Aura Biosciences, Inc.
For the period ended Dec 31, 2024. Filed Mar 24, 2025.
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FY2024 · Filed Mar 24, 2025
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Notes to Consolidated Financial Statements
- Description of Business
Aura Biosciences, Inc., or the Company or Aura, is a clinical-stage biotechnology company developing precision therapies to treat solid tumors designed to preserve organ function. Within these consolidated financial statements, unless the context otherwise requires, references to the Company or Aura refer to Aura Biosciences, Inc. and its subsidiaries on a consolidated basis. The Company’s proprietary platform is designed to enable the targeting of a broad range of solid tumors using Virus-Like Particles, that can be conjugated with drugs or loaded with nucleic acids to create Virus-Like Drug Conjugates, or VDCs. VDCs are a novel class of drugs with a dual mechanism of action that promote cancer cell death by both the delivery of the cytotoxic payload to generate acute necrosis and activation of a secondary immune mediated response. The Company’s initial focus is in ocular and urologic oncology, both areas of high unmet medical need where local targeted therapies may enable early intervention. The Company is evaluating the safety and efficacy of its lead candidate, bel-sar, as a potential vision-sparing therapy in an ongoing global Phase 3 CoMpass trial for the first-line treatment of adult patients with small choroidal melanoma and indeterminate lesions, or early-stage choroidal melanoma. Bel-sar is also in Phase 2 clinical development for metastases to the choroid, is being explored for cancers of the ocular surface and is in Phase 1 clinical development in bladder cancer. The Company envisions the potential for development of bel-sar in additional therapeutic areas. Aura’s headquarters are located in Boston, Massachusetts.
The Company’s operations to date have consisted primarily of conducting research and development and raising capital.
The Company is subject to risks common to companies in the biotechnology industry, including, but not limited to, the successful development and commercialization of products, fluctuations in operating results and financial risks, need for additional financing or alternative means of financial support or both to fund its current operating plan, protection of proprietary technology and patent risks, compliance with government regulations, dependence on key personnel, collaborative partners, contract development and manufacturing organizations and other third-parties, competition, customer demand, management of growth, and the effectiveness of marketing by the Company.
Liquidity
Through December 31, 2024, the Company has funded its operations primarily with proceeds from the initial and additional closings of its convertible preferred stock financings, and through its initial public offering, or IPO, follow-on offering and at-the-market offering, or ATM. On November 1, 2022, the Company filed a shelf registration statement on Form S-3, or the 2022 Shelf, with the Securities and Exchange Commission, or SEC, in relation to the registration of up to an aggregate offering price of $250.0 million of common stock, preferred stock, debt securities, warrants and units or any combination thereof. The Company also simultaneously entered into the Open Market Sale Agreement SM, or Sales Agreement, with Jefferies LLC, or the Sales Agent, to provide for the offering, issuance and sale by the Company of up to an aggregate of $75.0 million of common stock from time to time in the ATM under the 2022 Shelf and subject to the limitations thereof. On November 9, 2023, the Company issued and sold 11,000,000 shares of common stock at a price to the public of $9.00 per share for aggregate gross proceeds of $99.0 million, or the 2023 Follow-On Offering. The Company received approximately $92.6 million in net proceeds from the 2023 Follow-On Offering after deducting underwriting discounts and commissions and offering expenses. In connection with the 2023 Follow-On Offering, on November 6, 2023, the Company delivered written notice to Jefferies that the Company was suspending and terminating the prospectus related to the shares issuable in the ATM pursuant to the terms of the Sales Agreement. On March 27, 2024, the Company filed a new shelf registration statement on Form S-3, or the 2024 Shelf, with the SEC in relation to the registration of up to an aggregate offering price of $350.0 million of common stock, preferred stock, debt securities, warrants and units or any combination thereof, which superseded the 2022 Shelf. The 2024 Shelf included a prospectus supplement to provide for offerings in the ATM under the Sales Agreement. The Company issuedno shares of common stock during the year ended December 31, 2024 under the ATM.
As of the issuance date of these consolidated financial statements for the year ended December 31, 2024, the Company expects that its cash and cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements through at least 12 months from the issuance of these consolidated financial statements. The future viability of the Company beyond that point is dependent on its ability to raise additional capital to finance its operations.
- Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or U.S. GAAP. The consolidated financial statements include those accounts of the Company and its subsidiaries after elimination of all intercompany accounts and transactions.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Significant items subject to such estimates and assumptions include the fair value of stock-based compensation and accrued research and development costs. Management bases its estimates on historical experience and on various other market-specific relevant assumptions that management believes to be reasonable under the circumstances. Actual results could differ from those estimates.
Segment Information
Operating segments are defined as components of an entity about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business inone operating segment, which is the development of oncology targeted therapies for a range of cancer indications with high unmet need.
Cash and Restricted Cash
Cash consists of standard checking accounts. As of December 31, 2024, the restricted cash account is comprised of a $0.8 million security deposit held by the lessor for the Company’s operating lease.
Cash Equivalents
Cash equivalents are highly liquid investments with an original maturity of 90 days or less at the date of purchase and consist of time deposits and investments in money market funds that invest in U.S. Treasury obligations and government funds with commercial banks and financial institutions.
Marketable Securities
All marketable securities have original maturities greater than 90 days. The Company has classified its investments with maturities beyond one year as short-term, based on their highly liquid nature and because such marketable securities represent the investment of cash that is available for current operations. The Company considers its investment portfolio of marketable securities to be available-for-sale. Accordingly, these investments are recorded at fair value. When the fair value is below the amortized cost of the asset, an estimate of expected credit losses is made. The credit-related impairment amount is recognized in loss; the remaining impairment amount and unrealized gains or losses are reported as a component of accumulated other comprehensive income in stockholders’ equity. Credit losses are recognized through the use of an allowance for credit losses account and subsequent improvements in expected credit losses are recognized as a reversal of an amount in the allowance for credit losses account. If the Company has the intent to sell the security or it is more likely than not that the Company will be required to sell the security prior to recovery of its amortized cost basis, the allowance for the credit loss is written-off and the excess of the amortized cost basis of the asset over its fair value is recorded in the consolidated statements of operations and comprehensive loss. Regardless of the Company’s intent to sell a security, it performs additional analysis on all securities with unrealized losses to evaluate losses associated with the creditworthiness of the security. Credit losses are identified where the Company does not expect to receive cash flows sufficient to recover the amortized cost basis of a security. Unrealized gains and losses are reported as a component of accumulated other comprehensive income in stockholders’ equity. Amortization and accretion of premiums and discounts are recorded in other income (expense) within the consolidated statements of operations and comprehensive loss. Realized gains or losses are included in interest income or interest expense, respectively. If any adjustment to fair value reflects a decline in value of the investment, the Company considers all available evidence such as industry, financial inputs, and capital markets data to evaluate the extent to which the decline is other than temporary and, if so, marks the investment to market on the Company’s consolidated statement of operations and comprehensive loss.
Fair Value Measurements
Accounting Standards Codification 820, Fair Value Measurement, or ASC 820, establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs).
Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances.
ASC 820 identifies fair value as the exchange price, or 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 a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value hierarchy that distinguishes between the following:
Level 1—Inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities.
Level 2—Inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly.
Level 3—Inputs are unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability. Financial assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement.
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. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash and cash equivalents. The Company maintains its cash in bank deposit accounts which, at times, may exceed federally insured limits. The Company has not experienced any losses in such accounts. The Company believes it is not exposed to any significant credit risk on cash.
Property and Equipment
Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful life of the assets. Costs for property and equipment not yet placed into service are capitalized as assets under construction and depreciated in accordance with the aforementioned policy once placed into service. Upon retirement or disposal of property and equipment, the cost and related accumulated depreciation are removed from the consolidated balance sheet and any gain or loss is reflected in the consolidated statements of operations and comprehensive loss. Repair and maintenance expenditures are charged to expense as incurred.
The estimated useful lives of the Company’s property and equipment are as follows:
| Estimated Useful Life | |
| Leasehold improvements | The shorter of the life of the leasehold improvement or the remaining term of the lease |
|---|---|
| IT equipment | 3 years |
| Laboratory equipment | 5 years |
Impairment of Long-Lived Assets
The Company reviews all long-lived assets for impairment whenever events or circumstances indicate the carrying amount of such assets may not be recoverable. Recoverability of assets to be held and used is measured by comparison of the carrying value of the assets to the future undiscounted net cash flows expected to be generated by the asset. If such asset is considered to be unrecoverable, the impairment recognized is measured by the difference between the estimated fair value of the asset and its carrying value. The Company did not recognize any impairments of long-lived assets during the years ended December 31, 2024 or 2023.
Research and Development
Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including salaries, stock-based compensation and benefits, facilities costs, depreciation, third-party license fees, and external costs of outside vendors engaged to conduct preclinical development activities and clinical trials as well as to manufacture research and development materials. The Company accrues costs for clinical trial activities and contract manufacturers based upon estimates of the services received and related expenses incurred that have yet to be invoiced by the contract research organizations, clinical study sites, contract manufacturers, laboratories, consultants, or other vendors that perform the activities.
Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are deferred. Such amounts are expensed as the goods are delivered or the related services are performed or until it is no longer expected that the goods will be delivered, or the services rendered.
Costs incurred in obtaining technology licenses are recognized as research and development expense as incurred if the technology licensed has not reached technological feasibility and has no alternative future uses.
Patent and Trademark Costs
All patents and trademark related costs incurred in connection with filing and prosecuting patent and trademark applications are expensed as incurred due to uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses in the consolidated statements of operations and comprehensive loss.
Leases
Effective January 1, 2021, the Company accounts for leases in accordance with ASU No. 2016-02, Leases (Topic 842), or ASC 842. At contract inception, the Company determines if an arrangement is or contains a lease. A lease conveys the right to control the use of an identified asset for a period of time in exchange for consideration. If determined to be or contain a lease, the lease is assessed for classification as either an operating or finance lease at the lease commencement date, defined as the date on which the leased asset is made available for use by the Company, based on the economic characteristics of the lease. For each lease with a term greater than twelve months, the Company records a right-of-use asset and lease liability.
A right-of-use asset represents the economic benefit conveyed to the Company by the right to use the underlying asset over the lease term. A lease liability represents the obligation to make lease payments arising from the lease. The Company elected the practical expedient to not separate lease and non-lease components for all classes of underlying assets and therefore measures each lease payment as the total of the fixed lease and associated non-lease components. Lease liabilities are measured at lease commencement and calculated as the present value of the future lease payments in the contract using the rate implicit in the contract, when available. If an implicit rate is not readily determinable, the Company uses an incremental borrowing rate measured as the rate at which the Company could borrow, on a fully collateralized basis, a commensurate loan in the same currency over a period consistent with the lease term at the commencement date. Right-of-use assets are measured as the lease liability plus initial direct costs and prepaid lease payments, less lease incentives granted by the lessor. The lease term is measured as the noncancelable period in the contract, adjusted for any options to extend or terminate when it is reasonably certain the Company will extend the lease term via such options based on an assessment of economic factors present as of the lease commencement date. The Company elected the practical expedient to not recognize leases with a lease term of twelve months or less.
Components of a lease are split into three categories: lease components, non-lease components, and non-components. The fixed and in-substance fixed contract consideration (including any consideration related to non-components) are allocated, based on the respective relative fair values, to the lease components and non-lease components. The Company has elected to account for lease and non-lease components together as a single lease component for all underlying assets and allocate all of the contract consideration to the lease component only.
The Company’s operating leases are presented in the consolidated balance sheets as operating lease right-of-use assets, classified as noncurrent assets, and operating lease liabilities, classified as current and noncurrent liabilities. Operating lease expense is recognized on a straight-line basis over the lease term. Variable costs associated with a lease, such as maintenance and utilities, are not included in the measurement of the lease liabilities and right-of-use assets but rather are expensed when the events determining the amount of variable consideration to be paid have occurred.
Income Taxes
The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the Company’s consolidated financial statements and/or tax returns. Deferred tax assets and liabilities are based upon the differences between the financial statement carrying amounts and the tax bases of existing assets and liabilities and for loss and credit carryforwards using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if it is more likely than not that some portion or all the deferred tax asset will not be realized.
The Company provides reserves related to uncertain tax positions when management determines the related tax benefit is not more likely than not to be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as the consideration of the available facts and circumstances. The Company hasno reserves related to uncertain tax positions as of December 31, 2024 and 2023.
Interest and penalty charges, if any, related to uncertain tax positions would be classified as income tax expense in the accompanying consolidated statements of operations and comprehensive loss. As of December 31, 2024 and 2023, the Company hadno accrued interest related to uncertain tax positions.
Deferred Offering Costs
The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process preferred stock or common stock financings as deferred offering costs until such financings are consummated. After the closing of the IPO, follow-on offering and the ATM draw downs, these costs were recorded in stockholders' equity as a reduction of additional paid-in capital generated as a result of the financings.
Stock-Based Compensation
The Company recognizes stock-based compensation expense for all stock-based awards based on their grant date fair value.
The Company recognizes stock-based compensation expense over the requisite service period, which is generally the vesting period of the award. For awards that include performance-based vesting conditions, expense is recognized using the accelerated attribution method when the performance condition is deemed to be probable of being satisfied. The Company accounts for forfeitures as they occur. The Company determines the fair value of restricted stock awards in reference to the fair value of its common stock less any applicable purchase price.
The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model, which requires inputs based on certain subjective assumptions, including the expected stock price volatility, the expected term of the option, the risk-free interest rate for a period that approximates the expected term of the option and the Company’s expected dividend yield. The Company determines the volatility for awards granted based on an analysis of reported data for a group of guideline companies that have issued options with substantially similar terms. The expected volatility has been determined using a weighted average of the historical volatility measures of this group of guideline companies. The Company expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded stock price. The expected term of the Company’s stock options granted to employees has been determined utilizing the “simplified” method, using the midpoint between the vesting date and the contractual term. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. The Company has not paid, and does not anticipate paying, cash dividends on its common stock; therefore, the expected dividend yield is assumed to bezero.
The Company classifies stock-based compensation expense in its consolidated statements of operations and comprehensive loss in the same manner in which the award recipient’s cash compensation costs are classified.
Net Loss per Share
Net loss per share attributable to common stockholders is computed by using the two-class method, which is an earnings allocation formula that determines net loss per share for the holders of the Company’s common stock and participating securities. All series of preferred stock contain participation rights in any dividend declared or accumulated by the Company and are deemed to be participating securities. Income available to common stockholders and participating convertible preferred stock is allocated to each share on an as-converted basis as if all of the earnings for the period had been distributed. The participating securities do not include a contractual obligation to share in losses of the Company and are not included in the calculation of net loss per share in the periods that have a net loss.
Diluted net loss per share is computed using the if-converted method. The Company allocates earnings first to preferred stockholders based on dividend rights and then to common and preferred stockholders based on ownership interests. The weighted-average amount of common stock included in the computation of diluted loss gives effect to all potentially dilutive common equivalent shares, including outstanding stock options, warrants, and convertible preferred stock. Common stock equivalent shares are excluded from the computation of diluted loss per share if their effect is antidilutive.
Comprehensive Loss
Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources.
Recently Adopted Accounting Pronouncements
In November 2023, the FASB issued ASU No. 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosure.” The ASU updates reportable segment disclosure requirements, primarily through requiring enhanced disclosures about significant segment expenses and information used to assess segment performance. The amendments do not change how segments are determined, aggregated, or how thresholds are applied to determine reportable segments. The Company adopted ASU No. 2023-07 during the year ended December 31, 2024 and the standard did not have a material impact on its results of operations. The Company's reporting segments disclosure is included within the consolidated financial statements at Note 15 "Segment Reporting".
Accounting Pronouncements Not Yet Adopted
In November 2024, the FASB issued ASU No. 2024-03, "Disaggregation of Income Statement Expenses (Subtopic 220-40)." The ASU requires public entities to disaggregate, in a tabular presentation, certain income statement expenses into different categories, such as purchases of inventory, employee compensation, depreciation, and intangible asset amortization. The guidance is effective for fiscal years beginning after December 15, 2026, with early adoption permitted, and may be applied retrospectively. The Company is currently evaluating the impact of adopting the new ASU on our consolidated financial statements and related disclosures.
Other accounting standards that have been issued or proposed by FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s consolidated financial statements upon adoption.
- Fair Value of Assets and Liabilities
The following table presents information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicates the level of the fair value hierarchy utilized to determine such fair values as of December 31, 2024 and 2023 (in thousands):
| Description | December 31,2024 | Quoted pricesactive marketsfor identicalassets(Level 1) | Significantotherobservableinputs(Level 2) | Significantotherobservableinputs(Level 3) |
|---|---|---|---|---|
| Financial assets | ||||
| Cash equivalents: | ||||
| Money market funds | 30,845 | $30,845 | $— | $— |
| Marketable securities: | ||||
| U.S. Government agencies | 119,401 | — | 119,401 | — |
| Total financial assets | $150,246 | $30,845 | $119,401 | $— |
| Description | December 31,2023 | Quoted pricesactive marketsfor identicalassets(Level 1) | Significantotherobservableinputs(Level 2) | Significantotherobservableinputs(Level 3) |
|---|---|---|---|---|
| Financial assets | ||||
| Cash equivalents: | ||||
| Money market funds | $40,551 | $40,551 | $— | $— |
| Marketable securities: | ||||
| Commercial paper | 9,137 | — | 9,137 | — |
| Corporate bonds | 6,187 | — | 6,187 | — |
| U.S. Government agencies | 166,002 | — | 166,002 | — |
| Yankee bonds | 2,982 | — | 2,982 | — |
| Asset-backed securities | 779 | — | 779 | — |
| Total financial assets | $225,638 | $40,551 | $185,087 | $— |
There have been no transfers between levels for the years ended December 31, 2024 and 2023.
- Property and Equipment, Net
Property and equipment, net, consisted of the following (in thousands):
| December 31,2024 | December 31,2023 | |
|---|---|---|
| Assets under construction | $272 | $391 |
| IT equipment | 451 | 289 |
| Leasehold improvements | 471 | — |
| Lab equipment | 8,007 | 7,506 |
| $9,201 | $8,186 | |
| Less—accumulated depreciation | (5,986) | (5,036) |
| Property and equipment, net | $3,215 | $3,150 |
Depreciation expense was$1.2 million and$1.3 million for the years ended December 31, 2024 and 2023, respectively.
- Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):
| December 31,2024 | December 31,2023 | |
|---|---|---|
| Prepaid insurance | $1,696 | $1,817 |
| Prepaid research and development expenses | 6,007 | 1,399 |
| Other | 1,826 | 2,409 |
| Prepaid expenses and other current assets | $9,529 | $5,625 |
- Marketable Securities
Marketable securities consisted of the following (in thousands):
| Amortized Cost | Unrealized Gains | Unrealized Losses | Fair Value | |
|---|---|---|---|---|
| U.S. Government agencies | 119,130 | 297 | (26) | $119,401 |
| Total | $119,130 | $297 | $(26) | $119,401 |
| Amortized Cost | Unrealized Gains | Unrealized Losses | Fair Value | |
|---|---|---|---|---|
| Commercial paper | $9,144 | $— | $(7) | $9,137 |
| Corporate bonds | 6,186 | 3 | (2) | $6,187 |
| U.S. Government agencies | 165,453 | 563 | (14) | $166,002 |
| Yankee bonds | 2,985 | — | (3) | $2,982 |
| Asset-backed securities | 780 | — | (1) | $779 |
| Total | $184,548 | $566 | $(27) | $185,087 |
As of December 31, 2024 and December 31, 2023, the unrealized losses on the Company’s investments in U.S. government agencies securities, Yankee bonds, and asset-backed securities were caused by interest rate increases. The current credit ratings are all within the guidelines of the investment policy of the Company and the Company does not expect the issuers to settle any security at a price less than the amortized cost basis of the investment. The Company does not intend to sell the investments, and it is not probable that the Company will be required to sell the investments before recovery of their amortized cost basis.
As of December 31, 2024, one marketable security with a contractual maturity of one year or less was in an unrealized loss position totaling$0.03 million, and all marketable securities held by the Company had remaining contractual maturities of one year or less.
As of December 31, 2023,13 marketable securities with contractual maturities of one year or less were in an unrealized loss position totaling $0.03 million. All marketable securities held by the Company had remaining contractual maturities of one year or less, except for asset-backed securities and U.S. government agencies securities with a fair value of $58.7 million that had maturities of one to two years.
There wereno impairments of the Company’s marketable securities measured and carried at fair value during the years ended December 31, 2024 and 2023.
- Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
| December 31,2024 | December 31,2023 | |
|---|---|---|
| Accrued research and development expenses | $3,386 | $3,445 |
| Accrued compensation | 5,456 | 3,503 |
| Other | 618 | 935 |
| Accrued expenses and other current liabilities | $9,460 | $7,883 |
- Stockholders' Equity
The Company had 150,000,000 authorized shares of common stock, par value $0.00001 per share, of which 49,998,279 and 49,350,788 shares were issued and outstanding at December 31, 2024 and December 31, 2023, respectively.
In addition, the Company had 10,000,000 authorized shares of preferred stock, par value $0.00001 per share, all of which shares of preferred stock are undesignated. No authorized shares of preferred stock were issued and outstanding at December 31, 2024 and December 31, 2023.
Financings
On March 27, 2024, the Company filed the 2024 Shelf with the SEC in relation to the registration of up to an aggregate offering price of $350.0 million of common stock, preferred stock, debt securities, warrants and units or any combination thereof, which superseded the 2022 Shelf. The 2024 Shelf included a prospectus supplement to provide for offerings in the ATM under the Sales Agreement. The Company issued no shares of common stock during the year ended December 31, 2024 under the ATM.
On November 9, 2023, the Company issued and sold 11,000,000 shares of common stock at a price to the public of $9.00 per share for aggregate gross proceeds of $99.0 million in the 2023 Follow-On Offering. The Company received approximately $92.6 million in net proceeds from the 2023 Follow-On Offering after deducting underwriting discounts and commissions and offering expenses.
On November 1, 2022, the Company filed the 2022 Shelf with the SEC in relation to the registration of up to an aggregate offering price of $250.0 million of common stock, preferred stock, debt securities, warrants and units or any combination thereof. The Company also simultaneously entered into the Sales Agreement with the Sales Agent to provide for the offering, issuance and sale by the Company of up to an aggregate of $75.0 million of common stock from time to time in the ATM under the 2022 Shelf and subject to the limitations thereof. The Company issued 261,807 shares of common stock at an average price of $12.49 for aggregate gross proceeds of $3.3 million during the year ended December 31, 2023 under the ATM.
- Stock-Based Compensation
2018 Stock Option and Incentive Plan
On December 12, 2018, the Company adopted the Aura Biosciences, Inc. 2018 Equity Incentive Plan, or the 2018 Plan. The 2018 Plan will expire in 2028. Under the 2018 Plan, Aura may grant incentive stock options, non-qualified stock options, restricted and unrestricted stock awards and stock rights. The Board of Directors, or the Board, has determined not to make any further awards under the 2018 Plan as of November 2, 2021. However, the 2018 Plan will continue to govern outstanding equity awards granted thereunder.
2021 Stock Option and Incentive Plan
The 2021 Stock Option and Incentive Plan, or the 2021 Plan, was adopted by the Board on October 7, 2021, approved by the Company’s stockholders on October 22, 2021 and became effective on November 1, 2021. The 2021 Plan permits the granting of several award types, including restricted stock units and both options to purchase common stock intended to qualify as incentive stock options under Section 422 of the United States Internal Revenue Code, or the Code, and options that do not so qualify. The number of shares initially reserved for issuance under the 2021 Plan was 3,352,166, which increased on January 1, 2022 and will continue to increase each January 1 thereafter, by 5% of the outstanding number of shares of common stock on the immediately preceding December 31 or such lesser number of shares as determined by the Company’s compensation committee. The maximum number of shares of common stock that may be issued in the form of incentive stock options shall not exceed the initial limit, cumulatively increased on January 1, 2022 and on each January 1 thereafter by the lesser of the annual increase for such year or 3,352,166 shares of common stock. On January 1, 2024, the shares reserved for issuance was increased to 9,414,162 shares. With the transfer of shares to the 2021 Plan in connection with the termination or expiration of awards under the 2018 Plan, together with shares otherwise available under the 2021 Plan, at December 31, 2024 there were 4,164,754 shares available for grants under the 2021 Plan.
2021 Employee Stock Purchase Plan
The 2021 Employee Stock Purchase Plan, or the ESPP, was adopted by the Board on October 7, 2021, approved by the Company’s stockholders on October 22, 2021 and became effective on November 1, 2021. A total of 335,217 shares of common stock were initially reserved for issuance under this plan, which increased on January 1, 2022 and will continue to increase each January 1 thereafter through January 1, 2031, by the least of (i)335,217 shares of common stock, (ii)1% of the outstanding number of shares of common stock on the immediately preceding December 31 or (iii) such lesser number of shares of common stock as determined by the administrator of the ESPP. On January 1, 2024, the shares reserved for issuance was increased to 1,282,856 shares. The purchase price of the shares under the ESPP are at 85% of the lower of the fair market value of the Company’s common stock on the first trading day of the offering period or on the purchase date. As of December 31, 2024,1,258,379 shares were available to be issued under the ESPP. The Company recognized$0.1 million share-based compensation expense related to the ESPP for the years ended December 31, 2024 and 2023.
Stock Options
The Board is authorized to administer the 2021 Plan. In accordance with the provisions of the 2021 Plan, the Board determines the terms of Aura options and other awards issued pursuant thereto, including the following:
which employees, directors and consultants shall be granted awards;
the number of shares of common stock subject to options and other awards;
the exercise price of each option, which generally shall not be less than fair market value of the common stock on the date of grant;
the termination or cancellation provisions applicable to options;
the terms and conditions of other awards, including conditions for repurchase, termination or cancellation, issue price and repurchase price; and
all other terms and conditions upon which each award may be granted in accordance with the 2021 Plan.
In addition, the Board may award restricted shares of common stock and restricted stock units to participants subject to such conditions and restrictions as it may determine. The Board or any committee to which the Board delegates authority may, with the consent of the affected plan participants, re-price or otherwise amend outstanding awards consistent with the terms of the 2021 Plan.
The following table summarizes stock option activity under the 2018 Plan and 2021 Plan for the year ended December 31, 2024:
| Options | Weighted-AverageExercisePrice | Weighted-AverageRemainingContractualTerm(years) | Aggregate IntrinsicValue(in thousands) | |
|---|---|---|---|---|
| Outstanding at December 31, 2023 | 5,030,351 | $8.46 | 7.54 | $10,353 |
| Granted | 1,650,730 | 7.94 | ||
| Exercised | (312,769) | 4.53 | ||
| Cancelled/Forfeited | (845,959) | 10.78 | ||
| Outstanding at December 31, 2024 | 5,522,353 | $8.17 | 6.91 | $8,068 |
| Exercisable at December 31, 2024 | 3,244,171 | $7.73 | 5.62 | $7,119 |
The weighted-average grant date fair value of stock options granted during the years ended December 31, 2024 and 2023 was$5.99 and$7.50 per share, respectively. The total intrinsic value of options exercised was$1.5 million and$1.5 million for the years ended December 31, 2024 and 2023, respectively.
The fair value of the stock options issued as of December 31, 2024 and 2023 was measured with the following weighted-average assumptions:
| Year EndedDecember 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Risk-free interest rate | 3.93% | 3.94% |
| Expected term (years) | 6.03 | 6.04 |
| Expected volatility of the underlying stock | 88.63% | 86.15% |
| Expected dividend rate | —% | —% |
Restricted Stock Units
The Company has granted restricted stock units with service-based vesting conditions. Unvested restricted stock units may not be sold or transferred by the holder.
A summary of the restricted stock unit activity during the year ended December 31, 2024 is as follows:
| Restricted Stock Units | Weighted-AverageGrant Date Fair Value | |
|---|---|---|
| Unvested at December 31, 2023 | 1,093,402 | $10.27 |
| Granted | 1,159,205 | 8.04 |
| Vested/Released | (310,245) | 10.36 |
| Forfeited | (353,320) | 9.67 |
| Unvested at December 31, 2024 | 1,589,042 | $8.76 |
As a result of the 2021 Plan, the Company granted restricted stock units which vest in increments of 25% annually over a period offour years. During the year ended December 31, 2024,310,245 restricted stock units vested with a fair value of$3.2 million.
Stock-based Compensation Expense
The Company recorded stock-based compensation expense as follows (in thousands):
| Year EndedDecember 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Research and development | $5,696 | $3,929 |
| General and administrative | 6,026 | 4,843 |
| Total | $11,722 | $8,772 |
As of December 31, 2024, there was$13.1 million of unrecognized compensation expense related to stock options, which is expected to be recognized over a weighted-average period of 2.53 years.
As of December 31, 2024, there was$11.3 million of unrecognized compensation expense related to restricted stock units, which is expected to be recognized over a weighted-average period of 2.83 years.
- Common Stock Warrants
In February 2015 and May 2015, the Company issued warrants to purchase 1,650,098 and 887,536 shares of Series B convertible preferred stock, respectively, at an exercise price of $1.24235 per share, or the Series B Warrants. Each Series B Warrant was immediately exercisable and expiresten years from the original date of issuance. Pursuant to FASB ASC Topic 480, Distinguishing Liabilities from Equity, the Series B Warrants were classified as a liability and were re-measured to fair value at each balance sheet date. A total of 173,827 of the Series B Warrants were outstanding and were converted into warrants to purchase 12,686 shares of common stock with an exercise price of $17.03 upon the completion of the IPO in November 2021. As a result, the 12,686 common stock warrants were converted into equity instruments and remain outstanding as of December 31, 2024.
- Compensation
In January 2012, the Company adopted the Aura Biosciences 401(k) Profit Sharing Plan and Trust, or the 401(k) Plan, for its employees, which is designed to be qualified under Section 401(k) of the Code. Eligible employees are permitted to contribute to the 401(k) Plan within statutory and 401(k) Plan limits. The Company makes matching contributions of 100% of the first 6% of employee contributions. The Company made matching contributions in the amount of $0.9 million and $0.7 million for the years ended December 31, 2024 and 2023, respectively.
- Commitments and Contingencies
Lease Commitments
The Company has historically entered into lease arrangements for its facilities. The Company hasone operating lease for its office and laboratory facility with required future minimum payments as of December 31, 2024.
On May 16, 2022, the Company entered into an office and laboratory lease in Boston, MA with an initial 10-year term and one renewal option to extend the lease for an additional seven years which has not been deemed probable of being exercised by the Company as of December 31, 2024. The lease commenced on August 1, 2022, and estimated payments due under the initial term totaled $35.2 million. The lease requires a letter of credit totaling $0.8 million which is classified as long-term restricted cash and deposits on the consolidated balance sheets. The landlord will reimburse the Company up to $0.5 million for certain costs related to expansion of the laboratory space. As of December 31, 2024, the Company hascompleted the expansion and has incurred and been fully reimbursed for $0.5 million of expenses.
The following table contains a summary of the lease costs recognized under ASC 842 and other information pertaining to the Company’s leases for the years ended December 31, 2024 and 2023 (in thousands):
| Year EndedDecember 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Lease Costs | ||
| Operating lease costs | 3,509 | 3,517 |
| Variable lease costs | 1,193 | 883 |
| Short-term lease costs | — | 7 |
| Total lease costs | $4,702 | $4,407 |
| Cash paid for amounts included in the measurement of lease liabilities—operating leases | $2,822 | $3,002 |
|---|---|---|
| Weighted-average remaining lease term—operating leases (years) | 7.59 | 8.59 |
| Weighted-average discount rate—operating leases | 10.71% | 10.71% |
The following table reconciles the future minimum commitments to the Company’s operating lease liabilities at December 31, 2024 (in thousands):
| 2025 | 3,306 |
| 2026 | 3,405 |
| 2027 | 3,508 |
| 2028 | 3,611 |
| 2029 | 3,716 |
| Thereafter | 10,107 |
| Total lease payments | 27,653 |
| Less: interest | (8,884) |
| Total lease liabilities at December 31, 2024 | 18,769 |
| Less: current portion of lease liabilities | 3,149 |
| Lease liabilities, net of current portion | $15,620 |
License Agreements
The Company has entered into the following key agreements that relate to the core technology under development:
Rakuten License and Supply Agreement
In May 2024, the Company received notice from LI-COR, Inc., or LI-COR, that as of April 16, 2024, LI-COR assigned, and Rakuten Medical, Inc., or Rakuten, assumed, the 2014 Exclusive Agreement and the 2014 Non-Exclusive Agreement (each described below), each originally entered into by and between the Company and LI-COR. The 2014 Exclusive Agreement and 2014 Non-Exclusive Agreement were not otherwise modified by this assignment and assumption and remain in effect.
2014 Exclusive Agreement
In January 2014, the Company entered into an Exclusive License and Supply Agreement, or the 2014 Exclusive Agreement, with LI-COR for the license of IRDye 700DX and related licensed patent (now expired) for the treatment and diagnosis of ocular cancers in humans, as amended in January 2016, July 2017, April 2018 and April 2019. The 2014 Exclusive Agreement required a one-time upfront license issue fee of $0.1 million and aggregate milestone payments of up to $0.2 million upon certain regulatory and development milestones. The Company is also required to pay Rakuten low-single digit royalties on net sales. The term of the 2014 Exclusive Agreement expires on a country-by-country basis, until the longer of (i) ten years from the first commercial sale of a licensed product in such country and (ii) the last to expire valid claim in such country.
The Company recognizedno expenses related to this agreement and related amendments for the years ended December 31, 2024 and 2023, respectively.
2014 Non-Exclusive Agreement
In December 2014, the Company entered into a Non-Exclusive License Agreement, or the 2014 Non-Exclusive Agreement, with LI-COR for the supply of IRDye 700DX to the Company for the treatment and diagnosis of non-ocular solid tumor cancers in humans. Under the 2014 Non-Exclusive Agreement, the Company paid a license issue fee of $0.03 million on the effective date. The Company must also pay Rakuten a non-refundable, non-creditable fee of $0.03 million per each licensed product upon pre-IND designation, as defined of such licensed product, aggregate milestone payments of up to $0.3 million upon certain regulatory and development milestones; and during the term, the Company must pay Rakuten a low-single digit percentage royalty on net sales. Rakuten receives 10% of all sublicensee income within 30 days of the Company’s receipt from the sublicensee. The 2014 Non-Exclusive Agreement also required the Company to make certain payments upon the achievement of specified development and commercial milestones of up to $0.4 million in aggregate. During the years ended December 31, 2024 and 2023, the Company recognized no milestones related to this agreement.
Life Technologies Corporation License Agreement
In December 2014, the Company entered into a non-exclusive, perpetual license agreement with Life Technologies Corporation, or Life Technologies, which allows forfive licensed products. Under this agreement the Company is required to pay an initial license fee of $0.1 million for each product. An annual development fee of $0.1 million is due within a year from payment of the initial license fee and due annually or earlier of (i) payment of a commercialization fee or (ii) all development work is terminated. The commercialization fee is a one-time, non-refundable, non-creditable fee of $0.3 million due upon receipt of approval of a licensed product. In the event of a change of control, there will be a change of control fee of $0.2 million.
In January 2022, the Company entered into the First Amendment to the non-exclusive, perpetual license agreement with Life Technologies for use of the license in an additional indication. The cost of this amendment was a one-time fee of $0.05 million. During the years ended December 31, 2024 and 2023, the Company didnot recognize any expenses related to this agreement.
Effective in September 2022, the Company entered into a new non-exclusive, perpetual license agreement with Life Technologies for licensed products. Under this agreement, the Company is required to pay an initial license fee of $0.4 million for the first licensed product and $0.5 million for each additional licensed product. In addition, the agreement allows the Company the right to sublicense which would lead to a $0.2 million payment for each sublicense per licensed product and a $0.03 million payment for use of the cell line document package. In the event of a change of control, there will be a change of control fee of $0.5 million. During the years ended December 31, 2024 and 2023, the Company recognized$0.5 million and$0 million of expenses related to this agreement, respectively.
National Institute of Health (NIH)-Collaboration Research and Development Agreement
In July 2011, the Company entered into a Collaboration Research and Development Agreement, or the CRADA, with Dr. John Schiller at the NIH, for a period oftwo years with the rights to an exclusive license to all technology generated within the collaboration. Under this agreement, the Company is required to make annual payments of $0.03 million to fund the research activities, the first payment of which was paid within 30 days of the effective date. Subsequent payments are due within 30 days of the anniversary of the effective date. This agreement was previously amended in 2012, 2013, 2014, 2015, 2016, 2018, and 2020. During the years ended December 31, 2024 and 2023, the Company paidno research collaboration fees related to this agreement.
Aneighth amendment was effective in September 2022, requiring payment of $0.04 million within 30 days of November 1, 2022, and payment of another $0.03 million within 30 days of the 12th anniversary of the CRADA, which was in August 2023. This eighth amendment extended the term of the CRADA to September 30, 2024. During the years ended December 31, 2024 and 2023, the Company recognized$0 million and $0.03 million of expenses related to this agreement, respectively.
A ninth amendment was effective in September 2024, requiring payment of $0.06 million within 30 days of November 30, 2024, and payment of another $0.05 million within 30 days of September 30, 2025. This ninth amendment extended the term of the CRADA to September 30, 2026. During the year ended December 31, 2024, the Company recognized $0.1 million of expenses related to this agreement.
National Institute of Health (NIH)-Exclusive Patent License Agreement
In September 2013, the Company entered into an exclusive patent license agreement, or the NIH Exclusive License Agreement, with the NIH, that required the Company to pay a license issue royalty of $0.1 million and reimburse the NIH for any patent expenses incurred. Under the agreement, the Company is required to make low single-digit percentage royalty payments based on specified levels of annual net sales of licensed products subject to certain specified reductions. The Company is required to make development and regulatory milestone payments of up to $0.7 million in aggregate and sales milestone payments up to $0.6 million in the aggregate. The Company is also required to pay NIH a mid-single to low teen-digit percentage of any sublicensing revenue the Company receives. Additionally, the Company’s payment obligations to the NIH are subject to an annual minimum royalty payment of low five figures. The Company recognized$0.03 million and $0.2 million for patent licensing fees for the years ended December 31, 2024 and 2023, respectively.
In 2015, 2018 and 2019, the Company amended its exclusive patent license to include updates on the status of the commercial development and update/expand the list of licensed patents and patent applications. Each of those amendments required a $0.03 million payment that the Company paid.
Inserm-Transfert License Agreement
In November 2009, the Company entered into an exclusive, royalty-bearing patent license agreement with Inserm-Transfert of France. The agreement expires on a country-by-country basis based on the last to expire of any patent encompassed within the scope of the patent rights or 10 years from the date of the first commercial sales by the Company, whichever is later. The IND filing milestone of €0.01 million was accrued in 2016 and paid in 2017 by the Company. The milestones for the successful Phase I, II and III clinical trials are based on receiving a final report and achieving the primary endpoints defined in that trial, and the milestones for Phases I and II have been achieved as of December 31, 2024. Upon the sublicense by the Company of a product for which royalties are payable under the agreement, low- to mid-single-digit royalty payments would be due by the Company. The non-milestone payments in this agreement are subject to an anti-stacking clause. The Company recognized $0.1 million and $0 million in expenses related to this agreement for the years ended December 31, 2024 and 2023, respectively.
Clearside License Agreement
In July 2019, the Company entered into an exclusive license agreement, or the Clearside License Agreement, with Clearside Biomedical, Inc., or Clearside, for the license of Clearside’s Suprachoroidal Microneedle Technology for use in the treatment of indeterminate lesions and choroidal tumors. Upon execution of the Clearside License Agreement, the Company paid Clearside an upfront payment of $0.1 million which was expensed as incurred. Under the Clearside License Agreement, the Company is required to pay milestones up to $21.0 million in the aggregate upon the achievement of specified regulatory and development milestones, and upon the achievement of certain commercial sales milestones. The Company is also required to pay low to mid-single digit royalties on net sales. If the Company sublicenses a product for which royalties are payable, then the Company is required to pay the greater of 20% received or low single digit royalties on net sales.
The Clearside License Agreement expires on a country-by-country basis upon the later of the last to expire patent orten years from the date of the first commercial sale of a product.
The Company recognized$0 million and $1.0 million of expenses related to this agreement and related amendments for the years ended December 31, 2024 and 2023, respectively.
- Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is the same as basic net loss per share for the periods presented since the effects of potentially dilutive securities are antidilutive given the net loss of the Company.
The Company has calculated basic and diluted net loss per share for the years ended December 31, 2024 and 2023 as follows (in thousands, except share and per share data):
| Year EndedDecember 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Numerator: | ||
| Net loss | $(86,919) | $(76,408) |
| Denominator: | ||
| Weighted-average common stock outstanding—basic and diluted | 49,650,480 | 39,620,036 |
| Net loss per common share—basic and diluted | $(1.75) | $(1.93) |
The following potentially dilutive securities were excluded from the computation of the diluted net loss per share for the periods presented because their effect would have been antidilutive:
| Year EndedDecember 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Stock options to purchase common stock | 5,522,353 | 5,030,351 |
| Restricted stock units that vest into common stock | 1,589,042 | 1,093,402 |
| Warrants to purchase common stock | 12,686 | 12,686 |
| Total potential dilutive shares | 7,124,081 | 6,136,439 |
- Income Taxes
For the years ended December 31, 2024 and 2023, the loss before income taxes consisted of the following:
| 2024 | 2023 | |
|---|---|---|
| Domestic | $(86,185) | $(76,191) |
| Foreign | (622) | (80) |
| Total | $(86,807) | $(76,271) |
The Company has recorded a$0.1 million tax provision for the periods presented due to the current state income taxes and the losses incurred and the need for a full valuation allowance on net deferred tax assets. The difference between the income tax provision at the U.S. federal statutory rate and the recorded provision is primarily due to the valuation allowance recorded on all deferred tax assets.
The Company's income tax provision, net consisted of the following:
| 2024 | 2023 | |
|---|---|---|
| Components of income tax provision: | ||
| Current: | ||
| Federal | $— | $— |
| State | 112 | 137 |
| Foreign | — | — |
| Total Current | 112 | 137 |
| Deferred: | ||
| Federal | — | — |
| State | — | — |
| Foreign | — | — |
| Total Deferred | — | — |
| Total Income Tax Provision | $112 | $137 |
A reconciliation of the federal statutory income tax rate to the Company’s effective tax rate as of December 31, 2024 and 2023 is as follows:
| 2024 | 2023 | |
|---|---|---|
| Income tax provision at statutory rate | 21.0% | 21.0% |
| State taxes, net of federal benefit | 4.6% | 6.6% |
| Federal tax credits | 3.6% | 2.3% |
| Permanent items | (1.6)% | (1.0)% |
| Other | (0.1)% | (0.1)% |
| Decrease in valuation reserve | (27.5)% | (28.8)% |
| Total | 0.0% | 0.0% |
Temporary differences that give rise to significant deferred tax assets (liabilities) as of December 31, 2024 and 2023 are as follows (in thousands):
| 2024 | 2023 | |
|---|---|---|
| Deferred tax assets: | ||
| Net operating loss carryforwards | $55,826 | $45,999 |
| Stock-based compensation expense | 2,450 | 2,110 |
| Capitalized research and development expenses | 32,422 | 22,068 |
| Tax credit carryforwards | 13,582 | 10,007 |
| Accrued expenses and other current liabilities | 1,025 | 1,018 |
| Lease liability | 4,903 | 5,282 |
| Other | 938 | 766 |
| Total deferred tax assets | 111,146 | 87,250 |
| Deferred tax liabilities: | ||
| Right-of-use assets | (4,540) | (5,092) |
| Depreciable assets | (312) | (225) |
| Prepaid expenses and other current assets | (443) | — |
| Valuation allowance | (105,851) | (81,933) |
| Net deferred tax assets | $— | $— |
As of December 31, 2024, the Company had accumulated federal net operating loss carryforwards of approximately$209.8 million which may be available to offset future taxable income, of which$44.2 million begin to expire in 2029 and go through 2037 and$165.6 million do not expire. The Company had accumulated state net operating loss carryforwards of$183.6 million, which may be available to offset future taxable income and begin to expire in 2030, except for$1.2 million of state net operating losses, or NOLs, that do not expire. The Company had accumulated foreign net operating loss carryforwards of $0.7 million, which may be available to offset future taxable income and do not expire. As of December 31, 2024, the Company had federal and state research and development credit carryforwards of$11.3 million and $2.9 million, respectively, which may be available to offset future income tax liabilities and begin to expire in 2029 and 2028, respectively.
The Company’s ability to use its operating loss carryforwards and tax credit carryforwards to offset taxable income is subject to restrictions under Sections 382 and 383 of the Code. Under the Code provisions, certain substantial changes in the Company’s ownership, including the sale of the Company or significant changes in ownership due to sales of equity, have limited and may limit in the future, the amount of net operating loss carryforwards which could be used annually to offset future taxable income. The Company has not yet completed an analysis of ownership changes. The Company may also experience ownership changes in the future as a result of subsequent shifts in our stock ownership, some of which may be outside the Company’s control. As a result, the Company’s ability to use our pre-change NOLs to offset U.S. federal taxable income may be subject to limitations, which could potentially result in increased future tax liability to the Company. In addition, at the state level, there may be periods during which the use of NOLs is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed. All federal NOLs generated post tax reform have an indefinite life, are not subject to carryback provisions, and limited to 80% of taxable income in any year.
The Company has not conducted a study of its research and development credit carryforwards. A study may result in an adjustment to the Company’s research and development credit carryforwards; however, until a study is completed, and any adjustment is known, no amounts will be presented as an uncertain tax position. A full valuation allowance has been recorded against the Company’s research and development credit carryforwards and, if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance. Thus, there would be no impact to the consolidated balance sheets or statements of operations and comprehensive loss at this time, if an adjustment were required.
Management has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets, which are principally comprised of NOL carryforwards and tax credit carryforwards. Management has determined that it is more likely than not that the Company will not realize the benefits of its deferred tax assets, and as a result, a valuation allowance of$105.9 million has been recorded at December 31, 2024. The increase in the valuation allowance of$23.9 million during the year ended December 31, 2024 was primarily due to the increase in net operating losses generated by the Company and capitalized R&D expenses related to the Section 174 requirements.
As of December 31, 2024 and 2023, the Company hadno unrecognized tax benefits. Interest and penalty charges, if any, related to income taxes would be classified as a component of the income tax provision in the consolidated statements of operations and comprehensive loss. The Company does not expect any significant change in its uncertain tax positions in the next twelve months.
The Company files income tax returns in the United States federal tax jurisdiction and several state tax jurisdictions as well as in the Netherlands and Germany for its foreign subsidiaries. Since the Company is in a loss carryforward position, it is generally subject to examination by federal and state tax authorities for all tax years in which a loss carryforward is available.
With respect to the income of its foreign subsidiaries, the Company asserts the position that the undistributed earnings of its foreign subsidiaries are permanently invested in each jurisdiction. As a result, no additional income taxes have been provided on the possible repatriation of these earnings to the parent company. The Company does not have any unremitted earnings as of December 31, 2024.
- Segment Reporting
Segment reporting is prepared on the same basis that the Company's Chief Executive Officer, who is its chief operating decision maker, or CODM, manages the business and makes operating decisions to allocate resources across departments and functions in line with the Company's strategic goals. The Company operates inone reportable segment which includes all activities related to the research and development of oncology targeted therapies for a range of cancer indications with high unmet medical need. The CODM assesses performance and allocates resources based on comparing actual consolidated net loss to the budget. The measure of segment assets used in determining how to manage and allocate resources is reported within the Company's consolidated balance sheets as cash and cash equivalents and marketable securities.
As a single reportable segment entity, the Company’s segment performance measure is net loss. Significant segment expenses are presented below.
| Year EndedDecember 31, | ||
|---|---|---|
| 2024 | 2023 | |
| (in thousands) | ||
| Clinical, Preclinical, and R&D Operations | $(49,550) | $(43,427) |
| Chemistry, Manufacturing, and Controls | (23,752) | (21,806) |
| General and Administrative | (22,814) | (19,759) |
| Other Segment Items (1) | 9,197 | 8,584 |
| Net loss | $(86,919) | $(76,408) |
(1)Other segment items primarily include interest income, realized gains and losses, and income taxes.
- Subsequent Events
The Company has not identified any subsequent events that require disclosure.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.