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Aura Biosciences Inc

For the period ended Mar 31, 2025. Filed May 15, 2025.

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About this filing

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

Mar 31, 2025 · Filed May 15, 2025

AURA$6.56+3.5%Stored close · as of Nov 6, 2026

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Notes to Unaudited Condensed Consolidated Financial Statements

  1. 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 unaudited condensed 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, or VLPs, 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 clinical development in metastases to the choroid and bladder cancer, and is being explored for cancers of the ocular surface. 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 March 31, 2025, 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 offerings and at-the-market offering, or 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, 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. On November 1, 2022, the Company filed a shelf registration statement on Form S-3, or 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 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. 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 didnot issue any shares of common stock during thethree months ended March 31, 2025 under the ATM.

As of the issuance date of these unaudited condensed consolidated financial statements for the three months ended March 31, 2025, 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 unaudited condensed 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.

  1. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP. In management’s opinion, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which are necessary to present fairly the Company’s financial position, results of operations, and cash flows. The financial data and other information disclosed in these notes related to the three months ended March 31, 2025 and 2024 are also unaudited. The unaudited condensed results of operations are not necessarily indicative of the operating results that may occur for the full fiscal year ending December 31, 2025. Certain information and footnote disclosures normally included in annual consolidated financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to instructions, rules, and regulations prescribed by the United States Securities and Exchange Commission, or the SEC. Management believes that the disclosures provided here are adequate to make the information presented not misleading when these unaudited condensed consolidated financial statements are read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K.

Significant Accounting Policies

The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2024, in the Company’s Annual Report on Form 10-K filed with the SEC on March 24, 2025. There have been no changes to the Company’s significant accounting policies except as noted below.

Recently Adopted Accounting Pronouncements

In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. 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 standard became effective for interim reporting periods in fiscal years beginning after December 15, 2024. The Company adopted ASU No. 2023-07 during the year ended December 31, 2024 and the standard didnot have a material impact on its results of operations. The Company's segment reporting disclosure is included within the unaudited condensed consolidated financial statements at Note 15 "Segment Reporting".

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The standard requires the Company to provide further disaggregated income tax disclosures for specific categories on the effective tax rate reconciliation, as well as additional information about federal, state/local and foreign income taxes. The standard also requires the Company to annually disclose its income taxes paid (net of refunds received), disaggregated by jurisdiction. The Company adopted the standard on January 1, 2025 for fiscal year reporting. The standard is to be applied on a prospective basis although optional retrospective application is permitted. While the standard will require additional disclosures related to the Company’s income taxes within the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, the standard didnot have any impact on the Company’s consolidated operating results, financial condition or cash flows.

New Accounting Pronouncements Not Yet Adopted

In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. The standard requires the Company to provide further disaggregated information of relevant expense captions within its consolidated statements of operations, including employee compensation and depreciation, as well as the inclusion of other specific expenses, gains and losses required by existing GAAP. The standard is effective for fiscal years beginning after December 15, 2026 and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The standard may be applied prospectively or retrospectively. While the standard will require additional disclosures related to certain expenses included in the consolidated statements of operations, the standard is not expected to have any impact on the Company’s consolidated operating results, financial condition or cash flows.

  1. 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 March 31, 2025 and December 31, 2024 (in thousands):

DescriptionMarch 31,2025Quoted pricesactive marketsfor identicalassets(Level 1)Significantotherobservableinputs(Level 2)Significantotherobservableinputs(Level 3)
Financial assets
Cash equivalents:
Money market funds$37,245$37,245$—$—
Marketable securities:
U.S. Government agencies89,765—89,765—
Total financial assets$127,010$37,245$89,765$—
DescriptionDecember 31,2024Quoted 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 agencies119,401—119,401—
Total financial assets$150,246$30,845$119,401$—
  1. Property and Equipment, Net

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

March 31,2025December 31,2024
Assets under construction$245$272
IT equipment451451
Leasehold improvements471471
Lab equipment8,2228,007
$9,389$9,201
Less—accumulated depreciation(6,278)(5,986)
Property and equipment, net$3,111$3,215

Depreciation expense was$0.3 million for the three months ended March 31, 2025 and 2024.

  1. Prepaid Expenses and Other Current Assets

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

March 31,2025December 31,2024
Prepaid insurance$1,172$1,696
Prepaid research and development expenses3,5826,007
Other1,7721,826
Prepaid expenses and other current assets$6,526$9,529
  1. Marketable Securities

Marketable securities consisted of the following (in thousands):

Amortized CostUnrealized GainsUnrealized LossesFair Value
U.S. Government agencies$89,634$147$(16)$89,765
Total$89,634$147$(16)$89,765
Amortized CostUnrealized GainsUnrealized LossesFair Value
U.S. Government agencies119,130297(26)$119,401
Total$119,130$297$(26)$119,401

As of March 31, 2025, the unrealized losses on the Company’s investments in U.S. government agencies 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 March 31, 2025, one marketable security with contractual maturity of one year or less was in an unrealized loss position totaling$0.02 million, and all marketable securities held by the Company had remaining contractual maturities of one year or less.

As of March 31, 2024, four marketable securities with contractual maturities of one year or less were in an unrealized loss position totaling $0.01 million.

There wereno impairments of the Company’s marketable securities measured and carried at fair value during the three months ended March 31, 2025 and 2024.

  1. Accrued Expenses and Other Current Liabilities

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

March 31,2025December 31,2024
Accrued research and development expenses$3,355$3,386
Accrued compensation2,7635,456
Accrued audit, tax, and consulting expenses455430
Other412188
Accrued expenses and other current liabilities$6,985$9,460
  1. Stockholders' Equity

The Company had 150,000,000 authorized shares of common stock, par value $0.00001 per share, of which 50,225,312 and 49,998,279 shares were issued and outstanding at March 31, 2025 and December 31, 2024, 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 March 31, 2025 and December 31, 2024.

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 issuedno shares of common stock during thethree months ended March 31, 2025 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.

  1. 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 both options to purchase common stock intended to qualify as incentive stock options under Section 422 of 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, 2025, the shares reserved for issuance were increased to 11,667,747 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, there were 4,236,967 options and restricted stock units available for grant under the 2021 Plan at March 31, 2025.

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, 2025, the shares reserved for issuance were increased to 1,593,596 shares. The purchase price of the shares under the ESPP is 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 March 31, 2025,1,578,333 shares were available to be issued under the ESPP. The Company recognized$0.02 million and $0.03 million in stock-based compensation expense related to the ESPP for thethree months ended March 31, 2025 and 2024, respectively.

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 Planfor the three months ended March 31, 2025:

OptionsWeighted-AverageExercisePriceWeighted-AverageRemainingContractualTerm(years)Aggregate IntrinsicValue(in thousands)
Outstanding at December 31, 20245,522,353$8.176.91$8,086
Granted1,057,4107.64
Cancelled/Forfeited(4,311)9.57
Outstanding at March 31, 20256,575,452$8.087.20$2,596
Exercisable at March 31, 20253,641,859$7.805.72$2,577

The weighted-average grant date fair value of stock options granted during the three months ended March 31, 2025 and 2024 was$5.88 and$5.90 per share, respectively. The fair value of options vested during the three months ended March 31, 2025 and 2024 was$2.6 million and$2.2 million, respectively. The total intrinsic value of options exercised was$0 and$0.3 million for the three months ended March 31, 2025 and 2024, respectively.

The fair value of the stock options issued for thethree months ended March 31, 2025 and 2024 was measured with the following weighted-average assumptions:

Three Months EndedMarch 31,
20252024
Risk-free interest rate4.38%3.84%
Expected term (years)6.066.06
Expected volatility of the underlying stock90.89%88.50%
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 units activity during thethree months ended March 31, 2025 is as follows:

Restricted Stock UnitsWeighted-AverageGrant Date Fair Value
Unvested at December 31, 20241,589,042$8.76
Granted1,378,6627.65
Vested/Released(211,770)8.45
Forfeited(4,061)9.47
Unvested at March 31, 20252,751,873$8.23

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. For thethree months ended March 31, 2025,211,770 restricted stock units vested with a fair value of$1.8 million.

Stock-Based Compensation Expense

The Company recorded stock-based compensation expense as follows (in thousands):

Three Months EndedMarch 31,
20252024
Research and development$1,915$1,478
General and administrative1,5991,431
Total$3,514$2,909

As of March 31, 2025, there was$17.4 million of unrecognized compensation expense related to stock options, which is expected to be recognized over a weighted-average period of 2.9 years.

As of March 31, 2025, there was$20.3 million of unrecognized compensation expense related to restricted stock units, which is expected to be recognized over a weighted-average period of 3.2 years.

  1. 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 (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, of which 5,021 common stock warrants remain outstanding as of March 31, 2025. During the three months ended March 31, 2025,7,665 common stock warrants expired.

  1. Compensation

In January 2012, the Company adopted the Aura Biosciences 401(k) Profit Sharing Plan and Trust (the “401(k) Plan”) for its employees, which is designed to be qualified under Section 401(k) of the Internal Revenue 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 of$0.3 million and$0.2 million for the three months ended March 31, 2025 and 2024, respectively.

  1. 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 March 31, 2025.

On May 16, 2022, the Company entered into an office and laboratory lease in Boston, Massachusetts with an initial 10-year term and one renewal option to extend the lease for an additional seven years. The lease commenced on August 1, 2022, and estimated payments due under the initial term total $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 unaudited condensed consolidated balance sheets. The lease also provided for the landlord to reimburse the Company up to $0.5 million for certain costs related to expansion of the laboratory space. As of March 31, 2025, the Company has completed 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 three months ended March 31, 2025 and 2024 (in thousands):

Three Months EndedMarch 31,
20252024
Lease Costs
Operating lease costs$867$868
Variable lease costs269361
Total lease costs$1,136$1,229
Cash paid for amounts included in the measurement of lease liabilities—operating leases$816$751
Weighted-average remaining lease term—operating leases (years)7.348.34
Weighted-average discount rate—operating leases10.71%10.71%

The following table reconciles the future minimum commitments to the Company’s operating lease liabilities at March 31, 2025 (in thousands):

2025$2,490
20263,405
20273,508
20283,611
20293,715
Thereafter10,107
Total lease payments26,836
Less: interest(8,392)
Total lease liabilities at March 31, 202518,444
Less: current portion of lease liabilities3,172
Lease liabilities, net of current portion$15,272

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 700DC 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 three months ended March 31, 2025 and 2024, 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 three months ended March 31, 2025 and 2024, the Company recognized no milestones related to this agreement.

Life Technologies Corporation License Agreements

In December 2014, the Company entered into a non-exclusive, perpetual license agreement with Life Technologies Corporation, or the 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 three months ended March 31, 2025 and 2024, the Company recognized no 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 three months ended March 31, 2025 and 2024, the Company recognizedno expenses related to this agreement.

National Institute of Health (NIH)-Collaboration Research and Development Agreement

In July 2011, the Company entered into a Collaboration Research and Development Agreement, or 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, 2020, and 2022. During thethree months ended March 31, 2025 and 2024, the Company paidno research collaboration fees related to this agreement.

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 thethree months ended March 31, 2025 and 2024, the Company recognized no 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 the 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 did not recognize any patent licensing fees for the three months ended March 31, 2025 and 2024.

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 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; the Phase I and Phase II milestones have been achieved as of March 31, 2025. 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 did not incur any expenses related to milestones in the three months ended March 31, 2025 and 2024.

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 didnot recognize any expenses related to this agreement and related amendments for the three months ended March 31, 2025 and 2024.

  1. 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 thethree months ended March 31, 2025 and 2024 as follows (in thousands, except share and per share data):

Three Months EndedMarch 31,
20252024
Numerator:
Net loss$(27,483)$(19,706)
Denominator:
Weighted-average common stock outstanding—basic and diluted50,126,14849,451,943
Net loss per common share—basic and diluted$(0.55)$(0.40)

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:

Three Months EndedMarch 31,
20252024
Stock options to purchase common stock6,575,4525,956,888
Restricted stock units that vest into common stock2,751,8731,690,542
Warrants to purchase common stock5,02112,686
Total potential dilutive shares9,332,3467,660,116
  1. Income Taxes

For the three months ended March 31, 2025 and 2024, the Company recorded an income tax provision of$0.02 million and$0.05 million, respectively, resulting in an effective tax rate of 0.1% in each period. The income tax provision for the three months ended March 31, 2025 is attributable to state and foreign income taxes. The difference in the statutory rate and the effective tax rate is primarily the result of the valuation allowance recorded on all deferred tax assets.

Due to the Company’s history of losses since inception, there is not enough positive evidence at this time to support a position that the Company will generate future income of a sufficient amount and nature to utilize the benefits of its net deferred tax assets. Accordingly, the deferred tax assets have been reduced by a full valuation allowance, since the Company does not currently believe that realization of its deferred tax assets is more likely than not.

As of March 31, 2025, the Company hadno unrecognized income tax benefits that would reduce the Company’s effective tax rate if recognized.

  1. 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 unaudited condensed consolidated balance sheets as cash and cash equivalents and marketable securities.

As a single reportable segment entity, the Company’s segment performance measure is consolidated net loss. Significant segment expenses are presented below.

Three Months EndedMarch 31,
20252024
(in thousands)
Clinical, Preclinical, and R&D Operations (1)$(16,386)$(11,499)
Chemistry, Manufacturing, and Controls (1)(6,957)(5,553)
General and Administrative (1)(5,692)(5,261)
Other Segment Items (2)1,5522,607
Net loss$(27,483)$(19,706)

(1)Includes depreciation expense directly allocated to respective activities.

(2)Other segment items primarily include interest income, realized gains and losses, and income taxes.

  1. Subsequent Events

Subsequent events have been evaluated through the date of filing of the unaudited condensed consolidated financial statements. The Company has identified no subsequent events that require disclosure.

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