Aura Biosciences Inc
For the period ended Mar 31, 2024. Filed May 9, 2024.
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Mar 31, 2024 · Filed May 9, 2024
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Notes to Unaudited Condensed Consolidated Financial Statements
- Description of Business
Aura Biosciences, Inc., or the Company or Aura, is a clinical-stage biotechnology company developing precision immunotherapies to treat solid tumors designed to preserve the function of the organ with cancer. 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 being explored for choroidal metastases and 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 March 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 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 December 5, 2022, the Company issued and sold 7,705,000 shares of common stock, including the full exercise of the underwriters’ option to purchase additional shares at a price to the public of $12.00 per share for aggregate gross proceeds of $92.5 million, or the 2022 Follow-On Offering. The Company received approximately $86.7 million in net proceeds from the 2022 Follow-On Offering after deducting underwriting discounts, 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. As of November 6, 2023, the Company had issued 993,996 shares of common stock at an average price of $12.50 under the ATM. 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 three months ended March 31, 2024 under the ATM.
As of the issuance date of these unaudited condensed consolidated financial statements for the three months ended March 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
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, 2024 and 2023 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, 2024. 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, 2023, in the Company’s Annual Report on Form 10-K filed with the SEC on March 27, 2024. There have been no changes to the Company’s significant accounting policies except as noted below.
Recently Adopted Accounting Pronouncements
In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments,” which was subsequently amended in November 2018 through ASU No. 2018-19, “Codification Improvements to Topic 326, Financial Instruments—Credit Losses.” ASU No. 2016-13 will require entities to estimate lifetime expected credit losses for trade and other receivables, net investments in leases, financing receivables, debt securities and other instruments, which will result in earlier recognition of credit losses. Further, the new credit loss model will affect how entities in all industries estimate their allowance for losses for receivables that are current with respect to their payment terms. ASU No. 2018-19 further clarifies that receivables arising from operating leases are not within the scope of Topic 326. Instead, impairment from receivables of operating leases should be accounted for in accordance with Topic 842, Leases. As per the latest ASU 2020-02, FASB deferred the timelines for certain small public and private entities, thus the new guidance was adopted by the Company for the annual reporting period beginning January 1, 2023, including interim periods within that annual reporting period. The standard will apply as a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is adopted. The Company adopted this standard on January 1, 2023 and the standard didnot have a material impact on its results of operations, financial condition, and financial statement disclosures.
- 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, 2024 and December 31, 2023 (in thousands):
| Description | March 31,2024 | Quoted pricesactive marketsfor identicalassets(Level 1) | Significantotherobservableinputs(Level 2) | Significantotherobservableinputs(Level 3) |
|---|---|---|---|---|
| Financial assets | ||||
| Cash equivalents: | ||||
| Money market funds | $25,808 | $25,808 | $— | $— |
| Marketable securities: | ||||
| U.S. Government agencies | 176,098 | — | 176,098 | — |
| Asset-backed securities | 497 | — | 497 | — |
| Total financial assets | $202,403 | $25,808 | $176,595 | $— |
| 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 | $— |
- Property and Equipment, Net
Property and equipment, net, consisted of the following (in thousands):
| March 31,2024 | December 31,2023 | |
|---|---|---|
| Assets under construction | $555 | $391 |
| IT equipment | 289 | 289 |
| Lab equipment | 7,552 | 7,506 |
| $8,396 | $8,186 | |
| Less—accumulated depreciation | (5,342) | (5,036) |
| Property and equipment, net | $3,054 | $3,150 |
Depreciation expense was$0.3 million and$0.3 million for the three months ended March 31, 2024 and 2023, respectively.
- Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):
| March 31,2024 | December 31,2023 | |
|---|---|---|
| Prepaid insurance | $1,258 | $1,817 |
| Prepaid research and development expenses | 5,829 | 1,399 |
| Other | 2,288 | 2,409 |
| Prepaid expenses and other current assets | $9,375 | $5,625 |
- Marketable Securities
Marketable securities consist of the following (in thousands):
| Amortized Cost | Unrealized Gains | Unrealized Losses | Fair Value | |
|---|---|---|---|---|
| U.S. Government agencies | 176,079 | 67 | (48) | $176,098 |
| Asset-backed securities | 498 | — | (1) | $497 |
| Total | $176,577 | $67 | $(49) | $176,595 |
| 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 March 31, 2024, the unrealized losses on the Company’s investments in U.S. government agencies securities 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 March 31, 2024, four marketable securities with contractual maturities of one year or less were in an unrealized loss position totaling$0.01 million.
As of March 31, 2024, the Company had marketable securities with a fair value of $58.7 million that had maturities of one to two years.
There wereno impairments of the Company’s assets measured and carried at fair value during the three months ended March 31, 2024.
- Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
| March 31,2024 | December 31,2023 | |
|---|---|---|
| Accrued research and development expenses | $2,509 | $3,445 |
| Accrued compensation | 1,798 | 3,503 |
| Other | 682 | 935 |
| Accrued expenses and other current liabilities | $4,989 | $7,883 |
- Equity
The Company had 150,000,000 authorized shares of common stock, par value $0.00001 per share, of which 49,504,405 and 49,350,788 shares were issued and outstanding at March 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 March 31, 2024 and December 31, 2023.
Financings
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 December 5, 2022, the Company issued and sold 7,705,000 shares of common stock, including the full exercise of the underwriters’ option to purchase additional shares at a price to the public of $12.00 per share for aggregate gross proceeds of $92.5 million in the 2022 Follow-On Offering. The Company received approximately $86.7 million in net proceeds from the 2022 Follow-On Offering after deducting underwriting discounts, 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. As of November 6, 2023, the Company had issued 993,996 shares of common stock at an average price of $12.50 under the ATM. 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 the three months ended March 31, 2024 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 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, 2024, the shares reserved for issuance was increased to 9,414,162 shares. With the transfer of the available options from the 2018 Plan to the 2021 Plan, there were 4,110,430 options and restricted stock units available for grant under the 2021 Plan at March 31, 2024.
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 March 31, 2024,1,270,542 shares were available to be issued under the ESPP. The Company recognized$0.03 million share-based compensation expense related to the ESPP for the three months ended March 31, 2024.
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, 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 | 1,085,500 | 7.83 | ||
| Exercised | (51,180) | 3.10 | ||
| Cancelled/Forfeited | (107,783) | 11.12 | ||
| Outstanding at March 31, 2024 | 5,956,888 | $8.34 | 7.69 | $7,681 |
| Exercisable at March 31, 2024 | 2,902,169 | $7.37 | 6.34 | $6,627 |
The weighted-average grant date fair value of stock options granted during the three months ended March 31, 2024 and 2023 was$5.90 and$7.52 per share, respectively. The fair value of options vested during the three months ended March 31, 2024 and 2023 was$2.2 million and$1.2 million, respectively. The total intrinsic value of options exercised was$0.3 million and$0.1 million for the three months ended March 31, 2024 and 2023, respectively.
The fair value of the stock options issued for thethree months ended March 31, 2024 and 2023 was measured with the following weighted-average assumptions:
| Three Months EndedMarch 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Risk-free interest rate | 3.84% | 3.53% |
| Expected term (years) | 6.06 | 6.04 |
| Expected volatility of the underlying stock | 88.50% | 84.83% |
| 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, 2024 is as follows:
| Restricted Stock Units | Weighted-AverageGrant Date Fair Value | |
|---|---|---|
| Unvested at December 31, 2023 | 1,093,402 | $10.27 |
| Granted | 731,925 | 7.83 |
| Vested/Released | (90,123) | 10.08 |
| Forfeited | (44,662) | 10.05 |
| Unvested at March 31, 2024 | 1,690,542 | $9.23 |
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 the three months ended March 31, 2024,90,123 restricted stock units vested with a fair value of $1.0 million.
Stock-based Compensation Expense
The Company recorded stock-based compensation expense as follows (in thousands):
| Three Months EndedMarch 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Research and development | $1,478 | $767 |
| General and administrative | 1,431 | 1,146 |
| Total | $2,909 | $1,913 |
As of March 31, 2024, there was$18.8 million of unrecognized compensation expense related to stock options, which is expected to be recognized over a weighted-average period of 2.74 years.
As of March 31, 2024, there was$13.8 million of unrecognized compensation expense related to restricted stock units, which is expected to be recognized over a weighted-average period of 3.31 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 (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 March 31, 2024.
- 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 in the amount of $0.2 million for thethree months ended March 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 March 31, 2024 andone operating lease that was terminated in August 2022.
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. 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 consolidated balance sheet. The landlord will reimburse the Company up to $0.5 million for certain costs related to expansion of the laboratory space. As of March 31, 2024, the Company has incurred$0.1 millionof expenses related to the expansion, and has been reimbursed for $0.1 million of these 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 thethree months ended March 31, 2024 and 2023 (in thousands):
| Three Months EndedMarch 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Lease Cost | ||
| Operating lease costs | 868 | 881 |
| Variable lease costs | 361 | 309 |
| Short-term lease costs | — | 2 |
| Total lease costs | $1,229 | $1,192 |
| Cash paid for amounts included in the measurement of lease liabilities—operating leases | $751 | $768 |
|---|---|---|
| Weighted-average remaining lease term—operating leases (years) | 8.34 | 9.34 |
| 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 March 31, 2024 (in thousands):
| 2024 | $2,070 |
| 2025 | 3,306 |
| 2026 | 3,405 |
| 2027 | 3,507 |
| 2028 | 3,612 |
| Thereafter | 13,823 |
| Total lease payments | 29,723 |
| Less: interest | (10,403) |
| Total lease liabilities at March 31, 2024 | 19,320 |
| Less: current portion of lease liabilities | 2,741 |
| Lease liabilities, net of current portion | $16,579 |
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, 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 three months ended March 31, 2024 and 2023, the Company recognizedno 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, 2024 and 2023, the Company recognized $0.02 millionof expenses related to this agreement, respectively.
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, 2024 and 2023, 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 first amended in 2012, 2013, 2014, 2015, 2016, 2018 and in September of 2020. During thethree months ended March 31, 2024 and 2023, the Company paid no research collaboration fees related to this agreement.
A seventh amendment was made in October 2020, requiring payment of $0.04 million within 30 days of October 1, 2020, and another $0.03 million within 30 days of the 10th anniversary of the CRADA, which was paid in July 2021. This seventh amendment extended the term of the CRADA to September 30, 2022. The Company recognizedno milestones related to this agreement and related amendments for thethree months ended March 31, 2024 and 2023.
An eighth 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 three months ended March 31, 2024 and 2023, the Company recognizedno 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 recognizedno patent licensing fees for the three months ended March 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 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 those milestones have not been achieved as of March 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 Companydidnot incur any expense in the three months ended March 31, 2024 and 2023.
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 recognizedno expense related to this agreement and related amendments for thethree months ended March 31, 2024 and 2023.
- Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss per common share 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, 2024 and 2023 as follows (in thousands, except share and per share data):
| Three Months EndedMarch 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Numerator: | ||
| Net loss | $(19,706) | $(17,466) |
| Denominator: | ||
| Weighted-average common stock outstanding—basic and diluted | 49,451,943 | 37,784,282 |
| Net loss per common share—basic and diluted | $(0.40) | $(0.46) |
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, | ||
|---|---|---|
| 2024 | 2023 | |
| Stock options to purchase common stock | 5,956,888 | 4,891,746 |
| Restricted stock units that vest into common stock | 1,690,542 | 566,064 |
| Warrants to purchase common stock | 12,686 | 12,686 |
| Total potential dilutive shares | 7,660,116 | 5,470,496 |
- Income Taxes
For the three months ended March 31, 2024 and 2023, the Company recorded a tax provision of $0.05 million and $0 million, resulting in an effective tax rate of 0.1% and 0.0%, respectively. The income tax provision for the three months ended March 31, 2024 is attributable to state income taxes. The difference in the statutory rate and the effective tax rate is primarily the result of the valuation allowance recorded against the Company’s net 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, 2024, the Company hadno unrecognized income tax benefits that would reduce the Company’s effective tax rate if recognized.
- 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 except as noted below.
In May 2024, the Company received notice that LI-COR assigned and Rakuten assumed the 2014 Exclusive Agreement and the 2014 Non-Exclusive Agreement, as further described in Note 12 of these unaudited condensed consolidated financial statements.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.