Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Jul. 29, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | KOD | |
Entity Registrant Name | KODIAK SCIENCES INC. | |
Entity Central Index Key | 0001468748 | |
Entity Current Reporting Status | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Shell Company | false | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 52,040,246 | |
Entity File Number | 001-38682 | |
Entity Tax Identification Number | 27-0476525 | |
Entity Address, Address Line One | 1200 Page Mill Road | |
Entity Address, City or Town | Palo Alto | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94304 | |
City Area Code | 650 | |
Local Phone Number | 281-0850 | |
Entity Interactive Data Current | Yes | |
Title of 12(b) Security | Common stock, par value $0.0001 | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (unaudited) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 172,692 | $ 731,510 |
Marketable securities | 425,184 | |
Prepaid expenses and other current assets | 6,493 | 3,301 |
Total current assets | 604,369 | 734,811 |
Restricted cash | 6,324 | 6,324 |
Property and equipment, net | 54,575 | 41,330 |
Operating lease right-of-use asset | 63,076 | 66,744 |
Other assets | 53,561 | 55,011 |
Total assets | 781,905 | 904,220 |
Current liabilities: | ||
Accounts payable | 20,631 | 12,431 |
Accrued and other current liabilities | 43,158 | 48,319 |
Operating lease liability | 6,044 | 3,933 |
Total current liabilities | 69,833 | 64,683 |
Operating lease liability, net of current portion | 80,985 | 76,063 |
Liability related to sale of future royalties | 99,969 | 99,943 |
Other liabilities | 187 | 211 |
Total liabilities | 250,974 | 240,900 |
Commitments and contingencies (Note 6) | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value | ||
Common stock, $0.0001 par value | 5 | 5 |
Additional paid-in capital | 1,277,349 | 1,221,532 |
Accumulated other comprehensive income | (1,869) | |
Accumulated deficit | (744,554) | (558,217) |
Total stockholders’ equity | 530,931 | 663,320 |
Total liabilities and stockholders’ equity | $ 781,905 | $ 904,220 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) (unaudited) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred Stock, shares issued | 0 | 0 |
Preferred Stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 490,000,000 | 490,000,000 |
Common stock, shares issued | 52,024,621 | 51,826,257 |
Common stock, shares outstanding | 52,024,621 | 51,826,257 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Operating expenses | ||||
Research and development | $ 73,744 | $ 45,404 | $ 149,921 | $ 85,741 |
General and administrative | 18,324 | 10,505 | 37,914 | 20,726 |
Total operating expenses | 92,068 | 55,909 | 187,835 | 106,467 |
Loss from operations | (92,068) | (55,909) | (187,835) | (106,467) |
Interest income | 1,135 | 81 | 1,211 | 230 |
Interest expense | (5) | (5) | (10) | (11) |
Other income (expense), net | 310 | (19) | 297 | (51) |
Net loss | $ (90,628) | $ (55,852) | $ (186,337) | $ (106,299) |
Net loss per common share, basic | $ (1.74) | $ (1.08) | $ (3.57) | $ (2.06) |
Net loss per common share, diluted | $ (1.74) | $ (1.08) | $ (3.57) | $ (2.06) |
Weighted Average Number of Shares Outstanding, Basic | 52,218,773 | 51,573,894 | 52,195,972 | 51,644,946 |
Weighted Average Number of Shares Outstanding, Diluted | 52,218,773 | 51,573,894 | 52,195,972 | 51,644,946 |
Other comprehensive income (loss) | ||||
Change in unrealized losses related to available-for-sale debt securities, net of tax | $ (1,869) | $ (18) | $ (1,869) | $ (53) |
Total other comprehensive income (loss) | (1,869) | (18) | (1,869) | (53) |
Comprehensive loss | $ (92,497) | $ (55,870) | $ (188,206) | $ (106,352) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning Balance at Dec. 31, 2020 | $ 860,751 | $ 5 | $ 1,151,920 | $ 53 | $ (291,227) |
Beginning balance, shares at Dec. 31, 2020 | 51,112,302 | ||||
Issuance of common stock upon exercise of stock options | 1,483 | 1,483 | |||
Issuance of common stock upon exercise of stock options, shares | 113,559 | ||||
Stock-based compensation expense | 9,925 | 9,925 | |||
Other comprehensive loss | (35) | (35) | |||
Net loss | (50,447) | (50,447) | |||
Ending Balance at Mar. 31, 2021 | 821,677 | $ 5 | 1,163,328 | 18 | (341,674) |
Ending balance, shares at Mar. 31, 2021 | 51,225,861 | ||||
Beginning Balance at Dec. 31, 2020 | 860,751 | $ 5 | 1,151,920 | 53 | (291,227) |
Beginning balance, shares at Dec. 31, 2020 | 51,112,302 | ||||
Other comprehensive loss | (53) | ||||
Net loss | (106,299) | ||||
Ending Balance at Jun. 30, 2021 | 779,427 | $ 5 | 1,176,948 | (397,526) | |
Ending balance, shares at Jun. 30, 2021 | 51,434,408 | ||||
Beginning Balance at Mar. 31, 2021 | 821,677 | $ 5 | 1,163,328 | 18 | (341,674) |
Beginning balance, shares at Mar. 31, 2021 | 51,225,861 | ||||
Issuance of common stock upon exercise of stock options | 2,228 | 2,228 | |||
Issuance of common stock upon exercise of stock options, shares | 131,276 | ||||
Issuance of common stock upon vesting of restricted stock units, net of taxes withheld, shares | 72,976 | ||||
Issuance of common stock pursuant to employee stock purchase plans | 305 | 305 | |||
Issuance of common stock pursuant to employee stock purchase plans, shares | 4,295 | ||||
Stock-based compensation expense | 11,087 | 11,087 | |||
Other comprehensive loss | (18) | (18) | |||
Net loss | (55,852) | (55,852) | |||
Ending Balance at Jun. 30, 2021 | 779,427 | $ 5 | 1,176,948 | (397,526) | |
Ending balance, shares at Jun. 30, 2021 | 51,434,408 | ||||
Beginning Balance at Dec. 31, 2021 | 663,320 | $ 5 | 1,221,532 | (558,217) | |
Beginning balance, shares at Dec. 31, 2021 | 51,826,257 | ||||
Issuance of common stock upon exercise of stock options | 1,678 | 1,678 | |||
Issuance of common stock upon exercise of stock options, shares | 110,043 | ||||
Issuance of common stock upon vesting of restricted stock units, net of taxes withheld, shares | 3,581 | ||||
Stock-based compensation expense | 28,095 | 28,095 | |||
Net loss | (95,709) | (95,709) | |||
Ending Balance at Mar. 31, 2022 | 597,384 | $ 5 | 1,251,305 | (653,926) | |
Ending balance, shares at Mar. 31, 2022 | 51,939,881 | ||||
Beginning Balance at Dec. 31, 2021 | 663,320 | $ 5 | 1,221,532 | (558,217) | |
Beginning balance, shares at Dec. 31, 2021 | 51,826,257 | ||||
Other comprehensive loss | (1,869) | ||||
Net loss | (186,337) | ||||
Ending Balance at Jun. 30, 2022 | 530,931 | $ 5 | 1,277,349 | (744,554) | |
Ending balance, shares at Jun. 30, 2022 | 52,024,621 | ||||
Beginning Balance at Mar. 31, 2022 | 597,384 | $ 5 | 1,251,305 | (653,926) | |
Beginning balance, shares at Mar. 31, 2022 | 51,939,881 | ||||
Issuance of common stock upon exercise of stock options | 2 | ||||
Issuance of common stock upon exercise of stock options, shares | 320 | ||||
Issuance of common stock upon vesting of restricted stock units, net of taxes withheld, shares | 74,148 | ||||
Issuance of common stock pursuant to employee stock purchase plans | 64 | 64 | |||
Issuance of common stock pursuant to employee stock purchase plans, shares | 10,272 | ||||
Stock-based compensation expense | 25,978 | 25,978 | |||
Other comprehensive loss | (1,869) | (1,869) | |||
Net loss | (90,628) | (90,628) | |||
Ending Balance at Jun. 30, 2022 | $ 530,931 | $ 5 | $ 1,277,349 | $ (744,554) | |
Ending balance, shares at Jun. 30, 2022 | 52,024,621 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (186,337) | $ (106,299) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 1,075 | 466 |
Stock-based compensation | 54,073 | 21,012 |
Amortization (accretion) of premium (discount) on marketable securities | (314) | 25 |
Amortization of operating lease right-of-use asset | 3,742 | 3,897 |
Amortization of issuance costs | 26 | 26 |
Changes in assets and liabilities: | ||
Prepaid expenses and other current assets | (2,165) | (431) |
Other assets | 10,235 | (35) |
Accounts payable | 12,864 | (5,753) |
Accrued and other current liabilities | 1,545 | 15,459 |
Operating lease liability | 6,959 | 347 |
Net cash used in operating activities | (98,297) | (71,286) |
Cash flows from investing activities | ||
Purchase of property and equipment | (25,690) | (3,772) |
Deposits on property and equipment | (8,785) | (16,962) |
Purchase of marketable securities | (427,766) | |
Maturities of marketable securities | 0 | 24,500 |
Net cash provided by (used in) investing activities | (462,241) | 3,766 |
Cash flows from financing activities | ||
Proceeds from issuance of common stock upon options exercise | 1,680 | 3,711 |
Proceeds from issuance of common stock pursuant to employee stock purchase plans | 64 | 305 |
Principal payments of tenant improvement allowance payable | (24) | (22) |
Net cash provided by financing activities | 1,720 | 3,994 |
Net increase (decrease) in cash, cash equivalents and restricted cash | (558,818) | (63,526) |
Cash, cash equivalents and restricted cash, at beginning of period | 737,834 | 950,720 |
Cash, cash equivalents and restricted cash, at end of period | 179,016 | 887,194 |
Reconciliation of cash, cash equivalents and restricted cash to consolidated balance sheets | ||
Cash and cash equivalents | 172,692 | 880,870 |
Restricted cash | 6,324 | 6,324 |
Cash, cash equivalents and restricted cash, at end of period | 179,016 | 887,194 |
Supplemental disclosures of non-cash investing and financing information: | ||
Operating lease right-of-use asset obtained in exchange for operating lease liability | 74 | 498 |
Purchase of property and equipment under accounts payable and accruals | $ 9,718 | $ 1,821 |
The Company
The Company | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
The Company | 1. The Company Kodiak Sciences Inc. (the “Company”) is a clinical stage biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases in the United States and additional international markets. The Company devotes substantially all of its resources to the research and development of its product platforms and product candidates including activities to conduct clinical studies of its product candidates, manufacture product candidates and provide general and administrative support for these operations. Liquidity As of June 30, 2022, the Company had cash, cash equivalents and marketable securities of $ 597.9 million. Although the Company has incurred significant operating losses since inception and expects to continue to incur operating losses and negative operating cash flows for the foreseeable future, the Company believes that the cash, cash equivalents and marketable securities will be sufficient to meet the anticipated operating and capital expenditure requirements for the 12 months following the date of this Quarterly Report on Form 10-Q. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation The accompanying condensed consolidated financial statements are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) applicable to interim periods. The condensed consolidated financial statements, in the opinion of management, include all normal and recurring adjustments necessary to state fairly the Company's financial position and results of operations for the reported periods. These condensed consolidated financial statements have been prepared on a basis substantially consistent with, and should be read in conjunction with the audited financial statements for the year ended December 31, 2021 and notes thereto, the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 1, 2022. Certain information and note disclosures normally included in the audited financial statements prepared in accordance with GAAP have been condensed or omitted from this report. The results of operations for any interim period are not necessarily indicative of the results for the year ending December 31, 2022, or for any future period. The accompanying condensed consolidated financial statements reflect the operations of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated. Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and expenses during the reporting period. The impact of the ongoing COVID-19 pandemic continues to evolve. As a result, certain estimates and assumptions required increased judgment and carried a higher degree of variability and volatility, including but not limited to, the fair value of marketable securities, performance-based equity awards, and research and development accruals. As events continue to unfold and additional information becomes available, these estimates may change materially in future periods. Actual results could differ from those estimates . Risks and Uncertainties In March 2020, the World Health Organization declared a pandemic due to the global COVID-19 outbreak. The significant uncertainties caused by the ongoing COVID-19 pandemic may negatively impact the Company’s operations, liquidity, and capital resources and will depend on certain evolving developments, including the duration and spread of the outbreak, regulatory and private sector responses and the impact on employees and vendors including supply chain and clinical partners, all of which are uncertain and cannot be predicted. During this pandemic, the Company continues to work closely with clinical sites towards maximal patient safety and the lowest number of missed visits and study discontinuations. The Company has taken and continues to take proactive measures to maintain the integrity of its ongoing clinical studies. Despite these efforts, the ongoing COVID-19 pandemic could significantly impact clinical trial enrollment and completion of its clinical studies. As global economic conditions recover from the COVID-19 pandemic, business activity may not recover as quickly as anticipated, and it is not possible at this time to estimate the long-term impact that COVID-19 could have on the Company's business, as the impact will depend on future developments, which are highly uncertain and cannot be predicted. The Company will continue to monitor the COVID-19 situation and its impact on the ability to continue the development of, and seek regulatory approvals for, the Company’s product candidates, and begin to commercialize any approved products. Summary of Significant Accounting Policies The significant accounting policies used in preparation of these condensed consolidated financial statements for the three and six months ended June 30, 2022, respectively, are consistent with those discussed in Note 2 to the consolidated financial statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, except as noted below with respect to the Company's property and equipment and as noted within the “Recent Accounting Pronouncements” section. Property and Equipment, Net Property and equipment are stated at cost less accumulated depreciation for acquired assets. Construction in progress reflects amounts incurred for construction or improvements of property or equipment that have not been placed in service. Construction in progress is transferred to specific property and equipment and depreciation commences when these assets are ready for their intended use. Depreciation is computed using the straight-line method over the estimated useful lives of assets, which is generally four years for laboratory equipment, three years for computer equipment and office equipment, five years for computer software and five to seven years for furniture and fixtures. Leasehold improvements are stated at cost and amortized over the shorter of the useful life of the assets or the length of the lease. Upon sale or retirement of assets, the costs and related accumulated depreciation are removed from the consolidated balance sheet and the resulting gain or loss is reflected in operations. Maintenance and repairs are charged to operations as incurred. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board ("FASB"), under its Accounting Standards Codification ("ASC") or other standard setting bodies, and adopted by the Company as of the specified effective date. There have been no new accounting pronouncements issued nor adopted during the three and six months ended June 30, 2022 that are of significance to the Company. |
Accrued and Other Current Liabi
Accrued and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2022 | |
Accounts Payable and Accrued Liabilities, Current [Abstract] | |
Accrued and Other Current Liabilities | 3. Accrued and Other Current Liabilities Accrued and other current liabilities consist of the following (in thousands): June 30, December 31, Accrued clinical trial and related costs $ 18,175 $ 21,776 Accrued manufacturing and research & development costs 12,185 6,041 Accrued leasehold improvements 5,271 13,021 Accrued salaries and benefits 3,906 6,187 Accrued legal fees 573 403 Accrued professional fees 87 176 Accrued other liabilities 2,961 715 Total accrued and other current liabilities $ 43,158 $ 48,319 |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements The following tables present the Company’s fair value hierarchy for assets measured at fair value on a recurring basis (in thousands): Fair Value Measurements at June 30, 2022 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 121,277 $ — $ — $ 121,277 U.S. treasury securities — 32,977 — 32,977 Marketable securities: U.S. treasury securities — 425,184 — 425,184 Total $ 121,277 $ 458,161 $ — $ 579,438 Fair Value Measurements at December 31, 2021 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 706,703 $ — $ — $ 706,703 Total $ 706,703 $ — $ — $ 706,703 As of June 30, 2022 and December 31, 2021 , the fair value of the liability related to sale of future royalties is based on the Company's current estimates of future royalties expected to be paid to Baker Bros. Advisors, LP (“BBA”), which are considered Level 3 inputs. |
Marketable Securities
Marketable Securities | 6 Months Ended |
Jun. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | 5. Marketable Securities The marketable securities are classified as available-for-sale. The fair value measurement data for marketable securities is obtained from independent pricing services. The Company validates the prices provided by the third-party pricing services by understanding the valuation methods and data sources used and analyzing the pricing data in certain instances. The following table presents the Company's marketable securities by major security type (in thousands): As of June 30, 2022 Amortized Unrealized Unrealized Fair U.S. treasury securities $ 427,053 $ — $ ( 1,869 ) $ 425,184 Total $ 427,053 $ — $ ( 1,869 ) $ 425,184 The Company had no marketable securities at December 31, 2021. The marketable securities held at June 30, 2022 had effective maturities of less than one year . There were no realized gains or losses recognized on the sale or maturity of available-for-sale debt securities during the six months ended June 30, 2022 , and as a result, the Company did not reclassify any amounts out of accumulated comprehensive loss. There were no impairment charges or recoveries recorded during the six months ended June 30, 2022. As of June 30, 2022 , the Company had no allowance for credit losses for available-for-sale debt securities. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 6. Commitments and Contingencies Embedded Lease In August 2020, the Company and its wholly-owned subsidiary Kodiak Sciences GmbH entered into a manufacturing agreement with Lonza Ltd (“Lonza”) for the clinical and commercial supply of drug substance for tarcocimab. A custom-built manufacturing facility is planned to be completed and dedicated to the manufacture of the Company’s drug substance. The manufacturing agreement has an initial term of eight years , and the Company has the right to extend the term up to a total of 16 years . The Company and Lonza each have the ability to terminate this agreement upon the occurrence of certain conditions. In April 2021, the agreement was amended to provide for higher annual manufacturing capacity. The Company expanded and finalized the design and scope of the bioconjugate manufacturing facility with a revised estimated capital contribution of approximately 75.0 million Swiss Francs of which the Company has paid 40.0 million Swiss Francs of the capital contribution, equivalent to $ 44.1 million U.S. Dollars, which is recorded in other assets on the consolidated balance sheet as of June 30, 2022 . Over the period from 2022 through 2029, manufacturing payments totaling approximately 150.0 million Swiss Francs may be incurred for potential commercial supply of tarcocimab drug substance based on the amended agreement. The Company concluded that this agreement contains an embedded lease as the custom-built manufacturing suite will be dedicated for the Company’s use. As of June 30, 2022 , the Company did not have control of this manufacturing space and therefore, did no t record a right-of-use asset and corresponding lease liability. Manufacturing Agreements The Company has entered into service and equipment purchase agreements in the normal course of business with various providers, pursuant to which such providers agreed to perform activities in connection with the manufacturing process of certain materials. These agreements, and any related amendments, state that planned activities and purchases that are included in the signed work orders are, in some cases, binding and, hence, obligate the Company to pay the full price of the work order upon satisfactory delivery of products and services or obligate the Company to the binding amount regardless of whether such planned activities are in fact performed. Per the terms of the agreements, the Company has the option to cancel signed orders at any time upon written notice, which may or may not be subject to payment of a cancellation fee. The level of cancellation fees may be dependent on the timing of the written notice in relation to the commencement date of the work, with the maximum cancellation amount dependent on the agreement or the work order. Other Funding Commitments In the normal course of business, the Company enters into agreements with third-parties for services to be provided to the Company. Generally, these agreements provide for termination upon notice, with specified amounts due upon termination based on the timing of termination and the terms of the agreement. The actual amounts and timing of payments under these agreements are uncertain and contingent upon the initiation and completion of services to be provided to the Company. The Company has also entered into various cancellable license agreements for certain technology. The Company may be obligated to make payments on future sales of specified products associated with such license agreements. Such payments are dependent on future product sales and are not estimable. Legal Proceedings From time to time, the Company may become involved in legal proceedings arising from the ordinary course of its business. Management is currently not aware of any matters that could have a material adverse effect on the Company’s financial position, results of operations or cash flows. The Company records a legal liability when it believes that it is both probable that a liability may be imputed, and the amount of the liability can be reasonably estimated. Significant judgment by the Company is required to determine both probability and the estimated amount. Indemnification To the extent permitted under Delaware law, the Company has agreed to indemnify its directors and officers for certain events or occurrences while the director or officer is, or was serving, at the Company’s request in such capacity. The indemnification period covers all pertinent events and occurrences during the director’s or officer’s service. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is not specified in the agreements; however, the Company has director and officer insurance coverage that reduces its exposure and enables the Company to recover a portion of any future amounts paid. The Company believes the estimated fair value of these indemnification agreements in excess of applicable insurance coverage is minimal. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 7. Stock-Based Compensation In January 2022 and 2021 , the number of shares of common stock available for issuance under the 2018 Equity Incentive Plan (the "2018 Plan") was increased by approximately 2.1 million and 2.0 million shares, respectively, as a result of the automatic increase provision in the 2018 Plan. Stock Options Stock option activity, including stock options and performance-based stock options under the 2021 Long-Term Performance Incentive Plan (“2021 LTPIP”), 2018 Plan and 2015 Plan is summarized as follows : Number Weighted Weighted Aggregate Outstanding at December 31, 2021 14,523,917 $ 61.68 8.60 $ 335,440 Granted 388,820 $ 14.74 Exercised ( 110,363 ) $ 15.22 Forfeited or canceled ( 563,036 ) $ 81.32 Outstanding at June 30, 2022 14,239,338 $ 59.99 8.09 $ 6,444 Restricted Shares Restricted share activity, including restricted stock awards, restricted stock units, and performance-based restricted stock units, under the 2018 Plan and 2015 Plan is summarized as follows: Number of Weighted Unvested at December 31, 2021 363,930 $ 72.75 Granted 44,250 27.38 Vested ( 77,729 ) 69.50 Canceled ( 37,688 ) 74.65 Unvested at June 30, 2022 292,763 $ 66.51 Performance-Based Awards The Company did no t grant any performance-based equity awards during the three and six months ended June 30, 2022. In February 2021, the Company granted 190,831 performance-based stock options ("2021 Feb PSO"). Upon the achievement of the specific clinical development milestone for the 2021 Feb PSO, 25 % of the options vested in the first quarter of 2022. The remaining awards will continue to vest in 36 successive equal monthly installments after the performance criteria was achieved. Stock-Based Compensation Expense Stock-based compensation for options, restricted shares, and ESPP is classified in the condensed consolidated statements of operations and comprehensive loss as follows (in thousands): Three Months Ended Six Months Ended 2022 2021 2022 2021 Research and development $ 14,109 $ 5,770 $ 30,084 $ 11,169 General and administrative 11,869 5,317 23,989 9,843 Total stock-based compensation $ 25,978 $ 11,087 $ 54,073 $ 21,012 |
Net Loss per Common Share
Net Loss per Common Share | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss per Common Share | 8. Net Loss per Common Share The following common share equivalents were excluded from the computation of diluted net loss per common share for the periods presented because their inclusion would have been antidilutive: As of June 30, 2022 2021 Outstanding stock options 14,239,338 6,821,524 Unvested restricted shares 292,763 288,362 Total 14,532,101 7,109,886 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis Of Presentation And Principles Of Consolidation | Basis of Presentation and Principles of Consolidation The accompanying condensed consolidated financial statements are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) applicable to interim periods. The condensed consolidated financial statements, in the opinion of management, include all normal and recurring adjustments necessary to state fairly the Company's financial position and results of operations for the reported periods. These condensed consolidated financial statements have been prepared on a basis substantially consistent with, and should be read in conjunction with the audited financial statements for the year ended December 31, 2021 and notes thereto, the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 1, 2022. Certain information and note disclosures normally included in the audited financial statements prepared in accordance with GAAP have been condensed or omitted from this report. The results of operations for any interim period are not necessarily indicative of the results for the year ending December 31, 2022, or for any future period. The accompanying condensed consolidated financial statements reflect the operations of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and expenses during the reporting period. The impact of the ongoing COVID-19 pandemic continues to evolve. As a result, certain estimates and assumptions required increased judgment and carried a higher degree of variability and volatility, including but not limited to, the fair value of marketable securities, performance-based equity awards, and research and development accruals. As events continue to unfold and additional information becomes available, these estimates may change materially in future periods. Actual results could differ from those estimates . |
Risk and Uncertainties | Risks and Uncertainties In March 2020, the World Health Organization declared a pandemic due to the global COVID-19 outbreak. The significant uncertainties caused by the ongoing COVID-19 pandemic may negatively impact the Company’s operations, liquidity, and capital resources and will depend on certain evolving developments, including the duration and spread of the outbreak, regulatory and private sector responses and the impact on employees and vendors including supply chain and clinical partners, all of which are uncertain and cannot be predicted. During this pandemic, the Company continues to work closely with clinical sites towards maximal patient safety and the lowest number of missed visits and study discontinuations. The Company has taken and continues to take proactive measures to maintain the integrity of its ongoing clinical studies. Despite these efforts, the ongoing COVID-19 pandemic could significantly impact clinical trial enrollment and completion of its clinical studies. As global economic conditions recover from the COVID-19 pandemic, business activity may not recover as quickly as anticipated, and it is not possible at this time to estimate the long-term impact that COVID-19 could have on the Company's business, as the impact will depend on future developments, which are highly uncertain and cannot be predicted. The Company will continue to monitor the COVID-19 situation and its impact on the ability to continue the development of, and seek regulatory approvals for, the Company’s product candidates, and begin to commercialize any approved products. |
Recent accounting pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board ("FASB"), under its Accounting Standards Codification ("ASC") or other standard setting bodies, and adopted by the Company as of the specified effective date. There have been no new accounting pronouncements issued nor adopted during the three and six months ended June 30, 2022 that are of significance to the Company. |
Accrued and Other Current Lia_2
Accrued and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Accounts Payable and Accrued Liabilities, Current [Abstract] | |
Schedule of Accrued and Other Current Liabilities | Accrued and other current liabilities consist of the following (in thousands): June 30, December 31, Accrued clinical trial and related costs $ 18,175 $ 21,776 Accrued manufacturing and research & development costs 12,185 6,041 Accrued leasehold improvements 5,271 13,021 Accrued salaries and benefits 3,906 6,187 Accrued legal fees 573 403 Accrued professional fees 87 176 Accrued other liabilities 2,961 715 Total accrued and other current liabilities $ 43,158 $ 48,319 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of Fair Value Hierarchy for Assets Measured at Fair Value on Recurring Basis | The following tables present the Company’s fair value hierarchy for assets measured at fair value on a recurring basis (in thousands): Fair Value Measurements at June 30, 2022 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 121,277 $ — $ — $ 121,277 U.S. treasury securities — 32,977 — 32,977 Marketable securities: U.S. treasury securities — 425,184 — 425,184 Total $ 121,277 $ 458,161 $ — $ 579,438 Fair Value Measurements at December 31, 2021 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 706,703 $ — $ — $ 706,703 Total $ 706,703 $ — $ — $ 706,703 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Marketable Securities | The following table presents the Company's marketable securities by major security type (in thousands): As of June 30, 2022 Amortized Unrealized Unrealized Fair U.S. treasury securities $ 427,053 $ — $ ( 1,869 ) $ 425,184 Total $ 427,053 $ — $ ( 1,869 ) $ 425,184 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of stock options and performance-based stock options under 2021 LTPIP, 2018 Plan and 2015 Plan. | Stock option activity, including stock options and performance-based stock options under the 2021 Long-Term Performance Incentive Plan (“2021 LTPIP”), 2018 Plan and 2015 Plan is summarized as follows : Number Weighted Weighted Aggregate Outstanding at December 31, 2021 14,523,917 $ 61.68 8.60 $ 335,440 Granted 388,820 $ 14.74 Exercised ( 110,363 ) $ 15.22 Forfeited or canceled ( 563,036 ) $ 81.32 Outstanding at June 30, 2022 14,239,338 $ 59.99 8.09 $ 6,444 |
Summary of Restricted Shares | Restricted share activity, including restricted stock awards, restricted stock units, and performance-based restricted stock units, under the 2018 Plan and 2015 Plan is summarized as follows: Number of Weighted Unvested at December 31, 2021 363,930 $ 72.75 Granted 44,250 27.38 Vested ( 77,729 ) 69.50 Canceled ( 37,688 ) 74.65 Unvested at June 30, 2022 292,763 $ 66.51 |
Summary of Stock-based Compensation for Options and Restricted Shares Classified in Condensed Consolidated Statements of Operations and Comprehensive Loss | Stock-based compensation for options, restricted shares, and ESPP is classified in the condensed consolidated statements of operations and comprehensive loss as follows (in thousands): Three Months Ended Six Months Ended 2022 2021 2022 2021 Research and development $ 14,109 $ 5,770 $ 30,084 $ 11,169 General and administrative 11,869 5,317 23,989 9,843 Total stock-based compensation $ 25,978 $ 11,087 $ 54,073 $ 21,012 |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Summary of Anti-dilutive Securities Excluded from Computation of Diluted Net Loss per Common Share | The following common share equivalents were excluded from the computation of diluted net loss per common share for the periods presented because their inclusion would have been antidilutive: As of June 30, 2022 2021 Outstanding stock options 14,239,338 6,821,524 Unvested restricted shares 292,763 288,362 Total 14,532,101 7,109,886 |
The Company - Additional Inform
The Company - Additional Information (Details) $ in Millions | Jun. 30, 2022 USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Cash, cash equivalents and marketable securities | $ 597.9 |
Accrued and Other Current Lia_3
Accrued and Other Current Liabilities - Schedule of Accrued and Other Current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Accounts Payable and Accrued Liabilities, Current [Abstract] | ||
Accrued clinical trial and related costs | $ 18,175 | $ 21,776 |
Accrued manufacturing and research & development costs | 12,185 | 6,041 |
Accrued Leasehold Improvements | 5,271 | 13,021 |
Accrued salaries and benefits | 3,906 | 6,187 |
Accrued legal fees | 573 | 403 |
Accrued professional fees | 87 | 176 |
Accrued other liabilities | 2,961 | 715 |
Total accrued and other current liabilities | $ 43,158 | $ 48,319 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Fair Value Hierarchy for Assets Measured at Fair Value on Recurring Basis (Details) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total | $ 579,438 | $ 706,703 |
Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 121,277 | |
Marketable securities | 706,703 | |
U.S. Treasury Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 32,977 | |
Marketable securities | 425,184 | |
Quoted Price in Active Markets (Level 1) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total | 121,277 | 706,703 |
Quoted Price in Active Markets (Level 1) | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 121,277 | |
Marketable securities | 706,703 | |
Significant Observable Inputs (Level 2) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total | 458,161 | |
Significant Observable Inputs (Level 2) | U.S. Treasury Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 32,977 | |
Marketable securities | 425,184 | |
Significant Unobservable Inputs (Level 3) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total | $ 0 |
Marketable Securities - Summary
Marketable Securities - Summary of Marketable Securities (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Marketable Securities [Line Items] | |
Amortized Cost, current | $ 427,053 |
Unrealized Gains, Current | 0 |
Unrealized Losses, Current | (1,869) |
Fair Value, current | 425,184 |
U.S. Treasury Securities | |
Marketable Securities [Line Items] | |
Amortized Cost, current | 427,053 |
Unrealized Gains, Current | 0 |
Unrealized Losses, Current | (1,869) |
Fair Value, current | $ 425,184 |
Marketable Securities - Additio
Marketable Securities - Additional Information (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Dec. 31, 2021 | |
Marketable Securities [Line Items] | ||
Availability of Marketable Securities | $ 0 | |
Marketable securities, effective maturities | 1 year | |
Realized gains or losses recognized on sale or maturity of available-for-sale debt securities | $ 0 | |
Allowance for credit losses for available-for-sale debt securities | 0 | |
Impairment charges or recoveries related to marketable securities | $ 0 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Thousands, SFr in Millions | 1 Months Ended | 6 Months Ended | |||
Aug. 31, 2020 | Jun. 30, 2022 USD ($) | Jun. 30, 2022 CHF (SFr) | Dec. 31, 2021 USD ($) | Apr. 30, 2021 CHF (SFr) | |
Commitments And Contingencies Disclosure [Line Items] | |||||
Operating lease right-of-use asset | $ 63,076 | $ 66,744 | |||
Lease Agreement | |||||
Commitments And Contingencies Disclosure [Line Items] | |||||
Operating lease right-of-use asset | 0 | ||||
Lease liabilities | 0 | ||||
Clinical and Commercial Supply of Drug Substance | Manufacturing Agreement | Lonza | |||||
Commitments And Contingencies Disclosure [Line Items] | |||||
Annual suite fees payment | SFr | SFr 150 | ||||
Revised estimated capital contribution | SFr | SFr 75 | ||||
Manufacturing agreement initial term | 8 years | ||||
Clinical and Commercial Supply of Drug Substance | Maximum | Manufacturing Agreement | Lonza | |||||
Commitments And Contingencies Disclosure [Line Items] | |||||
Manufacturing agreement term that can be extended | 16 years | ||||
Other Assets [Member] | Manufacturing Agreement | |||||
Commitments And Contingencies Disclosure [Line Items] | |||||
Manufacturing Agreement Expense | $ 44,100 | SFr 40 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
Jan. 31, 2022 | Feb. 28, 2021 | Jan. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Stock-based compensation expense recognized | $ (25,978) | $ 11,087 | $ 54,073 | $ 21,012 | ||||
Common stock, shares issued | 52,024,621 | 52,024,621 | 51,826,257 | |||||
Stock based compensation expense related to ESPP | $ 64 | $ 305 | ||||||
Performance-based Stock Options | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Percentage of vested of award under performance based award | 25% | |||||||
Stock options, granted | 190,831 | 0 | 0 | |||||
2018 Equity Incentive Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Number of common stock available for issuance increased | 2,100,000 | 2,000,000 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Options Activity Under 2018 Plan and 2015 Equity Incentive Plan (Details) - 2018 Plan, 2015 Equity Incentive Plan and 2021 LTPIP $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | |
Number of Options | ||
Beginning balance | shares | 14,523,917 | |
Granted | shares | 388,820 | |
Exercised | shares | (110,363) | |
Forfeited or canceled | shares | (563,036) | |
Ending balance | shares | 14,239,338 | 14,523,917 |
Weighted Average Exercise Price | ||
Beginning balance | $ / shares | $ 61.68 | |
Granted | $ / shares | 14.74 | |
Exercised | $ / shares | 15.22 | |
Forfeited or canceled | $ / shares | 81.32 | |
Ending balance | $ / shares | $ 59.99 | $ 61.68 |
Weighted Average Remaining Contractual Term (in years) | ||
Weighted Average Remaining Contractual Term (in years) | 8 years 1 month 2 days | 8 years 7 months 6 days |
Aggregate Intrinsic Value | ||
Balance | $ | $ 6,444 | $ 335,440 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Restricted Shares (Details) - Restricted Shares | 6 Months Ended |
Jun. 30, 2022 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Unvested, beginning balance | shares | 363,930 |
Granted | shares | 44,250 |
Vested | shares | (77,729) |
Canceled | shares | (37,688) |
Unvested, ending balance | shares | 292,763 |
Weighted Average Grant Date Fair Value | |
Unvested, beginning balance | $ / shares | $ 72.75 |
Granted | $ / shares | 27.38 |
Vested | $ / shares | 69.50 |
Canceled | $ / shares | 74.65 |
Unvested, ending balance | $ / shares | $ 66.51 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Stock-based Compensation for Options and Restricted Shares Classified in Condensed Consolidated Statements of Operations and Comprehensive Loss (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ (25,978) | $ 11,087 | $ 54,073 | $ 21,012 |
Research and Development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | (14,109) | 5,770 | 30,084 | 11,169 |
General and Administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ (11,869) | $ 5,317 | $ 23,989 | $ 9,843 |
Net Loss per Common Share - Sum
Net Loss per Common Share - Summary of Anti-dilutive Securities Excluded from Computation of Diluted Net Loss per Common Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from the computation of diluted net loss per common share | 14,532,101 | 7,109,886 |
Outstanding Stock Options | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from the computation of diluted net loss per common share | 14,239,338 | 6,821,524 |
Unvested Restricted Shares | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from the computation of diluted net loss per common share | 292,763 | 288,362 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - shares | 1 Months Ended | 3 Months Ended | 6 Months Ended |
Feb. 28, 2021 | Jun. 30, 2022 | Jun. 30, 2022 | |
Performance-based Stock Options | |||
Subsequent Event [Line Items] | |||
Granted | 190,831 | 0 | 0 |