Kura Oncology, Inc.
For the period ended Dec 31, 2025. Filed Mar 5, 2026.
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FY2025 · Filed Mar 5, 2026
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Notes to Financial Statements
- Description of Business
Kura Oncology, Inc. is biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Our diversified pipeline consists of small molecules designed to target cancer signaling pathways and address significant unmet needs in oncology and hematology.
References in these Notes to Financial Statements to “Kura Oncology, Inc.,” “we,” “our” or “us,” refer to Kura Oncology, Inc.
- Summary of Significant Accounting Policies
Reclassifications
Certain prior period amounts have been reclassified to conform to the current period presentation. Specifically, accounts payable and accrued expenses and other current liabilities have been presented as separate line items on the balance sheets. In addition, the prior period receivable from contracts with collaborators balance has been reclassified to accounts receivable, net on the balance sheets, as described in Note 8, Kyowa Kirin Collaboration and License Agreement. These reclassifications had no effect on previously reported total current assets, total current liabilities, total liabilities, stockholders’ equity, or net loss.
Use of Estimates
Our financial statements are prepared in accordance with accounting principles generally accepted in the United States. The preparation of our 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.
Reported amounts and note disclosures reflect the overall economic conditions that are most likely to occur and anticipated measures management intends to take. Actual results could differ materially from those estimates. All revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.
Cash and Cash Equivalents
Cash and cash equivalents consist of checking, money market and highly liquid investments that are readily convertible to cash and that have an original maturity of three months or less from date of purchase. The carrying amounts approximate fair value due to the short maturities of these instruments.
Short-Term Investments
Short-term investments are marketable securities with maturities greater than three months from date of purchase that are specifically identified to fund current operations. These investments are classified as current assets, even though the stated maturity date may be one year or more beyond the current balance sheet date, which reflects management’s intention to use the proceeds from sales of these securities to fund our operations, as necessary. The cost of short-term investments is adjusted for amortization of premiums or accretion of discounts to maturity, and such amortization or accretion is included in interest income. Dividend and interest income is included in interest and other income, net on the statements of operations and comprehensive loss when earned. Short-term investments are classified as available-for-sale securities and carried at fair value with unrealized gains and non-credit related losses recorded in other comprehensive income (loss) and included as a separate component of stockholders’ equity. Realized gains and losses from the sale of available-for-sale securities are determined on a specific identification basis and included in interest and other income, net on the statements of operations and comprehensive loss.
Allowance for Credit Losses
For available-for-sale securities in an unrealized loss position, we first assess whether we intend to sell, or if it is more likely than not that we will be required to sell, the security before recovery of its amortized cost basis. If either of the criteria regarding intent or requirement to sell is met, the security’s amortized cost basis is written down to fair value through earnings. For available-for-sale securities that do not meet the aforementioned criteria, we evaluate whether the decline in fair value has resulted from credit losses or other factors. In making this assessment, we consider the severity of the impairment, any changes in interest rates, market conditions, changes to the underlying credit ratings and forecasted recovery, among other factors. The credit-related portion of unrealized losses, and any subsequent improvements, are recorded in interest and other income, net on the statements of operations and comprehensive loss through an allowance account. Any impairment that has not been recorded through an allowance for credit losses is included in other comprehensive income (loss) on the statements of operations and comprehensive loss.
We elected the practical expedient to exclude the applicable accrued interest from both the fair value and amortized costs basis of our available-for-sale securities for purposes of identifying and measuring an impairment. Accrued interest receivable on available-for-sale securities is recorded in prepaid expenses and other current assets on our balance sheets. Our accounting policy is to not measure an allowance for credit loss for accrued interest receivable and to write-off any uncollectible accrued interest receivable as a reversal of interest income in a timely manner, which we consider to be in the period in which we determine the accrued interest will not be collected by us.
Accounts Receivable, Net
Accounts receivable, net consists of amounts due primarily from specialty distributors and specialty pharmacies, our customers in the United States, related to sales of KOMZIFTI net of distribution-related deductions, and have standard payment terms. We analyze accounts that are past due for collectability. To date, we have not experienced any credit losses with respect to the collection of our accounts receivable and have not recorded an allowance for credit losses as of December 31, 2025. We have no financial instruments with off balance sheet risk of loss.
Concentration of Credit Risk
Financial instruments that potentially subject us to significant concentrations of credit risk consist primarily of cash, cash equivalents and short-term investments. We maintain deposits in federally insured financial institutions in excess of federally insured limits. We have established guidelines to limit our exposure to credit risk by placing investments with high credit quality financial institutions, diversifying our investment portfolio and placing investments with maturities that maintain safety and liquidity. We periodically review and modify these guidelines to maximize trends in yields and interest rates without compromising safety and liquidity.
Our receivable from contracts with collaborators, included within accounts receivable, net, is derived from contracts with our collaborators. We do not typically require collateral from our collaborators. We continuously monitor payments from collaborators and consider various factors including historical experience, age of the receivable balances, and other current economic conditions or other factors that may affect our collaborators’ ability to pay.
Inventory
Inventories are valued at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method for all inventories. Inventory is comprised of raw materials, work-in-process and finished goods, and includes costs related to third-party contract manufacturing, packaging, freight-in and overhead. Due to the nature of our supply chain process, inventory that is owned by us is physically stored at third-party logistics providers and contract manufacturers. Raw and intermediate materials that may be used for either research and development or commercial purposes where the intended use is not yet known are classified as inventory until the material is consumed or otherwise allocated for research and development. If the material is used or otherwise allocated for research and development, it is expensed as research and development in the period that determination is made.
Ourpolicy is to write down inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value and inventory in excess of expected requirements. The estimate of excess quantities is subjective and primarily dependent on our estimates of future demand. If our estimate of future demand changes, we consider the impact on the reserve for excess inventory and adjust the reserve as required. Increases in the reserve are recorded as cost of product sales. We classify our inventories based on our historical and anticipated levels of sales; any inventory in excess of its normal operating cycle is classified as long-term on our balance sheets. Our normal operating cycle is longer than 12 months. For product candidates that have not been approved by the U.S. Food and Drug Administration, or the FDA, inventory used in clinical trials is expensed at the time of production and recorded as research and development expense. For products that have been approved by the FDA, inventory used in clinical trials is expensed at the time the inventory is packaged for the clinical trial. Prior to receiving FDA approval, costs related to purchases of the API and the manufacturing of the product candidate, including pre-production design and development activities and process validation activities incurred under long-term supply arrangements, are recorded as research and development expense. Manufacturing costs incurred after approval and identified for commercial sale are capitalized into inventory.
Fair Value Measurements
Fair value is defined as the exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
Level 1 - Quoted prices (unadjusted) in active markets for identical assets or liabilities;
Level 2 - Inputs other than quoted prices included within Level 1 that are either directly or indirectly observable;
Level 3 - Unobservable inputs in which little or no market activity exists, therefore requiring an entity to develop its own assumptions about the assumptions that market participants would use in pricing.
Property and Equipment
Property and equipment are stated at cost and depreciated using the straight-line method over the estimated useful lives of the assets. Computer software and equipment are depreciated over their estimated useful lives ofthree tofive years. Laboratory equipment is depreciated over its estimated useful life offive years. Furniture and fixtures are depreciated over their estimated useful lives offive years. Leasehold improvements are depreciated over the lesser of the term of the related lease or the useful life of the asset.
Impairment of Long-Lived Assets
We review our long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. If such circumstances are determined to exist, an estimate of undiscounted future cash flows produced by the long-lived asset, including its eventual residual value, is compared to the carrying value to determine whether impairment exists. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written-down to their estimated fair values. For the years ended December 31, 2025, 2024 and 2023, there wereno impairments of the value of long-lived assets.
Leases
We determine if an arrangement is a lease or contains lease components at inception. Short-term leases with an initial term of 12 months or less are not recorded on the balance sheet. For operating leases with an initial term greater than 12 months, we recognize operating lease right-of-use, or ROU, assets and operating lease liabilities based on the present value of lease payments over the lease term at commencement date. Operating lease ROU assets are comprised of the lease liability plus any lease payments made and exclude lease incentives. Lease terms may include options toextend orterminate when we are reasonably certain that the options will be exercised. We do not separate lease components from non-lease components. For our operating leases, we generally cannot determine the interest rate implicit in the lease, in which case we use our incremental borrowing rate as the discount rate for the lease. We estimate our incremental borrowing rate for our operating leases based on what we would normally pay to borrow on a collateralized basis over a similar term for an amount equal to the lease payments. Operating lease expense is recognized on a straight-line basis over the lease term.
If a lease is modified, the modified contract is evaluated to determine whether it is or contains a lease. If a lease continues to exist, the lease modification is determined to be a separate contract when the modification grants the lessee an additional ROU that is not included in the original lease and the lease payments increase commensurate with the standalone price for the additional ROU. A lease modification that results in a separate contract will be accounted for in the same manner as a new lease. For a modification that is not a separate contract, we reassess the lease classification using the modified terms and conditions and the facts and circumstances as of the effective date of the modification and recognize the amount of the remeasurement of the lease liability for the modified lease as an adjustment to the corresponding operating lease ROU asset.
We sell KOMZIFTI to specialty distributors and specialty pharmacies, our customers in the United States. Our customers subsequently resell KOMZIFTI to pharmacies, health care providers and patients. In accordance with ASC 606, we recognize net product revenues from sales when a customer obtains control of our products, which typically occurs upon delivery to the customer.
Revenues from product sales are recorded at the net sales price, or transaction price, which includes estimates of variable consideration that result from (a) invoice discounts for prompt payment and distribution service fees, (b) government rebates, chargebacks, discounts and fees, (c) product returns and (d) costs of co-pay assistance programs for patients. Reserves are established for the estimates of variable consideration based on the amounts earned or to be claimed on the related sales. The reserves are classified as reductions to accounts receivables, net if payable to a customer or accrued liabilities if payable to a third-party. Where appropriate, we utilize the expected value method to determine the appropriate amount for estimates of variable consideration based on factors such as current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. The amount of variable consideration that is included in the transaction price is constrained and is included in net product revenues only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from our estimates. If actual results vary from our estimates, we recognize adjustments to net product revenue in the period in which changes in estimates become known.
Chargeback: A chargeback is the difference between the manufacturer's invoice price to the wholesaler and the wholesaler’s customer's contract price. The wholesaler tracks these sales and charges back the manufacturer for the difference between the negotiated prices paid between the wholesaler's customers and wholesaler's acquisition cost. We estimate the percentage of goods sold that are eligible for chargeback and adjust the transaction price for such discount at the time of sale to the customer.
Co-payment Assistance: Patients who meet certain eligibility requirements may receive co-payment assistance. We estimate percentage of goods sold that are eligible for co-payment assistance and adjust the transaction price for co-payment assistance based on actual program participation and estimates of program redemption using data provided by third-party administrators.
Distribution Service Fees: We engage with wholesalers to distribute our products to end customers. We pay the wholesalers a fee for services such as data reporting, inventory management, chargeback administration, and service level commitment. We estimate the amount of distribution services fees to be paid to the customers and adjust the transaction price with the amount of such estimate at the time of sale to the customer.
Product Returns: We provide customers a return credit for all products returned in accordance with the applicable returned goods policy. Once the product is returned, it is destroyed. We do not record a right-of-return asset. We estimate the percentage of product returns and adjust the transaction price for such discount at the time of sale to the customer.
Rebates and Discounts: We accrue rebates and discounts for contractually agreed-upon arrangements with customers and mandated discounts under government programs such as the Medicaid Drug Rebate Program in the United States. Our estimates for expected utilization of customer rebates and discounts are based on contractual terms and data received from our customers. Our estimates for rebates under government programs are based on statutory discount rates and expected utilization, and we adjust the transaction price for such rebates and discounts at the time of sale to the customer.
Collaboration Arrangements
We assess whether our licensing and other agreements are collaborative arrangements within the scope of Accounting Standards Codification, or ASC, Topic 808, Collaborative Arrangements, or Topic 808, based on whether they involve joint operating activities wherein both parties actively participate in the arrangement and are exposed to significant risks and rewards of the arrangement. For arrangements that we determine are collaborations under the Scope of Topic 808, we identify each unit of account by determining which promised goods or services are distinct in accordance with ASC Topic 606, Revenue from Contracts with Customers, or Topic 606, and then determine whether a customer relationship exists for that unit of account. If we determine a unit of account within the collaborative arrangement to be with a customer, we apply our revenue recognition accounting policy as further described below. For units of account within the collaborative arrangement under Topic 808 that are not with a customer in its entirety and are not within the scope of other relevant accounting topics, we apply recognition and measurement principles based on an analogy to authoritative accounting literature or, if there is no appropriate analogy, a reasonable, rational and consistently applied accounting policy election. See Note 8, Kyowa Kirin Collaboration and License Agreement, for more details.
We recognize revenue when control of the promised goods or services is transferred to our customers, in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services. To determine revenue recognition for arrangements that are within the scope of Topic 606, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation.
For enforceable contracts with our customers, we evaluate the promises in the contract that are based on goods and services that will be transferred to the customer and determine whether those promises are both (i) capable of being distinct and (ii) distinct in the context of the contract. Arrangements that include rights to additional goods or services that are exercisable at the customer’s discretion are generally considered customer options. We assess if these customer options provide a material right to the customer and, if so, these customer options are considered performance obligations.
The transaction price may comprise of payments received under our commercial arrangements, such as licensing technology rights, and may include non-refundable fees at the inception of the arrangements, cost reimbursements, milestone payments for specific achievements designated in the agreements, and royalties on the sale of products. Profit-sharing payments to our customers are generally not for a distinct good or service and, as such, are included as a reduction of the transaction price. At the inception of arrangements that include variable consideration, we may be required to exercise significant judgment to estimate the amount of variable consideration to include in the transaction price. In making such estimates, we generally use the most likely method for milestone payments and the expected value method for other forms of variable consideration. The amount of variable consideration that is included in the transaction price is only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in future periods. Milestone payments that are not within our or the licensee’s control, such as regulatory approvals, are not included in the transaction price until those approvals are received. At the end of each reporting period, we re-evaluate estimated variable consideration included in the transaction price and any related constraint and, as necessary, we adjust our estimate of the overall transaction price. Any adjustments are recorded on a cumulative catch-up basis, which affects revenues and earnings in the period of adjustment.
We develop estimates of the stand-alone selling price for each distinct performance obligation, which involve assumptions that may require significant judgment. Our estimates of the stand-alone selling price for license-related performance obligations may include forecasted revenues and expenses, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical, regulatory and commercial success. Our estimates of the stand-alone selling price for research and development or other service-related performance obligations generally include forecasting the expected costs of satisfying a performance obligation at market rates. We allocate the transaction price, including any unconstrained variable consideration, to the performance obligations within the arrangement based on the relative stand-alone selling prices. When the variable consideration relates specifically to our efforts to satisfy one or more, but not all, performance obligations and allocating the consideration specifically to those performance obligations is consistent with the overall allocation objectives within Topic 606, we allocate the consideration entirely to those performance obligations.
We use judgment to assess the nature of the performance obligation to determine whether the performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue related to the performance obligation. If the performance obligation is satisfied over time, we evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.
The selection of the method to measure progress towards completion of over-time performance obligations is based on the nature of the products or services to be provided. Our over-time performance obligations generally involve research and development or other services provided to the customer, and we generally use a cost-to-cost measure of progress because it best depicts the transfer of control to the customer. Under a cost-to-cost measure of progress, the extent of progress towards completion is measured based on the ratio of costs incurred to date compared to the total estimated costs at completion of the performance obligation (an “input method” under Topic 606). We use judgment to estimate the total cost expected to complete the research and development or other service-related performance obligations, which include subcontractors’ costs, labor, materials, other direct costs and an allocation of indirect costs. We evaluate these cost estimates and the progress each reporting period and, as necessary, we adjust the measure of progress and related revenue recognition.
For arrangements that include sales-based or usage-based royalties, we recognize 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.
Consideration received or invoices issued as stipulated in contracts prior to revenue recognition are recorded as contract liabilities in the accompanying balance sheets, classified as either current or long-term contract liabilities based on our best estimate of when such amounts will be recognized. Amounts recognized as revenue, but not yet invoiced are generally recognized as contract assets in other current assets in the accompanying balance sheets.
Cost of Product Sales
Cost of product sales consists primarily of direct and indirect costs related to the manufacture of KOMZIFTI for commercial sale, including third-party manufacturing costs, raw material and component costs, packaging services, freight, amortization of capitalized in-licensed costs, and royalties on product sales. Prior to the FDA approval of KOMZIFTI in November 2025, costs incurred for the manufacture of KOMZIFTI were recorded as research and development expenses, which resulted in zero-cost inventory. As a result, the cost of product sales related to KOMZIFTI will initially reflect a lower average per unit cost of materials, as previously expensed zero-cost inventory is utilized for commercial production and sold to customers. Our manufacturing timelines lengthen our operating cycle and delay the transition to inventory produced at commercial cost; accordingly, we expect the cost of product sales for KOMZIFTI to increase as zero-cost inventories are depleted. As of December 31, 2025, we had approximately $5.2 million in zero-cost inventory remaining and based on our current forecast, we expect zero-cost inventory, including raw materials, to be depleted in the second half of 2030.
We periodically evaluate zero-cost inventory for obsolescence. This evaluation considers the shelf life of raw materials, work in process, and finished goods as well as estimated sales trends. As of December 31, 2025, no zero-cost inventory was determined to be obsolete.
Research and Development Expenses
Research and development expenses consist of costs associated with our research and development activities including salaries, benefits, share-based compensation and other personnel costs, clinical trial costs, manufacturing costs for non-commercial products, fees paid to external service providers and consultants, facilities costs and supplies, equipment and materials used in clinical and preclinical studies and research and development. All such costs are charged to research and development expense as incurred when these expenditures have no alternative future uses. We are obligated to make upfront payments upon execution of certain research and development agreements. Advance payments, including nonrefundable amounts, for goods or services that will be used or rendered for future research and development activities are deferred. Such amounts are recognized as expense as the related goods are delivered or the related services are performed or such time when we do not expect the goods to be delivered or services to be performed. Payments that we make in connection with in-licensed technology for a particular research and development project that have no alternative future uses in other research and development projects or otherwise, and therefore have no separate economic value, are expensed as research and development costs at the time such costs are incurred. As of December 31, 2025, we had no in-licensed technologies that have alternative future uses in research and development projects or otherwise.
Clinical Trial Costs and Accruals
A significant portion of our clinical trial costs relate to contracts with contract research organizations, or CROs. The financial terms of our CRO contracts may result in payment flows that do not match the periods over which materials or services are provided to us under such contracts. Our objective is to reflect the appropriate clinical trial expenses in our financial statements by matching those expenses with the period in which services and efforts are expended. As part of the process of preparing our financial statements, we rely on cost information provided by our CROs concerning monthly expenses as well as reimbursement for pass through costs. We are also required to estimate certain of our expenses resulting from our obligations under our CRO contracts. Accordingly, our clinical trial expense accrual is dependent upon the timely and accurate reporting of CROs and other third-party vendors. If the contracted amounts are modified, for instance, as a result of changes in the clinical trial protocol or scope of work to be performed, we modify our accruals accordingly on a prospective basis. Revisions in the scope of a contract are charged to expense in the period in which the facts that give rise to the revision become reasonably certain. Historically, we have had no material changes in clinical trial expense that had a material impact on our results of operations or financial position.
Advertising
We expense the costs of advertising, including promotional expenses, as incurred. Subsequent to the FDA approval of our commercial product KOMZIFTI in November 2025, advertising expenses were approximately $2.8 million for the year ended December 31, 2025.
Patent Costs
We expense all costs as incurred in connection with patent applications, including direct application fees, and the legal and consulting expenses related to making such applications, and such costs are included in selling, general and administrative expenses on the statements of operations and comprehensive loss.
Share-Based Compensation
Our share-based awards are measured at fair value on the date of grant based upon the estimated fair value of common stock. The fair value of awards expected to vest are recognized and amortized on a straight-line basis over the requisite service period of the award less actual forfeitures. The fair value of each stock option is estimated on the date of grant using the Black-Scholes option pricing model, or Black-Scholes model, that requires the use of assumptions including volatility, expected term, risk-free rate and the fair value of the underlying common stock. We estimate the fair value of restricted stock units and performance-based restricted stock units granted based on the closing market price of our common stock on the date of grant. Actual forfeitures are applied as they occur, and any compensation cost previously recognized for awards for which the requisite service has not been completed is reversed in the period that the award is forfeited.
Income Taxes
Income taxes are accounted for using the asset and liability method. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates applicable to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance against deferred tax assets is recorded if, based upon the weight of all available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. For uncertain tax positions that meet “a more likely than not” threshold, we recognize the benefit of uncertain tax positions in the financial statements.
Comprehensive Loss
Comprehensive loss is defined as the change in equity during the period from transactions and other events and non-owner sources. For the periods presented, accumulated other comprehensive income (loss) consisted of unrealized gains and losses on short-term investments.
Net Loss per Share
Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, which includes the shares related to outstanding pre-funded warrants, but excludes other potential common stock equivalents. Pre-funded warrants are considered outstanding for the purposes of computing basic and diluted net loss per share because shares may be issued for little additional consideration, and are fully vested and exercisable. Diluted net loss per share is calculated by dividing net loss by the weighted-average number of common shares and common stock equivalents outstanding for the period. As we have reported net loss for the years ended December 31, 2025, 2024 and 2023, dilutive net loss per common share is the same as basic net loss per common share for those periods. Common stock equivalents outstanding are comprised of stock options, restricted stock units, or RSUs, performance-based restricted stock units, or PSUs, warrants and employee stock purchase plan rights and are only included in the calculation of diluted earnings per common share when net income is reported and their effect is dilutive. Common stock equivalents outstanding as of December 31, 2025, 2024 and 2023 totaling approximately 18,180,000,15,430,000 and 12,642,000, respectively, were excluded from the computation of dilutive weighted-average shares outstanding because their effect would be anti-dilutive.
Segment Reporting
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. We operate in asingle industry segment which is the discovery, development and commercialization of precision medicines for the treatment of cancer. Troy E. Wilson, Ph.D., J.D., ourpresident and chief executive officer, who serves as the Chief Operating Decision-Maker, or CODM, reviews the operating results on an aggregate basis and manages the operations as a single operating segment in the United States.
Recent Accounting Pronouncements
Improvements to Income Tax Disclosures
In December 2023, the Financial Accounting Standards Board, or FASB, issued ASU 2023-09 – Improvements to Income Tax Disclosures (Topic 740), which improves the transparency of income tax disclosures by requiring disaggregated information about our effective tax rate reconciliation as well as information on income taxes paid. For each annual period, we will be required to disclose specific categories in the rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items is equal to or greater than 5% of the amount computed by multiplying pretax income or loss by the applicable statutory income tax rate). ASU 2023-09 is effective for annual periods beginning after December 15, 2024. We adopted this ASU retrospectively on December 31, 2025. The adoption did not have a material effect on our financial statements, but resulted in expanded financial statement disclosures. See Note 13, Income Taxes, for further details.
Disaggregation of Income Statement Expenses
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, which requires disaggregated disclosure of certain costs and expenses on an interim and annual basis. ASU No. 2024-03 is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The disclosure updates are required to be applied prospectively with the option for retrospective application. We are currently evaluating the impact of adopting ASU 2024-03.
Intangibles – Goodwill and Other – Internal-Use Software (Subtopic 350-40)
In September 2025, the FASB issued ASU 2025-06, Intangibles – Goodwill and Other – Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software. Under this guidance, software capitalization will begin when management authorizes and commits to funding the software project and it is probable that the project will be completed and the software will be used for its intended purpose. ASU 2025-06 is effective for annual reporting periods beginning after December 15, 2027, and interim reporting periods within those periods, with early adoption permitted. We are currently evaluating the impact of adopting ASU 2025-06.
- Investments
We invest in available-for-sale securities consisting of U.S. Treasury securities, money market funds and U.S. Agency bonds. Available-for-sale securities are classified as either cash and cash equivalents or short-term investments on the balance sheets.
The following tables summarize, by major security type, our short-term investments that are measured at fair value on a recurring basis, in thousands:
| Maturities (years) | AmortizedCost | UnrealizedGains | UnrealizedLosses | Estimated Fair Value | |
|---|---|---|---|---|---|
| Cash equivalents | |||||
| Money market funds | 1 or less | $119,910 | $— | $— | $119,910 |
| Short-term investments | |||||
| U.S. Treasury securities | 2 or less | 464,623 | 1,042 | — | 465,665 |
| U.S. Agency bonds | 3 or less | 52,494 | 11 | (29) | 52,476 |
| Total short-term investments | 517,117 | 1,053 | (29) | 518,141 | |
| Total | $637,027 | $1,053 | $(29) | $638,051 | |
| Maturities (years) | AmortizedCost | UnrealizedGains | UnrealizedLosses | Estimated Fair Value | |
|---|---|---|---|---|---|
| Cash equivalents | |||||
| Money market funds | 1 or less | $200,024 | $— | $— | $200,024 |
| Short-term investments | |||||
| U.S. Treasury securities | 3 or less | 497,172 | 766 | — | 497,938 |
| U.S. Agency bonds | 3 or less | 4,997 | — | (2) | 4,995 |
| Total short-term investments | 502,169 | 766 | (2) | 502,933 | |
| Total | $702,193 | $766 | $(2) | $702,957 | |
Short-term investments are classified as current assets, even though the stated maturity date may be one year or more beyond the current balance sheet date, which reflects management’s intention to use the proceeds from sales of these securities to fund our operations, as necessary. As of December 31, 2025 and 2024, short-term investm ents of $367.2 millionand $393.1 million, respectively, had maturities less than one year, short-term investments of $135.9 million and $97.3 million, respectively, had maturities between one to two years, and short-term investments of $15.0 million and $12.5 million, respectively, had maturities between two to three years. Realized gains and losses were de minimis for the years ended December 31, 2025, 2024 and 2023.
As of December 31, 2025 and 2024, six available-for-sale securities with a fair market value of $22.5 million andtwo available-for-sale securities with a fair market value of $10.0 million, respectively, were in gross unrealized loss positions, noneof which were in a continuous unrealized loss position for greater than 12 months. We do not intend to sell these available-for-sale securities, and it is not more likely than not that we will be required to sell these securities prior to recovery of their amortized cost basis. We haveno allowance for credit losses as of December 31, 2025 and 2024. Unrealized gains and losses that are not credit-related are included in accumulated other comprehensive income (loss).
Accrued interest receivable on available-for-sale securities were$3.8 million and $3.3 million as of December 31, 2025 and 2024, respectively. We have not written off any accrued interest receivables for the years ended December 31, 2025, 2024 and 2023.
- Fair Value Measurements
As of December 31, 2025 and 2024, we had cash equivalents and short-term investments measured at fair value on a recurring basis.
Available-for-sale securities consist of money market funds and U.S. Treasury securities, which are measured at fair value using Level 1 inputs, and U.S. Agency bonds which are measured at fair value using Level 2 inputs. We determine the fair value of Level 2 related securities with the aid of valuations provided by third parties using proprietary valuation models and analytical tools. These valuation models and analytical tools use market pricing or prices for similar instruments that are both objective and publicly available, including matrix pricing or reported trades, benchmark yields, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids and/or offers. We validate the fair values of Level 2 financial instruments by comparing these fair values to a third-party pricing source. We did not reclassify any investments between levels in the fair value hierarchy during the periods presented.
The following tables summarize, by major security type, our cash equivalents and short-term investments that are measured at fair value on a recurring basis and are categorized using the fair value hierarchy, in thousands:
| Total | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|
| Cash equivalents | ||||
| Money market funds | $119,910 | $119,910 | $— | $— |
| Short-term investments | ||||
| U.S. Treasury securities | 465,665 | 465,665 | — | — |
| U.S. Agency bonds | 52,476 | — | 52,476 | — |
| Total short-term investments | 518,141 | 465,665 | 52,476 | — |
| Total | $638,051 | $585,575 | $52,476 | $— |
| Total | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|
| Cash equivalents | ||||
| Money market funds | $200,024 | $200,024 | $— | $— |
| Short-term investments | ||||
| U.S. Treasury securities | 497,938 | 497,938 | — | — |
| U.S. Agency bonds | 4,995 | — | 4,995 | — |
| Total short-term investments | 502,933 | 497,938 | 4,995 | — |
| Total | $702,957 | $697,962 | $4,995 | $— |
We believe that our term loan facility bears interest at a rate that approximates prevailing market rates for instruments with similar characteristics and, accordingly, the carrying value of the term loan facility approximates fair value. The fair value of our term loan facility is determined using Level 2 inputs in the fair value hierarchy. See Note 6, Long-Term Debt, for further discussion of our term loan facility.
- Balance Sheet Detail
Property and equipment consisted of the following, in thousands:
| December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Leasehold improvements | $6,919 | $1,743 |
| Laboratory and computer equipment | 1,958 | 2,004 |
| Furniture and fixtures | 1,878 | 1,210 |
| Property and equipment, gross | 10,755 | 4,957 |
| Less: accumulated depreciation | (2,900) | (3,275) |
| Property and equipment, net | $7,855 | $1,682 |
Depreciation expense was$1.0 million, $0.8 million and $0.8 millionfor the years ended December 31, 2025, 2024 and 2023, respectively.
Accrued expenses and other current liabilities consisted of the following, in thousands:
| December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Product revenue allowances | $377 | $— |
| Accrued clinical trial research and development expenses | 23,276 | 14,267 |
| Accrued other research and development expenses | 12,041 | 11,938 |
| Accrued compensation and benefits | 22,372 | 17,508 |
| Other accrued expenses | 3,392 | 2,710 |
| Income taxes payable | 239 | 2,061 |
| Total accrued expenses and other current liabilities | $61,697 | $48,484 |
- Long-Term Debt
In November 2022, we entered into a loan and security agreement with several banks and other financial institutions or entities party thereto, or collectively the Lenders, and Hercules Capital, Inc., or Hercules, in its capacity as administrative agent and collateral agent for itself and the Lenders, which was amended in October 2023 and October 2025, or the Loan Agreement, providing for up to $125.0 million in a series of term loans, or Term Loans. Under the terms of the Loan Agreement, we borrowed $10.0 million of an initial $25.0 million tranche of Term Loans. The remaining tranches of Term Loans expired without us drawing down such additional loans. The Term Loans have a maturity date of November 2, 2027, or the Maturity Date. Repayment of the Term Loans is interest only through May 1, 2027. After the interest-only payment period, borrowings under the Loan Agreement are repayable in monthly payments of principal and accrued interest until the Maturity Date. The per annum interest rate for the Term Loans is the greater of (i) the prime rate as reported in The Wall Street Journal minus 6.25% plus 8.65% and (ii) 8.65%. As of December 31, 2025, the interest rate on the Term Loans was 9.15%.
At our option, we may prepay all or any portion of the outstanding Term Loans at any time. We paid a facility charge of approximately $0.1 million upon closing and an additional approximately $0.2 million of facility charges in November 2023 due to the availability of the second tranche of the Term Loans. The Loan Agreement also contains an end of term fee in an amount equal to approximately $1.5 million (which is 6.05% of the maximum amount of the first tranche of loans), which is due and payable on the earliest to occur of (i) the Maturity Date, (ii) the date we prepay the outstanding loans in full, and (iii) the date that the secured obligations become due and payable. Our obligations under the Loan Agreement are secured by substantially all of our assets other than our intellectual property, but including proceeds from the sale, licensing or other disposition of our intellectual property. As part of the Loan Agreement, we are subject to certain negative covenants, which, among other things, prohibit us from selling, transferring, assigning, mortgaging, pledging, leasing, granting a security interest in or otherwise encumbering our intellectual property, subject to limited exceptions.
The Loan Agreement also contains a minimum cash covenant, which commenced on June 1, 2024, requiring us to hold cash in the United States and subject to a first-priority perfected security interest in favor of the Lenders in an amount greater than or equal to 35.0% of the outstanding loan obligations, provided that such cash covenant will not apply at any time our market capitalization is equal to or greater than $1,250.0 million. Additionally, the Loan Agreement contains minimum cash requirements in the event of (i) any Corporate Collaborations (as defined in the Loan Agreement) or (ii) any cash payment in respect of permitted convertible debt subject to the satisfaction of the Redemption Conditions (as defined in the Loan Agreement).
In addition, the Loan Agreement contains 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. The Loan Agreement also contains events of default that are customary for financings of this type relating to, among other things, payment defaults, breach of covenants, material adverse effects, breach of representations and warranties, cross-default to material indebtedness, bankruptcy-related defaults, judgment defaults, breach of the financial covenants described above, and the occurrence of certain change of control events. Following an event of default and any applicable cure period, a default interest rate equal to the then-applicable interest rate plus 5.0% may be applied to the outstanding principal balance, and the Lenders will have 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 them as our secured creditors. We were in compliance with all covenants of the Loan Agreement as of December 31, 2025.
Inaddition, in connection with the entry into the Loan Agreement, we issued warrants to certain of the Lenders, or collectively, the Warrants, to purchase up to 26,078 shares of our common stock at an exercise price of $14.38 per share, or the Warrant Shares. The Warrants may be exercised through the earlier of (i) the seventh anniversary of November 2, 2022 and (ii) the consummation of certain acquisition transactions involving us, as set forth in the Warrants. The number of Warrant Shares for which the Warrants are exercisable and the associated exercise price are subject to certain customary proportional adjustments for fundamental events, including stock splits and reverse stock splits, as set forth in the Warrants. The initial tranche 1 borrowing of $10.0 million and the warrants issued upon closing to purchase 26,078 shares of our common stock are accounted for as freestanding debt and equity financial instruments, respectively, as they are legally detachable and separately exercisable. In connection with the Loan Agreement, we recognized the initial issued Warrants to purchase 26,078 shares of our common stock at their relative fair value of approximately $0.3 million, and we incurred debt issuance costs of $0.6 million, which were recorded as debt discounts. The fair value of the Warrants, debt issuance costs and end of term fee are being amortized and accreted into interest expense using the effective interest rate method over the term of the loan. As of December 31, 2025, none of the Warrants had been exercised.
As of December 31, 2025, the long-term debt, net balance of approximately $9.7 million represents $10.0 million principal obligation under the term loan facility, which matures in 2027, net of $0.3 million of unamortized discounts.
- License Agreements
The University of Michigan License Agreement
In December 2014, we entered into a license agreement with the Regents of the University of Michigan, or the University of Michigan, which was most recently amended in August 2017, under which we received certain license rights in exchange for a non-refundable upfront license fee, annual maintenance fees and payments upon achievement of certain development and sales-based milestones. The licensed asset consists of several compounds, including ziftomenib. As between us and the University of Michigan, all future development, regulatory and commercial work on the asset will be completed fully and at our sole expense. The University of Michigan retains the right to use certain licensed compounds for non-commercial research, internal and/or educational purposes, with the right to grant the same limited rights to other non-profit research institutions.
The agreement will terminate upon the last-to-expire patent rights, or may be terminated by us at any time with 90 days written notice of termination or terminated by the University of Michigan upon a bankruptcy by us, payment failure by us that is not cured within 30 days or a material breach of the agreement by us that is not cured within 60 days.
Payments under License Agreements
Collectively, our license agreements provide for specified development, regulatory and sales-based milestone payments up to a total of $80.2 million payable upon occurrence of each stated event, of which $0.5 million relates to the initiation of certain development activities, $28.9 million relates to the achievement of specified regulatory approvals for the first indication and up to $50.8 million relates to the achievement of specified levels of product sales. Additional payments will be due for each subsequent indication if specified regulatory approvals are achieved. Furthermore, if all the programs are successfully commercialized, we will be required to pay sublicense fees and tiered royalties on annual net product sales ranging from the low single digits to the low teens, depending on the volume of sales and the respective agreement. For the year ended December 31, 2025, we incurred sublicense fees of $5.0 million. As of December 31, 2025, we have paid milestone payments totaling $1.4 million and incurred sublicense fees totaling $9.8 million. For the year ended December 31, 2025, we incurred royalties of approximately $0.1 million related to the product sales of KOMZIFTI.
- Kyowa Kirin Collaboration and License Agreement
On November 20, 2024, we and Kyowa Kirin Co., Ltd. and Kyowa Kirin, Inc., or together Kyowa Kirin, entered into a collaboration and license agreement, or the Kyowa License Agreement, to develop and commercialize globally our product candidate, ziftomenib, a potent, selective oral menin inhibitor, for the treatment, diagnosis and prevention of acute myeloid leukemia, or AML, and other hematologic malignancies, and if Kyowa Kirin exercises the Field Expansion Option (as defined below), the treatment, diagnosis and prevention of all cancers, or collectively the Field. We concluded that there were four distinct performance obligations under the Kyowa License Agreement: the Rest-of-World License, Development Services related to monotherapy, Development Services for combination therapies and Commercialization Services. Each of the four distinct performance obligations is defined below.
Development Services (inclusive of both monotherapy and combination therapies): We have the right and responsibility to lead development, manufacturing, and regulatory activities for ziftomenib in the United States under the oversight of a joint steering committee and applicable subcommittees. In accordance with the development plan and budget mutually agreed upon with Kyowa Kirin, or Development Plan, we are conducting multiple clinical trials of ziftomenib, as a monotherapy and in combination with other therapies, in AML and other hematologic malignancies to support regulatory approvals of ziftomenib in the United States. We and Kyowa Kirin will continue to conduct the activities required by the Development Plan as allocated to us by such plan. We are responsible for funding the specified development activities set forth in the initial Development Plan that are planned to be conducted prior to the end of 2028, and we will share with Kyowa Kirin equally (50/50) all development costs for all other development activities in the United States that are included in the Development Plan, including clinical trials and post-marketing commitments that are reasonably necessary for obtaining or maintaining regulatory approval of ziftomenib in the United States, or Development Services. In addition, we may conduct certain specified development and manufacturing activities outside the scope of the Development Plan at our sole cost and expense.
Commercialization Services: We and Kyowa Kirin share rights and responsibilities to commercialize KOMZIFTI in the United States in accordance with a co-created U.S. territory commercialization plan and budget, or Commercialization Services. We book sales of KOMZIFTI and the parties will share equally all profits or losses from, the commercialization of KOMZIFTI in the United States. In June 2025, we entered into a co-promotion and medical affairs agreement with Kyowa Kirin, Inc., or the Kyowa Co-Promotion Agreement, to co-promote and perform medical affairs activities with respect to KOMZIFTI for the treatment of patients with AML and other hematologic malignancies in the United States, and solely if Kyowa Kirin exercises its field expansion option under the Kyowa License Agreement, all approved indications for ziftomenib in the United States that are licensed under the Kyowa License Agreement. The Kyowa Co-Promotion Agreement was determined to be a separate contract from the Kyowa License Agreement for purposes of revenue recognition and reporting.
We are responsible for the global manufacture and supply of ziftomenib necessary for the development and commercialization activities described above, pursuant to the terms of a clinical supply agreement entered into with Kyowa Kirin Co., Ltd. effective as of March 31, 2025, or the Kyowa Clinical Supply Agreement, which was determined to be a separate contract from the Kyowa License Agreement for purposes of revenue recognition and reporting. Kyowa Kirin has the right to request that we conduct a manufacturing technology transfer and to take over the responsibility for the manufacture of commercial supply of ziftomenib outside the United States.
Rest-of-World License: Kyowa Kirin has the right and responsibility to lead commercial strategy and to commercialize and book sales of ziftomenib outside of the United States and is solely responsible for the conduct and funding of such activities that are specific to the exploitation of ziftomenib outside of the United States. Following regulatory approval, Kyowa Kirin will be solely responsible for the conduct and funding of commercialization of ziftomenib outside of the United States (including recording sales). Kyowa Kirin is required to use commercially reasonable efforts to conduct the development of ziftomenib outside the United States in accordance with an ex-U.S. territory development plan, including to conduct such development with the objective to achieve the development milestone events outside the United States that entitle us to receive corresponding development milestone payments, and to commercialize ziftomenib in each country outside of the United States where it has received regulatory approval. Development and commercialization activities outside of the United States will also be under the oversight of the joint steering committee and applicable subcommittees.
We granted Kyowa Kirin an exclusive license to enable or allow Kyowa Kirin to develop, manufacture, and commercialize ziftomenib within the Field outside of the United States, or the ROW License. We also granted Kyowa Kirin rights to fulfill their responsibilities related to the Development Services and Commercialization Services as part of the joint development and commercialization of ziftomenib in the United States. In addition, Kyowa Kirin has an option to expand the licensed Field, or Field Expansion Option, to include the development and commercialization of ziftomenib in gastrointestinal stromal tumors, or GIST, and other solid tumor indications, which option can be exercised within a specified time period after receipt of clinical data from the planned proof-of-concept study evaluating ziftomenib and imatinib in patients with advanced GIST who are not successfully treated with imatinib. After Kyowa Kirin’s exercise of the Field Expansion Option, the Field would include the treatment, diagnosis and prevention of all cancers, including GIST and other solid tumors.
In exchange for the ROW License and Kyowa Kirin’s rights to participate in the development and commercialization activities described above, we received an upfront payment of $330.0 million. We are eligible to receive, if Kyowa Kirin exercises the Field Expansion Option, up to an aggregate of $1.161 billion in development, regulatory, commercial milestone and additional upfront payments for the existing Field and the expanded Field, totaling up to $1.491 billion in upfront and milestone payments in the aggregate. We are also eligible to receive tiered double-digit royalties on sales of ziftomenib outside of the United States on a country-by-country basis until the latest of expiration of the last-to-expire valid claim of our patent rights licensed to Kyowa Kirin in such country, expiration of the last-to-expire regulatory exclusivity in such country and ten years after first commercial sale in such country, or the Royalty Term.
The Kyowa License Agreement will remain in effect in the United States until the latest of expiration of all valid claims of our patent rights licensed to Kyowa Kirin, expiration of the last-to-expire regulatory exclusivity or ten years after first commercial sale. The Kyowa License Agreement will remain in effect outside the United States until the expiration of the last-to-expire Royalty Term. Either party may terminate the Kyowa License Agreement for uncured material breach by or insolvency of the other party. Kyowa Kirin may terminate the Kyowa License Agreement for convenience upon 12 months’ prior written notice. In addition, Kyowa Kirin has the right to terminate the Kyowa License Agreement with a shorter specified notice period upon the occurrence of a material adverse regulatory event or certain other specified events. We may terminate the Kyowa License Agreement if Kyowa Kirin or any of its affiliates or sublicensees challenges the validity or enforceability of any of the patent rights licensed to Kyowa Kirin by us.
Based on our analysis of the key terms and activities required by the Kyowa License Agreement summarized above and given the involvement by both parties, we assessed the criteria under Topic 808 and concluded that both parties participate in a joint operating activity, are active participants, and are exposed to significant risks and rewards dependent on the commercial success of the activities. Therefore, the Kyowa License Agreement was determined to be within the scope of Topic 808.
We evaluated each of the required promised goods and services and determined the Kyowa License Agreement contains multiple units of account comprised of the ROW License, Development Services related to monotherapy and in combination with other therapies, and Commercialization Services. The ROW License is a unit of account under the scope of Topic 606 as it is reflective of a typical vendor-customer relationship, while the Development Services and Commercialization Services are under the scope of Topic 808 due to the joint participation in the services being performed and these services not being reflective of a typical vendor-customer relationship. However, we determined that Topic 606 was the most appropriate accounting model to apply by analogy to the recognition and measurement of these units of account.
As of December 31, 2025, we determined the transaction price to be $592.6 million, comprised of the $330.0 million upfront fixed payment, $240.0 million in unconstrained milestones and$22.6 million of profit and loss sharing payments received or expected to be received. All other variable consideration related to milestones have been fully constrained due to development, regulatory, or other factors that caused us to determine that it was not probable that a significant reversal of revenue would not occur as of December 31, 2025. We will recognize any royalties or sales-based milestones related to the ROW License granted to Kyowa Kirin when the associated sales occur, and relevant sales-based thresholds are met. As of December 31, 2025, no royalties or sales-based milestones have been recognized.
We allocated the transaction price to each performance obligation based on their relative stand-alone selling price. Variable consideration that relates specifically to our efforts to satisfy specific performance obligations, such as certain milestones, is allocated entirely to those performance obligations. Other components of variable consideration that do not relate specifically to our efforts to satisfy specific performance obligations are allocated based on the relative stand-alone selling price. We are entitled to cost-sharing reimbursements from Kyowa Kirin for certain development and commercialization activities we perform and determined that such reimbursements are specifically related to our efforts to satisfy the respective performance obligations while satisfying the overall allocation objective required by Topic 606.
As of December 31, 2025, the remaining unrecognized consideration allocated to the Development Services for monotherapy was $34.3 million, to the Development Services in combination with other therapies was $167.0 million, and to the Commercialization Services was $272.6 million.
The Development Services and Commercialization Services include variable consideration at inception, which requires us to exercise significant judgment to estimate the amount of variable consideration to include in the transaction price. In making such estimates, we generally use the most likely method for milestone payments and the expected value method for other forms of variable consideration. The amount of variable consideration that is included in the transaction price is only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in future periods. Milestone payments that are not within our or the licensee’s control, such as regulatory approvals, are not included in the transaction price until those approvals are received. At the end of each reporting period, we re-evaluate estimated variable consideration included in the transaction price and any related constraint and, as necessary, we adjust our estimate of the overall transaction price. Any adjustments are recorded on a cumulative catch-up basis, which affects revenues and earnings in the period of adjustment. As of December 31, 2025, based on management’s re-evaluation of estimated variable consideration under the expected value method, including consideration of the FDA’s approval of KOMZIFTI in November 2025 and forecasted profit and loss sharing related to our Commercialization Services, $250.0 million of consideration allocated to Commercialization Services and $22.6 million of profit and loss sharing payments received or expected to be received from Kyowa Kirin were constrained, and included in long-term contract liabilities on the balance sheets.
For the years ended December 31, 2025 and 2024, we recognized $20.4 million and $49.8 million, respectively, of revenue allocated to the ROW License at a point in time. The allocated consideration related to the Development Services performance obligations is being recognized over time using a cost-to-cost measure of progress. We estimated the total cost expected to perform the required activities and measured the progress towards completion of each of these obligations at the reporting period. For the years ended December 31, 2025 and 2024, we recognized $28.0 million and $0.5 million of revenue from Development Services for monotherapy, respectively. For the years ended December 31, 2025 and 2024, we recognized $19.3 million and $0.8 million of revenue from Development Services in combination with other therapies, respectively. For the year ended December 31, 2025, we also recognized $0.5 million of revenue pursuant to services performed under the Kyowa Clinical Supply Agreement.
As of December 31, 2025, the contract liability amount of $473.9 million represents the aggregate transaction price allocated to performance obligations that are unsatisfied under the Kyowa License Agreement or constrained based on our assessments under the expected value method, $49.0 million was classified as current contract liabilities, which represents the portion of the Development Services expected to be provided over the next year, and the remaining contract liability balance of $424.9 million was classified as long-term contract liabilities. As of December 31, 2024, the contract liability amount of $278.2 million represented the aggregate transaction price allocated to performance obligations that are unsatisfied under the Kyowa License Agreement, of which $24.3 million was classified as current contract liabilities, and $253.9 million was classified as long-term contract liabilities. As of December 31, 2025 and 2024, $6.4 million and $2.1 million of receivables from contracts with collaborators for profit and loss sharing with Kyowa Kirin, wasincluded within accounts receivable, net on the balance sheets, respectively.
- Commitments and Contingencies
Operating Leases
We currently havetwo operating leases for administrative and research and development office and lab space in San Diego, California and Boston, Massachusetts that expire between July 2031 and May 2033. Under the terms of the operating leases, as each may be amended from time to time, we are required to pay our proportionate share of property taxes, insurance and normal maintenance costs. Both of our leases include renewal options for an additional five years, which were not included in the determination of the ROU asset or lease liability as the renewal was not reasonably certain at the inception of the lease. Our Boston lease provided for $1.4 million in reimbursements for allowable tenant improvements and rent credits, which effectively reduced the total lease payments owed. Our San Diego research and development, lab, and principal executive office space lease entered into in January 2025 and amended in June 2025 provides (i) $2.4 million in rent credits, and (ii) a $6.2 million tenant improvement allowance expected to be received in the first half of 2026. The leases are also subject to additional variable charges for common area maintenance, property taxes, property insurance and other variable costs. Variable charges were not included in the measurement of our operating lease ROU assets.
Maturities of our lease liabilities as of December 31, 2025 are as follows, in thousands:
| Years Ending December 31, | |
|---|---|
| 2026 | $1,533 |
| 2027 | 3,658 |
| 2028 | 3,755 |
| 2029 | 3,853 |
| 2030 | 3,954 |
| Thereafter | 7,214 |
| Total lease payments | 23,967 |
| Less: imputed interest | (8,368) |
| Less: tenant improvement allowance reimbursements yet to be received | (4,853) |
| Total operating lease liabilities | $10,746 |
As of December 31, 2025 and 2024, the weighted-average discount rate was 12.3% and 11.4%, respectively, and the weighted-average remaining lease term was 6.4 years and 5.9 years, respectively.
Total cash paid for amounts included in the measurement of operating lease liabilities, net of tenant improvement reimbursements, was $0.9 million, $1.5 million and $2.1 million for the years ended December 31, 2025, 2024 and 2023, respectively. Operating lease ROU assets obtained in exchange for operating lease liabilities were $2.7 million and $4.7 million for the years ended December 31, 2025 and 2023, respectively. There wereno operating lease ROU assets obtained in exchange for operating liabilities for the years ended December 31, 2024.
Total operating lease expense and rent expense for the years ended December 31, 2025, 2024 and 2023 was approximately $3.1 million, $1.9 million and $2.0 million, respectively.
Litigation
From time to time, we may be involved in disputes, including litigation, relating to claims arising out of operations in the normal course of our business. Any of these claims could subject us to costly legal expenses and, while we generally believe that we have adequate insurance to cover many different types of liabilities, our insurance carriers may deny coverage or our policy limits may be inadequate to fully satisfy any damage awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on our results of operations and financial position. Additionally, any such claims, whether or not successful, could damage our reputation and business. We currently are not a party to any legal proceedings, the adverse outcome of which, in management’s opinion, individually or in the aggregate, would have a material adverse effect on our results of operations or financial position.
- Stockholders’ Equity
In January 2024, we completed a private placement in which we sold to certain institutional accredited investors an aggregate of 1,376,813 shares of our common stock at a purchase price of $17.25 per share and pre-funded warrants to purchase up to an aggregate of 7,318,886 shares of common stock at a purchase price of $17.2499 per pre-funded warrant (representing the $17.25 per share purchase price less the exercise price of $0.0001 per warrant share), or the Private Placement. Net proceeds from the Private Placement, after deducting expenses, were approximately $145.8 million. The common stock and pre-funded warrants met the accounting standards guidance for equity classification, and proceeds were allocated between common stock and pre-funded warrants based on their relative fair value. As of December 31, 2025, pre-funded warrants to purchase 6,902,036 of such shares of common stock from the Private Placement had been exercised and 416,850 remained outstanding.
In November 2023, we entered into a Sales Agreement with Leerink Partners LLC and Cantor Fitzgerald & Co., or the ATM Facility, under which we may offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $150.0 million. We have not sold any shares of our common stock under the ATM Facility.
In June 2023, we completed a public offering in which we sold an aggregate of 5,660,871 shares of common stock at a price of $11.50 per share as well as pre-funded warrants to purchase 3,034,782 shares of our common stock at a price of $11.4999 per pre-funded warrant (representing the $11.50 per share purchase price less the exercise price of $0.0001 per warrant share). Net proceeds from the public offering, after deducting underwriting discounts and commissions and offering expenses, were approximately $93.6 million. As of December 31, 2025, none of the pre-funded warrants from the public offering remained outstanding.
In November 2022, in connection with the Loan Agreement, we issued warrants to certain of the Lenders to purchase up to 26,078 shares of our common stock at an exercise price of $14.38 per share, which remained outstanding as of December 31, 2025.
In connection with a loan and security agreement with Oxford Finance LLC and Silicon Valley Bank in 2016, we issued a warrant to Oxford Finance LLC to purchase up to 33,988 shares of our common stock at an exercise price of $3.31 per share, which remained outstanding as of December 31, 2025. In February 2026, Oxford Finance LLC exercised its warrant to purchase 33,988 shares of common stock in a cashless exercise resulting in the issuance of 20,318 shares of our common stock.
- Share-Based Compensation
Equity Incentive Plan
In March 2015, our board of directors adopted our Amended and Restated 2014 Equity Incentive Plan, which was most recently amended in June 2025, or 2014 Plan, to, among other things, increase the shares available for future grant by 4,750,000 shares. The 2014 Plan provides for the grant of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock unit awards, performance-based stock awards and other forms of equity compensation to our employees, consultants and members of our board of directors. We issue shares of common stock upon the exercise of options and vesting of restricted stock unit awards and performance-based restricted stock unit awards with the source of those shares of common stock being newly issued shares. As of December 31, 2025,34,577,686 shares of common stock were reserved for issuance and 8,373,981 shares of common stock were available for grant under the 2014 Plan.
Inducement Option Plan
In December 2023, our board of directors adopted the 2023 Inducement Option Plan, which was most recently amended in October 2025, or Inducement Plan, to increase the shares available for future grant by 750,000 shares. The terms and conditions of the Inducement Plan are substantially similar to our 2014 Plan. As of December 31, 2025,3,250,000 shares of common stock were reserved for issuance and 869,550 shares of common stock were available for grant under the Inducement Plan.
Employee Stock Purchase Plan
In March 2015, our board of directors adopted the 2015 Employee Stock Purchase Plan, or ESPP. The ESPP permits eligible employees to purchase our common stock at a discount through payroll deductions during defined six-month offering periods. Eligible employees may elect to withhold up to 15% of their base earnings to purchase shares of our common stock at a price equal to 85% of the fair market value on the first day of the offering period or the last trading day prior to the purchase date, whichever is lower. As of December 31, 2025, we had issued 576,728 shares of common stock, and 327,697 shares of common stock were reserved for future issuance under the ESPP. Share-based compensation expense related to the ESPP for the years ended December 31, 2025, 2024 and 2023 was $0.7 million, $0.5 million and $0.3 million, respectively.
Stock Options, Restricted Stock Unit Awards and Performance-Based Restricted Stock Unit Awards
Stock Options
The exercise price of all stock options granted was equal to the fair market value of such stock on the date of grant. Stock options generally vest over afour-year period. The maximum contractual term for all stock options isten years. The following is a summary of stock option activity for the year ended December 31, 2025, in thousands (except per share and years data):
| Number ofOptions | Weighted AverageExercise Price per Share | Weighted AverageRemainingContractualTerm (years) | Aggregate Intrinsic Value | |
|---|---|---|---|---|
| Outstanding as of December 31, 2024 | 12,903 | $16.76 | ||
| Granted | 4,584 | $7.72 | ||
| Exercised | (90) | $5.84 | ||
| Canceled | (1,608) | $15.34 | ||
| Outstanding as of December 31, 2025 | 15,789 | $14.35 | 6.8 | $12,481 |
| Vested and expected to vest as of December 31, 2025 | 15,789 | $14.35 | 6.8 | $12,481 |
| Exercisable as of December 31, 2025 | 9,533 | $16.83 | 5.5 | $1,396 |
The aggregate intrinsic value in the above table is calculated as the difference between the closing price of our common stock as of December 31, 2025 of $10.39 per share and the exercise price of stock options that had strike prices below the closing price.
The following summarizes certain information regarding stock options, in thousands (except per share data):
| Years Ended December 31, | |||
|---|---|---|---|
| 2025 | 2024 | 2023 | |
| Cash received from options exercised | $527 | $7,655 | $534 |
| Intrinsic value of options exercised | $354 | $4,722 | $280 |
| Weighted-average grant date fair value per share | $4.69 | $10.05 | $6.99 |
As of December 31, 2025, unrecognized estimated compensation expense related to stock options was $36.6 million, which is expected to be recognized over the weighted-average remaining requisite service period of approximately 2.6 years.
Restricted Stock Unit Awards
RSUs are share awards that, upon vesting, will deliver to the holder shares of our common stock. The RSUs generally vest annually over four years.
The following is a summary of RSU activity for the year ended December 31, 2025, in thousands (except per share and years data):
| Number ofRSUs | Weighted AverageGrant Date Fair Value per Share | Weighted AverageRemainingVesting Period (years) | Aggregate Intrinsic Value | |
|---|---|---|---|---|
| Outstanding as of December 31, 2024 | 1,126 | $14.69 | ||
| Granted | 1,014 | $8.79 | ||
| Released | (401) | $14.91 | ||
| Canceled | (277) | $11.74 | ||
| Outstanding as of December 31, 2025 | 1,462 | $11.10 | 1.2 | $15,189 |
As of December 31, 2025, unrecognized estimated compensation expense related to RSUs was$11.0 million, which is expected to be recognized over the weighted-average remaining requisite service period of approximately 2.4 years.
Performance-Based Restricted Stock Unit Awards
PSUs are share awards that, upon vesting, will deliver to the holder shares of our common stock. The PSUs generally vest in six equal tranches upon the achievement of certain milestones and service conditions.
The following is a summary of PSU activity for the year ended December 31, 2025, in thousands (except per share and years data):
| Number ofRSUs | Weighted AverageGrant Date Fair Value per Share | |
|---|---|---|
| Outstanding as of December 31, 2024 | 1,313 | $13.32 |
| Granted | 222 | $9.12 |
| Released | (388) | $12.63 |
| Canceled | (323) | $13.32 |
| Outstanding as of December 31, 2025 | 824 | $12.52 |
As of December 31, 2025, unrecognized estimated compensation expense related to the vested PSUs was $1.3 million, which is expected to be recognized over the weighted-average remaining requisite service period of approximately 0.8 years. As of December 31, 2025, the vesting of PSUs covering 436,667 shares of common stock were determined to not be probable and have not been included in share-based compensation expense or unrecognized estimated compensation expense.
Share-Based Compensation Expense
Total share-based compensation expense included on the statements of operations and comprehensive loss was comprised of the following, in thousands:
| Years Ended December 31, | |||
|---|---|---|---|
| 2025 | 2024 | 2023 | |
| Research and development | $12,587 | $14,620 | $12,660 |
| Selling, general and administrative | 24,521 | 19,277 | 15,422 |
| Total share-based compensation expense | $37,108 | $33,897 | $28,082 |
We estimated the fair value of stock options and ESPP stock purchase rights using the Black-Scholes model based on the date of grant with the following assumptions:
| Options · ESPP | ||||||
|---|---|---|---|---|---|---|
| Years Ended December 31, | Years Ended December 31, | |||||
| 2025 | 2024 | 2023 | 2025 | 2024 | 2023 | |
| Expected term (in years) | 5.75 — 7.01 | 5.60 — 6.83 | 5.48 — 6.05 | 0.50 | 0.50 | 0.50 |
| Expected volatility | 62.8% — 65.6% | 60.0% — 63.9% | 59.9% — 66.9% | 60.7% — 85.3% | 40.0% — 74.4% | 51.0% — 52.7% |
| Risk-free interest rate | 3.8% — 4.4% | 3.5% — 4.6% | 3.5% — 4.7% | 3.8% — 4.3% | 4.4% — 5.4% | 5.4% |
| Expected dividend yield | — | — | — | — | — | — |
Expected term. The expected term of stock options represents the period that the stock options are expected to remain outstanding. We determined our expected term assumption using our own historical exercise experience. The expected term of the ESPP stock purchase rights is six months, which represents the length of each purchase period.
Expected volatility. Expected volatility for stock options and ESPP stock purchase rights was calculated based on our historical volatility.
Risk-free interest rate. The risk-free interest rates are based on the U.S. Treasury zero-coupon bonds with maturities similar to those of the expected term of the award being valued.
Expected dividend yield. The expected dividend yield of zero reflects that we have not paid cash dividends since inception and do not intend to pay cash dividends in the foreseeable future.
- Employee Benefit Plan
We have a defined contribution 401(k) plan for all employees. Under the terms of the plan, employees may make voluntary contributions as a percentage or defined amount of compensation. For the year ended December 31, 2025, we provided a matching contribution of up to 5% of eligible employees' compensation, subject to plan terms and limitations. For the years ended December 31, 2024 and 2023, we provided a safe harbor contribution of 5% and 4%, respectively, of the employee’s compensation, not to exceed eligible limits. For the years ended December 31, 2025, 2024, and 2023, we incurred approximately $2.9 million, $1.9 million, and $1.5 million, respectively, in expenses related to the 401(k) contribution.
- Income Taxes
For financial reporting purposes, income before income taxes includes the following components for the years presented, in thousands:
| Years Ended December 31, | |||
|---|---|---|---|
| 2025 | 2024 | 2023 | |
| Federal | $(278,369) | $(171,965) | $(152,631) |
| Foreign | — | — | — |
| Loss before income taxes | $(278,369) | $(171,965) | $(152,631) |
For the year ended December 31, 2025, we recordedno current federal tax provision, and state tax provisions of $0.3 million. For the year ended December 31, 2024, we recorded a current federal and state tax provision of $1.8 million and $0.3 million, respectively. For the year ended December 31, 2023, we didnot record a provision for income taxes due to a loss and a full valuation against our deferred taxes.
Pursuant to the disclosure requirements of ASU 2023-09, our effective income tax rate differs from the statutory federal rate of 21% for the years ended December 31, 2025, 2024, and 2023 due to the following, in thousands:
| Years Ended December 31, | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2025 · 2024 · 2023 | |||||||||||||
| Income taxes at statutory federal rate | $(58,466) | 21.0 | % | $(36,102) | 21.0 | % | $(32,053) | 21.0% | |||||
| State income taxes, net of federal benefit(1) | 264 | (0.1) | 287 | (0.2) | — | — | |||||||
| Tax credits | |||||||||||||
| Research and development credits | (2,795) | 1.0 | (2,468) | 1.5 | (2,390) | 1.5 | |||||||
| Orphan drug credits | (29,260) | 10.5 | (17,716) | 10.3 | (9,696) | 6.4 | |||||||
| Change in valuation allowance | 75,851 | (27.2) | 50,647 | (29.5) | 37,564 | (24.6) | |||||||
| Changes in unrecognized tax benefits | 8,507 | (3.1) | 4,463 | (2.6) | 2,744 | (1.8) | |||||||
| Nontaxable or nondeductible items | |||||||||||||
| Share-based compensation | 6,389 | (2.3) | 3,425 | (2.0) | 4,182 | (2.8) | |||||||
| Other | 116 | — | 67 | — | 58 | — | |||||||
| Other | (309) | 0.1 | (585) | 0.3 | (409) | 0.3 | |||||||
| Total | $297 | (0.1) | % | $2,018 | (1.2) | % | $— | — | |||||
(1)
In 2023 state taxes in California made up the majority (greater than 50%) of the tax effect in this category. In 2024 state taxes in Massachusetts made up the majority of the tax effect in this category. In 2025 state taxes in Florida and Pennsylvania made up the majority of the tax effect in this category.
Significant components of our deferred tax assets and liabilities are shown below, in thousands:
| December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Deferred tax assets | ||
| Contract liabilities | $113,953 | $66,821 |
| Net operating loss carryforwards | 111,461 | 97,605 |
| Research and development tax credit carryforwards | 67,259 | 41,831 |
| Section 174 capitalization | 46,790 | 59,497 |
| Other | 10,486 | 283 |
| Share-based compensation | 10,118 | 9,073 |
| Accruals | 4,987 | 3,707 |
| Operating lease liabilities | 2,584 | 1,699 |
| Total deferred tax assets | 367,638 | 280,516 |
| Deferred tax liabilities | ||
| Right-of-use assets | (1,756) | (1,394) |
| Other comprehensive income | (247) | (184) |
| Other | (1,745) | (79) |
| Total deferred tax liabilities | (3,748) | (1,657) |
| Less: valuation allowance | (363,890) | (278,859) |
| Net deferred tax assets | $— | $— |
As of December 31, 2025, we had federal net operating loss, or NOL, carryforwards of $310.5 million, that can be carried forward indefinitely. As of December 31, 2025, we had state loss carryforwards of $667.6 million, which will begin to expire in 2034, unless previously utilized. We also have federal and state research and development credit carryforwards of $82.1 million and $12.0 million, respectively. The federal research and development credits will begin to expire in 2040, unless previously utilized. Of the state research and development credits, $3.9 million will carryforward indefinitely and approximately $8.0 million will begin to expire in 2030, unless previously utilized.
We file tax returns as prescribed by the tax laws of the jurisdictions in which we operate. Our tax years since inception are subject to examination by the federal and state jurisdictions due to the carryforward of unutilized net operating losses and research and development credits. We have not been, nor are we currently, under examination by the federal or any state tax authority.
Management assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to use existing deferred tax assets. Based on the weight of the evidence, including our limited existence and losses since inception, management has determined that it is more likely than not that the deferred tax assets will not be realized and therefore has recorded a full valuation allowance against the deferred taxes. The valuation allowance increased by $85.0 million from December 31, 2024.
Pursuant to Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, or IRC, annual use of our NOL or research and development credit carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period. We completed a study to assess whether an ownership change, as defined by IRC Section 382, has occurred from our formation through December 31, 2025. We determined that an ownership change occurred in 2015, but concluded the annual utilization limitation would be sufficient to utilize our pre-ownership change NOLs and research and development credits prior to expiration. Therefore we do not expect any material limitations to the utilization of NOL’s or research and development credits. Future ownership changes may limit our ability to utilize remaining tax attributes. Any carryforwards that will expire prior to utilization as a result of such additional limitations will be removed from deferred tax assets, with a corresponding reduction of the valuation allowance.
In accordance with authoritative guidance, 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.
The following table summarizes the activity related to our unrecognized tax benefits, in thousands:
| December 31, | |||
|---|---|---|---|
| 2025 | 2024 | 2023 | |
| Gross unrecognized tax benefits at the beginning of the year | $15,447 | $10,114 | $6,485 |
| Increases related to prior year tax positions | — | 67 | 82 |
| Increases from tax positions taken in the current year | 10,274 | 5,266 | 3,547 |
| Gross unrecognized tax benefits at the end of the year | $25,721 | $15,447 | $10,114 |
Our practice is to recognize interest and penalties related to income tax matters in income tax expense. There wasno accrued interest or penalties included on the balance sheets as of December 31, 2025, 2024, or 2023, and we have not recognized interest and penalties on the statements of operations and comprehensive loss for the years ended December 31, 2025, 2024 or 2023.
We do not expect that there will be a significant change in the unrecognized tax benefits over the next 12 months. Due to the existence of the valuation allowance, future changes in our unrecognized tax benefits will not impact our effective tax rate.
Income taxes paid (net of refunds) were immaterial in 2023 and 2024. In 2025, Income taxes paid (net of refunds) exceeded 5% of total income taxes paid (net of refunds) in the following jurisdictions, in thousands:
| Year Ended December 31, | |
|---|---|
| Federal | $1,800 |
| State | |
| Pennsylvania | 180 |
| Illinois | 206 |
| Other | 122 |
| Total | $2,308 |
- Segment Reporting
Our CODM manages our operations on an integrated basis for the purpose of allocating resources. When evaluating our financial performance, the CODM regularly reviews total revenues, total expenses, and research and development expenses by project and the CODM makes decisions using this information.
The table below is a summary of the segment profit or loss, including significant expenses, in thousands:
| Years Ended December 31, | |||
|---|---|---|---|
| 2025 | 2024 | 2023 | |
| Revenue | |||
| Product revenue, net | $2,132 | $— | $— |
| Collaboration revenue | 65,350 | 53,883 | — |
| Total revenue | 67,482 | 53,883 | — |
| Less: | |||
| Cost of product sales | 57 | — | — |
| Ziftomenib-related costs | 142,579 | 79,338 | 35,933 |
| Darlifarnib-related costs | 26,714 | 18,829 | 10,629 |
| Tipifarnib-related costs | 3,490 | 4,770 | 12,190 |
| Discovery stage program-related costs | 7,230 | 6,621 | 5,399 |
| Research and development personnel costs and other expenses | 58,474 | 45,789 | 38,424 |
| Share-based compensation expense | 37,108 | 33,897 | 28,082 |
| Other segment expenses(1) | 95,461 | 57,834 | 35,147 |
| Total operating expenses | 371,113 | 247,078 | 165,804 |
| Other income (expenses) | |||
| Interest and other income, net | 26,774 | 22,849 | 14,722 |
| Interest expense | (1,512) | (1,619) | (1,549) |
| Income tax expense | (297) | (2,018) | — |
| Segment and net loss | $(278,666) | $(173,983) | $(152,631) |
(1)
Other segment expenses are comprised of selling, general and administrative expenses, excluding share-based compensation expense, which is shown separately.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.