Kodiak Sciences (KOD) 10-Q 14 Nov 24 2024 Q3 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2024	Oct. 31, 2024
Cover [Abstract]
Amendment Flag	false
Document Type	10-Q
Document Quarterly Report	true
Document Transition Report	false
Entity Common Stock, Shares Outstanding		52,623,774
Document Period End Date	Sep. 30, 2024
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q3
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 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

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets (unaudited) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 197,864	$ 285,507
Prepaid expenses and other current assets	4,629	3,802
Total current assets	202,493	289,309
Restricted cash	6,184	6,324
Property and equipment, net	106,688	120,482
Operating lease right-of-use asset	48,564	54,541
Other assets	8,740	8,716
Total assets	372,669	479,372
Current liabilities:
Accounts payable	3,292	13,608
Accrued and other current liabilities	10,572	18,351
Operating lease liability	10,196	9,770
Total current liabilities	24,060	41,729
Operating lease liability, net of current portion	63,239	71,862
Liability related to sale of future royalties	100,000	100,000
Total liabilities	187,299	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 September 30, 2024 and December 31, 2023, respectively	0	0
Common stock, $0.0001 par value, 490,000,000 shares authorized at September 30, 2024 and December 31, 2023; 52,623,087 and 52,508,602 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively	5	5
Additional paid-in capital	1,469,998	1,418,307
Accumulated deficit	(1,284,633)	(1,152,531)
Total stockholders’ equity	185,370	265,781
Total liabilities and stockholders’ equity	$ 372,669	$ 479,372

Condensed Consolidated Balanc_2

Condensed Consolidated Balance Sheets (Parenthetical) (unaudited) - $ / shares	Sep. 30, 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	52,623,087	52,508,602
Common stock, shares outstanding	52,623,087	52,508,602

Condensed Consolidated Statemen

Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Operating expenses
Research and development	$ 31,878	$ 36,188	$ 94,323	$ 159,669
General and administrative	14,754	18,312	46,347	54,278
Total operating expenses	46,632	54,500	140,670	213,947
Loss from operations	(46,632)	(54,500)	(140,670)	(213,947)
Interest income	2,711	4,536	9,018	12,836
Interest expense	0	(5)	0	(13)
Other income (expense), net	(25)	(38)	(450)	149
Net loss	$ (43,946)	$ (50,007)	$ (132,102)	$ (200,975)
Net loss per common share, basic	$ (0.84)	$ (0.95)	$ (2.51)	$ (3.84)
Net loss per common share, diluted	$ (0.84)	$ (0.95)	$ (2.51)	$ (3.84)
Weighted-average shares of common stock outstanding used in computing net loss per common share, Basic	52,616,183	52,455,620	52,560,489	52,391,083
Weighted-average shares of common stock outstanding used in computing net loss per common share, Diluted	52,616,183	52,455,620	52,560,489	52,391,083
Other comprehensive income (loss)
Change in unrealized gains (losses) related to available-for-sale debt securities, net of tax	$ 0	$ 0	$ 0	$ 1,307
Total other comprehensive income (loss)	0	0	0	1,307
Comprehensive loss	$ (43,946)	$ (50,007)	$ (132,102)	$ (199,668)

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 (loss)	1,211			1,211
Stock-based compensation expense	25,980		25,980
Net Income (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 income (loss)	1,307
Net Income (Loss)	(200,975)
Ending Balance at Sep. 30, 2023	302,417	$ 5	1,395,427		(1,093,015)
Ending balance, shares at Sep. 30, 2023		52,467,291
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
Issuance of common stock pursuant to employee stock purchase plan	131		131
Issuance of common stock pursuant to employee stock purchase plan, shares		25,840
Other comprehensive income (loss)	96			96
Stock-based compensation expense	25,801		25,801
Net Income (Loss)	(80,188)				(80,188)
Ending Balance at Jun. 30, 2023	338,478	$ 5	1,381,481		(1,043,008)
Ending balance, shares at Jun. 30, 2023		52,453,163
Issuance of common stock upon vesting of restricted stock units, shares		14,128
Other comprehensive income (loss)	0
Stock-based compensation expense	13,946		13,946
Net Income (Loss)	(50,007)				(50,007)
Ending Balance at Sep. 30, 2023	302,417	$ 5	1,395,427		(1,093,015)
Ending balance, shares at Sep. 30, 2023		52,467,291
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
Stock-based compensation expense	18,409		18,409
Net Income (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
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
Other comprehensive income (loss)	0
Net Income (Loss)	(132,102)
Ending Balance at Sep. 30, 2024	185,370	$ 5	1,469,998		(1,284,633)
Ending balance, shares at Sep. 30, 2024		52,623,087
Beginning Balance at Mar. 31, 2024	241,189	$ 5	1,436,754	$ 0	(1,195,570)
Beginning balance, shares at Mar. 31, 2024		52,523,447
Issuance of common stock upon vesting of restricted stock units, shares		64,476
Issuance of common stock pursuant to employee stock purchase plan	59		59
Issuance of common stock pursuant to employee stock purchase plan, shares		26,806
Stock-based compensation expense	18,375		18,375
Net Income (Loss)	(45,117)				(45,117)
Ending Balance at Jun. 30, 2024	214,506	$ 5	1,455,188		(1,240,687)
Ending balance, shares at Jun. 30, 2024		52,614,729
Issuance of common stock upon vesting of restricted stock units, shares		8,358
Other comprehensive income (loss)	0
Stock-based compensation expense	14,810		14,810
Net Income (Loss)	(43,946)				(43,946)
Ending Balance at Sep. 30, 2024	$ 185,370	$ 5	$ 1,469,998		$ (1,284,633)
Ending balance, shares at Sep. 30, 2024		52,623,087

Condensed Consolidated Statem_3

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Cash flows from operating activities
Net Income (Loss)	$ (132,102)	$ (200,975)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
Depreciation	14,084	13,572
Stock-based compensation	51,594	65,727
Net amortization (accretion) of premium (discount) on marketable securities	0	(846)
Settlement of derivative contracts	355	(314)
Amortization of operating lease right-of-use asset	5,940	5,711
Amortization of issuance costs	0	4
Changes in assets and liabilities:
Prepaid expenses and other current assets	(827)	6,994
Other assets	(24)	410
Accounts payable	(10,330)	3,114
Accrued and other current liabilities	(7,779)	(8,263)
Operating lease liability	(8,160)	(7,078)
Net cash provided by (used in) operating activities	(87,249)	(121,944)
Cash flows from investing activities
Purchase of property and equipment	(251)	(13,866)
Deposits on property and equipment	(25)	(77)
Purchase of marketable securities	0	(49,347)
Maturities of marketable securities	0	340,000
Settlement of derivative contracts	(355)	314
Net cash provided by (used in) investing activities	(631)	277,024
Cash flows from financing activities
Proceeds from issuance of common stock upon options exercise	38	60
Proceeds from issuance of common stock pursuant to employee stock purchase plans	59	131
Principal payments of tenant improvement allowance payable	0	(36)
Net cash provided by (used in) financing activities	97	155
Net increase (decrease) in cash, cash equivalents and restricted cash	(87,783)	155,235
Cash, cash equivalents and restricted cash, at beginning of period	291,831	196,757
Cash, cash equivalents and restricted cash, at end of period	204,048	351,992
Reconciliation of cash, cash equivalents and restricted cash to consolidated balance sheets
Cash and cash equivalents	197,864	345,668
Restricted cash	6,184	6,324
Total cash, cash equivalents and restricted cash in consolidated balance sheets	204,048	351,992
Supplemental disclosures of non-cash investing and financing information:
Operating lease right-of-use asset obtained in exchange for operating lease liability	(49)	2,668
Purchase of property and equipment under accounts payable and accruals	$ 14	$ 27,465

Pay vs Performance Disclosure

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (43,946)	$ (45,117)	$ (43,039)	$ (50,007)	$ (80,188)	$ (70,780)	$ (132,102)	$ (200,975)

Insider Trading Arrangements

Insider Trading Arrangements	3 Months Ended
	Sep. 30, 2024
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

The Company

The Company	9 Months Ended
	Sep. 30, 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 a broad spectrum of 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 September 30, 2024, the Company had cash and cash equivalents of $ 197.9 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. The Company plans to raise additional funding based on the status of its clinical trials and projected cash flows. While the Company has been able to raise multiple rounds of financing, there can be no assurance that such financing will be available on terms which are favorable or at all.

Summary of Significant Accounti

Summary of Significant Accounting Policies	9 Months Ended
	Sep. 30, 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 and nine months ended September 30, 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	9 Months Ended
	Sep. 30, 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): September 30, December 31, Accrued salaries and benefits $ 5,037 $ 6,078 Accrued manufacturing and research & development costs 2,626 8,662 Accrued clinical trial and related costs 2,137 2,701 Accrued legal fees and professional fees 429 196 Accrued other liabilities 343 714 Total accrued and other current liabilities $ 10,572 $ 18,351

Fair Value Measurements

Fair Value Measurements	9 Months Ended
	Sep. 30, 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 September 30, 2024 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 194,728 $ — $ — $ 194,728 Total $ 194,728 $ — $ — $ 194,728 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 September 30, 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	9 Months Ended
	Sep. 30, 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. 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. 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. 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. 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. 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	9 Months Ended
	Sep. 30, 2024
Share-Based Payment Arrangement [Abstract]
Stock-Based Compensation	6. 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 4,173,150 $ 2.56 Exercised ( 8,333 ) $ 4.54 Forfeited or canceled ( 1,105,760 ) $ 31.29 Outstanding at September 30, 2024 20,660,523 $ 36.21 7.10 $ 1,190 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 64,200 $ 3.02 Vested ( 79,346 ) $ 60.15 Canceled ( 27,322 ) $ 44.73 Unvested at September 30, 2024 122,349 $ 19.77 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 Nine Months Ended 2024 2023 2024 2023 Research and development $ 6,295 $ 2,733 $ 23,936 $ 32,093 General and administrative 8,515 11,213 27,658 33,634 Total stock-based compensation $ 14,810 $ 13,946 $ 51,594 $ 65,727

Net Loss per Common Share

Net Loss per Common Share	9 Months Ended
	Sep. 30, 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 September 30, 2024 2023 Outstanding stock options 20,660,523 18,629,117 Unvested restricted shares 122,349 186,267 Total 20,782,872 18,815,384

Summary of Significant Accoun_2

Summary of Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 30, 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 and nine months ended September 30, 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)	9 Months Ended
	Sep. 30, 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): September 30, December 31, Accrued salaries and benefits $ 5,037 $ 6,078 Accrued manufacturing and research & development costs 2,626 8,662 Accrued clinical trial and related costs 2,137 2,701 Accrued legal fees and professional fees 429 196 Accrued other liabilities 343 714 Total accrued and other current liabilities $ 10,572 $ 18,351

Fair Value Measurements (Tables

Fair Value Measurements (Tables)	9 Months Ended
	Sep. 30, 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 September 30, 2024 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 194,728 $ — $ — $ 194,728 Total $ 194,728 $ — $ — $ 194,728 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)	9 Months Ended
	Sep. 30, 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 4,173,150 $ 2.56 Exercised ( 8,333 ) $ 4.54 Forfeited or canceled ( 1,105,760 ) $ 31.29 Outstanding at September 30, 2024 20,660,523 $ 36.21 7.10 $ 1,190
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 64,200 $ 3.02 Vested ( 79,346 ) $ 60.15 Canceled ( 27,322 ) $ 44.73 Unvested at September 30, 2024 122,349 $ 19.77
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 Nine Months Ended 2024 2023 2024 2023 Research and development $ 6,295 $ 2,733 $ 23,936 $ 32,093 General and administrative 8,515 11,213 27,658 33,634 Total stock-based compensation $ 14,810 $ 13,946 $ 51,594 $ 65,727

Net Loss per Common Share (Tabl

Net Loss per Common Share (Tables)	9 Months Ended
	Sep. 30, 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 September 30, 2024 2023 Outstanding stock options 20,660,523 18,629,117 Unvested restricted shares 122,349 186,267 Total 20,782,872 18,815,384

The Company - Additional Inform

The Company - Additional Information (Details) $ in Millions	Sep. 30, 2024 USD ($)
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Cash, cash equivalents and marketable securities	$ 197.9

Accrued and Other Current Lia_3

Accrued and Other Current Liabilities - Schedule of Accrued and Other Current Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Accounts Payable and Accrued Liabilities, Current [Abstract]
Accrued salaries and benefits	$ 5,037	$ 6,078
Accrued manufacturing and research & development costs	2,626	8,662
Accrued clinical trial and related costs	2,137	2,701
Accrued legal fees and professional fees	429	196
Accrued other liabilities	343	714
Total accrued and other current liabilities	$ 10,572	$ 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	Sep. 30, 2024	Dec. 31, 2023
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Total	$ 194,728	$ 274,466
Money Market Funds
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Cash equivalents	194,728	274,466
Fair Value Inputs Level1 [Member]
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Total	194,728	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	194,728	274,466
Fair Value Inputs Level 2[Member]
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Total	0	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

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	9 Months Ended	12 Months Ended
	Sep. 30, 2024	Dec. 31, 2023
Number of Options
Beginning balance	17,601,466
Granted	4,173,150
Exercised	(8,333)
Forfeited or canceled	(1,105,760)
Ending balance	20,660,523	17,601,466
Weighted Average Exercise Price
Beginning balance	$ 43.86
Granted	2.56
Exercised	4.54
Forfeited or canceled	31.29
Ending balance	$ 36.21	$ 43.86
Weighted Average Remaining Contractual Term (in years)
Weighted Average Remaining Contractual Term (in years)	7 years 1 month 6 days	7 years 3 months 14 days
Aggregate Intrinsic Value
Aggregate Intrinsic Value Beginning balance	$ 933
Aggregate Intrinsic Value ending balance	$ 1,190	$ 933

Stock-Based Compensation - Su_2

Stock-Based Compensation - Summary of Restricted Shares (Details) - Restricted Shares	9 Months Ended
	Sep. 30, 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 | shares	164,817
Granted | shares	64,200
Vested | shares	(79,346)
Canceled | shares	(27,322)
Unvested, ending balance | shares	122,349
Weighted Average Grant Date Fair Value
Unvested, beginning balance | $ / shares	$ 49.87
Granted | $ / shares	3.02
Vested | $ / shares	60.15
Canceled | $ / shares	44.73
Unvested, ending balance | $ / shares	$ 19.77

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		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Total stock-based compensation	$ 14,810	$ 13,946	$ 51,594	$ 65,727
Research and Development
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Total stock-based compensation	6,295	2,733	23,936	32,093
General and Administrative
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Total stock-based compensation	$ 8,515	$ 11,213	$ 27,658	$ 33,634

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	9 Months Ended
	Sep. 30, 2024	Sep. 30, 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	20,782,872	18,815,384
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	20,660,523	18,629,117
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	122,349	186,267