SUTRO BIOPHARMA INC
For the period ended Sep 30, 2024. Filed Nov 13, 2024.
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Sep 30, 2024 · Filed Nov 13, 2024
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Notes to Unaudited Interim Condensed Financial Statements
- Organization and Principal Activities
Description of Business
Sutro Biopharma, Inc. (the “Company”), is a clinical-stage oncology company developing site-specific and novel-format antibody drug conjugates, or ADCs. The Company was incorporated on April 21, 2003, and is headquartered in South San Francisco, California.
The Company operates and manages its business as one operating segment. The Company’s Chief Executive Officer reviews financial information on an aggregate basis for the purposes of allocating resources and evaluating financial performance.
All the Company’s long-lived assets are maintained in the United States.
Liquidity
The Company has incurred significant losses and has negative cash flows from operations. As of September 30, 2024, there was an accumulated deficit of $714.4 million. Management expects to continue to incur additional substantial losses in the foreseeable future as a result of the Company’s research and development and other operational activities.
As of September 30, 2024, the Company had unrestricted cash, cash equivalents, and marketable securities of $388.3 million which are available to fund future operations. The Company will need to raise additional capital to support the completion of its research and development activities and to support its operations.
The Company believes that its unrestricted cash, cash equivalents, and marketable securitiesas of September 30, 2024 will enable the Company to maintain its operations for a period of at least 12 months following the filing date of its condensed financial statements.
- Summary of Significant Accounting Policies
Basis of Presentation and Use of Estimates
The accompanying interim condensed financial statements of the Company are unaudited. These interim condensed financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and the applicable rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, they do not include all the information and footnotes required by U.S. GAAP for complete financial statements. The December 31, 2023 condensed balance sheet was derived from the audited financial statements as of that date but does not include all of the information and footnotes required by U.S. GAAP for complete financial statements.
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates on historical experience and market-specific or other relevant assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s condensed Balance Sheets and the amounts of expenses and income reported for each of the periods presented are affected by estimates and assumptions, which are used for, but are not limited to, determining research and development periods under collaboration arrangements, stock-based compensation expense, impairment of long-lived assets, income taxes, deferred royalty obligation related to the sale of future royalties and related non-cash interest expense, and certain accrued liabilities. Actual results could differ from such estimates or assumptions.
The accompanying unaudited interim condensed financial statements have been prepared on the same basis as the audited financial statements and, in the opinion of management, reflect all adjustments of a normal recurring nature considered necessary to state fairly the Company’s financial position, results of operations, comprehensive loss, and cash flows for the interim periods. The interim results for the three and nine months ended September 30, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024, or for any other future annual or interim period.
The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the Company’s audited financial statements included in the Annual Report on Form 10-K pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, for the year ended December 31, 2023.
Recent Accounting Pronouncements Not Yet Adopted
In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which requires all public entities, including public entities with a single reportable segment, to provide in interim and annual periods one or more measures of segment profit or loss used by the chief operating decision maker to allocate resources and assess performance. Additionally, the standard requires disclosures of significant segment expenses and other segment items as well as incremental qualitative disclosures. The guidance in this update is effective for fiscal years beginning after December 15, 2023, and interim periods after December 15, 2024. The Company is currently in the process of evaluating the effects of this pronouncement on its related disclosures.
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures(“ASU 2023-09”). This new guidance is designed to enhance the transparency and decision usefulness of income tax disclosures. The amendments of this update are related to the rate reconciliation and income taxes paid. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company is currently assessing the impact that adopting this new accounting standard will have on its financial statements.
Cash, Cash Equivalents and Restricted Cash
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the Company's condensed Balance Sheets that sum to the total of the same amounts shown in the Company's condensed Statements of Cash Flows.
| September 30, | ||
|---|---|---|
| 2024 | 2023 | |
| (in thousands) | ||
| Cash and cash equivalents | $174,579 | $81,834 |
| Restricted cash | 857 | 872 |
| Total cash, cash equivalents, and restricted cash shown in the condensed Statements of Cash Flows | $175,436 | $82,706 |
Investments in Equity Securities
Vaxcyte common stock held by the Company is measured at fair value at each reporting period based on the closing price of Vaxcyte’s common stock on the last trading day of each reporting period, with any realized or unrealized gains and losses recorded in the Company’s condensed Statements of Operations.
Fair Value Measurements
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability, or an exit price, in the principal or most advantageous market for that asset or liability in an orderly transaction between market participants on the measurement date and establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs, where available, and minimize the use of unobservable inputs when measuring fair value. The Company determined the fair value of financial assets and liabilities using the fair value hierarchy that describes three levels of inputs that may be used to measure fair value, as follows:
Level 1—Quoted prices in active markets for identical assets and liabilities;
Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
The carrying amounts of accounts receivable, prepaid expenses, accounts payable, accrued liabilities and accrued compensation and benefits approximate fair value due to the short-term nature of these items.
The carrying value of the deferred royalty obligation related to the sale of future royalties under the 2015 License Agreement with Vaxcyte approximates its fair value as of September 30, 2024, and is based on our current estimates of future royalties expected to be earned over the estimated life of the royalty term arrangement. See Note 8. Deferred Royalty Obligation Related to the Sale of Future Royalties for a description of the Level 3 inputs used to estimate the fair value of the liability.
Revenue Recognition
When the Company enters into collaboration agreements, it assesses whether the arrangements fall within the scope of ASC 808, Collaborative Arrangements ("ASC 808") based on whether the arrangements involve joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards. To the extent that the arrangement falls within the scope of ASC 808, the Company assesses whether the payments between the Company and its collaboration partner fall within the scope of other accounting literature. If it concludes that payments from the collaboration partner to the Company represent consideration from a customer, such as license fees and contract research and development activities, the Company accounts for those payments within the scope of Accounting Standards Update (ASU) No. 2014-09 (Topic 606), Revenue from Contracts with Customers (“ASC 606”).
Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. However, if the Company concludes that its collaboration partner is not a customer for certain activities and associated payments, such as for certain collaborative research, development, manufacturing and commercial activities, the Company presents such payments as a reduction of research and development expense or general and administrative expense, based on where the Company presents the underlying expense.
The Company has no products approved for commercial sale and has not generated any revenue from commercial product sales. The total revenue to date has been generated principally from collaboration and license agreements and to a lesser extent, from manufacturing, supply and services, and materials the Company provides to its collaboration partners.
Collaboration Revenue: The Company derives revenue from collaboration arrangements, under which the Company may grant licenses to its collaboration partners to further develop and commercialize its proprietary product candidates. The Company may also perform research and development activities under the collaboration agreements. Consideration under these contracts generally includes a nonrefundable upfront payment, development, regulatory and commercial milestones and other contingent payments, and royalties based on net sales of approved products. Additionally, the collaborations may provide options for the customer to acquire from the Company materials and reagents, clinical product supply or additional research and development services under separate agreements.
The Company assesses which activities in the collaboration agreements are considered distinct performance obligations that should be accounted for separately. The Company develops assumptions that require judgement to determine whether the license to the Company’s intellectual property is distinct from the research and development services or participation in activities under the collaboration agreements.
At the inception of each agreement, the Company determines the arrangement transaction price, which includes variable consideration, based on the assessment of the probability of achievement of future milestones and contingent payments and other potential consideration. The Company recognizes revenue over time by measuring its progress towards the complete satisfaction of the relevant performance obligation using an appropriate input or output method based on the nature of the service promised to the customer.
For arrangements that include multiple performance obligations, the Company allocates the transaction price to the identified performance obligations based on the standalone selling price ("SSP"), of each distinct performance obligation. In instances where SSP is not directly observable, the Company develops assumptions that require judgment to determine the SSP for each performance obligation identified in the contract. These key assumptions may include full-time equivalent ("FTE"), personnel effort, estimated costs, discount rates and probabilities of clinical development and regulatory success.
Upfront Payments: For collaboration arrangements that include a nonrefundable upfront payment, if the license fee and research and development services cannot be accounted for as separate performance obligations, the transaction price is deferred and recognized as revenue over the expected period of performance using a cost-based input methodology. The Company uses judgement to assess the pattern of delivery of the performance obligation. In addition, amounts paid in advance of services being rendered may result in an associated financing component to the upfront payment. Accordingly, the interest on such borrowing cost component will be recorded as interest expense and revenue, based on an appropriate borrowing rate applied to the value of services to be performed by the Company over the estimated service performance period.
License Grants: For collaboration arrangements that include a grant of a license to the Company’s intellectual property, the Company considers whether the license grant is distinct from the other performance obligations included in the arrangement. For licenses that are distinct, the Company recognizes revenues from nonrefundable, upfront payments and other consideration allocated to the license when the license term has begun and the Company has provided all necessary information regarding the underlying intellectual property to the customer, which generally occurs at or near the inception of the arrangement.
Milestone and Contingent Payments: At the inception of the arrangement and at each reporting date thereafter, the Company assesses whether it should include any milestone and contingent payments or other forms of variable consideration in the transaction price using the most likely amount method. If it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty, the associated milestone value is included in the transaction price. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of each milestone and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Since milestone and contingent payments may become payable to the Company upon the initiation of a clinical study or filing for or receipt of regulatory approval, the Company reviews the relevant facts and circumstances to determine when the Company should update the transaction price, which may occur before the triggering event. When the Company updates the transaction price for milestone and contingent payments, the Company allocates the changes in the total transaction price to each performance obligation in the agreement on the same basis as the initial allocation. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment, which may result in recognizing revenue for previously satisfied performance obligations in such period. The Company’s collaborators generally pay milestones and contingent payments subsequent to achievement of the triggering event.
Research and Development Services: For amounts allocated to the Company’s research and development obligations in a collaboration arrangement, the Company recognizes revenue over time using a cost-based input methodology, representing the transfer of goods or services as activities are performed over the term of the agreement.
Materials Supply: The Company provides materials and reagents, clinical materials, and services to certain of its collaborators under separate agreements. The consideration for such services is generally based on FTE personnel effort used to manufacture those materials, reimbursed at an agreed upon rate in addition to agreed-upon pricing for the provided materials. The amounts billed are recognized as revenue as the performance obligations are met by the Company.
Revenue subject to governmental withholding taxes is recognized on a gross basis with the withholding taxes recorded as a component of income tax expense.
- Fair Value Measurements
The following table sets forth the fair value of the Company’s financial assets and liabilities measured on a recurring basis by level within the fair value hierarchy:
| Total · Level 1 · Level 2 · Level 3 | |||||||
|---|---|---|---|---|---|---|---|
| (in thousands) | |||||||
| Assets: | |||||||
| Money market funds | $60,363 | $60,363 | $ | - | $ | - | |
| Commercial paper | 76,720 | - | 76,720 | - | |||
| Corporate debt securities | 53,633 | - | 53,633 | - | |||
| Asset-backed securities | 58,161 | - | 58,161 | - | |||
| U.S. government securities | 134,237 | 134,237 | - | - | |||
| U.S. agency securities | 4,977 | - | 4,977 | - | |||
| Total | $388,091 | $194,600 | $193,491 | $ | - | ||
| Total · Level 1 · Level 2 · Level 3 | ||||||
|---|---|---|---|---|---|---|
| (in thousands) | ||||||
| Assets: | ||||||
| Money market funds | $56,397 | $56,397 | $ | - | $ | - |
| Commercial paper | 82,152 | - | 82,152 | - | ||
| Corporate debt securities | 61,894 | - | 61,894 | - | ||
| Equity securities | 41,937 | 41,937 | - | - | ||
| Asset-backed securities | 10,505 | - | 10,505 | - | ||
| U.S. government securities | 113,652 | 113,652 | - | - | ||
| U.S. agency securities | 4,961 | - | 4,961 | - | ||
| Total | $371,498 | $211,986 | $159,512 | $ | - | |
Where applicable, the Company uses quoted market prices in active markets for identical assets to determine fair value. This pricing methodology applies to Level 1 investments, which are comprised of money market funds and U.S. government securities.
If quoted prices in active markets for identical assets are not available, then the Company uses quoted prices for similar assets or inputs other than quoted prices that are observable, either directly or indirectly. These investments are included in Level 2 and consist of commercial paper, corporate debt securities, asset-backed securities, and U.S. agency securities. These assets are valued using market prices when available, adjusting for accretion of the purchase price to face value at maturity.
A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.
In certain cases where there is limited activity or less transparency around inputs to valuation, securities are classified as Level 3 within the valuation hierarchy. As of September 30, 2024 and December 31, 2023, the deferred royalty obligation related to the sale of future Vaxcyte royalties was classified as Level 3 within the valuation hierarchy. Refer to Note 8 below for information relating to the Purchase Agreement between the Company and Blackstone, pursuant to which the Company sold to Blackstone its 4% royalty, or revenue interest, in potential future net sales of Vaxcyte’s pneumococcal conjugate vaccine, or PCV, products, including VAX-24 and VAX-31.
Investment in Equity Securities
During the three and nine months ended September 30, 2024, the Company sold 667,780 shares of Vaxcyte common stock it heldat their fair market value of approximately $74.0 million, net of transaction costs.
During the three and nine months ended September 30, 2024, the Company recognized a gain of $23.7 million and $32.1 million on the Vaxcyte common stock sold, respectively, which is recorded under interest and other income (expense), net, in the Statements of Operations. No sharesof Vaxcyte common stock were sold during thethree and nine months ended September 30, 2023.
As of September 30, 2024, the Company didnot hold any shares of Vaxcyte common stock. As of December 31, 2023, the Company held 667,780 shares of Vaxcyte common stock with an estimated fair value of $41.9 million.
- Cash Equivalents and Marketable Securities
Cash equivalents and marketable securities consisted of the following:
| AmortizedCost Basis · UnrealizedGains · UnrealizedLosses · FairValue | ||||||
|---|---|---|---|---|---|---|
| (in thousands) | ||||||
| Money market funds | $60,363 | $ | - | $ | - | $60,363 |
| Commercial paper | 76,713 | 13 | (6) | 76,720 | ||
| Corporate debt securities | 53,617 | 16 | - | 53,633 | ||
| Asset-based securities | 58,146 | 16 | (1) | 58,161 | ||
| U.S. government securities | 134,171 | 66 | - | 134,237 | ||
| U.S. agency securities | 4,975 | 2 | - | 4,977 | ||
| Total | 387,985 | 113 | (7) | 388,091 | ||
| Less amounts classified as cash equivalents | (174,406) | (16) | 6 | (174,416) | ||
| Total marketable securities | $213,579 | $97 | $(1) | $213,675 | ||
| AmortizedCost Basis · UnrealizedGains · UnrealizedLosses · FairValue | ||||||
|---|---|---|---|---|---|---|
| (in thousands) | ||||||
| Money market funds | $56,397 | $ | - | $ | - | $56,397 |
| Commercial paper | 82,179 | 1 | (28) | 82,152 | ||
| Corporate debt securities | 61,887 | 12 | (5) | 61,894 | ||
| Asset-based securities | 10,505 | - | – | 10,505 | ||
| U.S. government securities | 113,612 | 40 | – | 113,652 | ||
| U.S. agency securities | 4,960 | 1 | – | 4,961 | ||
| Total | 329,540 | 54 | (33) | 329,561 | ||
| Less amounts classified as cash equivalents | (65,144) | (4) | - | (65,148) | ||
| Total marketable securities | $264,396 | $50 | $(33) | $264,413 | ||
No marketable securities had maturities of more thanone year as of September 30, 2024 and December 31, 2023.
There were $56.7 million and $110.9 million of investments in an unrealized loss position of $7,000 and $33,000 as of September 30, 2024 and December 31, 2023, respectively. During the three and nine months ended September 30, 2024, and 2023, the Company didnot record any other-than-temporary impairment charges on its available-for-sale securities. Based on the Company’s procedures under the expected credit loss model, including an assessment of unrealized losses on the portfolio after September 30, 2024, and 2023, the Company concluded that the unrealized losses for its marketable securities were not attributable to credit and therefore an allowance for credit losses for these securities has not been recorded as of September 30, 2024. Also, based on the scheduled maturities of the investments, the Company was more likely than not to hold these investments for a period of time sufficient for a recovery of the Company’s cost basis.
The Company recognized no material gains or losses on its cash equivalents and marketable securities as of September 30, 2024 and December 31, 2023 and as a result, the Company did not reclassify any amounts out of accumulated other comprehensive income (loss) for the period then ended.
- Collaboration and License Agreements and Supply Agreements
The Company has entered into collaboration and license agreements and supply agreements with various pharmaceutical and biotechnology companies. See “Note 5. Collaboration and License Agreements and Supply Agreements” to the Company’s financial statements included in the Annual Report on Form 10-K for the year ended December 31, 2023, or as further described below, for additional information on each of its collaboration agreements.
The Company’s accounts receivable balances may contain billed and unbilled amounts from upfront payments, milestones and other contingent payments, as well as reimbursable costs from collaboration and license agreements and supply agreements. The Company performs a regular review of its customers’ credit risk and payment histories, including payments made after the period end. Historically, the Company has not experienced credit loss from its accounts receivable and, therefore, hasnot recorded a reserve for estimated credit losses as of September 30, 2024 and December 31, 2023.
In accordance with the collaboration, license and supply agreements, the Company recognized revenue as follows:
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2024 | 2023 | 2024 | 2023 | |
| (in thousands) · (in thousands) | ||||
| Astellas Pharma Inc. (“Astellas”) | $7,661 | $9,988 | $43,798 | $23,593 |
| Tasly Biopharmaceuticals Co., Ltd. (“Tasly”) | 32 | 5,072 | 1,007 | 5,072 |
| Vaxcyte, Inc. ("Vaxcyte") | 656 | 1,592 | 2,149 | 2,970 |
| Ipsen Pharma SAS (“Ipsen”) | 166 | - | 261 | - |
| Merck Sharp & Dohme Corporation (“Merck”) | 5 | 83 | 19 | 2,776 |
| Bristol Myers Squibb Company (“BMS”) | - | 189 | - | 5,591 |
| Merck KGaA, Darmstadt, Germany (operating in the United States and Canada under the name “EMD Serono”) | - | - | - | 8 |
| Total revenue | $8,520 | $16,924 | $47,234 | $40,010 |
The following table presents the changes in the Company’s deferred revenue balance from the agreements during the nine months ended September 30, 2024:
| Nine Months Ended | |
|---|---|
| (in thousands) | |
| Deferred revenue—December 31, 2023 | $74,045 |
| Additions to deferred revenue | 50,429 |
| Recognition of revenue in current period | (33,915) |
| Deferred revenue—September 30, 2024 | $90,559 |
The Company’s balance of deferred revenue contains upfront and contingent paymentsfor obligations from our agreements which remain partially unsatisfied. The Company expects to recognize approximately $72.6 million of the deferred revenue over the next twelve months.
Astellas License and Collaboration Agreement
In June 2022, the Company entered into a License and Collaboration Agreement (the “Astellas Agreement”) with Astellas for the development of immunost imulatory antibody-drug conjugates for up tothree biological targets, to be identified by Astellas. The Company will conduct research and pre-clinical development of any compound (as designated by Astellas) in each of thethree programs in accor dance with the terms of a research plan between the Company and Astellas. Astellas will have an exclusive worldwide license to develop and commercialize any such designated compound, subject to the Company’s rights to participate in cost and profit sharing in the United States, as described below.
Pursuant to the Astellas Agreement, the Company received from Astellas a one-time, nonrefundable, non-creditable, upfront payment of $90.0 million during the year ended December 31, 2022. Under ASC 808 and ASC 606, the Company determined that both parties are active participants in the activities and are exposed to significant risks and rewards dependent on the success of the development program, and identified four performance obligations under the Astellas Agreement as: (1) performance of services related to the first target program; (2) performance of services related to the second target program; (3) performance of services related to the third target program; and (4) the Company’s estimated future services on the collaboration JSC. The transaction price of $90.0 millionwas allocated among the performance obligations using the Company’s best estimate of the standalone selling price, or SSP, for each of the associated performance obligations. Revenue allocated to thethree target programs, which totaled $89.1 million, was being recognized on a proportional performance basis, using FTE cost as the basis of measurement, with such performance expected to occur over an estimated service period offour years for each target program. For the JSC performance obligation, revenue allocated to such performance obligation was $0.9 million, and was being recognized on a proportional performance basis using FTE cost as the basis of measurement, and such effort is expected to be incurred on a relatively consistent basis throughout the term of the Astellas Agreement.
Additionally, under ASC 606, the Company determined a financing component associated with the $90.0 million upfront payment and has calculated $25.0 million as of September 30, 2024, on the unearned revenue portion beyond one year from the effective date of the agreement, which amount is being recognized as interest expense and revenue over the estimated service period for the target programs.
The Company is also eligible to receive up to $422.5 million in develo pment, regulatory and commercial milestones for each product candidate, and tiered royalties ranging from low double-digit to mid-teen percentages on worldwide sales of any commercial products that may result from the collaboration, subject to customary deductions under certain circumstances. The Company can also elect to convert any product candidate into a cost and profit-sharing arrangement, for the United States only. In the event the Company makes such election, it will share commercialization costs and profits relating to such product candidate equally with Astellas in the United States, and no royalties will be due from Astellas for net sales of such product candidates in the United States.
In June 2024, Astellas notified the Company that it would not be nominating a third target program. This decision was based on Astellas' strategic portfolio considerations. Pursuant to ASC 606, Astellas' decision to not elect a third target program is a change in the scope of the original contract and thus represents a contract modification. At the date of the modification, the Company determined that the remaining research and development activities related to the first target program and the second target program to be undertaken by the Company after the notice of termination were not distinct from the related activities performed on each target prior to the modification. Accordingly, after re-allocation of the updated transaction price, the Company updated the cost-based input measure of progress for the remaining performance obligations and recorded a cumulative catch-up adjustment to revenue of $17.8 million on the modification date relating to the ongoing unsatisfied performance obligations. For the JSC performance obligation, as the remaining services were determined to be distinct from those already provided, the Company determined that the contract modification should be treated as a termination of the existing contract and the creation of a new contract, to be accounted for prospectively.
Revenues under the Astellas Agreement were as follows:
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2024 | 2023 | 2024 | 2023 | |
| (in thousands) · (in thousands) | ||||
| Ongoing performance related to unsatisfied performance obligations | $5,095 | $5,612 | $33,915 | $11,423 |
| Research and development services | 1,274 | 1,920 | 4,278 | 4,639 |
| Financing component on unearned revenue | 1,268 | 2,456 | 5,186 | 7,531 |
| Materials supply | 24 | - | 419 | - |
| Total revenue | $7,661 | $9,988 | $43,798 | $23,593 |
As of September 30, 2024 and December 31, 2023, there was $35.1 million and $69.0 million of deferred revenue, respectively, related to the upfront payment received by the Company under the Astellas Agreement.
Collaboration with Tasly
Tasly License Agreement
In December 2021, the Company entered into a license agreement with Tasly to grant Tasly an exclusive license to develop and commercialize STRO-002, or luveltamab tazevibulin, or luvelta, in Greater China (the “Tasly License Agreement”). Tasly will pursue the clinical development, regulatory approval, and commercialization of luvelta in multiple indications, including ovarian cancer, non-small cell lung cancer, triple-negative breast cancer, and other indications in
Greater China. The Company will retain development and commercial rights of luvelta globally outside of Greater China, including the United States.
The Company determined that the Tasly License Agreement falls within the scope of ASC 808, as both parties are active participants in the activities and are exposed to significant risks and rewards dependent on the success of the commercialization of indications for luvelta in Greater China. The Company concluded that the Tasly License Agreement contained the following units of account: i) licensed know-how and Sutro patents, license to trademark rights, and initial regulatory data and information necessary to prepare an IND; and ii) collaboration governance and information sharing activities, such as JSC participation and ongoing regulatory and pharmacovigilance support.
The promises related to the licensed know-how and Sutro patents, license to trademark rights, and initial regulatory data and information necessary to prepare an IND are considered to be interdependent and not distinct from each other, representing a combined output. The Company determined that these promises are capable of being distinct from the collaboration governance and information sharing activities discussed below and further determined that this unit of account is a vendor-customer relationship and accounted for it in accordance with ASC 606. All potential future milestones and other payments were considered constrained at the inception of the Tasly License Agreement since the Company could not conclude it was probable that a significant reversal in the amount of revenue recognized would not occur. Since there is only one performance obligation accounted for under ASC 606, no allocation of the transaction price was necessary.
The Company determined that the unit of account consisting of collaboration governance and information sharing activities, such as JSC participation and ongoing regulatory and pharmacovigilance support, do not represent a customer-vendor relationship between the Company and Tasly. These promises are considered to be interdependent and not distinct from each other, representing a combined output. However, the Company determined that these promises are capable of being distinct from the intellectual property and data license promises discussed above. As such, based on the nature of the agreement and collaborative activities, the Company determined that the costs associated with these governance and information sharing activities performed under the agreement will be included in research and development expenses in the Statements of Operations, with any reimbursement of costs by Tasly reflected as a reduction of such expenses. During the three and nine months ended September 30, 2024, and 2023, the Company did not recognize any material reduction of research and development expenses under the Tasly License Agreement.
In April 2022, the Company entered into amendment No. 1 (the “Tasly Amendment”) to the Tasly License Agreement with Tasly. Pursuant to the Tasly Amendment, the initial nonrefundable upfront payment due by Tasly was amended to $25.0 million, and a $15.0 million payment will become payable to the Company upon the achievement of certain regulatory milestones. The Tasly Amendment also added an additional regulatory milestone payment to the Tasly License Agreement, providing additional potential payments totaling up to $350.0 million related to development, regulatory and commercialization milestones, beyond the payments described above, and made certain other ministerial edits.
During 2023, the Company recognized a $5.0 million contingent payment as revenue, net of withholding tax, after Tasly received its first IND clearance by National Medical Products Administration, or NMPA, in Greater China. The withholding tax of $0.5 million was recorded as an income tax charge related to the contingent payment.
During 2023, the Company also recorded a $5.0 million contingent payment, received by the Company from Tasly related to the first patient dosed in the Company’s REFRaME-O1 trial for luvelta, as deferred revenue, net of withholding tax of $0.5 million. The REFRaME-O1 study consists of two parts, Part I being the dose-finding portion and Part II being the portion of the study that will focus on the selected dose from Part I, and is intended to generate data to enable the potential registration of luvelta. Although it currently intends to conduct the REFRaME-O1 study to completion, the Company has the sole discretion to terminate the REFRaME-O1 study at any time. Given the above, the contingent payment received by the Company was considered constrained for accounting purposes during the three and nine months ended September 30, 2024, since the Company could not conclude it was probable that a significant reversal in the amount of revenue recognized would not occur. The withholding tax was recorded by the Company as a tax charge related to the received contingent payment.
2023 Tasly Supply Agreement
In June 2023, the Company entered into a Master Development and Clinical Supply Agreement (the “2023 Tasly Supply Agreement”) with Tasly, wherein Tasly requested the Company to provide development, manufacturing and supply chain management services, including clinical product supply.
Revenues under the Tasly agreements were as follows:
| Three Months Ended · Nine Months Ended | ||||||
|---|---|---|---|---|---|---|
| September 30, · September 30, | ||||||
| 2024 · 2023 · 2024 · 2023 | ||||||
| (in thousands) · (in thousands) | ||||||
| Contingent payment | $ | - | $5,000 | $ | - | $5,000 |
| Research and development services | 32 | 72 | 70 | 72 | ||
| Materials supply | - | - | 937 | - | ||
| Total revenue | $32 | $5,072 | $1,007 | $5,072 | ||
Agreements with Vaxcyte
Vaxcyte Supply Agreement
In May 2018, the Company entered into a Supply Agreement (the “Supply Agreement”) with Vaxcyte, wherein Vaxcyte engaged the Company to provide research and development services and to supply extracts and custom reagents, as requested by Vaxcyte. The pricing is based on an agreed upon cost-plus arrangement.
During 2020, upon Vaxcyte’s request and their agreement to reimburse the related costs, the Company entered into agreements with third-party contract manufacturing organizations, or CMOs, to conduct process transfers to allow for such CMOs to manufacture and supply extract and custom reagents for Vaxcyte. As part of the agreement with Vaxcyte, should the Company decide to purchase extract from the extract CMO, the Company would be required to reimburse Vaxcyte for a portion of all incurred process transfer costs. As of September 30, 2024 and December 31, 2023, there was $9.4 million and $6.9 million, respectively, in such accruals related to the Vaxcyte Supply Agreement.
For the three and nine months ended September 30, 2024, the agreed-upon reimbursements by Vaxcyte of the costs associated with such arrangements, principally for pass-through costs from the CMOs, were $2.8 million and $7.0 million, respectively, and were accounted for by the Company as a reduction to research and development expense based on the Company’s conclusion that Vaxcyte was not a customer for such activities and associated payments.
For the three and nine months ended September 30, 2023, the agreed-upon reimbursements by Vaxcyte of the costs associated with such arrangements, principally for pass-through costs from the CMOs, were $2.8 million and $5.6 million, respectively.
Vaxcyte Agreement
In December 2022, the Company entered into a letter agreement (the “Vaxcyte Agreement”) with Vaxcyte under which the Company granted to Vaxcyte (i) authorization to enter into an agreement with an independent alternate CMO to source cell-free extract solely for the products it licensed from the Company, allowing Vaxcyte to have direct oversight over financial and operational aspects of the relationship with the CMO (“CMO Relationship Rights”), and (ii) a right, but not an obligation, to obtain certain exclusive rights to internally manufacture and/or source extract from certain CMOs and the right to independently develop and make improvements to extract for use in connection with the exploitation of certain vaccine compositions (the “Option”).
In November 2023 (the "Exercise Date"), Vaxcyte exercised the Option by submitting written notice thereof to the Company and concurrently paid the Company $50.0 million in cash as the first oftwo installment payments for the Option exercise price. In May 2024, Vaxcyte paid the Company an additional $25.0 million in cash as the second of two installment payments for the Option exercise price under the Vaxcyte Agreement.
Upon the occurrence of certain regulatory milestones, Vaxcyte would be obligated to pay the Company certain additional payments totaling up to $60.0 million in cash. In the event that Vaxcyte undergoes a change of control, certain rights and payments may be accelerated. These contingent payments were considered constrained variable consideration or otherwise not eligible for revenue recognition at inception and as of September 30, 2024.
Revenues under the Vaxcyte agreements were as follows:
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2024 | 2023 | 2024 | 2023 | |
| (in thousands) · (in thousands) | ||||
| Research and development services | $563 | $636 | $1,860 | $1,707 |
| Materials supply | 93 | 956 | 289 | 1,263 |
| Total revenue | $656 | $1,592 | $2,149 | $2,970 |
Refer to Note 8 below for information relating to the Purchase Agreement between the Company and Blackstone, pursuant to which the Company sold to Blackstone its 4% royalty, or revenue interest, in potential future net sales of Vaxcyte products, including VAX-24 and VAX-31.
Ipsen Agreements
In March 2024, the Company and Ipsen Pharma SAS (“Ipsen”) entered into an Exclusive License Agreement (the “Ipsen License Agreement”) pursuant to which the Company licensed to Ipsen, on an exclusive basis, the right to research, develop, manufacture and commercialize STRO-003.
In consideration for the rights and licenses granted by the Company to Ipsen in the Ipsen License Agreement, (i) Ipsen paid the Company an upfront license fee in the amount of $50.0 million in April 2024 and (ii) Ipsen Biopharmaceuticals, Inc. (USA) (“Ipsen USA”), a fully-owned Affiliate of Ipsen, purchased 4,827,373 shares of the Company’s common stock for $25.0 million, at a price of approximately $5.18 per share, in accordance with the terms set forth in a certain investment agreement by and between the Company and Ipsen USA dated March 29, 2024 (the “Ipsen Investment Agreement”, and, together with the Ipsen License Agreement, the “Ipsen Agreements”). The fair market value of the common stock issued to Ipsen USA in April 2024 was $24.6 million, based on the stock price on the date of issuance, resulting in a $0.4 million premium on the Ipsen Investment Agreement.
Further, pursuant to the Ipsen License Agreement, upon the occurrence of a specified developmental milestone according to a specified timetable, the Company will receive a payment of up to $7.0 million and Ipsen is obligated to purchase up to an additional $10.0 million in shares of the Company’s common stock at a price per share representing a 17% premium to the VWAP of the Company’s common stock for the twenty trading day period prior to such milestone achievement, in accordance with the terms set forth in the Ipsen Investment Agreement. The Company is also eligible to receive up to an additional $447.0 million in developmental and regulatory milestones, assuming multiple indications, and up to $360.0 million in sales milestones, as well as tiered royalty payments ranging from low double-digit to mid-teen digit percentages of annual net sales of STRO-003, subject to certain adjustments specified in the Ipsen License Agreement.
The royalty payment obligations under the Ipsen License Agreement expire on a country-by-country basis no earlier than ten years following the first commercial sale of STRO-003 in the applicable country. Ipsen may terminate the Ipsen License Agreement for convenience with sixty calendar days prior written notice or for certain other specified reasons. The Company may terminate the Ipsen License Agreement if Ipsen or any of its Affiliates challenge the validity of any patents controlled by the Company that are licensed under the agreement. Both Ipsen and the Company may terminate the Ipsen License Agreement (i) for material breach by the other party and a failure to cure such breach within the time period specified in the Ipsen License Agreement or (ii) the other party’s bankruptcy event.
The Company concluded that the Ipsen License Agreement contains three promised goods and services consisting of the STRO-003 license, technology transfer, and IND-enabling activities. The Company concluded that these promised goods and services are not distinct from each other, and all play an integral role in allowing Ipsen to file an IND and begin its development of STRO-003. As such, the STRO-003 license, technology transfer, and IND-enabling activities are accounted for as one single performance obligation.
The Ipsen License Agreement and the Ipsen Investment Agreement are being accounted for as one arrangement because they were entered into at or near the same time and negotiated in contemplation of one another. The Company determined that the total transaction price of the Ipsen License Agreement was $50.4 million, comprised of the one-time, nonrefundable, non-creditable upfront payment of $50.0 million paid by Ipsen under the Ipsen License Agreement, and a $0.4 million premium from the Ipsen Investment Agreement.
Revenue for the performance obligation will be recognized at a point in time when the Company has completed all its deliverables, i.e., STRO-003 license, technology transfer, and IND-enabling activities, at which time Ipsen would have what it needs from the Company to file an IND for STRO-003.
Ipsen Transition Services Agreement ("TSA") and Material Transfer Agreement ("MTA")
In July 2024, the Company executed the Transition Services Agreement (“TSA”) with Ipsen. The TSA outlines the terms and conditions for transition services requested by Ipsen as part of the Ipsen License Agreement. Further, as part of the transition activities under the TSA, Ipsen and the Company executed a Material Transfer Agreement ("MTA") to govern the transfer of certain materials from the Company to Ipsen for research and development purposes. The pricing for the services and material supply is outlined in the TSA and MTA.
Revenues under the Ipsen agreements were as follows:
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2024 | 2023 | 2024 | 2023 | |
| (in thousands) · (in thousands) | ||||
| Research and development services | $93 | $– | $111 | $– |
| Materials supply | 73 | – | 150 | – |
| Total revenue | $166 | $– | $261 | $– |
As of September 30, 2024, there was $50.4 million of deferred revenue related to the Ipsen Agreements.
Collaboration with Merck
In August 2024, Merck informed the Company of its decision to discontinue the clinical trial of MK-1484 in patients. Merck stated that the decision was based on strategic portfolio considerations.
- Commitments and Contingencies
Leases
The Company leases certain office, labo ratory and manufacturing facilities in South San Francisco, California and San Carlos, California. These leases require monthly lease payments that may be subject to annual increases throughout the lease term. Certain of these leases also include renewal options at the election of the Company to renew or extend the lease for an additional 5 years. These renewal options have not been considered in the determination of the right-of-use assets and lease liabilities associated with these leases as the Company has determined it is not reasonably certain it will exercise such options.
The Company recognizes rent expense for these operating leases on a straight-line basis over the lease period. The components of lease costs, which the Company includes in operating expenses in the Company's condensed Statements of Operations, were as follows (in thousands):
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2024 | 2023 | 2024 | 2023 | |
| Operating lease cost | $1,984 | $1,979 | $5,952 | $5,055 |
| Short-term lease cost | 49 | 59 | 140 | 102 |
| Variable lease cost | 680 | 580 | 2,127 | 1,431 |
| Total lease costs | $2,713 | $2,618 | $8,219 | $6,588 |
During the three and nine months ended September 30, 2024, the Company recorded operating lease expense of $2.0 million and $6.0 million, respectively. For the nine months ended September 30, 2024, the Company paid$6.9 million of operating lease payments related to the lease liabilities, which the Company includes in net cash used in operating activities in the Company's condensed Statements of Cash Flows.
During the three and nine months ended September 30, 2023, the Company recorded operating lease expense of $2.0 million and $5.1 million, respectively. For the nine months ended September 30, 2023, the Company paid $5.7 million of operating lease payments related to the lease liabilities, which the Company includes in net cash used in operating activities in the Company's condensed Statements of Cash Flows.
As of September 30, 2024 and December 31, 2023, the weighted-average remaining lease term was 3.1 years and 3.8 years, respectively, and the weighted-average discount rate used to determine the operating lease liability was 10.8% for both periods.
As of September 30, 2024, the maturities of the Company’s operating lease liabilities were as follows (in thousands):
| Year Ending December 31, | Amount |
|---|---|
| (in thousands) | |
| Remaining in 2024 | $2,343 |
| 2025 | 9,533 |
| 2026 | 8,994 |
| 2027 | 8,289 |
| Total lease payments | 29,159 |
| Less: imputed interest | (4,295) |
| Operating lease liabilities | 24,864 |
| Less: current portion | (7,203) |
| Total lease liabilities, non-current | $17,661 |
Indemnification & Other
In the ordinary course of business, the Company may provide indemnifications of varying scope and terms to vendors, lessors, business partners, board members, officers, and other parties with respect to certain matters, including, but not limited to, losses arising out of breach of such agreements, services to be provided by the Company, negligence or willful misconduct of the Company, violations of law by the Company, or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with directors and certain officers and employees that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors, officers, or employees. No demands have been made upon the Company to provide indemnification under such agreements, and thus, there are no claims that the Company is aware of that could have a material effect on the Company’s condensed Balance Sheets, condensed Statements of Operations, or condensed Statements of Cash Flows. The Company currently has directors’ and officers’ liability insurance.
In addition, the Company enters into agreements in the normal course of business, including with contract research organizations for clinical trials, contract manufacturing organizations for certain manufacturing services, and vendors for preclinical studies and other services and products for operating purposes, which are generally cancelable upon written notice.
- Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consist of the following:
| September 30, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| (in thousands) | ||
| Vaxcyte-related accrual under Vaxcyte Supply Agreement | $9,440 | $6,933 |
| CMO-related accrual | 10,929 | 8,195 |
| Clinical trials-related accrual | 8,288 | 4,283 |
| Tax and related expenses | 18 | 15,165 |
| Other | 3,460 | 3,897 |
| Total accrued expenses and other current liabilities | $32,135 | $38,473 |
- Deferred Royalty Obligation related to the Sale of Future Royalties
In June 2023, the Company entered into the Purchase Agreement with Blackstone, pursuant to which the Company sold to Blackstone its 4% royalty, or revenue interest, in the potential future net sales of Vaxcyte products, including the Purchased Interest under the 2015 License Agreement. As described in Note 5. Collaboration and License Agreements and Supply Agreements, Vaxcyte Agreement, following agreement with Vaxcyte on the Form Definitive Agreement and upon effectiveness of the amendment No. 3 to the 2015 License Agreement, the revenue interest in the 4% royalty on potential future net sales of Vaxcyte products other than Vaxcyte’s PCV products reverted to the Company. The Company retains the right to discover and develop vaccines for the treatment or prophylaxis of any disease that is not caused by an infectious pathogen, including cancer.
In June 2023, Blackstone made an upfront payment of $140.0 million to the Company and will also pay up to an additional $250.0 million upon the achievement of various return thresholds as set forth in the Purchase Agreement.
Under the Purchase Agreement, and in connection with its sale of the Purchased Interest, the Company has agreed to certain covenants with respect to the exercise of its rights under the 2015 License Agreement, including with respect to the Company’s right to amend, assign and terminate the 2015 License Agreement. The Purchase Agreement contains other customary terms and conditions, including representations and warranties, covenants, and indemnification obligations in favor of each party.
The Company recorded the $140.0 million upfront payment from Blackstone as a deferred royalty obligation related to the sale of future royalties on the Company's condensed Balance Sheets. Due to the Company's then ongoing manufacturing obligations under the 2015 License Agreement, the Company accounted for the proceeds as imputed debt and, therefore, will recognize future non-cash royalty revenues. Non-cash interest expense will be recognized over the estimated life of the royalty term arrangement using the effective interest method based on the imputed interest rate derived from estimated amounts and timing of potential future royalty payments to be received from Vaxcyte. As part of the sale, the Company incurred approximately $3.8 million in transaction costs, which are being amortized over the estimated life of the royalty term arrangement using the effective interest method. As future royalties are earned from Vaxcyte by Blackstone, the balance of the deferred royalty obligation will be amortized over the estimated life of the royalty term arrangement.
There are a number of factors that could materially affect the fair value of the deferred royalty obligation. Such factors include, but are not limited to, the amount and timing of potential future royalty payments to be earned and received by Blackstone from Vaxcyte under the 2015 License Agreement, changing standards of care, the introduction of competing products, manufacturing or other delays, intellectual property matters, adverse events that result in governmental health authority imposed restrictions on the use of the vaccine products, and other events or circumstances that could result in reduced royalty payments from Vaxcyte to Blackstone, which are not within the Company's control, and all of which would result in a reduction or increase of non-cash royalty revenues and the non-cash interest expense over the estimated life of the royalty term arrangement. The Company periodically assesses the estimated royalty payments to be earned by Blackstone from Vaxcyte and, to the extent that the amount or timing of such payments is materially different than its original estimates, the Company prospectively adjusts the imputed interest rate and the related amortization of the deferred royalty obligation. As of September 30, 2024, the effective interest rate used by the Company to amortize the liability is 18.89%.
During the three and nine months ended September 30, 2024, the Company recognized approximately $7.9 million and $22.4 million, respectively, of non-cash interest expense on the deferred royalty obligation, which amount will increase such balance. During the three and nine months ended September 30, 2023, the Company recognized approximately $5.9 million and $6.4 million, respectively, of non-cash interest expense on the deferred royalty obligation. As of September 30, 2024, Blackstone has not received any royalty payment from Vaxcyte and, therefore, the deferred royalty obligation has not begun to be amortized.
The following table shows the activity of the deferred royalty obligation for the nine months ended September 30, 2024:
| (in thousands) | |
|---|---|
| Liability related to sale of future Vaxcyte royalties - beginning balance | $149,114 |
| Non-cash interest expense associated with the sale of future Vaxcyte royalties | 22,380 |
| Amortization of issuance costs | 473 |
| Liability related to the sale of future Vaxcyte royalties - ending balance | $171,967 |
- Stockholders’ Equity
Common Stock
Holders of common stock are entitled toone vote per share on all matters to be voted upon by the stockholders of the Company.
The Company has reserved common stock, on an if-converted basis, for issuance as follows:
| September 30, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| Common stock options issued and outstanding | 8,904,562 | 7,905,032 |
| Common stock awards issued and outstanding | 6,022,734 | 5,244,873 |
| Remaining shares reserved for issuance under 2018 Equity Incentive Plan and 2021 Equity Inducement Plan | 1,495,378 | 1,777,919 |
| Shares reserved for issuance under 2018 Employee Stock Purchase Plan | 1,213,418 | 914,911 |
| Warrants to purchase common stock | 127,616 | 127,616 |
| Total | 17,763,708 | 15,970,351 |
Preferred Stock
As of September 30, 2024 and December 31, 2023, the Company had 10,000,000 shares of preferred stock authorized with a par value of $0.001 per share. No shares of preferred stock were outstanding as of September 30, 2024 and December 31, 2023.
- Equity Incentive Plans, Equity Inducement Plans, Employee Stock Purchase Plan and Stock-Based Compensation
2004 Equity Incentive Plan, 2018 Equity Incentive Plan, 2021 Equity Inducement Plan, and Amended and Restated 2021 Equity Inducement Plan
In September 2018, the Company adopted the 2018 Equity Incentive Plan (“2018 Plan”), which became effective on September 25, 2018. As a result, the Company will not grant any additional awards under the 2004 Equity Incentive Plan (“2004 Plan”). The terms of the 2004 Plan and applicable award agreements will continue to govern any outstanding awards thereunder. In addition to the shares of common stock reserved for future issuance under the 2004 Plan that were added to the 2018 Plan upon its effective date, the Company initially reserved 2,300,000 shares of common stock for issuance under the 2018 Plan. In addition, the number of shares of common stock reserved for issuance under the 2018 Plan will automatically increase on the first day of January for a period of up toten years, commencing on January 1, 2019, in an amount equal to 5% of the total number of shares of the Company’s capital stock outstanding on the last day of the preceding year (rounded to the nearest whole share), or a lesser number of shares determined by the Company’s board of directors. As a result, common stock reserved for issuance under the 2018 Plan was increased by 3,050,491 shares on January 1, 2024.
In August 2021, the Company adopted the 2021 Equity Inducement Plan (“2021 Plan”), which became effective on August 4, 2021. Upon its effective date, the Company initially reserved 750,000 shares of common stock for issuance pursuant to non-qualified stock options and restricted stock units (“RSUs”) under the 2021 Plan. In accordance with Rule 5635(c)(4) of the Nasdaq listing rules, equity awards under the 2021 Plan may only be made to an employee if he or she is granted such equity awards in connection with his or her commencement of employment with the Company and such grant is an inducement material to his or her entering into employment with the Company or such subsidiary. In addition, awards under the 2021 Plan may only be made to employees who have not previously been an employee or member of the Board (or any parent or subsidiary of the Company) or following a bona fide period of non-employment of the employee by the Company (or a parent or subsidiary of the Company). At all times, the Company will reserve and keep available a sufficient number of shares as will be required to satisfy the requirements of all outstanding awards granted under the 2021 Plan.
In August 2022, the Company amended and restated the 2021 Plan (the “Amended and Restated 2021 Plan”) and reserved an additional 750,000 shares of common stock available for issuance under the Amended and Restated 2021 Plan to be granted by the Company to certain employees as a material inducement to their acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).
Additionally, in February 2023, the Company amended and restated the Amended and Restated 2021 Plan and reserved an additional 500,000 shares of common stock available for issuance under the Amended and Restated 2021 Plan to be granted by the Company to certain employees as a material inducement to their acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The total number of shares reserved for issuance pursuant to the Amended and Restated 2021 Plan is 2,000,000 shares.
As of September 30, 2024, the Company had a total of 1,495,378 shares available for grant under the 2018 Plan and the 2021 Plan.
The following table summarizes option activity under the Company’s 2004 Plan, 2018 Plan and 2021 Plan:
| Shares | Weighted-AverageExercise Price | |
|---|---|---|
| Stock options outstanding at December 31, 2023 | 7,905,032 | $11.24 |
| Granted | 1,545,209 | 4.18 |
| Exercised | (63,748) | 4.24 |
| Canceled and forfeited | (481,931) | 10.91 |
| Stock options outstanding at September 30, 2024 | 8,904,562 | 10.08 |
| Stock options exercisable at September 30, 2024 | 6,349,762 | $11.85 |
Restricted Stock Units
The RSUs vest annually, and generally, will become fully vested over four years. A summary of the status and activity of non-vested RSUs during the nine months ended September 30, 2024 is as follows:
| Number ofshares | WeightedAverage Grant-DateFair Value | |
|---|---|---|
| Non-vested December 31, 2023 | 5,244,873 | $8.31 |
| Granted | 2,710,030 | 4.40 |
| Vested and released | (1,555,054) | 9.71 |
| Canceled and forfeited | (377,115) | 8.00 |
| Non-vested September 30, 2024 | 6,022,734 | $6.21 |
2018 Employee Stock Purchase Plan
In September 2018, the Company adopted the 2018 Employee Stock Purchase Plan (“ESPP”), which became effective on September 26, 2018, in order to enable eligible employees to purchase shares of the Company’s common stock. The Company initially reserved 230,000 shares of common stock for sale under the ESPP. The aggregate number of shares reserved for sale under the ESPP will automatically increase on the first day of January for a period of up toten years, commencing on January 1, 2019, in an amount equal to 1% of the total number of shares of the Company’s capital stock outstanding on the last day of the preceding year (rounded to the nearest whole share), or a lesser number of shares determined by the Company’s board of directors. As a result, common stock reserved for issuance under the ESPP was increased by 114,754 shares on January 1, 2024. The aggregate number of shares issued over the term of the Company’s ESPP, subject to stock-splits, recapitalizations or similar events, may not exceed 2,300,000 shares of the Company’s common stock.
At the Company’s annual stockholder meeting in June 2024, the Company amended the ESPP (the “Amended ESPP”) to increase the overall limit on the number of shares that may be issued under the Amended ESPP throughout its ten-year term from 2,300,000 shares to 3,050,0000 shares of the Company’s common stock.
As of September 30, 2024,1,836,582 shares had been purchased and 1,213,418 shares were available for future issuance under the ESPP.
Stock-Based Compensation Expense
Total stock-based compensation expense recognized was as follows:
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2024 | 2023 | 2024 | 2023 | |
| (in thousands) · (in thousands) | ||||
| Research and development expense: | $3,268 | $2,877 | $9,514 | $8,825 |
| General and administrative expense: | 3,277 | 3,126 | 9,258 | 9,860 |
| Total | $6,545 | $6,003 | $18,772 | $18,685 |
As of September 30, 2024, unrecognized stock-based compensation expense related to the unvested stock options and RSUs granted was $9.4 million and $28.1 million, respectively. The remaining unrecognized compensation cost related to the unvested stock options and RSUs is expected to be recognized over a weighted-average period of 2.2 years and 2.4 years, respectively. As of September 30, 2024, there was $0.4 million of unrecognized stock-based compensation expense related to the ESPP.
As of September 30, 2023, unrecognized stock-based compensation expense related to the unvested stock options and RSUs granted was $12.9 million and $34.7 million, respectively. The remaining unrecognized compensation cost related to the unvested stock options and RSUs is expected to be recognized over a weighted-average period of 2.1 years and 2.4 years, respectively. As of September 30, 2023, there was $0.6 million of unrecognized stock-based compensation expense related to the ESPP.
- Net Loss Per Share
The following table sets forth the computation of the Company’s basic and diluted net loss per share.
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2024 | 2023 | 2024 | 2023 | |
| (in thousands, except share and per share amounts) | ||||
| Numerator: | ||||
| Net loss | $(48,787) | $(49,284) | $(155,018) | $(137,858) |
| Denominator: | ||||
| Shares used in computing net loss per share | 82,043,671 | 60,599,025 | 74,934,737 | 59,894,181 |
| Net loss per share, basic and diluted | $(0.59) | $(0.81) | $(2.07) | $(2.30) |
The following common stock equivalents were excluded from the computation of diluted net loss per share for the nine months ended September 30, 2024, and 2023, because including them would have been antidilutive:
| As of September 30, | ||
|---|---|---|
| 2024 | 2023 | |
| Common stock options issued and outstanding | 8,904,562 | 7,920,561 |
| Restricted stock units issued and outstanding | 6,022,734 | 5,213,248 |
| Warrants to purchase common stock | 127,616 | 127,616 |
| Shares to be issued under employee stock purchase plan | 35,293 | 38,772 |
| Total | 15,090,205 | 13,300,197 |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.