Nuvation Bio Inc.
For the period ended Sep 30, 2026. Filed Nov 4, 2026.
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Sep 30, 2026 · Filed Nov 4, 2026
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Notes to Unaudited Consolidated Financial Statements
Notes to Consolidated Financial Statements
- Nature of Operations
Nuvation Bio Inc. and subsidiaries (“Nuvation Bio”), a Delaware corporation, is a global oncology company focused on tackling some of the toughest challenges in cancer treatment with the goal of developing therapies that create a profound, positive impact on patients’ lives. Nuvation Bio was incorporated on March 20, 2018 (inception date) and has offices in New York, San Francisco, Boston and Shanghai.
On February 10, 2021, (the “Closing Date”), Nuvation Bio Inc., a Delaware corporation (“Legacy Nuvation Bio”), Panacea Acquisition Corp. (“Panacea”), and Panacea Merger Subsidiary Corp, a Delaware corporation and a direct, wholly owned subsidiary of Panacea (“Merger Sub”) consummated the transactions contemplated by an Agreement and Plan of Merger among them dated October 20, 2020 (“Merger Agreement”).
Pursuant to the terms of the Merger Agreement, a business combination of Panacea and Legacy Nuvation Bio was effected through the merger of Merger Sub with and into Legacy Nuvation Bio, with Legacy Nuvation Bio surviving as a wholly owned subsidiary of Panacea (the “Merger”) and, collectively with the other transactions described in the Merger Agreement. On the Closing Date, Legacy Nuvation Bio changed its name to Nuvation Bio Operating Company Inc. and Panacea changed its name to Nuvation Bio Inc. (the “Company” or “Nuvation Bio”).
On April 9, 2024 (the "Acquisition Date"), the Company completed its acquisition of AnHeart Therapeutics Ltd., an exempted company incorporated under the laws of the Cayman Islands (“AnHeart”), pursuant to that certain Agreement and Plan of Merger (the "AnHeart Merger Agreement"), by and among the Company, AnHeart, Artemis Merger Sub I, Ltd., an exempted company incorporated under the laws of the Cayman Islands and a wholly owned subsidiary of the Company, and Artemis Merger Sub II, Ltd., an exempted company incorporated under the laws of the Cayman Islands and a wholly owned subsidiary of the Company. Subsequent to the Acquisition Date, reference to AnHeart is used to represent the consolidated entity of the Company.
- Significant Accounting Policies
a. Basis of Presentation
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented.
b. Principles of Consolidation
The consolidated financial statements include the balances of the Company and its subsidiaries. All intercompany transactions and balances are eliminated in consolidation.
c. Unaudited Interim Financial Information
The accompanying unaudited consolidated financial statements as of September 30, 2026 and for the three and nine months ended September 30, 2026 and 2025, have been prepared in accordance with GAAP for interim financial statements and pursuant to Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, all adjustments have been made that are considered necessary for a fair statement of the financial position of the Company as of September 30, 2026, the results of operations for the three and nine months ended September 30, 2026 and 2025 and the cash flows for the nine months ended September 30, 2026 and 2025. The consolidated balance sheet as of December 31, 2025 has been derived from the Company’s audited consolidated financial statements. Operating results for the three and nine months ended September 30, 2026 are not necessarily indicative of the results that may be expected for the year ending December 31, 2026.
Certain information and disclosures normally included in the notes to annual financial statements prepared in accordance with GAAP have been omitted from these interim financial statements pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Accordingly, these unaudited consolidated financial statements should be read in conjunction with the financial statements for the fiscal year ended December 31, 2025, which are included in the Company’s 10-K filed with the SEC on March 2, 2026.
d. Liquidity
As of September 30, 2026, the Company has an accumulated deficit of approximately$1,214.7 million and net cash used in operating activities was approximately $76.5 million for the nine months ended September 30, 2026. Management expects to continue to incur operating losses and negative cash flows from operations for the foreseeable future.
As of September 30, 2026, the Company had cash, cash equivalents, and marketable securities of $663.4 million. The Company believes that its existing cash, cash equivalents, and marketable securities will be sufficient to meet its cash commitments for at least the next 12 months after the date that these consolidated financial statements are issued. The Company’s research and development activities can be costly, and the timing and outcomes are uncertain. The assumptions upon which the Company has based its estimates are routinely evaluated and may be subject to change. The actual amount of the Company’s expenditures will vary depending upon a number of factors including but not limited to the progress of the Company’s commercialization efforts for IBTROZI, research and development activities, potential regulatory approval of its product candidates, and the level of financial resources available.
e. Significant Risks and Uncertainties
The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of research and development, clinical testing and trial activities of the Company’s products, the Company’s ability to obtain and maintain regulatory approval to market its products, competition from products manufactured and sold or being developed by other companies, the price of, and demand for, Company’s products, the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, and the Company’s ability to raise capital.
Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. The Company operates in an environment of rapid change and is dependent upon the continued services of its employees and vendors and obtaining and protecting intellectual property.
f. Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amount of revenue and expenses during the year. Accordingly, actual results could differ from those estimates and those differences could be significant. Significant estimates and assumptions reflected in the accompanying consolidated financial statements include, but are not limited to, the fair value of in-process research and development acquired, warrant liabilities, leases, stock options granted, convertible debt, revenue recognition, interest expense and depreciation expense.
g. Functional Currency and Foreign Currency Translations
The Company's reporting currency is the U.S. dollar (“USD”). The functional currency of the Company's subsidiaries incorporated in People's Republic of China (“PRC”) is Renminbi (“RMB”). The functional currency of the Company and its subsidiaries incorporated outside the PRC is USD. Transactions denominated in currencies other than the functional currencies are re-measured into the functional currency of the entity at the exchange rates prevailing on the transaction dates. Foreign currency denominated financial assets and liabilities are re-measured at the balance sheet date exchange rate. The resulting exchange differences are included in the net loss of the statements of operations and comprehensive loss. Assets and liabilities of the Company with functional currency other than USD are translated into USD at fiscal year-end exchange rates. Equity amounts are translated at historical exchange rates. Income and expense items are translated at average exchange rates during the fiscal year. Translation adjustments arising from these are reported as foreign currency translation adjustments and are shown as a component of other comprehensive income (loss).
h. Cash and Cash Equivalents
Cash equivalents include short-term, highly liquid instruments, consisting of money market accounts, a money market mutual fund and short-term investments with maturities from the date of purchase of 90 days or less. The majority of cash and cash equivalents are maintained with major financial institutions in North America. Deposits with these financial institutions may exceed the amount of insurance provided on such deposits. These deposits may be redeemed upon demand which reduces counterparty performance risk.
i. Marketable Securities
Debt securities have been classified as available-for-sale which may be sold before maturity or are not classified as held to maturity or trading. Marketable debt securities classified as available-for-sale are carried at fair value with unrealized gains or losses reported in other comprehensive income (loss). Exchange traded funds are equity securities, which are reported as marketable securities with readily determinable fair values, are also carried at fair value with unrealized gains and losses included in other (expense) income, net. Realized gains and losses on both debt and equity securities are included in other (expense) income, net.
The Company is exposed to credit losses primarily through its available-for-sale investments. The Company assesses whether its available-for-sale investments are impaired at each reporting period. Unrealized losses or impairments resulting from the amortized cost basis of any available-for-sale debt security exceeding its fair value are evaluated for identification of credit losses and non-credit related losses. Any credit losses are charged to earnings against the allowance for credit losses of the debt security, limited to the difference between the fair value and the amortized cost basis of the debt security. Any difference between the fair value of the debt security and the amortized cost basis, less the allowance for expected credit losses, are reported in other comprehensive income (loss). Expected cash inflows due to improvements in credit are recognized through a reversal of the allowance for expected credit losses subject to the total allowance previously recognized. The Company’s expected loss allowance methodology for the debt securities includes reviewing the extent of the unrealized loss, the size, term, geographical location, and industry of the issuer, the issuers’ credit ratings and any changes in those ratings, as well as reviewing current and future economic market conditions and the issuers’ current status and financial condition. As of September 30, 2026, the Company had not recognized an allowance for expected credit losses related to available-for-sale investments as the Company has not identified any unrealized losses for these investments attributable to credit factors.
Interest income includes amortization and accretion of purchase premium and discount. Premiums and discounts on debt securities are amortized on the effective-interest method. Gains and losses on sales are recorded on the settlement date and determined using the specific identification method.
j. Acquisition of assets and businesses
The Company's consolidated financial statements include the operations of acquired businesses after the completion of the acquisitions. The Company accounts for acquired businesses using the acquisition method of accounting, which requires, among other things, that most assets acquired and liabilities assumed be recognized at their estimated fair values as of the acquisition date and that the fair value of acquired in-process research and development be recorded on the balance sheet. Transaction costs are expensed as incurred. Any excess of the consideration transferred over the assigned values of the net assets acquired is recorded as goodwill. When the Company acquires net assets that do not constitute a business, as defined in GAAP, no goodwill is recognized and acquired in-process research and development is expensed in acquired in-process research and development expenses. Contingent consideration in a business combination is included as part of the acquisition cost and is recognized at fair value as of the acquisition date. Fair value is generally estimated by using a probability-weighted discounted cash flow approach. Any liability resulting from contingent consideration is remeasured to fair value at each reporting date until the contingency is resolved.
k. Concentration of Risk
Concentration of credit risk
Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash, cash equivalents and marketable securities. The Company maintains its cash and cash equivalent balances in the form of business checking accounts and money market accounts, the balances of which, at times, may exceed federally insured limits. Exposure to cash and cash equivalents credit risk is reduced by placing such deposits with major financial institutions and monitoring their credit ratings. Marketable securities consist primarily of government and corporate bonds, municipal securities and exchange traded funds with fixed interest rates. Exposure to credit risk of marketable securities is reduced by maintaining a diverse portfolio and monitoring their credit ratings.
Concentration of customers
Below customers represent more than 10% of the Company's gross revenue for the three and nine months ended September 30, 2026 and 2025.
| For the three months ended September 30, | For the nine months ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Customer A | — | — | 31% | — |
| Customer B | 28% | 17% | 15% | 40% |
| Customer C | 19% | 24% | 14% | 16% |
| Customer D | 21% | 23% | 14% | 14% |
| Customer E | 12% | 14% | 10% | 10% |
Below customers represent more than 10% of the Company's balances of accounts receivable as of September 30, 2026.
| Customer A | 32% |
|---|---|
| Customer B | 23% |
| Customer C | 20% |
| Customer D | 10% |
l. Property and Equipment
Property and equipment are stated at cost less accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the related assets of generally five years for computers andseven years for furniture and equipment. The cost of leasehold improvements is amortized on the straight-line method over the lesser of the estimated asset life or remaining term of the lease. Maintenance costs are expensed as incurred, while major betterments are capitalized.
m. Impairment of Long-Lived Assets
The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable and an impairment assessment may be performed on the recoverability of the carrying amounts. If an impairment occurs, the loss is measured by comparing the fair value of the asset to its carrying amount.
n. Warrants
The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities from Equity (“ASC 480”) and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own ordinary shares, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.
For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded as a liability at their fair value on the date of issuance and each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations.
Following the Merger, there were 5,787,472 warrants to purchase Common Stock outstanding, consisting of 4,791,639 Public Warrants,162,500 Private Placement Warrants and 833,333 Forward Purchase Warrants. Each whole warrant entitles the registered holder to purchase one share of the Company's Class A Common Stock (the “Class A Common Stock”) at a price of $11.50 per share. Pursuant to the warrant agreement, a warrant holder may exercise its warrants only for a whole number of shares of Class A Common Stock.
As part of the consideration for AnHeart, the Company issued warrants collectively exercisable for approximately 2,893,720 shares of the Class A Common Stock at an exercise price of $11.50 per share (the “Consideration Warrants”). The fair value of the Consideration Warrants was determined to approximate the public warrant trading price as of the Acquisition Date, yielding a fair value of approximately $0.26 per share. The Consideration Warrants were restricted with respect to the exercise and transfer thereof until receipt of such stockholder approval and otherwise have terms identical to those of the Company’s outstanding Public Warrants. Accordingly, the Company classified the Consideration Warrants as liabilities, consistent with the classification of the Company’s Public Warrants. The Consideration Warrants are no longer restricted with respect to the exercise and transfer based on the stockholder approval from the 2024 Annual Meeting of Stockholders on September 3, 2024.
The Company evaluated Public Warrants, Private Placement Warrants, Consideration Warrants, and Forward Purchase Warrants (the “Warrants”) under ASC 815-40, Derivatives and Hedging—Contracts in Entity’s Own Equity, and concluded that they do not meet the criteria to be classified in stockholders’ equity. Specifically, the settlement value of the Warrants is dependent, in part, on the holder of the Warrants at the time of settlement. Because the holder of an instrument is not an input into the pricing of a fixed-for-fixed option on Class A Common Stock, the Warrants fail the indexation guidance in ASC 815-40, which would preclude classification in stockholders’ equity. Additionally, the exercise of the Warrants may be settled in cash upon the occurrence of a tender offer or exchange that involves more than 50% of the outstanding shares of the Class A Common Stock. Becausenot all of the Company’s stockholders need to participate in such tender offer or exchange to trigger the potential cash settlement and the Company does not control the occurrence of such an event, the Company concluded that the Warrants do not meet the conditions to be classified in equity. Since the Warrants meet the definition of a derivative under ASC 815, the Company recorded these Warrants as liabilities on the balance sheet at fair value upon the closing of the Merger, with subsequent changes in their respective fair values recognized in the consolidated statement of operations and comprehensive loss at each reporting date. The fair value of Consideration, Public, and Forward Purchase Warrants was determined using the closing price of the publicly traded warrants on the NYSE market. The fair value of the Private Placement Warrants was estimated using a Black-Scholes option pricing model. The Warrants expired on February 10, 2026.
o. Revenue Recognition
The Company applies ASC Topic 606, "Revenue from Contracts with Customers" (“ASC 606”) to account for its revenue transactions. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the five-step model. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer. Once a contract is determined to be within the scope of ASC 606 at contract inception, the Company reviews the contract to determine which performance obligations it must deliver and which of these performance obligations are distinct. The Company recognizes as revenue the amount of the transaction price that is allocated to each performance obligation when that performance obligation is satisfied or as it is satisfied. The Company recognizes shipping and handling costs as an expense in cost of revenue. Accounts receivable represents amounts invoiced and revenue recognized prior to invoicing when the Company has satisfied its performance obligation and has the unconditional right to payment.
Product revenue, net
The Company recognizes product revenue, net of variable consideration related to certain allowances and accruals, when the customer takes control of the product, which is typically upon delivery to the customer. Product revenue is recorded at the net sales price, or transaction price. The Company records product revenue reserves, which are classified as a reduction in product revenue, to account for the components of variable consideration. Variable consideration includes the following components: chargebacks, government rebates, commercial payor rebates, trade discounts and allowances, product returns, and co-payment assistance. Calculating certain of these items involves estimates and judgments based on sales or invoice data, contractual terms, historical utilization rates, new information regarding changes in applicable regulations and guidelines that would impact the amount of the actual rebates, expectations regarding future utilization rates and channel inventory data. The Company reviews the adequacy of its provisions for sales deductions on a quarterly basis. Amounts accrued for sales deductions are adjusted when trends or significant events indicate that adjustment is appropriate and to reflect actual experience. The most significant items deducted from gross product sales where we exercise judgment are rebates, sales returns and chargebacks.
p. Collaborative Arrangement
In November 2018, the FASB issued Topic 808, "Collaborative Arrangements" (“ASC 808”): Clarifying the Interaction between ASC 808 and ASC 606. This update clarifies that certain transactions between participants in a collaborative arrangement should be accounted for under ASC 606 when the counterparty is a customer and precludes an entity from presenting consideration from a transaction in a collaborative arrangement as revenue from contracts with customers if the counterparty is not a customer for that transaction. The Company adopted this standard for all periods presented. The Company enters into collaborative arrangements for the research and development, manufacture and/or commercialization of drug products and drug candidates. The Company assessed and determined that none of the collaboration agreements entered into during the periods presented were within the scope of ASC 808, as all of the agreements did not involve active participation by both parties in a joint research activity, and therefore did not qualify as collaborative arrangements under ASC 808. The Company has determined that all the elements of the above collaborations are reflective of a vendor-customer relationship and therefore within the scope of ASC 606. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the five-step model under ASC 606 noted above. The Company recognizes revenue to depict the transfer of control of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to receive in exchange for those goods or services. The Company's collaborative arrangements may contain more than one unit of account, or performance obligation, including grants of licenses to intellectual property rights, agreements to provide research and development services and other deliverables. The collaborative arrangements do not include a right of return for any deliverable. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. In developing the stand-alone selling price for a performance obligation, the Company considers competitor pricing for a similar or identical product, market awareness of and perception of the product, expected product life and current market trends. In general, the consideration allocated to each performance obligation is recognized when the respective obligation is satisfied either by delivering a good or providing a service, limited to the consideration that is not constrained. Non-refundable payments received before all of the relevant criteria for revenue recognition are satisfied are recorded as contract liabilities.
Licenses of intellectual property
If a license to the Company's intellectual property is determined to be distinct from the other promises or performance obligations identified in the contract, the Company recognizes revenue from the portion of the transaction price allocated to the license at a point in time, when the license is transferred to the customer and the customer is able to benefit from the license. For the nine months ended September 30, 2026, the Company has recognized approximately$58.7 million of license revenue from the Eisai license agreement.
Research and development services
The portion of a transaction price allocated to research and development services performance obligations is deferred and recognized as revenue over time as delivery or performance of such services occurs based on the use of an input method.
Customer options
A customer's right to choose, at its discretion, to make a payment for additional goods or services is generally considered an option. If the Company is not presently obligated to provide and does not have a right to consideration for delivering additional goods or services, the item is considered an option. The Company evaluates the customer options for material rights, such as the ability to acquire additional goods or services for free or a discount. Optional future services that reflect their standalone selling prices do not provide the customer with a material right and, therefore, are not considered performance obligations and are accounted for as separate contracts. The optional future services do not include a material right to be accounted for as performance obligations.
Milestone payments
The Company's collaboration agreements include development and regulatory milestones. The Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. The Company evaluates factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to achieve the particular milestone in making this assessment. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company's control or the licensee's control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts the estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment.
Royalties
For sales-based royalties, including milestone payments based on the level of sales, the Company determines whether the sole or predominant item to which the royalties relate is a license. When the license is the sole or predominant item to which the sales-based royalty relates, the Company recognizes revenue at the later of: (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). In September 2026, the Company has recognized $5.0 million of milestone payments upon Innovent achieving $20.0 million in annual net sales.
For the three months ended September 30, 2026 and 2025, the Company has recognized $2.7 millionand $0.3 million sales-based royalty revenue resulting from the Company's collaboration agreements, respectively. For the nine months ended September 30, 2026 and 2025, the Company has recognized$6.6 millionand $0.8 million sales-based royalty revenue resulting from the Company's collaboration agreements, respectively.
The Company receives payments from its customers based on billing terms established in the contract. Up-front payments and fees are recorded as contract liabilities (e.g., deferred revenue) upon receipt or when due until the Company performs its obligations under the arrangement.
In the event of an early termination of a collaboration agreement, any contract liabilities would be recognized in the period in which all of the Company's obligations under the agreement have been fulfilled.
For a complete discussion of accounting for revenue, see Note 4, "Revenue Recognition."
q. Costs to Fulfill a Contract with a Customer
The Company is required to capitalize costs incurred to fulfill customer contracts. These costs are required to be amortized to expense on a systematic basis that is consistent with the transfer to the customer of the goods or services to which the asset relates, compared to previously being expensed as incurred. Elements of the costs primarily include (i) payroll and other related costs of personnel related directly to the contract activities; (ii) costs related to pre-clinical testing and clinical trials such as payments to contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”), investigators, and clinical trial sites that conduct the contract activities; (iii) costs to develop the product candidates, including raw materials and supplies, product testing, depreciation, and facility-related expenses; and (iv) other research and development costs.
r. Accounts Receivable
In general, accounts receivable consists of amounts due from customers, net of customer allowances for cash discounts, product returns and chargebacks. The Company's contracts with customers have standard payment terms. The Company will analyze accounts that are past due for collectability, and regularly evaluate the creditworthiness of its customers so that it can properly assess and respond to changes in their credit profiles. As of September 30, 2026, the credit profiles for the Company’s customers were deemed to be in good standing and an allowance for credit losses was not considered necessary.
s. Inventory
Inventories are stated at the lower of cost or net realizable value and recognized on a first-in, first-out (“FIFO”) method. Inventory is capitalized based on when future economic benefit is expected to be realized.
The Company analyzes its inventory levels on a periodic basis to determine if any inventory is at risk for expiration prior to sale or has a cost basis that is greater than its estimated future net realizable value. Any adjustments are recognized through cost of goods sold in the period in which they are incurred. The Company's reserve for inventory as of September 30, 2026 and December 31, 2025 was $0.4 million andnil, respectively. This reserve was recognized through cost of sales.
The Company outsources the manufacturing of its products to contract manufacturers. The Company expects to use the inventory that is classified within current assets on its consolidated balance sheet over its operating cycle. Inventory that is not expected to be used within the Company’s normal operating cycle is classified as non-current. As of September 30, 2026, the Company had no non-current inventory.
t. Revenue Interest Financing Agreement
The carrying amount of the liability for sale of future royalties is based on management's estimate of the future royalties to be paid over the life of the Financing Agreement (as defined below) using an imputed rate of interest. The liability is amortized using the effective interest rate method, resulting in recognition of non-cash interest expense over the estimated term of the agreement. This requires the Company to estimate the total future royalty payments expected to be generated from product sales over the life of the agreement. The Company assesses at the end of each reporting period the amount and timing of expected royalty payments using a combination of internal projections and data from external sources. The estimates of future net product sales, and resulting royalty payments, are based on key assumptions including patient population, market penetration, gross-to-net assumptions, and sales price, among others. To the extent the Company's revised estimates of future global net sales are greater or less than previous estimates, or the estimated timing of such payments is different from previous estimates, the Company accounts for any such changes by adjusting the effective interest rate utilizing the prospective method. Changes in the effective interest rate also affect the period over which unamortized debt discount and issuance costs are amortized. Such costs are recognized under Interest expense in the Consolidated Statements of Operations and Comprehensive Loss and under Accrued expenses on the Consolidated Balance Sheets.
u. Leases
The Company determines if an arrangement contains a lease at inception. For arrangements where the Company is the lessee, operating leases are included in operating lease right-of-use, or ROU assets; current operating lease liabilities; and non-current operating lease liabilities on its balance sheets. The Company currently does not have any finance leases.
Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. ROU assets also include any initial direct costs incurred and any lease payments made on or before the lease commencement date, less lease incentives received. The Company uses its incremental borrowing rate based on the information available at the commencement date in determining the lease liabilities as the Company’s leases generally do not provide an implicit rate. The incremental borrowing rate is reevaluated upon a lease modification. The operating lease ROU asset also includes any initial direct costs and prepaid lease payments made less any lease incentives. The Company considered information available at the adoption date of Topic 842 to determine the incremental borrowing rate for leases in existence as of this date. The incremental borrowing rate used was the weighted average rate between secured and unsecured lending arrangements. Lease terms may include options to extend or terminate the lease when the Company is reasonably certain that the option will be exercised. Variable payments included in the lease agreement are expensed as incurred. Lease expense is recognized on a straight-line basis over the lease term.
The Company elected to apply each of the practical expedients described in ASC Topic 842-10-65-1(f) which allow companies not to reassess: (i) whether any expired or existing agreements contain leases, (ii) the classification of any expired or existing leases, and (iii) the capitalization of initial direct costs for any existing leases. The Company also elected to apply the short-term lease measurement and recognition exemption in which ROU assets and lease liabilities are not recognized for short-term operating leases. A short-term operating lease is a lease that, at the commencement date, has a lease term of 12 months or less and does not include an option to purchase the underlying asset that the lessee is reasonably certain to exercise. The Company also elected not to separate non-lease components from lease components and instead to account for each separate lease component and the non-lease components associated with that lease component as a single lease component.
v. Segment Information
The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company’s operations are focused on oncology development activities. Substantially all revenue was derived from customers located in the U.S., China and Japan.
The Company's Chief Executive Officer is the Chief Operating Decision Maker (“CODM”). The CODM utilizes the Company’s strategic product development roadmaps and financial models as a key input to resource allocation. The CODM is regularly provided with actual, budgeted and forecasted expense information to make decisions on resource allocation and assess performance of the business and monitor budget versus actual results using income from operations.
Significant expenses within income from operations, as well as within net income, include cost of revenue, research and development, and selling, general and administrative expenses, which are each separately presented on the Company’s Consolidated Statements of Operations and Comprehensive Loss. Other segment items within net income include interest income, interest expense, investment advisory fees, change in fair value of warrant liability, realized loss on marketable securities and other expense, net, and income tax expense.
w. Research and Development Costs
Costs incurred in connection with research and development activities are expensed as incurred. These costs include fees paid to consultants, vendors and various entities that perform certain research and testing on behalf of the Company.
The Company has acquired rights to develop and commercialize product candidates. Upfront payments that relate to the acquisition of a new product compound, as well as pre-commercial milestone payments, are immediately expensed as acquired in-process research and development in the period in which they are incurred, provided that the new product compound did not also include processes or activities that would constitute a “business” as defined under U.S. GAAP, and the product candidate has not achieved regulatory approval for marketing and, absent obtaining such approval, has no established alternative future use. Milestone payments made to third parties subsequent to regulatory approval which meet the capitalization criteria would be capitalized as intangible assets and amortized over the estimated remaining useful life of the related product. If the conditions enabling capitalization of development costs as an asset have not yet been met, all development expenditures are recognized in profit or loss when incurred.
x. Stock-based Compensation
The Company recognizes compensation cost for grants of employee stock options using a fair-value measurement method, that is recognized in operating results as compensation expense based on fair value over the requisite service period of the awards. Forfeitures are recorded as they occur instead of estimating forfeitures that are expected to occur.
The Company determines the fair value of stock-based awards that are based only on a service condition using the Black-Scholes option-pricing model which uses both historical and current market data to estimate fair value. The method incorporates various assumptions such as the risk-free interest rate, volatility, dividend yield, and expected life of the options.
The Company determines the fair value of stock-based awards that are based on both a service condition and achievement of the first to occur of a market or performance condition using a Monte Carlo simulation.
y. Income Taxes
The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company’s tax returns. The difference between the financial statement and tax basis of assets and liabilities is determined annually. Deferred income tax assets and liabilities are computed for those differences that have future tax consequences using the currently enacted tax laws and rates that apply to the years in which they are expected to affect taxable income. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense.
The Company uses a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken, or expected to be taken, in a tax return. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate. The Company’s policy is to record interest and penalties related to income taxes as part of the tax provision. Returns for tax years beginning with those filed for the period ended December 31, 2018 are open to federal and state tax examination.
z. Recent Accounting Pronouncements
In November 2024, the FASB issued Subtopic 220-40 “Disaggregation of Income Statement Expenses”, which requires an entity to disclose, on an annual and interim basis, disaggregated information about certain income statement expense line items in a tabular format in the notes to the financial statements. The standard will be effective for annual reporting periods beginning after December 15, 2026 and for interim reporting periods within annual reporting periods beginning after December 15, 2027, with early adoption permitted, and may be applied either prospectively or retrospectively. The Company is currently evaluating the potential effect that the updated standard will have on its financial statement disclosures.
- Fair Value Measurements and Marketable Securities Available-for-Sale
The Company provides disclosure of financial assets and financial liabilities that are carried at fair value based on the price that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements may be classified based on the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities using the following three levels:
Level 1 — Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
Level 2 — Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves, etc.) and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs).
Level 3 — Unobservable inputs that reflect the Company’s estimates of the assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available, including its own data.
The following table presents information about the Company’s marketable securities as of September 30, 2026 and December 31, 2025, as well as the Warrant liability as of December 31, 2025, measured at fair value on a recurring basis, and indicates the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value. The Company’s Warrant liabilities are included within the Level 1 fair value hierarchy. The fair value of the Consideration, Public and Forward Purchase Warrants is determined using the closing price of the warrants on the NYSE market. The fair value of the Private Placement Warrants is determined using the Black-Scholes option pricing formula. The primary unobservable input utilized in determining the fair value of the Private Warrants is the expected volatility. The expected volatility was estimated considering observable Public Warrant pricing, the Company's own historical volatility and the volatility of guideline public companies. There have not been any transfers between the levels during the periods. The Warrants expired on February 10, 2026.
| Total | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|
| (In thousands) | ||||
| Financial assets: | ||||
| Cash equivalents: | ||||
| Money market funds | $21,016 | $21,016 | $— | $— |
| Commercial paper | 15,466 | — | 15,466 | — |
| U.S. government securities | 25,901 | — | 25,901 | — |
| 62,383 | 21,016 | 41,367 | — | |
| Marketable securities: | ||||
| Certificate of deposits | 4,156 | — | 4,156 | — |
| Commercial paper | 60,332 | — | 60,332 | — |
| U.S. government and government agency securities | 284,301 | — | 284,301 | — |
| Corporate bonds | 160,815 | — | 160,815 | — |
| 509,604 | — | 509,604 | — | |
| Total financial assets: | $571,987 | $21,016 | $550,971 | $— |
| Total | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|
| (In thousands) | ||||
| Financial assets: | ||||
| Cash equivalents: | ||||
| Money market funds | $52,339 | $52,339 | $— | $— |
| U.S. government and government agency securities | 43,990 | — | 43,990 | — |
| 96,329 | 52,339 | 43,990 | — | |
| Marketable securities: | ||||
| Certificate of deposits | 3,918 | — | 3,918 | — |
| Commercial paper | 5,158 | — | 5,158 | — |
| U.S. government and government agency securities | 226,777 | — | 226,777 | — |
| Corporate bonds | 129,272 | — | 129,272 | — |
| 365,125 | — | 365,125 | — | |
| Total financial assets: | $461,454 | $52,339 | $409,115 | $— |
| Financial liabilities: | ||||
| Warrants | $2,865 | $2,865 | $— | $— |
Marketable securities consist primarily of U.S. government and government agency, certificate of deposits, commercial paper, corporate bond and municipal securities (“Debt Securities”). Based on the Company’s intentions regarding its marketable securities, all Debt Securities are classified as available-for-sale and are carried at fair value based on the price that would be received upon sale of the security.
The following table provides the amortized cost, aggregate fair value, and unrealized gains (losses) of marketable securities as of September 30, 2026 and December 31, 2025:
| AmortizedCost | Unrealized Gains | Unrealized Losses | Fair Value | |
|---|---|---|---|---|
| (In thousands) | ||||
| Cash equivalents: | ||||
| Money market funds | $21,016 | $— | $— | $21,016 |
| Commercial paper | 15,469 | — | (3) | 15,466 |
| U.S. government securities | 25,906 | — | (5) | 25,901 |
| 62,391 | — | (8) | 62,383 | |
| Marketable securities: | ||||
| Certificate of deposits | 4,160 | — | (4) | 4,156 |
| Commercial paper | 60,463 | 2 | (133) | 60,332 |
| U.S. government and government agency securities | 286,040 | 1 | (1,740) | 284,301 |
| Corporate bonds | 161,492 | 6 | (683) | 160,815 |
| 512,155 | 9 | (2,560) | 509,604 | |
| $574,546 | $9 | $(2,568) | $571,987 | |
| AmortizedCost | Unrealized Gains | Unrealized Losses | Fair Value | |
|---|---|---|---|---|
| (In thousands) | ||||
| Cash equivalents: | ||||
| Money market funds | $52,339 | $— | $— | $52,339 |
| U.S. government and government agency securities | 43,985 | 5 | — | 43,990 |
| 96,324 | 5 | — | 96,329 | |
| Marketable securities: | ||||
| Certificate of deposits | 3,909 | 9 | — | 3,918 |
| Commercial paper | 5,154 | 4 | — | 5,158 |
| U.S. government and government agency securities | 226,247 | 530 | — | 226,777 |
| Corporate bonds | 129,044 | 249 | (21) | 129,272 |
| 364,354 | 792 | (21) | 365,125 | |
| $460,678 | $797 | $(21) | $461,454 | |
For the three and nine months ended September 30, 2026 and 2025, there were no unrealized gains or losses on equity securities. The activity related to the net gains (losses) on marketable securities included in other income (expense) on the consolidated statements of operations and comprehensive loss were as follows (in thousands):
| For the three months ended September 30, | For the nine months ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Net realized gains (losses) on available-for-sale securities were as follows: | ||||
| Realized gains from sales of available-for-sale securities | $2 | $— | $30 | $3 |
| Realized losses from sales of available-for-sale securities | (15) | — | (26) | (1) |
| Net (losses) gains on marketable securities | $(13) | $— | $4 | $2 |
The following tables provide marketable securities with continuous unrealized losses for less than 12 months and 12 months or greater and the related fair values as of September 30, 2026 and December 31, 2025 were as follows:
| Less than 12 Months · 12 Months or Greater · Total · Total | ||||||
|---|---|---|---|---|---|---|
| Fair Value | Unrealized Losses | Fair Value | Unrealized Losses | Fair Value | Unrealized Losses | |
| (In thousands) | ||||||
| Certificate of deposits | $2,155 | $(4) | $— | $— | $2,155 | $(4) |
| Commercial paper | 56,073 | (133) | — | — | 56,073 | (133) |
| U.S. government and government agency securities | 274,001 | (1,740) | — | — | 274,001 | (1,740) |
| Corporate bonds | 145,218 | (667) | 3,436 | (16) | 148,654 | (683) |
| $477,447 | $(2,544) | $3,436 | $(16) | $480,883 | $(2,560) | |
| Less than 12 Months · 12 Months or Greater · Total · Total | ||||||
|---|---|---|---|---|---|---|
| Fair Value | Unrealized Losses | Fair Value | Unrealized Losses | Fair Value | Unrealized Losses | |
| (In thousands) | ||||||
| Corporate bonds | $18,157 | $(21) | $— | $— | $18,157 | $(21) |
| $18,157 | $(21) | $— | $— | $18,157 | $(21) | |
Unrealized losses from the marketable securities are primarily attributable to changes in interest rates and represent temporary impairments due to general market factors. The Company has not recognized an allowance for expected credit losses related to available-for-sale investments as the Company has not identified any unrealized losses for these investments attributable to credit factors during the three and nine months ended September 30, 2026. As of September 30, 2026, the Company does not intend to sell these securities nor does the Company believe that it will be required to sell these securities before the recovery of their amortized cost basis.
Maturity information based on fair value is as follows as of September 30, 2026:
| Within one year | After one yearthrough five years | Total | |
|---|---|---|---|
| (In thousands) | |||
| Certificate of deposits | $4,156 | $— | $4,156 |
| Commercial paper | 60,332 | — | 60,332 |
| U.S. government and government agency securities | 210,119 | 74,182 | 284,301 |
| Corporate bonds | 88,499 | 72,316 | 160,815 |
| $363,106 | $146,498 | $509,604 | |
Convertible Debt and Liability Related to Revenue Interest Financing Agreement
As of September 30, 2026, the estimated fair value of the convertible debt was $298.4 million. The fair value was estimated using quoted market prices obtained from brokers. Accordingly, it was categorized as Level 2 in the fair value hierarchy. The fair value of the liability related to the sale of future royalties is based on the Company's current estimates of future royalties expected to be paid to Sagard over the life of the arrangement. The Company periodically reassesses the amount and timing of estimated royalty payments based on internal sales projections and external information from market data sources, which are considered Level 3 inputs. As of September 30, 2026, the estimated fair value of the liability approximated the carrying amount.
- Revenue Recognition
The Company revenue by geographic region for the three and nine months ended September 30, 2026 and 2025 are summarized as follows (in thousands):
| For the three months ended September 30, | For the nine months ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| United States | $27,457 | $7,723 | $128,036 | $8,961 |
| China | 15,589 | 2,184 | 28,769 | 8,438 |
| Japan | 1,896 | 3,213 | 3,052 | 3,638 |
| Europe | 9 | — | 9 | — |
| Total revenue | $44,951 | $13,120 | $159,866 | $21,037 |
Net Product Revenue
Net product revenue was approximately$27.5 million and$69.2 million for the three and nine months ended September 30, 2026 from the U.S. sales of IBTROZI, respectively.
Net product revenue was approximately $7.7 million and $9.0 million for the three and nine months ended September 30, 2025 from the U.S. sales of IBTROZI, respectively. The Company began shipping IBTROZI to its U.S. customers in June 2025.
Collaboration and License Agreements Revenue
The Company enters into collaborative arrangements for the research and development, and commercialization of drug products and drug candidates. To date, these collaborative arrangements have included out-licensing of and options to out-license in-licensed compounds to other parties. These arrangements may include non-refundable upfront payments, contingent obligations for potential development, regulatory and commercial performance milestone payments, cost reimbursement arrangements, product supply and royalty payments.
In-Licensing Arrangements with Daiichi Sankyo Company Ltd. (“DS”)
The Company has in-licensed from DS the rights to develop, manufacture and commercialize taletrectinib and safusidenib globally. The development milestone payments are recognized when the achievement of the associated milestone becomes probable and estimable and have been expensed before regulatory approval has been obtained. In December 2024, a $2.0 million development milestone payment was capitalized as an intangible asset upon regulatory approval of taletrectinib in China. The Company reachedtwo taletrectinib-related milestones in 2024, and the resulting $6.0 million in development milestone payments owed were paid to DS in March 2025. In June 2025, upon regulatory approval of taletrectinib in the U.S., an $8.0 million milestone payment was owed to DS under the arrangement. This milestone payment was paid in July 2025 and was capitalized as an intangible asset. The Company paid
$3.0 million in February 2026 after converting the safusideninb SIGMA study into a pivotal study, which was expensed to research and development. The Company paid $0.5 million in April 2026 after amending and restating its safusidenib license agreement with DS to include Japan rights, effectively securing exclusive global development and commercialization rights to safusidenib. During the three months ended September 30, 2026, the Company achieved the $100.0 million cumulative worldwide sales of taletrectinib, thereby triggering the milestone payment obligation of $10.0 million to DS. This milestone obligation was capitalized as an intangible asset.
Out-Licensing Arrangements
The Company's revenue related to its out-licensing collaborative agreements consist of product revenue, upfront license fees, royalty revenue and research and development services revenue from its collaboration agreements with Innovent Biologics Co. Ltd. (“Innovent”), Nippon Kayaku Co., Ltd. (“NK”), and Eisai Co., Ltd. (“Eisai”) for taletrectinib (also known as “AB-106”).
Collaboration and License Agreement with Innovent
In May 2021, a wholly owned subsidiary of AnHeart entered into an agreement with Innovent, granting Innovent a sub-licensable, royalty-bearing, exclusive right and license to commercialize AB-106 in the People's Republic of China and Taiwan (the “Innovent Territory”). Following the acquisition of AnHeart by the Company, such AnHeart subsidiary was renamed Nuvation Bio China Ltd. Nuvation Bio China Ltd. is responsible for funding ongoing clinical trials of AB-106, regulatory submissions after development with Innovent responsible for commercialization. To date, under the agreement, Nuvation Bio China Ltd. has received $72.0 million in connection with an upfront payment, reimbursement of research and development expenses, and achievement of regulatory and commercial milestones. In addition, Nuvation Bio China Ltd. may receive up to $17.0 million upon achievement of additional regulatory milestones, up to $100.0 million upon achievement of commercial milestones, and tiered percentage royalties ranging from mid-teen to low-twenties on annual net sales of taletrectinib in the Innovent Territory subject to certain adjustments.
For the three months ended September 30, 2026, collaboration and license agreements revenue was comprised of research and development service revenue of$1.6 million, sales of products supply of $6.8 million, royalties of$2.1 million and sales milestone of $5.0 million. For the nine months ended September 30, 2026, collaboration and license agreements revenue was comprised of research and development service revenue of $4.2 million, sales of products supply of$14.1 million, royalties of$5.1 million and sales milestone of $5.0 million.
For the three months ended September 30, 2025, collaboration and license agreements revenue was comprised of research and development service revenue of $1.9 million and royalties of $0.3 million. For the nine months ended September 30, 2025, collaboration and license agreements revenue was comprised of research and development service revenue of $5.9 million, sales of products supply of $1.6 million and royalties of $0.8 million.
Collaboration and License Agreement with NK
In October 2023, AnHeart entered into an agreement with NK, granting NK a sub-licensable, royalty-bearing, exclusive right and license to commercialize AB-106 in Japan (the “NK Territory”). Following the acquisition of AnHeart by the Company, the agreement was assigned to the Company. The Company is responsible for funding ongoing clinical trials of AB-106 in the NK Territory, with NK responsible for funding regulatory submissions in the NK Territory. The Company also granted NK a sub-licensable, royalty-bearing, exclusive right and license to research, develop and commercialize any new indications of AB-106 in the NK Territory (“NK New Indication Right”). Under the agreement, the Company received a non-refundable upfront cash payment of $40.0 million, $25.0 million for achievement of a regulatory milestone (“Regulatory Milestone Payment”), and is eligible to receive up to $35.0 million upon achievement of commercial milestones and a lower-mid double digit percentage royalty on net sales of taletrectinib in the NK Territory. In September 2025, taletrectinib was approved by Japan’s Ministry of Health, Labour, and Welfare. Since the regulatory approval has now been obtained, all remaining contract liability for research and development service from the initial upfront payment was recognized as revenue. In December 2025, upon receipt of the Regulatory Milestone Payment, the Company recognized $21.2 million in license revenue and $3.8 million in research and development service revenue.
The Company collaboration and license agreements revenue was comprised of sales of products supply of $1.3 million and royalties of$0.6 million for the three months ended September 30, 2026. For the nine months ended September 30, 2026, collaboration and license agreements revenue was comprised of research and development service revenue of$0.2 million, sales of products supply of $1.4 million and royalties of $1.5 million.
For the three months ended September 30, 2025, collaboration and license agreements revenue was comprised of research and development service revenue of $2.6 million and sales of products supply of $0.6 million. For the nine months ended September 30, 2025, collaboration and license agreements revenue was comprised of research and development service revenue of $3.0 million and sales of products supply of $0.6 million.
Collaboration and License Agreement with Eisai
On January 11, 2026, the Company entered into a License and Collaboration Agreement (the “License Agreement”) with Eisai. Pursuant to the License Agreement, the Company granted Eisai an exclusive license to develop and commercialize licensed products containing taletrectinib in the following territories: the European Union and all member states thereof, Albania, Andorra, Armenia, Azerbaijan, Belarus, Bosnia and Herzegovina, Georgia, Kosovo, Moldova, Monaco, Montenegro, North Macedonia, San Marino, Serbia, Switzerland, Ukraine, Vatican City, the United Kingdom, Russia, Turkey, Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, the United Arab Emirates, Israel, Jordan, Iran, Iraq, Libya, Lebanon, Egypt, Sudan, Morocco, Algeria, Tunisia, Australia, New Zealand, Canada, Singapore, Philippines, Indonesia, Thailand, Malaysia, Vietnam and India (collectively, the “Territory”).
Under the terms of the License Agreement, the Company received €50.0 million (approximately USD $58.7 million) upfront and is eligible to receive up to €145.0 million (approximately USD $170.0 million) in regulatory and commercial milestone payments, as well as double-digit tiered royalties up to the high-teens as a percentage of future net sales in the Territory. Following the upfront payment, the Company will receive the first milestone payment of €25.0 million (approximately USD $30.0 million) from this transaction upon achievement of EU regulatory approval (conditional or full) of taletrectinib. In January 2026, upon receipt of the upfront payment, the Company recognized approximately $58.7 million in license revenue.
Contract assets and contract liabilities
When the Company satisfies its performance obligations by providing services to a customer before the customer pays consideration and before payment is due, the Company recognizes its rights to consideration as a contract asset.
The Company didnot recognize any contract assets as of September 30, 2026.
When a customer pays consideration before the Company provides services, the Company records its obligation as a contract liability representing the transaction price allocated to the remaining performance obligations. As of September 30, 2026, contract liabilities were $15.7 million, of which $0.3 million is expected to be recognized as product revenue and $15.4 million as research and development service revenue. Of the $15.4 million, $8.7 million is expected to be recognized within one year of the balance sheet date, with the remaining $6.7 million expected to be recognized over the next three years.
The Company recognized $4.2 million of revenue for the nine months ended September 30, 2026 that was included in the contract liability balance at December 31, 2025.
The costs incurred to fulfill customer contracts were capitalized and amortized to cost of revenue on a systematic basis that is consistent with the transfer of research and development services to the customer to which the asset relates. For the three and nine months ended September 30, 2026, $1.4 million and$3.8 million of costs incurred to fulfill customer contracts were capitalized and expensed in the same period, respectively. There were no balances related to the costs incurred to fulfill customer contracts as of September 30, 2026.
- Borrowing
Convertible Senior Notes Offering
In June 2026, the Company completed its registered underwritten public offering of $250.0 million aggregate principal amount of 0.75% Convertible Senior Notes due 2032 (the “Notes”). The Company granted the underwriters an option, exercisable within 30 days of the offering, to purchase up to an additional $37.5 million aggregate principal amount of Notes, issued pursuant to the exercise in full of the overallotment option granted by the Company to the Underwriters (defined below). The Notes were sold pursuant to the Underwriting Agreement, dated June 25, 2026 with Jefferies LLC, Citigroup Global Markets Inc., and Cantor Fitzgerald & Co. as representatives of the several underwriters (the “Underwriters”).
In July 2026, the Company announced the full exercise of the greenshoe option in its offering of the Notes. The Underwriters purchased an additional $37.5 million aggregate principal amount of notes, bringing the aggregate principal amount sold in the offering to $287.5 million, with net proceeds of approximately $279.1 million after deducting underwriting discounts and commissions, and offering expenses.
The Notes are general unsecured obligations of the Company and bear interest at a rate of 0.75% per year, payable semiannually in arrears on January 1 and July 1 of each year, beginning on January 1, 2027. The Notes will mature on July 1, 2032, unless earlier converted, redeemed or repurchased.
The initial conversion rate for the Notes is 127.4941 shares of Class A Common Stock per $1,000 principal amount of Notes, which is equivalent to an initial conversion price of approximately $7.84 pershare of Class A Common Stock. The conversion rate for the Notes is subject to customary adjustments for certain events as described in the indenture governing the Notes, but will not be adjusted for accrued and unpaid interest. In addition, following certain corporate events that occur prior to the maturity date or if the Company delivers a notice of redemption in respect of the Notes, the Company will, in certain circumstances, increase the conversion rateof the Notes for a holder who elects to convert its Notes in connection with such a corporate event or convert its Notes called (or deemed called) for redemption during the related redemption period, as the case may be.
The Company may not redeem the Notes prior to July 6, 2029. The Company has the option to redeem for cash all or any portion of the Notes (subject to certain limitations) on a redemption date on or after July 6, 2029 if the last reported sale price of the Class A Common Stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which the Company provides the related notice of redemption at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. No sinking fund is provided for the Notes, which means that the Company is not required to redeem or retire the Notes periodically.
Holders may convert all or any portion of their Notes at their option at any time prior to the close of business on the business day immediately preceding April 1, 2032 only upon satisfaction of one or more of the following conditions:
at any time during the 30 consecutive trading day period beginning on, and including, the 21st trading day of any calendar quarter commencing after the calendar quarter ending on September 30, 2026, if the last reported sale price of the Class A Common Stock exceeds 130% of the conversion price for each of at least five trading days (whether or not consecutive) during the first 20 consecutive trading days of such calendar quarter;
during the five business day period after any ten consecutive trading day period (the “measurement period”) in which the trading price per $1,000 principal amount of the Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the Class A Common Stock and the conversion rate for the Notes on each such trading day;
if the Company calls such Notes for redemption, at any time prior to the close of business on the second scheduled trading day immediately preceding the redemption date, but only with respect to the Notes called (or deemed called) for redemption; or
upon the occurrence of specified corporate events.
On or after April 1, 2032 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their Notes at their option at any time, regardless of the foregoing conditions. Upon conversion, the Company will pay or deliver, as the case may be, cash, shares of Class A Common Stock, or a combination of cash and shares of Class A Common Stock, at the Company’s election, in the manner and subject to the terms and conditions provided in the indenture governing the Notes.
The Notes are accounted for as long-term debt and are measured at amortized cost. Debt issuance costs of $8.0 million, including underwriting discounts and other offering costs, are recorded as a direct deduction from the carrying amount of the Notes and are amortized to interest expense over the contractual term of the Notes using the effective interest method.
The following table presents the carrying amount of the Notes as of September 30, 2026.
| (in thousands) | |
|---|---|
| Principal | $287,500 |
| Unamortized underwriter discounts and issuance costs | (8,041) |
| Net carrying amount | $279,459 |
The following table sets forth the total interest expense recognized and effective interest rates related to the Notes for the periods presented:
| Three months ended | Nine months ended | |
|---|---|---|
| September 30, 2026 | September 30, 2026 | |
| (in thousands) | ||
| Contractual interest expense | $541 | $541 |
| Amortization of debt discount and issuance costs | 340 | 343 |
| Total interest and amortization expense | $881 | $884 |
| Effective interest rate | 1.26% | 1.26% |
The following table presents future minimum payments under the Notes as of September 30, 2026 are as follows:
| (In thousands) | |
|---|---|
| 2026 (remaining 3 months) | $— |
| 2027 | 2,158 |
| 2028 | 2,156 |
| 2029 | 2,156 |
| 2030 | 2,156 |
| Thereafter | 291,813 |
| Total | 300,439 |
| Less: imputed interest | (12,939) |
| Less: unamortized debt discount and issuance costs | (8,041) |
| Total principal amount | $279,459 |
2026 Capped Call Transactions
In connection with the issuance of the Notes, the Company entered into capped call transactions in June 2026 and July 2026 with certain counterparties at a net cost of approximately $17.1 million. The capped call transactions are expected generally to reduce the potential dilution to the Class A Common Stock upon any conversion of the Notes and/or offset any cash payments the Company is required to make in excess of the principal amount of converted Notes, as the case may be, with such reduction and/or offset subject to a cap based on a cap price initially equal to $10.4580 per share, and is subject to certain adjustments under the terms of the capped call transactions.
For accounting purposes, the capped call transactions described above are separate transactions, and not part of the terms of the Notes. As these transactions met certain criteria under the applicable accounting guidance, each of the capped call transactions were recorded in stockholders’ equity and were not accounted for as derivatives. The cost of the capped call transactions was recorded as a reduction of the Company’s additional paid-in capital in the Company’s condensed consolidated balance sheet and will not be remeasured.
Loan Agreements
On March 3, 2025 (the “Loan Closing Date”), the Company entered into a $100.0 million senior secured loan agreement (the “Loan Agreement”), with Sagard Holdings Manager LP (“Sagard”) as administrative agent, and the lenders party thereto. The $50.0 million tranche of the term loan was funded on June 25, 2025, following the U.S. Food and Drug Administration’s (“FDA”) approval of IBTROZI. The second tranche of $50.0 million of the term loan was available but not borrowed. In connection with the issuance of the Notes, on June 30, 2026, the Company used approximately $58.7 million of the net proceeds thereof to repay in full all outstanding obligations and terminate the Loan Agreement and pay an amendment fee under the Financing Agreement (as defined below). The Company recorded a $9.5 million loss on debt extinguishment as a result of this transaction.
The senior secured loans under the Loan Agreement (the “Loans”) had a maturity date of September 30, 2030 and bore interest at a variable annual rate equal to the secured overnight financing rate (subject to a 4.00% floor) plus a margin of 6.00%, payable quarterly. The Company was required to pay a funding fee equal to a low single-digit percentage of each tranche, upon, and subject to, funding of such tranche, and an exit fee equal to a nominal percentage of each tranche upon repayment of such tranche.
The Loan Agreement permitted voluntarily prepayment of the Loans at any time subject to a prepayment premium which, in connection with the prepayment on June 30, 2026, was equal to the amount of interest that would have been paid up to, but not including, June 25, 2027, plus 3.00% of the principal amount of the Loans being repaid.
The obligations of the Company under the Loan Agreement were guaranteed by certain of its existing subsidiaries and were required to be guaranteed by subsequently acquired or organized subsidiaries, subject to certain exceptions (collectively, the “Guarantors”). The obligations of the Company under the Loan Agreement and the related guarantees thereunder were secured, subject to customary permitted liens and other agreed upon exceptions, by (i) a pledge of all of the equity interests of the Company’s and the Guarantors’ direct subsidiaries, and (ii) a perfected security interest in substantially all of the Company’s and the Guarantors’ tangible and intangible assets.
The Loan Agreement contained customary representations and warranties and customary affirmative and negative covenants, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of other indebtedness, and dividends and other distributions, subject to certain exceptions. In addition, the Loan Agreement contained a financial covenant requiring that the Company maintain not less than $25 millionof cash and certain cash equivalent investments. Failure of the Company tocomply with the financial covenant will result in an event of default, subject to certain cure rights of the Company other than under certain specified circumstances.
The Loan Agreement contained events of default which are customary for financings of this type, in certain circumstances subject to customary cure periods. Following an event of default and any cure period, if applicable, Sagard had the right upon notice to terminate any undrawn commitments and may accelerate all amounts outstanding under the Loan Agreement, in addition to other remedies available to it as a secured creditor of the Company.
Revenue Interest Financing Agreement
On the Loan Closing Date, the Company also entered into a Revenue Interest Financing Agreement (as amended by the First Amendment to Revenue Interest Financing Agreement dated June 24, 2026, the “Financing Agreement”) with Sagard Healthcare Partners Funding Borrower SPE 2, LP (as assignee of Sagard Healthcare Partners (Delaware) II LP) (the “Investor”), pursuant to which the Investor paid the Company $150 million (the “Investment Amount”) on June 25, 2025, following the FDA’s approval of IBTROZI. In exchange for the Investment Amount, the Company agreed to make tiered royalty payments to the Investor (the “Payments”) on U.S. net sales of IBTROZI equal to 5.5% of annual U.S. net sales up to $600 million and 3.0% of annual U.S. net sales between $600 million and $1 billion. The Company retains all annual U.S. net sales above $1 billion. The obligation to make the Payments will cease upon the earliest occurrence of total Payments reaching 1.6 times the Investment Amount by the calendar quarter ending on June 30, 2031, 1.75 times the Investment Amount by the calendar quarter ending on June 30, 2034, or 2.0 times the Investment Amount thereafter.
The Company is required to make a true up payment to the Investor to the extent the Investor has not received Payments equaling at least 100% of the Investment Amount by February 1, 2043 in an amount equal to any such shortfall.
The Company’s obligations under the Financing Agreement are secured, subject to customary permitted liens and other agreed upon exceptions, by a perfected security interest in (i) accounts receivable arising from U.S. net sales of IBTROZI and (ii) intellectual property, product registrations and regulatory approvals related to commercialization of IBTROZI in the United States.
The Company has the right, but not the obligation (the “Call Option”), to buy out the Investor’s interest in the Payments at a repurchase price (the “Put/Call Price”) equal to (a) on or prior to the second anniversary of the Loan Closing Date, an amount equal to 140% of the Investment Amount, less all Payments made to the applicable repurchase date, (b) after the second anniversary but on or prior to August 1, 2031, an amount equal to 160% of the Investment Amount, less all Payments made to the applicable repurchase date, (c) after August 1, 2031 but on or prior to August 1, 2034, an amount equal to 175% of the Investment Amount, less all Payments made to the applicable repurchase date, and (d) after August 1, 2034, an amount equal to 200% of the Investment Amount, less all Payments made to the applicable repurchase date.
The Financing Agreement contains customary representations and warranties and certain restrictions on the Company’s ability to incur indebtedness and grant liens on intellectual property, product registrations and regulatory approvals related to commercialization and development of taletrectinib in the United States. In addition, the Financing Agreement provides that if certain events (“Put Option Events”) occur, including certain bankruptcy events, non-payment of Payments, a change of control, expiration or termination of certain intellectual property rights or marketing authorization, an out-license or sale of all of the rights in and to taletrectinib in the United States and (subject to applicable cure periods) non-compliance with the covenants in the Financing Agreement, the Investor may require the Company to repurchase its interests in the Payments at the Put/Call Price.
The Financing Agreement was recorded as debt at the time the funding occurred and is accounted for at amortized cost using the effective interest method. The Company utilizes the prospective method to account for subsequent changes in the estimated future royalties to be paid by the Company to the counterparty over the estimated term of the obligation. Under the prospective method, a new effective interest rate is determined based on the revised estimate of remaining cash flows. The new rate is the discount rate that equates the present value of the revised estimate of remaining cash flows with the carrying amount of the debt, and it will be used to recognize interest expense for the remaining periods. If the amount or timing of expected royalty payments differs from prior estimates, the Company will prospectively adjust the amortization of the royalty financing obligations and the effective interest rate.
During the nine months ended September 30, 2026, there were no significant changes to the amount and timing of expected royalties under the Financing Agreement based on the Company’s latest forecasts subsequent to the initial measurement.
The following table shows the activity within the liability related to the Financing Agreement for the nine months ended September 30, 2026 as well as the effective interest rate as of September 30, 2026:
| Liabilities Related to Financing Agreement | |
|---|---|
| (in thousands) | |
| Carrying value of liability related to Financing Agreement at December 31, 2025 | $155,404 |
| Payments on Financing Agreement | (3,157) |
| Non-cash interest expense | 15,168 |
| Amortization of issuance costs | 619 |
| Carrying value of liability related to Financing Agreement at September 30, 2026 | $168,034 |
| Effective interest rate | 13.0% |
Bank Loan
In 2020, AnHeart entered into loan agreements with Bank of Hangzhou to obtain short-term borrowings to supplement its working capital. As of September 30, 2026, the outstanding balance net of repayments was $5.8 million. For the nine months ended September 30, 2026, there wereno borrowings or repayments. The fixed interest rate of these borrowings is 3.5%per annum.
- Leases
The Company's principal executive offices are located in New York, New York, where the Company leases approximately 7,900 square feet of office space under a lease that terminates in 2027, and in San Francisco, where the Company leases approximately 19,418 square feet of office space that terminates in 2029. In September 2026, the Company commenced a lease of approximately 18,563 square feet of office space in New York. The lease expires in 2037. The Company also occupies office space located in Burlington, Massachusetts, where the Company leases approximately 2,235 square feet of office space under a lease that terminates in 2027, as well as a total of approximately 1,799 square meters of office space in the People’s Republic of China, in the cities of Beijing, Guangzhou, Hangzhou and Shanghai, under leases that terminate in 2026 through 2029.
Operating lease expense was$0.6 million and $0.5 millionfor the three months ended September 30, 2026 and 2025, respectively, and$1.7 million and $2.3 million for the nine months ended September 30, 2026 and 2025, respectively. Expense related to variable leases wasnot significant for the three and nine months ended September 30, 2026 and 2025. Operating cash outflows for the nine months ended September 30, 2026 and 2025 included $1.9 million and $2.0 million, respectively.
The following table presents the future minimum lease analysis of the Company's operating lease liabilities showing the aggregate lease payments as of September 30, 2026.
| (In thousands) | |
|---|---|
| 2026 (remaining 3 months) | $551 |
| 2027 | 2,234 |
| 2028 | 3,290 |
| 2029 | 2,154 |
| 2030 | 1,986 |
| Thereafter | 14,346 |
| Total undiscounted lease payments | 24,561 |
| Less: imputed interest | (9,895) |
| Total operating lease liabilities | $14,666 |
The weighted average incremental borrowing rate used to determine the operating lease liabilities was 10.6%. The Company's weighted average remaining lease term was 8.98 years as of September 30, 2026.
- Net Income (Loss) per Share
Basic loss per share is computed by dividing net loss by the weighted-average number of shares of Class A and Class B Common Stock outstanding. Diluted loss per share reflects the potential dilution that could occur if the stock options to issue Common Stock were exercised. The Company had a net loss in all periods presented thus the dilutive net loss per common share is the same as
the basic net loss per common share as the effect of any options or conversions is anti-dilutive.
The earnings per share amounts are the same for the different classes of Common Stock because the holders of each class are legally entitled to equal per share distributions whether through dividends or liquidation.
The following securities outstanding at September 30, 2026 and 2025 have been excluded from the calculation of diluted weighted average shares outstanding for the periods presented because including them would have been antidilutive:
| As of September 30, | ||
|---|---|---|
| 2026 | 2025 | |
| Warrants | — | 8,681,182 |
| Class A Common Stock options | 78,229,809 | 77,074,354 |
| Restricted stock units | 3,814,301 | 116,641 |
| Assumed conversion of the Notes | 31,873,525 | — |
- Accumulated Other Comprehensive Income (Loss)
The following table presents a rollforward of the changes in accumulated other comprehensive income (losses) for the nine months ended September 30, 2026 and 2025, which is all attributable to unrealized gains (losses) on available-for-sale securities and currency translation impact. All amounts are net of tax.
| 2026 | 2025 | |
|---|---|---|
| Balance at beginning of period | $(187) | $573 |
| Unrealized loss | (3,333) | (215) |
| Amount reclassified for realized gain on marketable securities | (4) | (2) |
| Currency translation adjustment | (1,092) | (495) |
| Balance at end of period | $(4,616) | $(139) |
- Stock-Based Compensation
The 2021 Equity Incentive Plan
In March 2019, the Company adopted the 2019 Equity Incentive Plan or (“2019 Plan”), which provided for the grant of options, stock appreciation rights, restricted stock, and other stock awards. In January 2021, the Company's board of directors adopted the 2021 Equity Incentive Plan (the “2021 Plan”). The 2021 Plan was approved by the Company's stockholders in February 2021 and became effective immediately upon the Closing Date of the Merger. Shares available for future issuance under the 2019 Plan were canceled.
Awards. The 2021 Plan provides for the grant of incentive stock options (“ISOs”), within the meaning of Section 422 of the Code to employees, including employees of any parent or subsidiary, and for the grant of nonstatutory stock options (“NSOs”), stock appreciation rights, restricted stock awards, restricted stock unit awards, performance awards and other forms of awards to employees, directors and consultants, including employees and consultants of the Company's affiliates.
Authorized Shares. The maximum number of shares of Class A Common Stock reserved for issuance upon adoption of the 2021 Plan was 50,684,047 shares of Class A Common Stock. The number of shares of Class A Common Stock reserved for issuance under the 2021 Plan will automatically increase on January 1 of each year, starting on January 1, 2022 through January 1, 2031, in an amount equal to (1)4.0% of the total number of shares of Class A Common Stock and Class B Common Stock outstanding or issuable upon conversion or exercise of outstanding instruments on December 31 of the preceding year, or (2) a lesser number of shares of Class A Common Stock determined by the Company's board of directors prior to the date of the increase. The maximum number of shares of Class A Common Stock that may be issued on the exercise of ISOs under the 2021 Plan is three times the number of shares available for issuance upon the 2021 Plan becoming effective or 152,052,141 shares.
The Employee Stock Purchase Plan
In January 2021, the Company's board of directors adopted the 2021 Employee Stock Purchase Plan (the “ESPP”). The ESPP was approved by the Company's stockholders in February 2021 and became effective immediately upon the Closing Date of the Merger.
Share Reserve. The maximum number of shares of Class A Common Stock reserved for issuance upon the adoption of the 2021 ESPP was 4,750,354 shares of Class A Common Stock. The number of shares of Class A Common Stock reserved for issuance under the 2021 ESPP will automatically increase on January 1st of each year, beginning on January 1, 2022 and continuing through and including January 1, 2031, by 1.0% of the total number of shares of Class A Common Stock and Class B Common Stock outstanding or issuable upon conversion or exercise of outstanding instruments on December 31st of the preceding calendar year or such lesser number of shares of Class A Common Stock as determined by the Company's board of directors. Shares subject to purchase rights granted under the 2021 ESPP that terminate without having been exercised in full will not reduce the number of shares available for issuance under the 2021 ESPP.
The stock-based compensation expense included in the Company’s consolidated statement of operations and comprehensive loss for the three and nine months ended September 30, 2026 and 2025 is as follows (in thousands):
| Three months ended September 30, | Nine months ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Research and development | $3,873 | $3,557 | $12,199 | $12,119 |
| General and administrative | 6,197 | 4,464 | 17,364 | 15,787 |
| $10,070 | $8,021 | $29,563 | $27,906 | |
The following table summarizes stock option activity under the 2019 Plan, 2021 Plan and assumed options in the AnHeart acquisition for the nine months ended September 30, 2026.
| Shares | |
|---|---|
| Outstanding at December 31, 2025 | 73,963,104 |
| Granted | 14,115,046 |
| Exercised | (6,035,537) |
| Forfeited | (3,812,804) |
| Outstanding at September 30, 2026 | 78,229,809 |
| Exercisable at September 30, 2026 | 43,626,693 |
The weighted average exercise price of all outstanding options as of September 30, 2026 was$3.35 per share.
The following table summarizes the activity for the restricted stock units for the nine months ended September 30, 2026.
| Restricted Stock | |
|---|---|
| Units | |
| Non-vested at December 31, 2025 | 104,027 |
| Granted | 4,033,432 |
| Vested | (37,845) |
| Forfeited or canceled | (285,313) |
| Non-vested at September 30, 2026 | 3,814,301 |
- Commitments and Contingencies
Commitments
The Company has standby letters of credit with banks in the aggregate amount of $1.8 million which serve as security for the New York and San Francisco spaces operating leases. The standby letters of credit automatically renew annually.
The Company has certain non-cancelable purchase obligations related to the manufacturing of drug substance and drug product, and a commercial supply agreement with Asymchem Laboratories and Patheon Pharmaceuticals Inc., under which the Company has agreed to purchase a significant portion of its requirements for the drug substance over the next 6 months. Under these agreements, as of September 30, 2026, the Company is obligated to pay up to an aggregate of$10.3 million.
Contingencies
From time to time, the Company may be involved in routine litigation that arises in the ordinary course of business. There are no pending significant legal proceedings to which the Company is a party, for which management believes the ultimate outcome would have a material adverse effect on the Company’s financial position.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.