Protagonist Therapeutics (PTGX) 10-Q7 Nov 242024 Q3 Quarterly reportFinancial data

Company Profile

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2024	Oct. 31, 2024
Document And Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2024
Document Transition Report	false
Securities Act File Number	001-37852
Entity Registrant Name	PROTAGONIST THERAPEUTICS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	98-0505495
Entity Address, Address Line One	7707 Gateway Boulevard, Suite 140
Entity Address, City or Town	Newark
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94560-1160
City Area Code	510
Local Phone Number	474-0170
Title of 12(b) Security	Common Stock
Trading Symbol	PTGX
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Large Accelerated Filer
Entity Small Business	false
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		59,598,018
Entity Central Index Key	0001377121
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q3
Amendment Flag	false

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 131,121	$ 186,727
Marketable securities	337,600	154,890
Receivable from collaboration partner		10,000
Prepaid expenses and other current assets	8,048	3,960
Total current assets	476,769	355,577
Marketable securities - noncurrent	114,560
Property and equipment, net	2,468	1,195
Restricted cash - noncurrent	225	225
Operating lease right-of-use asset	9,835	954
Total assets	603,857	357,951
Current liabilities:
Accounts payable	3,049	772
Payable to collaboration partner		3
Accrued expenses and other payables	20,739	19,358
Deferred revenue	19,696
Income taxes payable	1,049
Operating lease liability	45	1,141
Total current liabilities	44,578	21,274
Deferred revenue - noncurrent	16,509
Operating lease liability - noncurrent	10,855
Total liabilities	71,942	21,274
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.00001 par value, 10,000,000 shares authorized; no shares issued and outstanding
Common stock, $0.00001 par value, 180,000,000 and 90,000,000 shares authorized as of September 30, 2024 and December 31, 2023, respectively; 59,521,903 and 57,708,613 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively	1	1
Additional paid-in capital	1,002,774	952,491
Accumulated other comprehensive income (loss)	1,336	(105)
Accumulated deficit	(472,196)	(615,710)
Total stockholders' equity	531,915	336,677
Total liabilities and stockholders' equity	$ 603,857	$ 357,951

Condensed Consolidated Balanc_2

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2024	Dec. 31, 2023
Consolidated Balance Sheets
Preferred stock, par value	$ 0.00001	$ 0.00001
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	$ 0.00001	$ 0.00001
Common stock, shares authorized	180,000,000	90,000,000
Common stock, shares issued	59,521,903	57,708,613
Common stock, shares outstanding	59,521,903	57,708,613

Condensed Consolidated Statemen

Condensed Consolidated Statements of Operations - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Condensed Consolidated Statements of Operations
License and collaboration revenue	$ 4,675	$ 0	$ 263,795	$ 0
Revenue from Contract with Customer, Product and Service [Extensible Enumeration]	License and Service [Member]	License and Service [Member]	License and Service [Member]	License and Service [Member]
Operating expenses:
Research and development	$ 35,970	$ 30,664	$ 103,224	$ 91,262
General and administrative	10,158	7,662	34,508	25,439
Total operating expenses	46,128	38,326	137,732	116,701
Income (loss) from operations	(41,453)	(38,326)	126,063	(116,701)
Interest income	7,682	4,252	19,462	10,656
Other income (expense), net	141	(31)	219	(245)
Income (loss) before income tax benefit (expense)	(33,630)	(34,105)	145,744	(106,290)
Income tax benefit (expense)	420	0	(2,230)	0
Net income (loss)	$ (33,210)	$ (34,105)	$ 143,514	$ (106,290)
Net income (loss) per share, basic	$ (0.54)	$ (0.58)	$ 2.34	$ (1.91)
Net income (loss) per share, diluted	$ (0.54)	$ (0.58)	$ 2.22	$ (1.91)
Weighted-average shares used to compute net income (loss) per share, basic	61,767,934	59,182,899	61,311,310	55,542,543
Weighted-average shares used to compute net income (loss) per share, diluted	61,767,934	59,182,899	64,611,941	55,542,543

Condensed Consolidated Statem_2

Condensed Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Condensed Consolidated Statements of Comprehensive Income (Loss)
Net income (loss)	$ (33,210)	$ (34,105)	$ 143,514	$ (106,290)
Other comprehensive income (loss):
Unrealized gain (loss) on marketable securities	1,585	28	1,441	(5)
Gain on translation of foreign operations				194
Comprehensive income (loss)	$ (31,625)	$ (34,077)	$ 144,955	$ (106,101)

Condensed Consolidated Statem_3

Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands	Common Stock At-the-market offering	Common Stock Public offerings	Common Stock	Additional Paid-in Capital [Member] At-the-market offering	Additional Paid-in Capital [Member] Public offerings	Additional Paid-in Capital [Member]	Accumulated Other Comprehensive Income (Loss)	Accumulated Deficit	At-the-market offering	Public offerings	Total
Balance, Beginning at Dec. 31, 2022						$ 752,722	$ (359)	$ (536,755)			$ 215,608
Balance, Beginning (in shares) at Dec. 31, 2022			49,339,252
Increase (Decrease) in Stockholders' Equity
Issuance of common stock, net of issuance costs	$ 1			$ 24,301	$ 107,790				$ 24,302	$ 107,790
Issuance of common stock, net of issuance costs (in shares)	1,749,199	5,750,000
Exercise of Warrants in exchange for issuance of Pre-funded Warrants						33,813					33,813
Issuance of common stock under equity incentive and employee stock purchase plans						4,255					4,255
Issuance of common stock under equity incentive and employee stock purchase plans (in shares)			796,240
Shares withheld for net settlement of tax withholding upon vesting of restricted stock units						(769)					(769)
Shares withheld for net settlement of tax withholding upon vesting of restricted stock units (in shares)			(31,963)
Issuance of common stock upon exercise of Warrants						559					559
Issuance of common stock upon exercise of Warrants (in shares)			44,748
Stock-based compensation expense						22,692					22,692
Other comprehensive income (loss)							189				189
Net income (loss)								(106,290)			(106,290)
Balance, Ending at Sep. 30, 2023			$ 1			945,363	(170)	(643,045)			302,149
Balance, Ending (in shares) at Sep. 30, 2023			57,647,476
Balance, Beginning at Jun. 30, 2023			$ 1			903,205	(198)	(608,940)			294,068
Balance, Beginning (in shares) at Jun. 30, 2023			57,494,185
Increase (Decrease) in Stockholders' Equity
Exercise of Warrants in exchange for issuance of Pre-funded Warrants						33,813					33,813
Issuance of common stock under equity incentive and employee stock purchase plans						1,021					1,021
Issuance of common stock under equity incentive and employee stock purchase plans (in shares)			108,543
Issuance of common stock upon exercise of Warrants						559					559
Issuance of common stock upon exercise of Warrants (in shares)			44,748
Stock-based compensation expense						6,765					6,765
Other comprehensive income (loss)							28				28
Net income (loss)								(34,105)			(34,105)
Balance, Ending at Sep. 30, 2023			$ 1			945,363	(170)	(643,045)			302,149
Balance, Ending (in shares) at Sep. 30, 2023			57,647,476
Balance, Beginning at Dec. 31, 2023			$ 1			952,491	(105)	(615,710)			$ 336,677
Balance, Beginning (in shares) at Dec. 31, 2023			57,708,613								57,708,613
Increase (Decrease) in Stockholders' Equity
Issuance of common stock under equity incentive and employee stock purchase plans						22,422					$ 22,422
Issuance of common stock under equity incentive and employee stock purchase plans (in shares)			1,749,094
Shares withheld for net settlement of tax withholding upon vesting of restricted stock units						(600)					$ (600)
Shares withheld for net settlement of tax withholding upon vesting of restricted stock units (in shares)			(20,793)
Issuance of common stock upon exercise of Warrants (in shares)			84,989								84,992
Stock-based compensation expense						28,461					$ 28,461
Other comprehensive income (loss)							1,441				1,441
Net income (loss)								143,514			143,514
Balance, Ending at Sep. 30, 2024			$ 1			1,002,774	1,336	(472,196)			$ 531,915
Balance, Ending (in shares) at Sep. 30, 2024			59,521,903								59,521,903
Balance, Beginning at Jun. 30, 2024			$ 1			980,558	(249)	(438,986)			$ 541,324
Balance, Beginning (in shares) at Jun. 30, 2024			58,762,063
Increase (Decrease) in Stockholders' Equity
Issuance of common stock under equity incentive and employee stock purchase plans						12,051					12,051
Issuance of common stock under equity incentive and employee stock purchase plans (in shares)			759,840
Issuance of common stock upon exercise of Warrants (in shares)			0
Stock-based compensation expense						10,165					10,165
Other comprehensive income (loss)							1,585				1,585
Net income (loss)								(33,210)			(33,210)
Balance, Ending at Sep. 30, 2024			$ 1			$ 1,002,774	$ 1,336	$ (472,196)			$ 531,915
Balance, Ending (in shares) at Sep. 30, 2024			59,521,903								59,521,903

Condensed Consolidated Statem_4

Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Cash Flows from Operating Activities
Net income (loss)	$ 143,514	$ (106,290)
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
Stock-based compensation	28,461	22,692
Operating lease right-of-use asset amortization	1,651	1,751
Depreciation	708	729
Accretion of discount on marketable securities	(6,115)	(3,221)
Other		194
Changes in operating assets and liabilities:
Receivable from collaboration partner	10,000	10
Prepaid expenses and other assets	(4,088)	1,582
Accounts payable	2,272	(2,271)
Payable to collaboration partner	(3)	(66)
Accrued expenses and other payables	1,061	(259)
Income taxes payable	1,049
Deferred revenue	36,205
Operating lease liability	(1,385)	(2,047)
Net cash provided by (used in) operating activities	213,330	(87,196)
Cash Flows from Investing Activities
Purchase of marketable securities	(507,293)	(93,077)
Proceeds from maturities of marketable securities	217,580	115,696
Purchases of property and equipment	(1,045)	(590)
Net cash (used in) provided by investing activities	(290,758)	22,029
Cash Flows from Financing Activities
Proceeds from exercise of Warrants in exchange for issuance of Pre-Funded Warrants		33,813
Proceeds from issuance of common stock upon exercise of Warrants		559
Proceeds from issuance of common stock upon exercise of stock options and purchases under employee stock purchase plan	22,422	4,255
Tax withholding payments related to net settlement of restricted stock units	(600)	(769)
Proceeds from public offering of common stock, net of issuance costs		107,790
Proceeds from at-the-market offering, net of issuance costs		24,302
Net cash provided by financing activities	21,822	169,950
Net increase (decrease) in cash, cash equivalents and restricted cash	(55,606)	104,783
Cash, cash equivalents and restricted cash, beginning of period	186,952	125,969
Cash, cash equivalents and restricted cash, end of period	131,346	230,752
Supplemental Disclosure of Non-Cash Financing and Investing Information:
Right-of-use asset obtained in exchange for lease obligation	10,511
Leasehold improvements obtained under tenant improvement allowance	613
Purchases of property and equipment in accounts payable and accrued liabilities	$ 325	$ 3

Organization and Description of

Organization and Description of Business	9 Months Ended
Organization and Description of Business	Sep. 30, 2024
Organization and Description of Business
Organization and Description of Business	PROTAGONIST THERAPEUTICS, INC. Notes to Unaudited Condensed Consolidated Financial Statements Note 1. Protagonist Therapeutics, Inc. (the “Company”) is a late-stage development biopharmaceutical company with two peptide-based new chemical entities: rusfertide and JNJ-2113. The Company’s Operating Segments Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the Chief Executive Officer, the Company’s chief operating decision maker, in deciding how to allocate resources and assessing performance. Liquidity As of September 30, 2024, the Company had cash, cash equivalents and marketable securities of $583.3 million. The Company has incurred cumulative net losses from inception through September 30, 2024 of $472.2 million. The Company’s ultimate success depends upon the outcome of its research and development and collaboration activities. The Company may incur additional losses in the future as it continues the development of rusfertide through Phase 3 development and a potential NDA filing and invests in its pre-clinical discovery programs and may need to raise additional capital to continue to execute its long-range business plan. Since the Company’s initial public offering in August 2016, it has financed its operations primarily through proceeds from offerings of common stock and payments received under license and collaboration agreements.

Summary of Significant Accounti

Summary of Significant Accounting Policies	9 Months Ended
Summary of Significant Accounting Policies	Sep. 30, 2024
Summary of Significant Accounting Policies
Summary of Significant Accounting Policies	Note 2. Basis of Presentation and Consolidation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”), the instructions to Form 10-Q and Rule 10-01 of Regulation S-X and applicable rules and regulations of the Securities and Exchange Commission (“SEC”) regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP have been condensed or omitted and, accordingly, the condensed consolidated balance sheet as of September 30, 2024 has been derived from the Company’s unaudited consolidated financial statements at that date but does not include all of the information required by GAAP for complete consolidated financial statements. These unaudited interim condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments (consisting of normal recurring adjustments) that are necessary for a fair presentation of the Company’s condensed consolidated financial statements. The results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024 or for any future period. The accompanying unaudited condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K, filed with the SEC on February 27, 2024. Principles of Consolidation The accompanying unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany transactions and balances have been eliminated upon consolidation. Use of Estimates The preparation of the condensed consolidated financial statements in conformity with GAAP requires management to make estimates, assumptions and judgments that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities as of the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, accruals for research and development activities, stock-based compensation, income taxes, marketable securities and leases. Estimates related to revenue recognition include assumptions used to determine standalone selling price utilized to allocate the transaction price between distinct performance obligations, assumptions used to recognize revenue over time for certain performance obligations for which a cost-based input method is used as the measure of progress and estimates of whether contingent consideration should be included in the transaction price at each reporting period. Management bases these estimates on historical and anticipated results, trends, and various other assumptions that the Company believes are reasonable under the circumstances, including assumptions as to forecasted amounts and future events. Actual results may differ materially from these estimates. There has been uncertainty and disruption in the global economy and financial markets due to a number of factors, including geopolitical instability, inflationary pressures, high interest rates, a recessionary environment, domestic and global monetary and fiscal policy and other factors. The Company has taken into consideration any known impacts in its accounting estimates to date and is not aware of any additional specific events or circumstances that would require any additional updates to its estimates or judgments or a revision of the carrying value of its assets or liabilities as of the filing date of this Quarterly Report on Form 10-Q. These estimates may change as new events occur and additional information is obtained. Actual results could differ materially from these estimates under different assumptions or conditions. Cash as Reported in Condensed Consolidated Statements of Cash Flows Cash as reported in the condensed consolidated statements of cash flows includes the aggregate amounts of cash and cash equivalents and the restricted cash as presented on the condensed consolidated balance sheets. Cash as reported in the condensed consolidated statements of cash flows consisted of (in thousands): September 30, 2024 2023 Cash and cash equivalents $ 131,121 $ 230,527 Restricted cash - noncurrent 225 225 Total cash reported on condensed consolidated statements of cash flows $ 131,346 $ 230,752 Stock-Based Compensation Expense The Company has granted stock options, restricted stock units (“RSUs”) and performance share units (“PSUs”). Stock-based compensation expense associated with stock options is based on the estimated grant date fair value using the Black-Scholes valuation model, which requires the use of subjective assumptions related to expected stock price volatility, option term, risk-free interest rate and dividend yield. The Company recognizes compensation expense over the vesting period of the awards that are ultimately expected to vest. Stock-based compensation expense associated with RSUs is based on the fair value of the Company’s common stock on the grant date, which equals the closing market price of the Company’s common stock on the grant date. For RSUs, the Company recognizes compensation expense over the vesting period of the awards that are ultimately expected to vest. PSUs allow the recipients of such awards to earn fully vested shares of the Company’s common stock upon the achievement of pre-established performance objectives. Stock-based compensation expense associated with PSUs is based on the fair value of the Company’s common stock on the grant date, which equals the closing market price of the Company’s common stock on the grant date and is recognized when the performance objective is expected to be achieved. The Company evaluates the probability of achieving the performance criteria on a quarterly basis. The cumulative effect on current and prior periods of a change in the estimated number of PSUs expected to be earned is recognized as compensation expense or as reduction of previously recognized compensation expense in the period of the revised estimate. The Company recognizes forfeitures of stock-based awards as they occur. Total stock-based compensation expense was as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Research and development $ 5,212 $ 3,780 $ 15,597 $ 13,171 General and administrative 4,953 2,985 12,864 9,521 Total stock-based compensation expense $ 10,165 $ 6,765 $ 28,461 $ 22,692 Significant Accounting Policies Collaborative Arrangements The Company analyzes its collaborative arrangements to assess whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards, and therefore are within the scope of Accounting Standards Codification Topic 808 - Collaborative Arrangements Revenue from Contracts with Customers Except as described above, there have been no other material changes to the Company’s significant accounting policies during the nine months ended September 30, 2024, as compared to those disclosed in Note 2. Summary of Significant Accounting Policies included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. Recently Adopted Accounting Pronouncements In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplified accounting for convertible instruments by removing major separation models required under current GAAP. ASU 2020-06 also removed certain settlement conditions that were required for equity-linked contracts to qualify for the derivative scope exception, and it simplified the diluted earnings per share calculation in certain areas. - was effective for the Company beginning on January 1, 2024. The Company adopted ASU 2020-06 effective January 1, 2024. The adoption of this guidance did not have a material impact on the Company’s condensed consolidated Recently Issued Accounting Pronouncements Not Yet Adopted as of September 30, 2024 In November 2023, the FASB issued Accounting Standards Update No. 2023-07 Segment Reporting (Topic 280) – Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which requires public entities to disclose incremental segment information on an annual and interim basis. ASU 2023-07 requires all public entities, including public entities with a single reportable segment, to provide one or more measures of segment profit or loss used by the chief operating decision maker to allocate resources and assess performance. Additionally, the guidance requires disclosures of significant segment expenses and other segment items as well as incremental qualitative disclosures. ASU 2023-07 is effective for the Company for fiscal years beginning on January 1, 2024, and interim periods within fiscal years beginning on January 1, 2025. The Company does not expect the adoption of this guidance to have a material impact on its consolidated financial statements or related disclosures. In December 2023, the FASB issued Accounting Standards Update No. 2023-09 Income Taxes (Topic 740) – Improvements to Income Tax Disclosures (“ASU 2023-09”), which requires public business entities to disclose specific categories in the income tax rate reconciliation annually and provide additional information for reconciling items that meet a qualitative threshold. ASU 2023-09 also requires that entities disclose annually additional information about income taxes paid and disaggregated information for certain items. ASU 2023-09 is effective for the Company beginning on January 1, 2025. The Company does not expect the adoption of this guidance to have a material impact on its financial position, results of operations or cash flows. In November 2024, the FASB issued Accounting Standards Update No. 2024-03 Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses

License and Collaboration Agree

License and Collaboration Agreements	9 Months Ended
License and Collaboration Agreements	Sep. 30, 2024
License and Collaboration Agreement..
License and Collaboration Agreements
License and Collaboration Agreements	Note 3. License and Collaboration Agreements Takeda Collaboration Agreement In January 2024, the Company entered into the Takeda Collaboration Agreement, which became effective in March 2024. Pursuant to the Takeda Collaboration Agreement, the Company and Takeda are jointly developing and commercializing rusfertide and potentially other specified second-generation injectable hepcidin mimetic compounds (the “Licensed Products”) in the United States (the “Profit-Share Territory”). Takeda is solely and exclusively responsible for the development and commercialization of the Licensed Products in all other countries (the “Takeda Territory”). The Company and Takeda share the costs of the development, manufacture and commercialization activities for the Licensed Products in the Profit-Share Territory, provided that (i) the Company leads, and is solely responsible for its costs associated with, completion of the ongoing Phase 3 VERIFY program evaluating rusfertide for the treatment of PV as well as associated U.S. regulatory activities; (ii) Takeda leads, and is solely responsible for its costs associated with, pre-commercialization activities related to rusfertide in the Profit-Share Territory; and (iii) Takeda leads commercialization of rusfertide in the Profit-Share Territory, with the Company holding an option to co-detail. Takeda is solely responsible for all costs for the development, manufacture and commercialization of the Licensed Products in the Takeda Territory. The Company granted Takeda a non-transferable, sublicensable and, except for certain specified exceptions, exclusive license to certain intellectual property of the Company to exercise its rights and perform its obligations under the Takeda Collaboration Agreement. The Company received a one-time, non-refundable upfront payment of $300.0 million in April 2024. In addition, the Company is eligible to receive additional worldwide development, regulatory and commercial milestone payments for rusfertide of up to $330.0 million, and tiered royalties from 10% to 17% on net sales of the Licensed Products in the Takeda Territory. The Company and Takeda also share equally in profits and losses (50% to the Company and 50% to Takeda) for Licensed Products in the Profit-Share Territory. Takeda will book sales of the Licensed Products globally. The Company has the right to opt-out entirely of profit- and loss-sharing in the Profit-Share Territory for rusfertide and all other Licensed Products (the “Full Opt-out Right”) (i) during the 90-day period beginning 120 days after the filing of an NDA with the U.S. Food and Drug Administration (“FDA”) for rusfertide for PV (the “Initial Opt-out Period”); and (ii) for convenience without receipt of the Opt-out Payment (as defined below) (generally following the Initial Opt-out Period). In addition, if the Company does not exercise the Full Opt-out Right, the Company may opt-out of any Licensed Product other than rusfertide on a Licensed Product-by-Licensed Product basis (each, a “Partial Opt-out Right” and either the Full Opt-out Right or a Partial Opt-out right being an “Opt-out Right”). Following the Company’s exercise of an Opt-out Right, the Company has agreed to transition applicable development and commercial activities to Takeda, and Takeda has agreed to assume sole operational and financial responsibility for such activities in the United States. The Takeda Collaboration Agreement provides for aggregate development, regulatory and commercial milestone payments from Takeda to the Company for rusfertide of up to $975 million if the Company exercises the Full Opt-out Right. In addition to these milestone payments, in the event the Company exercises the Full Opt-out Right during the Initial Opt-out Period, the Company will receive: (i) a $200 million payment following its exercise of the Full Opt-out Right; and (ii) an additional $200 million payment following FDA approval of the NDA for rusfertide for PV (together, the “Opt-out Payment”). If the Company exercises an Opt-out Right, Takeda has agreed to pay the Company royalties of 14% to 29% on worldwide net sales of the Licensed Products with respect to which the Company has exercised an Opt-out Right. Upcoming potential development and regulatory milestones under the Takeda Collaboration Agreement include: ● $25.0 million upon successful achievement of the primary endpoint in the Phase 3 VERIFY clinical trial for rusfertide in PV; and ● $50.0 million upon FDA approval of an NDA for rusfertide in PV (or $75.0 million if the Company exercises the Full Opt-out Right). The Company evaluated the Takeda Collaboration Agreement and concluded that it has elements that are within the scope of Topic 606 and Topic 808. As of the effective date of the Takeda Collaboration Agreement, the Company identified two distinct performance obligations: (i) the rusfertide license delivered upon the effectiveness of the Takeda Collaboration Agreement and (ii) certain development services to be provided prior to the Initial Opt-out Period, including the Company’s responsibilities to complete the VERIFY Phase 3 clinical trial in PV and to file an NDA with the FDA upon successful completion of the VERIFY trial and associated manufacturing services. The Company determined that the initial transaction price totaled $300.0 million, comprised of the upfront payment. The Company has excluded any future estimated milestones or royalties from this transaction price to date, all of which are either currently constrained or subject to the sales-and usage-based royalty exception. As part of the Company’s evaluation of this variable consideration constraint, it determined that the potential payments are contingent upon developmental and regulatory milestones that are uncertain and are highly susceptible to factors outside of its control. The Company allocated $254.1 million of the initial transaction price to the license and $45.9 million to the development services based upon the relative standalone selling price of each performance obligation. The estimate of standalone selling price for the license was determined based on discounted cash flows for the expected development and commercialization of rusfertide and includes assumptions for forecasted revenues, development timelines and expenses, discount rates, and probabilities of technical and regulatory success. The estimate of standalone selling price for the development services was determined based on forecasted costs and expenses over the expected development period. For the license of rusfertide, the Company determined that Takeda could benefit from the license at the time the license was granted and therefore, the related performance obligation was satisfied at a point in time. The amount allocated to the license, which represents functional intellectual property that was transferred at a point in time, was satisfied upon transfer of the license to Takeda. The amount allocated to development services will be recognized over time based on a measure of the Company’s efforts toward satisfying the performance obligation relative to the total expected efforts or inputs to satisfy the performance obligation (e.g., costs incurred compared to total budget). The Company recognized $9.7 million of revenue allocated to development services with respect to the period from the effective date of the contract through September 30, 2024. The Company determined that the Takeda Collaboration Agreement met the definition of a collaborative arrangement under Topic 808. Both parties are active participants in directing and carrying out the development of the Licensed Products and both are exposed to the significant risk and rewards related to the commercial success of the Products. If the Company does not exercise an Opt-out Right (“Company Opt-in”), the Company and Takeda would co-detail the Licensed Products in the U.S. and share in the economic results through a profit-sharing structure. The Company determined that development costs subsequent to the Company Opt-in date are within the scope of Topic 808, which does not provide recognition and measurement guidance. As such, the Company determined that Accounting Standards Codification Topic 730 – Research and Development JNJ License and Collaboration Agreement On July 27, 2021, the Company entered into an Amended and Restated License and Collaboration Agreement with JNJ, formerly Janssen Biotech, Inc., which amended and restated the License and Collaboration Agreement, effective July 13, 2017, by and between the Company and JNJ, as amended by the first amendment, effective May 7, 2019 (together, the “JNJ License and Collaboration Agreement”). During the fourth quarter of 2023, the Company earned a $50.0 million milestone payment in connection with the dosing of a third patient in the ICONIC-TOTAL Phase 3 clinical trial of JNJ-2113 in patients with moderate-to-severe psoriasis and a $10.0 million milestone payment upon t The JNJ License and Collaboration Agreement relates to the development, manufacture and commercialization of oral IL-23 receptor antagonist drug candidates and enables JNJ to develop collaboration compounds for multiple indications. Under the JNJ License and Collaboration Agreement, JNJ is required to use commercially reasonable efforts to develop at least one collaboration compound for at least two indications. Upcoming potential development and regulatory milestones include: ● $115.0 million upon a Phase 3 clinical trial for a second-generation compound for any indication meeting its primary clinical endpoint; ● $35.0 million upon the filing of an NDA for a second-generation compound with the FDA; ● $50.0 million upon FDA approval of an NDA for a second-generation compound; and ● $15.0 million upon the dosing of the third patient in a Phase 3 clinical trial for a second-generation compound for a second indication. Pursuant to the agreement, the Company is eligible to receive future sales milestone payments and tiered royalties on net product sales at percentages ranging from 6% to 10%. Revenue Recognition For the three months ended September 30, 2024, the Company recognized license and collaboration revenue of $4.7 million related to the Takeda Collaboration Agreement transaction price for development services provided by the Company during the period based on the cost-based input method. For the nine months ended September 30, 2024, the Company recognized license and collaboration For the three and nine months ended September 30, 2023, no license and collaboration revenue was recognized. The remaining unrecognized transaction price amount of $36.2 million related to the Takeda Collaboration Agreement was recorded as deferred revenue on the Company’s condensed consolidated balance sheet as of September 30, 2024 and will be recognized over time based on a measure of the Company’s efforts toward satisfying the performance obligation relative to the total expected efforts or inputs to satisfy the performance obligation (e.g. costs incurred compared to total budget). For the three months ended September 30, 2024, the Company recognized $4.7 million of revenue that was included in the deferred revenue liability balance at the beginning of the period. For the nine months ended September 30, 2024 and the three and nine months ended September 30, 2023, the Company did not recognize revenue from any amounts included in the deferred revenue liability balance at the beginning of each period. None of the costs to obtain or fulfill the contracts were capitalized.

Fair Value Measurements

Fair Value Measurements	9 Months Ended
Fair Value Measurements	Sep. 30, 2024
Fair Value Measurements
Fair Value Measurements	Note 4. Fair Value Measurements Financial assets and liabilities are recorded at fair value. The accounting guidance for fair value provides a framework for measuring fair value, clarifies the definition of fair value and expands disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows: Level 1 Level 2— Level 3 In determining fair value, the Company utilizes quoted market prices, broker or dealer quotations, or valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value. The following tables present the fair value of the Company’s financial assets determined using the inputs defined above (in thousands): September 30, 2024 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 32,623 $ — $ — $ 32,623 Certificates of deposit — 15,271 — 15,271 U.S. Treasury and agency securities — 241,787 — 241,787 Commercial paper — 169,249 — 169,249 Corporate debt securities — 116,528 — 116,528 Total financial assets $ 32,623 $ 542,835 $ — $ 575,458 December 31, 2023 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 19,212 $ — $ — $ 19,212 Certificates of deposit — 13,004 — 13,004 U.S. Treasury and agency securities — 145,085 — 145,085 Commercial paper — 130,296 — 130,296 Corporate debt securities — 7,672 — 7,672 Total financial assets $ 19,212 $ 296,057 $ — $ 315,269 The Company’s certificates of deposit, U.S. Treasury and agency securities, including U.S. Treasury bills, commercial paper and corporate debt securities are classified as Level 2 as they were valued based upon quoted market prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques, for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. The carrying amount of the Company’s remaining financial assets and liabilities, including cash, receivables and payables, approximates their fair value due to their short-term nature.

Cash Equivalents and Marketable

Cash Equivalents and Marketable Securities	9 Months Ended
Cash Equivalents and Marketable Securities	Sep. 30, 2024
Cash Equivalents and Marketable Securities
Cash Equivalents and Marketable Securities	Note 5. Cash Equivalents and Marketable Securities Cash equivalents and marketable securities consisted of the following (in thousands): September 30, 2024 Amortized Gross Unrealized Cost Gains Losses Fair Value Money market funds $ 32,623 $ — $ — $ 32,623 Certificates of deposit 15,222 49 — 15,271 U.S. Treasury and agency securities 240,780 1,048 (41) 241,787 Commercial paper 169,156 97 (4) 169,249 Corporate debt securities 116,230 310 (12) 116,528 Total cash equivalents and marketable securities $ 574,011 $ 1,504 $ (57) $ 575,458 Classified as: Cash equivalents $ 123,298 Marketable securities - current 337,600 Marketable securities - noncurrent 114,560 Total cash equivalents and marketable securities $ 575,458 December 31, 2023 Amortized Gross Unrealized Cost Gains Losses Fair Value Money market funds $ 19,212 $ — $ — $ 19,212 Certificates of deposit 12,998 6 — 13,004 U.S. Treasury and agency securities 145,024 63 (2) 145,085 Commercial paper 130,351 5 (60) 130,296 Corporate debt securities 7,678 — (6) 7,672 Total cash equivalents and marketable securities $ 315,263 $ 74 $ (68) $ 315,269 Classified as: Cash equivalents $ 160,379 Marketable securities - current 154,890 Total cash equivalents and marketable securities $ 315,269 All of the Company’s marketable securities are classified as available-for-sale. Current marketable securities of $337.6 million and $154.9 million held as of September 30, 2024 and December 31, 2023, respectively, had contractual maturities of less than one year. Noncurrent marketable securities of $114.6 million held as of September 30, 2024 had contractual maturities of at least one year but no more than two years. The Company does not intend to sell its securities that are in an unrealized loss position, and it is not more likely than not that the Company will be required to sell its securities before recovery of their amortized cost basis, which may be at maturity. There were no material realized gains or realized losses on marketable securities for the periods presented. The Company evaluated securities with unrealized losses to determine whether such losses, if any, were due to credit-related factors and determined that there were no credit-related losses to be recognized as of September 30, 2024.

Balance Sheet Components

Balance Sheet Components	9 Months Ended
Balance Sheet Components	Sep. 30, 2024
Balance Sheet Components
Balance Sheet Components	Note 6. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): September 30, December 31, 2024 2023 Prepaid clinical and research related expenses $ 3,775 $ 649 Prepaid insurance 217 1,410 Prepaid licenses 599 529 Other prepaid expenses 788 1,040 Other receivable 2,669 332 Prepaid expenses and other current assets $ 8,048 $ 3,960 Property and Equipment, Net Property and equipment, net consisted of the following (in thousands): September 30, December 31, 2024 2023 Laboratory equipment $ 6,224 $ 5,323 Furniture and computer equipment 1,403 1,143 Leasehold improvements 1,769 963 Total property and equipment 9,396 7,429 Accumulated depreciation (6,928) (6,234) Property and equipment, net $ 2,468 $ 1,195 Accrued Expenses and Other Payables Accrued expenses and other payables consisted of the following (in thousands): September 30, December 31, 2024 2023 Accrued clinical and research related expenses $ 11,619 $ 11,841 Accrued employee related expenses 8,155 6,786 Accrued professional service fees 846 632 Other 119 99 Total accrued expenses and other payables $ 20,739 $ 19,358

Lease

Lease	9 Months Ended
Lease	Sep. 30, 2024
Lease
Lease	Note 7. Lease The Company applies Accounting Standards Codification Topic 842 -- Leases On May 6, 2024, the Company amended its facility lease agreement dated as of March 6, 2017 (the “Amended Lease”) to extend the lease term for its existing office and laboratory space from one Balance sheet information related to the Company’s operating lease consisted of the following (dollars in thousands): September 30, December 31, Operating Leases: 2024 2023 Operating lease right-of-use asset $ 9,835 $ 954 Operating lease liability - current $ 45 $ 1,141 Operating lease liability - noncurrent 10,855 — Total operating lease liabilities $ 10,900 $ 1,141 Weighted-average remaining lease term (years) 5.2 0.4 Weighted-average discount rate 5.7% 10.4% The tenant improvement allowance under the Amended Lease represents a fixed amount that the Company is reasonably certain to use. As such, it is reflected in the determination of the operating lease liability as of the lease commencement date. Other information related to the Company’s operating lease consisted of the following (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Operating lease cost $ 757 $ 584 $ 2,079 $ 1,751 Short-term rent expense — — 51 — Less: Sublease income — (35) (34) (114) Total lease expense $ 757 $ 549 $ 2,096 $ 1,637 Supplemental cash flow information consisted of the following (in thousands): Nine Months Ended September 30, 2024 2023 Operating cash flow used by operating leases $ (1,385) $ (2,047) New operating lease asset obtained in exchange for operating lease liability $ (10,511) $ — Future minimum lease payments required under lease obligations as of September 30, 2024 consisted of the following (in thousands): Year Ending December 31: Amount Remainder of 2024 $ 223 2025 1,121 2026 2,786 2027 2,881 2028 2,983 Thereafter 2,825 Total future minimum lease payments 12,819 Less: Imputed interest (1,919) Present value of lease liabilities $ 10,900

Stockholders' Equity

Stockholders' Equity	9 Months Ended
Stockholders' Equity	Sep. 30, 2024
Stockholders' Equity
Stockholders' Equity	Note 8. Stockholders’ Equity Shares of Common Stock Authorized for Issuance At the Company’s 2024 Annual Meeting of Stockholders held on June 20, 2024, the Company’s stockholders approved an amendment to the Company’s Amended and Restated Certificate of Incorporation (the “Certificate of Incorporation”) to increase the number of authorized shares of the Company’s common stock from 90,000,000 to 180,000,000, which also has the effect of increasing the total number of authorized shares from 100,000,000 to 190,000,000 (the “Amendment”). On June 21, 2024, the Company filed a Certificate of Amendment to the Certificate of Incorporation with the Secretary of State of the State of Delaware to effect the Amendment, which became effective immediately upon such filing. Public Offering In April 2023, the Company completed an underwritten public offering of 5,000,000 shares of its common stock at a public offering price of $20.00 per share and issued an additional 750,000 shares of common stock at a price of $20.00 per share following the underwriters’ exercise of their option to purchase additional shares. Net proceeds, after deducting underwriting commissions and offering costs paid by the Company, were $107.8 million. ATM Offering In August 2022, the Company entered into an Open Market Sale Agreement SM , pursuant to which the Company may offer and sell up to $100.0 million shares of common stock from time to time in “at-the-market” offerings (the “2022 ATM Facility”). There were no sales of the Company’s common stock under the 2022 ATM Facility during the three and nine months ended September 30, 2024. During the nine months ended September 30, 2023, the Company sold 1,749,199 shares of its common stock under the 2022 ATM Facility for net proceeds of $24.3 million, after deducting issuance costs. There were no sales of the Company’s common stock under the 2022 ATM Facility during the three months September 30, 2023. Pre-Funded Warrants In August 2018, the Company entered into a Securities Purchase Agreement with certain accredited investors (each, an “Investor” and, collectively, the “Investors”), pursuant to which the Company sold an aggregate of 2,750,000 shares of its common stock at a price of $8.00 per share, for aggregate net proceeds of $21.7 million, after deducting offering expenses payable by the Company. In a concurrent private placement, the Company issued the Investors warrants to purchase an aggregate of 2,750,000 shares of its common stock (each, a “Warrant” and, collectively, the “Warrants”). Warrants to purchase 1,375,000 shares of the Company’s common stock had an exercise price of $10.00 per share and Warrants to purchase 1,375,000 shares of the Company’s common stock had an exercise price of $15.00 per share. In August 2023, prior to the expiration of the Warrants, the Company entered into certain agreements with the Investors and their affiliates under which the Company agreed to allow the Warrants to be exercised in exchange for pre-funded warrants representing the same number of Warrant Shares underlying the Warrants with an exercise price of $0.001 per share (the “Pre-Funded Warrants”). Subsequent to the execution of the agreements and prior to the expiration of the Warrants, all outstanding Warrants were exercised for gross proceeds of $34.4 million in exchange for 44,748 shares of the Company’s common stock and Pre-Funded Warrants to purchase 2,705,252 shares of common stock (subject to adjustment in the event of any stock dividends and splits, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Pre-Funded Warrants) with an exercise price of $0.001 per share. The Pre-Funded Warrants will expire upon the day they are exercised in full. The Pre-Funded Warrants are exercisable at any time prior to expiration except that the Pre-Funded Warrants cannot be exercised by the Investors if, after giving effect thereto, the Investors would beneficially own more than 9.99% of the Company’s common stock, subject to certain exceptions. The common stock and Pre-Funded Warrants met the criteria for equity classification and the net proceeds from the transaction were recorded as a credit to additional paid-in capital. In accordance with Accounting Standards Codification Topic 260, Earnings Per Share

Income Taxes

Income Taxes	9 Months Ended
Income Taxes	Sep. 30, 2024
Income Taxes
Income Taxes	Note 9. Income Taxes The Company recorded an income tax benefit of $0.4 million and income tax expense of $2.2 million for the three and nine months ended September 30, 2024, respectively. No income tax provision was recorded for the three and nine months ended September 30, 2023. The difference in tax expense as compared to the prior year was primarily due to taxable income for the nine months ended September 30, 2024 resulting from the recognition of revenue in connection with the Takeda Collaboration Agreement. The tax provision for the three and nine months ended September 30, 2024 was determined using an estimated annual effective tax rate, adjusted for discrete items, if any. Based on the available objective evidence during the three and nine months ended September 30, 2024, the Company believes it is more likely than not that its net deferred tax assets may not be realized. The primary difference between the effective tax rate and the statutory tax rate relates to the Company’s change in valuation allowance.

Net Income (Loss) per Share

Net Income (Loss) per Share	9 Months Ended
Net Income (Loss) per Share	Sep. 30, 2024
Net Income (Loss) per Share
Net Income (Loss) per Share	Note 10. Net Income (Loss) per Share The computation of basic net income (loss) per share of common stock is based on the weighted-average number of shares of common stock outstanding during each period. The computation of diluted net income (loss) per share of common stock is based on the weighted-average number of shares of common stock outstanding during the period plus, when their effect is dilutive, incremental shares consisting of shares subject to stock options, RSUs, PSUs, the Company’s employee stock purchase plan (“ESPP”), and warrants. In accordance with Accounting Standards Codification Topic 260, Earnings Per Share In periods when the Company has net income, the dilutive effect of all potentially outstanding shares is computed using the treasury stock method. In periods in which the Company reports a net loss, all common stock equivalents are deemed anti-dilutive such that basic net loss per share of common stock and diluted net loss per share of common stock are equal. The following table reconciles the numerator and denominator used to calculate diluted net income (loss) per share of common stock Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Numerator: Net income (loss) $ (33,210) $ (34,105) $ 143,514 $ (106,290) Denominator: Weighted-average shares of common stock, basic 61,767,934 59,182,899 61,311,310 55,542,543 Dilutive effect of common stock equivalents — — 3,300,631 — Weighted-average shares of common stock, dilutive 61,767,934 59,182,899 64,611,941 55,542,543 Net income (loss) per share of common stock Basic net income (loss) per share of common stock $ (0.54) $ (0.58) $ 2.34 $ (1.91) Diluted net income (loss) per share of common stock $ (0.54) $ (0.58) $ 2.22 $ (1.91) Approximately 9.2 million potentially dilutive shares of common stock (consisting of shares subject to outstanding stock options, RSUs, PSUs, and under the ESPP) were excluded from the diluted net loss per share of common stock computation for the three months ended September 30, 2024 due to the Company’s net loss for the period. Approximately 3.2 million potentially dilutive shares of common stock (consisting of shares subject to outstanding stock options, RSUs, and under the ESPP) were excluded from the diluted net income per share of common stock computations for the nine months ended September 30, 2024 because their effect was anti-dilutive. Approximately 8.9 million potentially dilutive shares of common stock (consisting of shares subject to outstanding stock options, RSUs, PSUs, under the ESPP and warrants) were excluded from the diluted net loss per share of common stock computations for the three and nine months ended September 30, 2023 due to the Company’s net losses for these periods.

Pay vs Performance Disclosure

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (33,210)	$ (34,105)	$ 143,514	$ (106,290)

Insider Trading Arrangements

Insider Trading Arrangements - Dinesh V. Patel	3 Months Ended
Insider Trading Arrangements - Dinesh V. Patel	Sep. 30, 2024
Trading Arrangements, by Individual
Material Terms of Trading Arrangement	On July 15, 2024 , Dinesh V. Patel , our Chief Executive Officer and a member of our Board , terminated a trading plan intended to satisfy Rule 10b5-1(c) which he adopted on April 22, 2024 to sell up to 300,000 shares of the Company’s common stock through July 31, 2025, or such earlier date when all transactions under the trading plan were completed, subject to certain conditions. During the fiscal quarter ended September 30, 2024, no other director or Section 16 officer adopted or terminated any Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement (in each case as defined in Item 408(a) of Regulation S-K).
Name	Dinesh V. Patel
Title	Chief Executive Officer and a member of our Board
Rule 10b5-1 Arrangement Terminated	true
Termination Date	July 15, 2024

Summary of Significant Accoun_2

Summary of Significant Accounting Policies (Policies)	9 Months Ended
Summary of Significant Accounting Policies (Policies)	Sep. 30, 2024
Summary of Significant Accounting Policies
Basis of Presentation and Consolidation	Basis of Presentation and Consolidation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”), the instructions to Form 10-Q and Rule 10-01 of Regulation S-X and applicable rules and regulations of the Securities and Exchange Commission (“SEC”) regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP have been condensed or omitted and, accordingly, the condensed consolidated balance sheet as of September 30, 2024 has been derived from the Company’s unaudited consolidated financial statements at that date but does not include all of the information required by GAAP for complete consolidated financial statements. These unaudited interim condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments (consisting of normal recurring adjustments) that are necessary for a fair presentation of the Company’s condensed consolidated financial statements. The results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024 or for any future period. The accompanying unaudited condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K, filed with the SEC on February 27, 2024.
Principles of Consolidation	Principles of Consolidation The accompanying unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany transactions and balances have been eliminated upon consolidation.
Use of Estimates	Use of Estimates The preparation of the condensed consolidated financial statements in conformity with GAAP requires management to make estimates, assumptions and judgments that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities as of the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, accruals for research and development activities, stock-based compensation, income taxes, marketable securities and leases. Estimates related to revenue recognition include assumptions used to determine standalone selling price utilized to allocate the transaction price between distinct performance obligations, assumptions used to recognize revenue over time for certain performance obligations for which a cost-based input method is used as the measure of progress and estimates of whether contingent consideration should be included in the transaction price at each reporting period. Management bases these estimates on historical and anticipated results, trends, and various other assumptions that the Company believes are reasonable under the circumstances, including assumptions as to forecasted amounts and future events. Actual results may differ materially from these estimates. There has been uncertainty and disruption in the global economy and financial markets due to a number of factors, including geopolitical instability, inflationary pressures, high interest rates, a recessionary environment, domestic and global monetary and fiscal policy and other factors. The Company has taken into consideration any known impacts in its accounting estimates to date and is not aware of any additional specific events or circumstances that would require any additional updates to its estimates or judgments or a revision of the carrying value of its assets or liabilities as of the filing date of this Quarterly Report on Form 10-Q. These estimates may change as new events occur and additional information is obtained. Actual results could differ materially from these estimates under different assumptions or conditions.
Cash as Reported in Condensed Consolidated Statements of Cash Flows	Cash as Reported in Condensed Consolidated Statements of Cash Flows Cash as reported in the condensed consolidated statements of cash flows includes the aggregate amounts of cash and cash equivalents and the restricted cash as presented on the condensed consolidated balance sheets. Cash as reported in the condensed consolidated statements of cash flows consisted of (in thousands): September 30, 2024 2023 Cash and cash equivalents $ 131,121 $ 230,527 Restricted cash - noncurrent 225 225 Total cash reported on condensed consolidated statements of cash flows $ 131,346 $ 230,752
Stock-based Compensation Expense	Stock-Based Compensation Expense The Company has granted stock options, restricted stock units (“RSUs”) and performance share units (“PSUs”). Stock-based compensation expense associated with stock options is based on the estimated grant date fair value using the Black-Scholes valuation model, which requires the use of subjective assumptions related to expected stock price volatility, option term, risk-free interest rate and dividend yield. The Company recognizes compensation expense over the vesting period of the awards that are ultimately expected to vest. Stock-based compensation expense associated with RSUs is based on the fair value of the Company’s common stock on the grant date, which equals the closing market price of the Company’s common stock on the grant date. For RSUs, the Company recognizes compensation expense over the vesting period of the awards that are ultimately expected to vest. PSUs allow the recipients of such awards to earn fully vested shares of the Company’s common stock upon the achievement of pre-established performance objectives. Stock-based compensation expense associated with PSUs is based on the fair value of the Company’s common stock on the grant date, which equals the closing market price of the Company’s common stock on the grant date and is recognized when the performance objective is expected to be achieved. The Company evaluates the probability of achieving the performance criteria on a quarterly basis. The cumulative effect on current and prior periods of a change in the estimated number of PSUs expected to be earned is recognized as compensation expense or as reduction of previously recognized compensation expense in the period of the revised estimate. The Company recognizes forfeitures of stock-based awards as they occur. Total stock-based compensation expense was as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Research and development $ 5,212 $ 3,780 $ 15,597 $ 13,171 General and administrative 4,953 2,985 12,864 9,521 Total stock-based compensation expense $ 10,165 $ 6,765 $ 28,461 $ 22,692
Collaborative Arrangements	Collaborative Arrangements The Company analyzes its collaborative arrangements to assess whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards, and therefore are within the scope of Accounting Standards Codification Topic 808 - Collaborative Arrangements Revenue from Contracts with Customers Except as described above, there have been no other material changes to the Company’s significant accounting policies during the nine months ended September 30, 2024, as compared to those disclosed in Note 2. Summary of Significant Accounting Policies included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.
Recently Adopted Accounting Pronouncement	Recently Adopted Accounting Pronouncements In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplified accounting for convertible instruments by removing major separation models required under current GAAP. ASU 2020-06 also removed certain settlement conditions that were required for equity-linked contracts to qualify for the derivative scope exception, and it simplified the diluted earnings per share calculation in certain areas. - was effective for the Company beginning on January 1, 2024. The Company adopted ASU 2020-06 effective January 1, 2024. The adoption of this guidance did not have a material impact on the Company’s condensed consolidated Recently Issued Accounting Pronouncements Not Yet Adopted as of September 30, 2024 In November 2023, the FASB issued Accounting Standards Update No. 2023-07 Segment Reporting (Topic 280) – Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which requires public entities to disclose incremental segment information on an annual and interim basis. ASU 2023-07 requires all public entities, including public entities with a single reportable segment, to provide one or more measures of segment profit or loss used by the chief operating decision maker to allocate resources and assess performance. Additionally, the guidance requires disclosures of significant segment expenses and other segment items as well as incremental qualitative disclosures. ASU 2023-07 is effective for the Company for fiscal years beginning on January 1, 2024, and interim periods within fiscal years beginning on January 1, 2025. The Company does not expect the adoption of this guidance to have a material impact on its consolidated financial statements or related disclosures. In December 2023, the FASB issued Accounting Standards Update No. 2023-09 Income Taxes (Topic 740) – Improvements to Income Tax Disclosures (“ASU 2023-09”), which requires public business entities to disclose specific categories in the income tax rate reconciliation annually and provide additional information for reconciling items that meet a qualitative threshold. ASU 2023-09 also requires that entities disclose annually additional information about income taxes paid and disaggregated information for certain items. ASU 2023-09 is effective for the Company beginning on January 1, 2025. The Company does not expect the adoption of this guidance to have a material impact on its financial position, results of operations or cash flows. In November 2024, the FASB issued Accounting Standards Update No. 2024-03 Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses

Summary of Significant Accoun_3

Summary of Significant Accounting Policies (Tables)	9 Months Ended
Summary of Significant Accounting Policies (Tables)	Sep. 30, 2024
Summary of Significant Accounting Policies
Schedule of cash as reported in the condensed consolidated statements of cash flows	Cash as reported in the condensed consolidated statements of cash flows consisted of (in thousands): September 30, 2024 2023 Cash and cash equivalents $ 131,121 $ 230,527 Restricted cash - noncurrent 225 225 Total cash reported on condensed consolidated statements of cash flows $ 131,346 $ 230,752
Schedule of stock-based compensation expense	Total stock-based compensation expense was as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Research and development $ 5,212 $ 3,780 $ 15,597 $ 13,171 General and administrative 4,953 2,985 12,864 9,521 Total stock-based compensation expense $ 10,165 $ 6,765 $ 28,461 $ 22,692

Fair Value Measurements (Tables

Fair Value Measurements (Tables)	9 Months Ended
Fair Value Measurements (Tables)	Sep. 30, 2024
Fair Value Measurements
Schedule of fair value of financial assets	The following tables present the fair value of the Company’s financial assets determined using the inputs defined above (in thousands): September 30, 2024 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 32,623 $ — $ — $ 32,623 Certificates of deposit — 15,271 — 15,271 U.S. Treasury and agency securities — 241,787 — 241,787 Commercial paper — 169,249 — 169,249 Corporate debt securities — 116,528 — 116,528 Total financial assets $ 32,623 $ 542,835 $ — $ 575,458 December 31, 2023 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 19,212 $ — $ — $ 19,212 Certificates of deposit — 13,004 — 13,004 U.S. Treasury and agency securities — 145,085 — 145,085 Commercial paper — 130,296 — 130,296 Corporate debt securities — 7,672 — 7,672 Total financial assets $ 19,212 $ 296,057 $ — $ 315,269

Cash Equivalents and Marketab_2

Cash Equivalents and Marketable Securities (Tables)	9 Months Ended
Cash Equivalents and Marketable Securities (Tables)	Sep. 30, 2024
Cash Equivalents and Marketable Securities
Schedule of cash equivalents and marketable securities	Cash equivalents and marketable securities consisted of the following (in thousands): September 30, 2024 Amortized Gross Unrealized Cost Gains Losses Fair Value Money market funds $ 32,623 $ — $ — $ 32,623 Certificates of deposit 15,222 49 — 15,271 U.S. Treasury and agency securities 240,780 1,048 (41) 241,787 Commercial paper 169,156 97 (4) 169,249 Corporate debt securities 116,230 310 (12) 116,528 Total cash equivalents and marketable securities $ 574,011 $ 1,504 $ (57) $ 575,458 Classified as: Cash equivalents $ 123,298 Marketable securities - current 337,600 Marketable securities - noncurrent 114,560 Total cash equivalents and marketable securities $ 575,458 December 31, 2023 Amortized Gross Unrealized Cost Gains Losses Fair Value Money market funds $ 19,212 $ — $ — $ 19,212 Certificates of deposit 12,998 6 — 13,004 U.S. Treasury and agency securities 145,024 63 (2) 145,085 Commercial paper 130,351 5 (60) 130,296 Corporate debt securities 7,678 — (6) 7,672 Total cash equivalents and marketable securities $ 315,263 $ 74 $ (68) $ 315,269 Classified as: Cash equivalents $ 160,379 Marketable securities - current 154,890 Total cash equivalents and marketable securities $ 315,269

Balance Sheet Components (Table

Balance Sheet Components (Tables)	9 Months Ended
Balance Sheet Components (Tables)	Sep. 30, 2024
Balance Sheet Components
Summary of prepaid expenses and other current assets	Prepaid expenses and other current assets consisted of the following (in thousands): September 30, December 31, 2024 2023 Prepaid clinical and research related expenses $ 3,775 $ 649 Prepaid insurance 217 1,410 Prepaid licenses 599 529 Other prepaid expenses 788 1,040 Other receivable 2,669 332 Prepaid expenses and other current assets $ 8,048 $ 3,960
Summary of property and equipment net	Property and equipment, net consisted of the following (in thousands): September 30, December 31, 2024 2023 Laboratory equipment $ 6,224 $ 5,323 Furniture and computer equipment 1,403 1,143 Leasehold improvements 1,769 963 Total property and equipment 9,396 7,429 Accumulated depreciation (6,928) (6,234) Property and equipment, net $ 2,468 $ 1,195
Schedule of accrued expenses and other payables	Accrued expenses and other payables consisted of the following (in thousands): September 30, December 31, 2024 2023 Accrued clinical and research related expenses $ 11,619 $ 11,841 Accrued employee related expenses 8,155 6,786 Accrued professional service fees 846 632 Other 119 99 Total accrued expenses and other payables $ 20,739 $ 19,358

Lease (Tables)

Lease (Tables)	9 Months Ended
Lease (Tables)	Sep. 30, 2024
Lease
Schedule of balance sheet information	Balance sheet information related to the Company’s operating lease consisted of the following (dollars in thousands): September 30, December 31, Operating Leases: 2024 2023 Operating lease right-of-use asset $ 9,835 $ 954 Operating lease liability - current $ 45 $ 1,141 Operating lease liability - noncurrent 10,855 — Total operating lease liabilities $ 10,900 $ 1,141 Weighted-average remaining lease term (years) 5.2 0.4 Weighted-average discount rate 5.7% 10.4%
Schedule of lease cost information	Other information related to the Company’s operating lease consisted of the following (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Operating lease cost $ 757 $ 584 $ 2,079 $ 1,751 Short-term rent expense — — 51 — Less: Sublease income — (35) (34) (114) Total lease expense $ 757 $ 549 $ 2,096 $ 1,637
Schedule of cash flow information	Supplemental cash flow information consisted of the following (in thousands): Nine Months Ended September 30, 2024 2023 Operating cash flow used by operating leases $ (1,385) $ (2,047) New operating lease asset obtained in exchange for operating lease liability $ (10,511) $ —
Schedule of minimum lease payments and lease liabilities	Future minimum lease payments required under lease obligations as of September 30, 2024 consisted of the following (in thousands): Year Ending December 31: Amount Remainder of 2024 $ 223 2025 1,121 2026 2,786 2027 2,881 2028 2,983 Thereafter 2,825 Total future minimum lease payments 12,819 Less: Imputed interest (1,919) Present value of lease liabilities $ 10,900

Net Income (Loss) per Share (Ta

Net Income (Loss) per Share (Tables)	9 Months Ended
Net Income (Loss) per Share (Tables)	Sep. 30, 2024
Net Income (Loss) per Share
Schedule of computation of the basic and diluted net income (loss) per share attributable to common stockholders	The following table reconciles the numerator and denominator used to calculate diluted net income (loss) per share of common stock Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Numerator: Net income (loss) $ (33,210) $ (34,105) $ 143,514 $ (106,290) Denominator: Weighted-average shares of common stock, basic 61,767,934 59,182,899 61,311,310 55,542,543 Dilutive effect of common stock equivalents — — 3,300,631 — Weighted-average shares of common stock, dilutive 61,767,934 59,182,899 64,611,941 55,542,543 Net income (loss) per share of common stock Basic net income (loss) per share of common stock $ (0.54) $ (0.58) $ 2.34 $ (1.91) Diluted net income (loss) per share of common stock $ (0.54) $ (0.58) $ 2.22 $ (1.91)

Organization and Description _2

Organization and Description of Business - Liquidity (Details) $ in Thousands	9 Months Ended
	Sep. 30, 2024 USD ($) segment	Dec. 31, 2023 USD ($)
Organization and Description of Business
Number of operating segments \| segment	1
Net losses from operations since inception
Cash, cash equivalents and marketable securities	$ 583,300
Accumulated deficit	$ (472,196)	$ (615,710)

Summary of Significant Accoun_4

Summary of Significant Accounting Policies - Restricted Cash and Cash and Cash Equivalents (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023	Sep. 30, 2023	Dec. 31, 2022
Aggregate amounts of cash and cash equivalents and the restricted cash
Cash and cash equivalents	$ 131,121	$ 186,727	$ 230,527
Restricted cash - noncurrent	225	225	225
Total cash reported on condensed consolidated statements of cash flows	$ 131,346	$ 186,952	$ 230,752	$ 125,969

Summary of Significant Accoun_5

Summary of Significant Accounting Policies - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Total stock-based compensation expense	$ 10,165	$ 6,765	$ 28,461	$ 22,692
Research and Development Expense [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Total stock-based compensation expense	5,212	3,780	15,597	13,171
General and Administrative Expense [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Total stock-based compensation expense	$ 4,953	$ 2,985	$ 12,864	$ 9,521

License and Collaboration Agr_2

License and Collaboration Agreements (Details) - USD ($)	1 Months Ended				3 Months Ended			9 Months Ended
License and Collaboration Agreements (Details) - USD ($)	Apr. 30, 2024	Mar. 31, 2024	Jan. 31, 2024	Jun. 30, 2022	Sep. 30, 2024	Dec. 31, 2023	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
License and collaboration revenue					$ 4,675,000		$ 0	$ 263,795,000	$ 0
Revenue from Contract with Customer, Product and Service [Extensible Enumeration]					License And Service		License And Service	License And Service	License And Service
Recognized revenue from deferred revenue contract liability					$ 4,700,000		$ 0	$ 0	$ 0
Contract with customer, deferred revenue contract liability					36,200,000			36,200,000
Janssen \| Restated Agreement \| Iconic Total Phase
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
License and collaboration revenue						$ 50,000,000
Janssen \| Restated Agreement \| Anthem Phase Two B Member
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
License and collaboration revenue						$ 10,000,000
Janssen \| Restated Agreement \| Minimum [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Percentage of royalties on net product sales				6%
Janssen \| Restated Agreement \| Maximum [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Percentage of royalties on net product sales				10%
Janssen \| Restated Agreement \| License And Service \| Phase 3 clinical trial for a second-generation compound for any indication
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upcoming potential development milestones					115,000,000			115,000,000
Janssen \| Restated Agreement \| License And Service \| Filing of New Drug Application ("NDA") for second-generation compound with the U.S. Food and Drug Administration
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upcoming potential development milestones					35,000,000			35,000,000
Janssen \| Restated Agreement \| License And Service \| FDA approval of NDA for second-generation compound
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upcoming potential development milestones					50,000,000			50,000,000
Janssen \| Restated Agreement \| License And Service \| Dosing Of Third Patient In Phase 3 Clinical Trial For Second Generation Compound For A Second Indication [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upcoming potential development milestones					15,000,000			15,000,000
Janssen \| License and collaboration agreement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Proceeds from Milestone Payments								172,500,000
Takeda Pharmaceuticals \| License And Service
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Profit (loss) share on U.S. profits and losses	50%
Takeda Pharmaceuticals \| Development Services
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront payment			$ 45,900,000
Revenue recognized								9,700,000
Takeda Pharmaceuticals \| License and collaboration agreement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Non-refundable upfront payment	$ 300,000,000
Final transaction price			300,000,000
Revenue recognized		$ 254,100,000			$ 4,700,000			$ 263,800,000
Takeda Pharmaceuticals \| License and collaboration agreement \| Phase Three Clinical Trial For Rusfertide In PV [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upcoming potential development and regulatory milestone payments receivable			25,000,000
Takeda Pharmaceuticals \| License and collaboration agreement \| Food And Drug Administration Approval Of New Drug Application For Rusfertide In PV [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upcoming potential development and regulatory milestone payments receivable			50,000,000
Takeda Pharmaceuticals \| License and collaboration agreement \| Food And Drug Administration Approval Of New Drug Application For Rusfertide In PV [Member] \| Exercise of Full Opt-out Right [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upcoming potential development and regulatory milestone payments receivable			$ 75,000,000
Takeda Pharmaceuticals \| License and collaboration agreement \| Minimum [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Percentage of royalties on ex-U.S. net sales	10%		14%
Takeda Pharmaceuticals \| License and collaboration agreement \| Maximum [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Collaborative arrangement, milestone payment, eligible to receive	$ 330,000,000
Additional payment eligible to receive from a collaborative arrangement			$ 200,000,000
Percentage of royalties on ex-U.S. net sales	17%		29%
Takeda Pharmaceuticals \| License and collaboration agreement \| Maximum [Member] \| Exercise of Full Opt-out Right [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Collaborative arrangement, milestone payment, eligible to receive			$ 975,000,000
Takeda Pharmaceuticals \| License and collaboration agreement \| Maximum [Member] \| Exercise of Full Opt-out Right During The Initial Opt-out Period (Member)
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Collaborative arrangement, milestone payment, eligible to receive			200,000,000
Takeda Pharmaceuticals \| License and collaboration agreement \| License and Maintenance
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront payment			$ 254,100,000

Fair Value Measurements (Detail

Fair Value Measurements (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total financial assets	$ 575,458	$ 315,269
Money Market Funds [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total financial assets	32,623	19,212
Certificates of deposit
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total financial assets	15,271	13,004
U.S. Treasury and agency securities
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total financial assets	241,787	145,085
Commercial Paper [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total financial assets	169,249	130,296
Corporate Debt Securities [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total financial assets	116,528	7,672
Fair Value, Inputs, Level 1 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total financial assets	32,623	19,212
Fair Value, Inputs, Level 1 [Member] \| Money Market Funds [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total financial assets	32,623	19,212
Fair Value, Inputs, Level 2 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total financial assets	542,835	296,057
Fair Value, Inputs, Level 2 [Member] \| Certificates of deposit
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total financial assets	15,271	13,004
Fair Value, Inputs, Level 2 [Member] \| U.S. Treasury and agency securities
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total financial assets	241,787	145,085
Fair Value, Inputs, Level 2 [Member] \| Commercial Paper [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total financial assets	169,249	130,296
Fair Value, Inputs, Level 2 [Member] \| Corporate Debt Securities [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total financial assets	$ 116,528	$ 7,672

Cash Equivalents and Marketab_3

Cash Equivalents and Marketable Securities - Cash Equivalents and Marketable Securities (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Cash Equivalents and Marketable Securities
Total cash equivalents and marketable securities, Amortized Cost	$ 574,011	$ 315,263
Total cash equivalents and marketable securities, Gross Unrealized Gains	1,504	74
Total cash equivalents and marketable securities, Gross Unrealized Losses	(57)	(68)
Total cash equivalents and marketable securities, Fair Value	575,458	315,269
U.S. Treasury and agency securities
Cash Equivalents and Marketable Securities
Total cash equivalents and marketable securities, Amortized Cost	240,780	145,024
Total cash equivalents and marketable securities, Gross Unrealized Gains	1,048	63
Total cash equivalents and marketable securities, Gross Unrealized Losses	(41)	(2)
Total cash equivalents and marketable securities, Fair Value	241,787	145,085
Corporate Debt Securities [Member]
Cash Equivalents and Marketable Securities
Total cash equivalents and marketable securities, Amortized Cost	116,230	7,678
Total cash equivalents and marketable securities, Gross Unrealized Gains	310
Total cash equivalents and marketable securities, Gross Unrealized Losses	(12)	(6)
Total cash equivalents and marketable securities, Fair Value	116,528	7,672
Money Market Funds [Member]
Cash Equivalents and Marketable Securities
Total cash equivalents and marketable securities, Amortized Cost	32,623	19,212
Total cash equivalents and marketable securities, Fair Value	32,623	19,212
Certificates of deposit
Cash Equivalents and Marketable Securities
Total cash equivalents and marketable securities, Amortized Cost	15,222	12,998
Total cash equivalents and marketable securities, Gross Unrealized Gains	49	6
Total cash equivalents and marketable securities, Fair Value	15,271	13,004
Commercial Paper [Member]
Cash Equivalents and Marketable Securities
Total cash equivalents and marketable securities, Amortized Cost	169,156	130,351
Total cash equivalents and marketable securities, Gross Unrealized Gains	97	5
Total cash equivalents and marketable securities, Gross Unrealized Losses	(4)	(60)
Total cash equivalents and marketable securities, Fair Value	$ 169,249	$ 130,296

Cash Equivalents and Marketab_4

Cash Equivalents and Marketable Securities - Classification of Cash Equivalents and Marketable Securities (Details) - USD ($) $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2024	Dec. 31, 2023
Classified as:
Cash equivalents	$ 123,298	$ 160,379
Marketable securities - current	337,600	154,890
Marketable securities - noncurrent	114,560
Total cash equivalents and marketable securities	$ 575,458	$ 315,269
Contractual maturities
Maximum period of current contractual maturities	1 year	1 year
Minimum period of noncurrent contractual maturities	1 year
Maximum period of Noncurrent contractual maturities	2 years
Realized Gain (loss)	$ 0	$ 0
Credit-related losses to be recognized	$ 0

Balance Sheet Components - Prep

Balance Sheet Components - Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Prepaid Expense and Other Assets, Current [Abstract]
Prepaid clinical and research related expenses	$ 3,775	$ 649
Prepaid insurance	217	1,410
Prepaid licenses	599	529
Other prepaid expenses	788	1,040
Other receivable	2,669	332
Prepaid expenses and other current assets	$ 8,048	$ 3,960

Balance Sheet Components - Prop

Balance Sheet Components - Property and Equipment, Net (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Property and Equipment
Total property and equipment	$ 9,396	$ 7,429
Accumulated depreciation	(6,928)	(6,234)
Property and equipment, net	2,468	1,195
Laboratory equipment
Property and Equipment
Total property and equipment	6,224	5,323
Furniture and computer equipment
Property and Equipment
Total property and equipment	1,403	1,143
Leasehold improvements
Property and Equipment
Total property and equipment	$ 1,769	$ 963

Balance Sheet Components - Accr

Balance Sheet Components - Accrued Expenses and Other Payables (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Accrued Expenses and Other Payables
Accrued clinical and research related expenses	$ 11,619	$ 11,841
Accrued employee related expenses	8,155	6,786
Accrued professional service fees	846	632
Other	119	99
Total accrued expenses and other payables	$ 20,739	$ 19,358

Lease - Agreement (Details)

Lease - Agreement (Details) $ in Thousands	Sep. 30, 2024 USD ($)	May 06, 2024 USD ($) ft²	May 05, 2024	Dec. 31, 2023 USD ($)
Lease
Operating lease, improvement allowance		$ 1,800
Operating lease right-of-use asset	$ 9,835	$ 10,500		$ 954
Second Amendment
Lease
Operating lease, term of contract		66 months	1 year
Area of land \| ft²		17,698

Lease - Supplemental balance sh

Lease - Supplemental balance sheet information (Details) - USD ($) $ in Thousands	Sep. 30, 2024	May 06, 2024	Dec. 31, 2023
Operating Leases:
Operating lease right-of-use asset	$ 9,835	$ 10,500	$ 954
Operating lease liability - current	45		1,141
Operating lease liability - noncurrent	10,855
Present value of lease liabilities	$ 10,900		$ 1,141

Lease - Weighted average lease

Lease - Weighted average lease term and discount rate (Details)	Sep. 30, 2024	Dec. 31, 2023
Lease
Weighted-average remaining lease term (years)	5 years 2 months 12 days	4 months 24 days
Weighted-average discount rate	5.70%	10.40%

Lease - Lease cost information

Lease - Lease cost information (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Lease
Operating lease cost	$ 757	$ 584	$ 2,079	$ 1,751
Short-term rent expense			51
Less: Sublease income		(35)	(34)	(114)
Total lease expense	$ 757	$ 549	$ 2,096	$ 1,637

Lease - Supplemental cash flow

Lease - Supplemental cash flow information (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Lease
Operating cash flow used by operating leases	$ (1,385)	$ (2,047)
New operating lease asset obtained in exchange for operating lease liability	$ (10,511)

Lease - Future lease payments r

Lease - Future lease payments required under lease obligations (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Minimum lease payments:
Remainder of 2024	$ 223
2025	1,121
2026	2,786
2027	2,881
2028	2,983
Thereafter	2,825
Total future minimum lease payments	12,819
Less: Imputed interest	(1,919)
Present value of lease liabilities	$ 10,900	$ 1,141

Stockholders' Equity (Details)

Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands	1 Months Ended				3 Months Ended		9 Months Ended
	Aug. 31, 2023	Apr. 30, 2023	Aug. 31, 2022	Aug. 31, 2018	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Jun. 20, 2024	Jun. 19, 2024	Dec. 31, 2023
Stock transactions
Common stock, shares authorized					180,000,000		180,000,000		180,000,000	90,000,000	90,000,000
Shares authorized									190,000,000	100,000,000
Warrants issued to purchase common stock, number of shares	2,705,252				2,620,260		2,620,260
Exercise Price (per share)	$ 0.001
Gross proceeds form exercise of warrants						$ 33,813		$ 33,813
Proceeds from exercise of Warrants in exchange for issuance of Pre-Funded Warrants	$ 34,400							33,813
Minimum percentage of common stock held by investors for not exercise of warrants	9.99%
Issuance of common stock upon exercise of Warrants (in shares)	44,748						84,992
Number of shares issued upon exercise of warrants	44,748						84,992
Proceeds from public offering of common stock, net of issuance costs								$ 107,790
2022 Sales Agreement
Stock transactions
Common stock issued (in shares)					0	0	0	1,749,199
Maximum aggregate offering price			$ 100,000
Aggregate net proceeds								$ 24,300
Underwritten public offering
Stock transactions
Net proceeds from sale of common stock		$ 107,800
Common stock issued (in shares)		5,000,000
Common stock issued, price per share		$ 20
Over-Allotment Option
Stock transactions
Common stock issued (in shares)		750,000
Common stock issued, price per share		$ 20
Common Stock [Member]
Stock transactions
Warrants issued to purchase common stock, number of shares						0		0
Issuance of common stock upon exercise of Warrants (in shares)					0	44,748	84,989	44,748
Number of shares issued upon exercise of warrants					0	44,748	84,989	44,748
Investors \| Private Placement [Member]
Stock transactions
Aggregate gross proceeds				$ 21,700
Investors \| Common Stock [Member] \| Private Placement [Member]
Stock transactions
Warrants issued to purchase common stock, number of shares				2,750,000
Common stock issued (in shares)				2,750,000
Common stock issued, price per share				$ 8
$10.00 per share \| Common Stock [Member] \| Private Placement [Member]
Stock transactions
Warrants to purchase common stock (in shares)				1,375,000
Exercise Price (per share)				$ 10
$15.00 per share \| Common Stock [Member] \| Private Placement [Member]
Stock transactions
Warrants to purchase common stock (in shares)				1,375,000
Exercise Price (per share)				$ 15

Income Taxes (Details)

Income Taxes (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
Income Taxes (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Income Taxes
Provision for income taxes	$ (420)	$ 0	$ 2,230	$ 0

Net Income (Loss) per Share (De

Net Income (Loss) per Share (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Aug. 31, 2023
Numerator:
Net income (loss)	$ (33,210)	$ (34,105)	$ 143,514	$ (106,290)
Denominator:
Weighted-average shares of common stock, basic	61,767,934	59,182,899	61,311,310	55,542,543
Dilutive effect of common stock equivalents			3,300,631
Weighted-average shares of common stock, dilutive	61,767,934	59,182,899	64,611,941	55,542,543
Basic net income (loss) per share of common stock	$ (0.54)	$ (0.58)	$ 2.34	$ (1.91)
Diluted net income (loss) per share of common stock	$ (0.54)	$ (0.58)	$ 2.22	$ (1.91)
Anti-dilutive securities (in shares)	9,200,000	8,900,000	3,200,000	8,900,000
Warrants issued to purchase common stock, number of shares	2,620,260		2,620,260		2,705,252