281 | $ 8,496 | ||||
Operating lease term | 10 years | |||||
Weighted average discount rate | 3 months | |||||
Operating lease liability | 2.85% | |||||
Operating lease payment obligations | $ 4,100 | $ 4,000 | ||||
Increase in initial base rent (as a percent) | 3.50% | |||||
Tenant improvement allowance | $ 4,900 | |||||
Corporate Office Space And Laboratory Facility | ||||||
Operating Leased Assets [Line Items] | ||||||
Area of leased property | ft² | 122 | |||||
Tenant improvement allowances | $ 15,200 | |||||
Corporate Office Space And Laboratory Facility | Leasehold improvements | ||||||
Operating Leased Assets [Line Items] | ||||||
Total leasehold improvements | $ 22,300 | |||||
Operating lease term | 7 years | |||||
Letter of Credit | ||||||
Operating Leased Assets [Line Items] | ||||||
Letter of credit | $ 2,500 | |||||
Minimum | ||||||
Operating Leased Assets [Line Items] | ||||||
Operating lease option additional extend term | 8 years | |||||
Maximum | ||||||
Operating Leased Assets [Line Items] | ||||||
Operating lease option additional extend term | 10 years | |||||
Monthly base rent | ||||||
Operating Leased Assets [Line Items] | ||||||
Operating lease, expense | $ 900 | |||||
Base rent, lease term | ||||||
Operating Leased Assets [Line Items] | ||||||
Operating lease, expense | $ 124,100 | |||||
Letter of Credit | Corporate Office Space And Laboratory Facility | ||||||
Operating Leased Assets [Line Items] | ||||||
Letter of credit as a security deposit | $ 1,500 | |||||
[1]The condensed consolidated balance sheet as of December 31, 2022 has been derived from the audited financial statements as of that date. |
Commitments and Contingencies_2
Commitments and Contingencies - Components of Lease Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Operating lease costs | $ 541 | $ 541 | $ 1,624 | $ 1,624 |
Variable lease costs | 338 | 314 | 1,067 | 962 |
Total lease cost | $ 879 | $ 855 | $ 2,691 | $ 2,586 |
Commitments and Contingencies_3
Commitments and Contingencies - Operating Lease Liability Maturity (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Total undiscounted lease payments for the remainder of the year ending December 31, 2023 | $ 1,384 |
Less: present value adjustment | (3) |
Present value of lease liabilities | $ 1,381 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Activity under 2008 Plan and 2018 Plan (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Number of Options (In Thousands) | ||
Beginning balance (in shares) | 14,215 | |
Options granted (in shares) | 5,161 | |
Options exercised (in shares) | (351) | |
Options forfeited (in shares) | (2,602) | |
Options expired (in shares) | (3,169) | |
Ending balance (in shares) | 13,254 | 14,215 |
Vested and expected to vest (in shares) | 12,863 | |
Exercisable (in shares) | 7,042 | |
Weighted Average Exercise Price | ||
Beginning balance (in dollars per share) | $ 14.74 | |
Options granted (in dollars per share) | 4.26 | |
Options exercised (in dollars per share) | 1.90 | |
Options forfeited (in dollars per share) | 11.40 | |
Options expired (in dollars per shares) | 13.20 | |
Ending balance (in dollars per share) | 12.03 | $ 14.74 |
Vested and expected to vest, weighted average exercise price (in dollars per share) | 12.12 | |
Exercisable, weighted average exercise price (in dollars per share) | $ 14.73 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | ||
Weighted Average Remaining Contractual Life (In Years) | 7 years 4 months 13 days | 6 years 10 months 20 days |
Vested and expected to vest, weighted average remaining contractual life | 7 years 3 months 25 days | |
Exercisable, weighted average remaining contractual life | 5 years 11 months 4 days | |
Aggregate intrinsic value | $ 0 | $ 1,749 |
Vested and expected to vest, aggregate intrinsic value | 0 | |
Exercisable, aggregate intrinsic value | $ 0 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) $ / shares in Units, $ in Millions | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2023 USD ($) shares | Sep. 30, 2023 USD ($) period $ / shares shares | Dec. 31, 2022 shares | |
Class of Stock [Line Items] | |||
Weighted-average grant date fair value of stock options, granted (in dollars per share) | $ / shares | $ 3.09 | ||
Common stock, shares issued (in shares) | 82,716,000 | 82,716,000 | 81,885,000 |
Share-based payment arrangement, nonvested award, option, cost not yet recognized, amount | $ | $ 33.6 | $ 33.6 | |
Share-based Compensation | |||
Class of Stock [Line Items] | |||
Total stock-based compensation expense | $ | $ 0.7 | ||
RSUs | |||
Class of Stock [Line Items] | |||
RSUs granted (in shares) | 1,000,000 | 1,000,000 | |
RSUs granted, weighted average grant date fair value (in dollar per shares) | $ / shares | $ 4.36 | ||
Awards, vesting period | 4 years | ||
RSUs vested (in shares) | 0 | ||
RSUs forfeited (in shares) | 300,000 | ||
Unrecognized share-based compensation cost related to unvested restricted stock units | $ | $ 2.3 | $ 2.3 | |
Unrecognized share-based compensation cost, period of recognition | 3 years 3 months 18 days | ||
Stock options | |||
Class of Stock [Line Items] | |||
Unrecognized share-based compensation cost, period of recognition | 2 years | ||
Shares committed under the ESPP | |||
Class of Stock [Line Items] | |||
Maximum percentage of payroll deductions of employee's compensation | 15% | 15% | |
Maximum duration for purchase under employee stock purchase plan | 24 months | ||
Number of purchase periods | period | 4 | ||
Duration of each purchase period | 6 months | ||
Percentage of purchase of common stock fair market value | 85% | ||
Common stock, shares issued (in shares) | 1,087,768 | 1,087,768 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Stock Based Compensation Expense (Details) - Employees and Directors - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 6,410 | $ 7,689 | $ 22,423 | $ 23,611 |
Research and development | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | 2,743 | 4,182 | 11,143 | 12,804 |
General and administrative | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 3,667 | $ 3,507 | $ 11,280 | $ 10,807 |
Workforce Reduction (Details)
Workforce Reduction (Details) $ in Thousands | 3 Months Ended | 9 Months Ended |
Jun. 30, 2023 people | Sep. 30, 2023 USD ($) | |
Restructuring Cost and Reserve [Line Items] | ||
Restructuring, expected number of positions eliminated | people | 74 | |
Restructuring, number of positions eliminated, percent | 33% | |
Restructuring charges | $ 4,916 | |
Research and development | ||
Restructuring Cost and Reserve [Line Items] | ||
Restructuring charges | 3,811 | |
General and administrative | ||
Restructuring Cost and Reserve [Line Items] | ||
Restructuring charges | 1,105 | |
Employee Severance | ||
Restructuring Cost and Reserve [Line Items] | ||
Restructuring charges | 4,200 | |
Share-based Compensation | ||
Restructuring Cost and Reserve [Line Items] | ||
Total stock-based compensation expense | $ 700 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event | Oct. 17, 2023 $ / shares shares |
Subsequent Event [Line Items] | |
Option repricing, minimum exercise price (in dollars per share) | $ / shares | $ 5 |
Option repricing, shares eligible for future issuance (in shares) | shares | 7,037,470 |