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Neurogene Inc

For the period ended Mar 31, 2024. Filed May 10, 2024.

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About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2024 · Filed May 10, 2024

NGNE$25.28-2.8%Stored close · as of Nov 10, 2026

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Item 1. Financial Statements

Item 1. Condensed Financial Statements

Condensed Consolidated Balance Sheets

March 31,2024December 31,2023
Assets
Current assets:
Cash and cash equivalents$150,140$148,210
Short-term investments19,39348,947
Prepaid expenses and other current assets4,6083,191
Total current assets174,141200,348
Property and equipment, net16,47517,174
Operating lease right-of-use assets3,5653,681
Finance lease right-of-use assets8798
Restricted cash339508
Other non-current assets743764
Total assets$195,350$222,573
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable$1,522$2,596
Accrued expenses and other current liabilities6,82417,495
Operating lease liabilities, current2,6702,559
Finance lease liabilities, current4342
Lease contingent value rights liability, current430281
Intellectual property contingent value rights liability329—
Total current liabilities11,81822,973
Operating lease liabilities, non-current11,64212,302
Finance lease liabilities, non-current5365
Lease contingent value rights liability, non-current8571,006
Other liabilities203203
Total liabilities24,57336,549
Stockholders' equity:
Preferred stock, $0.000001 par value; 50,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 0 shares issued and outstanding as of March 31, 2024 and December 31, 2023——
Common stock, $0.000001 par value; 450,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 12,860,995 and 12,823,665 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively——
Additional paid-in capital374,852373,178
Accumulated deficit(204,075)(187,154)
Total stockholders' equity170,777186,024
Total liabilities and stockholders' equity$195,350$222,573

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Condensed Consolidated Statements of Operations

Three Months EndedMarch 31,
20242023
Operating expenses:
Research and development expenses$13,541$10,283
General and administrative expenses5,2382,752
Total operating expenses18,77913,035
Loss from operations(18,779)(13,035)
Other income (expense):
Interest income2,320777
Interest expense(3)(2)
Other income143-
Other expense(602)(3)
Net loss$(16,921)$(12,263)
Per share information: (1)
Net loss per share, basic and diluted$(1.00)$(28.28)
Weighted-average shares of common stock outstanding, basic and diluted16,903,735433,623

(1) For the three months ended March 31, 2023, net loss per share information is presented for the Company’s then outstanding Class A common stock. For the three months ended March 31, 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.

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Condensed Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders’ Equity (Deficit)

Convertible Preferred Stock · Stockholders' Equity
Series A-1 ConvertiblePreferred Stock · Series A-2 ConvertiblePreferred Stock · Series B ConvertiblePreferred Stock · Preferred Stock · Class A Common Stock · Class B Common Stock · Common Stock
SharesAmountSharesAmountSharesAmountSharesAmountSharesAmountSharesAmountSharesAmountAdditionalPaid- InCapitalAccumulatedDeficitTotalStockholders'Equity
Balance- December 31, 2023—$——$——$——$——$——$—12,823,665$—$373,178$(187,154)$186,024
Stock-based compensation expense——————————————1,045—1,045
Common stock issued upon exercise of stock options————————————37,330—629—629
Net loss———————————————(16,921)(16,921)
Balance- March 31, 2024—$——$——$——$——$——$—12,860,995$—$374,852$(204,075)$170,777
Convertible Preferred Stock · Stockholders' Deficit
Series A-1 ConvertiblePreferred Stock · Series A-2 ConvertiblePreferred Stock · Series B ConvertiblePreferred Stock · Preferred Stock · Class A Common Stock · Class B Common Stock · Common Stock
SharesAmountSharesAmountSharesAmountSharesAmountSharesAmountSharesAmountSharesAmountAdditionalPaid- InCapitalAccumulatedDeficitTotalStockholders'Deficit
Balance- December 31, 202218,604,653$34,41413,291,208$28,67574,405,719$181,277—$—428,334$——$——$—$5,098$(150,837)$(145,739)
Stock-based compensation expense——————————————293—293
Class A common stock issued upon exercise of stock options————————13,532—————112—112
Net loss———————————————(12,263)(12,263)
Balance- March 31, 202318,604,653$34,41413,291,208$28,67574,405,719$181,277—$—441,866$——$——$—$5,503$(163,100)$(157,597)

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Condensed Consolidated Statements of Cash Flows

(In Thousands)

Three Months EndedMarch 31,
20242023
Operating activities
Net loss$(16,921)$(12,263)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense1,045293
Depreciation and amortization of property and equipment814812
Asset impairment91—
Non-cash operating lease expense176160
Amortization of finance lease right-of-use assets116
Amortization and accretion of premiums/discounts on held-to-maturity investments(446)—
Intellectual property contingent value rights liability329—
Changes in assets and liabilities:
Prepaid expenses and other current assets(1,417)(780)
Other assets21—
Accounts payable135825
Accrued expenses and other current liabilities(4,879)(2,444)
Operating lease liabilities(609)(164)
Net cash used in operating activities(21,650)(13,555)
Investing activities
Purchases of property and equipment(65)(29)
Proceeds from maturities of held-to-maturity investments30,000—
Net cash provided by (used in) investing activities29,935(29)
Financing activities
Offering costs in connection with pre-closing financing(4,287)—
Transaction costs related to reverse merger(2,855)—
Proceeds from the issuance of common stock upon exercise of options629112
Principal payments on finance leases(11)(5)
Net cash (used in) provided by financing activities(6,524)107
Net increase (decrease) in cash, cash equivalents and restricted cash1,761(13,477)
Cash, cash equivalents and restricted cash at beginning of period148,71882,021
Cash, cash equivalents and restricted cash at end of period$150,479$68,544
Supplemental disclosure of non-cash investing and financing activities:
Additions to operating lease right of use assets from new operating lease liabilities$60$—
Property and equipment included in accounts payable and accrued expenses$141$—
Supplemental cash flow information:
Cash paid for interest$3$2

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NEUROGENE INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

  1. 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 EXACT gene 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. In addition to NGN-401, Neurogene is also pursuing a conventional gene therapy program in an ongoing Phase 1/2 clinical trial of NGN-101 for the treatment of CLN5 Batten disease. 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”).

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  1. 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, 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 $16.9 million and $12.3 million for the three months ended March 31, 2024 and 2023, respectively. In addition, the Company used cash in operations of $21.7 million and $13.6 million for the three months ended March 31, 2024 and 2023, respectively, and had an accumulated deficit of $204.1 million as of March 31, 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 March 31, 2024, the Company had cash, cash equivalents and investments of approximately $169.5 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 dateof 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.

  1. 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 March 31, 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.

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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 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, 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 its Chief Executive Officer. The Company operates as a single operating segment and hasone 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):

March 31,2024December 31,2023
Cash and cash equivalents$150,140$148,210
Restricted cash339508
Total cash, cash equivalents and restricted cash$150,479$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 March 31, 2024, the Company had $149.9 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.

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.

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A summary of the accrued liabilities activity recorded in connection with the wind-down Neoleukin’s Phase 1 trial of NL-201 for the three months ended March 31, 2024 is as follows (in thousands):

Balance at December 31, 2023Liability AdjustmentAmounts PaidBalance at March 31, 2024
Trial wind-down costs:
Phase 1 NL-201 Trial$1,962$(3)$(319)$1,640

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.

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

Three Months Ended March 31,
2024 · 2023
Common stockClass AClass B
Numerator:
Net loss$(16,921)$(12,263)$—
Denominator:
Weighted-average shares outstanding in computing net loss per share, basic and diluted16,903,735433,623—
Net loss per share, basic and diluted$(1.00)$(28.28)$—

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

Three Months Ended March 31,
20242023
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 options1,475,458618,881
Total1,475,458106,920,461

(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 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 but does not expect the adoption of ASU 2023-09 to be material.

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  1. Investments

The following table summarizes the Company’s investment securities as of March 31, 2024 (in thousands):

March 31, 2024
Amortized cost, as adjustedGrossunrealizedholding gainsGrossunrealizedholding lossesEstimated fairvalue
Cash equivalents:
Money market funds$145,225$—$—$145,225
Short-term investments:
U.S. treasury notes19,393—(1)19,392
Total$164,618$—$(1)$164,617
December 31, 2023
Amortized cost, as adjustedGrossunrealizedholding gainsGrossunrealizedholding lossesEstimated fairvalue
Cash equivalents:
Money market funds$144,358$—$—$144,358
Short-term investments:
U.S. treasury notes48,94716—48,963
Total$193,305$16$—$193,321

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

  1. Fair Value of Financial Instruments

As of March 31, 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):

March 31, 2024
Level 1Level 2Level 3
Assets:
Money market funds$145,225$—$—
U.S. treasury notes19,393——
Total$164,618$—$—
December 31, 2023
Level 1Level 2Level 3
Assets:
Money market funds$144,358$—$—
U.S. treasury notes48,947——
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 March 31, 2024 and December 31, 2023.

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  1. Prepaid expenses and other current assets

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

March 31,2024December 31,2023
Refunds and other receivables$589$600
Prepaid expenses2,7651,496
Other current assets1,2541,095
Total prepaid and other current assets$4,608$3,191
  1. Property and Equipment, Net

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

March 31,2024December 31,2023
Lab equipment$3,115$3,144
Manufacturing equipment6,2626,142
Office Equipment1919
Leasehold improvements15,37415,376
Software268268
Construction in progress229234
Total property and equipment, cost25,26725,183
Less accumulated depreciation(8,792)(8,009)
Property and equipment, net$16,475$17,174

Depreciation and amortization expense for the three months ended March 31, 2024 and 2023 was approximately $0.8 million and $0.8 million, respectively.

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 three months ended March 31, 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.

  1. Accrued Expenses and Other Current Liabilities

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

March 31,2024December 31,2023
Compensation, bonuses and related benefits$1,109$3,496
Research and development4,7284,895
Accrued severance, bonus, and retention (1)682,476
Accrued offering costs in connection with pre-closing financing—3,334
Accrued transaction costs related to reverse merger—2,557
Other919737
Total accrued expenses and other current liabilities$6,824$17,495

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

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  1. Commitments and Contingencies

Operating and Finance Leases

Supplemental lease expense related to leases for the three months ended March 31, 2024 and 2023 was as follows (in thousands):

Three Months EndedMarch 31,
20242023
Operating lease cost$524$259
Finance lease cost
Amortization of finance leases116
Interest on finance lease liabilities32
Variable lease cost33154
Short-term lease cost2323
Total lease cost$892$344

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 March 31, 2024 (in thousands):

Maturity of operating lease liabilities
2024 (remaining)$2,923
20253,987
20263,695
20273,239
20283,294
2029616
Total lease payments$17,754
Less: interest(3,442)
Total operating lease liabilities$14,312
Maturity of finance lease liabilities
2024 (remaining)$38
202550
202615
20276
Total lease payments$109
Less: interest(13)
Total finance lease liabilities$96

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Supplemental balance sheet information related to leases as of March 31, 2024 was as follows (in thousands):

Leases
Operating right-of-use assets$3,565
Operating lease liabilities, current2,670
Operating lease liabilities, non-current11,642
Total operating lease liabilities$14,312
Finance right-of-use assets$87
Finance lease liabilities, current43
Finance lease liabilities, non-current53
Total finance lease liabilities$96
Other information
Cash paid for amounts included in measurement of operating lease liabilities (in thousands)$1,306
Cash paid for amounts included in measurement of finance lease liabilities (in thousands)$13
Weighted-average remaining lease term - operating leases (in years)4.64
Weighted-average remaining lease term - finance lease (in years)2.30
Weighted-average discount rate - operating leases9.72%
Weighted-average discount rate - finance lease11.49%

Lease CVR

As of March 31, 2024, $1.3 million was recorded on the Company’s condensed consolidated balance sheet as a lease CVR liability 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.

The following table summarizes the maturity of the Company’s lease CVR as of March 31, 2024 (in thousands):

Maturity of Lease CVR
2024 (remaining)$281
2025598
2026408
Total lease CVR payments$1,287

Intellectual Property CVR

In April 2024, the Company entered into a licensing and intellectual property assignment agreement with an unrelated third party to develop and commercialize legacy Neoleukin assets (the “Third Party Licensing Agreement”). The third party will make a one-time upfront payment of approximately $0.75 million to Neurogene less any unused portion of the $50,000 advance previously paid to Neurogene and the third party will reimburse Neurogene $10,000 for patent expenses paid by Neurogene. On April 29, 2024, the Company received the upfront payment of approximately $0.75 million under the Third Party Licensing Agreement. The Third Party Licensing Agreement contains development, regulatory and commercialization milestones totaling up to approximately $11.0 million, as well as royalty payments.

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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 sale 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 sale of Neoleukin’s pre-merger legacy assets pursuant any agreements entered into within one year after the Closing (the “Intellectual Property CVR”). Since the Third Party 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 Third Party Licensing Agreement. 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.

The Company has accrued approximately $0.6 million (80% of the upfront payment) as a contingent consideration liability related to the Intellectual Property CVR as the upfront payment was deemed probable and estimable as of March 31, 2024. However, as of March 31, 2024, the development and sales milestones were not deemed probable under the Third Party Licensing Agreement. As of March 31, 2024, the liability in the condensed consolidated balance sheet was $0.3 million, as it was reduced by approximately $0.3 million due to eligible expenses incurred by the Company that offset the liability.

All other payments under the Contingent Value Rights Agreement, dated as of December 18, 2023, by and between the Company and the Rights Agent (the “CVR Agreement”) were not considered probable and estimable as of March 31, 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 March 31, 2024, the Company had standing agreements with consultants, contractors or service providers that generally 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.

  1. Licenses

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.

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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.

The expense recorded by the Company related to the MCA was $0.4 million and $0.3 million for the three months ended March 31, 2024 and 2023, 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 three months ended March 31, 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. During the three months ended March 31, 2024 and 2023, the Company recorded a license expense of $0.06 million and $0, respectively.

No expenses were recorded related to other in-process license agreements during the three months ended March 31, 2024 and 2023. None will be due under these agreements unless and until certain development milestones are reached.

  1. Stockholders’ Equity (Deficit)

Common stock and pre-funded warrants

As of March 31, 2024, the Company is authorized to issue 450,000,000 shares of common stock with a par value of $0.000001 per share.

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The Company has pre-funded warrants outstanding to purchase an aggregate of 4,063,361 shares of common stock as of March 31, 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 the holders if, after giving effect thereto, the holders 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.

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

March 31,2024December 31,2023
Unvested restricted stock units482,384–
Options outstanding1,475,458823,833
Shares available for future grant under the 2023 Equity Incentive Plan1,526,6322,237,722
Total common stock reserved3,484,4743,061,555
  1. 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 EndedMarch 31,
20242023
Research and development$564$174
General and administrative481119
Total expense$1,045$293

The following table summarizes the option activity:

Numberofshares · Weightedaverageexercise priceper share · Weightedaverageremainingcontractualterm(years)
Outstanding at December 31, 2023823,833$31.435.89
Granted741,652$34.59
Exercised(37,330)$16.89
Expired/Forfeited(52,697)$72.62
Outstanding at March 31, 20241,475,458$31.037.77
Exercisable at March 31, 2024530,779$30.955.15

As of March 31, 2024, the aggregate intrinsic value of outstanding options and exercisable options was approximately $32.2 million and $15.1 million, respectively. The aggregate intrinsic value of options exercised was approximately $0.7 million for the three months ended March 31, 2024.

The weighted-average grant date fair value of options granted was $25.97 and $12.99 per share for the three months ended March 31, 2024 and 2023, respectively. The Company recorded stock-based compensation related to stock options of approximately $1.0 million and $0.3 million for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024, the total unrecognized compensation expense related to unvested stock option awards was approximately $18.7 million, which the Company expects to recognize over a weighted-average period of 3.43 years.

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

Three Months EndedMarch 31,
2024 · 2023
Expected volatility86.39%-87.64%82.96%-83.70%
Risk-free interest rate3.97%-4.32%3.45%-4.46%
Expected life (in years)5.77-6.083.58-6.08
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 three months ended March 31, 2024 is as follows:

Number of SharesWeighted Average Grant Date Fair Value
Unvested at December 31, 2023—$—
Restricted stock units granted482,384$36.06
Unvested at March 31, 2024482,384$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 receiveone share of the Company's common stock when the PSU vests. During the three months ended March 31, 2024, the related performance conditions were not met and are not currently considered probable to vest. As such, no expense is recognized as of March 31, 2024.

The Company recorded stock-based compensation expense related to RSUs of approximately $0.1 million for the three months ended March 31, 2024. As of March 31, 2024, there was approximately $8.2 million of unrecognized compensation cost related to unvested RSUs, which is expected to be recognized over a remaining weighted average vesting period of approximately 2.95 years.

  1. Subsequent Events

From April 1, 2024 until the financial statements were issued, the Company granted 14,415 options to employees,15,887 options were exercised and 103,407 pre-funded warrants were exercised.

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ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.