0000950170-24-124642 | 10-Q | XBRL Viewer

Commitments and Contingencies

9 Months Ended

Sep. 30, 2024

Commitments and Contingencies Disclosure [Abstract]

5. Commitments and Contingencies

Operating Leases

As of September 30, 2024 and December 31, 2023, the Company had two operating leases, in which the Company was the lessee for office space. As of September 30, 2024 and December 31, 2023, the lease terms were through 2025 and 2026. The Company had no finance leases as of September 30, 2024 and December 31, 2023.

The components of lease expense as of September 30, 2024 and 2023 were as follows (in thousands):


	Three Months Ended September 30,						Nine Months Ended September 30,
	2024			2023			2024			2023
Lease cost
Operating lease cost	$	77		$	57		$	173		$	179
Total lease cost	$	77		$	57		$	173		$	179
Other information
Cash paid for amounts included in the measurement of lease liabilities, included in operating cash flows	$	60		$	59		$	163		$	161
Weighted-average remaining lease term		1.41			2.35			1.41			2.35
Weighted-average discount rate		1.63	%		1.63	%		1.63	%		1.63	%

Maturities of lease liabilities as of September 30, 2024 were as follows (in thousands):


2024	$	60
2025		187
2026		52
Total lease payment		299
Less: amount representing imputed interest		(3	)
Total future minimum lease obligations	$	296

Legal Proceedings

A liability for loss contingencies arising from claims, assessments, litigation, fines, penalties, and other sources is recorded in the condensed 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, a complaint was filed against the Company in the Superior Court of the State of Delaware by ANI Pharmaceuticals, Inc. seeking a declaratory judgment that an assignment and technology transfer agreement between the Company and ANI, dated November 15, 2010, obligates the Company to pay ANI a royalty on certain "net sales" of cretostimogene. The Company disputes the allegations raised in the case and is vigorously defending the matter.

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, 2024, the Company had not experienced any losses related to these indemnification obligations, and no claims with respect thereto were outstanding.

Fair Value Measurements (Tables)

9 Months Ended

Sep. 30, 2024

Fair Value Disclosures [Abstract]

Summary of Financial Instruments Carried at Fair Value on Recurring Basis

The following tables present the financial instruments carried at fair value on a recurring basis as of September 30, 2024 and December 31, 2023, respectively, in accordance with the ASC 820, Fair Value Measurement (ASC 820) hierarchy (in thousands):


	Fair Value Measurements at September 30, 2024
	Level 1		Level 2		Level 3		Total
Assets
Cash equivalents	$	17,861	$	—	$	—	$	17,861
Marketable securities	$	—	$	497,299	$	—	$	497,299

	Fair Value Measurements at December 31, 2023
	Level 1		Level 2		Level 3		Total
Assets
Cash equivalents	$	8,240	$	—	$	—	$	8,240
Marketable securities	$	—	$	179,408	$	—	$	179,408

Liabilities
Success fee liability	$	—	$	—	$	365	$	365

Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders' Deficit (Parenthetical) $ in Thousands	3 Months Ended
	Sep. 30, 2023 USD ($)
Deemed dividend	$ 5,336
Series F Redeemable Convertible Preferred Stock
Deemed dividend	$ 410

Net Loss Per Share Attributable to Common Stockholders

9 Months Ended

Sep. 30, 2024

Earnings Per Share [Abstract]

Net Loss Per Share Attributable to Common Stockholders

11. 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,
	2024			2023			2024			2023
Numerator:
Net loss and comprehensive loss	$	(20,405	)	$	(11,768	)	$	(56,241	)	$	(32,052	)
Deemed dividend on redeemable convertible preferred stock issuances		—			(410	)		—			(410	)
Cumulative redeemable convertible preferred stock dividends		—			(5,336	)		—			(12,846	)
Net loss attributable to common stockholders	$	(20,405	)	$	(17,514	)	$	(56,241	)	$	(45,308	)
Denominator:
Weighted-average common shares outstanding, basic and diluted		67,143,744			4,383,131			60,311,003			4,053,341
Net loss per share attributable to common stockholders, basic and diluted	$	(0.30	)	$	(4.00	)	$	(0.93	)	$	(11.18	)

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.

The Company excluded the following from the computation of diluted net loss per share attributable to common stockholders at September 30, 2024 and 2023 because including them would have had an anti-dilutive effect:


	September 30,
	2024		2023
Stock options outstanding		5,203,163		4,691,982
Total		5,203,163		4,691,982

Accrued Expenses and Other Current Liabilities - Components of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Accrued Expenses and Other Current Liabilities [Line Items]
Total accrued expenses and other current liabilities	$ 11,329	$ 10,443
External Research and Development Expenses
Accrued Expenses and Other Current Liabilities [Line Items]
Total accrued expenses and other current liabilities	5,060	6,164
Personnel-related Expenses
Accrued Expenses and Other Current Liabilities [Line Items]
Total accrued expenses and other current liabilities	4,797	2,822
Professional Fees
Accrued Expenses and Other Current Liabilities [Line Items]
Total accrued expenses and other current liabilities	1,251	341
Deferred Offering Costs
Accrued Expenses and Other Current Liabilities [Line Items]
Total accrued expenses and other current liabilities		1,017
Other
Accrued Expenses and Other Current Liabilities [Line Items]
Total accrued expenses and other current liabilities	$ 221	$ 99

Stock-Based Compensation

9 Months Ended

Sep. 30, 2024

Share-Based Payment Arrangement [Abstract]

Stock-Based Compensation

8. 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, 2024, there were 992,459 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, 2024, there were 3,404,697 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 Plan 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 Plan and 2022 Plan 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, 2024, there were 806,007 shares of common stock subject to outstanding awards and 7,711,327 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, 2024 and 2023:


	Three Months Ended September 30,		Nine Months Ended September 30,
	2024	2023	2024	2023
Expected volatility	77.34% - 77.74%	81.8% - 82.1%	77.34% - 84.50%	81.4% - 83.7%
Risk-free interest rate	3.46% - 4.15%	4.33% - 4.35%	3.46% - 4.62%	3.58% - 4.35%
Expected dividend yield	0%	0%	0%	0%
Expected term (in years)	6.1	5.3 - 6.11	6.05 - 6.1	4.95 - 6.11

The weighted average grant-date fair value of the options granted was $17.14 and $3.22 per share for the nine months ended September 30, 2024 and 2023, respectively. The fair value of shares vested during the nine months ended September 30, 2024 and 2023 was $4.27 and $2.02 per share, respectively. The fair value of shares exercised during the nine months ended September 30, 2024 and 2023 was $2.07 and $1.47 per share, respectively.

The following table summarizes stock option activity for the nine months ended September 30, 2024 (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, 2023		5,532,871		$	4.12		8.55	$	40,290
Granted		806,007		$	24.03
Exercised		(872,520	)	$	2.07
Forfeited/Expired		(263,195	)	$	4.69
Balance at September 30, 2024		5,203,163		$	7.52		7.96	$	157,184
Vested and expected to vest at September 30, 2024		5,203,163		$	7.52		7.96	$	157,184
Exercisable at September 30, 2024		1,896,514		$	3.15		6.51	$	65,574

The Company recorded stock-based compensation expense related to stock options of $2.0 million and $0.4 million for the three months ended September 30, 2024 and 2023, respectively, and $5.1 million and $0.8 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, the Company had an aggregate $21.9 million of gross unrecognized stock-based compensation expense related to unvested options to be recognized over a weighted average period of 3.1 years.

Stock-based compensation expense related to stock options and the 2024 Employee Stock Purchase Plan (see Note 9) recorded in the accompanying statements of operations for the three and nine months ended September 30, 2024 and 2023 was as follows (in thousands):


	Three Months Ended September 30,				For the Nine Months Ended September 30,
	2024		2023		2024		2023
Research and development	$	901	$	238	$	2,223	$	430
General and administrative		1,748		156		4,189		320
Total stock-based compensation expense	$	2,649	$	394	$	6,412	$	750

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.

Common Stock - Schedule of Common Stock Reserved for Issuance Upon Conversion (Details)	Sep. 30, 2024 shares
Class of Stock [Line Items]
Common stock reserved for future issuance	13,697,591
Employee Stock Option
Class of Stock [Line Items]
Common stock reserved for future issuance	5,203,163
Reserved for Future Stock Option Issuances
Class of Stock [Line Items]
Common stock reserved for future issuance	7,711,332
Reserved for Future ESPP Issuances
Class of Stock [Line Items]
Common stock reserved for future issuance	783,096

- 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

Accrued Expenses and Other Current Liabilities

9 Months Ended

Sep. 30, 2024

Accounts Payable and Accrued Liabilities, Current [Abstract]

Accrued Expenses and Other Current Liabilities

4. Accrued Expenses and Other Current Liabilities

The components of accrued expenses and other current liabilities as of September 30, 2024 and as of December 31, 2023 were as follows (in thousands):


	September 30, 2024		December 31, 2023
External research and development expenses	$	5,060	$	6,164
Personnel-related expenses		4,797		2,822
Professional fees		1,251		341
Deferred offering costs		—		1,017
Other		221		99
Total accrued expenses and other current liabilities	$	11,329	$	10,443

Description of Business and Basis of Presentation - Additional Information (Details) $ / shares in Units, $ in Thousands		3 Months Ended						9 Months Ended
	Jan. 29, 2024 USD ($) $ / shares shares	Sep. 30, 2024 USD ($)	Jun. 30, 2024 USD ($)	Mar. 31, 2024 USD ($)	Sep. 30, 2023 USD ($)	Jun. 30, 2023 USD ($)	Mar. 31, 2023 USD ($)	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Dec. 31, 2023 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
Cash, cash equivalents and marketable securities		$ 540,700						$ 540,700
Working capital		536,500						536,500
Accumulated deficit		(186,183)						(186,183)		$ (129,942)
Net loss		$ (20,405)	$ (18,902)	$ (16,934)	$ (11,768)	$ (11,613)	$ (8,671)	(56,241)	$ (32,052)
Cash flows from operations								$ (58,051)	$ (31,034)
IPO [Member]
Description of Business and Basis of Presentation [Line Items]
Common shares offering \| shares	20,000,000
Share price \| $ / shares	$ 19
Net proceeds	$ 399,600
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

Common Stock (Tables)

9 Months Ended

Sep. 30, 2024

Equity [Abstract]

Schedule of Common Stock Reserved for Issuance Upon Conversion

As of September 30, 2024, the Company reserved the following shares of common stock for issuance:


	September 30,
	2024
Stock options outstanding		5,203,163
Reserved for future stock option issuances		7,711,332
Reserved for future ESPP issuances		783,096
Total		13,697,591

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (20,405)	$ (18,902)	$ (16,934)	$ (11,768)	$ (11,613)	$ (8,671)	$ (56,241)	$ (32,052)

- 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

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, 2024	Dec. 31, 2023
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of Outstanding Options, Beginning Balance	5,532,871
Number of Outstanding Options, Granted	806,007
Number of Outstanding Options, Exercised	(872,520)
Number of Outstanding Options, Forfeited/Expired	(263,195)
Number of Outstanding Options, Ending Balance	5,203,163	5,532,871
Number of Outstanding Options, Vested and expected to vest	5,203,163
Number of Outstanding Options, Exercisable	1,896,514
Weighted Average Exercise Price, Beginning Balance	$ 4.12
Weighted Average Exercise Price, Granted	24.03
Weighted Average Exercise Price, Exercised	2.07
Weighted Average Exercise Price, Forfeited/Expired	4.69
Weighted Average Exercise Price, Ending Balance	7.52	$ 4.12
Weighted Average Exercise Price, Vested and expected to vest	7.52
Weighted Average Exercise Price, Exercisable	$ 3.15
Weighted Average Remaining Contractual Term (Years)	7 years 11 months 15 days	8 years 6 months 18 days
Weighted Average Remaining Contractual Term (Years), Vested and expected to vest	7 years 11 months 15 days
Weighted Average Remaining Contractual Term (Years), Exercisable	6 years 6 months 3 days
Aggregate Intrinsic Value, Beginning Balance	$ 40,290
Aggregate Intrinsic Value, Ending Balance	157,184	$ 40,290
Aggregate Intrinsic Value, Vested and expected to vest	157,184
Aggregate Intrinsic Value, Exercisable	$ 65,574

Commitments and Contingencies - Additional Information (Details)	9 Months Ended	12 Months Ended
	Sep. 30, 2024 Claim Leases	Dec. 31, 2023 Leases
Commitments and Contingencies Disclosure [Abstract]
Operating leases, description	As of September 30, 2024 and December 31, 2023, the Company had two operating leases, in which the Company was the lessee for office space. As of September 30, 2024 and December 31, 2023, the lease terms were through 2025 and 2026.
Number of operating leases	2	2
Number of finance leases	0	0
Number of claims outstanding \| Claim	0

Stock-Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Jan. 11, 2024	Dec. 31, 2023
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Common stock reserved for future issuance	13,697,591		13,697,591
Stock-based compensation expense	$ 2,649	$ 394	$ 6,412	$ 750
Gross unrecognized stock-based compensation expense			$ 21,900
Weighted average period of unrecognized compensation expense remained to be amortized			3 years 1 month 6 days
Stock Options
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Common stock reserved for future issuance	5,203,163		5,203,163
Common stock, shares outstanding	5,203,163		5,203,163			5,532,871
Shares of common stock issuable upon the exercise of stock options			872,520
Weighted average grant-date fair value of the options granted			$ 17.14	$ 3.22
Fair value of shares vested			4.27	$ 2.02
Fair value of shares exercised	$ 3.15		$ 3.15
Stock-based compensation expense	$ 2,000	$ 400	$ 5,100	$ 800
2015 Plan
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Common stock, shares outstanding	992,459		992,459
2022 Plan
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Common stock, shares outstanding	3,404,697		3,404,697
2024 Plan
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Common stock, shares outstanding	806,007		806,007
Common stock available for future issuance	7,711,327		7,711,327		8,246,565
Fair Value \| Stock Options
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Fair value of shares exercised	$ 2.07	$ 1.47	$ 2.07	$ 1.47

Stock-Based Compensation (Tables)

9 Months Ended

Sep. 30, 2024

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, 2024 and 2023:


	Three Months Ended September 30,		Nine Months Ended September 30,
	2024	2023	2024	2023
Expected volatility	77.34% - 77.74%	81.8% - 82.1%	77.34% - 84.50%	81.4% - 83.7%
Risk-free interest rate	3.46% - 4.15%	4.33% - 4.35%	3.46% - 4.62%	3.58% - 4.35%
Expected dividend yield	0%	0%	0%	0%
Expected term (in years)	6.1	5.3 - 6.11	6.05 - 6.1	4.95 - 6.11

Summary of Stock Option Activity

The following table summarizes stock option activity for the nine months ended September 30, 2024 (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, 2023		5,532,871		$	4.12		8.55	$	40,290
Granted		806,007		$	24.03
Exercised		(872,520	)	$	2.07
Forfeited/Expired		(263,195	)	$	4.69
Balance at September 30, 2024		5,203,163		$	7.52		7.96	$	157,184
Vested and expected to vest at September 30, 2024		5,203,163		$	7.52		7.96	$	157,184
Exercisable at September 30, 2024		1,896,514		$	3.15		6.51	$	65,574

Summary of Stock-based Compensation Expense Related to Stock Options


	Three Months Ended September 30,				For the Nine Months Ended September 30,
	2024		2023		2024		2023
Research and development	$	901	$	238	$	2,223	$	430
General and administrative		1,748		156		4,189		320
Total stock-based compensation expense	$	2,649	$	394	$	6,412	$	750

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2024

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

The Company’s significant accounting policies are disclosed in the audited financial statements appearing in its 2023 Annual Report.

Deferred Offering Costs

The Company capitalizes as deferred offering costs all direct and incremental legal, professional, accounting and other third-party fees incurred in connection with the Company’s IPO. Upon the completion of the IPO in January 2024, the total deferred offering costs were reclassified to additional paid-in capital on the condensed balance sheets.

Classification of Redeemable Convertible Preferred Stock

Classification of the Company’s Series A-1, B, C, D, E and F redeemable convertible preferred stock as of December 31, 2023 was being treated as mezzanine equity and not as part of stockholders’ equity (deficit) because the holders of such shares had liquidation rights in the event of a deemed liquidation that, in certain situations, were not solely within the control of the Company and would have required the redemption of the then-outstanding redeemable convertible preferred stock. In addition, all of the Company’s redeemable convertible preferred stock was redeemable with the passage of time on or after July 28, 2028, by class and if requested by a requisite majority of each class. As a result of the Company’s IPO, the Company’s redeemable convertible preferred stock converted into common stock concurrently with the IPO.

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 condensed financial statements.

In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The guidance includes the requirements that a public entity disclose, on an annual and interim basis, significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, the title and position of the chief operating decision maker, and an explanation of how the chief operating decision maker uses the reported measure(s) of segment profit or loss in assessing segment performance and deciding how to allocate resources. The guidance also requires that a public entity that has a single reportable segment provide all the disclosures required by the guidance and all existing segment disclosures in Accounting Standards Codification (ASC) 280, Segment Reporting. The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. A public entity should apply the amendments in the guidance retrospectively to all prior periods presented in the financial statements. Upon transition, the segment expense categories and amounts disclosed in the prior periods should be based on the significant segment expense categories identified and disclosed in the period of adoption. The Company is currently evaluating the impact that this guidance may have on its 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 financial statements.

Summary of Significant Accounting Policies - Additional Information (Details)	9 Months Ended
	Sep. 30, 2024 Segment
Significant Accounting Policy [Line Items]
Number of reportable segments	1

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, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023
Earnings Per Share [Abstract]
Net Income (Loss)	$ (20,405)	$ (18,902)	$ (16,934)	$ (11,768)	$ (11,613)	$ (8,671)	$ (56,241)	$ (32,052)
Deemed dividend on redeemable convertible preferred stock issuances				(410)				(410)
Cumulative redeemable convertible preferred stock dividends	0			(5,336)			0	(12,846)
Net loss attributable to common stockholders	$ (20,405)			$ (17,514)			$ (56,241)	$ (45,308)
Weighted-average common shares outstanding, basic	67,143,744			4,383,131			60,311,003	4,053,341
Weighted-average common shares outstanding, diluted	67,143,744			4,383,131			60,311,003	4,053,341
Net loss per share attributable to common stockholders, basic	$ (0.3)			$ (4)			$ (0.93)	$ (11.18)
Net loss per share attributable to common stockholders, diluted	$ (0.3)			$ (4)			$ (0.93)	$ (11.18)

- Definition

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

+ References

+ Details

- Definition

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.

+ References

+ Details

- Definition

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

+ References

+ Details

- Definition

Amount, after deduction of tax, noncontrolling interests, dividends on preferred stock and participating securities; of income (loss) available to common shareholders.

+ References

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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Related Parties

9 Months Ended

Sep. 30, 2024

Related Parties

12. Related Parties

In 2023, the Company entered into an agreement with Danforth Advisors, LLC for the provision of interim Chief Financial Officer (CFO) services. Under the agreement, the Company paid Danforth Advisors, LLC for Stephen DiPalma’s services as part-time CFO approximately $0.1 million or less for services rendered for each of the three and nine months ended September 30, 2024 and 2023.

- Definition

The entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.

+ References

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

Condensed Balance Sheets (Parenthetical) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	700,000,000	493,530,000
Common stock, shares issued	67,537,858	5,222,283
Common Stock, shares outstanding	67,537,858	5,222,283
Series A-1 Redeemable Convertible Preferred Stock
Redeemable convertible preferred stock, par value	$ 0.0001	$ 0.0001
Redeemable convertible preferred stock, shares authorized	0	5,075,000
Redeemable convertible preferred stock, shares issued	0	5,075,000
Redeemable convertible preferred stock, shares outstanding	0	5,075,000
Redeemable convertible preferred stock, liquidation value	$ 0	$ 3,570
Series B Redeemable Convertible Preferred Stock
Redeemable convertible preferred stock, par value	$ 0.0001	$ 0.0001
Redeemable convertible preferred stock, shares authorized	0	11,973,000
Redeemable convertible preferred stock, shares issued	0	11,973,000
Redeemable convertible preferred stock, shares outstanding	0	11,973,000
Redeemable convertible preferred stock, liquidation value	$ 0	$ 10,000
Series C Redeemable Convertible Preferred Stock
Redeemable convertible preferred stock, par value	$ 0.0001	$ 0.0001
Redeemable convertible preferred stock, shares authorized	0	73,598,283
Redeemable convertible preferred stock, shares issued	0	73,598,283
Redeemable convertible preferred stock, shares outstanding	0	73,598,283
Redeemable convertible preferred stock, liquidation value	$ 0	$ 22,000
Series D Redeemable Convertible Preferred Stock
Redeemable convertible preferred stock, par value	$ 0.0001	$ 0.0001
Redeemable convertible preferred stock, shares authorized	0	53,271,754
Redeemable convertible preferred stock, shares issued	0	53,271,754
Redeemable convertible preferred stock, shares outstanding	0	53,271,754
Redeemable convertible preferred stock, liquidation value	$ 0	$ 47,300
Series E Redeemable Convertible Preferred Stock
Redeemable convertible preferred stock, par value	$ 0.0001	$ 0.0001
Redeemable convertible preferred stock, shares authorized	0	112,422,700
Redeemable convertible preferred stock, shares issued	0	112,422,700
Redeemable convertible preferred stock, shares outstanding	0	112,422,700
Redeemable convertible preferred stock, liquidation value	$ 0	$ 120,000
Series F Redeemable Convertible Preferred Stock
Redeemable convertible preferred stock, par value	$ 0.0001	$ 0.0001
Redeemable convertible preferred stock, shares authorized	0	81,587,937
Redeemable convertible preferred stock, shares issued	0	81,587,937
Redeemable convertible preferred stock, shares outstanding	0	81,587,937
Redeemable convertible preferred stock, liquidation value	$ 0	$ 105,020

Condensed Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Revenues
Research and collaboration revenue	$ 43	$ 9	$ 683	$ 203
Operating expenses
Research and development	19,622	11,735	55,302	29,412
General and administrative	8,716	2,317	21,998	6,885
Total operating expenses	28,338	14,052	77,300	36,297
Loss from operations	(28,295)	(14,043)	(76,617)	(36,094)
Other income (expense), net:
Interest income, net	7,892	2,283	20,379	4,100
Other (expense) income, net:	(2)	(8)	(3)	(58)
Total other income (expense), net	7,890	2,275	20,376	4,042
Net loss and comprehensive loss	(20,405)	(11,768)	(56,241)	(32,052)
Deemed dividend on redeemable convertible preferred stock issuances		(410)		(410)
Cumulative redeemable convertible preferred stock dividends	0	(5,336)	0	(12,846)
Net loss attributable to common stockholders	$ (20,405)	$ (17,514)	$ (56,241)	$ (45,308)
Net loss per share , basic	$ (0.3)	$ (4)	$ (0.93)	$ (11.18)
Net loss per share , diluted	$ (0.3)	$ (4)	$ (0.93)	$ (11.18)
Weighted average shares of common stock outstanding, basic	67,143,744	4,383,131	60,311,003	4,053,341
Weighted average shares of common stock outstanding, diluted	67,143,744	4,383,131	60,311,003	4,053,341

Debt - Additional Information (Details) $ in Millions	Mar. 05, 2024 USD ($)
Debt Instrument [Line Items]
Success fee	$ 0.4

- 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

Fair Value Measurements - Summary of Financial Instruments Carried at Fair Value on Recurring Basis (Details) - Fair Value, Recurring - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Success Fee Liability
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Liabilities		$ 365
Cash Equivalents
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Assets	$ 17,861	8,240
Marketable Securities
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Assets	497,299	179,408
Level 1 \| Cash Equivalents
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Assets	17,861	8,240
Level 2 \| Marketable Securities
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Assets	$ 497,299	179,408
Level 3 \| Success Fee Liability
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Liabilities		$ 365

Commitments and Contingencies - Schedule of Maturities of Lease Liabilities (Details) $ in Thousands	Sep. 30, 2024 USD ($)
Lessee, Operating Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract]
2024	$ 60
2025	187
2026	52
Total lease payment	299
Less: amount representing imputed interest	(3)
Total future minimum lease obligations	$ 296

Related Parties - Additional Information (Details) - USD ($) $ in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Danforth Advisors, LLC \| Maximum
Related Party Transaction [Line Items]
Amount paid to related party	$ 0.1	$ 0.1	$ 0.1	$ 0.1

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2024	Nov. 07, 2024
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Sep. 30, 2024
Document Fiscal Year Focus	2024
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	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		67,629,675

Debt

9 Months Ended

Sep. 30, 2024

Debt Disclosure [Abstract]

Debt

10. Debt

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. On March 5, 2024, the Company paid $0.4 million for the success fee under the Success Fee Agreement entered into in connection with the Loan Agreement.

- 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.

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+ Details

License and Collaboration Agreements

9 Months Ended

Sep. 30, 2024

License and Collaboration Agreements [Abstract]

License and Collaboration Agreements

6. License and Collaboration Agreements

Lepu Biotech Co., Ltd.

In March 2019, the Company entered into a development and license agreement with 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.

The Company recorded zero and less than $0.1 million in research and collaboration revenue for the three months ended September 30, 2024 and 2023, respectively. The Company recorded $0.5 million and less than $0.1 million in research and collaboration revenue for the nine months ended September 30, 2024 and 2023, respectively.

Kissei Pharmaceutical Co., Ltd.

In March 2020, and amended as of September 2022, the Company entered into a license and collaboration agreement with 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 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 less than $0.1 million and zero in research and collaboration revenue for the three months ended September 30, 2024 and 2023, respectively. The Company recorded $0.2 million and $0.2 million in research and collaboration revenue for the nine months ended September 30, 2024 and 2023, respectively.

Summary of Significant Accounting Policies (Policies)	9 Months Ended
Summary of Significant Accounting Policies (Policies)	Sep. 30, 2024
Accounting Policies [Abstract]
Deferred Offering Costs	Deferred Offering Costs The Company capitalizes as deferred offering costs all direct and incremental legal, professional, accounting and other third-party fees incurred in connection with the Company’s IPO. Upon the completion of the IPO in January 2024, the total deferred offering costs were reclassified to additional paid-in capital on the condensed balance sheets.
Classification of Redeemable Convertible Preferred Stock	Classification of Redeemable Convertible Preferred Stock Classification of the Company’s Series A-1, B, C, D, E and F redeemable convertible preferred stock as of December 31, 2023 was being treated as mezzanine equity and not as part of stockholders’ equity (deficit) because the holders of such shares had liquidation rights in the event of a deemed liquidation that, in certain situations, were not solely within the control of the Company and would have required the redemption of the then-outstanding redeemable convertible preferred stock. In addition, all of the Company’s redeemable convertible preferred stock was redeemable with the passage of time on or after July 28, 2028, by class and if requested by a requisite majority of each class. As a result of the Company’s IPO, the Company’s redeemable convertible preferred stock converted into common stock concurrently with the IPO.
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 condensed financial statements. In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The guidance includes the requirements that a public entity disclose, on an annual and interim basis, significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, the title and position of the chief operating decision maker, and an explanation of how the chief operating decision maker uses the reported measure(s) of segment profit or loss in assessing segment performance and deciding how to allocate resources. The guidance also requires that a public entity that has a single reportable segment provide all the disclosures required by the guidance and all existing segment disclosures in Accounting Standards Codification (ASC) 280, Segment Reporting. The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. A public entity should apply the amendments in the guidance retrospectively to all prior periods presented in the financial statements. Upon transition, the segment expense categories and amounts disclosed in the prior periods should be based on the significant segment expense categories identified and disclosed in the period of adoption. The Company is currently evaluating the impact that this guidance may have on its 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 financial statements.

Unaudited Condensed Statements of Cash Flows - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Operating Activities
Net loss	$ (56,241)	$ (32,052)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	32	13
Amortization of loan fees		12
Final payment amortization and loss on debt extinguishment		767
Success fee amortization		17
Stock-based compensation expense	6,412	750
Accretion of discount on short-term investments	(6,247)	(1,409)
Non-cash lease expense	(17)	14
Changes in operating assets and liabilities:
Prepaid expenses and other current assets	(4,875)	(2,168)
Accounts receivable - other	(45)	(1)
Other assets	(34)	13
Accounts payable	834	630
Accrued expenses and other current liabilities	2,130	2,380
Net cash used in operating activities	(58,051)	(31,034)
Investing Activities
Proceeds from sales and maturities of short-term investments	517,230	166,371
Purchases of short-term investments	(828,874)	(303,100)
Purchases of property and equipment	(25)
Net cash used in investing activities	(311,669)	(136,729)
Financing Activities
Proceeds from initial public offering, net of issuance costs	406,410
Proceeds from issuance of Series F redeemable convertible preferred stock, net of issuance costs		104,627
Payments of success fee or long-term debt	(365)	(16,284)
Proceeds from exercise of common stock options and issuance of common stock under the employee stock purchase plan	2,244	1,820
Deferred offering costs	(3,424)	(270)
Net cash provided by financing activities	404,865	89,893
Net increase (decrease) in cash, cash equivalents and restricted cash	35,145	(77,870)
Cash, cash equivalents and restricted cash at beginning of period	8,266	88,143
Cash, cash equivalents and restricted cash at end of period	43,411	10,273
Supplemental Disclosure of Cash Flow Information
Cash paid for interest		$ 376
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
Reclassification of deferred offering costs	$ 6,845

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, 2024	Sep. 30, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share, amount	5,203,163	4,691,982
Stock Options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share, amount	5,203,163	4,691,982

Stock-Based Compensation - Summary of Stock-based Compensation Expense Related to Stock Options (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation expense	$ 2,649	$ 394	$ 6,412	$ 750
Research and Development
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation expense	901	238	2,223	430
General and Administrative
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation expense	$ 1,748	$ 156	$ 4,189	$ 320

Commitments and Contingencies - Components of Lease Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Leases [Abstract]
Operating lease cost	$ 77	$ 57	$ 173	$ 179
Total lease cost	77	57	173	179
Cash paid for amounts included in the measurement of lease liabilities, included in operating cash flows	$ 60	$ 59	$ 163	$ 161
Weighted-average remaining lease term	1 year 4 months 28 days	2 years 4 months 6 days	1 year 4 months 28 days	2 years 4 months 6 days
Weighted-average discount rate	1.63%	1.63%	1.63%	1.63%

Fair Value Measurements - Additional Information (Details) - USD ($)	3 Months Ended	9 Months Ended	12 Months Ended
	Sep. 30, 2024	Sep. 30, 2024	Dec. 31, 2023	Mar. 05, 2024
Fair Value Disclosures [Abstract]
Marketable securities representing fixed income securities (U.S. treasury bills) maturity description		original maturities greater than 90 days
Success fee				$ 400,000
Transfers between Level 1 and Level 2 of fair value hierarchy	$ 0	$ 0	$ 0

Condensed Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 43,411	$ 8,266
Marketable securities	497,299	179,408
Prepaid expenses and other current assets	11,233	6,358
Accounts receivable - other	137	92
Total current assets	552,080	194,124
Property and equipment, net	63	69
Operating lease right-of-use assets	275	422
Other assets	53	19
Deferred offering costs		4,667
Total assets	552,471	199,301
Current liabilities:
Accounts payable	4,076	3,242
Success fee liability, current portion		352
Operating lease liabilities, current portion	225	217
Accrued expenses and other current liabilities	11,329	10,443
Total current liabilities	15,630	14,254
Success fee liability, non-current		13
Operating lease liabilities, net of current portion	71	244
Total liabilities	15,701	14,511
Commitments and contingencies
Stockholders' equity (deficit):
Common stock, $0.0001 par value per share; 700,000,000 and 493,530,000 shares authorized as of June 30, 2024 and December 31, 2023, respectively; 66,659,852 and 5,222,283 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively	7
Additional paid-in capital	722,946	6,842
Accumulated deficit	(186,183)	(129,942)
Total stockholders' equity (deficit)	536,770	(123,100)
Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit)	$ 552,471	199,301
Series A-1 Redeemable Convertible Preferred Stock
Redeemable convertible preferred stock:
Redeemable convertible preferred stock		3,570
Series B Redeemable Convertible Preferred Stock
Redeemable convertible preferred stock:
Redeemable convertible preferred stock		10,000
Series C Redeemable Convertible Preferred Stock
Redeemable convertible preferred stock:
Redeemable convertible preferred stock		22,000
Series D Redeemable Convertible Preferred Stock
Redeemable convertible preferred stock:
Redeemable convertible preferred stock		47,300
Series E Redeemable Convertible Preferred Stock
Redeemable convertible preferred stock:
Redeemable convertible preferred stock		120,000
Series F Redeemable Convertible Preferred Stock
Redeemable convertible preferred stock:
Redeemable convertible preferred stock		$ 105,020

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, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected volatility, Minimum	77.34%	81.80%	77.34%	81.40%
Expected volatility, Maximum	77.74%	82.10%	84.50%	83.70%
Risk-free interest rate, Minimum	3.46%	4.33%	3.46%	3.58%
Risk-free interest rate, Maximum	4.15%	4.35%	4.62%	4.35%
Expected dividend yield	0.00%	0.00%	0.00%	0.00%
Expected term (in years)	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 9 days	6 years 1 month 6 days	6 years 1 month 9 days
Minimum
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected term (in years)		5 years 3 months 18 days	6 years 18 days	4 years 11 months 12 days

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, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
License and Collaboration Agreements [Line Items]
Research and collaboration revenue			$ 43,000	$ 9,000	$ 683,000	$ 203,000
Lepu Biotech Co., Ltd.
License and Collaboration Agreements [Line Items]
One-time upfront payment		$ 4,500,000
Collaboration agreement transaction price		4,500,000
Research and collaboration revenue			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
Research and collaboration revenue				100,000		100,000
Kissei Pharmaceutical Co., Ltd.
License and Collaboration Agreements [Line Items]
One-time upfront payment	$ 10,000,000
Research and collaboration revenue			$ 100,000	$ (0)	$ 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
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

Employee Stock Purchase Plan - Additional Information (Details) - USD ($) $ in Millions		3 Months Ended	9 Months Ended
	Jan. 11, 2024	Sep. 30, 2024	Sep. 30, 2024
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of shares issued under ESPP		13,697,591	13,697,591
ESPP
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of shares issued under ESPP	812,242	800,000	800,000
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	$ 1.4
Gross unrecognized stock-based compensation cost		$ 3.3	$ 3.3
Unrecognized stock-based compensation expense expected to be recognized over weighted-average period			1 year 5 months 4 days
ESPP shares purchased during period (in shares)		29,146	29,146

Fair Value Measurements

9 Months Ended

Sep. 30, 2024

Fair Value Disclosures [Abstract]

Fair Value Measurements

3. Fair Value Measurements


	Fair Value Measurements at September 30, 2024
	Level 1		Level 2		Level 3		Total
Assets
Cash equivalents	$	17,861	$	—	$	—	$	17,861
Marketable securities	$	—	$	497,299	$	—	$	497,299

	Fair Value Measurements at December 31, 2023
	Level 1		Level 2		Level 3		Total
Assets
Cash equivalents	$	8,240	$	—	$	—	$	8,240
Marketable securities	$	—	$	179,408	$	—	$	179,408

Liabilities
Success fee liability	$	—	$	—	$	365	$	365

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, 2024 and December 31, 2023, 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.

The success fee liability associated with the Loan and Security Agreement (the Loan Agreement) the Company entered into in January 2021 was classified as a Level 3 fair value measurement, due to the use of unobservable inputs. On March 5, 2024, the Company paid $0.4 million for the success fee. See Note 10 for additional information on the success fee.

There were no transfers between Level 1 and Level 2 of the fair value hierarchy during the three and nine months ended September 30, 2024 and the year ended December 31, 2023.

- 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.

+ References

Reference 1: http://www.xbrl.org/2003/role/exampleRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 107
-Publisher FASB
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Reference 2: http://www.xbrl.org/2003/role/exampleRef
-Topic 820
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-Name Accounting Standards Codification
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-Paragraph 100
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
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-Paragraph 6A
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
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-Name Accounting Standards Codification
-Section 50
-Paragraph 6A
-Subparagraph (d)
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-URI https://asc.fasb.org/1943274/2147482106/820-10-50-6A

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 940
-SubTopic 820
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478119/940-820-50-1

+ Details

Commitments and Contingencies (Tables)

9 Months Ended

Sep. 30, 2024

Commitments and Contingencies Disclosure [Abstract]

Components of Lease Expense

The components of lease expense as of September 30, 2024 and 2023 were as follows (in thousands):


	Three Months Ended September 30,						Nine Months Ended September 30,
	2024			2023			2024			2023
Lease cost
Operating lease cost	$	77		$	57		$	173		$	179
Total lease cost	$	77		$	57		$	173		$	179
Other information
Cash paid for amounts included in the measurement of lease liabilities, included in operating cash flows	$	60		$	59		$	163		$	161
Weighted-average remaining lease term		1.41			2.35			1.41			2.35
Weighted-average discount rate		1.63	%		1.63	%		1.63	%		1.63	%

Schedule of Maturities of Lease Liabilities

Maturities of lease liabilities as of September 30, 2024 were as follows (in thousands):


2024	$	60
2025		187
2026		52
Total lease payment		299
Less: amount representing imputed interest		(3	)
Total future minimum lease obligations	$	296

Redeemable Convertible Preferred Stock - Summary of Redeemable Convertible Preferred Stock (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Series A-1 Redeemable Convertible Preferred Stock
Class of Stock [Line Items]
Authorized Shares	0	5,075,000
Shares Issued	0	5,075,000
Shares outstanding	0	5,075,000
Liquidation & Carrying Value		$ 3,570
Series B Redeemable Convertible Preferred Stock
Class of Stock [Line Items]
Authorized Shares	0	11,973,000
Shares Issued	0	11,973,000
Shares outstanding	0	11,973,000
Liquidation & Carrying Value		$ 10,000
Series C Redeemable Convertible Preferred Stock
Class of Stock [Line Items]
Authorized Shares	0	73,598,283
Shares Issued	0	73,598,283
Shares outstanding	0	73,598,283
Liquidation & Carrying Value		$ 22,000
Series D Redeemable Convertible Preferred Stock
Class of Stock [Line Items]
Authorized Shares	0	53,271,754
Shares Issued	0	53,271,754
Shares outstanding	0	53,271,754
Liquidation & Carrying Value		$ 47,300
Series E Redeemable Convertible Preferred Stock
Class of Stock [Line Items]
Authorized Shares	0	112,422,700
Shares Issued	0	112,422,700
Shares outstanding	0	112,422,700
Liquidation & Carrying Value		$ 120,000
Series F Redeemable Convertible Preferred Stock
Class of Stock [Line Items]
Authorized Shares	0	81,587,937
Shares Issued	0	81,587,937
Shares outstanding	0	81,587,937
Liquidation & Carrying Value		$ 105,020

Common Stock - Additional Information (Details) - shares	Sep. 30, 2024	Dec. 31, 2023
Equity [Abstract]
Common stock, shares authorized	700,000,000	493,530,000
Common stock, shares issued	67,537,858	5,222,283
Common Stock, shares outstanding	67,537,858	5,222,283

Condensed Statements of Cash Flows (Parenthetical)	9 Months Ended
Condensed Statements of Cash Flows (Parenthetical)	Sep. 30, 2024 shares
Statement of Cash Flows [Abstract]
Reclassification of redeemable convertible preferred stock	38,413,909
Reclassification of common stock	38,413,909

Accrued Expenses and Other Current Liabilities (Tables)

9 Months Ended

Sep. 30, 2024

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, 2024 and as of December 31, 2023 were as follows (in thousands):


	September 30, 2024		December 31, 2023
External research and development expenses	$	5,060	$	6,164
Personnel-related expenses		4,797		2,822
Professional fees		1,251		341
Deferred offering costs		—		1,017
Other		221		99
Total accrued expenses and other current liabilities	$	11,329	$	10,443

Employee Stock Purchase Plan

9 Months Ended

Sep. 30, 2024

Employee Stock Purchase Plan [Abstract]

Employee Stock Purchase Plan

9. 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 29,146 shares purchased under the ESPP during the three and nine months ended September 30, 2024. On September 30, 2024, there were approximately 0.8 million shares available for issuance under the ESPP.

The Company recorded stock-based compensation expense under the ESPP of approximately $0.6 million and $1.4 million for the three and nine months ended September 30, 2024, respectively. As of September 30, 2024, the Company had $3.3 million of gross unrecognized stock-based compensation expense under the ESPP to be recognized over a weighted average period of 1.43 years.

Net Loss Per Share Attributable to Common Stockholders (Tables)

9 Months Ended

Sep. 30, 2024

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,
	2024			2023			2024			2023
Numerator:
Net loss and comprehensive loss	$	(20,405	)	$	(11,768	)	$	(56,241	)	$	(32,052	)
Deemed dividend on redeemable convertible preferred stock issuances		—			(410	)		—			(410	)
Cumulative redeemable convertible preferred stock dividends		—			(5,336	)		—			(12,846	)
Net loss attributable to common stockholders	$	(20,405	)	$	(17,514	)	$	(56,241	)	$	(45,308	)
Denominator:
Weighted-average common shares outstanding, basic and diluted		67,143,744			4,383,131			60,311,003			4,053,341
Net loss per share attributable to common stockholders, basic and diluted	$	(0.30	)	$	(4.00	)	$	(0.93	)	$	(11.18	)

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


	September 30,
	2024		2023
Stock options outstanding		5,203,163		4,691,982
Total		5,203,163		4,691,982

Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders' Deficit - USD ($) $ in Thousands	Total	Initial Public Offering	Common Stock	Common Stock Initial Public Offering	Additional Paid-in Capital	Additional Paid-in Capital Initial Public Offering	Accumulated Deficit	Series A-1 Redeemable Convertible Preferred Stock	Series A-1 Redeemable Convertible Preferred Stock Preferred Stock	Series B Redeemable Convertible Preferred Stock	Series B Redeemable Convertible Preferred Stock Preferred Stock	Series C Redeemable Convertible Preferred Stock	Series C Redeemable Convertible Preferred Stock Preferred Stock	Series D Redeemable Convertible Preferred Stock	Series D Redeemable Convertible Preferred Stock Preferred Stock	Series E Redeemable Convertible Preferred Stock	Series E Redeemable Convertible Preferred Stock Preferred Stock	Series F Redeemable Convertible Preferred Stock	Series F Redeemable Convertible Preferred Stock Preferred Stock
Beginning balance, shares at Dec. 31, 2022									5,075,000		11,973,000		73,598,283		53,271,754		112,422,700
Beginning balance at Dec. 31, 2022									$ 3,570		$ 10,000		$ 22,000		$ 47,300		$ 120,000
Beginning balance, shares at Dec. 31, 2022			3,842,694
Beginning balance at Dec. 31, 2022	$ (77,693)				$ 3,642		$ (81,335)
Issuance of common stock, net of issuance costs, shares			13,656
Issuance of common stock, net of issuance costs	68				68
Stock-based compensation expense	179				179
Net loss	(8,671)						(8,671)
Ending balance, shares at Mar. 31, 2023									5,075,000		11,973,000		73,598,283		53,271,754		112,422,700
Ending balance at Mar. 31, 2023									$ 3,570		$ 10,000		$ 22,000		$ 47,300		$ 120,000
Ending balance, shares at Mar. 31, 2023			3,856,350
Ending balance at Mar. 31, 2023	(86,117)				3,889		(90,006)
Beginning balance, shares at Dec. 31, 2022									5,075,000		11,973,000		73,598,283		53,271,754		112,422,700
Beginning balance at Dec. 31, 2022									$ 3,570		$ 10,000		$ 22,000		$ 47,300		$ 120,000
Beginning balance, shares at Dec. 31, 2022			3,842,694
Beginning balance at Dec. 31, 2022	(77,693)				3,642		(81,335)
Net loss	(32,052)
Ending balance, shares at Sep. 30, 2023									10,150,000		23,946,000		73,598,283		53,271,754		112,422,700		81,587,937
Ending balance at Sep. 30, 2023									$ 7,140		$ 20,000		$ 22,000		$ 47,300		$ 120,000		$ 105,020
Ending balance, shares at Sep. 30, 2023			5,068,651
Ending balance at Sep. 30, 2023	(107,584)		$ 1		5,802		(113,387)
Beginning balance, shares at Mar. 31, 2023									5,075,000		11,973,000		73,598,283		53,271,754		112,422,700
Beginning balance at Mar. 31, 2023									$ 3,570		$ 10,000		$ 22,000		$ 47,300		$ 120,000
Beginning balance, shares at Mar. 31, 2023			3,856,350
Beginning balance at Mar. 31, 2023	(86,117)				3,889		(90,006)
Issuance of common stock, net of issuance costs, shares			183,790
Issuance of common stock, net of issuance costs	165				165
Stock-based compensation expense	177				177
Net loss	(11,613)						(11,613)
Ending balance, shares at Jun. 30, 2023									5,075,000		11,973,000		73,598,283		53,271,754		112,422,700
Ending balance at Jun. 30, 2023									$ 3,570		$ 10,000		$ 22,000		$ 47,300		$ 120,000
Ending balance, shares at Jun. 30, 2023			4,040,140
Ending balance at Jun. 30, 2023	(97,388)				4,231		(101,619)
Issuance of Series F redeemable convertible preferred stock (inclusive of deemed dividend of $410 to accrete to redemption value), shares																			81,587,937
Issuance of Series F redeemable convertible preferred stock (inclusive of deemed dividend of $410 to accrete to redemption value), value																			$ 105,020
Issuance of Series F redeemable convertible preferred stock (inclusive of deemed dividend of $410 to accrete to redemption value)	(410)				(410)
Net loss									$ 3,570		$ 10,000
Net loss, shares									5,075,000		11,973,000
Issuance of common stock, net of issuance costs, shares			1,028,511
Issuance of common stock, net of issuance costs	1,588		$ 1		1,587
Stock-based compensation expense	394				394
Net loss	(11,768)						(11,768)
Ending balance, shares at Sep. 30, 2023									10,150,000		23,946,000		73,598,283		53,271,754		112,422,700		81,587,937
Ending balance at Sep. 30, 2023									$ 7,140		$ 20,000		$ 22,000		$ 47,300		$ 120,000		$ 105,020
Ending balance, shares at Sep. 30, 2023			5,068,651
Ending balance at Sep. 30, 2023	(107,584)		$ 1		5,802		(113,387)
Beginning balance, shares at Dec. 31, 2023								5,075,000	5,075,000	11,973,000	11,973,000	73,598,283	73,598,283	53,271,754	53,271,754	112,422,700	112,422,700	81,587,937	81,587,937
Beginning balance at Dec. 31, 2023								$ 3,570	$ 3,570	$ 10,000	$ 10,000	$ 22,000	$ 22,000	$ 47,300	$ 47,300	$ 120,000	$ 120,000	$ 105,020	$ 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	5,075,000	11,973,000	11,973,000	73,598,283	73,598,283	53,271,754	53,271,754	112,422,700	112,422,700	81,587,937	81,587,937
Beginning balance at Dec. 31, 2023								$ 3,570	$ 3,570	$ 10,000	$ 10,000	$ 22,000	$ 22,000	$ 47,300	$ 47,300	$ 120,000	$ 120,000	$ 105,020	$ 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	38,413,909
Conversion of redeemable convertible preferred stock, shares	38,413,909
Net loss	$ (56,241)
Ending balance, shares at Sep. 30, 2024								0		0		0		0		0		0
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				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								0		0		0		0		0		0
Ending balance, shares at Sep. 30, 2024			67,537,858
Ending balance at Sep. 30, 2024	$ 536,770		$ 7		$ 722,946		$ (186,183)

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Sep. 30, 2024 shares
Leonard Post, PhD
Trading Arrangements, by Individual
Name	Leonard Post, PhD
Title	Officer or Director
Rule 10b5-1 Arrangement Adopted	true
Non-Rule 10b5-1 Arrangement Adopted	false
Adoption Date	September 6, 2024
Expiration Date	The earlier to occur of (i) November 28, 2025, and (ii) upon the execution of all instructions provided in the plan
Arrangement Duration	449 days
Aggregate Available	23,000
Charming Jade Limited
Trading Arrangements, by Individual
Name	Charming Jade Limited
Title	Officer or Director
Rule 10b5-1 Arrangement Adopted	true
Non-Rule 10b5-1 Arrangement Adopted	false
Adoption Date	September 13, 2024
Expiration Date	The earlier to occur of (i) June 11, 2025, and (ii) the execution of all instructions provided in the plan
Arrangement Duration	272 days
Aggregate Available	1,266,814

Common Stock

9 Months Ended

Sep. 30, 2024

Equity [Abstract]

Common Stock

7. Common Stock

The Company is authorized to issue up to 700,000,000 and 493,530,000 shares of common stock at September 30, 2024 and December 31, 2023, respectively, of which 67,537,858 and 5,222,283 shares were issued and outstanding at September 30, 2024 and December 31, 2023, 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.

Voting

Each holder of outstanding shares of common stock shall be entitled to one vote in respect of each share. The holders of outstanding shares of common stock, voting together as a single class, shall be entitled to elect one director. The number of authorized shares of common stock may be increased or decreased by the affirmative vote of a majority of the outstanding shares of common stock and preferred stock voting together as a single class.

Dividends

The holders of common stock shall be entitled to receive dividends out of funds legally available therefor 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, 2024, the Company reserved the following shares of common stock for issuance:


	September 30,
	2024
Stock options outstanding		5,203,163
Reserved for future stock option issuances		7,711,332
Reserved for future ESPP issuances		783,096
Total		13,697,591

- Definition

The entire disclosure for equity.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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-Subparagraph (i)
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-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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Reference 15: http://www.xbrl.org/2003/role/disclosureRef
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Reference 17: http://www.xbrl.org/2003/role/disclosureRef
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Reference 18: http://www.xbrl.org/2003/role/disclosureRef
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Reference 19: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Description of Business and Basis of Presentation

9 Months Ended

Sep. 30, 2024

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 condensed 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.

The shares of common stock underlying outstanding stock options and other equity instruments were proportionately reduced and the respective exercise prices, if applicable, were proportionately increased in accordance with the terms of the agreements governing such securities. In addition, the conversion ratios for each series of the Company’s redeemable convertible preferred stock, which automatically converted into shares of common stock upon the closing of the offering, were proportionally adjusted. Stockholders entitled to fractional shares as a result of the reverse stock split received a cash payment in lieu of receiving fractional shares.

On January 29, 2024, the Company completed the closing of its initial public offering (IPO) of 20,000,000 common shares at a price of $19.00 per share. Additionally, the underwriters exercised their option to purchase an additional 3,000,000 at a price of $19.00 per share. The common shares 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.

Basis of Presentation

The accompanying unaudited condensed financial statements as of September 30, 2024 and for the three and nine months ended September 30, 2024 and 2023 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 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, 2023 included in the Company's Annual Report on Form 10-K for the year ended December 31, 2023 (2023 Annual Report). In the opinion of management, the interim 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 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, 2024, the Company had approximately $540.7 million of cash, cash equivalents and marketable securities and working capital of approximately $536.5 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, 2024, the Company had an accumulated deficit of $186.2 million. During the three and nine months ended September 30, 2024, the Company incurred net losses of $20.4 million and $56.2 million, respectively, and negative cash flows from operations of $58.1 million during the nine months ended September 30, 2024. 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.