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Accrued Expenses and Other Current Liabilities - Components of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2025	Dec. 31, 2024
Accrued Expenses and Other Current Liabilities [Line Items]
Total accrued expenses and other current liabilities	$ 20,423	$ 14,665
External Research and Development Expenses
Accrued Expenses and Other Current Liabilities [Line Items]
Total accrued expenses and other current liabilities	12,574	7,181
Personnel-related Expenses
Accrued Expenses and Other Current Liabilities [Line Items]
Total accrued expenses and other current liabilities	6,085	5,793
Professional Fees
Accrued Expenses and Other Current Liabilities [Line Items]
Total accrued expenses and other current liabilities	961	1,255
Deferred Revenue
Accrued Expenses and Other Current Liabilities [Line Items]
Total accrued expenses and other current liabilities	259
Other
Accrued Expenses and Other Current Liabilities [Line Items]
Total accrued expenses and other current liabilities	$ 544	$ 436

Commitments and Contingencies

9 Months Ended

Sep. 30, 2025

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

7. Commitments and Contingencies

Operating Leases

As of September 30, 2025 and December 31, 2024, the Company had four and two operating leases, respectively. Of the four operating leases as of September 30, 2025, three are leases in which the Company was the lessee for office space. The remaining operating lease was acquired in connection with the Conversion Event and includes office, manufacturing, and warehouse space. As of September 30, 2025, the leases have varying terms expiring between 2026 and 2030. The Company had no finance leases as of September 30, 2025 and December 31, 2024.

The components of lease expense for the periods ended September 30, 2025 and 2024 were as follows (in thousands):


	Three Months Ended September 30,						Nine Months Ended September 30,
	2025			2024			2025			2024
Lease cost
Operating lease cost	$	377		$	77		$	384		$	173
Total lease cost	$	377		$	77		$	384		$	173
Other information
Operating lease right-of-use asset obtained in exchange for new operating lease liabilities	$	—		$	—		$	859		$	—
Cash paid for amounts included in the measurement of lease liabilities, included in operating cash flows	$	222		$	60		$	383		$	163
Weighted-average remaining lease term		4.22			1.41			4.22			1.41
Weighted-average discount rate		6.87	%		1.63	%		6.87	%		1.63	%

Maturities of lease liabilities as of September 30, 2025 were as follows (in thousands):


2025	$	291
2026		1,162
2027		1,137
2028		1,116
2029		1,039
Thereafter		164
Total lease payment		4,909
Less: amount representing imputed interest		(668	)
Total future minimum lease obligations	$	4,241

Legal Proceedings

A liability for loss contingencies arising from claims, assessments, litigation, fines, penalties, and other sources is recorded in the condensed consolidated financial statements if it is determined that it is probable that a loss has been incurred, and that the amount (or range) of the loss can be reasonably estimated.

On March 4, 2024, ANI Pharmaceuticals, Inc. (ANI) filed a complaint against the Company in the Superior Court of the State of Delaware seeking (i) a declaratory judgment that a provision in an assignment and technology transfer agreement between the Company and ANI, dated November 15, 2010 (the ANI Agreement), obligates the Company to pay ANI a royalty on certain “net sales” of cretostimogene, and (ii) compensatory damages alleging the Company was unjustly enriched by obtaining the benefit of certain non-patent assets under the ANI Agreement without paying adequate consideration to ANI. On July 16, 2025, the Superior Court granted the Company’s motion for summary judgment with respect to ANI’s request for a declaratory judgment to receive royalty payments from the potential sale of cretostimogene but denied the Company’s motion for summary judgment with respect to ANI’s unjust enrichment claim. On July 29, 2025, a jury entered a verdict in favor of the Company, unanimously rejecting all of ANI's claims for unjust enrichment damages. As a result, the Company will not owe ANI a future royalty of 5% on commercial sales of cretostimogene, no damages have been awarded to ANI, and there are no further payments due to ANI under the ANI Agreement. The Company will continue to vigorously defend any post-trial motions and appeals brought by ANI.

Indemnification

In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners, and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with officers and members of its board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. As of September 30, 2025, the Company had not experienced any losses related to these indemnification obligations, and no claims with respect thereto were outstanding.

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2025	Dec. 31, 2024
Current assets:
Cash and cash equivalents	$ 45,145	$ 257,068
Marketable securities	635,118	484,930
Inventory	1,501	0
Accounts receivable, net	515	0
Prepaid expenses and other current assets	13,511	12,212
Total current assets	695,790	754,210
Property and equipment, net	15,329	272
Operating lease right-of-use assets	4,203	221
Intangible assets, net	1,672	0
Goodwill	12,805	0
Other assets	114	94
Total assets	729,913	754,797
Current liabilities:
Accounts payable	9,193	6,517
Operating lease liabilities, current portion	912	186
Accrued expenses and other current liabilities	20,423	14,665
Total current liabilities	30,528	21,368
Long-term debt	3,000	0
Operating lease liabilities, net of current portion	3,329	52
Deferred tax liability	1,609	0
Other liabilities	3,804	0
Total liabilities	42,270	21,420
Commitments and contingencies
Stockholders' equity:
Common stock, $0.0001 par value per share; 700,000,000 and 700,000,000 shares authorized as of September 30, 2025 and December 31, 2024, respectively; 78,277,452 and 76,154,783 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively	8	8
Additional paid-in capital	1,025,302	951,350
Accumulated deficit	(337,667)	(217,981)
Total stockholders' equity	687,643	733,377
Total liabilities and stockholders' equity	$ 729,913	$ 754,797

Segment Disclosures - Additional Information (Details)	9 Months Ended
Segment Disclosures - Additional Information (Details)	Sep. 30, 2025 Segment
Segment Reporting [Abstract]
Number of operating segments	1
Segment Reporting, CODM, Individual Title and Position or Group Name [Extensible Enumeration]	srt:ChiefExecutiveOfficerMember
Segment Reporting, CODM, Profit (Loss) Measure, How Used, Description	The CODM uses consolidated net income (loss) to assess financial performance and allocate resources. The CODM does not review assets in evaluating the results of the single segment and therefore, such information is not presented.

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2025	Dec. 31, 2024
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	700,000,000	700,000,000
Common stock, shares issued	78,277,452	76,154,783
Common Stock, shares outstanding	78,277,452	76,154,783

Employee Stock Purchase Plan - Additional Information (Details) - USD ($) $ in Millions		3 Months Ended		9 Months Ended
	Jan. 11, 2024	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2025	Sep. 30, 2024
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of shares issued under ESPP		12,973,148		12,973,148
ESPP
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of shares issued under ESPP	812,242	713,703		713,703
Percentage of sale of common stock at fair value	85.00%
Percentage of earnings applied to purchase of stock under ESPP	15.00%
Maximum number of shares per employee (in shares)	100,000
Stock-based compensation expense under ESPP		$ 0.6	$ 0.6	$ 2.0	$ 1.4
Gross unrecognized stock-based compensation cost		$ 1.5		$ 1.5
Unrecognized stock-based compensation expense expected to be recognized over weighted-average period				1 year
ESPP shares purchased during period (in shares)		37,374	29,146	69,393	29,146

Property and Equipment, Net (Tables)

9 Months Ended

Sep. 30, 2025

Property, Plant and Equipment [Abstract]

Summary of Components of Property and Equipment, Net

The components of property and equipment, net as of September 30, 2025 and December 31, 2024 were as follows (in thousands):


	September 30, 2025			December 31, 2024
Leasehold Improvements	$	9,387		$	—
Manufacturing and lab equipment		5,982			—
Machinery and Equipment		583			359
Total property and equipment, cost		15,952			359
Less: Accumulated depreciation		(623	)		(87	)
Property and equipment, net	$	15,329		$	272

Debt - Additional Information (Details)		9 Months Ended	12 Months Ended
Debt - Additional Information (Details)	Jul. 20, 2025 USD ($)	Sep. 30, 2025 USD ($)	Dec. 31, 2021 Tranche	Mar. 05, 2024 USD ($)	Jan. 31, 2021 USD ($) Tranche
Debt Instrument [Line Items]
Debt description		In January 2021, the Company entered into a loan agreement with Silicon Valley Bank (SVB) (the Loan Agreement) for a term loan in three tranches. In 2021, the Company drew down on two of the tranches in the aggregate principal amount of $15.0 million. On May 12, 2023, the Company repaid all outstanding principal and accrued and unpaid interest on the funds received under the Loan Agreement and all other outstanding obligations with respect to the funds received under the Loan Agreement and made a final payment.
Biovire
Debt Instrument [Line Items]
Original principal amount	$ 3,000,000
Maximum \| Biovire
Debt Instrument [Line Items]
SOFR rate	25.00%
Minimum \| Biovire
Debt Instrument [Line Items]
SOFR rate	2.60%
Loan Agreement with SAB
Debt Instrument [Line Items]
Success fee					$ 5,000,000
Debt outstanding obligations		$ 0
Loan Agreement with Silicon Valley Bank (SVB)
Debt Instrument [Line Items]
Number of tranches \| Tranche					3
Number of tranches drawn \| Tranche			2
Original principal amount					$ 15,000,000
Success Fee Agreement with SVB
Debt Instrument [Line Items]
Success fee				$ 400,000	$ 125,000,000
Success fee agreement description		In connection with the Loan Agreement, the Company entered into a Success Fee Agreement (the Success Fee Agreement) with SVB in January 2021. In accordance with the Success Fee Agreement, the Company agreed to pay to SVB an amount equal to (a) the quotient of (i) the aggregate original principal amount of all Term Loan Advances made by SVB to the Company divided by (ii) $5 million, multiplied by (b) $125,000 (the Success Fee), upon the closing of a success fee event (the Success Fee Event) and, in the event of an IPO, within five business days of closing such IPO. In connection with the Company’s IPO, it became obligated to pay SVB the Success Fee.

Acquisition of Biovire - Summary of Preliminary Purchase Price Allocation (Details) - USD ($) $ in Thousands	Sep. 30, 2025	Jul. 20, 2025	Dec. 31, 2024
Liabilities assumed
Deferred tax liability	$ 1,609		$ 0
Goodwill	$ 12,805	$ 12,800	$ 0
Biovire
Identifiable assets acquired
Cash		4,033
Current assets		2,826
Operating lease right-of-use assets		3,413
Property and equipment, net		15,498
Intangible assets		1,700
Total identifiable assets acquired		27,470
Liabilities assumed
Current liabilities		2,227
Operating lease liabilities, non-current portion		2,800
Long-term debt		3,000
Deferred tax liability		1,609
Other long-term liabilities		3,795
Total liabilities assumed		13,431
Net identifiable assets acquired		14,039
Goodwill		12,805
Total fair value of consideration paid		$ 26,844

Acquisition of Biovire (Tables)

9 Months Ended

Sep. 30, 2025

Business Combination [Abstract]

Summary of Preliminary Purchase Price Allocation

The purchase price allocation is set forth in the table below and represents the Company’s provisional fair value estimates related to the acquisition as of July 20, 2025, and are subject to subsequent adjustments as additional information is obtained during the applicable measurement period.


	Estimated fair value
Identifiable assets acquired
Cash	$	4,033
Current assets		2,826
Operating lease right-of-use assets		3,413
Property and equipment, net		15,498
Intangible assets		1,700
Total identifiable assets acquired		27,470
Liabilities assumed
Current liabilities		2,227
Operating lease liabilities, non-current portion		2,800
Long-term debt		3,000
Deferred tax liability		1,609
Other long-term liabilities		3,795
Total liabilities assumed		13,431
Net identifiable assets acquired		14,039
Goodwill		12,805
Total fair value of consideration paid	$	26,844

Stock-Based Compensation - Summary of Assumptions Used in Determining Fair Value of Option Awards (Details) - Stock Options	3 Months Ended		9 Months Ended
	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2025	Sep. 30, 2024
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected volatility, Minimum	76.35%	77.34%	73.39%	77.34%
Expected volatility, Maximum	77.58%	77.74%	77.58%	84.50%
Risk-free interest rate, Minimum	3.70%	3.46%	3.70%	3.46%
Risk-free interest rate, Maximum	4.16%	4.15%	4.50%	4.62%
Expected dividend yield	0.00%	0.00%	0.00%	0.00%
Expected term (in years)	6 years 1 month 6 days	6 years 1 month 6 days
Maximum
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected term (in years)			6 years 1 month 6 days	6 years 1 month 6 days
Minimum
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected term (in years)			5 years 3 months	6 years 18 days

Goodwill and Intangibles, Net - Summary of Components of Intangible Assets (Details) - USD ($) $ in Thousands	Sep. 30, 2025	Dec. 31, 2024
Finite-Lived Intangible Assets [Line Items]
Gross Carrying Amount	$ 1,700
Accumulated Amortization	28
Net Carrying Amount	1,672	$ 0
Customer Relationships
Finite-Lived Intangible Assets [Line Items]
Gross Carrying Amount	1,400
Accumulated Amortization	23
Net Carrying Amount	$ 1,377
Useful Lives (in years)	10 years
Trade Names and Trademarks
Finite-Lived Intangible Assets [Line Items]
Gross Carrying Amount	$ 300
Accumulated Amortization	5
Net Carrying Amount	$ 295
Useful Lives (in years)	10 years

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

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+ Details

Description of Business and Basis of Presentation

9 Months Ended

Sep. 30, 2025

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Description of Business and Basis of Presentation

1. Description of Business and Basis of Presentation

Description of Business

CG Oncology, Inc. (the Company) is a late-stage clinical biopharmaceutical company focused on developing and commercializing its product candidate, cretostimogene grenadenorepvec, for patients with bladder cancer. The Company is at a clinical stage and does not project to generate significant revenues if and until the U.S. Food and Drug Administration (FDA) approves its product candidate, cretostimogene, and the Company is able to commercialize this product candidate.

On January 11, 2024, the Company’s board of directors approved a 1-for-9.535 reverse stock split of its issued and outstanding common stock and stock option awards which was effected on January 16, 2024. All issued and outstanding shares of common stock, stock option awards and per share data have been adjusted in these unaudited condensed consolidated financial statements, on a retrospective basis, to reflect the reverse stock split for all periods presented. The par value of the common stock and preferred stock was not adjusted as a result of the reverse stock split.

On January 29, 2024, the Company completed the closing of its initial public offering (IPO) of 23,000,000 shares of common stock, which included the exercise in full by the underwriters of their option to purchase 3,000,000 additional shares, at a price of $19.00 per share. The common stock began trading on the Nasdaq Global Market on January 25, 2024, under the symbol "CGON". The Company received net proceeds of $399.6 million, after deducting discounts and commissions and other offering expenses. In addition, as a result of its IPO, the Company’s redeemable convertible preferred stock converted into common stock concurrently with the IPO. In December 2024, we completed a follow-on offering of 8,500,000 shares of common stock at a price of $28.00 per share, including the exercise in full by the underwriters of their option to purchase an additional 1,200,000 shares of common stock. We received net proceeds of $223.1 million, after deducting discounts, commissions and other offering expenses.

In February 2025, the Company's wholly owned subsidiary, SafeGuard Healthcare, LLC, established a convertible note receivable with a principal amount of $26.8 million, including accrued interest, through a convertible promissory note (Note) from SP Healthcare SPV I, LLC (the SPV). The SPV used the proceeds from the Note to make an investment in Biovire, Inc. (Biovire) for the purpose of Biovire acquiring substantially all of the assets of a contract manufacturing organization that provides clinical supply of cretostimogene to the Company. On July 20, 2025, following the cessation of services by SkyPath to the SPV and Biovire (Conversion Event), the Company converted the Note and obtained control of the SPV and Biovire. See footnote 15 for more information on the Conversion Event.

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements as of September 30, 2025 and for the three and nine months ended September 30, 2025 and 2024 have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP) for interim financial information and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (SEC). Accordingly, they do not include all of the information and notes required by U.S. GAAP for complete financial statements. Because all of the disclosures required by U.S. GAAP for complete financial statements are not included herein, these unaudited condensed consolidated financial statements and the notes accompanying them should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2024 included in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 (2024 Annual Report). In the opinion of management, the unaudited condensed consolidated financial statements reflect all adjustments, which include only normal and recurring adjustments, considered necessary for a fair statement of the interim periods.

The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of revenue and expenses during the reporting period.

Liquidity and Management’s Plans

As of September 30, 2025, the Company had approximately $680.3 million of cash, cash equivalents and marketable securities and working capital of approximately $665.3 million. The Company has a relatively limited operating history, and the revenue and income potential of the Company’s business and market are unproven. The Company has experienced net losses and negative cash flows from operations since its inception and, as of September 30, 2025, the Company had an accumulated deficit of $337.7 million. During the three and nine months ended September 30, 2025, the Company incurred net losses of $43.8 million and $119.7 million, respectively, and had negative cash flows from operations of $96.1 million during the nine months ended September 30, 2025. The Company will continue to incur significant costs and expenses related to its ongoing operations until it successfully develops, obtains regulatory approval, and gains market acceptance of a product candidate and achieves a level of revenues adequate to support the Company’s operations.

At-the-Market Offering

On March 28, 2025, the Company entered into an Open Market Sale AgreementSM (Jefferies Sales Agreement) with Jefferies LLC, as agent, pursuant to which the Company may offer and sell, from time to time through Jefferies, up to $250.0 million in shares of the Company’s common stock. During the three months ended September 30, 2025, 1,515,151 shares were sold under the Jefferies Sales Agreement, at a price of $33.00 per share. The Company received net proceeds of $48.7 million, after deducting discounts and commissions and other offering expenses.

Common Stock (Tables)

9 Months Ended

Sep. 30, 2025

Equity [Abstract]

Schedule of Common Stock Reserved for Issuance Upon Conversion

As of September 30, 2025, the Company reserved the following shares of common stock for issuance:


	September 30,
	2025
Stock options and awards outstanding		8,029,081
Reserved for future stock award issuances		4,230,364
Reserved for future ESPP issuances		713,703
Total		12,973,148

Common Stock

9 Months Ended

Sep. 30, 2025

Equity [Abstract]

Common Stock

10. Common Stock

The Company is authorized to issue up to 700,000,000 shares of common stock at September 30, 2025 and December 31, 2024, of which 78,277,452 and 76,154,783 shares were issued and outstanding at September 30, 2025 and December 31, 2024, respectively.

Voting, dividend and liquidation rights of the holders of the common stock are subject to and qualified by the rights, powers and preferences of the holders of the preferred stock.

Dividends

The holders of common stock shall be entitled to receive dividends out of funds legally available therefore at such times and in such amounts as the board of directors may determine in its sole discretion.

Liquidation Rights

Upon any voluntary or involuntary liquidation, dissolution or winding-up of the Company or deemed liquidation event of the Company, all of the remaining assets of the Company available for distribution to the stockholders shall be distributed among the holders of the common stock, pro rata based on the number of shares held by each such holder.

Reserved Shares

As of September 30, 2025, the Company reserved the following shares of common stock for issuance:


	September 30,
	2025
Stock options and awards outstanding		8,029,081
Reserved for future stock award issuances		4,230,364
Reserved for future ESPP issuances		713,703
Total		12,973,148

- Definition

The entire disclosure for equity.

+ References

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+ Details

License and Collaboration Agreements

9 Months Ended

Sep. 30, 2025

License and Collaboration Agreements [Abstract]

License and Collaboration Agreements

8. License and Collaboration Agreements

Lepu Biotech Co., Ltd.

In March 2019, the Company entered into a development and license agreement with Lepu Biotech Co., Ltd. (Lepu) for cretostimogene (the Lepu License Agreement). Under the terms of the Lepu License Agreement, the Company granted to Lepu an exclusive license to develop, manufacture and commercialize cretostimogene and/or DDM to treat and/or prevent cancer in mainland China, including Hong Kong and Macau (the Lepu Territory). The Company is obligated to use commercially reasonable efforts to supply Lepu with its requirements of cretostimogene and DDM for its development activities at Lepu’s cost and to periodically provide Lepu with manufacturing documentation and, at Lepu’s cost, reasonably requested assistance related to the manufacture of clinical and, if applicable, commercial supplies of cretostimogene and DDM. The Company determined that control of the license was transferred to Lepu on March 2019 upon execution of the contract.

Lepu paid to the Company a one-time upfront payment of $4.5 million and is obligated to make regulatory milestone payments of up to $2.5 million and commercial milestone payments of up to $57.5 million. The Company is entitled to receive a high single-digit royalty on net sales of cretostimogene and/or DDM sold in the Lepu Territory, subject to a specified reduction. Lepu’s royalty obligations will expire upon termination of the Lepu License Agreement.

The Company assessed the Lepu License Agreement in accordance with ASC 606, Revenue Recognition (ASC 606) and determined that the performance obligation is comprised solely of the license grant to Lepu. The Company determined the transaction price was $4.5 million and recorded the entire amount upon transfer of control of the functional intellectual property license rights in 2019. The Company evaluated the provision of manufacturing activities related to clinical and commercial supply of the licensed products and concluded that the manufacturing activities were not performance obligations as the terms do not provide a material right to Lepu.

Future milestone payments are fully contingent as the risk of significant revenue reversal will only be resolved depending on future regulatory approval and sales level outcomes. The Company will re-evaluate the likelihood of achieving future milestones at the end of each reporting period.

The sales-based royalty fee is considered variable consideration and will be recognized as revenue as such sales occur. The sales-based royalty fee qualifies for the royalty constraint exception and does not require an estimate of the future transaction price.

During the nine months ended September 30, 2025 and 2024, the Company recognized zero and $0.5 million, respectively, in license and collaboration revenue. The Company recognized no license and collaboration revenue during the three months ended September 30, 2025 and 2024.

Kissei Pharmaceutical Co., Ltd.

In March 2020, and amended as of September 2022, the Company entered into a license and collaboration agreement with Kissei Pharmaceutical Co., Ltd. (Kissei) (the Kissei License Agreement). Under the terms of the Kissei License Agreement, the Company granted to Kissei an exclusive license to certain intellectual property rights in Bangladesh, Bhutan, Brunei, Cambodia, India, Indonesia, Japan, South Korea, Laos, Malaysia, Myanmar, Nepal, Pakistan, Palau, Philippines, Singapore, Sri Lanka, Taiwan, Thailand and Vietnam (the Kissei Territory), for Kissei to develop and commercialize, but not manufacture, cretostimogene in combination with DDM (the Licensed Product) for all uses in oncology indications for which marketing approval is being sought. Under the Kissei Agreement, the Company and Kissei agree to use commercially reasonable efforts to collaborate on clinical development activities in the Kissei Territory and each party is responsible for conducting the applicable activities pursuant to an agreed development plan. Kissei is responsible for the costs of developing the Licensed Product in the Kissei Territory, and the Company is responsible for the costs of developing the Licensed Product outside the Kissei Territory (Global Development), provided that Kissei is responsible for a low-double digit percentage and the Company is responsible for a high-double digit percentage of the cost of development activities that cannot be attributed solely to the Kissei Territory or outside the Kissei Territory. The Company is obligated to supply and Kissei will exclusively purchase its clinical and commercial requirements of Licensed Product from the Company. Kissei is responsible for commercializing the Licensed Product in the Kissei Territory and is obligated to use commercially reasonable efforts to seek regulatory approval for and commercialize at least one Licensed Product in a specified indication. Until a certain period of time has passed after the first regulatory approval of the Licensed Product, the Company is prohibited from commercializing certain competing products worldwide and Kissei is prohibited from researching, developing or commercializing certain competing products worldwide.

Under the terms of the Kissei License Agreement, the Company received a $10.0 million one-time upfront payment and, in connection with entry into this agreement, Kissei purchased $30.0 million worth of Series D redeemable convertible preferred stock as part of the Company’s Series D financing. Kissei is obligated to make development and regulatory milestone payments to the Company of up to $33.0 million and commercial milestone payments of up to $67.0 million. The Company has agreed to pay Kissei a royalty on net sales of Licensed Product outside the Kissei Territory and outside the Lepu Territory (as described above), including on any U.S. sales, in a low-single digit percentage, subject to certain capped reductions. The Company is entitled to receive a royalty on net sales of Licensed Product in the Kissei Territory in the mid-twenties percentage, subject to certain capped reductions. Also, Kissei has the right to offset the royalty payments due to the Company with respect to the cost for the supply of Licensed Product sold by the Company to Kissei, and to indefinitely carryforward credits for any excess supply amounts paid over royalty amounts owed in a given quarter. The Company is entitled to receive a specified minimum percentage of royalties on net sales of a given Licensed Product in a given country and a given quarter, unless, if for such Licensed Product in such country and such quarter, Kissei has taken the maximum allowable reductions and the ratio of the cost for the supply of Licensed Product to the sales price for Licensed Product exceeds a low-double digit percentage threshold, then the Company shall receive no royalties on the net sales of such Licensed Product in such country and such quarter. Kissei’s and the Company’s royalty obligations will expire on a Licensed Product-by-Licensed Product and country-by-country basis on the later of twelve years from the date of first commercial sale of such Licensed Product in such country or when there is no longer a valid patent claim covering such Licensed Product in such country.

The Kissei Agreement will expire on a Licensed Product-by-Licensed Product and country-by-country basis when there is no remaining royalty or milestone payment obligation due to a party with respect to such Licensed Product in such country. Following expiration of the Kissei Agreement in its entirety, the licenses the Company granted to Kissei will become non-exclusive, fully-paid royalty-free and irrevocable and Kissei will have the right to negotiate directly with the Company's product suppliers for the direct supply of Licensed Product to Kissei. The Kissei Agreement may be terminated either by Kissei or by the Company in the event of an uncured material breach by the other party or in the event the other party becomes subject to specified bankruptcy, insolvency or similar circumstances. In addition, the Company have the right to terminate the Kissei Agreement in the event that Kissei commences a legal action challenging the validity, enforceability or scope of any licensed patents under the Kissei Agreement. Kissei may terminate the Kissei Agreement at will upon specified written notice. Additionally, Kissei may terminate the Kissei Agreement for the Company's willful and malicious misconduct that results in substantial and irreparable harm to the commercial value of the Licensed Products in the Kissei Territory and upon any such termination, the licenses the Company granted to Kissei will become royalty-free and fully paid-up and Kissei will have the right to negotiate directly with the Company's contract manufacturing organizations for the supply of Licensed Product. Upon termination of the Kissei Agreement for any other reason all rights and licenses granted to Kissei to develop and commercialize the product under the Kissei Agreement will terminate, subject to certain rights to sell existing inventory of Licensed Products by Kissei and its sublicensees. Upon termination of the Kissei Agreement for Kissei’s breach, any sublicenses granted by Kissei may, upon the Company’s discretion, continue.

The Company evaluated the Kissei Agreement to determine whether it is a collaborative arrangement in the scope of ASC 808, Collaborative Arrangements (ASC 808). The Company concluded the Kissei Agreement is a collaborative agreement under ASC 808, as the Kissei Agreement involves a joint operating activity, each party is an active participant in the activities related to the Kissei Agreement, and both parties are exposed to significant risks and rewards dependent upon the commercial success of the activities related to the Kissei Agreement.

The Company determined the Kissei Agreement contained two material components: (i) an exclusive license granted to Kissei to certain intellectual property rights in the Kissei Territory, for Kissei to develop and commercialize, but not manufacture, the Licensed Product for all uses in oncology; and (ii) the parties’ participation in the Global Development of the Licensed Product. The Company used the criteria specified in ASC 606 to determine which of the components of the Kissei Agreement are performance obligations with a customer and concluded Kissei is the Company’s customer for the license and related activities in the Kissei Territory under ASC 606. The Global Development activities under the agreement does not present a transaction with a customer and the payments received by the Company for Global Development activities, including manufacturing, will be accounted for as a reduction of related expenses.

The Company evaluated the Kissei Territory specific license and related activities under ASC 606, as these transactions are considered transactions with a customer, and identified two material promises at the outset of the Kissei License Agreement, which consists of the following: (1) the exclusive license and (2) the manufacturing activities related to development and commercial supply of the Licensed Product in the Kissei Territory. The Company further evaluated the material promise associated with manufacturing activities related to development and commercial supply of the Licensed Products in the Kissei Territory. Given Kissei is not obligated to purchase any minimum amount or quantities of the development and commercial supply from the Company, the Company concluded, for the purpose of ASC 606, the provision of manufacturing activities related to development and commercial supply of the Licensed Product in the Kissei Territory was an option but not a performance obligation of the Company at the inception of the Kissei Agreement and will be accounted for if and when exercised. The Company also concluded there is no separate material right in connection with the development and commercial supply of the licensed product, as the expected pricing was not issued at a significant and incremental discount. Therefore, the manufacturing activities were excluded as a performance obligation at the outset of the arrangement.

The Company evaluated the license under ASC 606 and concluded the license is a functional intellectual property license. The Company determined Kissei benefited from the license at the time of grant and, therefore, the related performance obligation was satisfied at a point in time. Additionally, the Company is entitled to development and regulatory milestones as well as sales milestones and royalties from Kissei upon future sales of the Licensed Product in the Kissei Territory. Future milestone payments are fully contingent as the risk of significant reversal will only be resolved depending on future development milestones, regulatory approval and sales level outcomes. The Company re-evaluates the likelihood of achieving future milestones at the end of each reporting period. The royalties are considered variable consideration and will be recognized as revenue as such sales occur. The sales-based royalties qualify for the royalty constrain exception and do not require an estimate of the future transaction price.

The Company recorded $0.2 million and less than $0.1 million in license and collaboration revenue for the three months ended September 30, 2025 and 2024, respectively, and $0.2 million in license and collaboration revenue for the nine months ended September 30, 2025 and 2024.

Common Stock - Schedule of Common Stock Reserved for Issuance Upon Conversion (Details)	Sep. 30, 2025 shares
Class of Stock [Line Items]
Common stock reserved for future issuance	12,973,148
Employee Stock Option
Class of Stock [Line Items]
Common stock reserved for future issuance	8,029,081
Reserved For Future Stock Award Issuances
Class of Stock [Line Items]
Common stock reserved for future issuance	4,230,364
Reserved for Future ESPP Issuances
Class of Stock [Line Items]
Common stock reserved for future issuance	713,703

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

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Reference 21: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

License and Collaboration Agreements - Additional Information (Details) - USD ($)	1 Months Ended		3 Months Ended		9 Months Ended
	Mar. 31, 2020	Mar. 31, 2019	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2025	Sep. 30, 2024
License and Collaboration Agreements [Line Items]
License and collaboration revenue			$ 1,666,000	$ 43,000	$ 1,718,000	$ 683,000
Lepu Biotech Co., Ltd.
License and Collaboration Agreements [Line Items]
One-time upfront payment		$ 4,500,000
Collaboration agreement transaction price		4,500,000
License and collaboration revenue			0	0	0	500,000
Lepu Biotech Co., Ltd. \| Maximum
License and Collaboration Agreements [Line Items]
Regulatory milestone payments		2,500,000
Commercial milestone payments		$ 57,500,000
Kissei Pharmaceutical Co., Ltd.
License and Collaboration Agreements [Line Items]
One-time upfront payment	$ 10,000,000
License and collaboration revenue			$ 200,000		$ 200,000	$ 200,000
Royalties	0
Kissei Pharmaceutical Co., Ltd. \| Maximum
License and Collaboration Agreements [Line Items]
Commercial milestone payments	67,000,000
Development and regulatory milestone payments	33,000,000
License and collaboration revenue				$ 100,000
Kissei Pharmaceutical Co., Ltd. \| Series D Redeemable Convertible Preferred Stock
License and Collaboration Agreements [Line Items]
Purchase of redeemable convertible preferred stock	$ 30,000,000

Fair Value Measurements - Summary of Financial Instruments Carried at Fair Value on Recurring Basis (Details) - Fair Value, Recurring - USD ($) $ in Thousands	Sep. 30, 2025	Dec. 31, 2024
Cash Equivalents
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Assets	$ 41,109	$ 256,204
Marketable Securities
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Assets	635,118	484,930
Level 1 \| Cash Equivalents
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Assets	41,109	256,204
Level 2 \| Marketable Securities
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Assets	$ 635,118	$ 484,930

Goodwill and Intangibles, Net - Summary of Estimated Future Amortization Expense (Details) - USD ($) $ in Thousands	Sep. 30, 2025	Dec. 31, 2024
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract]
2025	$ 43
2026	170
2027	170
2028	170
2029	170
Thereafter	949
Net Carrying Amount	$ 1,672	$ 0

Description of Business and Basis of Presentation - Additional Information (Details)		1 Months Ended	3 Months Ended						9 Months Ended
	Jan. 29, 2024 USD ($) $ / shares shares	Dec. 31, 2024 USD ($) $ / shares shares	Sep. 30, 2025 USD ($) $ / shares shares	Jun. 30, 2025 USD ($) shares	Mar. 31, 2025 USD ($) shares	Sep. 30, 2024 USD ($) shares	Jun. 30, 2024 USD ($) shares	Mar. 31, 2024 USD ($) shares	Sep. 30, 2025 USD ($) $ / shares	Sep. 30, 2024 USD ($)	Mar. 28, 2025 USD ($)	Feb. 28, 2025 USD ($)
Description of Business and Basis of Presentation [Line Items]
Reverse stock split description									On January 11, 2024, the Company’s board of directors approved a 1-for-9.535 reverse stock split of its issued and outstanding common stock and stock option awards which was effected on January 16, 2024.
Reverse stock split conversion ratio									0.105
Net proceeds									$ 49,001,000
Cash, cash equivalents and marketable securities			$ 680,300,000						680,300,000
Working capital			665,300,000						665,300,000
Accumulated deficit		$ (217,981,000)	(337,667,000)						(337,667,000)
Net losses			$ (43,808,000)	$ (41,426,000)	$ (34,452,000)	$ (20,405,000)	$ (18,902,000)	$ (16,934,000)	(119,686,000)	$ (56,241,000)
Cash flows from operations									$ (96,130,000)	$ (58,051,000)
Common Stock [Member]
Description of Business and Basis of Presentation [Line Items]
Common shares offering \| shares			530,442	10,570	66,506	878,006	23,600	60
SafeGuard Healthcare, LLC [Member] \| Convertible Promissory Note [Member]
Description of Business and Basis of Presentation [Line Items]
Principal amount of convertible promissory note including accrued interest												$ 26,800,000
IPO [Member]
Description of Business and Basis of Presentation [Line Items]
Common shares offering \| shares	23,000,000
Net proceeds	$ 399,600,000
IPO [Member] \| Common Stock [Member]
Description of Business and Basis of Presentation [Line Items]
Common shares offering \| shares								23,000,000
Follow On Offering [Member]
Description of Business and Basis of Presentation [Line Items]
Common shares offering \| shares		8,500,000
Share price \| $ / shares		$ 28
Stock issued shares under writers option exercised \| shares		1,200,000
Net proceeds		$ 223,100,000
Underwriters [Member]
Description of Business and Basis of Presentation [Line Items]
Share price \| $ / shares	$ 19
Stock issued shares under writers option exercised \| shares	3,000,000
Open Market Sale Agreement [Member] \| Common Stock [Member] \| Jefferies LLC [Member]
Description of Business and Basis of Presentation [Line Items]
Share price \| $ / shares			$ 33						$ 33
Net proceeds			$ 48,700,000
Value of common stock issuable											$ 250,000,000
Sale of stock \| shares			1,515,151

Commitments and Contingencies (Tables)

9 Months Ended

Sep. 30, 2025

Commitments and Contingencies Disclosure [Abstract]

Components of Lease Expense

The components of lease expense for the periods ended September 30, 2025 and 2024 were as follows (in thousands):


	Three Months Ended September 30,						Nine Months Ended September 30,
	2025			2024			2025			2024
Lease cost
Operating lease cost	$	377		$	77		$	384		$	173
Total lease cost	$	377		$	77		$	384		$	173
Other information
Operating lease right-of-use asset obtained in exchange for new operating lease liabilities	$	—		$	—		$	859		$	—
Cash paid for amounts included in the measurement of lease liabilities, included in operating cash flows	$	222		$	60		$	383		$	163
Weighted-average remaining lease term		4.22			1.41			4.22			1.41
Weighted-average discount rate		6.87	%		1.63	%		6.87	%		1.63	%

Schedule of Maturities of Lease Liabilities

Maturities of lease liabilities as of September 30, 2025 were as follows (in thousands):


2025	$	291
2026		1,162
2027		1,137
2028		1,116
2029		1,039
Thereafter		164
Total lease payment		4,909
Less: amount representing imputed interest		(668	)
Total future minimum lease obligations	$	4,241

Segment Disclosures - Schedule of Selected Financial Information with Respect to Single Operating Segment (Details) - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
	Sep. 30, 2025	Jun. 30, 2025	Mar. 31, 2025	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2025	Sep. 30, 2024
Segment Reporting Information [Line Items]
Total revenues	$ 1,666			$ 43			$ 1,718	$ 683
Less:
Cost of sales	1,577			0			1,577	0
Research and development
Total research and development	27,884			19,622			86,683	55,302
General and administrative	23,334			8,716			55,532	21,998
Total operating costs and expenses	52,795			28,338			143,792	77,300
Loss from operations	(51,129)			(28,295)			(142,074)	(76,617)
Other income, net	7,321			7,890			22,388	20,376
Net loss and comprehensive loss	(43,808)	$ (41,426)	$ (34,452)	(20,405)	$ (18,902)	$ (16,934)	(119,686)	(56,241)
Commercial and Development Revenue
Segment Reporting Information [Line Items]
Total revenues	1,508			0			1,508	0
License and Collaboration Revenue
Segment Reporting Information [Line Items]
Total revenues	158			43			210	683
Operating Segments [Member]
Segment Reporting Information [Line Items]
Total revenues	1,666			43			1,718	683
Less:
Cost of sales	1,577			0			1,577	0
Research and development
Clinical and manufacturing	23,381			15,403			72,818	44,561
Other research and development	4,503			4,219			13,865	10,741
Total research and development	27,884			19,622			86,683	55,302
General and administrative	23,334			8,716			55,532	21,998
Total operating costs and expenses	52,795			28,338			143,792	77,300
Loss from operations	(51,129)			(28,295)			(142,074)	(76,617)
Other income, net	7,321			7,890			22,388	20,376
Net loss and comprehensive loss	(43,808)			(20,405)			(119,686)	(56,241)
Operating Segments [Member] \| Commercial and Development Revenue
Segment Reporting Information [Line Items]
Total revenues	1,508			0			1,508	0
Operating Segments [Member] \| License and Collaboration Revenue
Segment Reporting Information [Line Items]
Total revenues	$ 158			$ 43			$ 210	$ 683

Condensed Consolidated Statements of Cash Flows $ in Thousands	9 Months Ended
	Sep. 30, 2025 USD ($)	Sep. 30, 2024 USD ($)
Operating Activities
Net loss	$ (119,686)	$ (56,241)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	596	32
Stock-based compensation expense	19,489	6,412
Accretion of discount on short-term investments	(1,965)	(6,247)
Non-cash interest income	(844)
Non-cash lease expense	21	(17)
Changes in operating assets and liabilities:
Prepaid expenses and other current assets	(90)	(4,920)
Accounts receivable, net	(19)
Other assets	(20)	(34)
Accounts payable	1,835	834
Accrued expenses and other current liabilities	4,924	2,130
Inventory	(380)
Other liabilities	9
Net cash used in operating activities	(96,130)	(58,051)
Investing Activities
Proceeds from sales and maturities of investments	621,899	517,230
Purchases of investments	(770,122)	(828,874)
Acquisition, net of cash acquired	(21,967)
Purchases of property and equipment	(127)	(25)
Net cash used in investing activities	(170,317)	(311,669)
Financing Activities
Proceeds from initial public offering, net of issuance costs		406,410
Proceeds from at-the-market offering, net of issuance costs	49,001
Payments of success fee or long-term debt		(365)
Proceeds from exercise of common stock options and issuance of common stock under the employee stock purchase plan	5,800	2,244
Deferred offering costs	(277)	(3,424)
Net cash provided by financing activities	54,524	404,865
Net (decrease) increase in cash and cash equivalents	(211,923)	35,145
Cash and cash equivalents at beginning of period	257,068	8,266
Cash and cash equivalents at end of period	45,145	43,411
Supplemental Disclosure of Cash Flow Information
Cash paid for taxes	16
Supplemental Schedule of Non-cash Investing and Financing Activities:
Reclassification of 38,413,909 redeemable convertible preferred stock to 38,413,909 shares of common stock		307,890
Conversion of deferred offering costs		$ 6,845
Deferred offering costs, unpaid and accrued	61
Operating lease right-of-use asset obtained in exchange for new operating lease liabilities	$ 859

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Sep. 30, 2025	Jun. 30, 2025	Mar. 31, 2025	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2025	Sep. 30, 2024
Pay vs Performance Disclosure
Net Income (Loss)	$ (43,808)	$ (41,426)	$ (34,452)	$ (20,405)	$ (18,902)	$ (16,934)	$ (119,686)	$ (56,241)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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+ Details

Goodwill and Intangibles, Net (Tables)

9 Months Ended

Sep. 30, 2025

Goodwill and Intangible Assets Disclosure [Abstract]

Summary of Components of Intangible Assets

The components of intangible assets as of September 30, 2025 were as follows (in thousands):


	Gross Carrying Amount		Accumulated Amortization		Net Carrying Amount		Useful Lives (in years)
Customer relationships	$	1,400	$	23	$	1,377		10
Trade names and trade marks		300		5		295		10
Total intangible assets, net	$	1,700	$	28	$	1,672

Summary of Estimated Future Amortization Expense

The following table presents the estimated future amortization expense related to intangible assets as of September 30, 2025 (in thousands):


	Accumulated Amortization
2025	$	43
2026		170
2027		170
2028		170
2029		170
Thereafter		949
Total future amortization expense	$	1,672

Stock-Based Compensation (Tables)

9 Months Ended

Sep. 30, 2025

Share-Based Payment Arrangement [Abstract]

Summary of Assumptions Used in Determining Fair Value of Option Awards

The following table provides the assumptions used in determining the fair value of option awards for the three and nine months ended September 30, 2025 and 2024:


	Three Months Ended September 30,		Nine Months Ended September 30,
	2025	2024	2025	2024
Expected volatility	76.35% - 77.58%	77.34% - 77.74%	73.39% - 77.58%	77.34% - 84.50%
Risk-free interest rate	3.7% - 4.16%	3.46% - 4.15%	3.7% - 4.5%	3.46% - 4.62%
Expected dividend yield	0%	0%	0%	0%
Expected term (in years)	6.1	6.1	5.25 - 6.1	6.05 - 6.1

Summary of Stock Option Activity

The following table summarizes stock option activity for the nine months ended September 30, 2025 (in thousands, except share and per share amounts):


	Number of Outstanding Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term		Aggregate Intrinsic Value
						(Years)
Balance at December 31, 2024		6,574,580		$	14.19		8.20	$	108,155
Granted		2,566,341		$	21.03
Exercised		(538,125	)	$	8.79
Forfeited/Expired		(668,339	)	$	20.42
Balance at September 30, 2025		7,934,457		$	16.24		8.21	$	190,726
Vested and expected to vest at September 30, 2025		7,934,457		$	16.24		8.21	$	190,726
Exercisable at September 30, 2025		3,019,428		$	10.56		7.24	$	89,725

Summary of Performance-Based Restricted Stock Units


	Number of Shares		Weighted Average Grant Date Fair Value

Nonvested at December 31, 2024		—	$	—
Granted		94,624	$	36.48
Nonvested at September 30, 2025		94,624	$	36.48
Expected to vest at September 30, 2025		94,624	$	36.48

Summary of Stock-based Compensation Expense Related to Stock Awards

Stock-based compensation expense related to stock awards and the 2024 Employee Stock Purchase Plan (see Note 12) recorded in the accompanying statements of operations for the three and nine months ended September 30, 2025 and 2024 was as follows (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2025		2024		2025		2024
Research and development	$	2,455	$	901	$	6,410	$	2,223
General and administrative		4,876		1,748		13,079		4,189
Total stock-based compensation expense	$	7,331	$	2,649	$	19,489	$	6,412

Employee Stock Purchase Plan

9 Months Ended

Sep. 30, 2025

Employee Stock Purchase Plan [Abstract]

Employee Stock Purchase Plan

12. Employee Stock Purchase Plan

On January 11, 2024, the Company’s board of directors and stockholders approved the 2024 Employee Stock Purchase Plan (the ESPP), which became effective on the date on which the Company’s registration statement was declared effective by the SEC. The number of shares initially available for issuance pursuant to the ESPP is 812,242 shares. The ESPP provides for the sale of the Company's common stock to eligible employees at 85% of the fair market value of the Company's common stock at the commencement date of each offering period or the relevant date of purchase, whichever is lower. Payroll deductions are limited to 15% of the employee’s eligible compensation, subject to IRS limits. In addition, employees may not buy more than 100,000 shares during any purchase period or offering period. There were 37,374 and 69,393 shares purchased under the ESPP during the three and nine months ended September 30, 2025, respectively, and 29,146 shares purchased under the ESPP during the three and nine months ended September 30, 2024. On September 30, 2025, there were 713,703 shares available for issuance under the ESPP.

The Company recorded stock-based compensation expense under the ESPP of approximately $0.6 million and $0.6 million for the three months ended September 30, 2025 and 2024, respectively, and $2.0 million and $1.4 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, the Company had $1.5 million of gross unrecognized stock-based compensation expense under the ESPP to be recognized over a weighted average period of 1.0 years.

Stock-Based Compensation - Summary of Performance-Based Restricted Stock Units (Details) - Performance-Based Restricted Stock Units	9 Months Ended
	Sep. 30, 2025 $ / shares shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of shares, Granted \| shares	94,624
Number of shares, Nonvested, Ending Balance \| shares	94,624
Number of shares, Expected to vest \| shares	94,624
Weighted Average Grant Date Fair Value, Granted \| $ / shares	$ 36.48
Weighted Average Grant Date Fair Value, Nonvested, Ending Balance \| $ / shares	36.48
Weighted Average Grant Date Fair Value, Expected to vest \| $ / shares	$ 36.48

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

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+ Details

Acquisition of Biovire - Additional Information (Details) $ in Thousands	Jul. 20, 2025 USD ($)
SafeGuard Healthcare, LLC
Business Combination [Line Items]
Membership interest percentage	100.00%
SPV
Business Combination [Line Items]
Subsidiary, ownership percentage, parent	99.96%
Trade Names and Trademarks
Business Combination [Line Items]
Identifiable intangible assets, fair value	$ 300
Customer Relationships
Business Combination [Line Items]
Identifiable intangible assets, fair value	1,400
Biovire
Business Combination [Line Items]
Property and equipment, fair value	$ 15,498
Property and equipment, weighted average period	5 years 7 months 6 days
Biovire \| Trade Names and Trademarks
Business Combination [Line Items]
Identifiable intangible assets, fair value	$ 300
Identifiable intangible assets, amortization period	10 years
Biovire \| Customer Relationships
Business Combination [Line Items]
Identifiable intangible assets, fair value	$ 1,400
Identifiable intangible assets, amortization period	10 years

Accrued Expenses and Other Current Liabilities

9 Months Ended

Sep. 30, 2025

Accounts Payable and Accrued Liabilities, Current [Abstract]

Accrued Expenses and Other Current Liabilities

6. Accrued Expenses and Other Current Liabilities

The components of accrued expenses and other current liabilities as of September 30, 2025 and December 31, 2024 were as follows (in thousands):


	September 30, 2025		December 31, 2024
External research and development expenses	$	12,574	$	7,181
Personnel-related expenses		6,085		5,793
Professional fees		961		1,255
Deferred revenue		259		—
Other		544		436
Total accrued expenses and other current liabilities	$	20,423	$	14,665

Subsequent Events

9 Months Ended

Sep. 30, 2025

Subsequent Events [Abstract]

Subsequent Events

16. Subsequent Events

From October 1, 2025 through November 13, 2025, 2,343,967 shares were sold under the Jefferies Sales Agreement, at a weighted average price of $42.86 per share. The Company received net proceeds of $98.4 million, after deducting discounts and commissions and other offering expenses.

Goodwill and Intangibles, Net - Additional Information (Details) - USD ($)		3 Months Ended	9 Months Ended
	Jul. 20, 2025	Sep. 30, 2025	Sep. 30, 2025	Dec. 31, 2024
Finite-Lived Intangible Assets [Line Items]
Goodwill	$ 12,800,000	$ 12,805,000	$ 12,805,000	$ 0
Goodwill impairment		0	0
Maximum
Finite-Lived Intangible Assets [Line Items]
Intangible assets amortization expense		$ 100,000	$ 100,000
Customer Relationships
Finite-Lived Intangible Assets [Line Items]
Intangible assets, acquired	1,400,000
Trade Names and Trademarks
Finite-Lived Intangible Assets [Line Items]
Intangible assets, acquired	$ 300,000

- Definition

The aggregate expense charged against earnings to allocate the cost of intangible assets (nonphysical assets not used in production) in a systematic and rational manner to the periods expected to benefit from such assets.

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- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

+ Details

- Definition

Amount, after accumulated impairment loss, of asset representing future economic benefit arising from other asset acquired in business combination or from joint venture formation or both, that is not individually identified and separately recognized.

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-Paragraph 4
-Subparagraph (b)
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-URI https://asc.fasb.org/1943274/2147479581/805-30-50-4

+ Details

- Definition

Amount of impairment loss from asset representing future economic benefit arising from other asset acquired in business combination or from joint venture formation or both, that is not individually identified and separately recognized.

+ References + Details

Summary of Significant Accounting Policies (Policies)	9 Months Ended
Summary of Significant Accounting Policies (Policies)	Sep. 30, 2025
Accounting Policies [Abstract]
Business Combinations	Business Combinations The Company uses the acquisition method of accounting for business combinations which requires assets acquired and liabilities assumed to be recognized at their fair values on the acquisition date. Goodwill represents the excess of the purchase price over the fair value of the net assets acquired. The fair values of the assets acquired and liabilities assumed are determined based upon the valuation of the acquired business and involves making significant estimates and assumptions based on facts and circumstances that existed as of the acquisition date. The Company uses a measurement period following the acquisition date to gather information that existed as of the acquisition date that is needed to determine the fair value of the assets acquired and liabilities assumed. The measurement period ends once all information is obtained, but no later than one year from the acquisition date.
Intangible Assets, Net	Intangible Assets, Net Intangible assets acquired in a business combination or an asset acquisition are initially recognized at their fair value on the acquisition date. Acquired definite-lived intangible assets are amortized using the straight-line method over their respective estimated useful lives. The amortization of these intangible assets is included in general and administrative expense on the consolidated statement of operations. Intangible assets are tested for impairment at least annually or more frequently if indicators of potential impairment exist. To date, no such impairments have been recognized.
Recently Issued Accounting Standards	Recently Issued Accounting Standards Accounting standards not listed below were assessed and determined not to be applicable or are expected to have minimal impact on the Company’s unaudited condensed consolidated financial statements. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The guidance includes the requirement that public business entities, on an annual basis, disclose specific categories in the rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items is equal to or greater than 5% of the amount computed by multiplying pretax income (or loss) by the applicable statutory income tax rate). It also requires that all entities disclose, on an annual basis, the amount of income taxes paid (net of refunds received) disaggregated by federal (national), state, and foreign taxes and the amount of income taxes paid (net of refunds received) disaggregated by individual jurisdictions in which income taxes paid (net of refunds received) is equal to or greater than 5% of total income taxes paid (net of refunds received) and requires that all entities disclose income (or loss) from continuing operations before income tax expense (or benefit) disaggregated between domestic and foreign and income tax expense (or benefit) from continuing operations disaggregated by federal (national), state, and foreign. Lastly, the guidance eliminates the requirement for all entities to disclose the nature and estimate of the range of the reasonably possible change in the unrecognized tax benefits balance in the next 12 months or make a statement that an estimate of the range cannot be made. The guidance is effective for the Company for annual periods beginning after December 15, 2025. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. The guidance should be applied on a prospective basis. Retrospective application is permitted. The Company is currently evaluating the impact that this guidance may have on its future consolidated financial statements. In November 2024, the FASB issued ASU No. 2024-03, Comprehensive Income - Expense Disaggregation Disclosures, which will improve the disclosures about a public business entity's expenses and address requests from investors for more detailed information about the types of expenses in commonly presented expense captions such as cost of sales, selling, general and administrative, and research and development. The amendments are effective for fiscal years beginning after December 15, 2026. Early adoption is permitted for annual financial statements that have not yet been issued or made available. The amendments should be applied on either (1) prospectively to financial statements issued for reporting periods after the effective date or (2) retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating the provisions of the amendments and the effect on its future consolidated financial statements. In September 2025, the FASB issued ASU 2025-06, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software, which clarifies and modernizes the accounting for costs related to internal-use software. The amendments remove all references to project stages and clarify the threshold entities apply to begin capitalizing costs. The amendments are effective for fiscal years beginning after December 15, 2027 and interim reporting periods within those annual reporting periods, with early adoption permitted. The Company is currently evaluating the provisions of the amendments and the effect on its future consolidated financial statements.

- Definition

Disclosure of accounting policy for business combination.

+ References

+ Details

Subsequent Events - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands	1 Months Ended	9 Months Ended
	Nov. 13, 2025	Sep. 30, 2025
Subsequent Event [Line Items]
Proceeds from Issuance of Common Stock		$ 49,001
Subsequent Events [Member] \| Open Market Sale Agreement [Member]
Subsequent Event [Line Items]
Sale of stock	2,343,967
Share price	$ 42.86
Proceeds from Issuance of Common Stock	$ 98,400

Commitments and Contingencies - Additional Information (Details)		9 Months Ended	12 Months Ended
	Jul. 29, 2025 USD ($)	Sep. 30, 2025 Claim Leases	Dec. 31, 2024 Leases
Loss Contingencies [Line Items]
Operating leases, description		As of September 30, 2025 and December 31, 2024, the Company had four and two operating leases, respectively. Of the four operating leases as of September 30, 2025, three are leases in which the Company was the lessee for office space. The remaining operating lease was acquired in connection with the Conversion Event and includes office, manufacturing, and warehouse space. As of September 30, 2025, the leases have varying terms expiring between 2026 and 2030.
Number of operating leases			2
Number of finance leases		0	0
Number of claims outstanding \| Claim		0
ANI agreement
Loss Contingencies [Line Items]
Royalty net sales percentage	5.00%
Loss contingency damages value \| $	$ 0

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Accrued Expenses and Other Current Liabilities (Tables)

9 Months Ended

Sep. 30, 2025

Accounts Payable and Accrued Liabilities, Current [Abstract]

Components of Accrued Expenses and Other Current Liabilities

The components of accrued expenses and other current liabilities as of September 30, 2025 and December 31, 2024 were as follows (in thousands):


	September 30, 2025		December 31, 2024
External research and development expenses	$	12,574	$	7,181
Personnel-related expenses		6,085		5,793
Professional fees		961		1,255
Deferred revenue		259		—
Other		544		436
Total accrued expenses and other current liabilities	$	20,423	$	14,665

Debt

9 Months Ended

Sep. 30, 2025

Debt Disclosure [Abstract]

Debt

13. Debt

In January 2021, the Company entered into a loan agreement with Silicon Valley Bank (SVB) (the Loan Agreement) for a term loan in three tranches. In 2021, the Company drew down on two of the tranches in the aggregate principal amount of $15.0 million. On May 12, 2023, the Company repaid all outstanding principal and accrued and unpaid interest on the funds received under the Loan Agreement and all other outstanding obligations with respect to the funds received under the Loan Agreement and made a final payment.

In connection with the Loan Agreement, the Company entered into a Success Fee Agreement (the Success Fee Agreement) with SVB in January 2021. In accordance with the Success Fee Agreement, the Company agreed to pay to SVB an amount equal to (a) the quotient of (i) the aggregate original principal amount of all Term Loan Advances made by SVB to the Company divided by (ii) $5 million, multiplied by (b) $125,000 (the Success Fee), upon the closing of a success fee event (the Success Fee Event) and, in the event of an IPO, within five business days of closing such IPO. In connection with the Company’s IPO, it became obligated to pay SVB the Success Fee.

On March 5, 2024, the Company paid $0.4 million for the Success Fee under the Success Fee Agreement. As of September 30, 2025, the Company has no further obligations in connection with the Loan Agreement.

In connection with the Conversion Event, the Company assumed an unsecured promissory note held by Biovire (the Biovire Note) with an outstanding principal balance of $3.0 million. The Company determined that the carrying amount of the Biovire Note represented its fair value. The Biovire Note is due and payable on February 28, 2028 (Maturity Date) and accrues interest at the lesser of (i) the daily term SOFR rate plus 2.60% and (ii) 25.0%, or the highest rate permitted by applicable law, and is payable monthly. The Company has the ability to repay the Biovire Note in full prior to the Maturity Date without penalty.

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
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+ Details

Common Stock - Additional Information (Details) - shares	Sep. 30, 2025	Dec. 31, 2024
Equity [Abstract]
Common stock, shares authorized	700,000,000	700,000,000
Common stock, shares issued	78,277,452	76,154,783
Common Stock, shares outstanding	78,277,452	76,154,783

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2025

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

The Company’s significant accounting policies are disclosed in the audited financial statements appearing in its 2024 Annual Report.

Business Combinations

The Company uses the acquisition method of accounting for business combinations which requires assets acquired and liabilities assumed to be recognized at their fair values on the acquisition date. Goodwill represents the excess of the purchase price over the fair value of the net assets acquired. The fair values of the assets acquired and liabilities assumed are determined based upon the valuation of the acquired business and involves making significant estimates and assumptions based on facts and circumstances that existed as of the acquisition date. The Company uses a measurement period following the acquisition date to gather information that existed as of the acquisition date that is needed to determine the fair value of the assets acquired and liabilities assumed. The measurement period ends once all information is obtained, but no later than one year from the acquisition date.

Intangible Assets, Net

Intangible assets acquired in a business combination or an asset acquisition are initially recognized at their fair value on the acquisition date. Acquired definite-lived intangible assets are amortized using the straight-line method over their respective estimated useful lives. The amortization of these intangible assets is included in general and administrative expense on the consolidated statement of operations. Intangible assets are tested for impairment at least annually or more frequently if indicators of potential impairment exist. To date, no such impairments have been recognized.

Recently Issued Accounting Standards

Accounting standards not listed below were assessed and determined not to be applicable or are expected to have minimal impact on the Company’s unaudited condensed consolidated financial statements.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The guidance includes the requirement that public business entities, on an annual basis, disclose specific categories in the rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items is equal to or greater than 5% of the amount computed by multiplying pretax income (or loss) by the applicable statutory income tax rate). It also requires that all entities disclose, on an annual basis, the amount of income taxes paid (net of refunds received) disaggregated by federal (national), state, and foreign taxes and the amount of income taxes paid (net of refunds received) disaggregated by individual jurisdictions in which income taxes paid (net of refunds received) is equal to or greater than 5% of total income taxes paid (net of refunds received) and requires that all entities disclose income (or loss) from continuing operations before income tax expense (or benefit) disaggregated between domestic and foreign and income tax expense (or benefit) from continuing operations disaggregated by federal (national), state, and foreign. Lastly, the guidance eliminates the requirement for all entities to disclose the nature and estimate of the range of the reasonably possible change in the unrecognized tax benefits balance in the next 12 months or make a statement that an estimate of the range cannot be made. The guidance is effective for the Company for annual periods beginning after December 15, 2025. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. The guidance should be applied on a prospective basis. Retrospective application is permitted. The Company is currently evaluating the impact that this guidance may have on its future consolidated financial statements.

In November 2024, the FASB issued ASU No. 2024-03, Comprehensive Income - Expense Disaggregation Disclosures, which will improve the disclosures about a public business entity's expenses and address requests from investors for more detailed information about the types of expenses in commonly presented expense captions such as cost of sales, selling, general and administrative, and research and development. The amendments are effective for fiscal years beginning after December 15, 2026. Early adoption is permitted for annual financial statements that have not yet been issued or made available. The amendments should be applied on either (1) prospectively to financial statements issued for reporting periods after the effective date or (2) retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating the provisions of the amendments and the effect on its future consolidated financial statements.

In September 2025, the FASB issued ASU 2025-06, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software, which clarifies and modernizes the accounting for costs related to internal-use software. The amendments remove all references to project stages and clarify the threshold entities apply to begin capitalizing costs. The amendments are effective for fiscal years beginning after December 15, 2027 and interim reporting periods within those annual reporting periods, with early adoption permitted. The Company is currently evaluating the provisions of the amendments and the effect on its future consolidated financial statements.

Stock-Based Compensation - Summary of Stock Option Activity (Details) - Stock Options - USD ($) $ / shares in Units, $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2025	Dec. 31, 2024
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of Outstanding Options, Beginning Balance	6,574,580
Number of Outstanding Options, Granted	2,566,341
Number of Outstanding Options, Exercised	(538,125)
Number of Outstanding Options, Forfeited/Expired	(668,339)
Number of Outstanding Options, Ending Balance	7,934,457	6,574,580
Number of Outstanding Options, Vested and expected to vest	7,934,457
Number of Outstanding Options, Exercisable	3,019,428
Weighted Average Exercise Price, Beginning Balance	$ 14.19
Weighted Average Exercise Price, Granted	21.03
Weighted Average Exercise Price, Exercised	8.79
Weighted Average Exercise Price, Forfeited/Expired	20.42
Weighted Average Exercise Price, Ending Balance	16.24	$ 14.19
Weighted Average Exercise Price, Vested and expected to vest	16.24
Weighted Average Exercise Price, Exercisable	$ 10.56
Weighted Average Remaining Contractual Term (Years)	8 years 2 months 15 days	8 years 2 months 12 days
Weighted Average Remaining Contractual Term (Years), Vested and expected to vest	8 years 2 months 15 days
Weighted Average Remaining Contractual Term (Years), Exercisable	7 years 2 months 26 days
Aggregate Intrinsic Value, Beginning Balance	$ 108,155
Aggregate Intrinsic Value, Ending Balance	190,726	$ 108,155
Aggregate Intrinsic Value, Vested and expected to vest	190,726
Aggregate Intrinsic Value, Exercisable	$ 89,725

Net Loss Per Share Attributable to Common Stockholders - Schedule of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended						9 Months Ended
	Sep. 30, 2025	Jun. 30, 2025	Mar. 31, 2025	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2025	Sep. 30, 2024
Earnings Per Share [Abstract]
Net Income (Loss)	$ (43,808)	$ (41,426)	$ (34,452)	$ (20,405)	$ (18,902)	$ (16,934)	$ (119,686)	$ (56,241)
Weighted-average common stock outstanding, basic	76,729,726			67,143,744			76,383,376	60,311,003
Weighted-average common stock outstanding, diluted	76,729,726			67,143,744			76,383,376	60,311,003
Net loss per share attributable to common stockholders, basic	$ (0.57)			$ (0.3)			$ (1.57)	$ (0.93)
Net loss per share attributable to common stockholders, diluted	$ (0.57)			$ (0.3)			$ (1.57)	$ (0.93)

- Definition

The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.

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The amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period.

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The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

+ Details

Acquisition of Biovire

9 Months Ended

Sep. 30, 2025

Business Combination [Abstract]

Acquisition of Biovire

15. Acquisition of Biovire

On July 20, 2025, the Company obtained control of the SPV through the Conversion Event, resulting in SafeGuard owning 100% of the membership interest of the SPV. As a result of the Conversion Event, the Company also indirectly obtained control of Biovire as the SPV owns 99.96% of the capital stock of Biovire. As a result of this change in control, purchase accounting was applied by the Company and the operations of Biovire are consolidated as of the effective date of the conversion. See footnote 1 for more information on the Note.

Biovire is a contract manufacturer specializing in the fill and finish of novel drugs and medical devices for pharmaceutical and biotech companies. Prior to becoming a majority-owned subsidiary, Biovire was a vendor to the Company and continues to provide clinical supply of cretostimogene used in the Company’s clinical trials. The acquisition provides the Company the ability to supply its requirements of cretostimogene during the remainder of its clinical trials.

Consideration was determined to be the fair value of the note receivable that was exchanged for the majority of shares of the SPV and Biovire. The acquisition was accounted for as a business combination using the acquisition method of accounting, under which the acquired assets, including intangible assets, and assumed liabilities were recognized at their estimated fair values as of July 20, 2025, with the excess of the fair value of consideration transferred over the fair value of the net assets acquired recognized as goodwill. The Company's unaudited condensed consolidated financial statements include the operating results of the SPV and Biovire from the date of acquisition through September 30, 2025.


	Estimated fair value
Identifiable assets acquired
Cash	$	4,033
Current assets		2,826
Operating lease right-of-use assets		3,413
Property and equipment, net		15,498
Intangible assets		1,700
Total identifiable assets acquired		27,470
Liabilities assumed
Current liabilities		2,227
Operating lease liabilities, non-current portion		2,800
Long-term debt		3,000
Deferred tax liability		1,609
Other long-term liabilities		3,795
Total liabilities assumed		13,431
Net identifiable assets acquired		14,039
Goodwill		12,805
Total fair value of consideration paid	$	26,844

The purchase price was allocated to the tangible assets and identifiable intangible assets acquired and liabilities assumed based on their acquisition date estimated fair values. The carrying amount of accounts receivable and inventory acquired represented their fair value. Property and equipment were assigned a fair value of $15.5 million and will be amortized over a weighted average of 5.6 years. The identifiable intangible assets consist of trade names and trademarks and customer relationships which were assigned fair values of approximately $0.3 million and $1.4 million, respectively, and will be amortized on a straight-line basis over their estimated useful lives of 10 years. The acquired property and equipment and intangible assets were valued utilizing either the relief from royalty method or the multi-period excess earnings method as deemed most applicable. These approaches require judgment, including those related to projected net cash flows, revenue growth rates, and the weighted average cost of capital used to discount the cash flows.

Goodwill represents the excess of the purchase price over the identifiable tangible and intangible assets acquired in addition to liabilities assumed arising from the business combination. The Company believes the goodwill related to the acquisition was attributable to the expected synergies, value of the assembled workforce, and the collective experience of the management team with regards to its operations, customers, and industry.

- Definition

The entire disclosure for business combination.

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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479581/805-30-50-4

Reference 22: http://www.xbrl.org/2003/role/disclosureRef
-Topic 805
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)(3)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479907/805-20-50-1

Reference 23: http://www.xbrl.org/2003/role/disclosureRef
-Topic 805
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479907/805-20-50-1

Reference 24: http://www.xbrl.org/2003/role/disclosureRef
-Topic 805
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (h)(4)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479328/805-10-50-2

Reference 25: http://www.xbrl.org/2003/role/disclosureRef
-Topic 805
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (e)(1)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479328/805-10-50-2

Reference 26: http://www.xbrl.org/2003/role/disclosureRef
-Topic 805
-SubTopic 40
-Name Accounting Standards Codification
-Section 45
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479326/805-40-45-1

Reference 27: http://www.xbrl.org/2003/role/disclosureRef
-Topic 805
-SubTopic 30
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org/805-30/tableOfContent

Reference 28: http://www.xbrl.org/2003/role/disclosureRef
-Topic 805
-SubTopic 20
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org/805-20/tableOfContent

Reference 29: http://www.xbrl.org/2003/role/disclosureRef
-Topic 805
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 7
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479328/805-10-50-7

Reference 30: http://www.xbrl.org/2003/role/disclosureRef
-Topic 805
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479328/805-10-50-5

Reference 31: http://www.xbrl.org/2003/role/disclosureRef
-Topic 805
-SubTopic 10
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org/805-10/tableOfContent

+ Details

Property and Equipment, Net - Additional Information (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2025	Sep. 30, 2024
Property, Plant and Equipment [Line Items]
Depreciation expense	$ 500,000		$ 600,000
Maximum
Property, Plant and Equipment [Line Items]
Depreciation expense		$ 100,000		$ 100,000

Property and Equipment, Net

9 Months Ended

Sep. 30, 2025

Property, Plant and Equipment [Abstract]

Property and Equipment, Net

4. Property and Equipment, Net

The components of property and equipment, net as of September 30, 2025 and December 31, 2024 were as follows (in thousands):


	September 30, 2025			December 31, 2024
Leasehold Improvements	$	9,387		$	—
Manufacturing and lab equipment		5,982			—
Machinery and Equipment		583			359
Total property and equipment, cost		15,952			359
Less: Accumulated depreciation		(623	)		(87	)
Property and equipment, net	$	15,329		$	272

Depreciation expense for the three and nine months ended September 30, 2025 was $0.5 million and $0.6 million, respectively, and less than $0.1 million for the three and nine months ended September 30, 2024.

Property and Equipment, Net - Summary of Components of Property and Equipment, Net (Details) - USD ($) $ in Thousands	Sep. 30, 2025	Dec. 31, 2024
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	$ 15,952	$ 359
Less: Accumulated depreciation	(623)	(87)
Property and equipment, net	15,329	272
Leasehold Improvements
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	9,387	0
Manufacturing and Lab Equipment
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	5,982	0
Machinery and Equipment
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	$ 583	$ 359

Commitments and Contingencies - Schedule of Maturities of Lease Liabilities (Details) $ in Thousands	Sep. 30, 2025 USD ($)
Lessee, Operating Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract]
2025	$ 291
2026	1,162
2027	1,137
2028	1,116
2029	1,039
Thereafter	164
Total lease payment	4,909
Less: amount representing imputed interest	(668)
Total future minimum lease obligations	$ 4,241

Fair Value Measurements - Additional Information (Details) - USD ($)	3 Months Ended	9 Months Ended	12 Months Ended
	Sep. 30, 2025	Sep. 30, 2025	Dec. 31, 2024
Fair Value Disclosures [Abstract]
Marketable securities representing fixed income securities (U.S. treasury bills) maturity description		original maturities greater than 90 days
Transfers between Level 1 and Level 2 of fair value hierarchy	$ 0	$ 0	$ 0

Note Receivable - Additional Information (Details) $ in Millions	Feb. 28, 2025 USD ($)
SafeGuard Healthcare, LLC [Member] \| Convertible Promissory Note [Member]
Accounts, Notes, Loans and Financing Receivable [Line Items]
Principal amount of convertible promissory note including accrued interest	$ 26.8

Stock-Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2025	Sep. 30, 2024	Dec. 31, 2024	Jan. 11, 2024
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Stock-based compensation expense	$ 7,331	$ 2,649	$ 19,489	$ 6,412
Gross unrecognized stock-based compensation expense			$ 65,800
Weighted average period of unrecognized compensation expense remained to be amortized			3 years
Stock Options
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Common stock, shares outstanding	7,934,457		7,934,457		6,574,580
Shares of common stock issuable upon the exercise of stock options			538,125
Weighted average grant-date fair value of the options granted			$ 14.49	$ 17.14
Weighted average fair value of shares vested			12.55	$ 4.27
Weighted average fair value of shares exercised	$ 10.56		$ 10.56
Stock-based compensation expense	$ 6,700	$ 2,000	$ 17,500	$ 5,100
Performance-Based Restricted Stock Units
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Performance stock unit, description			A Performance Stock Unit (“PSU”) represents one equivalent share of the Company's common stock to be issued after achievement of the performance metrics specified in the grant.
Gross unrecognized stock-based compensation expense	$ 3,400		$ 3,400
Unrecognized stock-based compensation expense expected to be recognized over weighted-average period			2 years 6 months
2015 Plan
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Common stock, shares outstanding	669,684		669,684
2022 Plan
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Common stock, shares outstanding	3,202,963		3,202,963
2024 Plan
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Common stock, shares outstanding	4,156,434		4,156,434
Common stock available for future issuance	4,230,359		4,230,359			8,246,565
Fair Value \| Stock Options
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Weighted average fair value of shares exercised	$ 6.25	$ 2.07	$ 6.25	$ 2.07

Net Loss Per Share Attributable to Common Stockholders - Schedule of Antidilutive Securities Excluded from Computation of Diluted Net Loss Per Share Attributable to Common Stockholders (Details) - shares	9 Months Ended
	Sep. 30, 2025	Sep. 30, 2024
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share, amount	7,934,457	5,203,163
Stock Options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share, amount	7,934,457	5,203,163

Commitments and Contingencies - Components of Lease Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2025	Sep. 30, 2024
Leases [Abstract]
Operating lease cost	$ 377	$ 77	$ 384	$ 173
Total lease cost	377	77	384	173
Operating lease right-of-use asset obtained in exchange for new operating lease liabilities			859
Cash paid for amounts included in the measurement of lease liabilities, included in operating cash flows	$ 222	$ 60	$ 383	$ 163
Weighted-average remaining lease term	4 years 2 months 19 days	1 year 4 months 28 days	4 years 2 months 19 days	1 year 4 months 28 days
Weighted-average discount rate	6.87%	1.63%	6.87%	1.63%

Stock-Based Compensation

9 Months Ended

Sep. 30, 2025

Share-Based Payment Arrangement [Abstract]

Stock-Based Compensation

11. Stock-Based Compensation

In 2015, the Company established the 2015 Plan, under which the Company may grant options and restricted stock to its employees and certain non-employees. As of September 30, 2025, there were 669,684 shares of common stock subject to outstanding awards under the 2015 Plan. In 2022, the Company established the 2022 Plan, under which the Company may grant options, restricted stock units, restricted stock, stock appreciation rights, dividend equivalents and other stock and cash-based awards to its employees and certain non-employees. As of September 30, 2025, there were 3,202,963 shares of common stock subject to outstanding awards under the 2022 Plan.

On January 11, 2024, the Company’s board of directors and stockholders approved the 2024 Equity Incentive Plan (the 2024 Plan), which became effective on the date immediately preceding the date on which the Company’s registration statement was declared effective by the SEC. The 2024 Plan replaced the 2022 Plan, as the Company’s board of directors has determined to not make additional grants under the 2022 Plan following the closing of the offering. However, the 2015 and 2022 Plans will continue to govern outstanding equity awards granted under the 2015 and 2022 Plans. The 2024 Plan allows the Company to make equity-based and cash-based incentive awards to its officers, employees, directors and consultants. The number of shares initially available for issuance under awards granted pursuant to the 2024 Plan is (1) 8,246,565 shares, plus (2) any shares subject to outstanding awards under the 2015 and 2022 Plans as of the effective date of the 2024 Plan that become available for issuance under the 2024 Plan thereafter in accordance with its terms. As of September 30, 2025, there were 4,156,434 shares of common stock subject to outstanding awards and 4,230,359 shares of common stock remaining and available for issuance under the 2024 Plan.

The Company may grant options to purchase authorized but unissued shares of the Company’s common stock. Options granted under the 2015 Plan, 2022 Plan and 2024 Plan include incentive stock options that can be granted only to the Company’s employees and non-statutory stock options that can be granted to the Company’s employees, consultants, advisors and directors.

The exercise prices, vesting and other restrictions of the awards granted under the 2015 Plan, 2022 Plan and 2024 Plan are determined by the Board, except that no stock option may be issued with an exercise price less than the fair market value of the common stock at the date of the grant or have a term in excess of ten years. Options granted under the 2015 Plan, 2022 Plan and 2024 Plan are exercisable in whole or in part at any time subsequent to vesting.

Stock Options

The following table provides the assumptions used in determining the fair value of option awards for the three and nine months ended September 30, 2025 and 2024:


	Three Months Ended September 30,		Nine Months Ended September 30,
	2025	2024	2025	2024
Expected volatility	76.35% - 77.58%	77.34% - 77.74%	73.39% - 77.58%	77.34% - 84.50%
Risk-free interest rate	3.7% - 4.16%	3.46% - 4.15%	3.7% - 4.5%	3.46% - 4.62%
Expected dividend yield	0%	0%	0%	0%
Expected term (in years)	6.1	6.1	5.25 - 6.1	6.05 - 6.1

The weighted average grant-date fair value of the options granted was $14.49 and $17.14 per share for the nine months ended September 30, 2025 and 2024, respectively. The weighted average fair value of shares vested during the nine months ended September 30, 2025 and 2024 was $12.55 and $4.27 per share, respectively. The weighted average fair value of shares exercised during the nine months ended September 30, 2025 and 2024 was $6.25 and $2.07 per share, respectively.

The following table summarizes stock option activity for the nine months ended September 30, 2025 (in thousands, except share and per share amounts):


	Number of Outstanding Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term		Aggregate Intrinsic Value
						(Years)
Balance at December 31, 2024		6,574,580		$	14.19		8.20	$	108,155
Granted		2,566,341		$	21.03
Exercised		(538,125	)	$	8.79
Forfeited/Expired		(668,339	)	$	20.42
Balance at September 30, 2025		7,934,457		$	16.24		8.21	$	190,726
Vested and expected to vest at September 30, 2025		7,934,457		$	16.24		8.21	$	190,726
Exercisable at September 30, 2025		3,019,428		$	10.56		7.24	$	89,725

The Company recorded stock-based compensation expense related to stock options of $6.7 million and $2.0 million for the three months ended September 30, 2025 and 2024, respectively, and $17.5 million and $5.1 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, the Company had an aggregate $65.8 million of gross unrecognized stock-based compensation expense related to unvested options to be recognized over a weighted average period of 3.0 years.

Performance-Based Restricted Stock Units

A Performance Stock Unit (“PSU”) represents one equivalent share of the Company's common stock to be issued after achievement of the performance metrics specified in the grant. The Company estimates the fair value of a PSU based upon the expected achievement of the performance metrics specified in the grant and the closing market price of the Company's common stock on the date of grant.


	Number of Shares		Weighted Average Grant Date Fair Value

Nonvested at December 31, 2024		—	$	—
Granted		94,624	$	36.48
Nonvested at September 30, 2025		94,624	$	36.48
Expected to vest at September 30, 2025		94,624	$	36.48

Stock-based compensation expense associated with these PSUs is recognized if achievement of the underlying performance condition is considered probable of achievement based on the Company’s best estimates. As of September 30, 2025, the Company had an aggregate $3.4 million of gross unrecognized stock-based compensation expense related to unvested PSUs to be recognized over a weighted average period of 2.5 years.


	Three Months Ended September 30,				Nine Months Ended September 30,
	2025		2024		2025		2024
Research and development	$	2,455	$	901	$	6,410	$	2,223
General and administrative		4,876		1,748		13,079		4,189
Total stock-based compensation expense	$	7,331	$	2,649	$	19,489	$	6,412

The Company has not recognized and does not expect to recognize in the near future, any tax benefit related to employee stock-based compensation expense as a result of the full valuation allowance related to its net deferred tax assets.

Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders' Deficit - USD ($) $ in Thousands	Total	Public Offering [Member]	Common Stock	Common Stock Initial Public Offering	Common Stock Public Offering [Member]	Additional Paid-in Capital	Additional Paid-in Capital Initial Public Offering	Additional Paid-in Capital Public Offering [Member]	Accumulated Deficit	Series A-1 Redeemable Convertible Preferred Stock Preferred Stock	Series B Redeemable Convertible Preferred Stock Preferred Stock	Series C Redeemable Convertible Preferred Stock Preferred Stock	Series D Redeemable Convertible Preferred Stock Preferred Stock	Series E Redeemable Convertible Preferred Stock Preferred Stock	Series F Redeemable Convertible Preferred Stock Preferred Stock
Beginning balance, shares at Dec. 31, 2023										5,075,000	11,973,000	73,598,283	53,271,754	112,422,700	81,587,937
Beginning balance at Dec. 31, 2023										$ 3,570	$ 10,000	$ 22,000	$ 47,300	$ 120,000	$ 105,020
Beginning balance, shares at Dec. 31, 2023			5,222,283
Beginning balance at Dec. 31, 2023	$ (123,100)					$ 6,842			$ (129,942)
Conversion of redeemable convertible preferred stock, shares										(5,075,000)	(11,973,000)	(73,598,283)	(53,271,754)	(112,422,700)	(81,587,937)
Conversion of redeemable convertible preferred stock, value										$ (3,570)	$ (10,000)	$ (22,000)	$ (47,300)	$ (120,000)	$ (105,020)
Conversion of redeemable convertible preferred stock, shares			38,413,909
Conversion of redeemable convertible preferred stock, value	307,890		$ 4			307,886
Issuance of common stock, net of issuance costs, shares			60	23,000,000
Issuance of common stock, net of issuance costs	399,565			$ 3			$ 399,562
Stock-based compensation expense	1,517					1,517
Net loss	(16,934)								(16,934)
Ending balance, shares at Mar. 31, 2024			66,636,252
Ending balance at Mar. 31, 2024	568,938		$ 7			715,807			(146,876)
Beginning balance, shares at Dec. 31, 2023										5,075,000	11,973,000	73,598,283	53,271,754	112,422,700	81,587,937
Beginning balance at Dec. 31, 2023										$ 3,570	$ 10,000	$ 22,000	$ 47,300	$ 120,000	$ 105,020
Beginning balance, shares at Dec. 31, 2023			5,222,283
Beginning balance at Dec. 31, 2023	(123,100)					6,842			(129,942)
Net loss	(56,241)
Ending balance, shares at Sep. 30, 2024			67,537,858
Ending balance at Sep. 30, 2024	536,770		$ 7			722,946			(186,183)
Beginning balance, shares at Mar. 31, 2024			66,636,252
Beginning balance at Mar. 31, 2024	568,938		$ 7			715,807			(146,876)
Issuance of common stock, net of issuance costs, shares			23,600
Issuance of common stock, net of issuance costs	77					77
Stock-based compensation expense						2,246
Net loss	(18,902)								(18,902)
Ending balance, shares at Jun. 30, 2024			66,659,852
Ending balance at Jun. 30, 2024	552,359		$ 7			718,130			(165,778)
Issuance of common stock, net of issuance costs, shares			878,006
Issuance of common stock, net of issuance costs	2,167					2,167
Stock-based compensation expense	2,649					2,649
Net loss	(20,405)								(20,405)
Ending balance, shares at Sep. 30, 2024			67,537,858
Ending balance at Sep. 30, 2024	536,770		$ 7			722,946			(186,183)
Beginning balance, shares at Dec. 31, 2024			76,154,783
Beginning balance at Dec. 31, 2024	733,377		$ 8			951,350			(217,981)
Issuance of common stock, net of issuance costs, shares			66,506
Issuance of common stock, net of issuance costs	682					682
Stock-based compensation expense	5,151					5,151
Net loss	(34,452)								(34,452)
Ending balance, shares at Mar. 31, 2025			76,221,289
Ending balance at Mar. 31, 2025	704,758		$ 8			957,183			(252,433)
Beginning balance, shares at Dec. 31, 2024			76,154,783
Beginning balance at Dec. 31, 2024	$ 733,377		$ 8			951,350			(217,981)
Conversion of redeemable convertible preferred stock, shares	38,413,909
Conversion of redeemable convertible preferred stock, shares	38,413,909
Net loss	$ (119,686)
Ending balance, shares at Sep. 30, 2025			78,277,452
Ending balance at Sep. 30, 2025	687,643		$ 8			1,025,302			(337,667)
Beginning balance, shares at Mar. 31, 2025			76,221,289
Beginning balance at Mar. 31, 2025	704,758		$ 8			957,183			(252,433)
Issuance of common stock, net of issuance costs, shares			10,570
Issuance of common stock, net of issuance costs	19					19
Stock-based compensation expense	7,007					7,007
Net loss	(41,426)								(41,426)
Ending balance, shares at Jun. 30, 2025			76,231,859
Ending balance at Jun. 30, 2025	670,358		$ 8			964,209			(293,859)
Issuance of common stock, net of issuance costs, shares			530,442		1,515,151
Issuance of common stock, net of issuance costs	5,099	$ 48,663				5,099		$ 48,663
Stock-based compensation expense	7,331					7,331
Net loss	(43,808)								(43,808)
Ending balance, shares at Sep. 30, 2025			78,277,452
Ending balance at Sep. 30, 2025	$ 687,643		$ 8			$ 1,025,302			$ (337,667)

Segment Disclosures (Tables)

9 Months Ended

Sep. 30, 2025

Segment Reporting [Abstract]

Schedule of Selected Financial Information with Respect to Single Operating Segment

The following table presents selected financial information with respect to the Company's single operating segment for the three and nine months ended September 30, 2025 and 2024:


	Three Months Ended September 30,						Nine Months Ended September 30,
	2025			2024			2025			2024
Revenues
Commercial and development revenue	$	1,508		$	—		$	1,508		$	—
License and collaboration revenue		158			43			210			683
Total revenues		1,666			43			1,718			683
Less:
Cost of sales		1,577			—			1,577			—
Research and development
Clinical and manufacturing		23,381			15,403			72,818			44,561
Other research and development(1)		4,503			4,219			13,865			10,741
Total research and development		27,884			19,622			86,683			55,302
General and administrative		23,334			8,716			55,532			21,998
Total costs and operating expenses		52,795			28,338			143,792			77,300
Loss from operations		(51,129	)		(28,295	)		(142,074	)		(76,617	)
Other income, net		7,321			7,890			22,388			20,376
Net loss	$	(43,808	)	$	(20,405	)	$	(119,686	)	$	(56,241	)
(1) Other research and development consists of indirect costs incurred for the benefit of the research and development efforts, including certain personnel, supply chain, quality assurance, and regulatory affairs.

Condensed Consolidated Statements of Cash Flows (Parenthetical)	9 Months Ended
	Sep. 30, 2025 shares
Statement of Cash Flows [Abstract]
Reclassification of redeemable convertible preferred stock	38,413,909
Reclassification of common stock	38,413,909

Segment Disclosures

9 Months Ended

Sep. 30, 2025

Segment Reporting [Abstract]

Segment Disclosures

9. Segment Disclosures

The Company operates as a single operating segment. The Company's chief operating decision maker (CODM) is its chief executive officer, who reviews financial information presented on a consolidated basis. The CODM uses consolidated net income (loss) to assess financial performance and allocate resources. The CODM does not review assets in evaluating the results of the single segment and therefore, such information is not presented.

The following table presents selected financial information with respect to the Company's single operating segment for the three and nine months ended September 30, 2025 and 2024:


	Three Months Ended September 30,						Nine Months Ended September 30,
	2025			2024			2025			2024
Revenues
Commercial and development revenue	$	1,508		$	—		$	1,508		$	—
License and collaboration revenue		158			43			210			683
Total revenues		1,666			43			1,718			683
Less:
Cost of sales		1,577			—			1,577			—
Research and development
Clinical and manufacturing		23,381			15,403			72,818			44,561
Other research and development(1)		4,503			4,219			13,865			10,741
Total research and development		27,884			19,622			86,683			55,302
General and administrative		23,334			8,716			55,532			21,998
Total costs and operating expenses		52,795			28,338			143,792			77,300
Loss from operations		(51,129	)		(28,295	)		(142,074	)		(76,617	)
Other income, net		7,321			7,890			22,388			20,376
Net loss	$	(43,808	)	$	(20,405	)	$	(119,686	)	$	(56,241	)
(1) Other research and development consists of indirect costs incurred for the benefit of the research and development efforts, including certain personnel, supply chain, quality assurance, and regulatory affairs.

- Definition

The entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 21
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-21

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 21
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-21

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 32
-Subparagraph (e)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-32

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
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+ Details

Stock-Based Compensation - Summary of Stock-based Compensation Expense Related to Stock Awards (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2025	Sep. 30, 2024
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation expense	$ 7,331	$ 2,649	$ 19,489	$ 6,412
Research and Development
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation expense	2,455	901	6,410	2,223
General and Administrative
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation expense	$ 4,876	$ 1,748	$ 13,079	$ 4,189

Insider Trading Arrangements

3 Months Ended

Sep. 30, 2025

Trading Arrangements, by Individual

Material Terms of Trading Arrangement

From time to time, our Section 16 officers (as defined in Rule 16a–1(f)) and directors may enter into Rule 10b5-1 or non-Rule 10b5-1 trading arrangements (as each such term is defined in Item 408 of Regulation S-K) for the purchase or sale of our securities. During the three months ended September 30, 2025, except for Arthur Kuan's adoption of a 10b5-1 plan for the purchase of our securities, none of our officers or directors adopted, modified or terminated any such trading arrangements.


			Type of Trading Arrangement
Name and Position	Action	Date	Rule 10b5-1*	Non- Rule 10b5-1**	Total Shares to be Purchased	Expiration Date
Arthur Kuan, Chairman and Chief Executive Officer	Adoption	September 15, 2025	X		690,420	The earliest to occur of (i) September 15, 2026, and (ii) the date the aggregate number of shares of stock purchased under the plan is 690,420 shares.

* Contract, instruction or written plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.
** “Non-Rule 10b5-1 trading arrangement” as defined in Item 408(c) of Regulation S-K under the Exchange Act.

Rule 10b5-1 Arrangement Adopted

false

Non-Rule 10b5-1 Arrangement Adopted

false

Rule 10b5-1 Arrangement Terminated

false

Non-Rule 10b5-1 Arrangement Terminated

false

Rule 10b5-1 Arrangement Modified

false

Non-Rule 10b5-1 Arrangement Modified

false

Arthur Kuan

Trading Arrangements, by Individual

Name

Arthur Kuan

Title

Chairman and Chief Executive Officer

Rule 10b5-1 Arrangement Adopted

true

Adoption Date

September 15, 2025

Rule 10b5-1 Arrangement Terminated

true

Non-Rule 10b5-1 Arrangement Terminated

false

September 15, 2025

September 15, 2026

366 days

690,420

Net Loss Per Share Attributable to Common Stockholders (Tables)

9 Months Ended

Sep. 30, 2025

Earnings Per Share [Abstract]

Schedule of Basic and Diluted Net Loss Per Share

Basic and diluted net loss per share was calculated as follows (in thousands, except share and per share amounts):


	Three Months Ended September 30,						Nine Months Ended September 30,
	2025			2024			2025			2024
Numerator:
Net loss and comprehensive loss	$	(43,808	)	$	(20,405	)	$	(119,686	)	$	(56,241	)
Denominator:
Weighted-average common stock outstanding, basic and diluted		76,729,726			67,143,744			76,383,376			60,311,003
Net loss per share attributable to common stockholders, basic and diluted	$	(0.57	)	$	(0.30	)	$	(1.57	)	$	(0.93	)

Schedule of Antidilutive Securities Excluded from Computation of Diluted Net Loss Per Share Attributable to Common Stockholders

The Company excluded the following from the computation of diluted net loss per share attributable to common stockholders at September 30, 2025 and 2024 because including them would have had an anti-dilutive effect:


	September 30,
	2025		2024
Stock options outstanding		7,934,457		5,203,163
Total		7,934,457		5,203,163

Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2025	Sep. 30, 2024
Revenues
Total revenues	$ 1,666	$ 43	$ 1,718	$ 683
Operating costs and expenses
Cost of sales	1,577	0	1,577	0
Research and development	27,884	19,622	86,683	55,302
General and administrative	23,334	8,716	55,532	21,998
Total operating costs and expenses	52,795	28,338	143,792	77,300
Loss from operations	(51,129)	(28,295)	(142,074)	(76,617)
Other income (expense), net:
Interest income, net	7,421	7,892	22,487	20,379
Other (expense) income, net	(100)	(2)	(99)	(3)
Total other income, net	7,321	7,890	22,388	20,376
Net loss and comprehensive loss	$ (43,808)	$ (20,405)	$ (119,686)	$ (56,241)
Net loss per share , basic	$ (0.57)	$ (0.3)	$ (1.57)	$ (0.93)
Net loss per share , diluted	$ (0.57)	$ (0.3)	$ (1.57)	$ (0.93)
Weighted average shares of common stock outstanding, basic	76,729,726	67,143,744	76,383,376	60,311,003
Weighted average shares of common stock outstanding, diluted	76,729,726	67,143,744	76,383,376	60,311,003
Commercial and Development Revenue
Revenues
Total revenues	$ 1,508	$ 0	$ 1,508	$ 0
License and Collaboration Revenue
Revenues
Total revenues	$ 158	$ 43	$ 210	$ 683

Net Loss Per Share Attributable to Common Stockholders

9 Months Ended

Sep. 30, 2025

Earnings Per Share [Abstract]

Net Loss Per Share Attributable to Common Stockholders

14. Net Loss Per Share Attributable to Common Stockholders

Basic and diluted net loss per share was calculated as follows (in thousands, except share and per share amounts):


	Three Months Ended September 30,						Nine Months Ended September 30,
	2025			2024			2025			2024
Numerator:
Net loss and comprehensive loss	$	(43,808	)	$	(20,405	)	$	(119,686	)	$	(56,241	)
Denominator:
Weighted-average common stock outstanding, basic and diluted		76,729,726			67,143,744			76,383,376			60,311,003
Net loss per share attributable to common stockholders, basic and diluted	$	(0.57	)	$	(0.30	)	$	(1.57	)	$	(0.93	)

The Company’s potentially dilutive securities, which include redeemable convertible preferred stock and stock options, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Basic and diluted net loss per share attributable to common stockholders is computed in conformity with the two-class method required for participating securities. The Company considers all series of its redeemable convertible preferred stock to be participating securities as the holders of such stock have the right to receive dividends on a pari passu basis in the event that a dividend is paid on common stock. Under the two-class method, the net loss attributable to common stockholders is not allocated to the redeemable convertible preferred stock as the preferred stockholders do not have a contractual obligation to share in the Company’s losses.


	September 30,
	2025		2024
Stock options outstanding		7,934,457		5,203,163
Total		7,934,457		5,203,163

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2025	Nov. 12, 2025
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Sep. 30, 2025
Document Fiscal Year Focus	2025
Document Fiscal Period Focus	Q3
Current Fiscal Year End Date	--12-31
Document Quarterly Report	true
Document Transition Report	false
Entity File Number	001-41925
Entity Registrant Name	CG Oncology, Inc.
Entity Central Index Key	0001991792
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	37-1611499
Entity Address, Address Line One	400 Spectrum Center Drive
Entity Address, Address Line Two	Suite 2040
Entity Address, City or Town	Irvine
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92618
City Area Code	949
Local Phone Number	409-3700
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	CGON
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	false
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		80,666,179

Fair Value Measurements

9 Months Ended

Sep. 30, 2025

Fair Value Disclosures [Abstract]

Fair Value Measurements

3. Fair Value Measurements

The following tables present the financial instruments carried at fair value on a recurring basis as of September 30, 2025 and December 31, 2024, respectively, in accordance with the ASC 820, Fair Value Measurement (ASC 820) hierarchy (in thousands):


	Fair Value Measurements at September 30, 2025
	Level 1		Level 2		Level 3		Total
Assets
Cash equivalents	$	41,109	$	—	$	—	$	41,109
Marketable securities	$	—	$	635,118	$	—	$	635,118

	Fair Value Measurements at December 31, 2024
	Level 1		Level 2		Level 3		Total
Assets
Cash equivalents	$	256,204	$	—	$	—	$	256,204
Marketable securities	$	—	$	484,930	$	—	$	484,930

The Company’s cash equivalents represent deposits in a short-term U.S. Treasury money market fund quoted in an active market and were classified as a Level 1 fair value measurement. Marketable securities represent fixed income securities (U.S. treasury bills) with original maturities greater than 90 days and were classified as a Level 2 fair value measurement. As of September 30, 2025 and December 31, 2024, the amortized cost of the Company's available for sale marketable securities approximated their fair value. There was no material realized or unrealized gains or losses, either individually or in the aggregate.

There were no transfers between Level 1 and Level 2 of the fair value hierarchy during the three and nine months ended September 30, 2025 and the year ended December 31, 2024.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

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+ Details

Fair Value Measurements (Tables)

9 Months Ended

Sep. 30, 2025

Fair Value Disclosures [Abstract]

Summary of Financial Instruments Carried at Fair Value on Recurring Basis


	Fair Value Measurements at September 30, 2025
	Level 1		Level 2		Level 3		Total
Assets
Cash equivalents	$	41,109	$	—	$	—	$	41,109
Marketable securities	$	—	$	635,118	$	—	$	635,118

	Fair Value Measurements at December 31, 2024
	Level 1		Level 2		Level 3		Total
Assets
Cash equivalents	$	256,204	$	—	$	—	$	256,204
Marketable securities	$	—	$	484,930	$	—	$	484,930

Goodwill and Intangibles, Net

9 Months Ended

Sep. 30, 2025

Goodwill and Intangible Assets Disclosure [Abstract]

Goodwill and Intangibles, Net

5. Goodwill and Intangibles, Net

Goodwill

In connection with the Conversion Event in July 2025, the Company recognized goodwill of $12.8 million. See Note 15 for additional information on this transaction.

The Company annually assesses goodwill for impairment in the fourth quarter of each calendar year and at an interim date if indications of impairment exist. During the three and nine months ended September 30, 2025, no goodwill impairment was recognized.

Intangible Assets

As part of the Conversion Event, the Company acquired customer relationships of $1.4 million and trade names and trademarks of $0.3 million. The components of intangible assets as of September 30, 2025 were as follows (in thousands):


	Gross Carrying Amount		Accumulated Amortization		Net Carrying Amount		Useful Lives (in years)
Customer relationships	$	1,400	$	23	$	1,377		10
Trade names and trade marks		300		5		295		10
Total intangible assets, net	$	1,700	$	28	$	1,672

The Company's intangible assets are amortized on a straight-line basis over their useful lives. Intangible assets amortization expense was less than $0.1 million for the three and nine months ended September 30, 2025. The following table presents the estimated future amortization expense related to intangible assets as of September 30, 2025 (in thousands):


	Accumulated Amortization
2025	$	43
2026		170
2027		170
2028		170
2029		170
Thereafter		949
Total future amortization expense	$	1,672