0001404644-24-000104 | 10-Q | XBRL Viewer

Commitment and Contingencies

9 Months Ended

Sep. 30, 2024

Commitments and Contingencies Disclosure [Abstract]

Operating and Finance Leases

Supplemental lease expense related to leases for the three and nine months ended September 30, 2024 and 2023 was as follows (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Operating lease cost	$	508	$	259	$	1,553	$	777
Finance lease cost
Amortization of finance leases	12		10		39		24
Interest on finance lease liabilities	3		3		9		9
Variable lease cost	364		19		978		129
Short-term lease cost	18		21		53		63
Total lease cost	$	905	$	312	$	2,632	$	1,002

The following table summarizes the maturity of the Company’s operating and finance lease liabilities on an undiscounted cash flow basis and a reconciliation to the operating and finance lease liabilities recognized on the Company’s condensed consolidated balance sheet as of September 30, 2024 (in thousands):


Maturity of operating lease liabilities
2024 (remaining)	$	982
2025	3,987
2026	3,695
2027	3,239
2028	3,294
2029	613
Total lease payments	$	15,810
Less: interest	(2,784)
Total operating lease liabilities	$	13,026


Maturity of finance lease liabilities
2024 (remaining)	$	15
2025	60
2026	21
2027	6
Total lease payments	$	102
Less: interest	(9)
Total finance lease liabilities	$	93

Supplemental balance sheet information related to leases as of September 30, 2024 was as follows (in thousands):


Leases
Operating right-of-use assets	$	3,193

Operating lease liabilities, current	2,856
Operating lease liabilities, non-current	10,170
Total operating lease liabilities	$	13,026

Finance right-of-use assets	$	84

Finance lease liabilities, current	54
Finance lease liabilities, non-current	39
Total finance lease liabilities	$	93


Other information
Cash paid for amounts included in measurement of operating lease liabilities (in thousands)	$	2,899
Cash paid for amounts included in measurement of finance lease liabilities (in thousands)	$	45
Weighted-average remaining lease term - operating leases (in years)	4.18
Weighted-average remaining lease term - finance lease (in years)	1.87
Weighted-average discount rate - operating leases	9.73		%
Weighted-average discount rate - finance lease	11.05		%

Lease CVR

As of September 30, 2024, approximately $1.2 million was recorded as a component of the contingent value rights liability on the Company’s condensed consolidated balance sheet consisting of lease commitments that were probable and estimable at the Closing. The commitments relate to Neoleukin’s sublease agreement, effective October 31, 2023, for one of its properties with an unrelated third party for the remainder of the lease term.

Intellectual Property CVR

Under the CVR Agreement, each CVR holder is eligible to receive 100% of the net proceeds, if any, derived from any consideration paid as a result of the disposition of Neoleukin’s pre-merger legacy assets pursuant any agreements entered into before the Closing, and 80% of net proceeds, if any, derived from any consideration paid as a result of the disposition of Neoleukin’s pre-merger legacy assets pursuant any agreements entered into within one year after the Closing (the “Intellectual Property CVR”). Contingent consideration liabilities related to the CVR Agreement will only be recorded if the liabilities are probable and estimable as of the balance sheet date. Refer to the December 2023 CVR Licensing Agreement and April 2024 CVR Licensing Agreement subsections below for further detail on the current agreements related to our Intellectual Property CVR.

December 2023 CVR Licensing Agreement

Prior to the Closing, Neoleukin entered into a licensing agreement on December 13, 2023 with an unrelated third party to develop and commercialize certain legacy Neoleukin assets (the “December 2023 CVR Licensing Agreement”). In June 2024, an upfront payment of $0.2 million was received by the Company. Since the December 2023 CVR Licensing Agreement was entered into before the Closing, the CVR holders are eligible to receive 100% of the net proceeds derived from the December 2023 CVR Licensing Agreement. Accordingly, an upfront payment of $0.2 million was recorded as licensing revenue within the condensed consolidated statements of operations. The December 2023 CVR Licensing Agreement contains development, regulatory and commercialization milestones totaling up to approximately $13.4 million, as well as royalty payments. However, as of September 30, 2024, no other development and sales milestones were achieved nor deemed probable of achievement under the December 2023 CVR Licensing Agreement.

April 2024 CVR Licensing Agreement

In April 2024, the Company entered into a licensing and intellectual property assignment agreement with another unrelated third party to develop and commercialize certain legacy Neoleukin assets (the “April 2024 CVR Licensing Agreement”). In April 2024, the Company received a one-time upfront payment of approximately $0.8 million and reimbursement of $10,000 for patent expenses under the April 2024 CVR Licensing Agreement. Since the April 2024 CVR Licensing Agreement was entered into within one year after the Closing, the CVR holders are eligible to receive 80% of the net proceeds derived from the April 2024 CVR Licensing Agreement. Accordingly, the Company has recorded $0.8 million as licensing revenue within the condensed consolidated statements of operations. The April 2024 CVR Licensing Agreement contains development, regulatory and commercialization milestones totaling up to approximately $11.0 million, as well as royalty payments. However, as of September 30, 2024, no other development and sales milestones were achieved nor deemed probable of achievement under the April 2024 CVR Licensing Agreement.

The December 2023 CVR Licensing Agreement and April 2024 CVR Licensing Agreement collectively account for the total Intellectual Property CVR. The total amount of $0.9 million due under the Intellectual Property CVR was offset by approximately $0.4 million due to deductions permitted under the Merger Agreement and $0.5 million from the first CVR payment discussed below. As of September 30, 2024, $0.1 million is recorded within contingent value rights liability as an offset arising from the Intellectual Property CVR on the Company's condensed consolidated balance sheet, which can only be applied against licensing revenues from the December 2023 Licensing Agreement or the April 2024 CVR Licensing Agreement.

Sales Tax CVR

Prior to the Closing, Neoleukin entered into an agreement with an unrelated third party for refund analysis services of Washington state sales tax. As discussed and defined within the Contingent Value Rights section of Note 3, Summary of Significant Accounting Policies, the terms of the CVR Agreement include that CVR holders are eligible to receive net proceeds derived from an anticipated sales tax refund from Washington state relating to tax returns filed by Neoleukin prior to Closing. As of September 30, 2024, it was deemed probable that the Company will receive proceeds from Washington state for the sales tax refund and will remit the proceeds to the CVR holders. As of September 30, 2024, $0.3 million is accrued as a component of the contingent value rights liability arising from the Sales Tax CVR in the condensed consolidated balance sheet.

CVR Payment

In August 2024, the Company made the first CVR payment to CVR holders, net of expenses, for $0.6 million. $0.5 million was applied to the Intellectual Property CVR and $0.1 million was applied to the Lease CVR, reducing the respective liabilities.

The following table summarizes the components of the contingent value rights liability in the condensed consolidated balance sheet as of September 30, 2024 and December 31, 2023 (in thousands):


	September 30, 2024				December 31, 2023
	Current		Non-Current		Current		Non-Current
Lease CVR	$	436	$	717	$	281	$	1,006
Intellectual Property CVR, net	—		(71)		—		—
Sales Tax CVR	332		—		—		—
Total CVR liability	$	768	$	646	$	281	$	1,006

As per the CVR Agreement, the total amount owed to CVR holders, after deductions permitted under the Merger Agreement, must be at least $0.5 million to trigger a CVR payment prior to the end of the CVR term.

All other payments under the CVR Agreement were not considered probable and estimable as of September 30, 2024 and therefore no additional contingent consideration liability has been recorded. The Company will evaluate the probable and estimable range of outcomes under the CVR Agreement at each reporting period until the end of the CVR term and adjust the amounts accrued for as necessary.

Employment Agreements

The Company has employment and consulting agreements with key personnel providing for compensation and severance in certain circumstances, as defined in the respective employment agreements.

Other Research and Development Arrangements

As of September 30, 2024, the Company had standing agreements with consultants, contractors or service providers that generally can be terminated by the Company with 30 to 60 days written notice, unless otherwise indicated.

Litigation and Legal Proceedings

The Company is subject to litigation and other claims that arise in the ordinary course of business. While the ultimate result of outstanding legal matters cannot presently be determined, the Company does not expect that the ultimate disposition will have a material effect on its results of financial condition, results of operations or cash flows. However, legal matters are inherently unpredictable and subject to significant uncertainties, some of which are beyond the Company’s control. As such, there can be no assurance that the final outcome of any particular legal matter will not have a material adverse effect on the Company’s financial condition results of operations or cash flows.

Investments (Tables)

9 Months Ended

Sep. 30, 2024

Investments, Debt and Equity Securities [Abstract]

Debt Securities, Held-to-Maturity

The following table summarizes the Company’s investment securities as of September 30, 2024 and December 31, 2023 (in thousands):


	September 30, 2024
	Amortized cost, as adjusted		Gross unrealized holding gains		Gross unrealized holding losses		Estimated fair value
Cash equivalents:
Money market funds	$	63,120	$	—	$	—	$	63,120
Short-term investments:
U.S. treasury notes	72,360		172		—		72,532
Total	$	135,480	$	172	$	—	$	135,652


	December 31, 2023
	Amortized cost, as adjusted		Gross unrealized holding gains		Gross unrealized holding losses		Estimated fair value
Cash equivalents:
Money market funds	$	144,358	$	—	$	—	$	144,358
Short-term investments:
U.S. treasury notes	48,947		16		—		48,963
Total	$	193,305	$	16	$	—	$	193,321

- Definition

Tabular disclosure of information about investment in debt security measured at amortized cost (held-to-maturity).

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+ Details

Stockholders’ Equity (Deficit) - Reserved Shares for Future Issuance (Details) - shares	Sep. 30, 2024	Dec. 31, 2023
Class of Stock [Line Items]
Total common stock reserved (in shares)	3,330,198	3,061,555
Unvested restricted stock units
Class of Stock [Line Items]
Total common stock reserved (in shares)	477,613	0
Options outstanding
Class of Stock [Line Items]
Total common stock reserved (in shares)	1,384,182	823,833
2023 Equity Incentive Plan
Class of Stock [Line Items]
Total common stock reserved (in shares)	1,468,403	2,237,722

- 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

Subsequent Events (Details) - USD ($) $ / shares in Units, $ in Thousands		1 Months Ended	9 Months Ended
	Nov. 05, 2024	Nov. 13, 2024	Sep. 30, 2024	Dec. 18, 2023
Subsequent Event [Line Items]
Granted (in shares)			849,012
Common stock issued upon exercise of stock options (in shares)			83,795
Class of warrant or right, number of securities called by warrants or rights (in shares)				1,825,635
Subsequent Event
Subsequent Event [Line Items]
Granted (in shares)		34,695
Common stock issued upon exercise of stock options (in shares)		8,858
Sale of stock, consideration received on transaction	$ 189,500
Subsequent Event \| Private Placement
Subsequent Event [Line Items]
Sale of stock, number of shares issued in transaction (in shares)	1,835,000
Sale of stock, price per share (in dollars per share)	$ 50.00
Class of warrant or right, number of securities called by warrants or rights (in shares)	2,165,042
Class of warrant or right, purchase price of warrants or rights	$ 49.999
Class of warrant or right, exercise price of warrants or rights (in dollars per share)	$ 0.001
Sale of stock, consideration received on transaction, gross	$ 200,000

Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Operating activities
Net loss	$ (55,630)	$ (38,700)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense	5,833	1,063
Depreciation and amortization of property and equipment	2,410	2,445
Asset impairment	91	0
Non-cash operating lease expense	548	492
Amortization of finance lease right-of-use assets	39	24
Amortization and accretion of premiums/discounts on held-to-maturity investments	(1,460)	0
Contingent value rights liability	127	0
Changes in assets and liabilities:
Prepaid expenses and other current assets	(1,454)	(870)
Other assets	(25)	0
Accounts payable	339	1,509
Accrued expenses and other liabilities	(2,030)	88
Operating lease liabilities	(1,895)	(501)
Net cash used in operating activities	(53,107)	(34,450)
Investing activities
Purchases of property and equipment	(692)	(193)
Purchases of held-to-maturity investments	(80,203)	0
Proceeds from maturities of held-to-maturity investments	58,250	0
Net cash used in investing activities	(22,645)	(193)
Financing activities
Offering costs in connection with pre-closing financing	(4,287)	(1,961)
Transaction costs related to reverse merger	(2,855)	0
Proceeds from the issuance of common stock upon exercise of options	1,187	167
Principal payments on finance leases	(39)	(21)
Net cash used in financing activities	(5,994)	(1,815)
Net decrease in cash, cash equivalents and restricted cash	(81,746)	(36,458)
Cash, cash equivalents and restricted cash at beginning of period	148,718	82,021
Cash, cash equivalents and restricted cash at end of period	66,972	45,563
Supplemental disclosure of non-cash investing and financing activities:
Additions to operating lease right of use assets from new operating lease liabilities	60	0
Property and equipment included in accounts payable and accrued expenses	703	0
Additions to finance lease right of use assets from new finance lease liabilities	25	46
Deferred offering costs in accrued expenses	9	1,095
Supplemental cash flow information:
Cash paid for interest	$ 10	$ 9

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

Stock-Based Compensation - Summary of Operating Expenses (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Total expense	$ 2,474	$ 386	$ 5,833	$ 1,063
Research and development
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Total expense	1,272	242	3,212	657
General and administrative
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Total expense	$ 1,202	$ 144	$ 2,621	$ 406

- 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

Summary of Significant Accounting Policies - Narrative (Details) $ in Thousands	9 Months Ended
	Sep. 30, 2024 USD ($) segment	Dec. 31, 2023 USD ($)
Accounting Policies [Abstract]
Number of operating segments \| segment	1
Number of reportable segments \| segment	1
Restricted cash \| $	$ 339	$ 508
Cash and cash equivalents, at or above FDIC insurance limits \| $	$ 66,500

Stock-Based Compensation

9 Months Ended

Sep. 30, 2024

Share-Based Payment Arrangement [Abstract]

Stock-Based Compensation

The Company measures stock-based awards at their grant-date fair value and records compensation expense on a straight-line basis over the vesting period of the awards. The Company recorded stock-based compensation expense in the following expense categories in its accompanying statements of operations (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Research and development	$	1,272	$	242	$	3,212	$	657
General and administrative	1,202		144		2,621		406
Total expense	$	2,474	$	386	$	5,833	$	1,063

The following table summarizes the option activity:


	Number of shares	Weighted average exercise price per share		Weighted average remaining contractual term (years)
Outstanding at December 31, 2023	823,833	$	31.43	5.89
Granted	849,012	$	35.31
Exercised *	(83,795)	$	17.63
Expired/Forfeited	(204,868)	$	74.86
Outstanding at September 30, 2024	1,384,182	$	28.22	8.09
Exercisable at September 30, 2024	461,339	$	18.34	6.02

* 14,582 options were exercised on September 30, 2024 and the cash for the option exercise was received on October 1, 2024. Accordingly, a receivable of approximately $0.3 million was recorded as a reduction in additional paid-in-capital as of September 30, 2024 in the condensed consolidated balance sheet.

As of September 30, 2024, the aggregate intrinsic value of outstanding options and exercisable options was approximately $20.0 million and $11.8 million, respectively. The aggregate intrinsic value of options exercised was approximately $1.4 million for the nine months ended September 30, 2024.

The weighted-average grant date fair value of options granted was $26.52 and $12.99 per share for the nine months ended September 30, 2024 and 2023, respectively. The Company recorded stock-based compensation related to stock options of approximately $1.8 million and $0.4 million for the three months ended September 30, 2024 and 2023, respectively, and $4.3 million and $1.0 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, the total unrecognized compensation expense related to unvested stock option awards was approximately $19.9 million, which the Company expects to recognize over a weighted-average period of 3.08 years.

The fair value of each option was estimated on the grant date using the weighted average assumptions in the table below:


	Three Months Ended September 30,		Nine Months Ended September 30,
	2024	2023	2024	2023
Expected volatility	90.85%-92.31%	—%-—%	86.39%-92.31%	82.96%-83.70%
Risk-free interest rate	3.43%-4.40%	—%-—%	3.43%-4.60%	3.45% - 4.46%
Expected life (in years)	5.95-6.12	0.00-0.00	5.50-6.15	3.58 - 6.08
Expected dividend yield	—	—	—	—
Fair value of common stock (1)				$	18.39

(1) Prior to the reverse merger, the Company periodically estimated the fair value of the Company’s common stock considering, among other things, valuations of its common stock prepared by management with the assistance of a third-party valuation firm in accordance with the guidance provided by the American Institute of Certified Public Accountants 2013 Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. Following the reverse merger, the fair value of the Company’s common stock is based on the closing stock price on the date of grant as reported on the Nasdaq Global Market.

A summary of the Company’s RSU activity and related information for the nine months ended September 30, 2024 is as follows:


	Number of Shares	Weighted Average Grant Date Fair Value
Unvested at December 31, 2023	—	$	—
Restricted stock units granted	482,384	$	36.06
Restricted stock units forfeited	(4,771)	$	36.06
Unvested at September 30, 2024	477,613	$	36.06

252,124 of these RSUs were granted with vesting in two equal tranches based on certain performance conditions ("PSUs"). Each PSU entitles the holder to receive one share of the Company's common stock when the PSU vests. During the nine months ended September 30, 2024, the related performance conditions were not met and are not currently considered probable to vest. As such, no expense is recognized as of September 30, 2024.

The Company recorded stock-based compensation expense related to RSUs of approximately $0.7 million and $1.5 million for the three and nine months ended September 30, 2024, respectively. As of September 30, 2024, there was approximately $6.6 million of unrecognized compensation cost related to unvested RSUs, which is expected to be recognized over a remaining weighted average vesting period of approximately 2.44 years.

Prepaid expenses and other current assets (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
Refunds and other receivables	$ 672	$ 600
Prepaid expenses	2,382	1,496
Other current assets	1,600	1,095
Total prepaid and other current assets	$ 4,654	$ 3,191

Accrued Expenses and Other Current Liabilities

9 Months Ended

Sep. 30, 2024

Payables and Accruals [Abstract]

Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consist of the following (in thousands):


	September 30, 2024		December 31, 2023
Compensation, bonuses and related benefits	$	3,432	$	3,496
Research and development	6,483		4,895
Accrued severance, bonus, and retention (1)	—		2,476
Accrued offering costs in connection with pre-closing financing	—		3,334
Accrued transaction costs related to reverse merger	—		2,557
Other	523		737
Total accrued expenses and other current liabilities	$	10,438	$	17,495

(1) Includes accrued severance, bonus, and retention payments for former Neoleukin employees.

Stockholders’ Equity (Deficit) - Narrative (Details)	9 Months Ended
Stockholders’ Equity (Deficit) - Narrative (Details)	Sep. 30, 2024 $ / shares shares	Dec. 31, 2023 $ / shares shares
Class of Stock [Line Items]
Common stock, shares authorized (in shares)	450,000,000	450,000,000
Common stock, par or stated value per share (in dollars per share) \| $ / shares	$ 0.000001	$ 0.000001
Percentage of outstanding stock per stockholder, maximum	0.0999
Percentage of outstanding stock per stockholder, upon notice, maximum	0.1999
Class of warrant or right, notice period	61 days
Pre Funded Warrants
Class of Stock [Line Items]
Class of warrant or right, outstanding (in shares)	3,959,954
Class of warrant or right, exercise price of warrants or rights (in dollars per share) \| $ / shares	$ 0.000001
Shares issued upon the exercise of pre-funded warrants (in shares)	103,407

Stockholders’ Equity (Deficit) (Tables)

9 Months Ended

Sep. 30, 2024

Equity [Abstract]

Schedule of Common Stock Reserved for Future Issuance

The Company had reserved shares of common stock for future issuance as follows:


	September 30, 2024	December 31, 2023
Unvested restricted stock units	477,613	–
Options outstanding	1,384,182	823,833
Shares available for future grant under the 2023 Equity Incentive Plan	1,468,403	2,237,722
Total common stock reserved	3,330,198	3,061,555

Property and Equipment, Net (Tables)

9 Months Ended

Sep. 30, 2024

Property, Plant and Equipment [Abstract]

Property, Plant and Equipment

Property and equipment, net consist of the following (in thousands):


	September 30, 2024		December 31, 2023
Lab equipment	$	3,244	$	3,144
Manufacturing equipment	6,326		6,142
Office Equipment	19		19
Leasehold improvements	15,396		15,376
Software	268		268
Construction in progress	1,202		234
Total property and equipment, cost	26,455		25,183
Less accumulated depreciation	(10,387)		(8,009)
Property and equipment, net	$	16,068	$	17,174

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2024

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the United States Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, these financial statements do not include all of the information and footnotes required by U.S. GAAP for complete financial statements and should be read in conjunction with the audited consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 18, 2024.

In management’s opinion, the unaudited condensed consolidated financial statements reflect all adjustments (consisting of normal recurring adjustments) necessary to present fairly the financial position of the Company as of September 30, 2024, and results of operations and cash flows for all periods presented. The interim results presented are not necessarily indicative of results that can be expected for the full year ending December 31, 2024.

Use of Estimates

The preparation of the financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. In preparing these financial statements, management used significant estimates in the following areas, among others: recoverability of the Company’s net deferred tax assets and related valuation allowance, useful lives and recoverability of property and equipment, determining the incremental borrowing rate for calculating lease liabilities and related right-of-use assets and finance lease assets, revenue recognition, clinical trial accruals, accrual estimates for all contingent value rights (“CVRs”), the value attributed to employee stock options and other stock-based awards, and valuation of common stock. On an ongoing basis, the Company reviews its estimates to ensure that they appropriately reflect changes in the business or as new information becomes available. Actual results may differ from these estimates.

Segment Information

Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources and in assessing performance. The Company’s CODM is the Chief Executive Officer. The CODM assesses performance of the segment according to clinical and pre-clinical data along with program specific expenses and market conditions in the pharmaceutical and biotechnology sectors. The Company operates as a single operating segment and has one reportable segment. The Company’s operations and its assets are held in the United States.

Cash and Cash Equivalents

The Company considers all highly-liquid investments purchased with original maturities of 90 days or less at time of purchase to be cash equivalents. Cash and cash equivalents include cash held in banks and are stated at fair value.

The following table provides a reconciliation of cash, cash equivalents, and restricted cash in the balance sheets that sum to the total of the same such amounts shown in the statements of cash flows (in thousands):


	September 30, 2024		December 31, 2023
Cash and cash equivalents	$	66,633	$	148,210
Restricted cash	339		508
Total cash, cash equivalents and restricted cash	$	66,972	$	148,718

Cash equivalents consist of money market funds in which the carrying value equals the fair value. Restricted cash includes $0.3 million in cash deposits the Company maintains with its bank as collateral for the irrevocable letters of credits related to its lease obligations.

Concentrations of Credit Risk

Financial instruments that subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company’s cash and cash equivalent accounts, at times, may exceed federally insured limits. As of September 30, 2024, the Company had $66.5 million in excess of the federally insured limits. The Company places its cash in financial institutions that management believes to be of high credit quality.

Revenue Recognition

The Company recognizes revenue when its customers obtain control of promised goods or services in an amount that reflects the consideration that the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements within the scope of Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers, (“ASC 606”) the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the performance obligation is satisfied.

In applying the ASC 606 framework, the Company must apply judgment to determine the nature of the promises within a revenue contract and whether those promises represent distinct performance obligations. In determining the transaction price, the Company does not include amounts subject to uncertainties unless it is probable that there will be no significant reversal of cumulative revenue when the uncertainty is resolved. Milestone and other forms of variable consideration that the Company may earn are subject to significant uncertainties of research and development related achievements, which generally are deemed not probable until such milestones are actually achieved. For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and where the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Additionally, the Company develops assumptions that require judgment to determine the standalone selling price of each performance obligation identified in the contract. The Company then allocates the total transaction price to each performance obligation based on the estimated standalone selling prices of each performance obligation for which it recognizes revenue as or when the performance obligations are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the variable consideration and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis.

Under the Company’s license agreements, the Company grants the license to a customer as it exists at the point of transfer and the nature of the license is a right to use the Company’s intellectual property as transferred. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, upfront fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. As of September 30, 2024, the Company has two revenue-generating agreements that are related to the legacy Neoleukin business as part of the reverse merger: the December 2023 CVR Licensing Agreement (as defined below) and the April 2024 CVR Licensing Agreement (as defined below). Refer to Note 9, Commitments and Contingencies, for further discussion on the CVR components.

Contingent Value Rights

In conjunction with the reverse merger, the Company entered into a CVR Agreement on December 18, 2023 with the Rights Agent named therein (the “CVR Agreement”) prior to Closing. Included in the CVR Agreement are three different types of CVRs: (i) the Lease CVR, (ii) the Intellectual Property CVR, and (iii) the Sales Tax CVR (each as defined in the CVR agreement). The Company evaluated each of the CVRs to determine if they qualified as derivatives under ASC 815, Derivatives and Hedging, and concluded that since certain scope exceptions were met, the CVRs did not qualify as derivatives. Instead, the Company records a contingent consideration liability associated with the CVRs when payments are probable and estimable under ASC 450, Contingencies. In assessing whether payments are probable and estimable, the Company considers the existence of or ability to enter into agreements with third parties or government agencies and the timing of potential payments. Refer to Note 9, Commitments and Contingencies, for further discussion on the CVRs.

Exit and Disposal Costs

In connection with the reverse merger and through early fiscal 2025, the Company has incurred and expects to incur costs to wind-down Neoleukin’s Phase 1 trial of NL-201. This trial has ceased further development, and the Company has no plans to continue developing Neoleukin’s de novo protein technology. As a result, the trial’s activities do not provide the Company any future economic benefit. In accordance with ASC 420, Exit or Disposal Costs, the Company accrued the remaining costs to be incurred in the trial. The liability was classified as accrued expenses and other current liabilities in the condensed consolidated balance sheet.

A summary of the accrued liabilities activity recorded in connection with the wind-down of Neoleukin’s Phase 1 trial of NL-201 for the nine months ended September 30, 2024 is as follows (in thousands):


	Balance at December 31, 2023		Liability Adjustment		Amounts Paid		Balance at September 30, 2024
Trial wind-down costs:
Phase 1 NL-201 Trial	$	1,962	$	(201)	$	(999)	$	762

Significant Accounting Policies

The Company’s significant accounting policies are disclosed in the audited financial statements filed with the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. Since the date of those financial statements, there have been no changes to the Company’s significant accounting policies.

Net Loss Per Share Attributable to Common Stockholders

For the prior year period in which the Company had multiple classes of stock participating in earnings, the Company used the two-class method in calculating net loss per share. The two-class method requires income available to ordinary shareholders for the period to be allocated between ordinary shares and participating securities based upon their respective rights. The Company considered its convertible preferred stock to be participating securities as holders would be entitled to participate in dividends and earnings of the Company. As the holders of the convertible preferred stock have no obligation to fund losses, the two-class method is not applicable during periods with a net loss.

Basic net loss per share of Class A and Class B common stock was computed by dividing net loss attributable to the Company by the weighted-average number of shares of Class A and Class B common stock outstanding during the period. In periods of losses, diluted net loss per share was computed on the same basis as basic net loss per share as the inclusion of any other potential shares outstanding would be anti-dilutive.

Following the Company’s reverse merger in December 2023, the Company only has one class of common stock remaining, referred to throughout as “common stock.” Basic net loss per share of common stock is computed by dividing net income attributable to the Company by the weighted-average number of shares of common stock outstanding during the period. In periods of losses, diluted net loss per share is computed on the same basis as basic net loss per share as the inclusion of any other potential shares outstanding would be anti-dilutive.

The following table sets forth the computation of basic and diluted net loss per share (in thousands, except share amounts):


	Nine Months Ended September 30,
	2024		2023
	Common stock		Class A		Class B
Numerator:
Net loss	$	(55,630)	$	(38,700)	$	—
Denominator:
Weighted-average shares outstanding in computing net loss per share, basic and diluted	16,932,976		441,498		—
Net loss per share, basic and diluted	$	(3.29)	$	(87.66)	$	—

The following potentially dilutive securities have been excluded from the diluted per share calculations as they would be anti-dilutive:


	Nine Months Ended September 30,
	2024	2023
Series A-1 convertible preferred stock (1)	—	18,604,653
Series A-2 convertible preferred stock (1)	—	13,291,208
Series B convertible preferred stock (1)	—	74,405,719
Stock options	1,384,182	609,656
Total	1,384,182	106,911,236

(1) The convertible preferred stock does not reflect the application of the 0.0756 Exchange Ratio.

Recently Issued Accounting Standards

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on its condensed financial statements or disclosures.

Recently Issued Accounting Pronouncements Not Yet Adopted

In November 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280). The amendments in this update expand segment disclosure requirements, including new segment disclosure requirements for entities with a single reportable segment among other disclosure requirements. This update is effective for the Company in the consolidated financial statements for the year ending December 31, 2024, and interim periods beginning after January 1, 2025. The Company is analyzing the impact of this standard on its disclosures in the condensed consolidated financial statements.

In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which requires consistent categories and greater disaggregation of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction. This standard will be effective for annual periods beginning after December 15, 2024. The Company is currently evaluating the impact of this standard on the Company’s condensed consolidated financial statements and related disclosures

Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Payables and Accruals [Abstract]
Compensation, bonuses and related benefits	$ 3,432	$ 3,496
Research and development	6,483	4,895
Accrued severance, bonus, and retention	0	2,476
Accrued offering costs in connection with pre-closing financing	0	3,334
Accrued transaction costs related to reverse merger	0	2,557
Other	523	737
Total accrued expenses and other current liabilities	$ 10,438	$ 17,495

Summary of Significant Accounting Policies - Cash and Cash Equivalents (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023	Sep. 30, 2023	Dec. 31, 2022
Accounting Policies [Abstract]
Cash and cash equivalents	$ 66,633	$ 148,210
Restricted cash	339	508
Total cash, cash equivalents and restricted cash	$ 66,972	$ 148,718	$ 45,563	$ 82,021

Property and Equipment, Net - Property and Equipment (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	$ 26,455	$ 25,183
Less accumulated depreciation	(10,387)	(8,009)
Property and equipment, net	16,068	17,174
Lab equipment
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	3,244	3,144
Manufacturing equipment
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	6,326	6,142
Office Equipment
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	19	19
Leasehold improvements
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	15,396	15,376
Software
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	268	268
Construction in progress
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	$ 1,202	$ 234

Accrued Expenses and Other Current Liabilities (Tables)

9 Months Ended

Sep. 30, 2024

Payables and Accruals [Abstract]

Schedule of Accrued Liabilities

Accrued expenses and other current liabilities consist of the following (in thousands):


	September 30, 2024		December 31, 2023
Compensation, bonuses and related benefits	$	3,432	$	3,496
Research and development	6,483		4,895
Accrued severance, bonus, and retention (1)	—		2,476
Accrued offering costs in connection with pre-closing financing	—		3,334
Accrued transaction costs related to reverse merger	—		2,557
Other	523		737
Total accrued expenses and other current liabilities	$	10,438	$	17,495

(1) Includes accrued severance, bonus, and retention payments for former Neoleukin employees.

Prepaid expenses and other current assets

9 Months Ended

Sep. 30, 2024

Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]

Prepaid expenses and other current assets

Prepaid expenses and other assets consist of the following (in thousands):


	September 30, 2024		December 31, 2023
Refunds and other receivables	$	672	$	600
Prepaid expenses	2,382		1,496
Other current assets	1,600		1,095
Total prepaid and other current assets	$	4,654	$	3,191

Stock-Based Compensation (Tables)

9 Months Ended

Sep. 30, 2024

Share-Based Payment Arrangement [Abstract]

Share-Based Payment Arrangement, Expensed and Capitalized, Amount

The Company recorded stock-based compensation expense in the following expense categories in its accompanying statements of operations (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Research and development	$	1,272	$	242	$	3,212	$	657
General and administrative	1,202		144		2,621		406
Total expense	$	2,474	$	386	$	5,833	$	1,063

Share-Based Payment Arrangement, Option, Activity

The following table summarizes the option activity:


	Number of shares	Weighted average exercise price per share		Weighted average remaining contractual term (years)
Outstanding at December 31, 2023	823,833	$	31.43	5.89
Granted	849,012	$	35.31
Exercised *	(83,795)	$	17.63
Expired/Forfeited	(204,868)	$	74.86
Outstanding at September 30, 2024	1,384,182	$	28.22	8.09
Exercisable at September 30, 2024	461,339	$	18.34	6.02

Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions

The fair value of each option was estimated on the grant date using the weighted average assumptions in the table below:


	Three Months Ended September 30,		Nine Months Ended September 30,
	2024	2023	2024	2023
Expected volatility	90.85%-92.31%	—%-—%	86.39%-92.31%	82.96%-83.70%
Risk-free interest rate	3.43%-4.40%	—%-—%	3.43%-4.60%	3.45% - 4.46%
Expected life (in years)	5.95-6.12	0.00-0.00	5.50-6.15	3.58 - 6.08
Expected dividend yield	—	—	—	—
Fair value of common stock (1)				$	18.39

Share-Based Payment Arrangement, Restricted Stock and Restricted Stock Unit, Activity

A summary of the Company’s RSU activity and related information for the nine months ended September 30, 2024 is as follows:


	Number of Shares	Weighted Average Grant Date Fair Value
Unvested at December 31, 2023	—	$	—
Restricted stock units granted	482,384	$	36.06
Restricted stock units forfeited	(4,771)	$	36.06
Unvested at September 30, 2024	477,613	$	36.06

Commitment and Contingencies - Supplemental Balance Sheet Information Related to Leases (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Commitments and Contingencies Disclosure [Abstract]
Operating lease right-of-use assets	$ 3,193	$ 3,681
Operating lease liabilities, current	2,856	2,559
Operating lease liabilities, non-current	10,170	12,302
Total operating lease liabilities	13,026
Finance right-of-use assets	84
Finance lease liabilities, current	54	42
Finance lease liabilities, non-current	39	$ 65
Total finance lease liabilities	$ 93

Stock-Based Compensation - Summary of Restricted Stock Awards (Details)	9 Months Ended
	Sep. 30, 2024 $ / shares shares
Number of shares
Beginning balance (in shares) \| shares	0
Granted (in shares) \| shares	482,384
Forfeited (in shares) \| shares	(4,771)
Weighted- average grant date fair value
Forfeited (in dollars per share) \| $ / shares	$ 36.06
Restricted stock awards \| Class A Common Stock
Number of shares
Ending balance (in shares) \| shares	477,613
Weighted- average grant date fair value
Beginning balance (in dollars per share) \| $ / shares	$ 0
Granted (in dollars per share) \| $ / shares	36.06
Ending balance (in dollars per share) \| $ / shares	$ 36.06

Summary of Significant Accounting Policies (Policies)	9 Months Ended
Summary of Significant Accounting Policies (Policies)	Sep. 30, 2024
Accounting Policies [Abstract]
Basis of Presentation	Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the United States Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, these financial statements do not include all of the information and footnotes required by U.S. GAAP for complete financial statements and should be read in conjunction with the audited consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 18, 2024. In management’s opinion, the unaudited condensed consolidated financial statements reflect all adjustments (consisting of normal recurring adjustments) necessary to present fairly the financial position of the Company as of September 30, 2024, and results of operations and cash flows for all periods presented. The interim results presented are not necessarily indicative of results that can be expected for the full year ending December 31, 2024.
Use of Estimates	Use of Estimates The preparation of the financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. In preparing these financial statements, management used significant estimates in the following areas, among others: recoverability of the Company’s net deferred tax assets and related valuation allowance, useful lives and recoverability of property and equipment, determining the incremental borrowing rate for calculating lease liabilities and related right-of-use assets and finance lease assets, revenue recognition, clinical trial accruals, accrual estimates for all contingent value rights (“CVRs”), the value attributed to employee stock options and other stock-based awards, and valuation of common stock. On an ongoing basis, the Company reviews its estimates to ensure that they appropriately reflect changes in the business or as new information becomes available. Actual results may differ from these estimates.
Segment Information	Segment Information Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources and in assessing performance. The Company’s CODM is the Chief Executive Officer. The CODM assesses performance of the segment according to clinical and pre-clinical data along with program specific expenses and market conditions in the pharmaceutical and biotechnology sectors. The Company operates as a single operating segment and has one reportable segment. The Company’s operations and its assets are held in the United States.
Cash and Cash Equivalents	Cash and Cash Equivalents The Company considers all highly-liquid investments purchased with original maturities of 90 days or less at time of purchase to be cash equivalents. Cash and cash equivalents include cash held in banks and are stated at fair value.
Concentrations of Credit Risk	Concentrations of Credit Risk Financial instruments that subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company’s cash and cash equivalent accounts, at times, may exceed federally insured limits. As of September 30, 2024, the Company had $66.5 million in excess of the federally insured limits. The Company places its cash in financial institutions that management believes to be of high credit quality.
Revenue Recognition	Revenue Recognition The Company recognizes revenue when its customers obtain control of promised goods or services in an amount that reflects the consideration that the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements within the scope of Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers, (“ASC 606”) the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the performance obligation is satisfied. In applying the ASC 606 framework, the Company must apply judgment to determine the nature of the promises within a revenue contract and whether those promises represent distinct performance obligations. In determining the transaction price, the Company does not include amounts subject to uncertainties unless it is probable that there will be no significant reversal of cumulative revenue when the uncertainty is resolved. Milestone and other forms of variable consideration that the Company may earn are subject to significant uncertainties of research and development related achievements, which generally are deemed not probable until such milestones are actually achieved. For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and where the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Additionally, the Company develops assumptions that require judgment to determine the standalone selling price of each performance obligation identified in the contract. The Company then allocates the total transaction price to each performance obligation based on the estimated standalone selling prices of each performance obligation for which it recognizes revenue as or when the performance obligations are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the variable consideration and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis. Under the Company’s license agreements, the Company grants the license to a customer as it exists at the point of transfer and the nature of the license is a right to use the Company’s intellectual property as transferred. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, upfront fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. As of September 30, 2024, the Company has two revenue-generating agreements that are related to the legacy Neoleukin business as part of the reverse merger: the December 2023 CVR Licensing Agreement (as defined below) and the April 2024 CVR Licensing Agreement (as defined below). Refer to Note 9, Commitments and Contingencies, for further discussion on the CVR components.
Contingent Value Rights	Contingent Value Rights In conjunction with the reverse merger, the Company entered into a CVR Agreement on December 18, 2023 with the Rights Agent named therein (the “CVR Agreement”) prior to Closing. Included in the CVR Agreement are three different types of CVRs: (i) the Lease CVR, (ii) the Intellectual Property CVR, and (iii) the Sales Tax CVR (each as defined in the CVR agreement). The Company evaluated each of the CVRs to determine if they qualified as derivatives under ASC 815, Derivatives and Hedging, and concluded that since certain scope exceptions were met, the CVRs did not qualify as derivatives. Instead, the Company records a contingent consideration liability associated with the CVRs when payments are probable and estimable under ASC 450, Contingencies. In assessing whether payments are probable and estimable, the Company considers the existence of or ability to enter into agreements with third parties or government agencies and the timing of potential payments. Refer to Note 9, Commitments and Contingencies, for further discussion on the CVRs.
Exit and Disposals Costs	Exit and Disposal Costs In connection with the reverse merger and through early fiscal 2025, the Company has incurred and expects to incur costs to wind-down Neoleukin’s Phase 1 trial of NL-201. This trial has ceased further development, and the Company has no plans to continue developing Neoleukin’s de novo protein technology. As a result, the trial’s activities do not provide the Company any future economic benefit. In accordance with ASC 420, Exit or Disposal Costs, the Company accrued the remaining costs to be incurred in the trial. The liability was classified as accrued expenses and other current liabilities in the condensed consolidated balance sheet.
Net Income (Loss) Per Share	Net Loss Per Share Attributable to Common Stockholders For the prior year period in which the Company had multiple classes of stock participating in earnings, the Company used the two-class method in calculating net loss per share. The two-class method requires income available to ordinary shareholders for the period to be allocated between ordinary shares and participating securities based upon their respective rights. The Company considered its convertible preferred stock to be participating securities as holders would be entitled to participate in dividends and earnings of the Company. As the holders of the convertible preferred stock have no obligation to fund losses, the two-class method is not applicable during periods with a net loss. Basic net loss per share of Class A and Class B common stock was computed by dividing net loss attributable to the Company by the weighted-average number of shares of Class A and Class B common stock outstanding during the period. In periods of losses, diluted net loss per share was computed on the same basis as basic net loss per share as the inclusion of any other potential shares outstanding would be anti-dilutive. Following the Company’s reverse merger in December 2023, the Company only has one class of common stock remaining, referred to throughout as “common stock.” Basic net loss per share of common stock is computed by dividing net income attributable to the Company by the weighted-average number of shares of common stock outstanding during the period. In periods of losses, diluted net loss per share is computed on the same basis as basic net loss per share as the inclusion of any other potential shares outstanding would be anti-dilutive.
Recently Issued Accounting Standards	Recently Issued Accounting Standards From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on its condensed financial statements or disclosures. Recently Issued Accounting Pronouncements Not Yet Adopted In November 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280). The amendments in this update expand segment disclosure requirements, including new segment disclosure requirements for entities with a single reportable segment among other disclosure requirements. This update is effective for the Company in the consolidated financial statements for the year ending December 31, 2024, and interim periods beginning after January 1, 2025. The Company is analyzing the impact of this standard on its disclosures in the condensed consolidated financial statements. In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which requires consistent categories and greater disaggregation of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction. This standard will be effective for annual periods beginning after December 15, 2024. The Company is currently evaluating the impact of this standard on the Company’s condensed consolidated financial statements and related disclosures

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2024	Dec. 31, 2023
Statement of Financial Position [Abstract]
Preferred stock, par or stated value per share (in dollars per share)	$ 0.000001	$ 0.000001
Preferred stock, shares authorized (in shares)	50,000,000	50,000,000
Preferred Stock, shares, issued (in shares)	0	0
Preferred Stock, shares, outstanding (in shares)	0	0
Common stock, par or stated value per share (in dollars per share)	$ 0.000001	$ 0.000001
Common stock, shares authorized (in shares)	450,000,000	450,000,000
Common stock, shares, issued (in shares)	13,010,867	12,823,665
Common stock, shares, outstanding (in shares)	13,010,867	12,823,665

Commitment and Contingencies - Contingent Value Rights Liability (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Other Commitments [Line Items]
Contingent value rights liability, current	$ 768	$ 281
Contingent value rights liability, non-current	646	1,006
Lease CVR
Other Commitments [Line Items]
Contingent value rights liability, current	436	281
Contingent value rights liability, non-current	717	1,006
Intellectual Property CVR, net
Other Commitments [Line Items]
Contingent value rights liability, current	0	0
Contingent value rights liability, non-current	(71)	0
Sales Tax CVR
Other Commitments [Line Items]
Contingent value rights liability, current	332	0
Contingent value rights liability, non-current	$ 0	$ 0

Condensed Consolidated Statements of Operations - USD ($)
$ in Thousands

3 Months Ended

9 Months Ended

Sep. 30, 2024

Sep. 30, 2023

Sep. 30, 2024

Sep. 30, 2023

Income Statement [Abstract]

Revenue under licensing agreements

$ 0

$ 925

$ 0

Operating expenses:

Research and development expenses

16,285

11,606

45,570

32,210

General and administrative expenses

5,895

3,613

16,448

8,640

Total operating expenses

22,180

15,219

62,018

40,850

Loss from operations

(22,180)

(15,219)

(61,093)

(40,850)

Other income (expense):

Interest income

1,842

650

6,197

2,170

Interest expense

(3)

(4)

(10)

(9)

Other income

143

430

Other expense

(19)

(4)

(1,154)

(11)

Net loss

$ (20,217)

$ (14,577)

$ (55,630)

$ (38,700)

Per share information

Net income (loss) per share, basic (in dollars per share)

^[1]

$ (1.19)

$ (32.67)

$ (3.29)

$ (87.66)

Net income (loss) per share, diluted (in dollars per share)

^[1]

$ (1.19)

$ (32.67)

$ (3.29)

$ (87.66)

Weighted-average shares of common stock outstanding, basic (in shares)

^[1]

16,953,443

446,255

16,932,976

441,498

Weighted-average shares of common stock outstanding, Diluted (in shares)

^[1]

16,953,443

446,255

16,932,976

441,498

[1]

For the three and nine months ended September 30, 2023, net loss per share information is presented for the Company’s then outstanding Class A common stock. For the three and nine months ended September 30, 2024, net loss per share information is presented for the Company’s common stock. See Note 1, Reverse Merger and Pre-Closing Financing and Note 3, Net Loss Per Share Attributable to Common Stockholders, for additional information.

Commitment and Contingencies - Maturity of Finance Lease Liabilities (Details) $ in Thousands	Sep. 30, 2024 USD ($)
Commitments and Contingencies Disclosure [Abstract]
2024 (remaining)	$ 15
2025	60
2026	21
2027	6
Total lease payments	102
Less: interest	(9)
Total finance lease liabilities	$ 93

Organization and Description of Business (Details) $ / shares in Units, $ in Millions	Dec. 18, 2023 USD ($) $ / shares shares	Sep. 30, 2023 shares
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Stockholders' equity note, stock split, conversion ratio	0.25
Reverse merger, conversion ratio (in shares)	0.0756	0.0756
Convertible preferred stock, shares issued upon conversion (in shares)	7,231,747
Class of warrant or right, number of securities called by warrants or rights (in shares)	1,825,635
Pre-closing Financing
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Class of warrant or right, number of securities called by warrants or rights (in shares)	1,811,739
Sale of stock, number of shares issued in transaction (in shares)	2,792,206
Sale of stock, price per share (in dollars per share) \| $ / shares	$ 20.63
Class of warrant or right, exercise price of warrants or rights (in dollars per share) \| $ / shares	$ 20.63
Sale of stock, consideration received on transaction \| $	$ 95.0
Neoleukin
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Conversion of stock, shares converted (in shares)	3,240,888

Summary of Significant Accounting Policies - Earnings 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

Numerator:

Net loss

$ (20,217)

$ (18,492)

$ (16,921)

$ (14,577)

$ (11,860)

$ (12,263)

$ (55,630)

$ (38,700)

Denominator:

Weighted-average shares outstanding in computing net loss per share, basic (in shares)

^[1]

16,953,443

446,255

16,932,976

441,498

Weighted-average shares outstanding in computing net loss per share, Diluted (in shares)

^[1]

16,953,443

446,255

16,932,976

441,498

Net loss per share, basic (in dollars per share)

^[1]

$ (1.19)

$ (32.67)

$ (3.29)

$ (87.66)

Net loss per share, Diluted (in dollars per share)

^[1]

$ (1.19)

$ (32.67)

$ (3.29)

$ (87.66)

Class A Common Stock

Numerator:

Net loss

$ (38,700)

Denominator:

Weighted-average shares outstanding in computing net loss per share, basic (in shares)

441,498

Weighted-average shares outstanding in computing net loss per share, Diluted (in shares)

441,498

Net loss per share, basic (in dollars per share)

$ (87.66)

Net loss per share, Diluted (in dollars per share)

$ (87.66)

Class B Common Stock

Numerator:

Net loss

$ 0

Denominator:

Weighted-average shares outstanding in computing net loss per share, basic (in shares)

Weighted-average shares outstanding in computing net loss per share, Diluted (in shares)

Net loss per share, basic (in dollars per share)

$ 0

Net loss per share, Diluted (in dollars per share)

$ 0

[1]

- 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

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-6

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 9
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-9

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 805
-SubTopic 60
-Name Accounting Standards Codification
-Section 65
-Paragraph 1
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147476176/805-60-65-1

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 323
-Name Accounting Standards Codification
-Section 65
-Paragraph 2
-Subparagraph (g)(3)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478666/740-323-65-2

Reference 5: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 220
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 2
-Subparagraph (SX 210.5-03(20))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483621/220-10-S99-2

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(g)(1)(ii))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480678/235-10-S99-1

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 323
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481687/323-10-50-3

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 825
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 28
-Subparagraph (f)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482907/825-10-50-28

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 220
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482765/220-10-50-6

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-3

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (b)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-1

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 40
-Name Accounting Standards Codification
-Section 65
-Paragraph 1
-Subparagraph (f)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480175/815-40-65-1

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 8
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-8

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 11
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-11

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 11
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+ Details

Commitment and Contingencies - Narrative (Details) $ in Thousands	1 Months Ended		9 Months Ended
	Aug. 31, 2024 USD ($)	Apr. 30, 2024 USD ($)	Sep. 30, 2024 USD ($)	Jun. 30, 2024 USD ($)	Dec. 31, 2023 USD ($)
Other Commitments [Line Items]
Contingent consideration liability			$ 1,200
Intellectual property total amount			900
Intellectual property contingent value rights liability, current, deductions			400
Intellectual property contingent value rights liability, current			(100)
Contingent value rights liability, current			768		$ 281
Asset acquisition, contingent consideration, cash payment	$ 600
Asset acquisition, contingent consideration, covenant, minimum amount owed, net of deductions			$ 500
Intellectual Property CVR, net
Other Commitments [Line Items]
Asset acquisition, contingent consideration, cash payment	500
Lease CVR
Other Commitments [Line Items]
Asset acquisition, contingent consideration, cash payment	$ 100
December 2023 CVR Licensing Agreement \| License \| Collaborative Arrangement, Transaction with Party to Collaborative Arrangement
Other Commitments [Line Items]
Contract with customer, liability				$ 200
Collaborative arrangement, rights and obligations, maximum aggregate milestone payments, per product					$ 13,400
April 2024 CVR Licensing Agreement
Other Commitments [Line Items]
Collaborative arrangement, rights and obligations, eligibility to received net proceeds, maximum percentage		1
Collaborative arrangement, rights and obligations, eligibility to received net proceeds, percentage		0.80
April 2024 CVR Licensing Agreement \| Collaborative Arrangement, Transaction with Party to Collaborative Arrangement
Other Commitments [Line Items]
Collaborative arrangement, rights and obligations, reimbursement		$ 10
April 2024 CVR Licensing Agreement \| License \| Collaborative Arrangement, Transaction with Party to Collaborative Arrangement
Other Commitments [Line Items]
Contract with customer, liability		800
Collaborative arrangement, rights and obligations, maximum aggregate milestone payments, per product		$ 11,000

Cover - shares	9 Months Ended
Cover - shares	Sep. 30, 2024	Nov. 13, 2024
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2024
Document Transition Report	false
Entity File Number	001-36327
Entity Registrant Name	Neurogene Inc.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	98-0542593
Entity Address, Address Line One	535 W 24th St.
Entity Address, Address Line Two	5th Floor
Entity Address, City or Town	New York
Entity Address, State or Province	NY
Entity Address, Postal Zip Code	10011
City Area Code	855
Local Phone Number	508-3568
Title of 12(b) Security	Common stock, par value $0.000001 per share
Trading Symbol	NGNE
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	false
Entity Shell Company	false
Current Fiscal Year End Date	--12-31
Entity Central Index Key	0001404644
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q3
Amendment Flag	false
Entity Common Stock, Shares Outstanding		14,854,725

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 loss	$ (20,217)	$ (18,492)	$ (16,921)	$ (14,577)	$ (11,860)	$ (12,263)	$ (55,630)	$ (38,700)

- Definition

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

+ References

+ Details

Licenses	9 Months Ended
Licenses	Sep. 30, 2024
License Agreements [Abstract]
Licenses	Licenses License Agreement with The University of North Carolina In May 2019, Neurogene entered into an Exclusive License Agreement with the University of North Carolina at Chapel Hill (“UNC”) to obtain an exclusive, worldwide, royalty bearing license, with the right to grant sublicenses under certain patents to make, use, or sell products covered by such patents for prevention or treatment of disease or medical or genetic conditions, including CLN5 Batten disease or other diseases from dysfunction of the CLN5 gene. The Company is obligated to pay UNC up to $1.7 million in sales-related milestones for licensed products based on annual sales of the licensed product in excess of defined thresholds and low single-digit percentage royalties on net sales of licensed product for as long as there is a valid patent claim under the patent rights. Neurogene is also required to reimburse any patent expenses, as well as pay a nonrefundable annual maintenance fee which, when royalties become due and payable, will be creditable against such royalties. During the year ended December 31, 2021, the FDA granted Orphan Drug Designation for CLN5 and the Company made a milestone payment of $15,000 to UNC. During the year ended December 31, 2022, the Company dosed its first patient in a Phase 1 CLN5 study and made a milestone payment of $30,000 to UNC. The annual license fee was $4,000 for each of the nine months ended September 30, 2024 and 2023. In November 2024, the Company announced that it does not expect to move forward with the NGN-101 CLN5 Batten disease gene therapy program at this time due to the FDA’s denial for the Company’s RMAT application. The Company is currently evaluating options for the program. License Agreement with The University of Edinburgh In December 2020, the University Court of the University of Edinburgh (the “University of Edinburgh”) and Neurogene entered into the Master Collaboration Agreement (“MCA”). Under the MCA, Neurogene and the University of Edinburgh agreed to collaborate on certain research and development projects (“Projects”) and Neurogene agreed to provide funding for such Projects for a 40-month initial term, which term was extended in November 2023 for an additional 33 months and may be further extended by mutual agreement. In exchange for such funding, the University of Edinburgh granted Neurogene the option to exclusively license any intellectual property arising from such Projects. If Neurogene exercises an exclusive option for a particular Project, Neurogene will enter into a separate exclusive license agreement on its own terms with the University of Edinburgh. Under the MCA, Neurogene is obligated to pay semi-annual installment payments relating to funding of costs for personnel and lab consumables for the 40-month period. Either party may terminate the MCA for convenience upon 90 days’ notice. If Neurogene terminates the MCA, it would be responsible for all non-cancellable costs and commitments related to any particular Project and any and all funding costs for any person working on such Project. In March 2022, Neurogene exercised its option through the collaboration under the MCA and entered into a License Agreement (the “March 2022 Edinburgh License Agreement”) with University of Edinburgh, pursuant to which Neurogene licensed certain patents and know-how related to the EXACT technology and optimized MECP2 cassettes on an exclusive basis. Under the March 2022 Edinburgh License Agreement, Neurogene obtained an exclusive, worldwide license to the licensed patents to develop, manufacture, supply, sell, and commercialize any products that utilize the licensed patents (the “Licensed Products”) in exchange for low single-digit percentage royalties on future commercial net sales of the Licensed Products. Royalties are payable on a Licensed Product-by-Licensed Product and country-by-country basis until the latest of the expiration of the last licensed patent covering such Licensed Product in the country where the Licensed Product is sold, or, if no licensed patent exists or has expired in such country, then ten years from first commercial sale of such Licensed Product in such country. In connection with the license, Neurogene is also obligated to pay the University of Edinburgh up to $5.3 million in regulatory-related milestones and up to $25.0 million in sales-related milestones based on annual net sales of Licensed Products in excess of defined thresholds. During the nine months ended September 30, 2023, the Company expensed $0.3 million for a milestone related to the first patient dosing in the Phase 1/2 trial for Rett syndrome. For the nine months ended September 30, 2024 and 2023, the expense recorded by the Company related to the MCA was $1.1 million and $0.9 million, respectively. License Agreement with Virovek In September 2020, Neurogene entered into a Non-Exclusive License Agreement with Virovek, Inc., pursuant to which Neurogene has a license to use certain patents and know-how on a non-exclusive basis related to Neurogene’s baculovirus (“baculo”) process in exchange for low single-digit percentage royalties on future commercial net sales of each product using the baculo process, development milestone payments of up to $0.2 million in the aggregate, and a nonrefundable annual license fee. During the nine months ended September 30, 2023, the Company recorded a milestone expense of $0.1 million for the Rett Syndrome Investigational New Drug filing. License Agreement with Sigma-Aldrich Co In January 2023, Neurogene entered into a Non-Exclusive License Agreement with Sigma-Aldrich Co. LLC, pursuant to which Neurogene has a license to certain patents and know-how on a non-exclusive basis related to certain cell lines used in Neurogene’s baculo process in exchange for a small annual fee on a product-by-product basis, payable once the first product candidate enters the clinic. In addition, on a product-by-product basis, Neurogene is obligated to pay up to $2.5 million in the aggregate for development-related milestones. The Company recorded a license expense of $60,000 for each of the nine months ended September 30, 2024 and 2023. No expenses were recorded related to other in-process license agreements during the nine months ended September 30, 2024 and 2023. None will be due under these agreements unless and until certain development milestones are reached. License Agreement with Stanford In August 2024, the Company entered into a Nonexclusive License Agreement with the Board of Trustees of Leland Stanford Junior University (the “Stanford License Agreement”) to license, on a non-exclusive basis, certain biological materials used by the Company in the manufacturing process of Neurogene’s product candidates, including NGN-401. Over the 10-year term of the Stanford License Agreement, the Company is obligated to pay up to $0.5 million in licensing fees. The Company recorded a license expense of $50,000 for the nine months ended September 30, 2024.

Summary of Significant Accounting Policies (Tables)

9 Months Ended

Sep. 30, 2024

Accounting Policies [Abstract]

Schedule of Cash and Cash Equivalents


	September 30, 2024		December 31, 2023
Cash and cash equivalents	$	66,633	$	148,210
Restricted cash	339		508
Total cash, cash equivalents and restricted cash	$	66,972	$	148,718

Restrictions on Cash and Cash Equivalents


	September 30, 2024		December 31, 2023
Cash and cash equivalents	$	66,633	$	148,210
Restricted cash	339		508
Total cash, cash equivalents and restricted cash	$	66,972	$	148,718

Restructuring and Related Costs


	Balance at December 31, 2023		Liability Adjustment		Amounts Paid		Balance at September 30, 2024
Trial wind-down costs:
Phase 1 NL-201 Trial	$	1,962	$	(201)	$	(999)	$	762

Schedule of Earnings Per Share, Basic and Diluted

The following table sets forth the computation of basic and diluted net loss per share (in thousands, except share amounts):


	Nine Months Ended September 30,
	2024		2023
	Common stock		Class A		Class B
Numerator:
Net loss	$	(55,630)	$	(38,700)	$	—
Denominator:
Weighted-average shares outstanding in computing net loss per share, basic and diluted	16,932,976		441,498		—
Net loss per share, basic and diluted	$	(3.29)	$	(87.66)	$	—

Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share

The following potentially dilutive securities have been excluded from the diluted per share calculations as they would be anti-dilutive:


	Nine Months Ended September 30,
	2024	2023
Series A-1 convertible preferred stock (1)	—	18,604,653
Series A-2 convertible preferred stock (1)	—	13,291,208
Series B convertible preferred stock (1)	—	74,405,719
Stock options	1,384,182	609,656
Total	1,384,182	106,911,236

(1) The convertible preferred stock does not reflect the application of the 0.0756 Exchange Ratio.

Stock-Based Compensation - Summary of Option Activity (Details)	9 Months Ended	12 Months Ended
	Sep. 30, 2024 $ / shares shares	Dec. 31, 2023 $ / shares shares
Number of shares
Beginning balance (in shares) \| shares	823,833
Granted (in shares) \| shares	849,012
Exercised (in shares) \| shares	(83,795)
Expired/Forfeited (in shares) \| shares	(204,868)
Ending balance (in shares) \| shares	1,384,182	823,833
Exercisable at end of period (in shares) \| shares	461,339
Weighted average exercise price per share
Beginning balance (in dollars per share) \| $ / shares	$ 31.43
Granted (in dollars per share) \| $ / shares	35.31
Exercised (in dollars per share) \| $ / shares	17.63
Expired/Forfeited (in dollars per share) \| $ / shares	74.86
Ending balance (in dollars per share) \| $ / shares	28.22	$ 31.43
Exercisable at end of period (in dollars per share) \| $ / shares	$ 18.34
Weighted average remaining contractual term (years)
Outstanding (years)	8 years 1 month 2 days	5 years 10 months 20 days
Exercisable (years)	6 years 7 days

Organization and Description of Business	9 Months Ended
Organization and Description of Business	Sep. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Organization and Description of Business	Organization and Description of Business Neurogene Inc. (formerly known as Neoleukin Therapeutics, Inc.) (the “Company” or “Neurogene”) is a clinical-stage biotechnology company that is a result of the reverse merger discussed below. The operating entity of Neurogene Inc. is the wholly owned subsidiary incorporated in the state of Nevada and also named Neurogene Inc. (“Neurogene OpCo”). Neurogene OpCo was incorporated as a limited liability company in Delaware on January 26, 2018 and converted into a Delaware corporation on July 3, 2018, and then merged with a wholly owned subsidiary of the parent company and re-domiciled to Nevada on December 18, 2023 in connection with the reverse merger described below. Both Neurogene and Neurogene OpCo have a principal place of business in New York, NY. Neurogene was formed to harness the power of gene therapy, combined with its EXACTTM transgene regulation technology, to turn today’s complex devastating neurological diseases into treatable conditions. The Company’s first clinical-stage program to utilize the EXACT technology is NGN-401, which is in an ongoing Phase 1/2 clinical trial for the treatment of Rett syndrome. Since beginning operations, the Company has devoted substantially all its efforts to research and development, recruiting management and technical staff, administration, and raising capital. Reverse Merger and Pre-Closing Financing On July 18, 2023, Neoleukin Therapeutics, Inc. entered into an Agreement and Plan of Merger (the “Merger Agreement”) with its wholly owned subsidiary (“Merger Sub”) and Neurogene OpCo. Pursuant to the terms of the Merger Agreement, upon closing on December 18, 2023 (the “Closing”), Merger Sub merged with and into Neurogene OpCo, with Neurogene OpCo continuing as a wholly owned subsidiary of the Company and the surviving corporation of the merger (referred to herein as the “reverse merger”). At the time of Closing (or immediately prior to, where indicated), the following also occurred: •The Company changed its name from “Neoleukin Therapeutics, Inc.” to “Neurogene Inc.” and is referred to herein as the “Company.” Unless the context otherwise requires, references to “Neoleukin Therapeutics, Inc.” or “Neoleukin” refer to the Company prior to Closing. •Immediately prior to Closing, Neoleukin effected a 1-for-4 reverse stock split (the “Reverse Stock Split”). Unless noted otherwise, all references herein to share and per share amounts reflect the Reverse Stock Split. •All of the then outstanding shares of Neurogene OpCo Class A common stock were converted into 3,240,888 shares of the Company’s common stock, based on an exchange ratio of approximately 0.0756 (the “Exchange Ratio”). •All of the then outstanding shares of Neurogene OpCo preferred stock were converted into 7,231,747 shares of the Company’s common stock and 1,825,635 pre-funded warrants, based on the Exchange Ratio. •Each then outstanding Neurogene OpCo stock option was exchanged for an equivalent stock option of the Company, adjusted to reflect the Exchange Ratio as necessary. •Each then outstanding Neurogene OpCo pre-funded warrant to purchase shares of Neurogene OpCo common stock was converted into a pre-funded warrant to purchase shares of the Company’s common stock, adjusted to reflect the Exchange Ratio as necessary. Refer to the discussion below for further detail on Neurogene OpCo pre-funded warrants. Concurrently with the execution and delivery of the Merger Agreement, and in order to provide Neurogene OpCo with additional capital for its development programs, Neurogene OpCo entered into a subscription agreement (the “Subscription Agreement”) with certain investors. Pursuant to the terms of the Subscription Agreement, immediately prior to the Closing, Neurogene OpCo issued and sold to the investors: (i) 2,792,206 shares of Neurogene OpCo common stock and (ii) 1,811,739 pre-funded warrants, exercisable for 1,811,739 shares of Neurogene OpCo common stock, at a purchase price of approximately $20.63 per share or $20.63 per warrant, for an aggregate purchase price of approximately $95.0 million (the “Pre-Closing Financing”).

Commitment and Contingencies - Other Lease Information (Details) $ in Thousands	9 Months Ended
	Sep. 30, 2024 USD ($)
Commitments and Contingencies Disclosure [Abstract]
Cash paid for amounts included in measurement of operating lease liabilities (in thousands)	$ 2,899
Cash paid for amounts included in measurement of finance lease liabilities (in thousands)	$ 45
Weighted-average remaining lease term - operating leases (in years)	4 years 2 months 4 days
Weighted-average remaining lease term - finance lease (in years)	1 year 10 months 13 days
Weighted-average discount rate - operating leases	9.73%
Weighted-average discount rate - finance lease	11.05%

Stock-Based Compensation - Narrative (Details) $ / shares in Units, $ in Thousands	3 Months Ended						9 Months Ended
	Sep. 30, 2024 USD ($) tranche shares	Jun. 30, 2024 USD ($)	Mar. 31, 2024 USD ($)	Sep. 30, 2023 USD ($)	Jun. 30, 2023 USD ($)	Mar. 31, 2023 USD ($)	Sep. 30, 2024 USD ($) tranche $ / shares shares	Sep. 30, 2023 USD ($) $ / shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Common stock issued upon exercise of stock options (in shares) \| shares							83,795
Common stock issued upon exercise of stock options	$ 143	$ 415	$ 629	$ 35	$ 20	$ 112
Intrinsic Value	20,000						$ 20,000
Intrinsic Value	11,800						11,800
Share-based compensation arrangement by share-based payment award, options, exercised, intrinsic value	1,400						$ 1,400
Share-based compensation arrangement by share-based payment award, options, grants in period, weighted average grant date fair value (in dollars per share) \| $ / shares							$ 26.52	$ 12.99
Share-based payment arrangement, expense	$ 2,474			386			$ 5,833	$ 1,063
Granted (in shares) \| shares							482,384
Number of shares common stock holder to receive when restricted stock unit vests (in shares) \| shares	1						1
Stock options
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Common stock issued upon exercise of stock options (in shares) \| shares							14,582
Common stock issued upon exercise of stock options							$ 300
Share-based payment arrangement, expense	$ 1,800			$ 400			4,300	$ 1,000
Share-based payment arrangement, nonvested award, option, cost not yet recognized, amount	$ 19,900						$ 19,900
Share-based payment arrangement, nonvested award, cost not yet recognized, period for recognition							3 years 29 days
Performance Based RSUs \| Class A Common Stock
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Granted (in shares) \| shares							252,124
Share-based payment arrangement, number of tranches \| tranche	2						2
Restricted stock awards
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Share-based payment arrangement, expense	$ 700						$ 1,500
Share-based payment arrangement, nonvested award, option, cost not yet recognized, amount	$ 6,600						$ 6,600
Award vesting period							2 years 5 months 8 days

Commitment and Contingencies - Lease Costs (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Commitments and Contingencies Disclosure [Abstract]
Operating lease cost	$ 508	$ 259	$ 1,553	$ 777
Finance lease cost
Amortization of finance leases	12	10	39	24
Interest on finance lease liabilities	3	3	9	9
Variable lease cost	364	19	978	129
Short-term lease cost	18	21	53	63
Total lease cost	$ 905	$ 312	$ 2,632	$ 1,002

Summary of Significant Accounting Policies - Summary of Accrued Liabilities Activity (Details) - Phase 1 NL-201 Trial $ in Thousands	9 Months Ended
	Sep. 30, 2024 USD ($)
Restructuring Reserve [Roll Forward]
Balance at December 31, 2023	$ 1,962
Liability Adjustment	(201)
Amounts Paid	(999)
Balance at September 30, 2024	$ 762

Risks and Uncertainties (Details) - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
Risks and Uncertainties (Details) - 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	Dec. 31, 2023
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Net loss	$ 20,217	$ 18,492	$ 16,921	$ 14,577	$ 11,860	$ 12,263	$ 55,630	$ 38,700
Cash used in operations							53,107	$ 34,450
Accumulated deficit	242,784						242,784		$ 187,154
Cash, cash equivalents and investments	139,000						139,000
Sales Agreement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Sale of stock, maximum aggregate offering price	$ 40,000						$ 40,000

- Definition

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

+ References

+ Details

- Definition

Amount of accumulated undistributed earnings (deficit).

+ References + Details

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 66,633	$ 148,210
Short-term investments	72,360	48,947
Prepaid expenses and other current assets	4,654	3,191
Total current assets	143,647	200,348
Property and equipment, net	16,068	17,174
Operating lease right-of-use assets	3,193	3,681
Finance lease right-of-use assets	84	98
Restricted cash	339	508
Other non-current assets	789	764
Total assets	164,120	222,573
Current liabilities:
Accounts payable	1,684	2,596
Accrued expenses and other current liabilities	10,438	17,495
Operating lease liabilities, current	2,856	2,559
Finance lease liabilities, current	54	42
Contingent value rights liability, current	768	281
Total current liabilities	15,800	22,973
Operating lease liabilities, non-current	10,170	12,302
Finance lease liabilities, non-current	39	65
Contingent value rights liability, non-current	646	1,006
Other liabilities	51	203
Total liabilities	26,706	36,549
Stockholders' equity:
Preferred stock, $0.000001 par value; $50,000,000 shares authorized as of September 30, 2024 and December 31, 2023; 0 shares issued and outstanding as of September 30, 2024 and December 31, 2023	0	0
Common stock, $0.000001 par value; $450,000,000 shares authorized as of September 30, 2024 and December 31, 2023; $13,010,867 and $12,823,665 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively	0	0
Additional paid-in capital	380,198	373,178
Accumulated deficit	(242,784)	(187,154)
Total stockholders' equity	137,414	186,024
Total liabilities and stockholders' equity	$ 164,120	$ 222,573

Property and Equipment, Net - Narrative (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Property, Plant and Equipment [Abstract]
Depreciation and amortization of property and equipment	$ 800	$ 800	$ 2,410	$ 2,445
Impairment losses on idle equipment			$ 100

Summary of Significant Accounting Policies - Potentially Antidilutive Securities (Details) - shares	3 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Dec. 18, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share, amount (in shares)	1,384,182	106,911,236
Reverse merger, conversion ratio (in shares)		0.0756	0.0756
Series A-1 Convertible Preferred Stock
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share, amount (in shares)	0	18,604,653
Series A-2 Convertible Preferred Stock
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share, amount (in shares)	0	13,291,208
Series B Convertible Preferred Stock
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share, amount (in shares)	0	74,405,719
Stock options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share, amount (in shares)	1,384,182	609,656

Commitment and Contingencies - Maturity of Operating Lease Liabilities (Details) $ in Thousands	Sep. 30, 2024 USD ($)
Commitments and Contingencies Disclosure [Abstract]
2024 (remaining)	$ 982
2025	3,987
2026	3,695
2027	3,239
2028	3,294
2029	613
Total lease payments	15,810
Less: interest	(2,784)
Total operating lease liabilities	$ 13,026

Property and Equipment, Net

9 Months Ended

Sep. 30, 2024

Property, Plant and Equipment [Abstract]

Property and Equipment, Net

Property and equipment, net consist of the following (in thousands):


	September 30, 2024		December 31, 2023
Lab equipment	$	3,244	$	3,144
Manufacturing equipment	6,326		6,142
Office Equipment	19		19
Leasehold improvements	15,396		15,376
Software	268		268
Construction in progress	1,202		234
Total property and equipment, cost	26,455		25,183
Less accumulated depreciation	(10,387)		(8,009)
Property and equipment, net	$	16,068	$	17,174

The Company recorded depreciation and amortization expense of $0.8 million for each of the three months ended September 30, 2024 and 2023. The Company recorded depreciation and amortization expense of $2.4 million for each of the nine months ended September 30, 2024 and 2023.

Management has reviewed its property and equipment for impairment whenever events and circumstances indicate that the carrying value of an asset might not be recoverable. During the nine months ended September 30, 2024, the Company recorded impairment losses on idle equipment of $0.1 million, which was charged to research and development expenses in the condensed consolidated statement of operations. Fair value for the idle assets was determined by a quoted purchase price for the assets

Licenses (Details) - USD ($) $ in Thousands		1 Months Ended			9 Months Ended
Licenses (Details) - USD ($) $ in Thousands	Aug. 06, 2024	Aug. 09, 2024	Nov. 30, 2023	Dec. 31, 2020	Sep. 30, 2024	Sep. 30, 2023	Jan. 31, 2023	Dec. 31, 2022	Mar. 31, 2022	Dec. 31, 2021	Sep. 30, 2020	May 31, 2019
University of North Carolina \| Collaborative Arrangement, Transaction with Party to Collaborative Arrangement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Collaborative arrangement, rights and obligations, maximum aggregate milestone payments, per product								$ 30		$ 15		$ 1,700
Annual license maintenance fee					$ 4	$ 4
University of North Carolina and University of Pennsylvania
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Annual license maintenance fee					1,100	900
University of North Carolina and University of Pennsylvania \| Collaborative Arrangement, Transaction with Party to Collaborative Arrangement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Collaborative arrangement, rights and obligations, additional term			33 months
University of Edinburgh \| Collaborative Arrangement, Transaction with Party to Collaborative Arrangement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Collaborative arrangement, rights and obligations, term				40 months
Research collaboration and license agreement, option to terminate				90 days
University of Edinburgh \| Collaborative Arrangement, Transaction with Party to Collaborative Arrangement \| Regulatory-Related Milestones
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Collaborative arrangement, rights and obligations, maximum aggregate milestone payments, per product									$ 5,300
University of Edinburgh \| Collaborative Arrangement, Transaction with Party to Collaborative Arrangement \| Sales-Related Milestones
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Collaborative arrangement, rights and obligations, maximum aggregate milestone payments, per product									$ 25,000
Collaborative arrangement, rights and obligations, expense						300
Virovek, Inc License Agreement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Collaborative arrangement, rights and obligations, expense						$ 100
Virovek, Inc License Agreement \| Collaborative Arrangement, Transaction with Party to Collaborative Arrangement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Collaborative arrangement, rights and obligations, maximum aggregate milestone payments, per product											$ 200
Sigma-Aldrich Co
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Annual license maintenance fee					60
Sigma-Aldrich Co \| Collaborative Arrangement, Transaction with Party to Collaborative Arrangement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Collaborative arrangement, rights and obligations, maximum aggregate milestone payments, per product							$ 2,500
Stanford License Agreement \| Collaborative Arrangement, Transaction with Party to Collaborative Arrangement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Annual license maintenance fee	$ 500				$ 50
Term of agreement		10 years

Stock-Based Compensation - Summary of Weighted Average Assumptions (Details) - $ / shares	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 rate, minimum	90.85%	0.00%	86.39%	82.96%
Expected volatility rate, maximum	92.31%	0.00%	92.31%	83.70%
Risk-free interest rate, minimum	3.43%	0.00%	3.43%	3.45%
Risk-free interest rate, maximum	4.40%	0.00%	4.60%	4.46%
Minimum
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected life (in years)	5 years 11 months 12 days	0 years	5 years 6 months	3 years 6 months 29 days
Maximum
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected life (in years)	6 years 1 month 13 days	0 years	6 years 1 month 24 days	6 years 29 days
Stock options
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected dividend yield	0.00%	0.00%	0.00%	0.00%
Fair value of common stock (in dollars per share)		$ 18.39		$ 18.39

Prepaid expenses and other current assets (Tables)

9 Months Ended

Sep. 30, 2024

Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]

Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure

Prepaid expenses and other assets consist of the following (in thousands):


	September 30, 2024		December 31, 2023
Refunds and other receivables	$	672	$	600
Prepaid expenses	2,382		1,496
Other current assets	1,600		1,095
Total prepaid and other current assets	$	4,654	$	3,191

Investments (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Schedule of Held-to-Maturity Securities [Line Items]
Amortized cost, as adjusted	$ 135,480	$ 193,305
Gross unrealized holding gains	172	16
Gross unrealized holding losses	0	0
Estimated fair value	135,652	193,321
Money market funds \| Cash equivalents:
Schedule of Held-to-Maturity Securities [Line Items]
Amortized cost, as adjusted	63,120	144,358
Gross unrealized holding gains	0	0
Gross unrealized holding losses	0	0
Estimated fair value	63,120	144,358
U.S. treasury notes \| Short-term investments:
Schedule of Held-to-Maturity Securities [Line Items]
Amortized cost, as adjusted	72,360	48,947
Gross unrealized holding gains	172	16
Gross unrealized holding losses	0	0
Estimated fair value	$ 72,532	$ 48,963

- Definition

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

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-5

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5
-Subparagraph (aaa)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-5

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-5

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5
-Subparagraph (e)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-5

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5
-Subparagraph (f)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-5

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5
-Subparagraph (f)(1)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-5

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5
-Subparagraph (f)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-5

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5
-Subparagraph (f)(3)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-5

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5
-Subparagraph (f)(4)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-5

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5A
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-5A

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5A
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-5A

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5A
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-5A

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5B
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-5B

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5B
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-5B

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5B
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-5B

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5B
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-5B

Reference 17: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5B
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-5B

Reference 18: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-5

+ Details

Fair Value of Financial Instruments - Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Assets:
U.S. treasury notes	$ 135,652	$ 193,321
Fair Value, Recurring \| Level 1
Assets:
U.S. treasury notes	72,532	48,947
Total	135,652	193,305
Fair Value, Recurring \| Level 1 \| Money market funds
Assets:
Money market funds	63,120	144,358
Fair Value, Recurring \| Level 2
Assets:
U.S. treasury notes	0	0
Total	0	0
Fair Value, Recurring \| Level 2 \| Money market funds
Assets:
Money market funds	0	0
Fair Value, Recurring \| Level 3
Assets:
U.S. treasury notes	0	0
Total	0	0
Fair Value, Recurring \| Level 3 \| Money market funds
Assets:
Money market funds	$ 0	$ 0

Risks and Uncertainties	9 Months Ended
Risks and Uncertainties	Sep. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Risks and Uncertainties	Risks and Uncertainties The Company is subject to risks common to companies in the biotechnology industry, including, but not limited to, successful development of technology, obtaining additional funding, protection of proprietary technology, compliance with government regulations, risks of failure of pre-clinical studies, clinical studies and clinical trials, the need to obtain marketing approval for its drug candidates and its consumer products, fluctuations in operating results, economic pressure impacting therapeutic pricing and reimbursement, dependence on key personnel, risks associated with changes in technologies, development by competitors of technological innovations and the ability to transition from pilot scale manufacturing to large scale production. Liquidity and Financial Condition Since its inception, the Company has funded its operations primarily with proceeds from the sales of equity securities and has incurred significant recurring losses, including net losses of $55.6 million and $38.7 million for the nine months ended September 30, 2024 and 2023, respectively. In addition, the Company used cash in operations of $53.1 million and $34.5 million for the nine months ended September 30, 2024 and 2023, respectively, and had an accumulated deficit of $242.8 million as of September 30, 2024. Management expects to incur substantial and increasing losses in future periods as the Company advances its products through its clinical and regulatory process and will rely on outside capital to fund its operations for the foreseeable future. The Company has not generated positive cash flows from operations, and there are no assurances that the Company will be successful in obtaining an adequate level of financing for the development and commercialization of its product candidates. As of September 30, 2024, the Company had cash, cash equivalents and investments of approximately $139.0 million. On December 18, 2023, the Company closed the reverse merger and the Pre-Closing Financing. The Company expects its available cash and cash equivalents on hand as of the issuance date of these financial statements will be sufficient to fund its obligations as they become due for at least one year beyond the issuance date of these financial statements. As a result of the reverse merger with Neoleukin Therapeutics, the Company assumed an ATM or “at-the-market” Equity Offering Sales Agreement with BofA Securities, Inc., as agent (“BofA”), pursuant to which the Company was able to offer and sell, from time to time through BofA, shares of the Company’s common stock, having an aggregate offering price of up to $40.0 million. The Registration Statement on Form S-3 that was prepared for the ATM expired on December 21, 2023, and in March 2024, the Company formally terminated the ATM. In the event the Company is unable to secure additional outside capital, management will be required to seek other alternatives which may include, among others, a delay or termination of clinical trials or the development of its product candidates, temporary or permanent curtailment of the Company’s operations, a sale of assets, or other alternatives with strategic or financial partners. The accompanying condensed consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties. Accordingly, the condensed consolidated financial statements have been prepared on a basis that assumes the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.

Fair Value of Financial Instruments (Tables)

9 Months Ended

Sep. 30, 2024

Fair Value Disclosures [Abstract]

Fair Value, Assets Measured on Recurring Basis

As of September 30, 2024 and December 31, 2023, financial assets measured at fair value on a recurring basis are categorized in the table below based upon the lowest level of significant input to the valuations (in thousands):


	September 30, 2024
	Level 1		Level 2		Level 3
Assets:
Money market funds	$	63,120	$	—	$	—
U.S. treasury notes	72,532		—		—
Total	$	135,652	$	—	$	—


	December 31, 2023
	Level 1		Level 2		Level 3
Assets:
Money market funds	$	144,358	$	—	$	—
U.S. treasury notes	48,947		—		—
Total	$	193,305	$	—	$	—

Subsequent Events	9 Months Ended
Subsequent Events	Sep. 30, 2024
Subsequent Events [Abstract]
Subsequent Events	Subsequent Events From October 1, 2024 until the financial statements were issued, the Company granted 34,695 options to employees and 8,858 options were exercised. 2024 private placement On November 5, 2024, the Company closed a private investment in public equity financing in which the Company sold 1,835,000 shares of common stock at a purchase price of $50.00 per share and, in lieu of shares of common stock, pre-funded warrants to purchase up to an aggregate of 2,165,042 shares of common stock, at a purchase price of $49.999 per pre-funded warrant, to certain institutional accredited investors. The pre-funded warrants are immediately exercisable until exercised in full at a price of $0.001 per share of common stock. The aggregate gross proceeds to the Company are approximately $200.0 million. Net proceeds, after deducting commissions and other offering expenses, are expected to total approximately $189.5 million.

Commitment and Contingencies (Tables)

9 Months Ended

Sep. 30, 2024

Commitments and Contingencies Disclosure [Abstract]

Lease, Cost

Supplemental lease expense related to leases for the three and nine months ended September 30, 2024 and 2023 was as follows (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Operating lease cost	$	508	$	259	$	1,553	$	777
Finance lease cost
Amortization of finance leases	12		10		39		24
Interest on finance lease liabilities	3		3		9		9
Variable lease cost	364		19		978		129
Short-term lease cost	18		21		53		63
Total lease cost	$	905	$	312	$	2,632	$	1,002

Lessee, Operating Lease, Liability, to be Paid, Maturity


Maturity of operating lease liabilities
2024 (remaining)	$	982
2025	3,987
2026	3,695
2027	3,239
2028	3,294
2029	613
Total lease payments	$	15,810
Less: interest	(2,784)
Total operating lease liabilities	$	13,026

Finance Lease, Liability, to be Paid, Maturity


Maturity of finance lease liabilities
2024 (remaining)	$	15
2025	60
2026	21
2027	6
Total lease payments	$	102
Less: interest	(9)
Total finance lease liabilities	$	93

Assets And Liabilities, Lessee

Supplemental balance sheet information related to leases as of September 30, 2024 was as follows (in thousands):


Leases
Operating right-of-use assets	$	3,193

Operating lease liabilities, current	2,856
Operating lease liabilities, non-current	10,170
Total operating lease liabilities	$	13,026

Finance right-of-use assets	$	84

Finance lease liabilities, current	54
Finance lease liabilities, non-current	39
Total finance lease liabilities	$	93


Other information
Cash paid for amounts included in measurement of operating lease liabilities (in thousands)	$	2,899
Cash paid for amounts included in measurement of finance lease liabilities (in thousands)	$	45
Weighted-average remaining lease term - operating leases (in years)	4.18
Weighted-average remaining lease term - finance lease (in years)	1.87
Weighted-average discount rate - operating leases	9.73		%
Weighted-average discount rate - finance lease	11.05		%

Asset Acquisition, Contingent Consideration

The following table summarizes the components of the contingent value rights liability in the condensed consolidated balance sheet as of September 30, 2024 and December 31, 2023 (in thousands):


	September 30, 2024				December 31, 2023
	Current		Non-Current		Current		Non-Current
Lease CVR	$	436	$	717	$	281	$	1,006
Intellectual Property CVR, net	—		(71)		—		—
Sales Tax CVR	332		—		—		—
Total CVR liability	$	768	$	646	$	281	$	1,006

Condensed Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders’ Equity (Deficit) - USD ($) $ in Thousands	Total	Series A-1 Convertible Preferred Stock	Series A-2 Convertible Preferred Stock	Series B Convertible Preferred Stock	Class A Common Stock	Class B Common Stock	Preferred Stock	Common Stock	Common Stock Class A Common Stock	Common Stock Class B Common Stock	Additional Paid- In Capital	Accumulated Deficit
Beginning balance (in shares) at Dec. 31, 2022		18,604,653	13,291,208	74,405,719
Beginning balance at Dec. 31, 2022		$ 34,414	$ 28,675	$ 181,277
Ending balance at Mar. 31, 2023		$ 34,414	$ 28,675	$ 181,277
Ending balance (in shares) at Mar. 31, 2023		18,604,653	13,291,208	74,405,719
Beginning balance (in shares) at Dec. 31, 2022							0
Beginning balance (in shares) at Dec. 31, 2022								0	428,334	0
Beginning balance at Dec. 31, 2022	$ (145,739)						$ 0	$ 0	$ 0	$ 0	$ 5,098	$ (150,837)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock-based compensation expense	293										293
Common stock issued upon exercise of stock options (in shares)									13,532
Common stock issued upon exercise of stock options	112										112
Net loss	(12,263)											(12,263)
Ending balance at Mar. 31, 2023	(157,597)						$ 0	$ 0	$ 0	$ 0	5,503	(163,100)
Ending balance (in shares) at Mar. 31, 2023								0	441,866	0
Ending balance (in shares) at Mar. 31, 2023							0
Beginning balance (in shares) at Dec. 31, 2022		18,604,653	13,291,208	74,405,719
Beginning balance at Dec. 31, 2022		$ 34,414	$ 28,675	$ 181,277
Ending balance at Sep. 30, 2023		$ 34,414	$ 28,675	$ 181,277
Ending balance (in shares) at Sep. 30, 2023		18,604,653	13,291,208	74,405,719
Beginning balance (in shares) at Dec. 31, 2022							0
Beginning balance (in shares) at Dec. 31, 2022								0	428,334	0
Beginning balance at Dec. 31, 2022	(145,739)						$ 0	$ 0	$ 0	$ 0	5,098	(150,837)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss	(38,700)				$ (38,700)	$ 0
Ending balance at Sep. 30, 2023	(183,209)						$ 0	$ 0	$ 0	$ 0	6,328	(189,537)
Ending balance (in shares) at Sep. 30, 2023								0	448,644	0
Ending balance (in shares) at Sep. 30, 2023							0
Beginning balance (in shares) at Mar. 31, 2023		18,604,653	13,291,208	74,405,719
Beginning balance at Mar. 31, 2023		$ 34,414	$ 28,675	$ 181,277
Ending balance at Jun. 30, 2023		$ 34,414	$ 28,675	$ 181,277
Ending balance (in shares) at Jun. 30, 2023		18,604,653	13,291,208	74,405,719
Beginning balance (in shares) at Mar. 31, 2023							0
Beginning balance (in shares) at Mar. 31, 2023								0	441,866	0
Beginning balance at Mar. 31, 2023	(157,597)						$ 0	$ 0	$ 0	$ 0	5,503	(163,100)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock-based compensation expense	384										384
Common stock issued upon exercise of stock options (in shares)									2,751
Common stock issued upon exercise of stock options	20										20
Net loss	(11,860)											(11,860)
Ending balance at Jun. 30, 2023	(169,053)						$ 0	$ 0	$ 0	$ 0	5,907	(174,960)
Ending balance (in shares) at Jun. 30, 2023								0	444,617	0
Ending balance (in shares) at Jun. 30, 2023							0
Ending balance at Sep. 30, 2023		$ 34,414	$ 28,675	$ 181,277
Ending balance (in shares) at Sep. 30, 2023		18,604,653	13,291,208	74,405,719
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock-based compensation expense	386										386
Common stock issued upon exercise of stock options (in shares)									4,027
Common stock issued upon exercise of stock options	35										35
Net loss	(14,577)											(14,577)
Ending balance at Sep. 30, 2023	$ (183,209)						$ 0	$ 0	$ 0	$ 0	6,328	(189,537)
Ending balance (in shares) at Sep. 30, 2023								0	448,644	0
Ending balance (in shares) at Sep. 30, 2023							0
Beginning balance (in shares) at Dec. 31, 2023		0	0	0
Beginning balance at Dec. 31, 2023		$ 0	$ 0	$ 0
Ending balance at Mar. 31, 2024		$ 0	$ 0	$ 0
Ending balance (in shares) at Mar. 31, 2024		0	0	0
Beginning balance (in shares) at Dec. 31, 2023	0						0
Beginning balance (in shares) at Dec. 31, 2023	12,823,665							12,823,665	0	0
Beginning balance at Dec. 31, 2023	$ 186,024						$ 0	$ 0	$ 0	$ 0	373,178	(187,154)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock-based compensation expense	1,045										1,045
Common stock issued upon exercise of stock options (in shares)								37,330
Common stock issued upon exercise of stock options	629										629
Net loss	(16,921)											(16,921)
Ending balance at Mar. 31, 2024	$ 170,777						$ 0	$ 0	$ 0	$ 0	374,852	(204,075)
Ending balance (in shares) at Mar. 31, 2024								12,860,995	0	0
Ending balance (in shares) at Mar. 31, 2024							0
Beginning balance (in shares) at Dec. 31, 2023		0	0	0
Beginning balance at Dec. 31, 2023		$ 0	$ 0	$ 0
Ending balance at Sep. 30, 2024		$ 0	$ 0	$ 0
Ending balance (in shares) at Sep. 30, 2024		0	0	0
Beginning balance (in shares) at Dec. 31, 2023	0						0
Beginning balance (in shares) at Dec. 31, 2023	12,823,665							12,823,665	0	0
Beginning balance at Dec. 31, 2023	$ 186,024						$ 0	$ 0	$ 0	$ 0	373,178	(187,154)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Common stock issued upon exercise of stock options (in shares)	83,795
Net loss	$ (55,630)
Ending balance at Sep. 30, 2024	$ 137,414						$ 0	$ 0	$ 0	$ 0	380,198	(242,784)
Ending balance (in shares) at Sep. 30, 2024	13,010,867							13,010,867	0	0
Ending balance (in shares) at Sep. 30, 2024	0						0
Beginning balance (in shares) at Mar. 31, 2024		0	0	0
Beginning balance at Mar. 31, 2024		$ 0	$ 0	$ 0
Ending balance at Jun. 30, 2024		$ 0	$ 0	$ 0
Ending balance (in shares) at Jun. 30, 2024		0	0	0
Beginning balance (in shares) at Mar. 31, 2024							0
Beginning balance (in shares) at Mar. 31, 2024								12,860,995	0	0
Beginning balance at Mar. 31, 2024	$ 170,777						$ 0	$ 0	$ 0	$ 0	374,852	(204,075)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock-based compensation expense	2,314										2,314
Shares issued upon the exercise of pre-funded warrants (in shares)								103,407
Common stock issued upon exercise of stock options (in shares)								24,806
Common stock issued upon exercise of stock options	415										415
Net loss	(18,492)											(18,492)
Ending balance at Jun. 30, 2024	155,014						$ 0	$ 0	$ 0	$ 0	377,581	(222,567)
Ending balance (in shares) at Jun. 30, 2024								12,989,208	0	0
Ending balance (in shares) at Jun. 30, 2024							0
Ending balance at Sep. 30, 2024		$ 0	$ 0	$ 0
Ending balance (in shares) at Sep. 30, 2024		0	0	0
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock-based compensation expense	2,474										2,474
Common stock issued upon exercise of stock options (in shares)								21,659
Common stock issued upon exercise of stock options	143										143
Net loss	(20,217)											(20,217)
Ending balance at Sep. 30, 2024	$ 137,414						$ 0	$ 0	$ 0	$ 0	$ 380,198	$ (242,784)
Ending balance (in shares) at Sep. 30, 2024	13,010,867							13,010,867	0	0
Ending balance (in shares) at Sep. 30, 2024	0						0

Investments

9 Months Ended

Sep. 30, 2024

Investments, Debt and Equity Securities [Abstract]

Investments

The following table summarizes the Company’s investment securities as of September 30, 2024 and December 31, 2023 (in thousands):


	September 30, 2024
	Amortized cost, as adjusted		Gross unrealized holding gains		Gross unrealized holding losses		Estimated fair value
Cash equivalents:
Money market funds	$	63,120	$	—	$	—	$	63,120
Short-term investments:
U.S. treasury notes	72,360		172		—		72,532
Total	$	135,480	$	172	$	—	$	135,652


	December 31, 2023
	Amortized cost, as adjusted		Gross unrealized holding gains		Gross unrealized holding losses		Estimated fair value
Cash equivalents:
Money market funds	$	144,358	$	—	$	—	$	144,358
Short-term investments:
U.S. treasury notes	48,947		16		—		48,963
Total	$	193,305	$	16	$	—	$	193,321

All of the Company’s investments mature within the next 12 months.

Stockholders’ Equity (Deficit)

9 Months Ended

Sep. 30, 2024

Equity [Abstract]

Stockholders’ Equity (Deficit)

Common stock and pre-funded warrants

As of September 30, 2024, the Company is authorized to issue 450,000,000 shares of common stock with a par value of $0.000001 per share.

The Company has pre-funded warrants outstanding to purchase an aggregate of 3,959,954 shares of common stock as of September 30, 2024. The pre-funded warrants are exercisable at any time for an exercise price of $0.000001, except that the pre-funded warrants cannot be exercised by a holder if, after giving effect thereto, such holder would beneficially own more than 9.99% of the outstanding common stock, subject to certain exceptions. However, any holder may increase or decrease such percentage to any other percentage (not in excess of 19.99%) upon at least 61 days’ prior notice from the holder to the Company. The holders of the pre-funded warrants will not have the right to vote the shares underlying the pre-funded warrants on any matter except to the extent required by Delaware law. These warrants were classified as equity.

During the nine months ended September 30, 2024, 103,407 shares of common stock were issued upon the exercise of pre-funded warrants. Proceeds of the exercise to the Company were immaterial.

The Company had reserved shares of common stock for future issuance as follows:


	September 30, 2024	December 31, 2023
Unvested restricted stock units	477,613	–
Options outstanding	1,384,182	823,833
Shares available for future grant under the 2023 Equity Incentive Plan	1,468,403	2,237,722
Total common stock reserved	3,330,198	3,061,555

- Definition

The entire disclosure for equity.

+ References

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+ Details

Fair Value of Financial Instruments

9 Months Ended

Sep. 30, 2024

Fair Value Disclosures [Abstract]

Fair Value of Financial Instruments


	September 30, 2024
	Level 1		Level 2		Level 3
Assets:
Money market funds	$	63,120	$	—	$	—
U.S. treasury notes	72,532		—		—
Total	$	135,652	$	—	$	—


	December 31, 2023
	Level 1		Level 2		Level 3
Assets:
Money market funds	$	144,358	$	—	$	—
U.S. treasury notes	48,947		—		—
Total	$	193,305	$	—	$	—

Money market funds are cash equivalents and are included in cash and cash equivalents in the condensed consolidated balance sheet as of September 30, 2024 and 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.

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