Sana Biotechnology, Inc.
For the period ended Dec 31, 2024. Filed Mar 17, 2025.
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FY2024 · Filed Mar 17, 2025
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Notes to Consolidated Financial Statements
- Organization
Sana Biotechnology, Inc. (the Company or Sana) is a biotechnology company focusing on utilizing engineered cells as medicines. The Company’s operations to date have included identifying and developing potential product candidates, executing preclinical studies, establishing manufacturing capabilities, preparing for and executing clinical trials of its product candidates and supporting clinical trials of product candidates developed using its technologies, acquiring technologies, staffing the Company, business planning, establishing and maintaining the Company’s intellectual property portfolio, raising capital, and providing general and administrative support for these operations.
Liquidity and capital resources
The Company is subject to a number of risks and uncertainties similar to other biotechnology companies in the development stage, including, but not limited to, those related to the need to obtain adequate additional funding, possible failure of preclinical testing or clinical trials, the need to obtain marketing approval for its product candidates, building out internal and external manufacturing capabilities, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of the Company’s products, the need to protect the Company’s intellectual property and proprietary technologies, and the need to attract and retain key scientific and management personnel. If the Company does not successfully commercialize or partner any of its product candidates, it will be unable to generate product revenue or achieve profitability. Until such time as the Company can generate significant revenue from product sales, if ever, it expects to finance its operations with the proceeds from additional equity or debt financings or capital obtained in connection with strategic collaborations or licensing or other arrangements. In the event that additional financing is required, the Company may not be able to raise capital on terms acceptable to it or at all.
In February 2024, the Company completed an underwritten public offering pursuant to which it sold 21.8 million shares of its common stock, including 4.5 million shares pursuant to the full exercise of the underwriters' option to purchase additional shares, and pre-funded warrants to purchase 12.7 million shares of its common stock for net proceeds of approximately $180.0 million, after deducting underwriting discounts and commissions and offering expenses.
In August 2022, the Company entered into a sales agreement with Cowen and Company, LLC (Cowen), acting as sales agent, pursuant to which it may offer and sell through Cowen up to $150.0 million in shares of the Company’s common stock from time to time in a series of one or more at the market equity offerings (collectively, the ATM facility). As of December 31, 2024, the Company sold an aggregate of 4.9 million shares of the Company's common stock under the ATM facility for net proceeds of $28.6 million, after deducting commissions and expenses.
In November 2024, the Company announced a portfolio prioritization to prioritize clinical and preclinical development in type 1 diabetes, B-cell mediated autoimmune diseases, refractory B-cell malignancies, and the fusogen platform for generatingin vivo CAR T cells. The Company suspended development of SC291, the Company's HIP-modified CD19 allogeneic CAR T therapy, in oncology and SC379, its glial progenitor cell program, as it seeks partnerships for these programs. The portfolio prioritization resulted in a workforce reduction of approximately 45%. During the year ended December 31, 2024, the Company recognized $5.8 millionof cash-based expenses related to employee severance, benefits, and related costs. The Company anticipates that the portfolio update and associated workforce reduction will be substantially complete in the first quarter of 2025.
The Company has incurred operating losses each year since inception and expects such losses to continue for the foreseeable future. As of December 31, 2024, the Company had cash, cash equivalents, and marketable securities of $152.5 million, and an accumulated deficit of $1.6 billion, which includes cumulative non-cash charges related to the revaluation of the success payment liabilities and contingent consideration of $2.1 million and $57.7 million, respectively. Management has determined that the Company's current capital resources may not be sufficient to fund its planned operationsfor at least one year from the date of this Annual Report, andthere is substantial doubt as to the Company's ability to continue as a going concern. The Company's ability to continue as a going concern will depend on, among other things, its ability to obtain additional funding and appropriately manage the amount of cash used to fund its operations. The Company plans to address this condition through proceeds from additional equity or debt financings or capital obtained in connection with strategic collaborations or licensing or other arrangements. If the Company is unable to obtain such financing, it may be required to modify its operational plans by delaying, reducing the scope of, or ceasing its research and development programs.
- Summary of significant accounting policies
Basis of presentation
The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, and have been prepared in accordance with generally accepted accounting principles in the United States (GAAP). Certain prior period amounts have been reclassified to conform to current period presentation.
Use of estimates
The preparation of the financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could materially differ from those estimates. The most significant estimates in the Company’s consolidated financial statements relate to success payment liabilities, contingent consideration, business combinations, accrued expenses, and operating lease right-of-use (ROU) assets and liabilities.
Cash and cash equivalents
Cash and cash equivalents include cash and highly liquid investments with original maturities of three months or less at acquisition. Cash equivalents include investments in money market funds with commercial banks and financial institutions and are stated at fair value.
Marketable securities
Marketable securities are classified as available-for-sale debt securities and are carried at fair value, which is derived from independent pricing sources based on quoted prices in active markets for similar securities. Investments in securities with maturities of less than one year, or those for which management intends to use to fund current operations, are included in current assets. Unrealized gains and losses that are deemed to be temporary in nature are reported as a component of accumulated comprehensive income (loss). Amortization, accretion, and dividends are included in interest income, net on the consolidated statement of operations. The cost of securities sold is based on the specific-identification method. Each reporting period, the Company evaluates whether declines in fair value below carrying value are due to expected credit losses, as well as the Company’s ability and intent to hold the investment until a forecasted recovery occurs. Expected credit losses are recorded as an allowance through other income (expense), net.
Concentrations of credit risk and off-balance sheet risk
The Company maintains its cash, cash equivalents, and marketable securities with high quality, accredited financial institutions. These amounts, at times, may exceed federally insured limits. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to significant risk on these funds. The Company has no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts, or other hedging arrangements.
Fair value measurement
The Company accounts for certain assets and liabilities at fair value and is required to disclose information that enables an assessment of the inputs used in determining the reported fair values. The fair value hierarchy prioritizes valuation inputs based on the observable nature of those inputs. The hierarchy applies only to the valuation inputs used to determine the reported fair value of the investments and is not a measure of the investment credit quality. The hierarchy defines three levels of valuation inputs:
Level 1 – Quoted prices in active markets for identical assets or liabilities.
Level 2 – Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly.
Level 3 – Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability.
The Company’s financial instruments include cash and cash equivalents, short- and long-term marketable securities, accounts payable, contingent consideration, success payment liabilities, and other accrued liabilities. The carrying amounts of cash, cash equivalents, accounts payable, and accrued liabilities approximate fair value due to the short-term nature of these instruments. To the extent the valuation of financial instruments is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. See Note 7, Fair value measurements for more information on how the Company determines fair value.
Property and equipment, net
Property and equipment are stated at cost, net of accumulated depreciation. Depreciation of property and equipment is computed using the straight-line method over the estimated useful lives of the respective assets, generally three tofive years. Leasehold improvements are depreciated over the lesser of their useful lives or the remaining life of the lease. When assets are retired or otherwise disposed of, the cost and related accumulated depreciation are removed from the balance sheet and the resulting gain or loss is recorded in research and development expenses in the period realized. During the fourth quarters of 2024 and 2023, the Company recognized $1.9 million and $7.0 million, respectively, in research and development expenses for the impairment of certain lab equipment and leasehold improvement as a result of theportfolio prioritizations in the fourth quarters of 2024 and 2023. Repairs and maintenance are expensed as incurred.
Impairment of long-lived assets
The Company reviews the carrying value and estimated lives of its long-lived assets whenever events or circumstances indicate the carrying values may not be recoverable. Should an impairment exist, the impairment loss would be measured based on the excess of the asset’s carrying amount over its fair value.
The Company accounts for business combinations using the acquisition method of accounting, which requires the assets acquired, including in-process research and development (IPR&D), and liabilities assumed be recorded at fair value as of the acquisition date. Any excess of the purchase price over the fair value of net assets acquired is recorded as goodwill. The determination of the estimated fair value of these items requires significant estimates and assumptions. Transaction costs associated with business combinations are recorded in general and administrative expense as they are incurred.
If the Company determines the acquisition does not meet the definition of a business combination under the acquisition method of accounting, the transaction is accounted for as an asset acquisition. In an asset acquisition, up-front payments allocated to IPR&D are recorded in research and development expense if it is determined that there is no alternative future use, and subsequent milestone payments are recorded in research and development expense when achieved.
Goodwill and intangible assets
Goodwill represents the excess of the purchase price over the estimated fair value of the identifiable assets acquired and liabilities assumed in a business combination. The Company evaluates goodwill for impairment annually or when a triggering event occurs that could indicate a potential impairment. The evaluation for impairment includes assessing qualitative factors or performing a quantitative analysis to determine whether it is more-likely-than-not that the fair value of net assets is below the carrying amount. As of December 31, 2024, the Company had goodwill of $140.6 million related to its acquisition of Cobalt Biomedicine, Inc. (Cobalt) in 2019 (the Cobalt acquisition), which represents the excess of the purchase price over the estimated fair value of the net assets acquired. There have beenno impairments of goodwill since the acquisition.
Intangible assets acquired in a business combination are recognized separately from goodwill and are initially recognized at fair value at the acquisition date. The fair value of the IPR&D is estimated using the replacement cost method. Under this method, the Company estimates the cost to recreate the technology and derive an estimated value to develop the technology. IPR&D assets are required to be classified as indefinite-lived assets and are not amortized until they become finite-lived assets upon the successful completion of the associated research and development technology. At that time, the useful life of the asset will be determined, and amortization will begin. If the associated research and development technology is abandoned, the related IPR&D asset will be written off and an impairment charge recorded. Intangible assets are reviewed for impairment at least annually or when a triggering event occurs that could indicate a potential impairment. There has beenno amortization or impairment of the intangible asset since the Cobalt acquisition.
Contingent consideration from business combinations
Contingent consideration from a business combination is recorded at fair value on the acquisition date and remeasured at each subsequent reporting period with changes in fair value recognized in research and development related success payments and contingent consideration. Changes in fair values reflect changes to the Company’s assumptions regarding probabilities of successful achievement of related milestones, the timing in which the milestones are expected to be achieved, and the discount rate used to estimate the fair value of the obligation.
Pursuant to the terms and conditions of the Cobalt acquisition agreement, we are obligated to pay to certain former Cobalt stockholders contingent consideration (Cobalt Contingent Consideration). See Note 4, Acquisitions for more details on the Cobalt Consideration.
The Company agreed to pay success payments to Cobalt (Cobalt Success Payment) pursuant to the terms of its acquisition agreement with Cobalt and to the President and Fellows of Harvard College (Harvard) (Harvard Success Payments) pursuant to the terms of its exclusive license agreement with Harvard. See Note 4, Acquisitions and Note 5, License and collaboration agreements for more details on the success payments.
The success payments are accounted for under Accounting Standards Codification (ASC) 815, Derivatives and Hedging. The Cobalt Success Payment was recorded as a liability on the consolidated balance sheet at fair value on the acquisition date and is remeasured at each subsequent reporting period, with changes in fair value recognized in research and development related success payments and contingent consideration. For the Harvard Success Payments, both the initial value and subsequent changes in fair value are recorded in research and development related success payments and contingent consideration.
To determine the estimated fair value of the success payment liabilities, the Company uses a Monte Carlo simulation methodology, which models the value of the liabilities based on several key assumptions, including the remaining terms of the success payments, risk-free interest rate, estimated number and timing of valuation measurement dates on the basis of which payments may be triggered, and expected volatility of the Company’s common stock. Expected volatility is estimated using the volatility of peer companies for a period of time commensurate with the remaining terms of the success payments. Additionally, the computation of the estimated fair value of the Cobalt Success Payment liability incorporates the market capitalization of the Company at the end of each reporting period, and the computation of the estimated fair value of the Harvard Success Payments incorporates the per share fair market value of the Company’s common stock at the end of each reporting period.
Leases
At the inception of an arrangement with a third party, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present in the arrangement. Lease liabilities represent an obligation to make payments arising from a lease and are measured at the present value of the remaining future lease payments over the term of the lease. The present value of the lease payments is determined using an incremental borrowing rate (IBR), which reflects the fixed rate at which the Company could borrow the amount of the lease payments, on a collateralized basis, for a similar term and economic environment. The lease terms may include the impact of options to extend or terminate the lease when it is reasonably certain that the Company will exercise the option. Assumptions made by the Company at the lease commencement date are re-evaluated upon the occurrence of certain events, including a lease modification. When a lease modification results in a separate contract, it is accounted for in the same manner as a new lease. ROU assets represent the right to use the underlying asset identified in the lease for the term of the agreement. The calculation of the ROU asset incorporates the value of the lease liability and excludes any lease incentives received and initial direct costs incurred.
The Company’s lease portfolio consists of operating leases related to its facilities for office, laboratory, and manufacturing space. The Company does not have any financing leases. Leases with a term of 12 months or less are considered short-term and do not require recognition on the balance sheet, and payments associated with short-term leases are expensed as incurred. Rent expense for operating leases is recognized on a straight-line basis over the lease term.
Claims and contingencies
From time to time, the Company may become involved in litigation and proceedings relating to claims arising in the ordinary course of business. The Company accrues a liability if the likelihood of an adverse outcome is probable, and the amount can be reasonably estimated. If the likelihood of an adverse outcome is only reasonably possible, or if an adverse outcome is probable, but an estimate is not determinable, the Company provides disclosure of the material claim or contingency.
Stock-based compensation
The Company recognizes compensation costs related to restricted stock awards (RSAs), restricted stock units (RSUs), and stock options granted to employees and nonemployees based on the estimated fair value of the awards on the date of grant and recognizes expense on a straight-line basis over the requisite service period, which is generally the vesting period of the award. Forfeitures are recognized as they occur. For RSAs and RSUs, the fair value of the Company’s common stock is used to determine the resulting stock-based compensation expense. The fair value of stock options is estimated on the date of grant using a Black-Scholes option pricing model which requires management to apply judgment and make estimates, including:
Fair Value of Common Stock—The fair value of common stock is based on the closing price as reported on The Nasdaq Global Select Market on the date of grant.
Expected Term—The expected term represents the period that a stock-based award is expected to be outstanding. The Company uses the simplified method to determine the expected term, which is based on the average of the time-to-vesting and the contractual life of the option.
Expected Volatility—Due to the Company's limited operating history, the expected volatility is estimated based on the average historical volatilities of common stock of comparable publicly traded companies and the Company's historical common stock volatility over a period of time commensurate with the expected term of the stock option grants. The comparable companies are chosen based on their size, stage in the product development cycle, or area of specialty. The Company will continue to apply this process until sufficient historical information regarding the volatility of its own stock price becomes available.
Risk-Free Interest Rate—The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero-coupon U.S. Treasury notes with maturities approximately equal to the expected term of the awards.
Expected Dividend—The Company has never paid dividends on its common stock and has no plans to pay dividends on its common stock. Therefore, the Company used an expected dividend yield ofzero.
Research and development expense
The Company records expense for research and development costs as incurred. Nonrefundable, advance payments for goods or contracts for services are deferred, and expense is recognized in the period in which the goods are received or the services are rendered. Research and development expense consists of personnel-related costs, including salaries, benefits, and non-cash stock-based compensation, external research and development expenses incurred under arrangements with third parties, including CDMO manufacturing costs (including pass-through costs), clinical trial costs, costs for laboratory supplies, costs to acquire and license technologies aligned with the Company’sex vivo andin vivo cell engineering platforms, facility expenses, including rent, depreciation, and costs related to the impairment of certain lab equipment and leasehold improvements, and other allocated expenses.
Research and development related success payments and contingent consideration include the change in the estimated fair value of the Cobalt Success Payment and Harvard Success Payment liabilities and Cobalt Contingent Consideration. Research and development expense related to the success payment liabilities and contingent consideration is unpredictable and may vary significantly from quarter-to-quarter and year-to-year due to changes in the assumptions used in the calculations.
General and administrative expenses consist of personnel costs, including salaries, benefits, and non-cash stock-based compensation, for employees in finance, legal, executive, human resources, information technology, and other administrative functions, legal and consulting fees, recruiting costs, restructuring expenses, and facility costs not otherwise included in research and development expenses. Legal fees include those related to corporate and patent matters. Included in general and administrative expenses for the year ended December 31, 2023 are costs incurred for the early termination of the Company's lease (Fremont lease) for its previously planned manufacturing facility in Fremont, California (Fremont facility).
Income taxes
The Company determines its deferred tax assets and liabilities based on the differences between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. A valuation allowance is recorded when it is more likely than not that the deferred tax asset will not be recovered. The Company applies judgment in the determination of the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The Company recognizes any material interest and penalties related to unrecognized tax benefits in income tax expense.
The Company is required to file income tax returns in the United States (U.S.) federal jurisdiction, and other state and local jurisdictions. The Company is generally subject to examination by U.S. federal and local income tax authorities for all tax years in which the loss carryforward is available. The Company is currently not under examination by the Internal Revenue Service or other jurisdictions for any tax years.
Segments
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business inone operating segment.
JOBS Act accounting election
The Company is an emerging growth company (EGC), as defined in the Jumpstart Our Business Startups Act of 2012 (JOBS Act). Under the JOBS Act, an EGC can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies; however, the Company may adopt new or revised accounting standards early if the standard allows for early adoption.
In addition, the Company will utilize other exemptions and reduced reporting requirements provided to EGCs by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, an EGC is not required to, among other things, (i) provide an auditor’s attestation report on the company’s system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, (ii) provide all of the compensation disclosure that may be required of non-EGC public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act, (iii) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis), or (iv) disclose certain executive compensation-related items, such as the correlation between executive compensation and performance and comparisons of the chief executive officer’s compensation to median employee compensation.
Recent accounting pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB) or other standard-setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed, the Company does not believe that the adoption of any recently issued standards has had or may have a material impact on its consolidated financial statements or disclosures.
In November 2023, the FASB issued ASU 2023-07 Segment Reporting (Topic 280) Improvements to Reportable Segment Disclosures. The amendments in this update expand segment disclosure requirements, including new segment disclosure requirements for entities with a single reportable segment, among other disclosure requirements. The Company adopted the guidance in the fiscal year 2024. There was no impact on the Company's reportable segment identified and additional required disclosures have been included in Note 3, Segment reporting, to the Company's consolidated financial statements included in this Annual Report.
In December 2023, the FASB issued ASU 2023-09 Income Taxes (Topic 740) Improvements to Income Tax Disclosures, which requires disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures. This ASU is effective for the Company's fiscal year 2025. Early adoption is permitted. The Company is currently evaluating income tax disclosures related to its annual report for fiscal year 2025.
- Segment reporting
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by thechief operating decision-maker (CODM), the Company's Chief Executive Officer, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business inone operating segment. When evaluating the Company's financial performance, the CODM reviews total expenses and expenses by function. Further, the CODM reviews the segment's assets based on total assets reported on the consolidated balance sheet.
The table below is a summary of the segment loss, including significant segment expenses (in thousands):
| Twelve months ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| Operating expenses: | |||
| Research and laboratory | $51,133 | $85,197 | $105,482 |
| Technical operations and manufacturing | 39,713 | 52,359 | 55,621 |
| Clinical development | 35,389 | 27,370 | 22,093 |
| Facility costs | 49,429 | 54,778 | 49,186 |
| Support functions | 45,587 | 54,355 | 51,390 |
| Stock-based compensation | 37,678 | 35,533 | 36,397 |
| Portfolio prioritization costs | 5,840 | 5,203 | 8,704 |
| Other(1) | 16,835 | 27,327 | 28,573 |
| Research and development related success payments and contingent consideration | (8,881) | (48,981) | (84,882) |
| Total operating expenses | 272,723 | 293,141 | 272,564 |
| Loss from operations | (272,723) | (293,141) | (272,564) |
| Interest income, net | 10,471 | 9,938 | 3,762 |
| Other expense, net | (4,507) | (52) | (674) |
| Net loss | $(266,759) | $(283,255) | $(269,476) |
(1) Other segment expenses includes licensing costs, consulting fees, business taxes, insurance costs, impairment of certain lab equipment and leasehold improvements for the years ended December 31, 2024 and 2023, and costs incurred for the early termination of the Fremont lease for the year ended December 31, 2023.
- Acquisitions
Cobalt Biomedicine, Inc.
In February 2019, the Company acquired 100% of the outstanding equity of Cobalt, a privately-held early-stage biotechnology company developing a platform technology using its fusogen technology to specifically and consistently deliver various biological payloads to cells (the Cobalt acquisition).
As part of the Cobalt acquisition, the Company recorded an intangible asset of $59.2 million, which consists of in-process research and development that is classified as indefinite-lived until the successful completion of the associated research and development technology, at which point it becomes a finite-lived asset and will be amortized over its estimated useful life. If the research and development technology is abandoned, an impairment charge will be recorded. The Company is actively developing the fusogen technology and, accordingly, the intangible asset is not complete. Amortization will begin when regulatory approval of a product candidate developed using the fusogen technology is obtained in a major market, typically either the United States or the European Union.
The Company recognized $140.6 million of goodwill as a result of the Cobalt acquisition, which is primarily attributable to the value the acquisition provides the Company by complementing the Company’sex vivo portfolio within vivo fusogen cell engineering technology and furthering the Company’s research in using engineered cells as medicines. The goodwill is not deductible for income tax purposes. There wereno impairments of the intangible asset or goodwill since the acquisition.
Pursuant to the terms and conditions in the Cobalt acquisition agreement, the Company has an obligation to pay to certain former Cobalt stockholders contingent consideration (Cobalt Contingent Consideration) of up to an aggregate of $500.0 million upon the achievement of certain specified development milestones and a success payment (Cobalt Success Payment) of up to $500.0 million, each of which is payable in cash or stock. The Cobalt Success Payment is payable if, at pre-determined valuation measurement dates, the Company’s market capitalization equals or exceeds $8.1 billion, and the Company is advancing a program based on the fusogen technology in a clinical trial pursuant to an investigational new drug application, or has filed, or received approval for, a biologics license application or new drug application for a product developed using the fusogen technology. The Cobalt Success Payment can be achieved over a maximum of 20 years from the date of the acquisition, but this period could be shorter upon the occurrence of certain events. A valuation measurement date would also be triggered upon a change of control of the Company if at least one of the Company’s programs based on the fusogen technology is an active research program at the time of such change of control. If the Company’s market capitalization is below $8.1 billion as of the date of a change of control, the amount of the potential Cobalt Success Payment will decrease, and the amount of potential Cobalt Contingent Consideration will increase. As of December 31, 2024, a Cobalt Success Payment had not been triggered.
The following table sets forth various thresholds for the Company’s market capitalizations as of the date of a change of control and the resulting potential Cobalt Success Payment and additional potential Cobalt Contingent Consideration:
| Sana market capitalization upon a change of control and resulting impact to Cobalt Success Payment and additional potential Cobalt Contingent Consideration · Cobalt SuccessPayment · Additionalpotential CobaltContingentConsideration | |||
|---|---|---|---|
| (in millions) | |||
| Equal to or exceeds $8.1 billion | $500 | $ | - |
| Equal to or exceeds $7.4 billion, but less than $8.1 billion | 150 | 350 | |
| Equal to or exceeds $6.8 billion, but less than $7.4 billion | 100 | 400 | |
| Less than $6.8 billion | - | 500 | |
The Cobalt Success Payment and Cobalt Contingent Consideration liabilities are carried at fair value with changes in fair value recognized in research and development related success payments and contingent consideration. As of December 31, 2024 and 2023, the estimated fair value of the Cobalt Success Payment liability was $4.2 million and $11.2 million, respectively, and was recorded in long-term liabilities. In connection with the change in estimated fair value of the Cobalt Success Payment, the Company recognized gains of $6.9 million, $7.9 million, and $69.3 million for the years ended December 31, 2024, 2023, and 2022, respectively.
As of December 31, 2024 and 2023, the estimated fair value of the Cobalt Contingent Consideration was $109.0 million and $109.6 million, respectively, and was recorded in long-term liabilities. In connection with the change in estimated fair value of the Cobalt Contingent Consideration, the Company recognized gains of $0.6 million, $40.8 million, and $3.4 million for the years ended December 31, 2024, 2023, and 2022, respectively.
- License and collaboration agreements
Beam Therapeutics Inc.
In October 2021, the Company entered into an option and license agreement with Beam Therapeutics Inc. (Beam), pursuant to which the Company was granted a non-exclusive license to use Beam’s proprietary CRISPR Cas12b nuclease editing technology to research, develop, and commercialize engineered cell therapy products that (i) are directed to certain antigen targets, with respect to the Company’s allogeneic T cell programs, or (ii) comprise certain human cell types, with respect to the Company’s stem cell-derived programs. The Company made an upfront payment of $50.0 million to Beam, which was recorded in research and development expense for the year ended December 31, 2021. Additionally, under the terms of the agreement, the Company may be obligated to pay up to $65.0 million in specified developmental and commercial milestone payments and royalties on licensed products for each licensed product. At the time of the entry into the option and license agreement, a member of the Company’s board of directors was a beneficial owner of greater than 10% of the outstanding shares of Beam. This director is also affiliated with a member of the board of directors of Beam.
President and Fellows of Harvard College
In March 2019, the Company entered into an exclusive license agreement with Harvard to access certain intellectual property for the development of hypoimmune-modified cells.
Under the terms of the agreement, the Company paid to Harvard aggregate consideration of $12.0 million, comprising $9.0 million in common stock and $3.0 million in cash. Additionally, the Company may be required to pay to Harvard up to an aggregate of $175.0 million in success payments, payable in cash, based on increases in the fair value of the Company’s common stock. The potential Harvard Success Payments are based on multiples of increased value ranging from 5x to 40x, based on a comparison of the fair market value of the Company’s common stock relative to the original issuance price of $4.00 per share at ongoing pre-determined valuation measurement dates. The Harvard Success Payments can be achieved over a maximum of 12 years from the effective date of the agreement. If a higher success payment tier is first met at the same time a lower tier is first met, both tiers will be owed. Any previous success payments made to Harvard would be credited against the success payment owed as of any valuation measurement date so that Harvard does not receive multiple success payments in connection with the same threshold. As of December 31, 2024, a Harvard Success Payment had not been triggered.
The following table summarizes the potential success payments and common stock price required for payment:
| Multiple of Equity Value at Issuance | 5x | 10x | 20x | 30x | 40x |
|---|---|---|---|---|---|
| Per share common stock price required for payment | $20.00 | $40.00 | $80.00 | $120.00 | $160.00 |
| Success payment(s) (in millions) | $5.0 | $15.0 | $30.0 | $50.0 | $75.0 |
The Harvard Success Payment liabilities are carried at fair value, with the initial value and changes in fair value recognized in research and development related success payments and contingent consideration. As of December 31, 2024 and December 31, 2023, the estimated fair value of the Harvard Success Payment liability was $0.3 million and $1.6, respectively, and was recorded in long-term liabilities. In connection with the change in the estimated fair value of the Harvard Success Payment liability, the Company recognized gains of $1.3 million, $0.3 million, and $12.2 million for the years ended December 31, 2024, 2023, and 2022, respectively.
- Restricted cash
The Company maintains standby letters of credit that are collateralized with a bank account at a financial institution in accordance with certain lease agreements. The aggregate amount of such standby letters of credit was $3.8 million as of December 31, 2024 and 2023, respectively.
- Fair value measurements
The following tables summarize the Company’s financial assets and liabilities measured at fair value on a recurring basis based on the three-tier fair value hierarchy:
| ValuationHierarchy · Amortized Cost · GrossUnrealizedHolding Gains · GrossUnrealizedHolding Losses · EstimatedFair Value | |||||||
|---|---|---|---|---|---|---|---|
| (in thousands) | |||||||
| Financial assets: | |||||||
| Cash equivalents: | |||||||
| Money market funds | Level 1 | $66,641 | $ | - | $ | - | $66,641 |
| U.S. government and agency securities | Level 2 | 25,237 | 5 | - | 25,242 | ||
| Total cash equivalents | 91,878 | 5 | - | 91,883 | |||
| Short-term marketable securities: | |||||||
| U.S. government and agency securities | Level 2 | 19,137 | 7 | - | 19,144 | ||
| Corporate debt securities | Level 2 | 5,785 | 2 | - | 5,787 | ||
| Total short-term marketable securities | 24,922 | 9 | - | 24,931 | |||
| Total financial assets | $116,800 | $14 | $ | - | $116,814 | ||
| Financial liabilities: | |||||||
| Long-term financial liabilities: | |||||||
| Contingent consideration | Level 3 | 108,968 | - | - | 108,968 | ||
| Success payment liabilities | Level 3 | 4,556 | - | - | 4,556 | ||
| Total long-term financial liabilities | 113,524 | - | - | 113,524 | |||
| Total financial liabilities | $113,524 | $ | - | $ | - | $113,524 | |
| ValuationHierarchy · Amortized Cost · GrossUnrealizedHolding Gains · GrossUnrealizedHolding Losses · EstimatedFair Value | |||||||
|---|---|---|---|---|---|---|---|
| (in thousands) | |||||||
| Financial assets: | |||||||
| Cash equivalents: | |||||||
| Money market funds | Level 1 | $70,315 | $ | - | $ | - | $70,315 |
| U.S. government and agency securities | Level 2 | 33,091 | 3 | - | 33,094 | ||
| Corporate debt securities | Level 2 | 1,062 | - | - | 1,062 | ||
| Total cash equivalents | 104,468 | 3 | - | 104,471 | |||
| Short-term marketable securities: | |||||||
| U.S. government and agency securities | Level 2 | 57,924 | 7 | (78) | 57,853 | ||
| Corporate debt securities | Level 2 | 13,817 | 9 | (1) | 13,825 | ||
| Total short-term marketable securities | 71,741 | 16 | (79) | 71,678 | |||
| Other assets | Level 3 | 359 | - | - | 359 | ||
| Total financial assets | $176,568 | $19 | $(79) | $176,508 | |||
| Financial liabilities: | |||||||
| Long-term financial liabilities: | |||||||
| Contingent consideration | Level 3 | 109,606 | - | - | 109,606 | ||
| Success payment liabilities | Level 3 | 12,799 | - | - | 12,799 | ||
| Total long-term financial liabilities | 122,405 | - | - | 122,405 | |||
| Total financial liabilities | $122,405 | $ | - | $ | - | $122,405 | |
The Company measures the fair value of money market funds based on quoted prices in active markets for identical assets or liabilities. The Level 2 marketable securities include U.S. government and agency securities and corporate debt securities and are valued based on either recent trades of securities in inactive markets or quoted market prices of similar instruments and other significant inputs derived from or corroborated by observable market data.
There wereno available-for-sale debt securities in a material loss position as of December 31, 2024 and 2023. The Company determined that there was no material change in the credit risk of the investments during the year ended December 31, 2024. As such, an allowance for credit losses has not been recognized. As of December 31, 2024, the Company does not intend to sell such securities, and it is not more-likely-than-not that the Company will be required to sell the securities prior to the recovery of the amortized cost basis.
As of December 31, 2024, all marketable securities had an effective maturity date oftwo years or less. Investments in securities with maturities of less thanone year, or those for which management intends to use to fund current operations, are included in current assets and classified as available-for-sale. As of December 31, 2024 and 2023, the balance in accumulated other comprehensive loss included net unrealized gains (losses) related to the Company’s available-for-sale debt securities.
The following table sets forth a summary of the changes in the fair value of the Company’s Level 3 financial liabilities:
| ContingentConsideration | Cobalt Success PaymentLiability | Harvard Success PaymentLiability | |
|---|---|---|---|
| (in thousands) | |||
| Balance as of December 31, 2023 | $109,606 | $11,160 | $1,639 |
| Changes in fair value – expense | 5,384 | 27,920 | 4,703 |
| Balance as of March 31, 2024 | 114,990 | 39,080 | 6,342 |
| Changes in fair value – gain | (3,369) | (20,687) | (3,888) |
| Balance as of June 30, 2024 | 111,621 | 18,393 | 2,454 |
| Changes in fair value – expense (gain) | 235 | (4,909) | (823) |
| Balance as of September 30, 2024 | 111,856 | 13,484 | 1,631 |
| Changes in fair value – gain | (2,888) | (9,248) | (1,311) |
| Balance as of December 31, 2024 | $108,968 | $4,236 | $320 |
Contingent consideration
The Company utilizes significant estimates and assumptions it believes would be made by a market participant in determining the estimated fair value of the Cobalt Contingent Consideration at each balance sheet date. The fair value of the Cobalt Contingent Consideration was determined by calculating the probability-weighted estimated value of the pre-specified development milestone payments based on the assessment of the likelihood and estimated timing that the milestones would be achieved and the applicable discount rates. The discount rate captures the credit risk associated with the payment of the contingent consideration when earned and due. The Company assesses these estimates on an ongoing basis as additional data impacting the assumptions are obtained.
The fair value of the Cobalt Contingent Consideration was calculated using the following unobservable inputs:
| December 31, 2024 | December 31, 2023 | |||
|---|---|---|---|---|
| Unobservable Input | Range | Weighted-Average | Range | Weighted-Average |
| Discount rates | 11.3% – 12.3% | 11.9% | 11.7% – 12.4% | 11.9% |
| Probability of milestone achievement | 5.0% –55.0% | 25.7% | 5.0% – 55.0% | 25.7% |
The weighted-average unobservable inputs were calculated based on the relative value of the pre-specified development milestones. The estimated fair value of the Cobalt Contingent Consideration may change significantly as development progresses and additional data are obtained, impacting the assumptions regarding probabilities of successful achievement of the milestones used to estimate the fair value of the liability and the timing in which they are expected to be achieved. In evaluating the fair value assumptions, judgment is required to interpret the market data used to develop the estimates. The estimates of fair value may not be indicative of the amounts that could be realized in a current market exchange. Accordingly, the use of different market assumptions, inputs and/or different valuation techniques could result in materially different fair value estimates.
The Company utilizes significant estimates and assumptions in determining the estimated fair value of the success payment liabilities and the associated expense or gain at each balance sheet date. The estimated fair value of the Cobalt Success Payment and Harvard Success Payment liabilities was determined using a Monte Carlo simulation methodology, which models the estimated fair value of the liability based on several key assumptions, including the expected volatility, remaining term, risk-free interest rate, estimated number and timing of valuation measurement dates on the basis of which payment may be triggered, and, for the Cobalt Success Payment, the Company’s market capitalization, and for the Harvard Success Payments, the per share fair value of the Company’s common stock.
The fair values of the Cobalt Success Payments and Harvard Success Payments were calculated using the following unobservable inputs:
| December 31, 2024 | December 31, 2023 | |||
|---|---|---|---|---|
| Unobservable Input | Cobalt | Harvard | Cobalt | Harvard |
| Expected stock price volatility | 75.0% | 75.0% | 72.5% | 72.5% |
| Expected term (years) | 14.1 | 6.2 | 15.1 | 7.2 |
- Property and equipment, net
Property and equipment, net consists of the following:
| December 31, 2024 | December 31, 2023 | |
|---|---|---|
| (in thousands) | ||
| Laboratory equipment | $52,957 | $51,643 |
| Leasehold improvements | 33,344 | 31,361 |
| Construction in progress | 40,337 | 26,332 |
| Computer equipment, software, and other | 4,836 | 3,124 |
| Total property and equipment, at cost | 131,474 | 112,460 |
| Less: Accumulated depreciation | (54,166) | (41,771) |
| Property and equipment, net | $77,308 | $70,689 |
Depreciation expense was $17.4 million, $24.6 million, and $15.6 million for the years ended December 31, 2024, 2023, and 2022, respectively. Depreciation expense for the years ended December 31, 2024 and 2023 includes $1.9 million and $7.0 million, respectively, for the impairment of certain lab equipment and leasehold improvements which were primarily related to theportfolio prioritizations in the fourth quarters of 2024 and 2023.
- Accrued liabilities
Accrued compensation and accrued expenses and other current liabilities consist of the following:
| December 31, 2024 | December 31, 2023 | |
|---|---|---|
| (in thousands) | ||
| Accrued compensation: | ||
| Accrued bonuses | $7,704 | $14,379 |
| Accrued paid time off | 3,151 | 4,731 |
| Accrued payroll | 3,021 | 3,936 |
| Other accrued compensation | 573 | 676 |
| Total accrued compensation | $14,449 | $23,722 |
| Accrued expenses and other current liabilities: | ||
| Accrued research and development services | $10,493 | $10,110 |
| Accrued professional fees | 993 | 1,470 |
| Accrued property and equipment | - | 9,200 |
| Other accrued current liabilities | 1,754 | 2,682 |
| Total accrued expenses and other current liabilities | $13,240 | $23,462 |
- Commitments and contingencies
Lease commitments
The Company’s lease portfolio primarily comprises operating leases for office, laboratory, and manufacturing space. These leases contain various rent abatement periods, after which they require monthly lease payments that may be subject to annual increases throughout the lease term. Certain leases include options to extend the term. The renewal option is considered in the remaining lease term for the lease only when the Company is reasonably certain it will renew the lease. Certain leases provide the Company with the right to make tenant improvements, including the addition of laboratory space or build-out of manufacturing capabilities, and include a lease incentive allowance.
In June 2022, the Company entered into a lease agreement for 79,565 square feet of office, laboratory, and manufacturing space located in Bothell, Washington (the Bothell facility). The initial term of the lease expires in February 2039, withthe option to extend the lease for up to three additional five-year terms. The lease agreement also provides for up to $19.9 million for reimbursement of tenant improvements, as well as an additional $8.0 million loan for tenant improvements, available at the Company’s election, which the Company would be obligated to repay to the landlord monthly over the initial term of the lease with interest at a rate of 6.5% per year (the Tenant Improvement Loan). The Company elected to receive the Tenant Improvement Loan in the second quarter of 2024. As of December 31, 2024, $0.3 million was included in accrued expenses and other current liabilities and $7.4 million was included in other non-current liabilities. The Company is obligated to pay base rent of approximately $68.8 million over the initial term of the lease. In accordance with the lease agreement, the Company has obtained a letter of credit in the amount of $1.6 million.
In April 2024, the Company amended the terms of certain agreements for its vivarium spaces in Cambridge, Massachusetts and South San Francisco, California, which resulted in these agreements no longer requiring recognition on the balance sheet. In the second quarter of 2024, the Company derecognized the remaining balances related to the right-of-use asset and lease liability of $6.4 million and $6.2 million, respectively.
The following table contains additional information related to the Company’s operating leases:
| Location | Use | Approximate Square Footage | Commencement Dates | Expiration Dates |
|---|---|---|---|---|
| Seattle, WA | Office/Laboratory | 48,000 | March 2019 to September 2020 | December 2026 to April 2028 |
| Cambridge, MA | Office/Laboratory | 56,000 | March 2019 to January 2020 | June 2027 to February 2028 |
| South San Francisco, CA | Office/Laboratory | 99,000 | December 2019 to April 2022 | April 2030 |
| Rochester, NY | Office/Laboratory | 3,000 | January 2022 | January 2027 |
| Bothell, WA | Office/Laboratory/ Manufacturing | 80,000 | January 2023 | January 2039 |
Throughout the term of each lease agreement, the Company is responsible for paying, in addition to base rent, certain operating costs, such as common area maintenance, taxes, utilities, and insurance. These additional charges are considered variable lease costs and are recognized in the period in which the costs are incurred.
The following table summarizes the Company’s lease costs:
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| (in thousands) | |||
| Operating lease cost | $18,540 | $27,277 | $23,881 |
| Short-term lease cost | 4,669 | - | - |
| Variable lease cost | 8,505 | 7,527 | 7,193 |
| Total lease cost | $31,714 | $34,804 | $31,074 |
As of December 31, 2024, the weighted-average remaining lease term was 9.6 years and the weighted-average IBR was 11.5%.
The following table reconciles the Company’s undiscounted operating lease cash flows by fiscal year to the present value of the operating lease liabilities as of December 31, 2024 (in thousands):
| 2025 | $21,769 |
| 2026 | 22,473 |
| 2027 | 19,389 |
| 2028 | 14,698 |
| 2029 | 14,071 |
| 2030 and thereafter | 79,380 |
| Total undiscounted lease payments | 171,780 |
| Less: imputed interest | (77,583) |
| Present value of operating lease liabilities | 94,197 |
| Less: current portion of operating lease liabilities | $(12,534) |
| Operating lease liabilities, net of current portion | $81,663 |
- Stockholders’ equity
In February 2024, the Company completed an underwritten public offering pursuant to which it sold 21.8 million shares of its common stock, including 4.5 million shares pursuant to the full exercise of the underwriters' option to purchase additional shares, and pre-funded warrants to purchase 12.7 million shares of its common stock, for net proceeds of approximately $180.0 million, after deducting underwriting discounts and commissions and offering expenses. The pre-funded warrants have an exercise price of $0.0001 per share of common stock. As the pre-funded warrants are indexed to the Company’s common stock and otherwise meet the requirements to be classified in equity, the Company recorded the consideration received from the issuance of the pre-funded warrants as additional paid-in capital on the Company’s consolidated balance sheet. The pre-funded warrants are exercisable at any time; however, the holders of pre-funded warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially own more than 4.99% of the number of shares of the Common Stock outstanding immediately after giving effect to such exercise. The holders of pre-funded warrants may increase or decrease such percentages not in excess of 19.99% by providing at least 61 days’ prior notice to the Company. The pre-funded warrants do not expire. During the twelve months ended December 31, 2024, no pre-funded warrants were exercised.
In August 2022, the Company entered into a sales agreement with Cowen, acting as sales agent, pursuant to which it may offer and sell through Cowen up to $150.0 million in shares of the Company's common stock from time to time in a series of one or more at the market equity offerings. As of December 31, 2024, the Company sold an aggregate of 4.9 million shares of the Company's common stock under the ATM facility, and received $28.6 million in net proceeds, after deducting commissions and expenses.
- Stock-based compensation
Equity incentive plans
In February 2021, the Company adopted the 2021 Incentive Award Plan (2021 Plan) and the 2021 Employee Stock Purchase Plan (2021 ESPP), both of which became effective on the completion of the Company’s initial public offering. The 2021 Plan provides for a variety of stock-based compensation awards, including stock options, restricted stock awards (RSAs), and restricted stock units (RSUs). The 2021 ESPP allows eligible employees to purchase shares of the Company’s common stock at a discount through payroll deductions of up to 15% of their earnings, subject to plan limitations. Unless otherwise determined by the Company’s board of directors, employees may purchase shares at 85% of the lower of the fair market value of the Company’s common stock on the first date of an offering period or on the purchase date. As of December 31, 2024,24.6 million shares and 6.0 million shares were available for future issuance under the 2021 Plan and the 2021 ESPP, respectively.
Stock-based compensation expense
Stock-based compensation expense is recognized in the consolidated statements of operations as follows:
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| (in thousands) | |||
| Research and development | $23,365 | $23,240 | $26,583 |
| General and administrative | 14,313 | 12,293 | 11,754 |
| Total stock-based compensation expense | $37,678 | $35,533 | $38,337 |
Unrecognized stock-based compensation costs related to unvested awards and the weighted-average period over which the costs are expected to be recognized as of December 31, 2024 are as follows:
| Stock Options | RSUs | |
|---|---|---|
| Unrecognized stock-based compensation expense (in thousands) | $38,856 | $18,175 |
| Weighted-average period costs expected to be recognized (in years) | 2.4 | 3.0 |
Stock options
A summary of the Company’s stock option activity is as follows:
| Stock Options (in thousands) | Weighted-AverageExercise Price perShare | Weighted-AverageRemainingContractual Life (in years) | Aggregate IntrinsicValue(in thousands) | |
|---|---|---|---|---|
| Outstanding as of December 31, 2023 | 26,849 | $6.60 | 8.0 | $11,235 |
| Granted | 7,831 | 8.58 | ||
| Exercised | (2,631) | 3.59 | ||
| Forfeited/Cancelled | (6,987) | 7.92 | ||
| Outstanding as of December 31, 2024 | 25,062 | $7.16 | 7.4 | $271 |
| Exercisable as of December 31, 2024 | 15,194 | $7.18 | 6.7 | $271 |
The fair value of stock options granted to employees, directors, and consultants was estimated on the date of grant using the Black-Scholes option pricing model using the following assumptions:
| Year Ended December 31, | |||
|---|---|---|---|
| Assumptions | 2024 | 2023 | 2022 |
| Risk free interest rate | 3.7% – 4.7% | 3.36% – 4.98% | 1.56% – 4.31% |
| Expected volatility | 72.5% – 75.0% | 70.0% – 72.5% | 70.0% |
| Expected term (years) | 5.50 – 6.25 | 5.50 – 6.50 | 5.50 – 6.25 |
| Expected dividend | 0% | 0% | 0% |
The following table summarizes additional information related to stock option activity:
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| Weighted average grant date fair value per share for options granted | $5.82 | $2.62 | $3.92 |
| Aggregate intrinsic value of stock options exercised (in thousands) | $8,006 | $3,532 | $6,133 |
Restricted stock
A summary of the Company’s RSU activity is as follows:
| RSUs (in thousands) | RSUsWeighted-AverageGrant Date FairValue per Share | |
|---|---|---|
| Unvested as of December 31, 2023 | 2,341 | $3.88 |
| Granted | 3,619 | 8.31 |
| Vested | (967) | 5.10 |
| Forfeited | (1,423) | 7.21 |
| Unvested as of December 31, 2024 | 3,570 | $6.72 |
No RSAs vested during the year ended December 31, 2024. The fair value of vested RSAs wasimmaterial for the year ended December 31, 2023, and $1.8 million for the year ended December 31, 2022. The fair value of vested RSUs was $6.4 million, $1.9 million, and $0.5 million for the years ended December 31, 2024, 2023, and 2022, respectively.
- Income taxes
As of December 31, 2024, the Company had U.S. federal and state tax-effected net operating loss (NOL) carryforwards of $184.1 million and $60.0 million, respectively, which are available to reduce future taxable income. As of December 31, 2024, the Company also had federal and state research tax credits of $59.6 million and $27.9 million, respectively, which may be used to offset future liabilities. The Tax Cuts and Jobs Act enacted on December 22, 2017, altered the carryforward period for federal net operating losses and as a result, all net operating losses generated in 2018 and forward have an indefinite life. Of the federal net operating losses reported, we have accumulated $182.4 million with an indefinite life as of December 31, 2024. The state NOL will begin to expire in 2036. The federal tax credit carryforward will begin to expire in 2037, and the state tax credit will carry forward indefinitely. The NOL and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. Subsequent ownership changes may further affect the limitation in future years.
A reconciliation of income taxes computed using the U.S. federal statutory rate to that reflected in operations follows:
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| Federal statutory tax | 21.00% | 21.00% | 21.00% |
| State income tax, net of federal benefit | (6.31) | 15.38 | 13.49 |
| Valuation allowance | (18.00) | (45.30) | (43.69) |
| Success payment liabilities | 0.55 | 0.58 | 5.40 |
| Contingent consideration | 0.05 | 3.02 | 0.26 |
| Tax credits | 3.83 | 6.59 | 4.93 |
| Other | (1.12) | (1.27) | (1.39) |
| Effective income tax rate | 0.00% | 0.00% | 0.00% |
The principal components of the Company’s net deferred tax assets are as follows:
| December 31, | ||||
|---|---|---|---|---|
| 2024 · 2023 | ||||
| (in thousands) | ||||
| Deferred tax assets: | ||||
| Net operating loss carryforwards | $227,866 | $192,179 | ||
| Capitalized research and development | 101,732 | 101,136 | ||
| Tax credit carryforwards | 81,697 | 69,070 | ||
| Lease liabilities | 24,040 | 31,503 | ||
| Stock-based compensation | 13,258 | 12,607 | ||
| Intangibles | 8,902 | 10,744 | ||
| Accrued liabilities and allowances | 4,329 | 6,050 | ||
| Fixed assets | 1,935 | 1,073 | ||
| Success payment liabilities | 82 | 496 | ||
| Other | 1,475 | 285 | ||
| Gross deferred tax assets | 465,316 | 425,143 | ||
| Valuation allowance | (450,666) | (402,658) | ||
| Deferred tax assets, net of valuation allowance | 14,650 | 22,485 | ||
| Deferred tax liabilities: | ||||
| Right-of-use assets | (14,650) | (22,485) | ||
| Net deferred taxes assets | $ | - | $ | - |
The valuation allowance relates primarily to net U.S. deferred tax assets from operating losses, research tax credit carryforwards, capitalized research and development, and amounts paid and accrued to enter into various agreements for which the tax treatment requires capitalization and amortization.
The Company maintains a full valuation allowance on its net U.S. deferred tax assets. The assessment regarding whether a valuation allowance is required considers both positive and negative evidence when determining whether it is more likely than not that deferred tax assets are recoverable. In making this assessment, significant weight is given to evidence that can be objectively verified. In its evaluation, the Company considered its cumulative losses and its forecasted losses in the near term as significant negative evidence. Based upon a review of the four sources of income identified within ASC 740, Accounting for Income Taxes, the Company determined that the negative evidence outweighed the positive evidence, and a full valuation allowance on its net deferred tax assets should be maintained. The Company will continue to assess the realizability of its deferred tax assets going forward and will adjust the valuation allowance as needed.
The Company determines its uncertain tax positions based on a determination of whether and how much of the tax benefit the Company takes in its tax filings or positions is more likely than not to be sustained upon examination by the relevant income tax authorities. The Company is generally subject to examination by U.S. federal and local income tax authorities for all tax years in which the loss carryforward is available. The Company applies judgment in its determination of the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. As of December 31, 2024 and 2023, the Company’s uncertain tax positions were immaterial.
- Net loss per share
Basic and diluted net loss per common share are calculated by dividing net loss by the weighted-average number of common shares outstanding during the period, without consideration for common stock equivalents. The Company was in a loss position for all periods presented, and basic net loss per share and diluted net loss per share are therefore the same for all periods, as the inclusion of all potential common securities outstanding would have been anti-dilutive.
The following securities were excluded from the computation of net loss per diluted share of common stock for periods presented as their effect would have been anti-dilutive:
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| (in thousands) | |||
| Options to purchase common stock | 25,062 | 26,849 | 23,686 |
| Unvested restricted common stock | - | - | 12 |
| Unvested RSUs | 3,570 | 2,341 | 885 |
| Total | 28,632 | 29,190 | 24,583 |
- Employee benefit plan
In January 2019, the Company adopted a 401(k) retirement and savings plan (the 401(k) Plan) covering all employees. The 401(k) Plan allows employees to make pre- and post-tax contributions up to the maximum allowable amount set by the IRS. The Company matches each participant’s 401(k) contributions, up to $4,000 per year per participant.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.