Contineum Therapeutics Inc
For the period ended Dec 31, 2024. Filed Mar 6, 2025.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Mar 6, 2025
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Notes to Audited Financial Statements
1. Organization and Basis of Presentation
Organization and Nature of Operations
Contineum Therapeutics, Inc. (the “Company”), is a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of NI&I indications with significant unmet need. The Company was incorporated in the state of Delaware in2009, and in* November 2023*changed its name from Pipeline Therapeutics, Inc. to Contineum Therapeutics, Inc.
Reverse Stock Split
On* April 1, 2024,the Company filed an amendment to itsfourth* amended and restated certificate of incorporation as amended and effected a1-for-5.5972 reverse stock split of its capital stock. All share and per-share amounts presented in the financial statements and related notes have been retroactively adjusted to reflect the reverse stock split as of the beginning of thefirst period presented.
Initial Public Offering
On* April 9, 2024,the Company closed its IPO, pursuant to which it issued and sold an aggregate of 6,875,000 shares of its common stock at a public offering price of $16.00 per share and on April 19, 2024,*the Company issued and sold 548,682 additional shares of its common stock to the underwriters of the IPO pursuant to the partial exercise of their option to purchase additional shares, resulting in net proceeds of approximately $107.9 million, after deducting underwriting discounts, commissions and other offering expenses. Upon the closing of the IPO, the Company’s outstanding convertible preferred stock automatically converted into Class A common stock or Class B common stock, as applicable. Converted redeemable convertible preferred stock outstanding as of the date of the IPO consisted of 15,906,236 shares that were outstanding immediately prior to the closing of the IPO. Following the closing of the IPO,no shares of redeemable convertible preferred stock were authorized or outstanding.
In connection with the closing of its IPO, on* April 9, 2024,the Company’s certificate of incorporation was amended and restated to (i) authorize 220,000,000 shares of common stock of which 200,000,000 are designated as Class A common stock and 20,000,000 of which are designated as Class B common stock; (ii) eliminate all references to the previously existing series of preferred stock; and (iii) authorize 10,000,000 shares of undesignated preferred stock that maybe issued from time to time by the Company’s board of directors inone* or more series.
Liquidity and Capital Resources
Since its inception, the Company has devoted substantially all its resources to research and development activities, business planning, establishing and maintaining its intellectual property portfolio, hiring personnel, raising capital to support and expand such activities and providing general and administrative support for these operations. The Company incurred a net loss of $42.3 million for the year ended* December 31, 2024*. The Company had an accumulated deficit of $117.4 million as of* December 31, 2024*. From its inception through* December 31, 2024*, the Company has financed its operations primarily through issuance of convertible promissory notes, convertible preferred stock financings, a term loan, a global license and development agreement (the “J&J License Agreement”) the Company entered in* February 2023with Janssen Pharmaceutica NV, a Johnson & Johnson company, and net proceeds of approximately $107.9 million received in April 2024*from the Company's IPO.
As of* December 31, 2024,the Company had cash, cash equivalents and marketable securities of $204.8 million. Management believes the Company’s existing cash, cash equivalents, and marketable securities will be sufficient to support its operations for at least12* months from the date of this Annual Report on Form10-K.
As the Company continues to pursue its business plan, it expects to finance its operations through both public and private sales of equity, debt financings or other commercial arrangements, which could include income from collaborations, strategic partnerships or marketing, distribution, licensing or other strategic arrangements withthird parties. However, there can beno assurance that any additional financing or strategic transactions will be available to the Company on acceptable terms, if at all. If events or circumstances occur such that the Company doesnot obtain additional funding, it* mayneed to delay, reduce or eliminate its product development or future commercialization efforts, which could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows. Further, if the Company raises funds through licensing or other similar arrangements withthird* parties, it* maybe required to relinquish valuable rights to its technology, future revenue streams, research programs or drug candidates or maybe required to grant licenses on terms that may**not* be favorable to it and/or* may*reduce the value of its common stock.
2. Summary of Significant Accounting Policies
Basis of Presentation
The Company’s financial statements are prepared in accordance with U.S. GAAP.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the Company’s financial statements and accompanying notes. Accounting estimates and management judgments reflected in the financial statements include: the accrual of research and development expenses; the incremental borrowing rate used to recognize the right-of-use assets and lease liabilities, the fair value of common stock and convertible preferred stock; stock-based compensation; and the fair value of the investor preferred stock purchase rights and obligations liability. Although these estimates are based on the Company’s knowledge of current events and actions it* mayundertake in the future, actual results may*materially differ from these estimates and assumptions.
Concentration of Credit Risk
Financial instruments which potentially subject the Company to significant concentration of credit risk consist of cash, cash equivalents and marketable securities. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company hasnot experienced any losses in such accounts, and management believes that the Company isnot exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. However, to the extent the Company holds cash deposits in amounts that exceed the FDIC insurance limitation, it* may*incur a loss in the event of a failure of any of the financial institutions where it maintains deposits.
Comprehensive Income (Loss)
Comprehensive income (loss) is defined as a change in equity during a period from transactions and other events and circumstances from non-owner sources.
Fair Value of Financial Instruments
The accounting guidance defines fair value, establishes a consistent framework for measuring fair value, and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as an exit price representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability.
Cash and Cash Equivalents
The Company considers all highly liquid investments with an original maturity ofthree months or less at the date of purchase to be cash equivalents. Cash equivalents primarily represent funds invested in readily available money market accounts and short-term securities. As of* December 31, 2024* and2023, the Company had cash and cash equivalents balances deposited at major financial institutions.
Marketable Securities
The Company classifies all marketable debt securities as available for sale, as the sale of such securities* maybe required prior to maturity. These marketable securities are carried at fair value, with unrealized gains and losses reported in accumulated other comprehensive income (loss) until realized. The cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion, as well as interest and dividends, are included in interest income. Realized gains and losses from the sale of available for sale securities, if any, are determined on a specific identification basis and are also included in interest income. The Company’s marketable securities are classified as current assets, even though the stated maturity date maybeone* year or more beyond the current balance sheet date, which reflects management’s ability and intent to use the proceeds from sales of these securities to fund its operations, as necessary.
F-8
Property and Equipment, Net
Property and equipment, which consist of leasehold improvements, furniture and fixtures, lab equipment, and computer equipment and software are stated at cost less accumulated depreciation and amortization. Depreciation and amortization are calculated using the straight-line method over the estimated useful lives of the assets, which ranges fromtwo tofive years. Leasehold improvements are amortized over the shorter of the estimated useful life of the asset and the remaining life of the lease for leasehold improvements at the time the asset is placed into service.
Leases
The Company applies Accounting Standards Codification (“ASC”)842, Leases which requires the Company to determine if a contract contains a lease at the inception of the contract and evaluate each lease agreement to determine whether the lease is an operating or finance lease. For leases where the Company is the lessee, right-of-use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent an obligation to make lease payments arising from the lease. Liabilities from operating leases are included in current portion of operating lease liabilities, and operating lease liabilities, net of current portion on the accompanying balance sheets (see Note11 for a summary of the Company’s right-of-use-assets and lease liabilities as of* December 31, 2024*). The Company doesnot have any financing leases. Short-term leases with an initial term of12 months or less arenot recorded on the balance sheet. The Company doesnot have material short-term lease costs.
Lease liabilities are measured at the present value of the remaining lease payments discounted using the discount rate for the lease established at the lease commencement date. To determine the present value, the implicit rate is used when readily determinable. For those leases where the implicit rate isnot provided, the Company determines an incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments. ROU assets are measured at the present value of the lease payments and also include any prepaid lease payments made and any other indirect costs incurred, and reduced by any lease incentives received. Lease terms* may*include the impact of options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for operating leases is recognized on a straight-line basis over the lease term. The Company’s operating leases are subject to additional variable charges, including common area maintenance, property taxes, property insurance and other variable costs. Variable lease costs are experienced in the period incurred. The Company has elected the practical expedient to account for the lease and non-lease components, such as common area maintenance charges, as a single lease component for the Company’s facilities leases.
Revenue Recognition
The Company currently hasno product revenue. The Company generates revenues from the J&J License Agreement, in which the Company transferred to J&J the worldwide rights to develop, manufacture, and commercialize products containing PIPE-307. Revenue for the J&J License Agreement is recognized in accordance with ASC606, Revenue from Contracts with Customers (“ASC606”). Revenue is recognized when control of the promised goods or services are transferred to the customer, in an amount that reflects the consideration the Company expects to be entitled to in exchange for transferring those goods or services. The steps for recognizing revenue consist of: (1) identifying the contract; (2) identifying the distinct performance obligations; (3) determining the transaction price for which the Company expects to be entitled in exchange for the goods and services; (4) allocating the transaction price to the performance obligations in the contract; and (5) recognizing revenue when or as the performance obligations are satisfied.
F-9
The Company allocates fixed and variable consideration based on relative standalone selling prices, unless an allocation exception for variable consideration is met. The allocated transaction price is recognized when (or as) each respective performance obligation is satisfied. For performance obligations that are satisfied at a point in time, the Company evaluates the indicators of control in ASC606 to determine the point in time upon which control is transferred and therefore the performance obligation is satisfied. For performance obligations that are satisfied over time, the Company uses a measure of progress that best reflects the Company’s effort in satisfying the respective performance obligation to recognize revenue. The measure of progress is subject to estimates by management and* may*change over the course of the agreement.
A contract modification is a change in the scope or price (or both) of a contract that is approved by the parties to the contract. A contract modification exists when the rights and obligations that are created or changed by a modification are enforceable. The Company accounts for a contract modification as a separate contract when the scope of the contract increases, and the price of the contract increases by an amount that reflects the standalone selling prices of the additional promised goods or services that are distinct. If a contract modification isnot accounted for as a separate contract, the Company’s accounting of the contract modification depends on whether the remaining goods or services are distinct from those already provided on or before the date of the contract modification. If the remaining goods or services are distinct from those already provided, the Company accounts for the contract modification as a termination of the existing contract and creation of a new contract. The amount of the consideration to be allocated to the remaining performance obligations consists of the consideration promised by the customer that was included in the estimate of the transaction price for the existing contract and that hadnot been recognized as revenues and the consideration promised as part of the contract modification. If the remaining goods or services arenot distinct from those already provided, the Company accounts for the contract modification as if it were part of the existing contract and accounts for the effect that the contract modification has on the transaction price, and on the measure of progress toward complete satisfaction of the performance obligation, as a cumulative catch-up adjustment at the date of the contract modification.
Contractual Terms for Receipt of Payments
The contractual terms that establish the Company’s right to collect specified amounts from its customers and that require contemporaneous evaluation and documentation under U.S. GAAP for the corresponding timing and amount of revenue recognition, are as follows:
(1)Upfront License Fees: The Company allocates non-refundable license fee consideration to the distinct performance obligations identified in the contract on a relative standalone selling price basis and recognizes those amounts when or as each performance obligation is satisfied. Non-refundable license fee consideration that is allocated to a distinct license of functional intellectual property is recognized at the point in time upon which control of the license transfers to the customer andnot before the customer has both access and the is able to use and benefit from the license.
(2)Development Milestones: The Company utilizes the most likely amount method to estimate the amount of consideration to which it will be entitled for achievement of the development milestones as these represent variable consideration. Variable consideration is included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized willnot occur when the uncertainty associated with the variable consideration is subsequently resolved. For those payments based on development milestones (e.g., patient dosing in a clinical trial or the achievement of statistically significant clinical results), the Company assesses the probability that the milestone will be achieved, including its ability to control the timing or likelihood of achievement, and any associated revenue constraint. Given the high degree of uncertainty around the occurrence of these events, the Company determines the milestone and other contingent amounts to be constrained until it becomes probable that a significant reversal in the amount of cumulative revenue willnot occur. At each reporting period, the Company re-evaluates this associated revenue recognition constraint. Any resulting adjustments are recorded to revenue on a cumulative catch-up basis and reflected in the financial statements in the period of adjustment.
F-10
(3)Regulatory Milestones: The Company utilizes the most likely amount method to estimate the consideration to which it will be entitled for achievement of the regulatory milestones as these represent variable consideration. Variable consideration is included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized willnot occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company recognizes regulatory milestones in the period in which it becomes probable that a significant reversal in the amount of cumulative revenue willnot occur (the regulatory milestone isno longer constrained). Due to the inherent uncertainty of achieving regulatory approval, associated milestones are deemed constrained for revenue recognition until achievement. At each reporting period, the Company re-evaluates this associated revenue recognition constraint. Any resulting adjustments are recorded to revenue on a cumulative catch-up basis and reflected in the financial statements in the period of adjustment.
(4)Royalties: Under the sales-or-usage-based royalty exception the Company recognizes revenue based on the contractual percentage of the licensee’s sale of products to its customers at the later of (i) the occurrence of the related product sales or (ii) the date upon which the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied.
(5)Sales Threshold Milestones: Similar to royalties, applying the sales-or-usage-based royalty exception, the Company recognizes revenue from sales threshold milestones at the later of (i) the period the licensee achieves theone-time annual product sales levels in their territories for which the Company is contractually entitled to a specified lump-sum receipt, or (ii) the date upon which the performance obligation to which some or all of the milestone has been allocated has been satisfied or partially satisfied.
Impairment of Property and Equipment
The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset* may**not* be recoverable. If circumstances require a long-lived asset or asset group to be tested for possible impairment, the Companyfirst compares undiscounted cash flows expected to be generated by that asset or asset group to its carrying value. If the carrying value of the long-lived asset or asset group isnot recoverable on an undiscounted-cash-flow basis, an impairment is recognized to the extent that the carrying value exceeds its fair value. The Company didnot recognize impairment losses for the years ended* December 31, 2024* and2023.
F-11
Research and Development
Research and development expenses consist primarily of direct and indirect costs incurred in connection with the Company’s discovery efforts, and the preclinical and formulation development of its drug candidates. In the future, the Company expects a substantial portion of its research and development expenses will relate to the clinical development of its drug candidates. Direct costs include contracted research development and manufacturing, consulting fees, license fees, laboratory supplies and other expenses incurred to sustain research and development programs. Indirect costs include salaries, benefits, travel, stock-based compensation charges for those individuals involved in research and development efforts, and associated overhead expenses. Research and development costs are expensed as incurred.
Accrued Research and Development Expense
The Company is required to estimate its expenses resulting from its obligations under contracts with vendors, consultants, and contract research organizations, in connection with conducting research and development activities. The Company reflects research and development expenses in its financial statements by matching those expenses with the period in which services and efforts are expended. The Company accounts for these expenses according to the progress of the activity as measured by the timing of various aspects of the study or related activities. The Company determines accrual estimates through review of the underlying contracts along with preparation of financial models taking into account discussions with research and other key personnel as to the progress of studies, or other services being conducted. During the course of an activity, the Company adjusts its rate of expense recognition if actual results differ from its estimate. Nonrefundable advance payments for goods and services, including fees for process development or manufacturing and distribution of clinical supplies that will be used in future research and development activities, are deferred and recognized as expense in the period that the related services are performed.
Convertible Preferred Stock
The Company records convertible preferred stock at fair value on the dates of issuance, net of issuance costs. Upon the occurrence of certain events that are outside the Company’s control, including a deemed liquidation event, holders of the convertible preferred stock can cause redemption for cash or other assets. Therefore, convertible preferred stock is classified outside of stockholders’ equity (deficit) on the* December 31, 2023balance sheet as events triggering the liquidation preferences arenot* solely within the Company’s control. The carrying values of the convertible preferred stock are adjusted to their liquidation preferences if and when it becomes probable that such a liquidation event will occur.
Warrant
The Company has issued a warrant to purchase shares of its convertible preferred stock. Because the underlying convertible preferred stock is classified outside of permanent equity, this warrant is classified as a liability in the accompanying balance sheets as a component of other long-term liabilities. This warrant is recorded at its estimated fair value on the date of issuance and is revalued at each subsequent reporting period, with fair value changes recognized as increases or reductions to other income (expense), net in the accompanying statements of operations and comprehensive income (loss). The Company estimates the fair value of this warrant using the Black-Scholes option pricing model. This method requires certain assumptions be used as inputs, see “Stock-Based Compensation” below.
Upon the closing of the IPO, the warrant to purchase shares of preferred stock converted to a warrant to purchase shares of common stock, and upon conversion the warrant met the equity classification requirements and was reclassified to equity. See Note4.
F-12
Investor Rights and Obligations Liability
In* November 2019,in connection with the closing of our Series B convertible preferred stock financing, an investor agreed to pay a premium for the preferred stock in exchange for certain additional rights and obligations which werenot* provided to the other Series B convertible preferred stock investors. The Company evaluated these additional rights and obligations and concluded they met the definition of a derivative and therefore these rights and obligations were recorded at their calculated fair value at issuance. The Company initially assessed the fair value of these rights and obligations as the additional premium paid by this investor to acquire these rights and obligations. The investor rights and obligations liability is revalued at each reporting period with changes in the fair value of the liability recorded as change in fair value of investor rights and obligations in the statements of operations and comprehensive income (loss). The noted agreement was amended and replaced in its entirety on in* November 2022.In April**2023,* the Company was notified that an event occurred resulting in the termination of the transfer and put option rights and related obligations.
Patent Costs
The Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting expenses related to making such applications) and such costs are included in general and administrative expenses in the statement of operations and comprehensive income (loss).
Stock-Based Compensation
Stock-based compensation represents the cost of the grant date fair value of employee, officer, director and non-employee stock option grants, recognized on a straight-line basis over the vesting period. The vesting period generally approximates the expected service period of the awards. The Company recognizes forfeitures as they occur.
The fair value of stock options is estimated using a Black-Scholes valuation model on the date of grant. This method requires certain assumptions be used as inputs, such as the fair value of the underlying common stock, expected term of the option before exercise, expected volatility of the Company’s common stock, risk-free interest rate and expected dividend yield. Options granted have a maximum contractual term often years. The Company has limited historical stock option activity and therefore estimates the expected term of stock options granted using the simplified method, which represents the arithmetic average of the original contractual term of the stock option and its weighted-average vesting term. The expected volatility of stock options is based upon the historical volatility of a number of publicly traded companies in similar stages of clinical development. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. The risk-free interest rates used are based on the U.S. Treasury yield in effect at the time of grant forzero-coupon U.S. treasury notes with maturities approximately equal to the expected term of the stock options. The Company has historicallynot declared or paid any dividends and doesnot currently expect to do so in the foreseeable future, and therefore has estimated the dividend yield to be zero.
Commitments and Contingencies
The Company recognizes a liability with regards to loss contingencies when it believes it is probable a liability has been incurred, and the amount can be reasonably estimated. If some amount within a range of loss appears at the time to be a better estimate than any other amount within the range, the Company accrues that amount. Whenno amount within the range is a better estimate than any other amount, the Company accrues the minimum amount in the range. The Company hasnot recorded any such liabilities as of* December 31, 2024* and2023.
F-13
Segment Reporting
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision- making group (“CODM”). The Company has identified its President and Chief Executive Officer, Carmine Stengone, as the CODM who is responsible for making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business asone operating segment. The Company’s long-lived assets consist primarily of property and equipment, net, which are all held in the United States.
Income Taxes
The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date.
The Company recognizes deferred tax assets to the extent that the Company believes these assets are more likely thannot to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If management determines that the Company would be able to realize its deferred tax assets in the future in excess of their recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes.
As of* December 31, 2024* and2023, the Company maintained valuation allowances against its deferred tax assets as the Company concluded it hadnot met the “more likely thannot” to be realized threshold. Changes in the valuation allowance, when they are recognized in the provision for income taxes,* may*result in a change in the estimated annual effective tax rate.
The Company records uncertain tax positions on the basis of atwo-step process whereby (1) management determines whether it is more likely thannot that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits within income tax expense. Any accrued interest and penalties are included within the related tax liability. As of and for the years ended* December 31, 2024* and2023, the Company hadno accrued interest or penalties related to unrecognized tax benefits.
Net Income (Loss) Per Share
Basic net income (loss) per share allocable to common stockholders is presented in conformity with thetwo-class method required for participating securities. All classes of outstanding preferred stock are considered participating securities as, in the event a dividend is paid on common stock, the holders of preferred stock would be entitled to receive dividends as the higher of their dividend preference or the amount they would receive if the shares were converted to common stock immediately prior to the dividend. Thetwo-class method determines net income per share for each class of common and participating securities according to dividends declared or accumulated as well as participation rights in undistributed earnings. Thetwo-class method requires income available to stockholders for the period to be allocated between common and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed. Under thetwo-class method, any net loss attributable to common stockholders isnot allocated to the preferred stock as the holders of the preferred stock donot have a contractual obligation to share in losses.
F-14
Basic net income (loss) is calculated by dividing net income (loss) attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Common shares used in diluted net income (loss) per share include the dilutive effect of potentially dilutive securities, which include common stock options, a common stock warrant, shares available for issuance under the2024 Plan, and common stock reserved under the2024 ESPP. However, potentially issuable common shares arenot used in computing diluted net loss per ordinary share as their effect would be anti-dilutive due to the loss recorded during the year ended* December 31, 2024*, and therefore diluted net loss per share is equal to basic net loss per share. During the year ended* December 31, 2023*, diluted net income per share is computed by giving effect to all dilutive potential common shares.
Recently Adopted Accounting Pronouncements
In* November 2023,the FASB issued ASUNo.* 2023-07, Segment Reporting (Topic280*): Improvements to Reportable Segment Disclosures* (“ASU2023-07”). This standard requires a public entity to disclose significant segment expenses and other segment items on an interim and annual basis. Additionally, it requires a public entity to disclose the title and position of the Chief Operating Decision Maker. ASU2023-07 is effective for fiscal years beginning after* December 15, 2023,and interim periods within fiscal years beginning after December 15, 2024,with early adoption permitted. A public entity should apply the amendments in this ASU retrospectively to all prior periods presented in the financial statements. The Company adopted ASU2023*-07 for the fiscal year ended* December 31, 2024and interim financial statements thereafter, on a retrospective basis for all prior periods presented in the financial statements. The adoption of ASU2023*-07 didnot change the way that the Company identifies its reportable segments and, as a result, didnot have a material impact on the Company’s financial position or results of operations. See Note13 - Segment Reporting for further information.
Recently Issued Accounting PronouncementsNot Yet Adopted**
In* December 2023,the FASB issued ASUNo.* 2023-09, Income Taxes (Topic740*): Improvements to Income Tax Disclosures* (“ASU2023-09”). This standard requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. ASU2023-09 is effective for public entities with annual periods beginning after* December 15, 2024,*with early adoption permitted. The Company is currently evaluating the impact of this guidance on its financial statements.
In* November 2024,the FASB issued ASUNo.* 2024-03, Income Statement — Reporting Comprehensive Income — Expense Disaggregation Disclosures (Subtopic220*-40): Disaggregation of Income Statement Expenses* (“ASU2024-03”). This standard requires a public entity to disaggregate certain income statement expenses. ASU2024-03 is effective for annual reporting periods beginning after* December 15, 2026,and interim reporting periods within annual reporting periods beginning after December 15, 2027,*with early adoption permitted. The Company is currently evaluating the impact of this guidance on its financial statements.
F-15
3. Marketable Securities
The Company invests its excess cash in marketable securities, including debt securities, commercial paper, asset-backed securities, yankee debt, certificate of deposit, and U.S. Government agency securities.
The following table summarizes the amortized cost and fair value of the Company’s marketable securities by major investment category (in thousands):
| Unrealized | |||||
|---|---|---|---|---|---|
| Maturity in Years | Amortized Cost | Gains | Losses | Fair Value | |
| U.S. Government agency securities | 3 years or less | $57,232 | $57 | $(134) | $57,155 |
| Certificate of deposit | Less than 1 | 8,519 | 6 | (1) | 8,524 |
| Corporate debt securities | 2 years or less | 80,751 | 110 | (39) | 80,822 |
| Commercial paper | Less than 1 | 22,265 | 11 | (1) | 22,275 |
| Yankee debt | Less than 1 | 2,145 | 1 | — | 2,146 |
| Asset-backed securities | 2 years or less | 11,834 | 61 | — | 11,895 |
| $182,746 | $246 | $(175) | $182,817 | ||
| Unrealized | |||||
|---|---|---|---|---|---|
| Amortized | |||||
| Maturity in Years | Cost | Gains | Losses | Fair Value | |
| U.S. Government agency securities | 2 years or less | $18,883 | $11 | $— | $18,894 |
| Certificate of deposit | Less than 1 | 5,232 | 13 | — | 5,245 |
| Corporate debt securities | 2 years or less | 52,310 | 65 | (6) | 52,369 |
| Commercial paper | Less than 1 | 28,108 | 19 | (1) | 28,126 |
| Yankee debt | Less than 1 | 2,445 | 3 | — | 2,448 |
| Asset-backed securities | 3 years or less | 2,576 | 7 | (1) | 2,582 |
| $109,554 | $118 | $(8) | $109,664 | ||
The Company regularly reviews the securities in an unrealized loss position and evaluates the current expected credit loss by considering factors such as historical experience, market data, issuer-specific factors, current and expected future economic conditions. The Company hasno requirement or intention to sell these securities before maturity or recovery of their amortized cost basis. As of* December 31, 2024and December 31, 2023,the Company didnot* record an allowance for credit loss related to its investment portfolio. As of* December 31, 2024,86 out of 252 of our available-for-sale debt securities were in an aggregate gross unrealized loss position. As of December 31, 2023,37 out of 178 of our available-for-sale debt securities were in an aggregate gross unrealized loss position. All of our available-for-sale debt securities in an unrealized loss position for which an allowance for credit losses hasnot* been recorded had continuous unrealized loss position for less than12 months.
The following tables summarize our available-for-sale debt securities in an unrealized loss position for which an allowance for credit losses hasnot been recorded, aggregated by major security type (in thousands):
| Fair Value | Unrealized Losses | |
|---|---|---|
| U.S. Government agency securities | $30,155 | $(134) |
| Certificate of deposit | 3,722 | (1) |
| Corporate debt securities | 22,528 | (39) |
| Commercial paper | 4,556 | (1) |
| $60,961 | $(175) |
| Fair Value | Unrealized Losses | |
|---|---|---|
| Corporate debt securities | $12,521 | $(6) |
| Commercial paper | 5,188 | (1) |
| Asset-backed securities | 439 | (1) |
| $18,148 | $(8) |
F-16
4. Fair Value Measurements
The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes athree-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
Level1—Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities.
Level2—Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that arenot active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability.
Level3—Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e. supported by little orno market activity).
Assets and liabilities measured at fair value on a recurring basis are as follows (in thousands):
| Fair Value Measurements Using | ||||
|---|---|---|---|---|
| Quoted Prices in · Significant Other · Significant | ||||
| Active Markets · Observable · Unobservable | ||||
| for Identical · Inputs · Inputs | ||||
| Total | Assets (Level 1) | (Level 2) | (Level 3) | |
| December 31, 2024: | ||||
| Assets: | ||||
| Cash equivalents | $21,042 | $21,042 | $— | $— |
| U.S. Government agency securities | 57,155 | 57,155 | — | — |
| Certificates of deposit | 8,524 | — | 8,524 | — |
| Corporate debt securities | 80,822 | — | 80,822 | — |
| Commercial paper | 22,275 | — | 22,275 | — |
| Yankee debt | 2,146 | — | 2,146 | — |
| Asset-backed securities | 11,895 | — | 11,895 | — |
| Total financial assets | $203,859 | $78,197 | $125,662 | $— |
| December 31, 2023: | ||||
| Assets: | ||||
| Cash equivalents | $14,646 | $14,646 | $— | $— |
| U.S. Government agency securities | 18,894 | 16,360 | 2,534 | — |
| Certificates of deposits | 5,245 | — | 5,245 | — |
| Corporate debt securities | 52,369 | — | 52,369 | — |
| Commercial paper | 28,126 | — | 28,126 | — |
| Yankee Debt | 2,448 | — | 2,448 | — |
| Asset-backed securities | 2,582 | — | 2,582 | — |
| Total financial assets | $124,310 | $31,006 | $93,304 | $— |
| Liabilities: | ||||
| Preferred stock warrant liability | $(110) | $— | $— | $(110) |
| Total financial liabilities | $(110) | $— | $— | $(110) |
The carrying amounts of the Company’s financial instruments, including cash, cash equivalents and marketable securities, prepaid and other current assets, accounts payable, and accrued liabilities, approximate fair value due to their short maturities. Included in cash and cash equivalents at* December 31, 2024* and2023 are money market funds with a carrying value and fair value of $3.9 million and $11.8 million, respectively, based upon a Level1 fair value assessment.
F-17
Warrant
As of* December 31, 2023,the Company had a preferred stock warrant liability (included on the balance sheet under other long-term liabilities), which consisted of the fair value of a warrant to purchase Series B convertible preferred stock and was based on significant unobservable inputs, which represent a Level3* measurement within the fair value hierarchy. The Company classified this warrant as a liability on its balance sheets and remeasured to fair value at each reporting date, and the Company recognized changes in the fair value of the warrant liability as a component of other income (expense) in its statements of operations and comprehensive income (loss).
Upon the closing of the IPO, the warrant to purchase shares of Series B preferred stock converted to a warrant to purchase shares of Class A common stock, and upon conversion the warrant met the equity classification requirements and was reclassified to equity. The warrant was remeasured to fair value immediately prior to the conversion to a common stock warrant and the Company recognized changes in the fair value of the warrant liability in other income (expense) until* April 9, 2024.*
The Company’s valuation of the preferred stock warrant as of* April 9, 2024and December 31, 2023utilized the Black-Scholes option-pricing model. The quantitative elements associated with the Company’s Level3* inputs impacting the fair value measurement of the preferred stock warrant liability include the fair value per share of the underlying Series B convertible preferred stock, the remaining contractual term of the warrant, risk-free interest rate, expected dividend yield and expected volatility of the price of the underlying preferred stock. The most significant assumption in the Black-Scholes option-pricing model impacting the fair value of the preferred stock warrant is the fair value of the Company’s Series B convertible preferred stock as of each remeasurement date. The Company determines the fair value per share of the underlying preferred stock by taking into consideration its most recent sales of its convertible preferred stock as well as additional factors that the Company deems relevant. The Company historically has been a private company and lacks company-specific historical and implied volatility information of its stock. Therefore, it estimates its expected stock volatility based on the historical volatility of publicly traded peer companies for a term equal to the remaining contractual term of the warrant.
The risk-free interest rate is determined by reference to the U.S. Treasury yield curve for time periods approximately equal to the remaining contractual term of the warrant. The Company has estimated a 0% dividend yield based on the expected dividend yield and the fact that the Company has never paid or declared dividends.
Significant increases or decreases in any of these inputs in isolation would result in a significantly different fair value measurement. An increase in the risk-free interest rate, and/or an increase in the remaining contractual term or expected volatility, and/or an increase in the fair value of the convertible preferred stock would result in an increase in the fair value of the warrant.
F-18
The following table summarizes the change in fair value of the warrant liability, a Level3 recurring fair value measurement, for the year ended* December 31, 2024* (in thousands):
| Investor Rights and | ||
|---|---|---|
| Warrant | Obligations Liability | |
| Balance at December 31, 2022 | $115 | $2,867 |
| Change in fair value of warrant liability | (5) | — |
| Change in fair value of investor rights and obligations liability | — | (2,867) |
| Balance at December 31, 2023 | $110 | $— |
| Change in fair value of warrant liability | 106 | — |
| Balance at April 9, 2024 | $216 | $— |
| Reclassification to equity | (216) | — |
| Balance at December 31, 2024 | $— | $— |
5. Property and Equipment, Net
Property and equipment, net consisted of the following (in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Lab equipment | $2,244 | $2,052 |
| Leasehold improvements | 175 | 48 |
| Computer equipment and software | 124 | 50 |
| Furniture and fixtures | 163 | 5 |
| Property and equipment at cost | 2,706 | 2,155 |
| Less: accumulated depreciation and amortization | (1,717) | (1,477) |
| Total property and equipment, net | $989 | $678 |
The Company recognized $0.3 million and $0.2 million in depreciation and amortization expense for the years ended* December 31, 2024* and2023, respectively.
F-19
6. Accrued Expenses
Accrued expenses consisted of the following (in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Accrued compensation expenses | $3,338 | $1,904 |
| Accrued research and development expenses | 3,151 | 1,546 |
| Accrued professional and consulting expenses | 98 | 834 |
| Other accrued expenses | 124 | 101 |
| Total accrued expenses | $6,711 | $4,385 |
7. Debt
In* September 2020,the Company entered into a loan and security agreement (the “Loan Agreement”, and all amounts borrowed thereunder the “Term Loan”) with First Citizens Bank, as administrative and collateral agent, and lender. The Company borrowed $5.0 million at the inception of the Loan Agreement and had the option to borrow an additional $5.0 million upon closing a new capital round ofno* less than $30.0 million from a syndicate of investors. The option to borrow an additional $5.0 million expired on* June 30, 2021.*
In* June 2023,*the Company fully paid the remaining balance of the Term Loan and final prepayment fee of $3.0 million.
8. Convertible Preferred Stock and Stockholders’** Equity (Deficit)**
Upon the closing of the IPO, the Company’s outstanding convertible preferred stock automatically converted into 9,177,064 shares of Class A common stock and 6,729,172 shares of Class B common stock. Converted preferred stock outstanding as of the date of the IPO consisted of 15,906,236 shares. Each share of outstanding Series A, Series A-1, Series B, and Series C convertible preferred stock was convertible intoone share of common stock at the option of the holder, subject to certain anti-dilution adjustments.
Convertible Preferred Stock
As of* December 31, 2023*, the Company’s Series A, Series A-1, Series B, and Series C convertible preferred stock were classified as temporary equity in the accompanying balance sheet given that a majority of the Company’s board of director seats were held and/or voted upon by convertible preferred stockholders, and those convertible preferred stockholders could cause certain events to occur requiring redemption of the preferred stock that were outside of the Company’s control. The Company didnot adjust the carrying values of the convertible preferred stock to the respective liquidation preferences of such shares as the instruments werenot currently redeemable and it wasnot probable that the instruments would become redeemable.
F-20
The authorized, issued, and outstanding shares of convertible preferred stock as of* December 31, 2023* consist of the following:
| Shares · Liquidation | |||
|---|---|---|---|
| Shares | Issued and | Preference | |
| Authorized | Outstanding | (in thousands) | |
| Series A | 1,786,607 | 1,786,604 | $10,000 |
| Series A-1 | 1,429,286 | 1,423,119 | 11,179 |
| Series B | 3,362,377 | 3,346,607 | 32,034 |
| Series C | 10,362,324 | 9,349,906 | 140,249 |
| Total convertible preferred stock | 16,940,594 | 15,906,236 | $193,462 |
F-21
Common Stock
The Company hastwo classes of common stock: Class A common stock and Class B common stock. Class A common stock hasone vote per share and Class B common stock hasno votes per share. As of* December 31, 2024*, of the authorized 200,000,000 shares of Class A common stock,19,125,377 shares of Class A common stock were issued and outstanding, and of the authorized 20,000,000 shares of Class B common stock,6,729,172 shares of Class B common stock were issued and outstanding.
F-22
Class A common stock reserved for future issuance consisted of the following:
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Convertible preferred stock | — | 15,906,236 |
| Common stock options granted and outstanding | 4,045,500 | 2,674,405 |
| Shares available for issuance under the 2024 Plan | 1,674,309 | — |
| Shares available for issuance under the 2012 Plan | — | 502,491 |
| Preferred stock warrant | — | 15,764 |
| Common stock warrant | 15,764 | — |
| Common stock reserved under the 2024 Employee Stock Purchase Plan | 262,004 | — |
| Total common stock reserved for future issuance | 5,997,577 | 19,098,896 |
There areno shares of Class B common stock reserved for future issuance as of* December 31, 2024and December 31, 2023.*
Stock Options
In* March 2024,the Company's board of directors and its stockholders adopted and approved the2024* Equity Incentive Plan (the*“2024* Plan”). The2024 Plan is the successor of the Company's2012 Equity Incentive Plan (the*“2012* Plan”). However, awards outstanding under the2012 Plan will continue to be governed by their existing terms. The2024 Plan allows for the issuance of incentive stock options, nonstatutory stock options, stock appreciation rights, restricted shares, restricted stock units, and other stock awards to the Company's employees, members of its board of directors, and consultants.
The number of shares initially reserved for issuance under the2024 Plan was 2,700,000. As of* December 31, 2024,there were 1,674,309 shares of the Company’s Class A common stock available for issuance under the2024* Plan. The aggregate number of shares reserved for issuance under the2024 Plan will automatically increase on thefirst day of each fiscal year of the Company, commencing in2025 and ending in (and including)2034, by a number equal to the lesser of (a)5% of the aggregate shares of Class A common stock and Class B common stock issued and outstanding as of the last day of the prior fiscal year, or (b) a number of shares of Class A common stock determined by the Company's board of directors.
Under the2024 Plan, the exercise price for options granted under the2024 Plan* may**not* be less than 100% of the fair market value of the Class A common stock on the grant date. Optionees will be permitted to pay the exercise price in cash or, with the consent of the compensation committee (i) with shares of common stock that the optionee already owns, (ii) by an immediate sale of shares through a broker approved by the Company, (iii) by instructing the Company to withhold a number of shares otherwise deliverable upon exercise having an aggregate fair market value that doesnot exceed the exercise price, or (iv) by other methods permitted by applicable law.
The Company's board of directors (or a committee thereof to which the Company's board of directors has delegated authority)* mayamend or terminate the2024* Plan at any time. If the Company's board of directors amends the2024 Plan, it doesnot need stockholder approval of the amendment unless required by applicable law, regulation or rules. The2024 Plan will terminate automaticallyten years after the date when the Company's board of directors adopted the2024 Plan.
F-23
Stock option activity under the2024 Plan and2012 Plan is as follows:
| Weighted- | ||||
|---|---|---|---|---|
| Weighted- · Average · Aggregate | ||||
| Average · Remaining · Intrinsic | ||||
| Options | Exercise | Contractual | Value | |
| Outstanding | Price | Term | (in thousands) | |
| Balance at December 31, 2023 | 2,674,405 | $5.93 | 7.14 | $14,888 |
| Options granted | 1,528,182 | 16.15 | — | — |
| Options exercised | (157,087) | 2.58 | — | — |
| Options cancelled and forfeited | — | — | — | — |
| Options expired | — | — | — | — |
| Balance at December 31, 2024 | 4,045,500 | $9.91 | 7.52 | $21,470 |
| Options Vested and Expected to Vest as of December 31, 2024 | 4,045,500 | $9.91 | 7.52 | $21,470 |
| Options Exercisable as of December 31, 2024 | 2,114,772 | $5.33 | 5.87 | $19,764 |
The aggregate intrinsic value of options exercised during the years ended* December 31, 2024* and2023 was $2.1 million and $0.6 million, respectively, determined as of the date of exercise. Options exercisable include options which arenot vested but are available to be early exercised as of* December 31, 2024*. As of* December 31, 2024,*of the 2,114,772 options exercisable,35,794 options are available to be early exercised.
The Company estimated the fair value of stock options using the Black-Scholes valuation model. The Company accounts for any forfeitures of options when they occur. Previously recognized compensation expense for an award is reversed in the period that the award is forfeited. The fair value of stock options was estimated using the following weighted-average assumptions:
| Years Ended | ||
|---|---|---|
| December 31, | ||
| 2024 | 2023 | |
| Assumptions: | ||
| Expected term (in years) | 6.03 | 6.08 |
| Expected volatility | 110.40% | 94.57% |
| Risk free interest rate | 4.41% | 4.74% |
| Dividend yield | — | — |
The weighted-average grant-date fair value per share of stock options granted during the years ended* December 31, 2024* and2023 was $13.66 and $8.56 per share, respectively. The Company recorded $4.0 million and $2.8 million in stock-based compensation in general and administrative and research and development, respectively, for the year ended* December 31, 2024*. The Company recorded $1.2 million and $1.1 million in stock-based compensation in general and administrative and research and development, respectively, for the year ended* December 31, 2023*.
As of* December 31, 2024,there was approximately $20.7 million of total unrecognized stock-based compensation related to nonvested stock-based compensation arrangements, which is expected to be recognized over a weighted-average period of approximately 2.9 years. As of December 31, 2023,*there was approximately $6.6 million of total unrecognized stock-based compensation related to nonvested stock-based compensation arrangements, which was expected to be recognized over a weighted-average period of approximately 1.3 years.
Employee Stock Purchase Plan
In* March 2024,the Company's board of directors and its stockholders adopted and approved the2024* Employee Stock Purchase Plan (the*“2024* ESPP”). The2024 ESPP became effective as of* April 9, 2024.The purpose of the2024* ESPP is to provide eligible employees with an opportunity to increase their interest in the success of the Company by purchasing shares of Class A common stock from the Company on favorable terms and to pay for such purchases through payroll deductions or other approved contributions. The new payroll deduction rate* maybe any whole percentage of the participant’s compensation, butnot* less than 1% nor more than 15%.
As of* December 31, 2024,there were 262,004 shares of the Company’s common stock reserved and available for issuance under the2024* ESPP. The number of shares reserved for issuance under the2024 ESPP will automatically increase on thefirst day of each fiscal year of the Company, commencing in2025 and ending in (and including)2044, by a number equal to the lesser of (i)280,000 shares, (ii)1% of the aggregate shares of Class A common stock and Class B common stock issued and outstanding on the last day of the prior fiscal year, or (iii) a number of shares determined by the Company's board of directors. The number of shares reserved under the2024 ESPP will automatically be adjusted in the event of a stock split, stock dividend or a reverse stock split (including an adjustment to the per-purchase period share limit). During the year ended* December 31, 2024,there were 17,996 shares were purchased under the2024* ESPP and the Company recorded expense of $0.2 million.
F-24
9. Income Taxes
The following is a reconciliation between the provision for income taxes and income taxes computed using the U.S. federal statutory corporate tax rate for the years ended* December 31, 2024* and2023 is as follows (in thousands):
| Years Ended | ||
|---|---|---|
| December 31, | ||
| 2024 | 2023 | |
| Expected tax benefit at statutory rate | $(8,885) | $4,886 |
| State income tax, net of federal benefit | 1 | 5 |
| Change in fair value of investor rights and obligations liability | — | (602) |
| Permanent differences | 1,018 | 127 |
| Research credits | (2,149) | (1,140) |
| IRC Sec. 382 & 383 adjustments | — | — |
| Change in valuation allowance | 10,015 | (2,826) |
| $— | $450 | |
For the year ended* December 31, 2023*, the Company recorded $0.4 million of current federal tax expense due to tax law limitations on the ability to fully utilize net operating loss and research and development credit carryforwards against taxable income.
The tax effects of temporary differences that give rise to significant portions of the deferred tax assets and deferred tax liabilities as of* December 31, 2024* and2023 are as follows:
| Years Ended | ||
|---|---|---|
| December 31, | ||
| 2024 | 2023 | |
| Deferred tax assets: | ||
| Net operating loss carryforwards | $14,478 | $12,498 |
| Research and development credit carryforwards | 6,618 | 4,476 |
| Capitalized research and development | 12,699 | 7,469 |
| Lease liabilities | 1,314 | 120 |
| Stock-based compensation | 1,121 | — |
| Other, net | 608 | 1,017 |
| Total deferred tax assets | 36,838 | 25,580 |
| Valuation allowance | (35,548) | (25,328) |
| Deferred tax assets, net of valuation allowance | 1,290 | 252 |
| Deferred tax liabilities: | ||
| Property and equipment | (142) | (101) |
| Right-of-use assets | (1,148) | (151) |
| Total deferred tax liabilities | (1,290) | (252) |
| Net deferred tax assets/(liabilities) | $— | $— |
F-25
The Company has established a valuation allowance against its net deferred tax assets due to the uncertainty surrounding the realization of such assets. The Company periodically evaluates the recoverability of the deferred tax assets. At such time as it is determined that it is more likely thannot that deferred tax assets will be realizable, the valuation allowance will be reduced. The Company has recorded a full valuation allowance of $35.5 million and $25.3 million as of* December 31, 2024and2023,* respectively, as it doesnot believe it is more likely thannot that certain deferred tax assets will be realized primarily due to the generation of pre-tax book losses,no ability to carryback losses, the lack of feasible tax-planning strategies, the limited existing taxable temporary differences, and the subjective nature of forecasting future taxable income into the future.
At* December 31, 2024,the Company had federal and California tax loss carry forwards of approximately $46.7 million and $81.4 million, respectively. Out of the total federal net operating losses, approximately $46.7 million were generated after January 1, 2018,and therefore donot* expire. Net operating losses generated after* January 1, 2018,are subject to80%* limitation in accordance with the Tax Cuts and Jobs Act of2017. The remaining federal and state net operating loss carry forwards begin to expire in2037 and2036, respectively, if unused.
At* December 31, 2024,the Company had federal and state research and development tax credit carryforwards of approximately $5.7 and $3.3 million, respectively. The federal credits will begin to expire in2032,* if unused, and the state credits carry forward indefinitely.
Pursuant to the IRC, as amended, specifically IRC*§382* and IRC*§383,* the Company’s ability to use net operating loss and R&D tax credit carry forwards (“tax attribute carry forwards”) to offset future taxable income is limited if the Company experiences a cumulative change in ownership of more than50% within athree-year testing period. The Company has completed an ownership change analysis pursuant to IRC Section382 and identified that ownership changes occurred in* July 2012,** April 2018,** March 2019and February 2021.The Company’s deferred tax assets related to the tax attributes impacted have been adjusted through December 31, 2021based on such analysis. As a result of limitations arising from the prior ownership changes, $0.5 million of federal and $3.7 million of California net operating loss carry-forwards were removed from the inventory of deferred tax assets. In addition, $0.2 million of federal R&D tax credits were removed as of December 31, 2022.If further ownership changes within the meaning of IRC Section382* are identified as having occurred, the amount of remaining tax attribute carry-forwards available to offset future taxable income and income tax expense in future years* maybe significantly restricted or eliminated. Further, the Company’s deferred tax assets associated with such tax attributes could be significantly reduced upon realization of an ownership change within the meaning of IRC§382.*
The following table summarizes the reconciliation of the unrecognized tax benefits activity during the years ended* December 31, 2024* and2023 (in thousands):
| Years Ended | ||
|---|---|---|
| December 31, | ||
| 2024 | 2023 | |
| Unrecognized tax benefits—beginning | $2,574 | $2,749 |
| Gross increases—tax positions in current period | 525 | 357 |
| Decreases related to prior year positions | (5) | (532) |
| Unrecognized tax benefits—ending | $3,094 | $2,574 |
The unrecognized tax benefit amounts are reflected in the determination of the Company’s deferred tax assets. If recognized,none of these amounts would affect the Company’s effective tax rate, since it would be offset by an equal corresponding adjustment in the deferred tax asset valuation allowance. The Company doesnot foresee material changes to its liability for uncertain tax benefits within the nexttwelve months.
F-26
During the year ended* December 31, 2023,the Company reduced its reserve against research and development credits generated prior to2022* as a result of the completion of a formal study of research and development credits generated through that period. The reduction in the reserve for uncertain tax positions was fully offset by an offsetting increase in the valuation allowance against research and development credit carryforwards resulting inno net tax provision impact from the change in the reserve.
The Company’s policy is to recognize interest and/or penalties related to income tax matters in income tax expense. The Company hadno accrual for interest or penalties on the Company’s balance sheets as of* December 31, 2024and2023* and hasnot recognized interest and/or penalties in the statement of operations and comprehensive income (loss) for the years ended* December 31, 2024and2023.*
All tax years for both federal and state purposes remain open and subject to examination by tax jurisdictions.
10. License Agreement
In* February 2023,the Company entered into the J&J License Agreement, pursuant to which the Company granted J&J an exclusive, worldwide license to develop, manufacture and commercialize PIPE-307 in all indications. The J&J License Agreement allows the Company to elect, at its sole discretion and cost, to conduct a Phase2* trial of PIPE-307 for patients with multiple sclerosis. After such trial, J&J* may,at its sole discretion, further develop PIPE-307 for patients with multiple sclerosis. Additionally, upon J&J deciding to conduct afirst* Phase3 clinical trial for a product using PIPE-307, the J&J License Agreement allows the Company the option to co-fund a portion of all Phase3 and subsequent development costs for PIPE-307, with such costs capped annually. If the Company opts to fund such development costs, then the royalties the Company is eligible to receive will increase. Pursuant to the terms of the J&J License Agreement, the Company received an upfront, non-refundable and non-creditable payment of $50.0 million upon transferring the license and know-how, existing inventory and manufacturing technology. The Company is also eligible to receive approximately $1.0 billion in non-refundable, non-creditable milestone payments. Additionally, the Company is eligible to receive tiered royalties in the low-double digit to high-teen percent range on net sales of products containing PIPE-307.
The Company sold approximately 1.7 million shares of series C convertible preferred stock to Johnson & Johnson Innovation - JJDC, Inc., an affiliate of J&J, at $15.00 per share, for an aggregate purchase price of approximately $25.0 million, in* April 2023.*The Company determined that this preferred stock purchase was at fair value as other new investors purchased shares of preferred stock at the same price.
The Company concluded that J&J represented a customer and applied relevant guidance from ASC606 to evaluate the appropriate accounting for the J&J License Agreement. The Company evaluated the J&J License Agreement and concluded that it had promises to transfer a license of functional intellectual property, know-how, existing inventory and manufacturing technology (each of which was determined to be a distinct performance obligation). Control of the promised goods was transferred to J&J in thesecond quarter of2023, and the $50.0 million upfront payment was recognized in* May 2023upon satisfaction of the performance obligations. The remaining consideration consists of future contingent milestone-based payments and sales-based royalties. As of December 31, 2024,*all variable consideration under the J&J License Agreement was fully constrained.
F-27
In* August 2023,the Company elected to conduct a Phase2* trial using PIPE-307 for patients with multiple sclerosis, which was considered a contract modification under the accounting guidance that added promised goods or services that are distinct at a price that is below the standalone selling price. Therefore, the Company accounted for the modification as a termination of the existing contract and creation of a new contract. Accordingly, the amount of consideration to be allocated to the remaining performance obligations consists of future contingent milestone-based payments and sales-based royalties, all of which were constrained. The only remaining performance obligation is the promise to conduct the Phase2 trial, as the other performance obligations had been satisfied prior to the modification date. Accordingly, the variable consideration allocated to the Phase2 trial will be recognized as the study is completed using a cost-based measure of progress and when the amounts areno longer probable of a significant reversal. As of* December 31, 2024,*no amounts had been recognized related to the Phase2 trial asno additional variable consideration has been received subsequent to the contract modification.
11. Commitments and Contingencies
Operating Lease
The Company leases office and lab space in San Diego, California under a non-cancelable operating lease (“Science Center Drive Lease”). The lease commenced in* March 2018and has a 5-year initial term. The lease includes a renewal option, which includes an option to renew forfive additional years. During2021,* the Company amended the lease to include additional space in the building with the right to use the new space beginning in* October 2021,for an additional 3 years. Base rent for the new unit was abated for thefirst* three months of the lease term and thereafter is $0.05 million per month during thefirst year of the lease term, with specified annual increases thereafter.
In* October 2023,the Company executed a noncancelable operating lease for new premises to be used for office, research and development and laboratory purposes (“General Atomics Court Lease”), with the same landlord as the Science Center Drive Lease. The General Atomics Court Lease commenced for accounting purposes in October 2024when the Company took control of the premises and has a 5-year initial term from the commencement date. The General Atomics Court Lease has afive-year term with an option to extend for another three-year period subject to certain conditions, which the Company isnot* reasonably certain to exercise and therefore wasnot considered in determining the ROU assets and lease liabilities balance.
As a result of the new lease, the Company received rent abatement from* Januaryto October 2024on the Science Center Drive Lease. This resulted in a modification of the Science Center Drive Lease and a remeasurement of the existing lease liability and the associated right-of-use asset in October 2023.*As a result, $0.6 million from the payments of the new lease were allocated to the Science Center Drive Lease, based on a relative standalone selling price analysis.
The Company’s operating lease ROU asset and the related lease liabilities are initially measured at the present value of future lease payments over the lease term. Upon commencement of the new lease, in* October 2024,the Company recorded an ROU asset and lease liability of approximately $5.6 million. This includes the $0.6 million allocation, which led to a corresponding decrease in the ROU asset value for the new lease. The lease agreement includes variable payments which arenot* included in the measurement of the ROU assets and lease liability.
F-28
Below is a summary of the Company’s operating lease right-of-use assets and lease liabilities as of* December 31, 2024and2023* (in thousands, except for years and %):
| Years Ended | ||
|---|---|---|
| December 31, | ||
| 2024 | 2023 | |
| Operating lease right-of-use assets | $5,467 | $719 |
| Operating lease liability obligations, current | $1,452 | $464 |
| Operating lease liability obligations, less current portion | 4,807 | 108 |
| Total lease liability obligations | $6,259 | $572 |
| Weighted-average remaining lease term | 4.4 | 0.8 |
| Weighted-average discount rate | 9.0% | 9.0% |
During the years ended* December 31, 2024* and2023, the Company recognized $1.1 million and $0.9 million, respectively, in operating lease expenses, which are included in operating expenses in the Company's statements of operations and comprehensive income (loss).
Supplemental cash flow information related to operating leases as follows (in thousands):
| Years Ended | ||
|---|---|---|
| December 31, | ||
| 2024 | 2023 | |
| Cash paid for amounts included in the measurement of lease liabilities | $126 | $2,020 |
Future minimum lease payments for the Company’s operating lease liabilities as of* December 31, 2024*were as follows (in thousands):
| 2025 | $1,519 |
| 2026 | 1,564 |
| 2027 | 1,611 |
| 2028 | 1,660 |
| 2029 | 1,292 |
| Total minimum lease payments | 7,646 |
| Less: amount representing interest | 1,387 |
| Total lease liability obligations | 6,259 |
| Less: Current portion of operating lease liabilities | 1,452 |
| Operating lease liabilities, net of current portion | $4,807 |
Litigation
From time to time, the Company* maybecome involved in various legal proceedings and claims that arise in the ordinary course of our business activities. As of December 31, 2024and2023,* the Company wasnot currently a party to any material legal proceedings.
Other Commitments
The Company has various manufacturing, clinical, research and other contracts with vendors in the conduct of the normal course of its business. Such contracts are generally terminable with advanced written notice and payment for any products or services received by the Company through the effective time of termination and any non-cancelable and non-refundable obligations incurred by the vendor at the effective time of the termination. In the case of terminating a clinical trial agreement at a particular site, the Company would also be obligated to provide continued support for appropriate medical procedures at that site until completion or termination.
F-29
12. Net Income (Loss) Per Share
The following table sets forth the computation of the basic and diluted net loss per share (in thousands, except share and per share amounts):
| Years Ended | ||
|---|---|---|
| December 31, | ||
| 2024 | 2023 | |
| Numerator, basic: | ||
| Net income (loss) | $(42,258) | $22,720 |
| Allocation of earnings to participating preferred stockholders | — | 19,574 |
| Net income (loss) applicable to common stockholders | $(42,258) | $3,146 |
| Denominator, basic: | ||
| Weighted average common shares issued | 19,352,859 | 2,313,115 |
| Less: weighted average unvested common stock issued upon early exercise of stock options | — | (4,143) |
| Weighted average shares used to compute net income (loss) per common share, basic | 19,352,859 | 2,308,972 |
| Numerator, diluted: | ||
| Net income (loss) attributable to common stockholders | $(42,258) | $3,146 |
| Change in fair value of preferred stock warrant liability | — | (5) |
| Change in fair value of investor rights and obligations liability | — | (2,867) |
| Net income (loss) applicable to common stockholders | $(42,258) | $274 |
| Denominator, diluted: | ||
| Weighted average shares used to compute net income (loss) per common share, diluted | 19,352,859 | 2,308,972 |
| Common stock options | — | 998,452 |
| Unvested common stock issued upon early exercise of stock options | — | 4,143 |
| Preferred stock warrants (as converted to common stock) | — | 1,695 |
| Investor rights and obligations | — | 82,249 |
| Weighted average shares used to compute net income (loss) per common share, diluted | 19,352,859 | 3,395,514 |
| Net income (loss) per share, basic | $(2.18) | $1.36 |
| Net income (loss) per share, diluted | $(2.18) | $0.08 |
F-30
For the year ended* December 31, 2024,*net loss is attributable equally to each share of Class A common stock and Class B common stock and is determined based on the weighted-average number of the respective class of common stock outstanding. Weighted-average common shares include shares of the Company's Class A common stock and Class B common stock. The basic and diluted net loss per share amounts are the same for Class A common stock and Class B common stock.
For the year ended* December 31, 2023,there wereno* shares of Class B common stock outstanding.
The Company’s potentially dilutive securities, which include common stock options and a common stock warrant have been excluded from the computation of diluted net loss per share for the year ended* December 31,*2024, as the effect would reduce the net loss per share. Therefore, the weighted-average number of shares of common stock outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same.
The following potentially dilutive securities have been excluded from the diluted per share calculation for the periods presented as they would be anti-dilutive:
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Common stock options | 4,045,500 | 723,655 |
| Common stock warrant | 15,764 | — |
| Total potentially dilutive securities | 4,061,264 | 723,655 |
F-31
13. Segment Reporting
The Company operates inone reportable segment, pioneering differentiated therapies for the treatment of NI&I indications with significant unmet need.
Our CODM is our President and Chief Executive Officer, Carmine Stengone. The CODM uses operating expenses, as reported on our statements of operations and comprehensive income (loss). The CODM makes decisions on resource allocation, assesses performance of the business, and monitors budget versus actual results of the Company as a whole using operating expenses. Net income (loss) is also a measure that is considered in monitoring budget versus actual results. The CODM doesnot review assets in evaluating the results of the Company, and therefore, such information isnot presented.
Significant segment expenses within net income (loss) include research and development related to PIPE-791, PIPE-307, CTX-343, discovery programs and unallocated internal costs, general and administrative and interest income. Other segment items within net income (loss) include change in fair value of warrant liability, change in fair value of investor rights and obligations liability, interest expense, other expense, net and provision for (benefit from) income taxes.
The following table provides the operating financial results of our single reportable segment (in thousands):
| Years Ended | ||
|---|---|---|
| December 31, | ||
| 2024 | 2023 | |
| Total revenue | $— | $50,000 |
| Less: Significant and other segment expenses | ||
| Research and development | ||
| PIPE-791 | 11,257 | 11,181 |
| PIPE-307 | 11,249 | 4,565 |
| CTX-343 | 2,460 | 742 |
| Discovery programs | 4,789 | 3,457 |
| Unallocated internal costs | 8,667 | 7,658 |
| General and administrative | 12,472 | 6,320 |
| Interest income | 8,905 | 4,606 |
| Other segment items (1) | (269) | 2,037 |
| Net income (loss) | $(42,258) | $22,270 |
| (1) | Other segment items primarily include change in fair value of warrant liability, change in fair value of investor rights and obligations liability, interest expense, other expense, net, and provision for (benefit from) income taxes. |
License revenue for the year ended* December 31, 2023*was generated solely from the upfront payment from J&J pursuant to the J&J License Agreement. Revenue is primarily attributed to individual countries based on the location of the customer or licensee.
14. Employee Benefit Plan
In* January 2018,the Company adopted a defined contribution retirement savings plan under Section401*(k) of the IRC. This plan covers all employees who meet minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. The Company’s contributions to the plan* maybe made at the discretion of the Company’s board of directors. Total contributions by the Company during the years ended December 31, 2024* and2023 was $0.3 million and $0.2 million, respectively.
15. Related Party Transactions
In thesecond quarter of2023, the Company issued 1,860,999 shares of its Series C convertible preferred stock for total cash proceeds of $27.9 million tothree significant stockholderstwo that have designated members on the Company’s board of directors and each of whom is considered to be a related party. As of* December 31, 2024,thetwo* designated members wereno longer on the Company's board of directors.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.