Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2023 | Jul. 31, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
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 | Non-accelerated Filer | |
Entity Shell Company | false | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 52,453,163 | |
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, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 378,670 | $ 190,433 |
Marketable securities | 0 | 288,500 |
Prepaid expenses and other current assets | 8,289 | 7,072 |
Total current assets | 386,959 | 486,005 |
Restricted cash | 6,324 | 6,324 |
Property and equipment, net | 130,121 | 56,384 |
Operating lease right-of-use asset | 57,251 | 59,369 |
Other assets | 9,004 | 58,546 |
Total assets | 589,659 | 666,628 |
Current liabilities: | ||
Accounts payable | 12,347 | 9,130 |
Accrued and other current liabilities | 54,044 | 33,440 |
Operating lease liability | 7,851 | 9,926 |
Total current liabilities | 74,242 | 52,496 |
Operating lease liability, net of current portion | 76,939 | 77,807 |
Liability related to sale of future royalties | 100,000 | 99,996 |
Other liabilities | 0 | 162 |
Total liabilities | 251,181 | 230,461 |
Commitments and contingencies (Note 7) | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value, 10,000,000 shares authorized; 0 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | 0 | 0 |
Common stock, $0.0001 par value, 490,000,000 shares authorized at June 30, 2023 and December 31, 2022; 52,453,163 and 52,333,850 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | 5 | 5 |
Additional paid-in capital | 1,381,481 | 1,329,509 |
Accumulated other comprehensive income (loss) | 0 | (1,307) |
Accumulated deficit | (1,043,008) | (892,040) |
Total stockholders’ equity | 338,478 | 436,167 |
Total liabilities and stockholders’ equity | $ 589,659 | $ 666,628 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) (unaudited) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
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 | 52,453,163 | 52,333,850 |
Common stock, shares outstanding | 52,453,163 | 52,333,850 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Operating expenses | ||||
Research and development | $ 66,961 | $ 73,744 | $ 123,481 | $ 149,921 |
General and administrative | 17,871 | 18,324 | 35,966 | 37,914 |
Total operating expenses | 84,832 | 92,068 | 159,447 | 187,835 |
Loss from operations | (84,832) | (92,068) | (159,447) | (187,835) |
Interest income | 4,683 | 1,494 | 8,300 | 1,570 |
Interest expense | (4) | (5) | (8) | (10) |
Other income (expense), net | (35) | (49) | 187 | (62) |
Net loss | $ (80,188) | $ (90,628) | $ (150,968) | $ (186,337) |
Net loss per common share, basic | $ (1.53) | $ (1.74) | $ (2.88) | $ (3.57) |
Net loss per common share, diluted | $ (1.53) | $ (1.74) | $ (2.88) | $ (3.57) |
Weighted-average shares of common stock outstanding used in computing net loss per common share, Basic | 52,378,729 | 52,218,773 | 52,358,279 | 52,195,972 |
Weighted-average shares of common stock outstanding used in computing net loss per common share, Diluted | 52,378,729 | 52,218,773 | 52,358,279 | 52,195,972 |
Other comprehensive income (loss) | ||||
Change in unrealized gains (losses) related to available-for-sale debt securities, net of tax | $ 96 | $ (1,869) | $ 1,307 | $ (1,869) |
Total other comprehensive income (loss) | 96 | (1,869) | 1,307 | (1,869) |
Comprehensive loss | $ (80,092) | $ (92,497) | $ (149,661) | $ (188,206) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning Balance at Dec. 31, 2021 | $ 663,320 | $ 5 | $ 1,221,532 | $ 0 | $ (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, 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 | 0 | (653,926) |
Ending balance, shares at Mar. 31, 2022 | 51,939,881 | ||||
Beginning Balance at Dec. 31, 2021 | 663,320 | $ 5 | 1,221,532 | 0 | (558,217) |
Beginning balance, shares at Dec. 31, 2021 | 51,826,257 | ||||
Other comprehensive lncome | (1,869) | ||||
Net loss | (186,337) | ||||
Ending Balance at Jun. 30, 2022 | 530,931 | $ 5 | 1,277,349 | (1,869) | (744,554) |
Ending balance, shares at Jun. 30, 2022 | 52,024,621 | ||||
Beginning Balance at Mar. 31, 2022 | 597,384 | $ 5 | 1,251,305 | 0 | (653,926) |
Beginning balance, shares at Mar. 31, 2022 | 51,939,881 | ||||
Issuance of common stock upon exercise of stock options | 2 | 2 | |||
Issuance of common stock upon exercise of stock options, shares | 320 | ||||
Issuance of common stock upon vesting of restricted stock units, shares | 74,148 | ||||
Stock based compensation expense related to ESPP | 64 | 64 | |||
Issuance of common stock pursuant to employee stock purchase plans, shares | 10,272 | ||||
Other comprehensive lncome | (1,869) | 1,869 | |||
Stock-based compensation expense | 25,978 | 25,978 | |||
Net loss | (90,628) | (90,628) | |||
Ending Balance at Jun. 30, 2022 | 530,931 | $ 5 | 1,277,349 | (1,869) | (744,554) |
Ending balance, shares at Jun. 30, 2022 | 52,024,621 | ||||
Beginning Balance at Dec. 31, 2022 | 436,167 | $ 5 | 1,329,509 | (1,307) | (892,040) |
Beginning balance, shares at Dec. 31, 2022 | 52,333,850 | ||||
Issuance of common stock upon exercise of stock options | 9 | 9 | |||
Issuance of common stock upon exercise of stock options, shares | 1,098 | ||||
Issuance of common stock upon vesting of restricted stock units, shares | 9,793 | ||||
Other comprehensive lncome | 1,211 | 1,211 | |||
Stock-based compensation expense | 25,980 | 25,980 | |||
Net loss | (70,780) | (70,780) | |||
Ending Balance at Mar. 31, 2023 | 392,587 | $ 5 | 1,355,498 | (96) | (962,820) |
Ending balance, shares at Mar. 31, 2023 | 52,344,741 | ||||
Beginning Balance at Dec. 31, 2022 | 436,167 | $ 5 | 1,329,509 | (1,307) | (892,040) |
Beginning balance, shares at Dec. 31, 2022 | 52,333,850 | ||||
Other comprehensive lncome | 1,307 | ||||
Net loss | (150,968) | ||||
Ending Balance at Jun. 30, 2023 | 338,478 | $ 5 | 1,381,481 | 0 | (1,043,008) |
Ending balance, shares at Jun. 30, 2023 | 52,453,163 | ||||
Beginning Balance at Mar. 31, 2023 | 392,587 | $ 5 | 1,355,498 | (96) | (962,820) |
Beginning balance, shares at Mar. 31, 2023 | 52,344,741 | ||||
Issuance of common stock upon exercise of stock options | 51 | 51 | |||
Issuance of common stock upon exercise of stock options, shares | 6,430 | ||||
Issuance of common stock upon vesting of restricted stock units, shares | 76,152 | ||||
Stock based compensation expense related to ESPP | 131 | 131 | |||
Issuance of common stock pursuant to employee stock purchase plans, shares | 25,840 | ||||
Other comprehensive lncome | 96 | (96) | |||
Stock-based compensation expense | 25,801 | 25,801 | |||
Net loss | (80,188) | (80,188) | |||
Ending Balance at Jun. 30, 2023 | $ 338,478 | $ 5 | $ 1,381,481 | $ 0 | $ (1,043,008) |
Ending balance, shares at Jun. 30, 2023 | 52,453,163 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Cash flows from operating activities | ||
Net loss | $ (150,968) | $ (186,337) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | ||
Depreciation | 8,568 | 1,075 |
Stock-based compensation | 51,781 | 54,073 |
Net amortization (accretion) of premium (discount) on marketable securities | (846) | (314) |
Settlement of derivative contracts | (314) | 0 |
Amortization of operating lease right-of-use asset | 3,745 | 3,742 |
Amortization of issuance costs | 4 | 26 |
Changes in assets and liabilities: | ||
Prepaid expenses and other current assets | 3,964 | (2,165) |
Other assets | 181 | 10,235 |
Accounts payable | 3,549 | 12,864 |
Accrued and other current liabilities | (4,274) | 1,545 |
Operating lease liability | (4,570) | 6,959 |
Net cash provided by (used in) operating activities | (89,180) | (98,297) |
Cash flows from investing activities | ||
Purchase of property and equipment | (13,640) | (25,690) |
Deposits on property and equipment | (77) | (8,785) |
Purchase of marketable securities | (49,347) | (427,766) |
Maturities of marketable securities | 340,000 | 0 |
Proceeds from derivative activity | 314 | 0 |
Net cash provided by (used in) investing activities | 277,250 | (462,241) |
Net cash provided by (used in) financing activities | ||
Proceeds from issuance of common stock upon options exercise | 60 | 1,680 |
Proceeds from issuance of common stock pursuant to employee stock purchase plans | 131 | 64 |
Principal payments of tenant improvement allowance payable | (24) | (24) |
Net cash provided by financing activities | 167 | 1,720 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 188,237 | (558,818) |
Cash, cash equivalents and restricted cash, at beginning of period | 196,757 | 737,834 |
Cash, cash equivalents and restricted cash, at end of period | 384,994 | 179,016 |
Reconciliation of cash, cash equivalents and restricted cash to consolidated balance sheets | ||
Cash and cash equivalents | 378,670 | 172,692 |
Restricted cash | 6,324 | 6,324 |
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents, Including Disposal Group and Discontinued Operations, Total | 384,994 | 179,016 |
Supplemental disclosures of non-cash investing and financing information: | ||
Operating lease right-of-use asset obtained in exchange for operating lease liability | 1,473 | 74 |
Purchase of property and equipment under accounts payable and accruals | $ 27,662 | $ 9,718 |
The Company
The Company | 6 Months Ended |
Jun. 30, 2023 | |
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. 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, 2023, the Company had cash and cash equivalents of $ 378.7 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 and cash equivalents 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, 2023 | |
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, 2022 and notes thereto, the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 28, 2023. 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, 2023, 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. Reclassification Certain prior period amounts in the consolidated financial statements have been reclassified to conform to the current period presentation. 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. Such estimates include, but are not limited to, accrued research and development and stock-based compensation. Actual results could differ from those estimates . Risks and Uncertainties Global economic and business activities continue to face widespread macroeconomic uncertainties, including health epidemics, labor shortages, bank failures, inflation and monetary supply shifts, recession risks and potential disruptions from the Russia-Ukraine conflict. The Company continues to actively monitor the impact of these macroeconomic factors on its financial condition, liquidity, operations, and workforce. The extent of the impact of these factors on the Company’s operational and financial performance, including its ability to execute its business strategies and initiatives in the expected timeframe, will depend on future developments, which are uncertain and cannot be predicted; however, any continued or renewed disruption resulting from these factors could negatively impact the Company’s business. The Company’s future results of operations involve a number of risks and uncertainties common to clinical stage companies in the biotechnology industry. The Company’s product candidates are in development and the Company operates in an environment of rapid change in technology and substantial competition from other pharmaceutical and biotechnology companies. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, uncertainty of results of clinical trials and reaching milestones, uncertainty of regulatory approval of the Company’s potential drug candidates, uncertainty of market acceptance of any of the Company’s product candidates that receive regulatory approval, competition from new technological innovations, substitute products and larger companies, securing and protecting proprietary technology, strategic relationships and dependence on key individuals, contract manufacturer and research organizations, and other suppliers. Products developed by the Company require approvals from the U.S. Food and Drug Administration (“FDA”) or other international regulatory agencies prior to commercial sales. There can be no assurance that any of the Company’s product candidates will receive the necessary approvals. If the Company is denied approval, approval is delayed or the Company is unable to maintain approvals, it could have a materially adverse impact on the Company. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company expects to incur substantial operating losses for the next several years and will need to obtain additional financing in order to complete clinical trials, launch and commercialize any product candidates for which it receives regulatory approval. There can be no assurance that such financing will be available or will be on terms acceptable by the Company. 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, 2023, 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, 2022 , except as noted below within the “Recent Accounting Pronouncements” section. 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, 2023 that are of significance to the Company. |
Accrued and Other Current Liabi
Accrued and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2023 | |
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 property and equipment $ 26,873 $ 1,893 Accrued clinical trial and related costs 16,052 18,334 Accrued salaries and benefits 4,331 6,033 Accrued manufacturing and research & development costs 3,531 5,978 Accrued legal fees and professional fees 531 283 Accrued other liabilities 2,726 919 Total accrued and other current liabilities $ 54,044 $ 33,440 |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2023 | |
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, 2023 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 368,661 $ — $ — $ 368,661 Marketable securities: U.S. treasury securities — — — — Total $ 368,661 $ — $ — $ 368,661 Fair Value Measurements at December 31, 2022 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 173,617 $ — $ — $ 173,617 Marketable securities: U.S. treasury securities — 288,500 — 288,500 Total $ 173,617 $ 288,500 $ — $ 462,117 As of June 30, 2023 , 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, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | 5. Marketable Securities Marketable securities are classified as available-for-sale. The Company obtains fair value measurement data from third party pricing services and understands the valuation methods and data sources to validate this information. The following table presents the Company's marketable securities by major security type (in thousands): As of December 31, 2022 Amortized Unrealized Unrealized Fair U.S. treasury securities $ 289,807 $ — $ ( 1,307 ) $ 288,500 Total $ 289,807 $ — $ ( 1,307 ) $ 288,500 As of June 30, 2023, there were no marketable securities. There were no reclassifications out of accumulated other comprehensive income (loss), impairment charges or recoveries and no allowance for credit losses recorded during the six months ended June 30, 2023 . |
Derivatives
Derivatives | 6 Months Ended |
Jun. 30, 2023 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Derivatives | 6. Derivatives The Company uses certain derivative instruments, that are not designated as hedges for accounting purposes, which include foreign currency forward contracts. As of June 30, 2023 , these derivatives have been net settled. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 7. Commitments and Contingencies Ursus Facility 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 the Company’s antibody biopolymer conjugate drug substance which included a custom-built manufacturing facility. 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 greater manufacturing flexibility, to define a comprehensive mandate as an antibody biopolymer conjugates manufacturing facility to be used for the Company’s antibody biopolymer conjugates pipeline, at clinical as well as commercial scales, across a broad capacity range under the tight quality controls required for ophthalmology and retinal medicines, and to allow for future process and equipment changes as needed. The Company expanded and finalized the design and scope of the antibody biopolymer conjugates manufacturing facility with a revised estimated capital contribution of approximately 75.0 million Swiss Francs. Over the period from 2022 through 2030, manufacturing payments totaling approximately 150.0 million Swiss Francs may be incurred for the potential clinical and commercial supply of tarcocimab and other antibody biopolymer conjugates medicines based on the amended agreement. The Company concluded that this agreement contained an embedded lease as the custom-built manufacturing suite would be dedicated for the Company’s use. On January 31, 2023, the custom-built manufacturing suite was commissioned as a cGMP facility. The consideration was allocated to lease and non-lease components as this agreement contained a significant service component (manufacturing services). The Company recognized an operating lease right-of-use asset and corresponding liability based on the present value of remaining lease payments discounted at the Company’s estimated incremental borrowing rate of 6.3 % over the remaining lease term of 7.2 years. The Company determined that the renewal options were not reasonably certain at lease inception. The Company recognized $ 0.2 million and $ 0.3 million as part of operating lease costs during the three and six months ended June 30, 2023, respectively. Fixed assets of approximately 75.0 million Swiss Francs, equivalent to $ 81.7 million, in leasehold improvements and machinery and equipment, were placed in service and capitalized as of January 31, 2023. As of June 30, 2023 , $2 6.8 million of these fixed assets were unpaid and recorded to accrued property and equipment under accrued and other current liabilities on the condensed consolidated balance sheet. 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, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 8. Stock-Based Compensation In January 2023 and 2022 , 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 2.1 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, 2022 16,542,107 $ 51.48 7.91 $ 5,410 Granted 3,257,000 $ 7.16 Exercised ( 7,528 ) $ 7.96 Forfeited or canceled ( 47,798 ) $ 25.88 Outstanding at June 30, 2023 19,743,781 $ 44.25 7.79 $ 5,023 Restricted Shares Restricted share activity, including restricted stock awards, restricted stock units, and performance-based restricted stock units, under the 2018 Plan is summarized as follows: Number of Weighted Unvested at December 31, 2022 280,522 $ 60.17 Granted 23,250 $ 6.76 Vested ( 85,945 ) $ 63.52 Canceled ( 4,850 ) $ 44.16 Unvested at June 30, 2023 212,977 $ 53.35 Stock-Based Compensation Expense Stock-based compensation is classified in the condensed consolidated statements of operations and comprehensive loss as follows (in thousands): Three Months Ended Six Months Ended 2023 2022 2023 2022 Research and development $ 14,660 $ 14,109 $ 29,360 $ 30,084 General and administrative 11,141 11,869 22,421 23,989 Total stock-based compensation $ 25,801 $ 25,978 $ 51,781 $ 54,073 |
Net Loss per Common Share
Net Loss per Common Share | 6 Months Ended |
Jun. 30, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss per Common Share | 9. 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, 2023 2022 Outstanding stock options 19,743,781 14,239,338 Unvested restricted shares 212,977 292,763 Total 19,956,758 14,532,101 |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 10. Subsequent Events On July 24, 2023, the Company announced topline results from three Phase 3 studies of tarcocimab, its novel antibody biopolymer conjugate. Based on these data, and despite demonstrating potential, the Company announced a business decision to discontinue further development of tarcocimab. The Company continues to assess a variety of strategic and operational alternatives relating to the tarcocimab program, including the possibility that additional clinical trials may be conducted in the future, as well as the potential impact to the financial statements; however, the full impact cannot be ascertained at this time. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
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, 2022 and notes thereto, the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 28, 2023. 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, 2023, 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. |
Reclassification | Reclassification Certain prior period amounts in the consolidated financial statements have been reclassified to conform to the current period presentation. |
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. Such estimates include, but are not limited to, accrued research and development and stock-based compensation. Actual results could differ from those estimates . |
Risk and Uncertainties | Risks and Uncertainties Global economic and business activities continue to face widespread macroeconomic uncertainties, including health epidemics, labor shortages, bank failures, inflation and monetary supply shifts, recession risks and potential disruptions from the Russia-Ukraine conflict. The Company continues to actively monitor the impact of these macroeconomic factors on its financial condition, liquidity, operations, and workforce. The extent of the impact of these factors on the Company’s operational and financial performance, including its ability to execute its business strategies and initiatives in the expected timeframe, will depend on future developments, which are uncertain and cannot be predicted; however, any continued or renewed disruption resulting from these factors could negatively impact the Company’s business. The Company’s future results of operations involve a number of risks and uncertainties common to clinical stage companies in the biotechnology industry. The Company’s product candidates are in development and the Company operates in an environment of rapid change in technology and substantial competition from other pharmaceutical and biotechnology companies. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, uncertainty of results of clinical trials and reaching milestones, uncertainty of regulatory approval of the Company’s potential drug candidates, uncertainty of market acceptance of any of the Company’s product candidates that receive regulatory approval, competition from new technological innovations, substitute products and larger companies, securing and protecting proprietary technology, strategic relationships and dependence on key individuals, contract manufacturer and research organizations, and other suppliers. Products developed by the Company require approvals from the U.S. Food and Drug Administration (“FDA”) or other international regulatory agencies prior to commercial sales. There can be no assurance that any of the Company’s product candidates will receive the necessary approvals. If the Company is denied approval, approval is delayed or the Company is unable to maintain approvals, it could have a materially adverse impact on the Company. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company expects to incur substantial operating losses for the next several years and will need to obtain additional financing in order to complete clinical trials, launch and commercialize any product candidates for which it receives regulatory approval. There can be no assurance that such financing will be available or will be on terms acceptable by the Company. |
Summary of Significant Accounting Policies | 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, 2023, 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, 2022 , except as noted below within the “Recent Accounting Pronouncements” section. |
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, 2023 that are of significance to the Company. |
Accrued and Other Current Lia_2
Accrued and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
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 property and equipment $ 26,873 $ 1,893 Accrued clinical trial and related costs 16,052 18,334 Accrued salaries and benefits 4,331 6,033 Accrued manufacturing and research & development costs 3,531 5,978 Accrued legal fees and professional fees 531 283 Accrued other liabilities 2,726 919 Total accrued and other current liabilities $ 54,044 $ 33,440 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Summary of Fair Value Hierarchy for Assets and Liabilities 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, 2023 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 368,661 $ — $ — $ 368,661 Marketable securities: U.S. treasury securities — — — — Total $ 368,661 $ — $ — $ 368,661 Fair Value Measurements at December 31, 2022 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 173,617 $ — $ — $ 173,617 Marketable securities: U.S. treasury securities — 288,500 — 288,500 Total $ 173,617 $ 288,500 $ — $ 462,117 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
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 December 31, 2022 Amortized Unrealized Unrealized Fair U.S. treasury securities $ 289,807 $ — $ ( 1,307 ) $ 288,500 Total $ 289,807 $ — $ ( 1,307 ) $ 288,500 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
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, 2022 16,542,107 $ 51.48 7.91 $ 5,410 Granted 3,257,000 $ 7.16 Exercised ( 7,528 ) $ 7.96 Forfeited or canceled ( 47,798 ) $ 25.88 Outstanding at June 30, 2023 19,743,781 $ 44.25 7.79 $ 5,023 |
Summary of Restricted Shares | Restricted share activity, including restricted stock awards, restricted stock units, and performance-based restricted stock units, under the 2018 Plan is summarized as follows: Number of Weighted Unvested at December 31, 2022 280,522 $ 60.17 Granted 23,250 $ 6.76 Vested ( 85,945 ) $ 63.52 Canceled ( 4,850 ) $ 44.16 Unvested at June 30, 2023 212,977 $ 53.35 |
Summary of Stock-based Compensation for Options and Restricted Shares Classified in Condensed Consolidated Statements of Operations and Comprehensive Loss | Stock-based compensation is classified in the condensed consolidated statements of operations and comprehensive loss as follows (in thousands): Three Months Ended Six Months Ended 2023 2022 2023 2022 Research and development $ 14,660 $ 14,109 $ 29,360 $ 30,084 General and administrative 11,141 11,869 22,421 23,989 Total stock-based compensation $ 25,801 $ 25,978 $ 51,781 $ 54,073 |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
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, 2023 2022 Outstanding stock options 19,743,781 14,239,338 Unvested restricted shares 212,977 292,763 Total 19,956,758 14,532,101 |
The Company - Additional Inform
The Company - Additional Information (Details) $ in Millions | Jun. 30, 2023 USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Cash, cash equivalents and marketable securities | $ 378.7 |
Accrued and Other Current Lia_3
Accrued and Other Current Liabilities - Schedule of Accrued and Other Current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Accounts Payable and Accrued Liabilities, Current [Abstract] | ||
Accrued property and equipment | $ 26,873 | $ 1,893 |
Accrued clinical trial and related costs | 16,052 | 18,334 |
Accrued salaries and benefits | 4,331 | 6,033 |
Accrued manufacturing and research & development costs | 3,531 | 5,978 |
Accrued legal fees and professional fees | 531 | 283 |
Accrued other liabilities | 2,726 | 919 |
Total accrued and other current liabilities | $ 54,044 | $ 33,440 |
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, 2023 | Dec. 31, 2022 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total | $ 368,661 | $ 462,117 |
Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 368,661 | 173,617 |
U.S. Treasury Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Marketable securities | 0 | 288,500 |
Quoted Price in Active Markets (Level 1) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total | 368,661 | 173,617 |
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 | 368,661 | 173,617 |
Quoted Price in Active Markets (Level 1) | U.S. Treasury Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Marketable securities | 0 | 0 |
Significant Observable Inputs (Level 2) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total | 0 | 288,500 |
Significant Observable Inputs (Level 2) | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 0 | 0 |
Significant Observable Inputs (Level 2) | U.S. Treasury Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Marketable securities | 0 | 288,500 |
Significant Unobservable Inputs (Level 3) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 0 | 0 |
Significant Unobservable Inputs (Level 3) | U.S. Treasury Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 0 | $ 0 |
Marketable Securities - Summary
Marketable Securities - Summary of Marketable Securities (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Marketable Securities [Line Items] | |
Amortized Cost, current | $ 289,807 |
Unrealized Gains, Current | 0 |
Unrealized Losses, Current | (1,307) |
Fair Value, current | 288,500 |
U.S. Treasury Securities | |
Marketable Securities [Line Items] | |
Amortized Cost, current | 289,807 |
Unrealized Gains, Current | 0 |
Unrealized Losses, Current | (1,307) |
Fair Value, current | $ 288,500 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended |
Aug. 31, 2020 | Jun. 30, 2023 | Jun. 30, 2023 | |
Commitments And Contingencies Disclosure [Line Items] | |||
Operating lease cost | $ 0.2 | $ 0.3 | |
Subordinated Borrowing, Interest Rate | 6.30% | ||
Manufacturing agreement capital contributions fixed assets | 75 | $ 75 | |
Manufacturing Agreement Expense | $ 150 | ||
Manufacturing agreement initial term | 7 years 2 months 12 days | ||
Lease liabilities | 6.8 | $ 6.8 | |
Lonza | |||
Commitments And Contingencies Disclosure [Line Items] | |||
Manufacturing agreement capital contributions fixed assets | 75 | 75 | |
leasehold improvements and machinery and equipment | $ 81.7 | $ 81.7 | |
Manufacturing Agreement | Clinical and Commercial Supply of Drug Substance | Maximum | Lonza | |||
Commitments And Contingencies Disclosure [Line Items] | |||
Manufacturing agreement initial term | 8 years | ||
Manufacturing agreement term that can be extended | 16 years |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - shares | 1 Months Ended | |
Jan. 31, 2023 | Jan. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of common stock available for issuance increased | 2,100,000 | 2,100,000 |
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, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | |
Number of Options | ||
Beginning balance | shares | 16,542,107 | |
Granted | shares | 3,257,000 | |
Exercised | shares | (7,528) | |
Forfeited or canceled | shares | (47,798) | |
Ending balance | shares | 19,743,781 | 16,542,107 |
Weighted Average Exercise Price | ||
Beginning balance | $ / shares | $ 51.48 | |
Granted | $ / shares | 7.16 | |
Exercised | $ / shares | 7.96 | |
Forfeited or canceled | $ / shares | 25.88 | |
Ending balance | $ / shares | $ 44.25 | $ 51.48 |
Weighted Average Remaining Contractual Term and Aggregate Intrinsic Value | ||
Weighted Average Remaining Contractual Term (in years) | 7 years 9 months 14 days | 7 years 10 months 28 days |
Aggregate Intrinsic Value | $ | $ 5,023 | $ 5,410 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Restricted Shares (Details) - Restricted Shares | 6 Months Ended |
Jun. 30, 2023 $ / 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 | 280,522 |
Granted | shares | 23,250 |
Vested | shares | (85,945) |
Canceled | shares | (4,850) |
Unvested, ending balance | shares | 212,977 |
Weighted Average Grant Date Fair Value | |
Unvested, beginning balance | $ / shares | $ 60.17 |
Granted | $ / shares | 6.76 |
Vested | $ / shares | 63.52 |
Canceled | $ / shares | 44.16 |
Unvested, ending balance | $ / shares | $ 53.35 |
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, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ 25,801 | $ 25,978 | $ 51,781 | $ 54,073 |
Research and Development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | 14,660 | 14,109 | 29,360 | 30,084 |
General and Administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ 11,141 | $ 11,869 | $ 22,421 | $ 23,989 |
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, 2023 | Jun. 30, 2022 | |
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 | 19,956,758 | 14,532,101 |
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 | 19,743,781 | 14,239,338 |
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 | 212,977 | 292,763 |