Item 1. Financial Statements
Item 1. Financial Statements
CAMP4 Therapeutics Corporation
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
As of September 30,
As of December 31,
2024
2023
(Unaudited)
Current assets:
Cash and cash equivalents
$
2,528
$
38,380
Accounts receivable
1,000
—
Prepaid expenses and other current assets
1,976
1,633
Total current assets
5,504
40,013
Restricted cash
1,624
1,624
Deferred offering costs
3,324
—
Property and equipment, net
3,831
4,797
Operating lease right-of-use assets, net
6,479
7,764
Finance lease right-of-use assets, net
602
748
Total assets
$
21,364
$
54,946
Current liabilities:
Accounts payable
$
3,873
$
1,042
Accrued expenses
3,677
3,302
Deferred revenue, short-term
1,000
—
Operating lease liabilities, current portion
2,919
2,704
Finance lease liabilities, current portion
170
354
Financing liability, current portion
190
405
Total current liabilities
11,829
7,807
Long-term liabilities:
Operating lease liabilities, net of current portion
6,274
8,487
Finance lease liabilities, net of current portion
87
148
Financing liability, net of current portion
—
85
Other long-term liabilities
2
2
Total liabilities
18,192
16,529
Commitments and contingencies (Note 7)
Convertible preferred stock, $ 0.0001 par value; 149,673,284 shares authorized as of September 30, 2024 and December 31, 2023; 130,648,426 shares issued and outstanding as of September 30, 2024 and December 31, 2023; liquidation preference of $ 162,885 as of September 30, 2024 and December 31, 2023
162,147
162,147
Stockholders' deficit:
Common stock, $ 0.0001 par, 210,000,000 shares authorized as of September 30, 2024 and December 31, 2023, 1,036,537 and 1,026,057 shares issued, 1,005,930 and 460,704 shares outstanding as of September 30, 2024 and December 31, 2023, respectively
2
1
Additional paid-in capital
39,497
36,231
Accumulated deficit
( 198,474 )
( 159,962 )
Total stockholders' deficit
( 158,975 )
( 123,730 )
Total liabilities, convertible preferred stock, and stockholders' deficit
$
21,364
$
54,946
The accompanying notes are an integral part of these condensed consolidated financial statements.
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CAMP4 Therapeutics Corporation
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except for share and per share data)
Three months ended September 30,
Nine months ended September 30,
2024
2023
2024
2023
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Revenue
Research and collaboration revenue
$
—
$
350
$
—
$
350
Operating Expenses:
Research and development
9,702
9,819
28,821
29,955
General and administrative
3,814
2,869
10,233
8,798
Total operating expenses
13,516
12,688
39,054
38,753
Loss from operations
( 13,516 )
( 12,338 )
( 39,054 )
( 38,403 )
Other income (expense), net:
Interest income
94
689
720
2,239
Other expense
( 62 )
( 47 )
( 178 )
( 137 )
Total other income, net
32
642
542
2,102
Net loss attributable to common stockholders and comprehensive loss
$
( 13,484 )
$
( 11,696 )
$
( 38,512 )
$
( 36,301 )
Net loss per share attributable to common stockholders, basic and diluted
$
( 24.19 )
$
( 29.21 )
$
( 76.50 )
$
( 94.62 )
Weighted-average shares of common stock outstanding, basic and diluted
557,437
400,426
503,455
383,653
The accompanying notes are an integral part of these condensed consolidated financial statements.
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CAMP4 Therapeutics Corporation
Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Deficit
( In thousands, except share amounts)
(Unaudited)
Total
Convertible preferred stock
Common stock
Additional paid-in
Accumulated
stockholders'
Shares
Amount
Shares
Amount
capital
deficit
deficit
Balance at December 31, 2023
130,648,426
$
162,147
460,704
$
1
$
36,231
$
( 159,962 )
$
( 123,730 )
Issuance of common stock
—
—
971
—
2
—
2
Vesting of restricted common stock
—
—
14,589
—
—
—
—
Stock-based compensation expense
—
—
—
—
856
—
856
Net loss
—
—
—
—
—
( 12,456 )
( 12,456 )
Balance at March 31, 2024
130,648,426
$
162,147
476,264
$
1
$
37,089
$
( 172,418 )
$
( 135,328 )
Issuance of common stock
—
—
88
—
—
—
—
Vesting of restricted common stock
—
—
14,525
—
—
—
—
Stock-based compensation expense
—
—
—
—
786
—
786
Net loss
—
—
—
—
—
( 12,572 )
( 12,572 )
Balance at June 30, 2024
130,648,426
$
162,147
490,877
$
1
$
37,875
$
( 184,990 )
$
( 147,114 )
Issuance of common stock
—
—
500,531
1
30
—
31
Vesting of restricted common stock
—
—
14,522
—
—
—
—
Stock-based compensation expense
—
—
—
—
1,592
—
1,592
Net loss
—
—
—
—
—
( 13,484 )
( 13,484 )
Balance at September 30, 2024
130,648,426
$
162,147
1,005,930
$
2
$
39,497
$
( 198,474 )
$
( 158,975 )
Total
Convertible preferred stock
Common stock
Additional paid-in
Accumulated
stockholders'
Shares
Amount
Shares
Amount
capital
deficit
deficit
Balance at December 31, 2022
130,648,426
$
162,147
356,759
$
1
$
33,139
$
( 110,671 )
$
( 77,531 )
Issuance of common stock
—
—
2,751
—
7
—
7
Vesting of restricted common stock
—
—
16,331
—
—
—
—
Stock-based compensation expense
—
—
—
—
763
—
763
Net loss
—
—
—
—
—
( 12,506 )
( 12,506 )
Balance at March 31, 2023
130,648,426
$
162,147
375,841
$
1
$
33,909
$
( 123,177 )
$
( 89,267 )
Issuance of common stock
—
—
1,818
—
4
—
4
Vesting of restricted common stock
—
—
15,111
—
—
—
—
Stock-based compensation expense
—
—
—
—
786
—
786
Net loss
—
—
—
—
—
( 12,100 )
( 12,100 )
Balance at June 30, 2023
130,648,426
$
162,147
392,770
$
1
$
34,699
$
( 135,277 )
$
( 100,577 )
Issuance of common stock
—
—
232
—
1
—
1
Vesting of restricted common stock
—
—
14,739
—
—
—
—
Stock-based compensation expense
—
—
—
—
722
—
722
Net loss
—
—
—
—
—
( 11,696 )
( 11,696 )
Balance at September 30, 2023
130,648,426
$
162,147
407,741
$
1
$
35,422
$
( 146,973 )
$
( 111,550 )
The accompanying notes are an integral part of these condensed consolidated financial statements .
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CAMP4 Therapeutics Corporation
Condensed Consolidated Statements of Cash Flows
(In thousands)
Nine months ended September 30,
2024
2023
(Unaudited)
(Unaudited)
Operating activities
Net loss
$
( 38,512 )
$
( 36,301 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
1,278
1,243
Stock-based compensation expense
3,235
2,271
Non-cash lease expense
1,285
1,310
Non-cash interest expense
68
62
Change in operating assets and liabilities:
Prepaid expenses and other current assets
( 343 )
( 333 )
Accounts payable
1,024
( 965 )
Accrued expenses and other liabilities
( 310 )
( 698 )
Operating lease assets and liabilities
( 1,999 )
1,039
Net cash used in operating activities
( 34,274 )
( 32,372 )
Investing activities
Purchases of property and equipment
( 178 )
( 435 )
Net cash used in financing activities
( 178 )
( 435 )
Financing activities
Proceeds from issuance of common stock
33
12
Proceeds from financing obligation, net of transaction costs
—
706
Principal payments on financing obligation
( 345 )
( 153 )
Principal payments on finance leases
( 268 )
( 201 )
Payments of deferred offering costs
( 820 )
—
Net cash (used in) provided by financing activities
( 1,400 )
364
Net decrease in cash, cash equivalents and restricted cash
( 35,852 )
( 32,443 )
Cash, cash equivalents and restricted cash – beginning of year
40,004
84,536
Cash, cash equivalents and restricted cash – end of period
$
4,152
$
52,093
Supplemental disclosures of cash flow information:
Operating lease right-of-use asset obtained in exchange for lease liabilities
$
—
$
1,397
Finance lease right-of-use asset obtained in exchange for lease liabilities
$
—
$
368
Deferred offering costs in accounts payable and accrued expenses
$
2,504
$
—
Purchase of property and equipment in accounts payable and accrued expenses
$
—
$
56
The accompanying notes are an integral part of these condensed consolidated financial statements.
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CAMP4 Therapeutics Corporation
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. Description of Business and Basis of Presentation
Description of Business
CAMP4 Therapeutics Corporation, formerly Marauder Therapeutics, Inc., and its subsidiary (collectively, the “Company”), is a clinical-stage biopharmaceutical company pioneering the discovery and development of regulatory RNA-based therapeutics with the goal of upregulating gene expression and restoring healthy protein levels to treat a broad range of genetic diseases. The Company is initially focusing on genetic diseases of the central nervous system and liver. The Company was organized in September 2015 and began operations in 2016.
Basis of Presentation and Principles of Consolidation
The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative standards of U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”).
These unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s consolidated financial position, consolidated results of operations, and consolidated cash flows for the interim periods presented. The results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024 or for any other future annual or interim period.
The condensed consolidated balance sheet as of December 31, 2023 included herein was derived from the audited consolidated financial statements as of that date which was included in the prospectus (the “IPO Prospectus”) filed on October 11, 2024 pursuant to Rule 424(b) under the Securities Act of 1933, as amended (“the Securities Act”) with the Securities and Exchange Commission (“the SEC”). These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements for the year ended December 31, 2023 contained in the IPO Prospectus.
The Company’s consolidated financial statements include the accounts of CAMP4 Therapeutics Corporation and its wholly owned subsidiary, CAMP4 Therapeutics Pty Ltd (“CAMP4 AUS”), which was established on September 15, 2023. All intercompany balances and transactions have been eliminated in consolidation.
Reverse-Stock Split
On October 3, 2024, the Company effected a one -for-11.2158 reverse stock split of its issued and outstanding shares of common stock and a proportional adjustment to the existing conversion ratios for each series of the Company’s convertible preferred stock. Accordingly, all share and per share amounts for all periods presented in the accompanying condensed consolidated financial statements and notes thereto have been adjusted retroactively, where applicable, to reflect this reverse stock split and adjustment of the preferred stock conversion ratios. The par value and the number of authorized shares of the convertible preferred stock and common stock were not adjusted in connection with the reverse stock split.
Liquidity and Going Concern
As of September 30, 2024, the Company had approximately $ 2.5 million of unrestricted cash and cash equivalents and working capital of approximately $ 0.6 million. The Company has experienced net losses and negative cash flows from operations since its inception and, as of September 30, 2024, the Company had an accumulated deficit of $ 198.5 million. The revenue and income potential of the Company’s business and market are unproven. During the nine months ended September 30, 2024, the Company incurred a net loss of $ 38.5 million and had negative cash flows from operations of $ 34.3 million. The Company will continue to incur significant costs and expenses related to its ongoing operations until it successfully develops, obtains regulatory approval for and gains market acceptance of a product candidate and achieves revenues adequate to support the Company’s operations.
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On October 15, 2024, upon the closing of the Company’s initial public offering (the “IPO”), the Company received aggregate proceeds, net of underwriting discounts and commissions, of $ 69.8 million. In addition, on November 1, 2024, the Company received additional proceeds of $ 6.6 million pursuant to the partial exercise by the underwriters of their option to purchase additional shares in the IPO. Collectively, the Company received aggregate net proceeds of $ 76.4 million from the IPO and the subsequent partial exercise by the underwriters of their option to purchase additional shares (“IPO Proceeds”). The IPO Proceeds, together with the Company’s existing cash and cash equivalents, will be sufficient to fund the Company’s planned operations for at least 12 months beyond the issuance date of these condensed financial statements. As such, substantial doubt does not exist about the Company’s ability to continue as a going concern for the one year period following the date that these unaudited condensed financial statements and accompanying notes were issued. The Company will eventually require additional funding in order to fund its planned operations. If the Company is unable to obtain additional funding before achieving sufficient profitability and positive cash flows from operations, if ever, the Company will be forced to delay, reduce or eliminate some or all of its research and development programs, which could adversely affect its business prospects, or the Company may be unable to continue operations. Although management continues to pursue plans to obtain additional funding before achieving sufficient profitability and positive cash flows from operations, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations, if at all.
2. Summary of Significant Accounting Policies
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates assumptions, and judgments that affect the reported amounts of assets, liabilities, expenses and related disclosures in the accompanying notes. The Company bases its estimates, assumptions and judgments on historical experience when available and on various factors that it believes to be reasonable under the circumstances as of the date of the accompanying condensed consolidated financial statements, including the fair value of common stock, stock-based compensation expense, accrued expenses, lease accounting and the recoverability of the Company’s net deferred tax assets and related valuation allowance. In addition, other factors may affect estimates, including the expected business and operational changes, the sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Actual results could differ materially from the estimates and assumptions used in the preparation of the accompanying condensed consolidated financial statements under different assumptions or conditions.
Cash and Cash Equivalents
The Company considers all highly liquid investments and instruments with original maturities of 90 days or less that can be liquidated without prior notice or penalty to be cash equivalents. Cash equivalents primarily represent funds invested in readily available money market accounts. As of September 30, 2024 and December 31, 2023, the Company had cash and cash equivalents balances deposited at one major financial institution.
Restricted Cash
In connection with its operating leases, the Company is required to maintain security deposits totaling $ 1.5 million, which were issued in the form of letters of credit with a bank. As of September 30, 2024 and December 31, 2023, the Company held cash in this amount in separate restricted bank accounts as collateral for the letters of credit. The restricted cash balance is classified as long-term restricted cash on the accompanying condensed consolidated balance sheets. In addition, the Company held cash of $ 0.1 million as of September 30, 2024 and December 31, 2023, in money market accounts as collateral for the Company’s credit card obligation and increased letter of credit due to an amendment to the lease.
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the condensed consolidated balance sheets to the corresponding amounts shown in the condensed consolidated statements of cash flows (in thousands):
September 30, 2024
September 30, 2023
Cash and cash equivalents
$
2,528
$
50,469
Restricted cash
1,624
1,624
Total cash, cash equivalents, and restricted cash
$
4,152
$
52,093
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Concentration of Credit Risks
Financial instruments that subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company deposits cash and cash equivalents with high credit quality financial institutions in the United States. These deposits are held in checking and money market accounts and may, from time to time, exceed the federally insured amounts. The Company has not experienced any losses in such accounts. The Company believes it is not exposed to any significant risk in its cash and cash equivalents. The primary objectives of the Company’s investment portfolio are the preservation of capital and maintenance of liquidity.
The Company is subject to risks common to companies in the biopharmaceutical industry, including, but not limited to, risks related to the successful development and commercialization of product candidates, fluctuations in operating results and financial risks, the ability to successfully raise additional funds when needed, protection of proprietary rights and patents, patent litigation, compliance with government regulations, dependence on key personnel and collaboration partners, dependence on third-party manufacturers and competition from other products in the marketplace.
Fair Value Measurements
The Company applies fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures. Fair value is measured as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. A fair value measurement assumes that the transaction to sell the asset or transfer the liability occurs in the principal market for the asset or liability or, in the absence of a principal market, the most advantageous market. A framework is used for measuring fair value utilizing a three-tier hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3).
The three levels of the fair value hierarchy are as follows:
Level 1 —Observable inputs such as unadjusted quoted prices in active markets that are accessible at the measurement date for identical unrestricted assets or liabilities the Company has the ability to access;
Level 2 —Inputs (other than quoted prices included within Level 1) that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the asset or liability. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active; and
Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
Financial instruments are categorized in their entirety based on the lowest level of input that is significant to the fair value measurement. The assessment of the significance of a particular input to the fair value measurement requires judgment and considers factors specific to the investment. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. The Company reviews the fair value hierarchy classification at each reporting date. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain assets or liabilities within the fair value hierarchy. The Company did not have any transfers of assets and liabilities between the levels of the fair value measurement hierarchy during the periods presented.
Foreign Currency Remeasurement
The Company’s reporting currency and the functional currency of its foreign subsidiary, CAMP4 AUS, is the United States Dollar (“USD”). At the date a foreign currency denominated transaction is recognized, each asset, liability, revenue, expense, gain or loss arising from the transaction is measured initially in USD based on the exchange rate in effect at that date. Subsequently, at each balance sheet date, balances related to monetary assets and liabilities are adjusted to reflect the current exchange rate, which is the rate at which the related receivable or payable could be settled at that date.
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Foreign exchange transaction gains and losses are included in other income (expense), net in the accompanying condensed consolidated statements of operations and comprehensive loss and were immaterial for the three and nine months ended September 30, 2024 and 2023.
Comprehensive Loss
There were no differences between net loss and comprehensive loss presented in the condensed consolidated statements of operations for the three and nine months ended September 30, 2024 and 2023.
Property and Equipment, Net
Property and equipment are stated at cost less accumulated depreciation. Expenditures for maintenance and repairs are charged to expense as incurred, whereas major betterments are capitalized as additions to property and equipment. Depreciation is calculated using the straight-line method over the following estimated useful lives of the assets:
Description
Useful Life
Computer and software
Three years
Laboratory equipment
Five years
Furniture and fixtures
Seven years
Leasehold improvements
Shorter of asset life or remaining lease term
Impairment of Long-Lived Assets
The Company evaluates its long-lived assets, which consist of property and equipment, operating lease right-of-use assets, and finance lease right-of-use assets, for impairment at least annually and whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If the asset is considered to be impaired, the amount of any impairment is measured as the difference between the carrying value and the fair value of the impaired asset. The Company did not recognize any impairment losses for the three and nine months ended September 30, 2024 and 2023.
Commitments and Contingencies
Contractual Commitments
The Company enters into contracts in the normal course of business with contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), academic institutions and other third parties for preclinical and clinical research studies, testing and manufacturing services. These contracts generally do not contain minimum purchase commitments and are cancellable by the Company upon prior written notice, although purchase orders for preclinical materials are generally non-cancellable. Payments due upon cancellation consist primarily of payments for services provided or expenses incurred, including non-cancellable obligations from the Company’s service providers, up to the date of cancellation or upon the completion of a manufacturing run.
Guarantees and Indemnifications
Indemnification Obligations
The Company has entered into indemnification agreements with its officers and directors that require the Company to indemnify such individuals for certain events or occurrences while each such officer or director is, or was, serving at the Company’s request in such capacity. The maximum potential future payments the Company could be required to make is, in many cases, unlimited. The Company has directors’ and officers’ liability insurance coverage that limits its exposure and enables the Company to recover a portion of any future amounts paid.
The Company leases office and laboratory space under operating leases. The Company has standard indemnification arrangements under the leases that require it to indemnify the landlords against all costs, expenses, fines, suits, claims, demands, liabilities and actions directly resulting from any breach, violation or nonperformance of any covenant or condition of the Company’s leases.
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In the ordinary course of its business, the Company enters into indemnification agreements with certain suppliers and business partners pursuant to which the Company has certain indemnification obligations limited to the costs, expenses, fines, suits, claims, demands, liabilities and actions directly resulting from the Company’s gross negligence or willful misconduct, and in certain instances, breaches, violations or nonperformance of covenants or conditions under the agreements.
As of September 30, 2024 and December 31, 2023, the Company had not experienced any material losses related to these indemnification obligations, and no material claims with respect thereto were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established.
The Company is subject to the possibility of loss contingencies arising in the ordinary course of business. Management considers the likelihood of loss related to an asset, or the incurrence of a liability, as well as its ability to reasonably estimate the amount of the loss, in determining loss contingencies. An estimated loss contingency is accrued when it is probable that an asset has been impaired, or a liability has been incurred and the amount of loss can be reasonably estimated. The Company regularly evaluates current information available to determine whether such accruals should be adjusted and whether new accruals are required.
Legal Proceedings
From time to time, the Company may become involved in litigation relating to claims arising from the ordinary course of business. Management believes that there are no claims or actions pending against the Company currently, the ultimate disposition of which would have a material adverse effect on the Company’s condensed consolidated results of operations, financial condition or cash flows.
Leases
In accordance with ASC 842, Leases , the Company determines if an arrangement is or contains a lease at inception. A contract is or contains a lease if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. The Company classifies leases at the lease commencement date as operating or finance leases and records a right-of-use asset and a lease liability on the condensed consolidated balance sheet for all leases with an initial lease term of greater than 12 months. Leases with an initial term of 12 months or less are not recorded in the condensed consolidated balance sheet, but payments are recognized as expense on a straight-line basis over the lease term.
A lease qualifies as a finance lease if any of the following criteria are met at the inception of the lease: (i) there is a transfer of ownership of the leased asset to the Company by the end of the lease term, (ii) the Company holds an option to purchase the leased asset that it is reasonably certain to exercise, (iii) the lease term is for a major part of the remaining economic life of the leased asset, (iv) the present value of the sum of lease payments equals or exceeds substantially all of the fair value of the leased asset, or (v) the nature of the leased asset is specialized to the point that it is expected to provide the lessor no alternative use at the end of the lease term. All other leases are recorded as operating leases.
The Company enters into contracts that contain both lease and non-lease components. Non-lease components may include maintenance, utilities and other operating costs. The Company combines the lease and non-lease components of fixed costs in its lease arrangements as a single lease component. Variable costs, such as utilities or maintenance costs, are not included in the measurement of right-of-use assets and lease liabilities, but rather are expensed when the event determining the amount of variable consideration to be paid occurs.
Finance and operating lease assets and liabilities are recognized at the lease commencement date based on the present value of the lease payments over the lease term using the discount rate implicit in the lease. If the rate implicit is not readily determinable, the Company utilizes an estimate of its incremental borrowing rate based upon the available information at the lease commencement date. Operating lease assets are further adjusted for prepaid or accrued lease payments. Operating lease assets are expensed using the straight-line method as an operating expense over the lease term. Finance lease assets are amortized to depreciation expense using the straight-line method. Finance lease payments are bifurcated into (i) a portion that is recorded as imputed interest expense and (ii) a portion that reduces the finance liability associated with the lease.
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Certain of the Company’s leases provide a lease incentive in the form of reimbursable leasehold improvements. Due to the unpredictability of the payout of leasehold improvement reimbursements, the Company recognizes a reduction to the right-of-use asset and the lease liability once it has incurred costs that qualify as reimbursable by the lessor. The reduction to the right-of-use asset is recognized prospectively over the remainder of the lease term.
Certain of the Company’s leases include options to extend or terminate the lease. The amounts determined for the Company’s right-of-use assets and lease liabilities generally do not assume that renewal options or early-termination provisions, if any, are exercised, unless it is reasonably certain that the Company will exercise such options.
In addition, the Company examines other contracts with suppliers, vendors and outside parties to identify whether such contracts contain an embedded lease and, as applicable, records such embedded leases in accordance with ASC 842, Leases .
Financing Obligation (Failed Sale-Leaseback)
In accordance with ASC 842, Leases , for potential sale-leaseback transactions, the Company assesses the contract to identify if a sale occurred in accordance with ASC 606. Sale-and-leaseback transactions occur when the Company sells assets to a third-party and simultaneously leases them back. The resulting leases that qualify for sale-and-leaseback accounting are evaluated and accounted for as operating leases. A transaction that does not qualify for sale-and-leaseback accounting as a result of finance lease classification or the failure to meet certain revenue recognition criteria is accounted for as a financing transaction. For a financing transaction, the Company will retain the assets sold within Property, plant and equipment, net and record a financing obligation equal to the amount of cash proceeds received. Rental payments under such transactions are recognized as a reduction of the financing obligation and as interest expense using an effective interest method. To date, the Company has entered into one failed sale-leaseback transaction. See additional discussion in Note 7. Commitments and Contingencies .
Revenue Recognition and Accounting for Collaboration Agreements
Revenue from Contracts with Customers
The Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation.
As part of the accounting for revenue from contracts with customers, the Company uses judgment to determine: (a) the performance obligations based on the determination under step (ii) above; (b) the transaction price under step (iii) above; and (c) the recognition of revenue as services are performed under step (v) above. The Company also uses judgment to determine whether development milestones or other variable consideration, with the exception of royalties and sales-based milestones, should be included in the transaction price as described further below.
The Company applies the five-step model to contracts when the arrangement is not a collaboration pursuant to ASC Topic 808, Collaborative Arrangements (“ASC 808”), and it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
During the three and nine months ended September 30, 2024 and 2023, the Company did not recognize any revenue under ASC 606.
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Collaborative Agreements
The Company analyzes its collaboration agreements to assess whether they are within the scope of ASC 808 by determining whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards that are dependent on the commercial success of such activities. To the extent the arrangement is within the scope of ASC 808, the Company assesses whether aspects of the arrangement between the Company and the collaboration partner are within the scope of other accounting literature. If the Company concludes that some or all aspects of the arrangement represent a transaction with a customer, the Company accounts for those aspects of the arrangement within the scope of ASC 606. If the Company concludes that some or all aspects of the arrangement are within the scope of ASC 808 and do not represent a transaction with a customer, the Company recognizes the Company’s share of the allocation of the shared costs incurred with respect to the jointly conducted activities as a component of the related expense in the period incurred.
Research and Development Expenses
Research and development (“R&D”) expenses consist of costs incurred for R&D of its lead product candidate, CMP-CPS-001, and are recorded to operating expenses when incurred. The Company’s R&D expenses consist primarily of costs incurred in performing R&D activities, including personnel-related expenses such as salaries, stock-based compensation and benefits, facilities costs, depreciation and external costs of outside vendors engaged to conduct clinical and preclinical development activities and to manufacture CMP-CPS-001. The Company accrues expenses related to development activities performed by third parties based on an evaluation of services received and efforts expended pursuant to the terms of the contractual arrangements. Payments under some of these contracts depend on preclinical trial milestones. Non-refundable advance payments for goods and services that will be used over time for research and development are deferred and capitalized as research and development prepaid expenses on the Company’s condensed consolidated balance sheets. The capitalized amounts are recognized as an expense as the goods are delivered or as the related services are performed. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual or prepaid expense accordingly. Costs to acquire technologies to be used in R&D that have not reached technological feasibility and have no alternative future use are also expensed as incurred.
General and Administrative Expenses
General and administrative (“G&A”) expenses consist primarily of personnel-related expenses, including salaries, bonuses, benefits, travel and stock-based compensation expenses for employees in executive, accounting and finance, business development, human resources, legal, and other administrative functions. Other significant G&A expenses include allocated facility-related costs, legal fees relating to corporate and intellectual property matters, professional fees for accounting, audit and tax services, consulting fees and insurance costs. G&A costs are expensed as incurred.
Patent Costs
All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts are classified as G&A expenses.
Offering Costs
The Company complies with the requirements of ASC 340, Other Assets and Deferred Costs , with regards to offering costs. Prior to the completion of an offering of common stock, direct offering costs are capitalized as deferred offering costs. The deferred offering costs are charged to additional paid-in capital for offerings of common stock or as a reduction in the carrying value of preferred stock for offerings of preferred stock. Pursuant to ASC 340-10-S99-1, initial public offering costs directly attributable to an offering of equity securities are deferred and charged against the gross proceeds of the offering as a reduction of additional paid-in capital. Deferred offering costs consist of professional and registration fees that are directly related to the proposed public offering. Upon the completion of the IPO, the deferred offering costs were expensed immediately as a charge to operating expenses in the Company’s consolidated statements of operations and comprehensive loss. As of September 30, 2024 and December 31, 2023, the Company recorded deferred offering costs of $ 3.3 million and $ 0 , respectively, as presented on the condensed consolidated balance sheets.
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Stock-Based Compensation
The Company periodically grants equity-based payment awards in the form of stock options to employees, directors and non-employees and records stock-based compensation expenses for awards of stock-based payments based on their estimated fair value at the grant date. The Company recognizes stock-based compensation expense for all equity-based payments, including stock options. Stock-based compensation costs are calculated based on the estimated fair value of the underlying option using the Black-Scholes option-pricing model on the date of grant for stock options and are recognized as expense in the accompanying condensed consolidated statements of operations and comprehensive loss on a straight-line basis over the requisite service period, which is typically the vesting period. Determining the appropriate fair value model and related input assumptions requires judgment, including estimating the fair value of the Company’s common stock and stock price volatility.
Given the absence of a public trading market prior to the Company’s IPO in October 2024, the fair value of the Company’s common stock was determined by the Company’s Board of Directors (the “Board”) at the time of each option grant by considering a number of objective and subjective factors. These factors include the valuation of a select group of representative public companies within the industry that focus on biotechnology that the Board believes is comparable to the Company’s operations; operating and financial performance; the lack of liquidity of the common stock and trends in the broader economy and biotechnology industry also impact the determination of the fair value of the common stock.
The other inputs to the Black-Scholes option-pricing model include the following:
● The risk-free interest rate used is based on the published U.S. Department of Treasury interest rates in effect at the time of stock option grant for zero coupon U.S. Treasury notes with maturities approximating each grant’s expected term;
● The dividend yield is zero as the Company has not paid dividends and does not anticipate paying a cash dividend in the foreseeable future;
● The expected term for options granted is calculated using the simplified method and represents the average time that options are expected to be outstanding based on the mid-point between the vesting date and the end of the contractual term of the award; and
● Expected volatility is derived from the historical volatilities of a select group of representative companies, for a look-back period commensurate with the expected term of the stock options, as the Company had no trading history of its common stock prior to the IPO.
The Company recognizes forfeitures related to stock-based compensation awards as they occur.
The Company classifies stock-based compensation expense in the condensed consolidated statement of operations and comprehensive loss in the same manner in which the award recipients’ payroll costs are classified or in which the award recipients’ service payments are classified.
Classification of Convertible Preferred Stock
The Company’s convertible preferred stock is classified as temporary equity in the accompanying condensed consolidated balance sheets and is excluded from stockholders’ deficit as the potential redemption of such stock is outside the Company’s control. The convertible preferred stock is not redeemable except for in the event of a liquidation, dissolution or winding up of the Company. Costs incurred in connection with the issuance of convertible preferred stock are recorded as a reduction of gross proceeds from issuance. The Company does not accrete the carrying values of the preferred stock to the redemption values since the occurrence of these events was not considered probable as of September 30, 2024 and December 31, 2023. Subsequent adjustments of the carrying values to the ultimate redemption values will be made only when it becomes probable that these events will occur.
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Net Loss Per Share Attributable to Common Stockholders
The Company determined all of its convertible preferred stock qualifies as participating securities, as defined in ASC 260, Earnings Per Share (“ASC 260”). Under ASC 260, securities are considered participating securities if the securities may participate in undistributed earnings with common stock, whether that participation is conditioned upon the occurrence of a specified event or not. In accordance with ASC 260, a company is required to use the two-class method when computing net income (loss) per share when a company has securities that qualify as participating securities. The two-class method is an earnings allocation formula that determines net income (loss) per share for each class of common stock and participating security according to dividends declared (or accumulated) and participation rights in undistributed earnings. Diluted net income (loss) per share for the Company’s common stock is computed using the more dilutive of the two-class method or the if-converted method.
Basic net income (loss) per share attributable to common stockholders is computed by dividing the net income (loss) attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period. Diluted net income (loss) attributable to common stockholders is computed by adjusting net income (loss) per share attributable to common stockholders to reallocate undistributed earnings based on the potential impact of dilutive securities. Diluted net income (loss) per share attributable to common stockholders is computed by dividing the diluted net income (loss) attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period, including potential dilutive common shares. For purpose of this calculation, outstanding options to purchase common stock, unvested restricted stock awards, and shares of convertible preferred stock are considered potential dilutive common shares. The Company generated a net loss in all periods presented, and therefore the basic and diluted net loss per share attributable to common stockholders are the same as the inclusion of the potentially dilutive securities would be anti-dilutive.
Segment Information
Operating segments are defined as components of an enterprise (business activity from which it earns revenue and incurs expenses) about which discrete financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company’s chief operating decision maker is its Chief Executive Officer. The chief operating decision maker reviews consolidated operating results to make decisions about allocating resources and assessing performance for the entire company. The Company views its operations and manages its business as one operating segment.
Emerging Growth Company Status
The Company is an emerging growth company (“EGC”) as defined in the Jumpstart Our Business Startups Act of 2012, as amended (the “JOBS Act”), and may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not EGCs. The Company may take advantage of these exemptions until it is no longer an EGC under Section 107 of the JOBS Act and has elected to use the extended transition period for complying with new or revised accounting standards. As a result of this election, the Company’s condensed consolidated financial statements may not be comparable to companies that comply with public company FASB standards’ effective dates.
Recently Issued Accounting Standards
Accounting standards not listed below were assessed and determined not to be applicable or are expected to have a minimal impact on the Company’s condensed consolidated financial statements.
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In December 2023, the FASB issued ASU 2023-09, Income Taxes (“Topic 740”): Improvements to Income Tax Disclosures . The guidance includes the requirement that public business entities, on an annual basis, disclose specific categories in the rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items is equal to or greater than 5% of the amount computed by multiplying pretax income (or loss) by the applicable statutory income tax rate). It also requires that all entities disclose, on an annual basis, the amount of income taxes paid (net of refunds received) disaggregated by federal (national), state, and foreign taxes and the amount of income taxes paid (net of refunds received) disaggregated by individual jurisdictions in which income taxes paid (net of refunds received) is equal to or greater than 5% of total income taxes paid (net of refunds received) and requires that all entities disclose income (or loss) from continuing operations before income tax expense (or benefit) disaggregated between domestic and foreign and income tax expense (or benefit) from continuing operations disaggregated by federal (national), state, and foreign. Lastly, the guidance eliminates the requirement for all entities to disclose the nature and estimate of the range of the reasonably possible change in the unrecognized tax benefits balance in the next 12 months or make a statement that an estimate of the range cannot be made. For public business entities, the guidance is effective for annual periods beginning after December 15, 2024. Early adoption is permitted for annual consolidated financial statements that have not yet been issued or made available for issuance. The guidance should be applied on a prospective basis. Retrospective application is permitted. The Company is currently evaluating the impact that this guidance may have on its consolidated financial statements.
3. Fair Value Measurements
The following tables present the financial instruments carried at fair value on a recurring basis as of September 30, 2024 and December 31, 2023, respectively, in accordance with the ASC 820 hierarchy (in thousands):
Fair Value Measurements at September 30, 2024
Level 1
Level 2
Level 3
Total
Assets
Cash equivalents
$
735
$
—
$
—
$
735
Fair Value Measurements at December 31, 2023
Level 1
Level 2
Level 3
Total
Assets
Cash equivalents
$
37,074
$
—
$
—
$
37,074
The Company’s carrying amounts reflected in the condensed consolidated balance sheet for prepaid expenses and other current assets, accounts payable and accrued expenses and other liabilities are shown at their historical values which approximate their fair values.
4. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):
September 30, 2024
December 31, 2023
Variable lease expenses
$
7
$
105
Federal R&D tax credit receivable
108
442
Software and subscription expenses
252
287
Research and development (R&D) expenses
1,319
480
Other
290
318
Total prepaid expenses and other current assets
$
1,976
$
1,633
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5. Property and Equipment, Net
Property and equipment consisted of the following (in thousands):
September 30, 2024
December 31, 2023
Laboratory equipment
$
3,488
$
3,322
Computer and software
938
938
Furniture and fixtures
524
524
Leasehold improvements
4,518
4,518
Total property and equipment
9,468
9,302
Less: accumulated depreciation and amortization
( 5,637 )
( 4,505 )
Total property and equipment, net
$
3,831
$
4,797
The Company incurred depreciation and amortization expense of $ 0.4 million and $ 1.3 million for the three and nine months ended September 30, 2024, respectively. Depreciation and amortization expense for the three and nine months ended September 30, 2024 included less than $ 0.1 million and $ 0.1 million of finance lease right-of-use asset amortization, respectively. The Company incurred depreciation and amortization expense of $ 0.4 million and $ 1.2 million for the three and nine months ended September 30, 2023, respectively. Depreciation and amortization expense for the three and nine months ended September 30, 2023 included less than $ 0.1 million and $ 0.1 million of finance lease right-of-use asset amortization, respectively. See additional discussion in Note 7. Commitments and Contingencies .
6. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
September 30, 2024
December 31, 2023
Payroll and employee related expenses
$
1,703
$
1,937
Professional fees and other general and administrative expenses
1,211
475
Research and development expenses
394
601
Other
369
289
Total accrued expenses
$
3,677
$
3,302
7. Commitments and Contingencies
Operating Leases
The Company currently leases approximately 30,000 square feet of office space and laboratory space in Cambridge, Massachusetts and approximately 5,300 square feet of office and lab space in Boulder, Colorado. The office and laboratory space lease in Cambridge, Massachusetts expires on June 30, 2027. The lease provides a lease incentive in the form of reimbursable leasehold improvements of up to $ 3.6 million. As of September 30, 2024 and December 31, 2023, the Company had capitalized $ 4.5 million of leasehold improvement costs to date under this lease, of which $ 3.6 million was reimbursed through the lease incentive. Amounts received for lease incentives are included in the changes in operating lease assets and liabilities line in the condensed consolidated statement of cash flows. As of September 30, 2024, this operating lease accounted for $ 5.3 million of operating lease right-of-use assets, $ 2.7 million of current operating lease liabilities and $ 5.3 million of non-current operating lease liabilities.
In September 2023, the Company leased certain office and laboratory space under an operating lease in Boulder, Colorado for approximately 5,300 square feet of space. The five-year lease commenced on September 1, 2023. The lease for this office and laboratory space in Boulder, Colorado expires on September 30, 2028. As of September 30, 2024, this operating lease accounted for $ 1.2 million of operating lease right-of-use assets, $ 0.3 million of current operating lease liabilities and $ 0.9 million of non-current operating lease liabilities.
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The table below summarizes the Company’s operating lease costs for the three and nine months ended September 30, 2024 and 2023 (in thousands except for lease terms and borrowing rates):
Three months ended September 30,
Nine months ended September 30,
2024
2023
2024
2023
Operating lease costs:
Lease expense
$
609
$
554
$
1,827
$
1,880
Short-term lease expense
14
31
40
88
Variable lease expense
344
286
1,017
862
Total operating lease costs
$
967
$
871
$
2,884
$
2,830
Other information:
Cash paid for amounts included in the measurement of lease liabilities, including in operating cash flows
$
770
$
755
$
2,523
$
2,449
Weighted-average remaining lease term (in years)
2.9
3.9
2.9
3.9
Weighted-average incremental borrowing rate
6.72
%
6.72
%
6.72
%
6.72
%
Maturities of operating lease liabilities as of September 30, 2024 were as follows (in thousands):
Maturity of operating lease liabilities
2024 remaining
$
852
2025
3,455
2026
3,558
2027
1,980
2028
264
Total lease payments
10,109
Less: amount representing imputed interest
( 916 )
Total future minimum lease obligations
$
9,193
Finance Leases
The Company leases certain specialized lab equipment under several finance lease agreements with maturities ranging from November 2024 to November 2028.
The table below summarizes the Company’s finance lease costs for the three and nine months ended September 30, 2024 and 2023 (in thousands except for lease terms and borrowing rates):
Three months ended
Nine months ended
September 30,
September 30,
Classification
2024
2023
2024
2023
Finance lease costs:
Amortization of right-of-use assets
Depreciation and amortization
$
49
$
41
$
146
$
100
Interest on lease liabilities
Other expense
6
10
22
23
Total finance lease costs
$
55
$
51
$
168
$
123
Other information:
Cash paid for amounts included in the measurement of lease liabilities, including in operating cash flows
$
89
$
89
$
268
$
201
Weighted-average remaining lease term
1.8
1.4
1.8
1.4
Weighted-average incremental borrowing rate
8.24
%
8.22
%
8.24
%
8.22
%
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Maturities of finance lease liabilities as of September 30, 2024 were as follows (in thousands):
Maturity of finance lease liabilities
2024 remaining
$
114
2025
98
2026
31
2027
31
Total lease payments
$
274
Less: amount representing imputed interest
( 17 )
Total future minimum lease obligations
$
257
Financing Obligation
In April 2023, the Company (seller-lessee) sold certain laboratory equipment to an unrelated third-party (buyer-lessor) and simultaneously entered into a 26-month lease agreement for the laboratory equipment with the buyer-lessor through June 2025. The lease requires monthly payments of less than $ 0.1 million and provides a fixed price repurchase option at the end of the lease term of $ 0.1 million.
The repurchase option precludes accounting for the transfer of the asset to the buyer-lessor as a sale under ASC 842 since the exercise price of the repurchase option is fixed and, therefore, is not the fair value of the asset on the exercise date of the option. Thus, the agreement is considered a financing transaction (i.e., failed sale-leaseback) as the Company is reasonably certain to exercise the repurchase option at the end of the lease. The net proceeds received amounted to $ 0.7 million, which is recorded as a financing liability in the Company’s condensed consolidated balance sheet. The Company imputes interest at a rate of 0.86 % on a monthly basis. For each of the three and nine months ended in September 30, 2024 and 2023, the Company recorded less than $ 0.1 million of interest expense related to this financing transaction in other expense in the condensed consolidated statements of operations and comprehensive loss.
Legal Proceedings
A liability for loss contingencies arising from claims, assessments, litigation, fines, penalties and other sources is recorded in the consolidated financial statements if it is determined that it is probable that a loss has been incurred and the amount (or range) of the loss can be reasonably estimated. There are no matters currently outstanding for which any liabilities have been accrued or require disclosure.
8. Collaboration and License Agreements
In-License Agreements
Children’s Medical Center Corporation
In April 2018, the Company entered into a development and license agreement (the “Children’s Medical Center Corporation Agreement”) with Children’s Medical Center Corporation (“CMCC”). The agreement allows the Company to use CMCC’s proprietary intellectual property to conduct research, development and commercialization of products utilizing CMCC’s proprietary intellectual property in return for specified payments. The proprietary intellectual property licensed pursuant to this agreement is related to certain legacy programs the Company is not pursuing and was subsequently sublicensed to Fulcrum Therapeutics, Inc., or Fulcrum, as described below. As part of the agreement, the Company issued a total of 15,123 shares of common stock to CMCC and its affiliates based on the fair value of the common stock on the date of issuance.
The Company is obligated to pay potential development milestone payments under the terms of the Children’s Medical Center Corporation Agreement of up to $ 7.7 million for the first licensed target, $ 3.9 million for the second licensed target and $ 1.9 million for the third licensed target upon the achievement of certain specified contingent events. If commercial sales of a licensed product commence, the Company will pay CMCC royalties at percentage rates ranging in the low- to mid-single digits on net sales of licensed products in countries where such product is protected by patent rights. The Company incurred less than $ 0.1 million of royalties owed to CMCC under the agreement during each of the three and nine months ended September 30, 2024 and 2023, and recorded the amounts in R&D expense in the condensed consolidated statements of operations and comprehensive loss. The Company re-evaluates the likelihood of achieving future milestones at the end of each reporting period. As of September 30, 2024, the Company determined that the likelihood of achieving future milestones was not probable.
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Whitehead Institute for Biomedical Research
In October 2019, the Company entered into a patent license agreement with the Whitehead Institute for Biomedical Research (the “Whitehead Institute”), which was subsequently amended on December 14, 2021 (the “Whitehead First Amendment”), and on November 7, 2023 (the “Whitehead Second Amendment”). Under the agreement, the Company was granted a worldwide, royalty-bearing, sublicensable license under certain patent rights owned or controlled by the Whitehead Institute. As part of the agreement, the Company paid an initial $ 0.1 million license issuance fee, and de minimis additional fees in connection with each of the Whitehead First Amendment and Whitehead Second Amendment that were recorded as research and development expense in the condensed consolidated statement of operations and comprehensive loss. The Company is also obligated to pay annual license maintenance fees for the term of the agreement, pursuant to which the Company has paid an aggregate of $ 0.20 million through September 30, 2024. In addition, the Company is obligated to pay certain filing, prosecution and maintenance fees with respect to certain patent rights licensed to us under the agreement, pursuant to which we have paid an aggregate of $ 0.27 million through September 30, 2024. The Company is obligated to pay potential development milestone payments to the Whitehead Institute of up to an aggregate of $ 1.9 million under the terms of the agreement upon the achievement of certain specified contingent events. In addition, if the Company successfully commercializes a product under the agreement, we are also obligated to pay tiered royalties at percentage rates ranging from less than one percent to the mid-single digits of net sales or of running royalties of net sales, subject to specified reductions, until either the last-to-expire valid claim of a Whitehead Institute patent covering the product or a seven years after the first commercial sale, in each case on a product-by-product and country-by-country basis. We incurred de minimis amounts of license maintenance and amendment issuance fees during each of the three and nine months ended September 30, 2024 and 2023 under the amended agreement and recorded the amounts in our research and development expense in our condensed consolidated statements of operations and comprehensive loss.
Sublicense Agreement
Fulcrum Therapeutics, Inc.
In July 2023, the Company entered into a license agreement (the “Fulcrum Agreement”) with Fulcrum. Under the Fulcrum Agreement, the Company granted an exclusive license related to the Company’s intellectual property (“IP”) and granted a sublicense for IP obtained through the Children’s Medical Center Corporation Agreement. In exchange for the license rights, Fulcrum paid the Company a $ 0.35 million upfront payment. In the event that Fulcrum achieves certain development and commercial milestones, Fulcrum will be obligated to pay the Company one-time milestone payments ranging from $ 1.0 million to $ 20.0 million (with respect to a Tier 1 Product, as defined in the Fulcrum Agreement) or $ 0.6 million to $ 12.0 million (with respect to a Tier 2 Product, as defined in the Agreement), depending on the milestone achieved. In addition, the Fulcrum Agreement includes both potential nominal minimum annual royalty payments as well as sales-based royalties upon commercialization of up to the low-double digits.
The Company assessed this arrangement in accordance with ASC 606 and concluded that the contract counterparty, Fulcrum, is a customer. In accordance with ASC 606, the Company determined that there is one performance obligation in the Fulcrum Agreement, consisting of the exclusive and non-exclusive license rights granted to Fulcrum. The transaction price was comprised of the fixed consideration of $ 0.35 million and was recognized upon transfer of control of the licenses at a point in time upon contract execution. The arrangement includes significant variable consideration primarily in the form of milestone payments, which was fully constrained at the inception of the contract and at September 30, 2024. All variable consideration is remeasured and the related constraint on each element of variable consideration is reassessed each reporting period.
The sales-based royalty fee is considered variable consideration and will be recognized as revenue as such sales occur. The sales-based royalty fee qualifies for the royalty constraint exception and does not require an estimate of the future transaction price.
During the three and nine months ended September 30, 2024, the Company did no t record any license revenue pursuant to the Fulcrum Agreement. During the three and nine months ended September 30, 2023, the Company recorded $ 0.35 million of license revenue pursuant to the Fulcrum Agreement.
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Collaborative Arrangement
Eli Lilly and Company
In July 2023, the Company executed a Material Transfer Agreement (“MTA”) with Eli Lilly and Company (“Eli Lilly”), which was subsequently amended in July 2024. As part of the MTA, the Company and Eli Lilly agreed to perform research and development activities to generate up to three antisense oligonucleotides (“ASOs”) in accordance with a prescribed workplan. For the three and nine months ended September 30, 2024, the Company received $ 0.2 million and $ 0.4 million from Eli Lilly related to the MTA. The Company evaluated the MTA under ASC 808 and concluded that it is a collaboration arrangement. The Company and Eli Lilly are jointly overseeing the research and development activities under the MTA and both parties are exposed to the significant risks and potential rewards under the MTA. For the three and nine months ended September 30, 2024, the Company recorded $ 0.1 million and $ 0.3 million, respectively, as a reduction in R&D expense in the condensed consolidated statement of operations and comprehensive loss. For the three and nine months ended September 30, 2023, the Company recorded $ 0.2 million and $ 0.2 million, respectively, as a reduction in R&D expense in the condensed consolidated statement of operations and comprehensive loss. Additionally, the Company had an unbilled receivable of less than $ 0.1 million and $ 0.1 million recorded within prepaid expenses and other current assets on the condensed consolidated balance sheets as of September 30, 2024 and December 31, 2023, respectively.
Research and Collaboration Agreement
BioMarin Pharmaceutical Inc.
On September 26, 2024, the Company entered into a Collaboration and License Agreement (the “BioMarin Agreement”) with BioMarin Pharmaceutical Inc. (“BioMarin”), pursuant to which the Company and BioMarin agreed to collaborate with respect to the research and discovery of regulatory RNA-targeting ASOs using the Company’s proprietary RAP Platform to modulate the expression of two undisclosed genetic targets under two distinct programs. Under the terms of the agreement, BioMarin will pay an upfront, nonrefundable payment of $ 1.0 million, and will reimburse the Company for the research activities the Company will conduct for each program under an agreed research plan and budget. On a per-program basis, the Company will be eligible to receive up to $ 5.0 million in future contingent preclinical milestones, up to $ 75.0 million in future contingent development and regulatory milestones and up to $ 105.0 million in commercial sales milestones. The Company will be further eligible to receive tiered royalties at percentage rates ranging from low-single digits to the high-single digits of net sales, subject to specified reductions, until either the last-to-expire valid claim of patent covering the product, ten years after the first commercial sale, or the expiration of any applicable regulatory exclusivity obtained for the product, in each case on a product-by-product and country-by-country basis. The agreement may be terminated in its entirety or on a program-by-program basis for convenience by BioMarin. The agreement may also be terminated by either the Company or BioMarin under certain other circumstances, including material breach, as set forth in the agreement. The notice periods for termination provisions range from 30 days to 270 days depending on the reason of termination.
The Company assessed this arrangement in accordance with ASC 606 and concluded that the contract counterparty, BioMarin, is a customer. In accordance with ASC 606, the Company determined that there is one performance obligation in the BioMarin Agreement, consisting of the bundle of R&D activities to be provided by the Company and both the exclusive and non-exclusive license rights granted to BioMarin under the arrangement. The transaction price is comprised of the fixed consideration of $ 1.0 million for the upfront fee along with the research activity reimbursements under the agreed upon research plan and budget. The associated revenue will be recognized over time based upon a cost-to-cost method, i.e., the input method, as the transfer of control occurs over a period of time and this is the best measure of progress towards satisfying the performance obligation. The estimated remaining period over which revenue is expected to be recognized is 12 months from September 30, 2024. The arrangement includes significant variable consideration primarily in the form of milestone payments, which is fully constrained at the inception of the contract and at September 30, 2024. All variable consideration is remeasured and the related constraint on each element of variable consideration is reassessed each reporting period.
The sales-based royalty fee is considered variable consideration and will be recognized as revenue as such sales occur. The sales-based royalty fee qualifies for the royalty constraint exception and does not require an estimate of the future transaction price.
During the three and nine months ended September 30, 2024, the Company did no t record any research and collaboration revenue pursuant to the BioMarin Agreement as no R&D activities were provided by the Company. At contract execution, the Company had the unconditional right to bill BioMarin for the non-refundable upfront fee of $ 1.0 million. The $ 1.0 million upfront fee billing is presented within accounts receivable and short-term deferred revenue on the condensed consolidated balance sheet as of September 30, 2024.
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9. Convertible Preferred Stock and Stockholders’ Deficit
Convertible Preferred Stock
As of September 30, 2024 and December 31, 2023, the Company’s Series A Prime and Series B convertible preferred stock have been classified as temporary equity in the accompanying condensed consolidated balance sheets.
Convertible preferred stock consisted of the following as of September 30, 2024 and December 31, 2023 (in thousands, except share amounts):
Common Stock
Shares
Issuable
Authorized
Issued and
Liquidation
Upon
Shares
Outstanding
Value
Conversion
Series A Prime
68,173,692
62,389,791
$
62,381
5,562,653
Series B
81,499,592
68,258,635
$
100,504
6,085,929
Series B Convertible Preferred Stock
In 2022, the Company entered into a securities purchase agreement (the “Series B Agreement”) to sell shares of Series B convertible preferred stock (the “Series B Preferred Stock”) at $ 1.4724 per share. From June through July 2022, the Company issued 68,258,635 shares of Series B Preferred Stock to existing and new investors for gross cash proceeds of $ 100.5 million, less issuance costs of $ 0.3 million, resulting in net proceeds of $ 100.2 million.
Rights, Preferences, Privileges and Restrictions
Voting Rights
Each preferred stockholder is entitled to cast the number of votes equal to the number of whole shares of common stock into which the shares of preferred stock held by such holder are convertible at the time of such vote . All preferred stockholders are entitled to vote on all matters upon which holders of common stock have the right to vote, other than matters that must by law be voted by class or series vote.
Conversion Rights
Each share of convertible preferred stock is convertible at the option of the holder at any time into a share of common stock. Each share of convertible preferred stock is convertible into that number of common shares as is determined by dividing the applicable initial purchase price) of such share by the applicable conversion price. The conversion rate is subject to adjustment upon the occurrence of certain events, including diluting issues of shares, stock splits, stock combinations, certain dividends and distributions, a merger and a reorganization.
All shares of the convertible preferred stock are automatically convertible into shares of common stock, in a firm commitment underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933, as amended, covering the offer and sale of common stock for the account of the Company which results in at least $ 75.0 million of gross proceeds to the Company.
In conjunction with the closing of the Company’s IPO on October 15, 2024, all shares of preferred stock, including 62,389,791 shares of Series A Prime convertible preferred stock and 68,258,635 shares of Series B convertible preferred stock, converted automatically into an aggregate of 11,648,582 shares of common stock.
Dividend Rights
Preferred stockholders are entitled to receive, when and as declared by the Board of Directors, preferential non-cumulative cash dividends at a rate of 6 % per annum of the original issue price per share. Such dividends are payable only when and if declared by the Company’s board of directors. No such dividends have been declared or paid through September 30, 2024.
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Liquidation Preference
In the event of any voluntary or involuntary liquidation, dissolution, or winding up of the Company, the holders of shares of the preferred stock shall be paid an amount per share first out of the assets and legally available funds of the Company available for distribution to holders of the Company’s capital stock of all classes, an amount equal to the greater of the original issue price, plus all declared dividends accrued but unpaid with respect to each such shares, as adjusted for any stock dividend, stock split, recapitalization, or other similar event. After payment of all preferential amounts to the holders of preferred shares, any assets and funds of the Company that remain available for distribution shall be distributed ratably among the holders of the common stock.
Redemption Rights
The holders of the shares of the Preferred Stock may redeem their shares for the original issue price per share and any declared dividends upon a Deemed Liquidation Event, as defined per the terms of the applicable preferred stock agreement.
Common Stock
Voting, dividend and liquidation rights of the holders of the common stock are subject to and qualified by the rights, powers and preferences of the holders of the convertible preferred stock.
Voting
Each holder of outstanding shares of common stock is entitled to one vote in respect of each share. The holders of outstanding shares of common stock, voting together as a single class, are entitled to elect one director. The number of authorized shares of common stock may be increased or decreased by the affirmative vote of a majority of the outstanding shares of common stock and preferred stock voting together as a single class.
Dividends
Subject to the payment in full of all preferential dividends to which the holders of the preferred stock are entitled, the holders of common stock are entitled to receive dividends out of funds legally available therefor at such times and in such amounts as the board of directors may determine in its sole discretion, with holders of preferred stock and common stock sharing pari passu in such dividends.
Liquidation Rights
After payment in full of all preferential amounts to which the holders of preferred stock are entitled upon any voluntary or involuntary liquidation, dissolution or winding-up of the Company or deemed liquidation event of the Company, all of the remaining assets of the Company available for distribution to the stockholders shall be distributed among the holders of the preferred stock and common stock, pro rata based on the number of shares held by each such holder on an as converted to common stock basis.
Reserved Shares
As of September 30, 2024, the Company reserved the following shares of common stock for issuance upon conversion of the outstanding convertible preferred stock and exercise of stock options:
As of September 30, 2024
Shares reserved for convertible preferred stock
11,648,582
Shares reserved for future issuance under the 2016 Stock Incentive Plan
869,646
Shares reserved for stock option exercises
2,078,470
Shares reserved for warrants
142
Shares reserved for restricted stock vesting
30,607
Total
14,627,447
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10. Stock-Based Compensation
In 2016, the Company adopted the Marauder Therapeutics, Inc. 2016 Stock Option and Grant Plan (the “Plan”). All of the Company’s employees, officers, directors, consultants and advisors are eligible to be granted options, restricted stock units and other stock-based awards under the terms of the Plan. When the Plan was initially established, it provided for the grant of 18,904 shares of common stock. During 2018, the Board of Directors approved an increase to 1,416,218 shares of common stock available under the Plan. During 2021, the Board of Directors approved an increase to 1,521,972 shares of common stock available under the Plan. During 2022, the Board of Directors approved another increase to 3,803,266 shares of common stock available under the Plan. As of September 30, 2024, there were 869,646 shares of common stock remaining and available for issuance under the 2016 Plan.
The Company may grant options to purchase authorized but unissued shares of the Company’s common stock. Options granted under the 2016 Plan include incentive stock options that can be granted only to the Company’s employees and non-statutory stock options that can be granted to the Company’s employees, consultants, advisors and directors.
The exercise prices, vesting and other restrictions of the awards to be granted under the 2016 Plan is determined by the board of directors, except that no stock option may be issued with an exercise price less than the fair market value of the common stock at the date of the grant or have a term in excess of ten years . Options granted under the 2016 Plan are exercisable in whole or in part at any time subsequent to vesting, which is typically over a four-year period.
Stock Options
The following table summarizes stock option activity for the nine months ended September 30, 2024 (in thousands, except share and per share amounts):
Weighted-
Average
Number
Weighted-
Remaining
of
Average
Contractual
Aggregate
Options
Exercise Price
Term
Intrinsic Value
Balance at December 31, 2023
2,273,221
$
6.06
8.05
$
6,893
Options granted
398,212
$
10.33
Options cancelled
( 91,373 )
$
7.18
Options exercised (1)
( 501,590 )
$
0.06
$
6,378
Balance at September 30, 2024
2,078,470
$
7.80
7.92
$
10,353
Vested and expected to vest as of September 30, 2024
2,078,470
$
7.80
7.92
$
10,353
Exercisable at September 30, 2024
1,002,581
$
6.62
7.15
$
6,177
(1) The exercised options for the three months ended September 30, 2024, include 388,488 stock options deemed outstanding common shares in connection with the forgiveness of secured promissory notes issued to certain executive officers, as further described in the IPO Prospectus.
The Company recorded stock-based compensation expense related to stock options of $ 1.6 million and $ 3.2 million for the three and nine months ended September 30, 2024, respectively. The Company recorded stock-based compensation expense related to stock options of $ 0.7 million and $ 2.3 million for the three and nine months ended September 30, 2023, respectively. The Company has an aggregate $ 7.2 million of gross unrecognized stock-based compensation expense as of September 30, 2024 remaining to be recognized over a weighted average period of 2.5 years.
A summary of restricted stock award activity for the nine months ended September 30, 2024 is as follows:
Weighted Average
Number of Shares
Fair Value
Unvested at December 31, 2023
74,243
$
2.02
Granted
—
—
Vested
( 43,636 )
$
2.13
Forfeited
—
—
Unvested at September 30, 2024
30,607
$
1.86
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All restricted common stock awards were initially issued at a price determined to be fair value on the date of grant. The Company recognizes forfeitures of restricted common stock as they occur. As of September 30, 2024, total unrecognized stock-based compensation expense relating to unvested restricted common stock was less than $ 0.1 million. This amount is expected to be recognized over a weighted average period of 0.5 years. The fair value of shares that vested during the three and nine months ended September 30, 2024 was $ 0.2 million and $ 0.5 million, respectively.
Stock-based compensation expense related to stock options and restricted stock recorded in the accompanying condensed consolidated statements of operations is as follows (in thousands):
Three months ended September 30,
Nine months ended September 30,
2024
2023
2024
2023
Research and development
$
519
$
368
$
1,424
$
1,229
General and administrative
1,073
354
1,811
1,042
Total
$
1,592
$
722
$
3,235
$
2,271
The Company has not recognized and does not expect to recognize in the near future, any tax benefit related to employee stock-based compensation expense as a result of the full valuation allowance related to its net deferred tax assets.
11. Income Taxes
No provision for federal, state, or foreign income taxes has been recorded for the three and nine months ended September 30, 2024 and 2023. The Company has incurred net operating losses for all the periods presented and has not reflected any benefit for such net operating loss carryforwards in the accompanying condensed consolidated financial statements due to uncertainty around utilizing these tax attributes within their respective carryforward periods. The Company has recorded a full valuation allowance against all of its deferred tax assets as it is not more likely than not that such assets will be realized in the near future. The Company’s policy is to recognize interest expense and penalties related to income tax matters as tax expense. For the three and nine months ended September 30, 2024 and 2023, the Company has no t recognized any interest or penalties related to income taxes.
12. Net Loss Per Share Attributable to Common Stockholders
Basic and diluted net loss per share was calculated as follows (in thousands, except share and per share amounts):
Three months ended
Nine months ended
September 30,
September 30,
2024
2023
2024
2023
Numerator:
Net loss attributable to common stockholders
$
( 13,484 )
$
( 11,696 )
$
( 38,512 )
$
( 36,301 )
Denominator:
Weighted-average common shares outstanding, basic and diluted
557,437
400,426
503,455
383,653
Net loss per share attributable to common stockholders, basic and diluted
$
( 24.19 )
$
( 29.21 )
$
( 76.5 )
$
( 94.62 )
The Company’s potentially dilutive securities, which include convertible preferred stock, outstanding stock options, unvested restricted common stock, and convertible preferred stock warrants, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same.
The Company excluded the following from the computation of diluted net loss per share attributable to common stockholders at September 30, 2024 and 2023 because including them would have had an anti-dilutive effect:
September 30,
2024
2023
Conversion of outstanding convertible preferred stock
11,648,582
11,648,582
Options to purchase common stock
2,078,470
2,284,676
Unvested restricted common stock
30,607
46,181
Conversion of preferred stock warrant
142
142
Total
13,757,801
13,957,292
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13. Employee Benefit Plan
On January 1, 2017, the Company’s board of directors approved the Company’s 401(k) retirement plan (the “401(k) Plan”). Employees of the Company are eligible to participate in the 401(k) Plan. Participants may contribute up to 100 % of their annual compensation to the 401(k) Plan, subject to statutory limitations. Effective January 1, 2022, under the 401(k) Plan “Safe Harbor Match”, the Company matches one hundred percent ( 100 %) of the first three percent ( 3 %) of employee contributions and these contributions vest in full at the time of match.
For the three and nine months ended September 30, 2024, the Company made matching contributions of less than $ 0.1 million and $ 0.3 million, respectively. For the three and nine months ended September 30, 2023, the Company made matching contributions of less than $ 0.1 million and $ 0.3 million, respectively.
14. Related Parties
In September 2015, the Company entered into consulting agreements with its two founders, related parties who hold shares of the Company’s common stock, to provide R&D and strategic planning services. For the three and nine months ended September 30, 2024, the Company recognized R&D expense of less than $ 0.1 million and $ 0.2 million, respectively, related to work performed under the founder agreements. For the three and nine months ended September 30, 2023, the Company recognized R&D expense of less than $ 0.1 million and $ 0.2 million, respectively, related to work performed under the founder agreements. For both the three and nine months ended September 30, 2024, the Company recognized stock-based compensation expense of less than $ 0.1 million and $ 0.1 million, related to the consulting agreements, respectively. For both the three and nine months ended September 30, 2023, the Company recognized stock-based compensation expense of less than $ 0.1 million and $ 0.2 million, related to the consulting agreements, respectively. The Company had no amounts due to the founders at September 30, 2024.
In March 2019, the Company entered into a consulting agreement with an executive consultant, a related party who holds shares of the Company’s common stock. For both the three and nine months ended September 30, 2024, the Company recognized G&A expense totaling less than $ 0.1 million, related to work performed under the consulting agreement. For both the three and nine months ended September 30, 2023, the Company recognized G&A expense of less than $ 0.1 million, related to work performed under the consulting agreement. For the three and nine months ended September 30, 2024, the Company recognized stock-based compensation expense of less than $ 0.1 million and $ 0.1 million, related to the consulting agreement. For the three and nine months ended September 30, 2023, the Company recognized stock-based compensation expense of less than $ 0.1 million and $ 0.2 million, related to the consulting agreement. The Company had no amounts due to the consultant at September 30, 2024.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.