Vera Therapeutics Inc
For the period ended Dec 31, 2024. Filed Feb 28, 2025.
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FY2024 · Filed Feb 28, 2025
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Notes to Financial Statements
- ORGANIZATION AND DESCRIPTION OF THE BUSINESS
Description of Business
Vera Therapeutics, Inc. (the Company) is a clinical stage biotechnology company focused on developing and commercializing treatments for patients with serious immunological diseases. The Company was incorporated in May 2016 in Delaware. The Company’s headquarters are in Brisbane, California. The Company operates in one segment, Therapeutics, focused on developing and commercializing transformative treatments for patients with serious immunological diseases.
Liquidity
Since inception, the Company devoted substantially all of its resources to its research and development efforts, pre-clinical studies and clinical trials, establishing and maintaining its intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations. The Company has incurred recurring net operating losses and has not generated positive cash flows from operations since its inception and had an accumulated deficit of$461.3 million as of December 31, 2024. The Company had cash, cash equivalents and marketable securities of$640.9 million as of December 31, 2024. The Company has funded its operations primarily through the issuance of common stock, redeemable convertible preferred stock, debt financing and convertible notes. Management expects to continue to incur losses and negative cash flows from operations for at least the next several years.
Management believes that the Company’s cash, cash equivalents and marketable securities as of December 31, 2024 will be sufficient to fund its planned operations and capital expenditure requirements for at least 12 months subsequent to the issuance date of these financial statements. The Company intends to raise additional capital through public or private equity offerings, debt financing, or other capital sources, which may include strategic collaborations or other arrangements with third parties in order to achieve its long-term business objectives. If the Company fails to obtain necessary capital when needed on acceptable terms, or at all, it could force the Company to delay, limit, reduce or terminate its product development programs, commercialization efforts or other operations.
- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (GAAP) and applicable rules and regulations of the Securities and Exchange Commission (the SEC) regarding financial reporting. The U.S. dollar is the Company’s functional and reporting currency.
Transition from Emerging Growth Company and Smaller Reporting Company Status
The Company was previously classified as an “emerging growth company” (EGC) as defined in the Jumpstart Our Business Startups Act of 2012 (JOBS Act). Under the JOBS Act, emerging growth companies 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 was previously classified as a “smaller reporting company” (SRC), as defined in the Securities Exchange Act of 1934 (Exchange Act), as amended. SRCs may choose to comply with scaled disclosure requirements in Regulation S-X. The overarching principles about the form and content of the financial statements of a SRC are that those statements need only cover two annual periods instead of three and that the financial statements comply with GAAP and not with most of the other S-X form and content requirements.
Based on the Company’s public float as of June 28, 2024, the last business day of the Company’s second fiscal quarter, the Company became a “large accelerated filer” and no longer qualifies as an EGC or an SRC as of December 31, 2024. Accordingly, the Company may no longer take advantage of EGC-related delayed adoption timelines for new or revised accounting standards. Although the Company is a large accelerated filer for the year ended December 31, 2024, the Company may choose to continue using the scaled disclosure requirements permitted for SRCs in the current fiscal year and has chosen to provide such scaled disclosures in this Annual Report for the year ended December 31, 2024, as permitted under SEC rules.
Use of Estimates
Thepreparation of the Company’s financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Management estimates that affect the reported amounts of assets and liabilities include the accrual of research and development expenses, valuation of equity awards for stock-based compensation, determination of incremental borrowing rate for operating leases, the valuation allowance for deferred tax assets, and fair value of marketable securities. The Company evaluates and adjusts its estimates and assumptions on an ongoing basis using historical experience and other factors. Actual results could differ from those estimates.
Concentrations of Credit Risk and Other Risks and Uncertainties
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company maintains bank deposits in federally insured financial institutions and these deposits may exceed federally insured limits. The Company is exposed to credit risk in the event of default by the financial institution holding its cash, cash equivalents, and marketable securities to the extent recorded in the balance sheet. The Company has not experienced any losses to date related to these concentrations.
The Company’s future results of operations involve a number of other risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, uncertainty of results of clinical trials and reaching milestones, uncertainty of regulatory approval of the Company’s current and potential future product candidates, uncertainty of market acceptance of the Company’s product candidates, competition from substitute products and larger companies, securing and protecting proprietary technology, strategic relationships and dependence on key individuals or sole-source suppliers. The Company relies on one supply chain for each of its product candidates. If any of the single source suppliers in any of the supply chains fails to satisfy the Company’s requirements on a timely basis, it could suffer delays in its clinical development programs and activities, which could adversely affect operating results.
The Company’s product candidates require approvals from the U.S. Food and Drug Administration and comparable foreign regulatory authorities prior to commercial sales in their respective jurisdictions. There can be no assurance that any product candidates will receive the necessary approvals. If the Company was denied approval, approval was delayed, or the Company was unable to maintain approval for any product candidate, it could have a materially adverse impact on the Company.
Cash and Cash Equivalents
Cash and cash equivalents consist of cash on deposit with financial institutions and highly liquid investments, primarily money market funds, with maturities of 90 days or less from the date of purchase.
Marketable Securities
The Company holds investments in marketable securities, consisting of U.S. government bonds, U.S. government agency securities, and investment grade corporate debt securities. Marketable debt securities with stated maturities of three months or less from the date of purchase are classified as cash equivalents and those with stated maturities of greater than three months as marketable securities on the balance sheet. The Company determines the appropriate classification of marketable debt securities at the time of purchase. The Company has the ability, if necessary, to liquidate its investments to meet its liquidity needs in the next 12 months, without significant penalty. Accordingly, those investments with contractual maturities greater than one year from the date of purchase are classified as current assets on the accompanying balance sheets. All marketable debt securities are classified as available-for-sale and are reported at estimated fair value, with unrealized gains and losses recorded in accumulated other comprehensive income within stockholders’ equity. Interest, amortization and accretion of purchase premiums and discounts on marketable debt securities are included in other income (expense), net, in the statements of operations and comprehensive loss.
The cost of available-for-sale marketable securities sold is based on the specific identification method. Realized gains and losses on the sale of available-for-sale marketable securities are recorded in other income (expense), net in the statements of operations and comprehensive loss.
The Company periodically reviews marketable debt securities for impairment. For debt securities in an unrealized loss position, the Company determines whether a credit loss exists. The credit loss is estimated by considering available information relevant to the collectability of the security and information about past events, current conditions, and reasonable and supportable forecasts. Any decline in fair value due to a credit loss is recorded in other income (expense), net in the statements of operations and comprehensive loss. Unrealized losses due to factors other than the credit loss are recognized in accumulated other comprehensive income (loss). In addition, if the Company has the intent to sell a debt security or it is more likely than not that the Company will be required to sell the security before recovery of the entire cost basis, an impairment charge equal to the difference between fair value and the cost basis is recordedin other income (expense), net in the statements of operations and comprehensive loss. No impairment loss was recognized for the fiscal years ended December 31, 2024 and 2023.
The amortized or accreted cost basis of the marketable securities approximates its fair value.
Deferred Offering Costs
Deferred offering costs consist of legal, accounting and filing fees relating to equity offerings. Deferred offering costs are included in prepaid expenses and other assets, current on the Company’s balance sheets. Upon completion of the offering, these amounts are offset against the proceeds of the offering.
Leases
The Company leases office space under operating leases and determines if the arrangement is a lease at inception. These lease agreements generally contain lease and non-lease components. Non-lease components primarily include fixed payments for maintenance, utilities, and management fees. The fixed costs of the lease components and associated non-lease components are combined and accounted together as a single lease component which is recognized as an increase to the operating lease right-of-use (ROU) assets and operating lease liabilities. For leases with a lease term of 12 months or less, ROU assets and lease liabilities are not recognized on the balance sheets.
Certain lease agreements may also contain variable payments, such as common area maintenance, real estate taxes, and insurance, which are expensed as incurred and not included in the lease ROU assets and lease liabilities. Operating lease cost (excluding variable lease costs) is recognized on a straight-line basis over the lease term.
ROU assets and lease liabilities are recognized at the present value of future lease payments at the lease commencement date. As the rate implicit in the Company’s leases is not readily determinable, the Company uses an incremental borrowing rate based on information available at commencement date in determining the present value of future lease payments. The incremental borrowing rate is the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.
Operating lease ROU assets represent the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent the Company’s obligation to make the contractual lease payments over the lease term. The current portion of operating lease liabilities is included in current liabilities, and the long-term portion is included in operating lease liabilities, noncurrent.
Foreign Currency Translations
Transactions denominated in foreign currencies are initially measured in U.S. dollars using the exchange rate on the date of the transaction. Foreign currency denominated monetary assets and liabilities are subsequently re-measured at the end of each reporting period using the exchange rate at that date, with the corresponding foreign currency transaction gain or loss recorded in the statements of operations and statements of cash flows. Nonmonetary assets and liabilities are not subsequently re-measured.
Fair Value Measurements
Fair value is defined as the exchange price to sell an asset or transfer a liability (exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. Fair value should be based on the assumptions market participants would use when pricing the asset or liability. The valuation hierarchy is based upon the transparency of inputs to the valuation of an asset or liability as of the measurement date.
Fair value measurements are classified and disclosed in one of the following three categories:
Level 1 – Quoted unadjusted prices for identical instruments in active markets.
Level 2 – Quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, and model-derived valuations in which all significant inputs and value drivers are observable in active markets.
Level 3 – Model derived valuations in which one or more significant inputs or significant value drivers are unobservable, including assumptions developed by the Company.
Fair value accounting is applied to all financial assets and liabilities that are recognized or disclosed in the financial statements on a recurring basis. The Company’s financial instruments consist of cash and cash equivalents, marketable securities, prepaid expenses and other current assets, accounts payable and accrued expenses and long-term debt. Cash and marketable securities are reported at their respective fair values on the Company’s balance sheets. The carrying amount of long-term debt approximates fair value due to its variable interest rate. The remaining financial instruments are reported on the Company’s balance sheets at cost, which approximates their fair value due to their short-term nature.
Money market funds are highly liquid investments that are actively traded. The pricing information for the Company’s money market funds is readily available and can be independently validated as of the measurement date. This approach results in the classification of these instruments as Level 1 within the fair value hierarchy.
There were no transfers of financial assets or liabilities between Levels 1, 2, or 3 for any of the periods presented.
Comprehensive Loss
Comprehensive loss consists of two components: net loss and other comprehensive income. Other comprehensive income refers to unrealized gains and losses that are recorded as an element of stockholders’ equity and are excluded from net loss. For the years ended December 31, 2024 and 2023, other comprehensive income consists of unrealized gains and losses on marketable securities.
Research and Development Costs
Research and development costs are expensed as incurred and consist primarily of employees’ salaries and related benefits, including stock-based compensation and termination expenses for employees engaged in research and development efforts, allocated overhead including rent, depreciation, information technology and utilities, contracted services, license fees, and external expenses to conduct and support the Company’s operations that are directly attributable to the Company’s research and development efforts. Payments made to third parties under these arrangements in advance of the performance of the related services by the third parties are recorded as prepaid expenses until the services are rendered.
Costs incurred in obtaining technology licenses including upfront and milestone payments incurred under the Company’s licensing agreements are recorded as expense in the period in which they are incurred, provided that the licensed technology, method or process has no alternative future uses other than for the Company’s research and development activities. Where contingent milestone payments are due to third parties under license or other agreements, the milestone payment obligations are recognized as expense when achievement of the contingent milestone is probable, which is generally upon achievement of the milestone.
The Company enters into various research and development and other agreements with commercial firms, researchers, and others for provisions of goods and services from time to time. These agreements are generally cancellable, and the related costs are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research and development costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies or clinical trials, including the phase or completion of events, invoices received and contracted costs. Judgments and estimates are made to determine the accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates.
Stock-Based Compensation
The Company recognizes compensation expense based on estimated fair values for all stock-based payment awards made to the Company’s employees, nonemployee directors and consultants that are expected to vest. The valuation of stock option awards is determined at the date of grant using the Black-Scholes option pricing model. The Black-Scholes option pricing model requires the Company to make assumptions and judgments about the inputs used in the calculations, such as the fair value of the common stock, expected term, expected volatility of the Company’s common stock, risk-free interest rate and expected dividend yield. The valuation of restricted stock awards is measured by the fair value of the Company’s Class A common stock on the date of the grant.
For all stock options granted, the Company calculated the expected term using the simplified method (derived from the average midpoint between the weighted average vesting period and the contractual term of the award), as the Company has limited historical information to develop expectations about future exercise patterns and post-vesting employment termination behavior. The estimate of expected volatility is based on comparative companies’ volatility. The risk-free rate is based on the yield available on United States Treasury zero-coupon issues corresponding to the expected term of the award. The Company records forfeitures when they occur. The Company determines the fair value of its Class A common stock using the market closing price on the date of grant.
The Company records compensation expense for service-based awards on a straight-line basis over the requisite service period, which is generally the vesting period of the award. The amount of stock-based compensation expense recognized during a period is based on the value of the portion of the awards that are ultimately expected to vest.
Income Taxes
Income taxes are accounted for under the asset and liability method. Deferred income taxes are recorded for temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities reflect tax rates expected to be in effect for the years in which the differences are expected to be reversed. A valuation allowance is provided if it is more likely than not that some or all of the deferred tax assets will not be realized.
Net Loss Per Share Attributable to Common Stockholders
Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period, adjusted for outstanding shares that are subject to repurchase.
Diluted net loss per share is computed by giving effect to all potentially dilutive securities outstanding for the period using the treasury stock method or the if-converted method based on the nature of such securities. For periods in which the Company reports net losses, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders, because potentially dilutive shares are not assumed to have been issued if their effect is anti-dilutive.
Recently Adopted Accounting Pronouncements
In June 2022, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2022-03, Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions. This standard update clarifies the guidance in Topic 210, related to measuring the fair value of an equity security subject to contractual sale restrictions that prohibit the sale of an equity security and introduces new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value in accordance with Topic 820. The guidance is effective for annual periods beginning after December 15, 2023, with early adoption permitted. The Company adopted this standard on January 1, 2024, and it did not have a material impact on the Company’s financial statements or related disclosures, because the Company does not carry any equity securities subject to contractual sale restrictions.
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This update improves reportable segment disclosure requirements and requires enhanced disclosures related to significant segment expenses regularly provided to the chief operating decision maker (CODM) and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. Amendments in this update are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company adopted this standard as of and for the year ended December 31, 2024. There was no impact on the Company’s determination of its reportable segment and additional required disclosures have been included in Note 14, Segment Reporting.
Recently Issued Accounting Pronouncements Not Yet Adopted
In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures (Topic 740). The ASU is intended to enhance the transparency and decision usefulness of income tax disclosures. The amendments in ASU 2023-09 address investor requests for enhanced income tax information primarily through changes to the rate reconciliation and income taxes paid information. Early adoption is permitted. A public entity should apply the amendments in ASU 2023-09 prospectively to all annual periods beginning after December 15, 2024. The Company will adopt the standard as of and for the year ended December 31, 2025, and is currently evaluating the impact of this standard on its financial statements and related disclosures.
In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. This update will improve disclosures about a public business entity’s expenses and address requests from investors for more detailed information about the types of expenses (including purchases of inventory, employee compensation, depreciation, amortization, and depletion) in commonly presented expense captions (such as cost of sales, selling, general, and administrative expenses, and research and development). The ASU is effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027, with early adoption permitted. This ASU will result in the required additional disclosures being included in the Company’s financial statements upon adoption.
- OTHER FINANCIAL STATEMENT INFORMATION
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consist of the following(in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Interest income receivable | $3,773 | $512 |
| Prepaid clinical trial costs | 2,228 | 5,273 |
| Prepaid commercial planning costs | 933 | 789 |
| Prepaid insurance | 709 | 597 |
| Prepaid software costs | 660 | 237 |
| Prepaid professional services fees | 659 | 198 |
| Prepaid medical affairs costs | 246 | — |
| Prepaid rent | 224 | 257 |
| Prepaid drug manufacturing costs | 21 | 1,207 |
| Other | 913 | 2,237 |
| Total prepaid expenses and other current assets | $10,366 | $11,307 |
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consist of the following(in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Accrued payroll | $6,822 | $3,932 |
| Accrued clinical and drug manufacturing expenses | 6,742 | 2,213 |
| Accrued commercial expenses | 689 | 19 |
| Accrued information technology expenses | 455 | 37 |
| Accrued legal fees | 257 | 59 |
| Related party payable | 217 | 1,926 |
| Other accrued expenses and current liabilities | 1,041 | 563 |
| Total accrued expenses and other current liabilities | $16,223 | $8,749 |
Related party payable represents amounts due to Ares Trading S.A. (Ares), an affiliate of Merck KGaA, Darmstadt, Germany, related to manufacturing technology and know-how transfer services performed for atacicept pursuant to the license agreement between the Company and Ares (see Note 9).
- CASH, CASH EQUIVALENTS, AND MARKETABLE SECURITIES
The Company’s cash equivalents and marketable securities are classified within the fair value hierarchy as defined by authoritative guidance. Level 1 securities consist of highly liquid money market funds for which the carrying amount approximates the fair value of identical assets as quoted in the active markets. Level 2 securities, consisting of U.S. Treasuries, U.S. agency securities and corporate debt securities, are measured based on other observable inputs, including broker or dealer quotations or other valuations using observable market data. The Company’s debt securities are accounted for as available-for-sale securities.
Unrealized gains and losses are reported as a component of other comprehensive income (loss). Fair value of the debt securities was $552.8 million and $115.0 million as of December 31, 2024 and December 31, 2023, respectively.
The following table presents the Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy(in thousands):
| Fair Value Hierarchy Level | Amortized Cost | Unrealized Gains | Unrealized Losses | Estimated Fair Value | Cash and Cash Equivalents | Marketable Securities | |
|---|---|---|---|---|---|---|---|
| Money market funds | Level 1 | $85,135 | $— | $— | $85,135 | $85,135 | $— |
| U.S. Government bonds | Level 2 | 322,960 | 389 | (16) | 323,333 | — | 323,333 |
| U.S. Government agency securities | Level 2 | 999 | 1 | — | 1,000 | — | 1,000 |
| Corporate debt securities | Level 2 | 228,446 | 182 | (163) | 228,465 | 4,592 | 223,873 |
| Total cash equivalents and marketable securities | 637,540 | 572 | (179) | 637,933 | 89,727 | 548,206 | |
| Cash | 2,919 | — | — | 2,919 | 2,919 | — | |
| Total | $640,459 | $572 | $(179) | $640,852 | $92,646 | $548,206 | |
| Fair Value Hierarchy Level | Amortized Cost | Unrealized Gains | Unrealized Losses | Estimated Fair Value | Cash and Cash Equivalents | Marketable Securities | |
| Money market funds | Level 1 | $44,650 | $— | $— | $44,650 | $44,650 | $— |
| U.S. Government bonds | Level 2 | 63,619 | 70 | (6) | 63,683 | — | 63,683 |
| U.S. Government agency securities | Level 2 | 19,665 | 7 | (14) | 19,658 | — | 19,658 |
| Corporate debt securities | Level 2 | 31,500 | 194 | — | 31,694 | — | 31,694 |
| Total cash equivalents and marketable securities | 159,434 | 271 | (20) | 159,685 | 44,650 | 115,035 | |
| Cash | 1,031 | — | — | 1,031 | 1,031 | — | |
| Total | $160,465 | $271 | $(20) | $160,716 | $45,681 | $115,035 |
Marketable debt securities that had been in unrealized loss positions as of December 31, 2024 and 2023 were in an unrealized loss position for less than 12 months. Unrealized losses from marketable debt securities are primarily attributable to changes in interest rates. Management does not believe any remaining unrealized losses represent impairments based on evaluation of available evidence.
The following table classifies the estimated fair value of investments in available-for-sale marketable debt securities by effective contractual maturity dates(in thousands):
| Due within one year | $376,468 |
|---|---|
| Due after one year to two years | 171,738 |
| Total marketable securities | $548,206 |
- LEASES
The Company has entered into non-cancellable operating leases, including a sublease entered into in August 2024 for an office facility serving as its corporate headquarters in Brisbane, California. This sublease expires in 2029. The Company also leases a facility in South San Francisco, California, that is subleased to a third party under a non-cancellable agreement, which ends concurrently with the original lease in September 2025.
Components of net lease cost are as follows(in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Operating lease cost | $2,728 | $2,577 |
| Variable lease cost | 45 | 14 |
| Total operating lease cost | 2,773 | 2,591 |
| Less: Sublease income | (1,954) | (1,928) |
| Net lease cost | $819 | $663 |
Other supplemental information related to operating leases is as follows(in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Cash paid for operating lease liabilities | $3,116 | $3,000 |
| Addition to right-of-use assets obtained from operating lease liabilities | 2,487 | — |
| December 31, | ||
| 2024 | 2023 | |
| Weighted-average discount rate for operating leases | 11.3% | 9.1% |
| Weighted-average remaining lease term | 3.0 years | 1.5 years |
As of December 31, 2024, the maturities of operating lease liabilities are as follows(in thousands):
| 2025 | $2,293 |
| 2026 | 830 |
| 2027 | 966 |
| 2028 | 995 |
| 2029 | 254 |
| Total minimum lease payments | 5,338 |
| Less: Imputed interest | (1,387) |
| Total operating lease liabilities | 3,951 |
| Less: Current portion of operating lease liabilities | (1,483) |
| Non-current operating lease liabilities | $2,468 |
As of December 31, 2024, under the terms of the sublease agreement of the South San Francisco facility to a third party, the Company is entitled to receive sublease payments of $1.5 million in 2025, and the Company remains responsible for future lease payments of $1.9 million under the terms of the lease for this facility. As of December 31, 2024, the Company had not executed any leases that were yet to commence.
- NOTES PAYABLE
Notes payable consist of the following(in thousands):
| December 31, | |||||
|---|---|---|---|---|---|
| 2024 · 2023 | |||||
| Maturity | Effective Interest Rate | Amount | Effective Interest Rate | Amount | |
| Collateralized note 2021-12 | 2027 | 13.96% | $5,000 | 14.73% | $5,000 |
| Collateralized note 2022-11 | 2027 | 14.09% | 20,000 | 14.87% | 20,000 |
| Collateralized note 2023-12 | 2027 | 14.59% | 25,000 | 15.37% | 25,000 |
| Total borrowings | 50,000 | 50,000 | |||
| Accrued exit fee net of unamortized issuance costs | 687 | (123) | |||
| Net carrying amount of debt | $50,687 | $49,877 | |||
In December 2021, the Company entered into a non-revolving loan and security agreement (the Loan Agreement) with Oxford Finance. The Loan Agreement has a borrowing capacity of up to $50.0 million, of which $5.0 million was funded in December 2021, with the remaining credit facility available for draw until December 2022, with maturity of the outstanding balance in December 2026. In November 2022, the Company entered into an amendment of the Loan Agreement. Among other changes, the amendment extended the scheduled expiration of the Loan Agreement from December 2022 to December 2023 and modified the reference rate from the London Interbank Offered Rate (LIBOR) to the Secured Overnight Financing Rate (SOFR). In conjunction with the amendment, the Company borrowed an additional $20.0 million under the Loan Agreement. In December 2023, the Company borrowed the remaining $25.0 million under the Loan Agreement. As of December 31, 2024, the Company’s outstanding borrowing under the Loan Agreement was $50.0 million.
In March 2023, upon achievement of a clinical data milestone, the Company elected to exercise a borrower option to extend the maturity of the outstanding loan by 12 months, from December 2026 to December 2027. The end date of the interest-only payment period was also extended by 12 months, from December 2025 to December 2026. The Company is permitted to prepay the loan, subject tocertain conditions. Upon the maturity date or prepayment of the loan, the Company is required to pay an exit fee equal to 7% of the aggregate principal amount of the loan.
The variable interest rate on the drawn amount is adjusted SOFR plus 825 basis points, subject to a per annum floor rate of 8.25%. The Loan Agreement contains a subjective acceleration clause in the case of an event of default. If such a matter occurs and is continuing, the lender may legally demand the outstanding principal and interest immediately due and payable. There are no financial covenants associated with the Loan Agreement and the loan is secured by the Company’s assets. The Loan Agreement is available for working capital, capital expenditures, and other general corporate purposes.
Principal installments due on the notes are as follows(in thousands):
| 2025 | — |
| 2026 | — |
| 2027 | 50,000 |
| Total long-term debt | $50,000 |
- COMMON STOCK
As of December 31, 2024, the Company’s amended and restated certificate of incorporation authorized the Company to issue 500,000,000 shares of Class A common stock and 14,600,000 shares of Class B common stock, each with a par value of $0.001 per share. Each share of Class A common stock entitles the holder toone vote on all matters submitted to a vote of the Company’s stockholders. Class B common stock is non-voting. There wereno shares of Class B common stock outstanding as of December 31, 2024 and 2023. Common stockholders are entitled to receive dividends, as may be declared by the board of directors. Through December 31, 2024, no cash dividends have been declared or paid.
In February 2023, the Company completed a follow-on public offering pursuant to which the Company issued and sold 16,428,572 shares of its Class A common stock at a public offering price of $7.00 per share, including 2,142,857 shares of Class A common stock pursuant to the full exercise of the underwriters’ option to purchase additional shares.
In February 2024, the Company completed a follow-on public offering pursuant to which the Company issued and sold 9,274,194 shares of its Class A common stock at a public offering price of $31.00 per share, including 1,209,677 shares of Class A common stock pursuant to the full exercise of the underwriters’ option to purchase additional shares.
In October 2024, the Company completed a follow-on public offering pursuant to which the Company issued and sold 7,142,858 shares of its Class A common stock at a public offering price of $42.00 per share, and in November 2024, the Company issued and sold an additional 1,071,428 shares of Class A common stock, pursuant to the full exercise of the underwriters’ option to purchase additional shares at the public offering price.
- STOCK COMPENSATION
Equity Plans
2024 Inducement Plan
In February 2024, the Company adopted the 2024 Inducement Plan (Inducement Plan). The Inducement Plan was adopted by the compensation committee of the Company’s board of directors without stockholder approval pursuant to Nasdaq Listing Rule 5635(c)(4). In accordance with Rule 5635(c)(4), awards made under the Inducement Plan, including stock options and restricted stock units, may only be granted to newly hired employees as a material inducement to accept employment with the Company. Awards granted under the Inducement Plan expire no later thanten years from the date of grant.
2021 Equity Incentive Plan and 2017 Equity Incentive Plan
The 2021 Equity Incentive Plan (2021 EIP) and the 2017 Equity Incentive Plan (2017 EIP) became effective in May 2021 and February 2017, respectively. Awards granted under the 2021 EIP and 2017 EIP expire no later than 10 years from the date of grant.
The 2017 EIP permitted the granting of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock units and other stock-based awards to employees, directors and consultants. Since the adoption of the 2021 EIP, no additional equity awards can be granted under the 2017 EIP. Shares reserved and remaining available for issuance under the 2017 EIP were added to shares reserved for the 2021 EIP plan in May 2021. The terms of the 2017 EIP continue to govern outstanding equity awards granted thereunder.
Under the 2021 EIP, we may grant incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards and restricted stock units, performance awards and other awards to employees, consultants and directors. Stock options granted to new employees generally vest over four years at a rate of 25% upon the first anniversary of the vesting commencement date and monthly thereafter. Other stock options granted to employees generally vest monthly over four years from the vesting commencement date. The number of shares reserved for issuance under the 2021 EIP increases automatically on the first day of each fiscal year, beginning on January 1, 2022, by a number equal to 5% of the total number of shares of the Company’s capital stock (including all classes of the Company’s common stock) outstanding on December 31 of the preceding year, or such lower number of shares (including no shares) approved by the Company’s board of directors prior to January 1 of a given year.
2021 Employee Stock Purchase Plan
The 2021 Employee Stock Purchase Plan (ESPP) became effective in May 2021. The ESPP enables eligible employees to purchase shares of the Company’s Class A common stock at the end of each offering period at a price equal to 85% of the fair market value of the shares on the first trading day or the last trading day of the offering period, whichever is lower. Eligible employees generally include all employees. Share purchases are funded through payroll deductions of at least 1% and up to 15% of an employee’s eligible compensation for each payroll period. The number of shares reserved for issuance under the ESPP increases automatically on the first day of each fiscal year, beginning on January 1, 2022, by a number equal to the lesser of 440,502 shares,1% of the total number of shares of the Company’s capital stock (including all classes of the Company’s common stock) outstanding on December 31 of the preceding year, or such lower number of shares (including no shares) approved by the Company’s board of directors prior to January 1 of a given year. As of December 31, 2024,88,752 shares have been issued pursuant to the ESPP. The ESPP generally provides for six-month consecutive offering periods beginning on September 14, 2021. The ESPP is a compensatory plan as defined by the authoritative guidance for stock compensation.
The table below summarizes the Company's equity plans as of December 31, 2024:
| Plan | Maximum Number of Shares Authorized | Shares Available for Future Issuance |
|---|---|---|
| 2024 Inducement Plan | 1,250,000 | 71,075 |
| 2021 Equity Incentive Plan | 6,873,404 | 682,278 |
| 2017 Equity Incentive Plan | 2,275,305 | — |
| 2021 Employee Stock Purchase Plan | 1,148,444 | 1,059,692 |
Option Activity
Stock option activity under the 2017 EIP, 2021 EIP, and 2024 Inducement Plan is summarized as follows:
| Number of Options | Weighted-Average Exercise Price per Share | Weighted-Average Remaining Contractual Life (Years) | Aggregate Intrinsic Value (000s) | |
|---|---|---|---|---|
| Outstanding as of December 31, 2023 | 5,762,236 | $9.42 | 7.66 | $39,197 |
| Granted | 2,799,750 | $25.83 | ||
| Exercised | (1,486,314) | $8.66 | ||
| Cancelled and forfeited | (463,875) | $10.93 | ||
| Outstanding as of December 31, 2024 | 6,611,797 | $16.44 | 8.11 | $172,630 |
| Options exercisable as of December 31, 2024 | 2,703,670 | $9.65 | 7.11 | $88,257 |
| Vested and expected to vest as of December 31, 2024 | 6,611,797 | $16.44 | 8.11 | $172,630 |
The aggregate intrinsic value of stock options exercised during the year ended December 31, 2024 was$46.8 million. The weighted-average grant date fair value of options granted during the years ended December 31, 2024 and 2023, was $19.65 per share and $5.92 per share, respectively.
In August 2024, the Company repurchased 4,450 unvested shares that were previously outstanding due to a stock option that was early exercised. The unvested shares were repurchased at the original exercise price of $2.8968 per share.
Award Activity
The Company grants restricted stock units (RSU) pursuant to the 2021 EIP and satisfies such grants through the issuance of the Company’s Class A common stock. The following table shows RSU activity for the period ending December 31, 2024:
| Number of Shares | Weighted-Average Grant Date Fair Value per Share | |
|---|---|---|
| Unvested balance at December 31, 2023 | 131,679 | $18.36 |
| Granted | 713,812 | 29.67 |
| Vested | (111,396) | 19.03 |
| Cancelled and forfeited | (37,207) | 22.33 |
| Unvested balance at December 31, 2024 | 696,888 | $29.63 |
Stock-Based Compensation Expense
The following tables summarize the stock-based compensation expense for stock options and restricted stock units granted to employees and nonemployees and for ESPP stock-based compensation that was recorded in the Company’s statements of operations and comprehensive loss for the years ended December 31, 2024 and 2023(in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Research and development | $8,537 | $4,845 |
| General and administrative | 12,265 | 6,648 |
| Total stock-based compensation expense | $20,802 | $11,493 |
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Employees | $18,356 | $10,494 |
| Nonemployees | 2,446 | 999 |
| Total stock-based compensation expense | $20,802 | $11,493 |
As of December 31, 2024, the Company had $49.3 million of unrecognized stock-based compensation expense related to unvested stock options, which is expected to be recognized over a weighted-average period of approximately 2.7 years. For the year ended December 31, 2024, the Company recognized $17.1 million of stock-based compensation expense for stock options.
As of December 31, 2024, the Company had $18.6 million of unrecognized stock-based compensation expense related to unvested RSUs, which is expected to be recognized over a weighted-average period of approximately 3.5 years. For the year ended December 31, 2024, the Company recognized $3.4 million of stock-based compensation expense for restricted stock units.
Stock-based compensation expense related to the ESPP for the years ended December 31, 2024 and 2023 was $0.3 million and $0.2 million, respectively.
No tax benefit was recognized related to stock-based compensation expense since the Company has never reported taxable income and has established a full valuation allowance to offset all of the potential tax benefits associated with its deferred tax assets.
The fair value of stock options granted during the years ended December 31, 2024 and 2023, was estimated using the Black-Scholes option pricing model based on the following assumptions:
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Expected term (in years) | 5.4 – 6.1 | 5.5 – 6.1 |
| Expected volatility | 69.7% – 73.2% | 79.5% – 80.5% |
| Risk-free rate | 3.6% – 4.6% | 3.4% – 4.7% |
| Dividend yield | — | — |
- LICENSES AND COLLABORATIONS
Ares Trading S.A.
In October 2020, the Company entered into a license agreement with Ares (the Ares Agreement), pursuant to which the Company obtained an exclusive worldwide license to certain patents and related know-how to research, develop, manufacture, use and commercialize therapeutic products containing atacicept, a recombinant fusion protein used to inhibit B cell growth and differentiation, which could potentially treat some autoimmune diseases.
As consideration for the Ares Agreement, the Company paid a non-refundable license issue fee to Ares in the form of shares of redeemable convertible preferred stock valued at $13.1 million, resulting in Ares becoming a related party to the Company. The redeemable convertible preferred stock subsequently converted into 1,913,501 shares of common stock in May 2021.
In December 2020, the Company paid Ares a milestone payment of $25.0 million upon delivery and initiation of the transfer of specified information and materials. The non-refundable license issue fee and milestone payment were recorded to research and development expense in the period incurred. The Company is obligated to pay Ares aggregate milestone payments of up to $176.5 million upon the achievement of specified BLA filing or regulatory approval milestones, beginning with $15.0 million upon the first filing of an approval application and $20.0 million upon regulatory approval in the U.S., and up to $515.0 million upon the achievement of specified commercial milestones, beginning with $15.0 million if worldwide aggregate annual net sales reach $250.0 million and $50.0 million if worldwide aggregate annual net sales reach $500.0 million.
Subsequent to the effective date of the Ares Agreement, Ares has performed transfer of manufacturing technology and know-how to the Company. The Company recorded related party expense of $0.3 million and $2.8 million to Ares for these services during the years ended December 31, 2024 and 2023, respectively. These amounts are included in research and development expenses on the statements of operations and comprehensive loss.
Commencing on the first commercial sale of licensed products, the Company is obligated to pay Ares tiered royalties of low double-digit to mid-teen percentages on annual net sales of the licensed products covered by the license. The Company is obligated to pay royalties on a licensed product-by-licensed product and country-by-country basis from the first commercial sale of a product in a country until the latest of (i) 15 years after the first commercial sale of such licensed product in such country; (ii) the expiration of the last valid claim of a licensed patent that covers such licensed product in, or its use, importation or manufacture with respect to, such country; and (iii) expiration of all applicable regulatory exclusivity periods, including data exclusivity, in such country with respect to such product. If the Company were to sublicense its rights under the Ares Agreement, the Company would be obligated to pay Ares a percentage ranging from the mid-single-digit to the low double-digits of specified sublicensing income received.
Amplyx Pharmaceuticals, Inc.
In December 2021, the Company entered into an asset purchase agreement (the Amplyx Agreement) with Amplyx Pharmaceuticals, Inc. (Amplyx), a wholly owned subsidiary of Pfizer Inc. Pursuant to the terms of the Amplyx Agreement, the Company paid $5.0 million to Amplyx to purchase assets relating to an anti-BKV monoclonal antibody referred to as MAU868 for the treatment of BKV infection pursuant to a License Agreement between Amplyx and Novartis International Pharmaceutical AG (Novartis). In addition, the Company recognized a $2.0 million contingent milestone obligation as an assumed liability related to the asset purchase. The acquisition cost of $7.0 million was recorded as research and development expense in the statement of operations and comprehensive loss on the acquisition date.
In connection with the Amplyx asset purchase, Amplyx assigned the Exclusive License Agreement between Amplyx and Novartis (the Novartis License) and Manufacturing and Supply Agreements to the Company. Under the Novartis License, the Company has exclusive worldwide rights from Novartis to develop, manufacture and commercialize MAU868. The Company will be solely responsible for all research, development, regulatory, manufacturing and commercialization activities of MAU868.
Under the Amplyx Agreement, the Company is obligated to make future milestone payments to Amplyx and Novartis upon the achievement of specified development, regulatory and commercial milestones. In September 2022, the Company and Novartis entered into an amendment to the Novartis License to modify the terms of future milestone payments. Pursuant to this amendment, the Company issued 283,034 shares of Class A common stock to Novartis in exchange for a reduction of $7.0 million in contingent future development milestones, including the $2.0 million contingent milestone obligation accrued by the Company in December 2021. The value of the shares issued was $5.7 million based on the closing market value of the Company’s Class A common stock as of the effective date of the amendment.
The Company is obligated to make future milestone payments of up to $7.0 million to Amplyx, contingent upon the achievement of certain regulatory milestones. The Company is also obligated to make future milestone payments of up to $62.0 million to Novartis, contingent upon the achievement of specified development, regulatory and commercial milestones. In the event that MAU868 is commercialized, the Company will be obligated to pay royalties to Amplyx and Novartis based on net sales by country and by product.
- INCOME TAXES
For financial reporting purposes, loss before provision for income taxes includes the following components(in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Domestic | $(152,147) | $(95,989) |
| Foreign | — | — |
| Loss before income taxes | $(152,147) | $(95,989) |
Provision for Income Taxes
The provision for income taxes consisted of the following(in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Current: | ||
| Federal | $— | $— |
| State | 1 | 1 |
| Total current | 1 | 1 |
| Total deferred | — | — |
| Provision for income taxes | $1 | $1 |
A reconciliation of the provision for income taxes computed using the U.S. statutory federal income tax rate compared to the income tax provision included in the statement of operations and comprehensive loss is as follows(in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Tax on U.S. statutory rate on income before income taxes | $(31,951) | $(20,158) |
| State taxes | (1,010) | (489) |
| State valuation allowance | 1,011 | 490 |
| Federal valuation allowance | 34,449 | 21,250 |
| Tax credits | (1,294) | (1,598) |
| Stock based compensation | (1,845) | — |
| Other | 641 | 506 |
| Provision for income taxes | $1 | $1 |
Deferred Tax Assets and Liabilities
Deferred tax assets and liabilities are determined based on the differences between financial reporting and income tax bases of assets and liabilities, as well as net operating loss carryforwards and are measured using the enacted tax rates and laws in effect when the differences are expected to reverse. The significant components of the Company’s net deferred tax assets and liabilities are as follows(in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Deferred tax assets: | ||
| Federal and state NOL carryforward | $38,736 | $27,539 |
| Research and other credits | 8,190 | 6,051 |
| Capitalized R&D | 46,225 | 25,264 |
| Fixed assets | 5 | 3 |
| Reserves and accruals | 1,310 | 755 |
| Stock based compensation | 4,311 | 2,978 |
| Other intangibles | 7,641 | 8,313 |
| Other DTA | 400 | 384 |
| Lease liability | 831 | 804 |
| Total gross DTA | 107,649 | 72,091 |
| Less: valuation allowance | (106,857) | (71,372) |
| Total deferred tax assets | 792 | 719 |
| Deferred tax liabilities: | ||
| Right of use | (709) | (619) |
| Other DTL | (83) | (100) |
| Total gross DTL | (792) | (719) |
| Net deferred tax assets | $— | $— |
As of December 31, 2024, the Company has federal and state net operating loss carryforwards of $171.8 million and $37.5 million, respectively, of which $10.2 million of federal net operating loss carryforwards and $37.0 million of state net operating carryforwards will begin expiring in the year 2032 and 2036, respectively, if not utilized. The Company also has $161.5 million of federal net operating loss carryforwards as of December 31, 2024 that do not expire. The Company has $7.0 million of federal research and development tax credit carryforwards, which begin to expire in the year 2037. The Company has $3.2 million of state research and development tax credit carryforwards, which have no expiration date.
Utilization of the federal and state net operating loss and tax credit carryforwards may be subject to a substantial annual limitation due to the “change in ownership” provisions of the Internal Revenue Code of 1986. The annual limitation may result in the expiration of net operating losses and credits before utilization. The Company has not performed an analysis to determine if such ownership changes have occurred. An analysis will be performed prior to recognizing the benefits of any losses or credits in the financial statements.
Management assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to use the existing deferred tax assets. Based on the weight of all evidence including a history of operating losses, management has determined that it is not more likely than not that the net deferred tax assets will be realized. A valuation allowance of$106.9 million and$71.4 million as of December 31, 2024 and 2023, respectively, has been established to offset the deferred tax assets as realization of such assets is uncertain. The valuation allowance increased by $35.5 million and $21.8 million during the years ended December 31, 2024 and 2023, respectively.
Uncertain Tax Benefits
The Company has the following activity relating to the gross amount of unrecognized tax benefits(in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Beginning balance | $1,513 | $941 |
| Additions based on tax positions related to prior year | — | — |
| Decreases based on tax positions related to prior year | — | — |
| Additions based on tax positions related to current year | 535 | 572 |
| Ending balance | $2,048 | $1,513 |
The Company accounts for income taxes in accordance with authoritative accounting guidance which states the impact of an uncertain income tax position is recognized at the largest amount that is “more likely than not” to be sustained upon audit by the relevant taxing authority. An uncertain tax position will not be recognized if it has less than a 50% likelihood of being sustained. None of these uncertain tax positions will impact the Company’s effective tax rate if assessed. The Company’s policy is to classify interest and penalties associated with unrecognized tax benefits as income tax expense. The Company hadno interest or penalty accruals associated with uncertain tax benefits in its balance sheet and statement of operations for the years ended December 31, 2024 and 2023. The Company files income tax returns in the U.S. and various states. The Company is not currently under examination by any major tax jurisdictionsnor has it been in the past. Because of net operating losses and research credit carryovers, substantially all of our tax years remain open to examination. Although it is reasonably possible that certain unrecognized tax benefits may increase or decrease within the next 12 months due to tax examination changes, settlement activities, expirations of statute of limitations, or the impact on recognition and measurement considerations related to the results of published tax cases or other similar activities, the Company does not anticipate any significant changes to unrecognized tax benefits over the next 12 months.
- COMMITMENTS AND CONTINGENCIES
Legal Proceedings
The Company believes that there are no actions pending which would have a material adverse effect on its results of operations, financial condition, or cash flows.
Indemnifications
As of December 31, 2024, the Company did not have any material indemnification claims that were probable or reasonably possible, and consequently no related liabilities have been recorded.
Employee Agreements
The Company has signed employment agreements with certain key employees pursuant to which, if their employment is terminated following a change of control of the Company, the employees are entitled to receive certain benefits, including severance and accelerated vesting of equity incentives.
Development and Manufacturing Services Agreements
The Company enters into development and manufacturing contracts with vendors in the conduct of its business. Contracts with these vendors may be terminated at the Company’s option, with varying provisions regarding termination. If a contract with a specific vendor were to be terminated, the Company would be obligated to pay for the products or services that had been provided or received at the time the termination became effective, and potentially additional compensation based upon the period of time remaining between the date of notice of cancellation and the scheduled manufacturing.
- NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS
The following outstanding potentially dilutive shares were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented, because including them would have been anti-dilutive (on an as-converted basis).
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Class A common stock options issued and outstanding | 6,611,797 | 5,762,236 |
| Unvested restricted stock units | 696,888 | 131,679 |
| Vested but unsettled stock units | 2,987 | — |
| Unvested ESPP shares | 6,034 | 229 |
| Total | 7,317,706 | 5,894,144 |
- RELATED PARTY TRANSACTIONS
In October 2020, the Company entered into the Ares Agreement with Ares, pursuant to which the Company obtained an exclusive worldwide license to certain patents and related know-how to research, develop, manufacture, use and commercialize therapeutic products containing atacicept, a recombinant fusion protein used to inhibit B cell growth and differentiation, which could potentially treat some autoimmune diseases. As consideration for the agreement, the Company paid a non-refundable license issue fee to Ares in the form of redeemable convertible preferred stock, which was subsequently converted into shares of common stock in May 2021. Related party transactions and balances in the current periods presented are described in Note 3 and Note 9.
Sofinnova Venture Partners X, L.P. (SVP X) is an investment fund in which Maha Katabi (Dr. Katabi), a member of the Company’s board of directors, has a pecuniary interest. SVP X completed transactions in the Company’s common stock within a six-month period ended March 25, 2024. The transactions included both purchases and sales of shares of the Company’s common stock that may be matchable for purposes of Section 16(b) of the Securities Exchange Act of 1934, as amended. These transactions could be deemedto have resulted in short-swing profits to Dr. Katabi of $36,620. Dr. Katabi voluntarily agreed to disgorge the profits and has paid $36,620 to the Company as a result of these transactions.
- SEGMENT REPORTING
The Company hasone reportable segment: Therapeutics. This segment is dedicated to developing and commercializing transformative treatments for patients with serious immunological diseases. The Company’s lead product candidate, atacicept, a fully humanized TACI-Fc fusion protein that binds both B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL) and is self-administered subcutaneously, is currently being evaluated for the treatment of immunoglobulin A nephropathy (IgAN). The Company also holds worldwide, exclusive development and commercial rights to MAU868, a potentially first-in-class monoclonal antibody to treat reactivated BK virus (BKV) infections for which the Company completed a Phase 2 clinical trial in 2022.
Since inception, the Company has devoted substantially all its resources to research and development efforts, pre-clinical studies and clinical trials, establishing and maintaining intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations. The Company does not have any product candidates approved for commercial sale and has not generated any revenue from product sales.
The accounting policies used in the segment reporting are the same as those described in the summary of significant accounting policies (Note 2). The Company’s Chief Operating Decision Maker (CODM) is the Chief Executive Officer. The CODM assesses performance for the single reportable segment and decides how to allocate resources based on net loss and total operating expenses. As the Company has not generated any revenue, total operating expenses is equivalent to loss from operations on the statements of operations and comprehensive loss. The measure of segment assets is reported on the balance sheet as total assets.
The CODM uses net loss as the reportable segment’s primary measure of profit or loss to evaluate the segment’s financial position and to determine the need for additional financing or equity offerings. The CODM also uses total operating expenses as a measure to evaluate controllable spend from total current assets, in deciding how to allocate resources within the Therapeutics segment.
The Company's reportable segment total operating expenses, including significant segment expenses, and net loss for the years ended December 31, 2024 and 2023, consisted of the following (in thousands):
| Therapeutics | ||
|---|---|---|
| Year Ended December 31, | ||
| 2024 | 2023 | |
| Operating expenses: | ||
| Payroll and related | $48,843 | $28,878 |
| Direct research and development - clinical trials | 32,279 | 19,611 |
| Direct research and development - contract manufacturing | 50,753 | 35,049 |
| Depreciation and amortization | 105 | 22 |
| Other segment items* | 35,190 | 18,452 |
| Total operating expenses | 167,170 | 102,012 |
| Loss from operations | (167,170) | (102,012) |
| Other income (expense): | ||
| Interest income | 20,714 | 7,979 |
| Interest expense | (7,626) | (3,786) |
| Other segment items** | 1,935 | 1,830 |
| Loss before provision for income taxes | (152,147) | (95,989) |
| Provision for income taxes | (1) | (1) |
| Segment and consolidated net loss | $(152,148) | $(95,990) |
| Other Significant Items: | ||
| Expenditures for additions to long-lived assets | $(972) | $(63) |
*Other segment items included in total operating expenses primarily consist of consulting and contractors, professional services, equipment and software, travel and entertainment, facilities, medical affairs, commercial planning, and corporate communications.
**Other segment items included in loss before provision for income taxes consist of currency exchange gains and losses and other income/expense.
The Company's reportable segment assets consisted of the following (in thousands):
| Therapeutics | ||
|---|---|---|
| December 31, | ||
| 2024 | 2023 | |
| Total segment assets | $655,681 | $175,546 |
| Total consolidated assets | $655,681 | $175,546 |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.