Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | Apr. 30, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2024 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
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 | 52,534,947 | |
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 | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 245,919 | $ 285,507 |
Prepaid expenses and other current assets | 5,593 | 3,802 |
Total current assets | 251,512 | 289,309 |
Restricted cash | 6,184 | 6,324 |
Property and equipment, net | 115,801 | 120,482 |
Operating lease right-of-use asset | 52,561 | 54,541 |
Other assets | 8,701 | 8,716 |
Total assets | 434,759 | 479,372 |
Current liabilities: | ||
Accounts payable | 2,485 | 13,608 |
Accrued and other current liabilities | 12,765 | 18,351 |
Operating lease liability | 9,605 | 9,770 |
Total current liabilities | 24,855 | 41,729 |
Operating lease liability, net of current portion | 68,715 | 71,862 |
Liability related to sale of future royalties | 100,000 | 100,000 |
Total liabilities | 193,570 | 213,591 |
Commitments and contingencies (Note 5) | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value, 10,000,000 shares authorized: 0 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | 0 | 0 |
Common stock, $0.0001 par value, 490,000,000 shares authorized at March 31, 2024 and December 31, 2023; 52,523,447 and 52,508,602 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | 5 | 5 |
Additional paid-in capital | 1,436,754 | 1,418,307 |
Accumulated deficit | (1,195,570) | (1,152,531) |
Total stockholders’ equity | 241,189 | 265,781 |
Total liabilities and stockholders’ equity | $ 434,759 | $ 479,372 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) (unaudited) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
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 | 52,523,447 | 52,508,602 |
Common stock, shares outstanding | 52,523,447 | 52,508,602 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating expenses | ||
Research and development | $ 29,931 | $ 56,520 |
General and administrative | 16,124 | 18,095 |
Total operating expenses | 46,055 | 74,615 |
Loss from operations | (46,055) | (74,615) |
Interest income | 3,353 | 3,617 |
Interest expense | 0 | (4) |
Other income (expense), net | (337) | 222 |
Net loss | $ (43,039) | $ (70,780) |
Net loss per common share, basic | $ (0.82) | $ (1.35) |
Net loss per common share, diluted | $ (0.82) | $ (1.35) |
Weighted-average shares of common stock outstanding used in computing net loss per common share, Basic | 52,510,460 | 52,337,603 |
Weighted-average shares of common stock outstanding used in computing net loss per common share, Diluted | 52,510,460 | 52,337,603 |
Other comprehensive income (loss) | ||
Change in unrealized gains (losses) related to available-for-sale debt securities, net of tax | $ 0 | $ 1,211 |
Total other comprehensive income (loss) | 0 | 1,211 |
Comprehensive loss | $ (43,039) | $ (69,569) |
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, 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 income | 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, 2023 | 265,781 | $ 5 | 1,418,307 | 0 | (1,152,531) |
Beginning balance, shares at Dec. 31, 2023 | 52,508,602 | ||||
Issuance of common stock upon exercise of stock options | 38 | 38 | |||
Issuance of common stock upon exercise of stock options, shares | 8,333 | ||||
Issuance of common stock upon vesting of restricted stock units, shares | 6,512 | ||||
Other comprehensive income | 0 | ||||
Stock-based compensation expense | 18,409 | 18,409 | |||
Net loss | (43,039) | (43,039) | |||
Ending Balance at Mar. 31, 2024 | $ 241,189 | $ 5 | $ 1,436,754 | $ 0 | $ (1,195,570) |
Ending balance, shares at Mar. 31, 2024 | 52,523,447 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash flows from operating activities | ||
Net loss | $ (43,039) | $ (70,780) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | ||
Depreciation | 4,703 | 3,810 |
Stock-based compensation | 18,409 | 25,980 |
Net amortization (accretion) of premium (discount) on marketable securities | 0 | (518) |
Settlement of derivative contracts | 144 | 0 |
Amortization of operating lease right-of-use asset | 1,943 | 1,846 |
Amortization of issuance costs | 0 | 4 |
Changes in assets and liabilities: | ||
Prepaid expenses and other current assets | (1,791) | 2,326 |
Other assets | 15 | (12) |
Accounts payable | (11,123) | (1,900) |
Accrued and other current liabilities | (5,586) | (5,370) |
Operating lease liability | (3,275) | (2,607) |
Net cash provided by (used in) operating activities | (39,600) | (47,221) |
Cash flows from investing activities | ||
Purchase of property and equipment | (22) | (12,170) |
Deposits on property and equipment | 0 | (77) |
Purchase of marketable securities | 0 | (49,347) |
Maturities of marketable securities | 0 | 235,000 |
Settlement of derivative contracts | (144) | 0 |
Net cash provided by (used in) investing activities | (166) | 173,406 |
Cash flows from financing activities | ||
Proceeds from issuance of common stock upon options exercise | 38 | 9 |
Principal payments of tenant improvement allowance payable | 0 | (12) |
Net cash provided by (used in) financing activities | 38 | (3) |
Net increase (decrease) in cash, cash equivalents and restricted cash | (39,728) | 126,182 |
Cash, cash equivalents and restricted cash, at beginning of period | 291,831 | 196,757 |
Cash, cash equivalents and restricted cash, at end of period | 252,103 | 322,939 |
Reconciliation of cash, cash equivalents and restricted cash to consolidated balance sheets | ||
Cash and cash equivalents | 245,919 | 316,615 |
Restricted cash | 6,184 | 6,324 |
Total cash, cash equivalents and restricted cash in consolidated balance sheets | 252,103 | 322,939 |
Supplemental disclosures of non-cash investing and financing information: | ||
Operating lease right-of-use asset obtained in exchange for operating lease liability | (49) | 1,473 |
Purchase of property and equipment under accounts payable and accruals | $ 0 | $ 28,795 |
The Company
The Company | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024, the Company had cash and cash equivalents of $ 245.9 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 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 | 3 Months Ended |
Mar. 31, 2024 | |
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, 2023 and notes thereto, including the Company’s critical accounting policies for accrued research and development, stock-based compensation, and impairment of long-lived assets, the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 28, 2024. 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, 2024, 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 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, stock-based compensation and impairment of long-lived assets. 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 geopolitical conflicts. 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 months ended March 31, 2024, 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, 2023 , 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. In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280), which requires disclosure of incremental segment information on an annual and interim basis, including enhanced disclosures for companies that have a single reportable segment. The amendment is effective for fiscal years beginning after December 15, 2023 and interim periods beginning after December 15, 2024, and early adoption is permitted. The Company is currently assessing the impact of this amendment on its consolidated financial statements and related disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740), which enhances the disclosures required for income taxes in annual consolidated financial statements. The amendment is effective for fiscal years beginning after December 15, 2024, and early adoption is permitted. The Company is currently assessing the impact of this amendment on its consolidated financial statements and related disclosures. |
Accrued and Other Current Liabi
Accrued and Other Current Liabilities | 3 Months Ended |
Mar. 31, 2024 | |
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): March 31, December 31, Accrued salaries and benefits $ 5,681 $ 6,078 Accrued manufacturing and research & development costs 4,812 8,662 Accrued clinical trial and related costs 1,094 2,701 Accrued legal fees and professional fees 225 196 Accrued other liabilities 953 714 Total accrued and other current liabilities $ 12,765 $ 18,351 |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 235,575 $ — $ — $ 235,575 Total $ 235,575 $ — $ — $ 235,575 Fair Value Measurements at December 31, 2023 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 274,466 $ — $ — $ 274,466 Total $ 274,466 $ — $ — $ 274,466 As of March 31, 2024 , 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. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 5. Commitments and Contingencies Leases Palo Alto, California Leases In June 2020, the Company entered into lease agreements for two buildings at 1200 and 1250 Page Mill Road in Palo Alto, California, which are now the Company’s U.S. corporate offices. The facilities are approximately 82,662 square feet and 72,812 square feet, respectively and include office and laboratory space. For 1200 Page Mill Road, the monthly rent during the initial 6.5 -year term will be approximately $ 0.6 million, with annual year-over-year increases of 3 % plus certain operating expenses and taxes and total rent abatement of approximately $ 7.2 million. The Company has an option to extend the lease term for a period of 6.5 years . For 1250 Page Mill Road, the monthly rent during the initial 13 -year term will be approximately $ 0.5 million, with annual year-over-year increases of 3 % plus certain operating expenses and taxes and total rent abatement of approximately $ 6.3 million. The Company has two options to extend the lease term for a period of 5 years each. The Company determined that the renewal options were not reasonably certain at lease inception for the two buildings. The Company executed a $ 10.9 million cash-collateralized letter of credit, which was subsequently reduced to $ 6.2 million as a result of meeting certain reduction requirements specified therein in 2020. The cash collateralizing the letter of credit is classified as restricted cash on the Company’s consolidated balance sheet. The Landlord will provide a tenant improvement allowance of approximately $ 1.2 million for 1200 Page Mill Road and $ 10.6 million for 1250 Page Mill Road. As of March 31, 2024 , the Company utilized $ 10.6 million of the tenant improvement allowance for 1250 Page Mill Road. Under ASC 842, the Company classified these leases as operating leases and recorded right-of-use assets and lease liabilities on the lease commencement date. Switzerland Lease In April 2020, the Company entered into a lease agreement for office and laboratory space at Rottenstrasse 5 in Visp, Switzerland. The space is approximately 1,000 square meters. The initial lease term is 5 years, with automatic renewals every 5 years for a maximum lease term of 15 years. The monthly rent during the initial 5 -year term will be approximately 32.0 thousand Swiss Francs plus certain operating expenses and taxes. Under ASC 842, the Company classified this lease as an operating lease and recorded a right-of-use asset and lease liability on the lease commencement date. 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 events. 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 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). Under ASC 842, the Company classified the lease portion as an operating lease and recorded a right-of-use asset and lease liability on the lease commencement date. The Company determined that the renewal options were not reasonably certain at lease inception. Manufacturing Agreements The Company has entered into service and equipment purchase agreements and manufacturing 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 | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | . Stock-Based Compensation In January 2024 and 2023 , 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 shares in each period, 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, 2023 17,601,466 $ 43.86 7.29 $ 933 Granted — — Exercised ( 8,333 ) $ 4.54 Forfeited or canceled ( 273,057 ) $ 40.76 Outstanding at March 31, 2024 17,320,076 $ 43.93 6.94 $ 2,070 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, 2023 164,817 $ 49.87 Granted — — Vested ( 6,512 ) $ 55.80 Canceled ( 6,589 ) $ 70.63 Unvested at March 31, 2024 151,716 $ 48.71 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 2024 2023 Research and development $ 8,703 $ 14,700 General and administrative 9,706 11,280 Total stock-based compensation $ 18,409 $ 25,980 |
Net Loss per Common Share
Net Loss per Common Share | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
Net Loss per Common Share | 7. 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 March 31, 2024 2023 Outstanding stock options 17,320,076 16,572,661 Unvested restricted shares 151,716 280,979 Total 17,471,792 16,853,640 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
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, 2023 and notes thereto, including the Company’s critical accounting policies for accrued research and development, stock-based compensation, and impairment of long-lived assets, the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 28, 2024. 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, 2024, 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 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, stock-based compensation and impairment of long-lived assets. 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 geopolitical conflicts. 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 months ended March 31, 2024, 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, 2023 , 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. In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280), which requires disclosure of incremental segment information on an annual and interim basis, including enhanced disclosures for companies that have a single reportable segment. The amendment is effective for fiscal years beginning after December 15, 2023 and interim periods beginning after December 15, 2024, and early adoption is permitted. The Company is currently assessing the impact of this amendment on its consolidated financial statements and related disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740), which enhances the disclosures required for income taxes in annual consolidated financial statements. The amendment is effective for fiscal years beginning after December 15, 2024, and early adoption is permitted. The Company is currently assessing the impact of this amendment on its consolidated financial statements and related disclosures. |
Accrued and Other Current Lia_2
Accrued and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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): March 31, December 31, Accrued salaries and benefits $ 5,681 $ 6,078 Accrued manufacturing and research & development costs 4,812 8,662 Accrued clinical trial and related costs 1,094 2,701 Accrued legal fees and professional fees 225 196 Accrued other liabilities 953 714 Total accrued and other current liabilities $ 12,765 $ 18,351 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 235,575 $ — $ — $ 235,575 Total $ 235,575 $ — $ — $ 235,575 Fair Value Measurements at December 31, 2023 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 274,466 $ — $ — $ 274,466 Total $ 274,466 $ — $ — $ 274,466 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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, 2023 17,601,466 $ 43.86 7.29 $ 933 Granted — — Exercised ( 8,333 ) $ 4.54 Forfeited or canceled ( 273,057 ) $ 40.76 Outstanding at March 31, 2024 17,320,076 $ 43.93 6.94 $ 2,070 |
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, 2023 164,817 $ 49.87 Granted — — Vested ( 6,512 ) $ 55.80 Canceled ( 6,589 ) $ 70.63 Unvested at March 31, 2024 151,716 $ 48.71 |
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 2024 2023 Research and development $ 8,703 $ 14,700 General and administrative 9,706 11,280 Total stock-based compensation $ 18,409 $ 25,980 |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024 2023 Outstanding stock options 17,320,076 16,572,661 Unvested restricted shares 151,716 280,979 Total 17,471,792 16,853,640 |
The Company - Additional Inform
The Company - Additional Information (Details) $ in Millions | Mar. 31, 2024 USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Cash, cash equivalents and marketable securities | $ 245.9 |
Accrued and Other Current Lia_3
Accrued and Other Current Liabilities - Schedule of Accrued and Other Current Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Accounts Payable and Accrued Liabilities, Current [Abstract] | ||
Accrued salaries and benefits | $ 5,681 | $ 6,078 |
Accrued manufacturing and research & development costs | 4,812 | 8,662 |
Accrued clinical trial and related costs | 1,094 | 2,701 |
Accrued legal fees and professional fees | 225 | 196 |
Accrued other liabilities | 953 | 714 |
Total accrued and other current liabilities | $ 12,765 | $ 18,351 |
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 | Mar. 31, 2024 | Dec. 31, 2023 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total | $ 235,575 | $ 274,466 |
Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 235,575 | 274,466 |
Fair Value Inputs Level1 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total | 0 | 274,466 |
Fair Value Inputs Level1 [Member] | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 235,575 | 274,466 |
Fair Value Inputs Level 2[Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total | 235,575 | 0 |
Fair Value Inputs Level 2[Member] | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 0 | 0 |
Fair Value Inputs Level3 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total | 0 | 0 |
Fair Value Inputs Level3 [Member] | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | $ 0 | $ 0 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Millions | 1 Months Ended | ||||
Aug. 31, 2020 | Jun. 30, 2020 USD ($) ft² Building | Apr. 30, 2020 CHF (SFr) m² | Mar. 31, 2024 USD ($) | Jul. 01, 2020 USD ($) | |
California | Lease Agreement on June 2020 | |||||
Commitments And Contingencies Disclosure [Line Items] | |||||
Number of buildings leased | Building | 2 | ||||
Cash-collateralized letter of credit | $ 10.9 | $ 6.2 | |||
Rottenstrasse 5 in Visp | Switzerland | Lease Agreement on April 2020 | |||||
Commitments And Contingencies Disclosure [Line Items] | |||||
Lease area | m² | 1,000 | ||||
Initial lease term | 5 years | ||||
Automatic renewal interval | 5 years | ||||
Monthly rent expense | SFr | SFr 32,000 | ||||
Rottenstrasse 5 in Visp | Maximum | Switzerland | Lease Agreement on April 2020 | |||||
Commitments And Contingencies Disclosure [Line Items] | |||||
Lessee, operating lease, term of contract | 15 years | ||||
1200 Page Mill Road in Palo Alto | California | Lease Agreement on June 2020 | |||||
Commitments And Contingencies Disclosure [Line Items] | |||||
Lease area | ft² | 82,662 | ||||
Initial lease term | 6 years 6 months | ||||
Monthly rent expense | $ 0.6 | ||||
Annual rent year-over-year increase percentage | 3% | ||||
Total rent abatement | $ 7.2 | ||||
Lessee operating lease option to extend | 6.5 years | ||||
Tenant improvement allowance | $ 1.2 | ||||
1250 Page Mill Road in Palo Alto | California | Lease Agreement on June 2020 | |||||
Commitments And Contingencies Disclosure [Line Items] | |||||
Lease area | ft² | 72,812 | ||||
Initial lease term | 13 years | ||||
Monthly rent expense | $ 0.5 | ||||
Annual rent year-over-year increase percentage | 3% | ||||
Total rent abatement | $ 6.3 | ||||
Lessee operating lease option to extend | 5 | ||||
Tenant improvement allowance | $ 10.6 | $ 10.6 | |||
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, extended term | 16 years |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - shares | 1 Months Ended | |
Jan. 31, 2024 | Jan. 31, 2023 | |
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 - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Number of Options | ||
Beginning balance | 17,601,466 | |
Granted | 0 | |
Exercised | (8,333) | |
Forfeited or canceled | (273,057) | |
Ending balance | 17,320,076 | 17,601,466 |
Weighted Average Exercise Price | ||
Beginning balance | $ 43.86 | |
Exercised | 4.54 | |
Forfeited or canceled | 40.76 | |
Ending balance | $ 43.93 | $ 43.86 |
Weighted Average Remaining Contractual Term (in years) | ||
Weighted Average Remaining Contractual Term (in years) | 6 years 11 months 8 days | 7 years 3 months 14 days |
Aggregate Intrinsic Value | ||
Aggregate Intrinsic Value | $ 2,070 | $ 933 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Restricted Shares (Details) - Restricted Shares | 3 Months Ended |
Mar. 31, 2024 $ / 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 | 164,817 |
Granted | 0 |
Vested | (6,512) |
Canceled | (6,589) |
Unvested, ending balance | 151,716 |
Weighted Average Grant Date Fair Value | |
Unvested, beginning balance | $ / shares | $ 49.87 |
Vested | $ / shares | 55.8 |
Canceled | $ / shares | 70.63 |
Unvested, ending balance | $ / shares | $ 48.71 |
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 | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | $ 18,409 | $ 25,980 |
Research and Development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | 8,703 | 14,700 |
General and Administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | $ 9,706 | $ 11,280 |
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 | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
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 | 17,471,792 | 16,853,640 |
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 | 17,320,076 | 16,572,661 |
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 | 151,716 | 280,979 |