Kura Oncology, Inc.
For the period ended Sep 30, 2026. Filed Nov 10, 2026.
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Sep 30, 2026 · Filed Nov 10, 2026
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Notes to Condensed Financial Statements (unaudited)
Notes to Unaudited Condensed Financial Statements
- Organization and Basis of Presentation
Kura Oncology, Inc. is a 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 Unaudited Condensed Financial Statements to the “Company,” “we,” “our” or “us,” refer to Kura Oncology, Inc.
Basis of Presentation
The accompanying unaudited condensed financial statements should be read in conjunction with the audited financial statements and notes thereto in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed with the Securities and Exchange Commission on March 5, 2026, from which we derived our balance sheet as of December 31, 2025. The accompanying unaudited condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP, for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, since they are interim statements, the accompanying unaudited condensed financial statements do not include all of the information and notes required by GAAP for complete financial statements. The accompanying unaudited condensed financial statements reflect all adjustments, consisting of normal recurring adjustments, that are, in the opinion of our management, necessary to a fair statement of the results for the interim periods presented. Interim results are not necessarily indicative of results for a full year.
The preparation of the unaudited condensed financial statements in accordance with GAAP requires our management to make estimates and assumptions that affect the amounts reported on our unaudited condensed financial statements and accompanying notes. The amounts reported could differ under different estimates and assumptions. On an ongoing basis, we evaluate our estimates and judgments, which are based on historical and anticipated results and trends and on various other assumptions that management believes to be reasonable under the circumstances. By their nature, estimates are subject to an inherent degree of uncertainty and, as such, actual results may differ from management’s estimates.
- Summary of Significant Accounting Policies
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 unaudited condensed 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 unaudited condensed statements of operations and comprehensive loss.
We elected the practical expedient to exclude the applicable accrued interest from both the fair value and amortized cost 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 unaudited condensed 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.
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.
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 ASC 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 ASC 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 ASC 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 ASC 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 9, Kyowa Kirin Collaboration and License Agreement, for more details.
Variable Interest Entities
We evaluate our ownership, contractual and other interests in entities to determine whether an entity is a variable interest entity, or VIE, and, if so, whether we are the primary beneficiary in accordance with ASC Topic 810, Consolidation, or ASC Topic 810. We consolidate a VIE when we have both (i) the power to direct the activities that most significantly impact the VIE’s economic performance and (ii) the obligation to absorb losses of or the right to receive benefits from the VIE that could potentially be significant to the VIE. We reassess whether we are the primary beneficiary of a VIE when events occur that change the design, governance or allocation of decision-making authority of the entity. A VIE for which we are not the primary beneficiary is not consolidated. See Note 5, Variable Interest Entities, for additional information regarding our involvement with an unconsolidated VIE.
Equity Method Investments
We account for investments over which we have the ability to exercise significant influence, but not control, using the equity method of accounting in accordance with ASC Topic 323, Investments – Equity Method and Joint Ventures, or ASC Topic 323. Equity method investments are initially recognized at cost or, when retained following a deconsolidation, at fair value. We recognize our share of an investee’s earnings or losses in the period in which they are reported by the investee, adjusted for investor-level basis differences and other adjustments required under the equity method.
When an investee’s capital structure results in disproportionate allocations of earnings and losses among investors, we determine our share of the investee’s earnings and losses in accordance with the applicable provisions of ASC Topic 323.
We discontinue recognizing our share of losses when the carrying amount of our investment and other interests that are considered part of our investment have been reduced to zero, unless we have guaranteed obligations of the investee, are otherwise committed to provide further financial support or the investee’s return to profitability is imminent. If the investee subsequently reports net income, we resume recognizing our share of earnings only after our share of earnings equals the share of losses not previously recognized. See Note 3, Investments, for additional information regarding our equity method investment.
Nonmarketable Equity Securities
Our nonmarketable equity securities consist of investments in privately held companies that do not have readily determinable fair values and are not accounted for under the equity method. We measure these investments at cost, less impairment, adjusted for observable price changes in orderly transactions involving identical or similar securities of the same issuer in accordance with ASC Topic 321, Investments – Equity Securities, or ASC Topic 321. Adjustments resulting from impairment or observable price changes are recognized in earnings.
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 three months ended September 30, 2026 and 2025, 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 at September 30, 2026 and 2025 totaling approximately 23,661,000 and 18,559,000, respectively, were excluded from the computation of dilutive weighted-average shares outstanding because their effect would be anti-dilutive.
Recent Accounting Pronouncements
Disaggregation of Income Statement Expenses
In November 2024, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or 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 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
Marketable Securities
We invest in available-for-sale securities consisting of U.S. Treasury securities, U.S. Agency bonds and money market funds. Available-for-sale securities are classified as either cash and cash equivalents or short-term investments on the unaudited condensed 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) | Amortized Cost | Unrealized Gains | Unrealized Losses | EstimatedFair Value | |
|---|---|---|---|---|---|
| Cash equivalents | |||||
| Money market funds | 1 or less | $32,889 | $— | $— | $32,889 |
| Short-term investments | |||||
| U.S. Treasury securities | 2 or less | 386,346 | 10 | (1,374) | 384,982 |
| U.S. Agency bonds | 3 or less | 49,997 | — | (820) | 49,177 |
| Total short-term investments | 436,343 | 10 | (2,194) | 434,159 | |
| Total | $469,232 | $10 | $(2,194) | $467,048 | |
| Maturities (years) | Amortized Cost | Unrealized Gains | Unrealized Losses | EstimatedFair 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 | |
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 September 30, 2026 and December 31, 2025, short-term investments of $332.9 million and $367.2 million, respectively, had maturities less than one year, short-term investments of $89.1 million and $135.9 million, respectively, had maturities between one to two years, and short-term investments of $12.2 million and $15.0 million, respectively, had maturities between two to three years. Realized gains and losses were de minimis for the three and nine months ended September 30, 2026 and 2025.
As of September 30, 2026 and December 31, 2025, 60 available-for-sale securities with a fair market value of $411.9 million andsix available-for-sale securities with a fair market value of $22.5 million, respectively, were in a gross unrealized loss position. None of such securities were in a continuous unrealized loss position for greater than 12 months. We do not intend to sell such available-for-sale securities, and it is not more likely than not that we will be required to sell such securities prior to recovery of their amortized cost basis. Based on our review of these available-for-sale securities, the unrealized losses at September 30, 2026 were primarily due to changes in interest rates and not due to increased credit risks associated with specific securities. As such we haveno allowance for credit losses as of September 30, 2026 and December 31, 2025. 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 was $3.1 million and $3.8 million as of September 30, 2026 and December 31, 2025, respectively. We have not written off any accrued interest receivables for the nine months ended September 30, 2026 and 2025.
Equity Method Investment in Caspian
On September 8, 2026, following the completion of the Series A preferred stock financing described in Note 5, Variable Interest Entities, we deconsolidated Caspian Therapeutics, Inc., or Caspian, and retained 10,010,000 shares of Caspian common stock, representing 100% of Caspian’s outstanding common stock.
The following table summarizes activity in our Caspian equity method investment for the period from September 8, 2026 through September 30, 2026, in thousands:
| Fair value of retained Caspian common stock at September 8, 2026 | $30,586 |
|---|---|
| Loss associated with in-process research and development basis difference | (30,586) |
| Carrying amount at September 30, 2026 | $— |
Caspian’s capital structure includes substantive preferential rights held by its Series A preferred stockholders. Accordingly, we determine our share of Caspian’s earnings and losses using a hypothetical liquidation at book value, or HLBV, methodology. Under HLBV, our share of earnings and losses is determined based on the change in the amount we would receive if Caspian were hypothetically liquidated at book value, after giving effect to the contractual rights and preferences of its outstanding equity securities.
Because the carrying amount of our Caspian common stock investment was reduced to zero, subsequent losses allocable to us under HLBV are applied to the adjusted carrying amount of our Caspian Series A preferred stock investment based on the contractual liquidation seniority of our interests. Additional allocable losses are suspended after the adjusted carrying amounts of both investments have been reduced to zero, as we have not guaranteed Caspian’s obligations and are not otherwise committed to provide additional financial support.
The allocation of Caspian’s earnings and losses may be affected by future equity issuances, conversions, exercises or other changes to Caspian’s capital structure. We reassess the HLBV calculation and the allocation of Caspian’s earnings and losses upon the occurrence of such changes.
Nonmarketable Equity Security
In connection with Caspian’s Series A preferred stock financing, we purchased 1,062,500 shares of Caspian Series A preferred stock for approximately $4.3 million on the same terms as the other investors participating in the financing. The Series A preferred stock has a substantive liquidation preference and does not have risk and reward characteristics that are substantially similar to Caspian’s common stock. Accordingly, the Series A preferred stock is not accounted for under the equity method and is accounted for as a nonmarketable equity security under ASC Topic 321.
As of September 30, 2026, the adjusted carrying amount of the Series A preferred stock investment was approximately $4.3 million and was included in other long-term assets on the unaudited condensed balance sheet. During the three and nine months ended September 30, 2026, and cumulatively through September 30, 2026, we recognizedno impairment charges or upward or downward adjustments resulting from observable price changes. During the three and nine months ended September 30, 2026, we didnot recognize any equity method losses as an adjustment to the carrying amount of the Series A preferred stock investment.
- Fair Value Measurements
As of September 30, 2026 and December 31, 2025, we had cash equivalents and short-term investments measured at fair value on a recurring basis.
Available-for-sale securities consist of U.S. Treasury securities and money market funds, 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 | $32,889 | $32,889 | $— | $— |
| Short-term investments | ||||
| U.S. Treasury securities | 384,982 | 384,982 | — | — |
| U.S. Agency bonds | 49,177 | — | 49,177 | — |
| Total short-term investments | 434,159 | 384,982 | 49,177 | — |
| Total | $467,048 | $417,871 | $49,177 | $— |
| 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 | $— |
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.
- Variable Interest Entities
In July 2026, we formed Caspian to focus on the development of KO-7246 and other next-generation menin inhibitors for the treatment of diabetes and other cardiometabolic diseases and we purchased from Caspian 10,000 shares of Caspian common stock.
On September 8, 2026, we entered into a Contribution and License Agreement, or the Caspian Contribution Agreement, with Caspian pursuant to which we contributed certain diabetes and cardiometabolic menin inhibitor compounds and related intellectual property, know-how, development data and other assets, or the Caspian Assets, to Caspian. In consideration for the Caspian Assets, Caspian issued us 10,000,000 shares of Caspian common stock.
On September 8, 2026, Caspian completed the sale and issuance of $50.0 million of shares of its Series A preferred stock in a private financing, or the Series A Financing. We invested approximately $4.3 million in the Series A Financing. Following completion of the financing, we held 10,010,000 shares of Caspian common stock and 1,062,500 shares of Caspian Series A preferred stock, representing approximately 49.2% of Caspian’s outstanding common and preferred stock on an as-converted basis.
Upon completion of the financing, Caspian’s ownership and governance structure changed, including through the issuance of a majority of its outstanding common and preferred stock on an as-converted basis to third-party investors and changes to the composition and appointment rights of Caspian’s board of directors. As a result of these changes, we no longer have the power to direct the activities that most significantly impact Caspian’s economic performance and, therefore, are no longer the primary beneficiary of Caspian. Accordingly, we deconsolidated Caspian on September 8, 2026.
Upon deconsolidation, we derecognized Caspian’s assets and liabilities and measured our retained Caspian common stock at its estimated fair value of approximately $30.6 million. We recognized a gain on deconsolidation of subsidiary of approximately$30.6 million during the three and nine months ended September 30, 2026 on the unaudited condensed statements of operations and comprehensive loss.
Following the Series A financing, Caspian continues to be a VIE. Although we have the ability to exercise significant influence over Caspian, we are not the primary beneficiary because we do not have the power to direct the activities that most significantly impact Caspian’s economic performance. Accordingly, Caspian is not consolidated in our unaudited condensed financial statements.
We have not guaranteed any of Caspian's obligations and are not contractually required to provide additional financial support to Caspian beyond our obligations under the contractual arrangements described in Note 6, Related-Party Transactions.
- Related Party Transactions
Troy E. Wilson, Ph.D., J.D., our president and chief executive officer, is the chairman of Caspian’s board of directors. A family trust related to Dr. Wilson also participated in Caspian’s Series A financing for an aggregate purchase price of $5.0 million.
In connection with Caspian’s Series A financing, we entered into an Intercompany Services Agreement, or the Caspian Services Agreement, with Caspian pursuant to which we provide certain administrative and research and development services to Caspian. The scope of services is mutually agreed by the parties, including through individually agreed work orders. Service fees consist of personnel costs calculated using specified FTE rates plus a 10% markup, together with reimbursement of third-party out-of-pocket costs without markup.
Pursuant to the Caspian Contribution Agreement, Caspian will reimburse us for up to $1.5 million of certain expenditures associated with the Caspian Assets. In addition, Caspian will reimburse us approximately $0.4 million for legal, organizational, and transaction-related costs incurred in connection with its formation and completion of the Series A financing.
As of September 30, 2026, amounts due from Caspian under the Caspian Services Agreement and reimbursements under the Caspian Contribution Agreement were $1.3 million and were included in accounts receivable, net on the unaudited condensed balance sheet. As of September 30, 2026, income from services provided to Caspian pursuant to the Caspian Services Agreement was approximately $0.1 million and was included in interest and other income, net on the unaudited condensed statements of operations and comprehensive loss.
- Balance Sheet Detail
Property and equipment consisted of the following, in thousands:
| September 30, 2026 | December 31, 2025 | |
|---|---|---|
| Leasehold improvements | $7,315 | $6,919 |
| Laboratory and computer equipment | 2,113 | 1,958 |
| Furniture and fixtures | 1,965 | 1,878 |
| Property and equipment, gross | 11,393 | 10,755 |
| Less: accumulated depreciation | (3,936) | (2,900) |
| Property and equipment, net | $7,457 | $7,855 |
Accrued expenses and other current liabilities consisted of the following, in thousands:
| September 30, 2026 | December 31, 2025 | |
|---|---|---|
| Product revenue allowances | $4,305 | $377 |
| Accrued clinical trial research and development expenses | 23,320 | 23,276 |
| Accrued compensation and benefits | 18,414 | 22,372 |
| Accrued other research and development expenses | 16,953 | 12,041 |
| Other accrued expenses | 3,714 | 3,631 |
| Total accrued expenses and other current liabilities | $66,706 | $61,697 |
- 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 right-of-use, or 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. 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 lease liabilities as of September 30, 2026 are as follows, in thousands:
| Year Ending December 31, | |
|---|---|
| 2026 (remaining) | $509 |
| 2027 | 3,658 |
| 2028 | 3,755 |
| 2029 | 3,853 |
| 2030 | 3,954 |
| Thereafter | 7,214 |
| Total lease payments | 22,943 |
| Less: imputed interest | (6,946) |
| Total operating lease liabilities | $15,997 |
As of September 30, 2026 and December 31, 2025, the weighted-average discount rate was 12.4% and 12.3%, respectively, and the weighted-average remaining lease term was 6.1 years and 6.4 years, respectively.
For the three months ended September 30, 2026 and 2025, tenant improvement reimbursements, net of cash paid for amounts included in the measurement of operating lease liabilities, were $0.9 million, and cash paid for amounts included in the measurement of operating lease liabilities, net of tenant improvement reimbursements, was $0.5 million, respectively. For the nine months ended September 30, 2026 and 2025, tenant improvement reimbursements, net of cash paid for amounts included in the measurement of operating lease liabilities, were $3.8 million, and cash paid for amounts included in the measurement of operating lease liabilities, net of tenant improvement reimbursements, was $1.4 million, respectively. For the nine months ended September 30, 2026, there wereno operating lease ROU assets obtained in exchange for operating lease liabilities compared to $2.7 million for the nine months ended September 30, 2025.
Total operating lease and rent expense for the three months ended September 30, 2026 and 2025 were approximately $0.6 million and $0.8 million, respectively. Total operating lease and rent expense for the nine months ended September 30, 2026 and 2025 were approximately $1.8 million and $2.4 million, respectively.
- 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 ziftomenib globally. In addition, we are responsible for the global manufacture and supply of ziftomenib pursuant to a clinical supply agreement with Kyowa Kirin Co., Ltd., or Kyowa Supply Agreement. The Kyowa Supply Agreement was determined to be a separate contract from the Kyowa License Agreement for purposes of revenue recognition and reporting.
On June 27, 2025, we entered into a co-promotion and medical affairs agreement with Kyowa Kirin, Inc., which was determined to be a separate contract from the Kyowa License Agreement for purposes of revenue recognition and reporting.
The Kyowa License Agreement includes performance obligations for monotherapy development services, combination therapy development services, and commercialization services. We have the right and responsibility to lead all development, manufacturing, and commercialization activities for ziftomenib in the United States. We are responsible for funding the specified development activities set forth in the initial development plan and budget mutually agreed upon with Kyowa Kirin, or Development Plan, and we and Kyowa Kirin share equally (50/50) all other development costs in the United States. The parties share equally profits or losses from the commercialization of ziftomenib in the United States.
Through the Kyowa License Agreement, we granted Kyowa Kirin an exclusive license to develop, manufacture and commercialize ziftomenib outside of the United States, or ROW License, within the field of acute myeloid leukemia, or AML, and other hematologic malignancies.
As of September 30, 2026, we have received $595.8 million under the Kyowa License Agreement, consisting of $570.0 million in upfront and milestone payments and $25.8 million in profit and loss and expense sharing, including $0.5 million in reimbursements for costs associated with postmarketing requirements and commitments. We are eligible to receive an additional $693.0 million in development, regulatory, and commercial milestone payments for the existing field (i.e., AML and other hematologic malignancies) and, if Kyowa Kirin exercises its option to expand the ROW License, an additional $228.0 million in upfront payments and development, regulatory, and commercial milestone payments for the expanded field (i.e., gastrointestinal stromal tumors and other solid tumor indications), 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.
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, expiration of the last-to-expire regulatory exclusivity or ten years after first commercial sale. The Kyowa License Agreement will remain in effect outside of 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 twelve months’ prior written notice.
Based on our analysis of the key terms and activities required by the Kyowa License Agreement, we assessed the criteria under ASC 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 is within the scope of ASC Topic 808.
We evaluated each of the 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, development services related to combination therapies and commercialization services. The ROW License is a unit of account under the scope of ASC Topic 606, while the development services and commercialization services are under the scope of ASC Topic 808. We determined that ASC Topic 606 is the most appropriate accounting model to apply by analogy to the recognition and measurement of these units of account.
As of September 30, 2026, the transaction price of $595.8 million includes fixed consideration and variable consideration to the extent that it is probable that a significant reversal of revenue recognized will not occur. The transaction price excludes variable consideration when uncertainties related to development, regulatory and commercial outcomes exist.
We allocated the transaction price to each performance obligation based on their relative stand-alone selling price. Transaction price allocated to the ROW License is recognized in collaboration revenue at a point in time as the performance obligation was completed upon transfer of the license. Transaction price allocated to development services for monotherapy and combination therapies is recognized in collaboration revenue over time using a cost-to-cost measure of progress.
For the three and nine months ended September 30, 2026, we recognized $5.0 million and $15.9 million, respectively, of revenue from development services in combination with other therapies, and $3.8 million and $17.2 million, respectively, of revenue from development services for monotherapy. Collaboration revenue recognized for the three and nine months ended September 30, 2026 was included in contract liabilities as of December 31, 2025.
As of September 30, 2026, the total contract liability was $443.9 million, of which $63.5 million was classified as current, and $380.4 million was classified as long-term. As of September 30, 2026, the remaining unrecognized consideration allocated to the development services for monotherapy was $17.1 million and to the development services in combination with other therapies was $151.5 million. As of September 30, 2026, $275.3 million of consideration allocated to commercialization services and profit and loss and expense sharing received was constrained and included in contract liabilities, of which $17.0 million was classified as current, and $258.3 million was classified as long-term.
- Stockholders’ Equity
In November 2023, we entered into a sales agreement with Leerink Partners LLC and Cantor Fitzgerald & Co., or the Sales Agreement, under which we could 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, or the Original ATM Facility. During each of the three and nine months ended September 30, 2026, we sold 2,563,568 shares of our common stock under the Original ATM Facility, at an average sales price of $12.64 per share, for net proceeds of approximately $31.5 million, after deducting sales agent commissions and offering expenses. As of September 30, 2026, approximately $117.6 million remained available for future sales under the Original ATM Facility. On November 2, 2026, our November 2023 automatic shelf registration statement on Form S-3 and prospectus therein relating to the Original ATM Facility expired. On November 10, 2026, we entered into an Amendment No. 1 to Sales Agreement with Leerink Partners LLC and Cantor Fitzgerald & Co., or Amendment No. 1, to, among other things, remove the $150.0 million aggregate offering price limitation from the Sales Agreement. Promptly following the filing of this Quarterly Report on Form 10-Q, we plan to file with the SEC an automatic shelf registration statement on Form S-3 and related prospectus under which we may offer and sell, from time to time, at our sole discretion, shares of our common stock under the Sales Agreement, as amended by Amendment No. 1, having an aggregate offering price of up to an additional $150.0 million.
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 Hercules Lenders, and Hercules Capital, Inc., in its capacity as administrative agent and collateral agent for itself and the Hercules Lenders, which was amended in October 2023 and October 2025, or the Hercules Loan Agreement. In connection with the Hercules Loan Agreement, we issued warrants to certain of the Hercules 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 September 30, 2026.
- Share-Based Compensation
The following table summarizes share-based compensation expense for all share-based compensation arrangements, in thousands:
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Research and development | $3,104 | $3,212 | $9,557 | $9,253 |
| Selling, general and administrative | 5,067 | 7,753 | 15,239 | 16,503 |
| Total share-based compensation expense | $8,171 | $10,965 | $24,796 | $25,756 |
As of September 30, 2026, unrecognized estimated compensation expense related to stock options, RSUs and PSUs was approximately $47.1 million, $16.8 million, and $0.1 million, resp ectively, which is expected to be recognized over a weighted average period of approxim ately 2.7 years,2.7 years, and 0.1 years, respectively. As of September 30, 2026, the vesting of PSUs covering 2,286,667 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.
- Segment Reporting
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 asingle operating segment in the United States. When evaluating our financial performance, the CODM regularly reviews total revenues, total expenses, and research and development expenses by program 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:
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Revenue | ||||
| Product revenue, net | $13,922 | $— | $28,810 | $— |
| Collaboration revenue | 8,917 | 20,750 | 33,168 | 50,146 |
| Total revenue | 22,839 | 20,750 | 61,978 | 50,146 |
| Less: | ||||
| Cost of product sales | 371 | — | 876 | — |
| Ziftomenib-related costs | 37,160 | 40,320 | 108,978 | 107,851 |
| Darlifarnib-related costs | 8,853 | 8,494 | 21,406 | 19,871 |
| Discovery stage program-related costs | 1,459 | 1,744 | 4,760 | 5,323 |
| Research and development personnel costs and other expenses | 16,302 | 14,138 | 49,331 | 44,368 |
| Share-based compensation expense | 8,171 | 10,965 | 24,796 | 25,756 |
| Other segment expenses(1) | 25,181 | 25,086 | 78,314 | 64,340 |
| Total operating expenses | 97,497 | 100,747 | 288,461 | 267,509 |
| Other income (expenses) | ||||
| Interest and other income, net | 4,793 | 6,274 | 15,652 | 21,088 |
| Interest expense | (350) | (393) | (1,031) | (1,166) |
| Loss on equity method investment | (30,586) | — | (30,586) | — |
| Gain on deconsolidation of subsidiary | 30,586 | — | 30,586 | — |
| Income tax expense | — | — | (13) | (226) |
| Segment and net loss | $(70,215) | $(74,116) | $(211,875) | $(197,667) |
(1)
Other segment expenses are comprised of selling, general and administrative expenses, excluding share-based compensation expense, which is shown separately.
- Subsequent Events
Loan and Security Agreement
On November 9, 2026, we entered into a loan and security agreement with the lenders party thereto, or the Lenders, and KRGD SA, LLC, an affiliate of Oberland Capital Management LLC, or Oberland, in its capacity as administrative agent and collateral agent for itself and the Lenders, or the Oberland Loan Agreement. At closing, we borrowed $50.0 million and used a portion of the proceeds to repay our outstanding obligations under the Hercules Loan Agreement, which we terminated at closing. We may borrow up to an additional $225.0 million, consisting of (i) a $50.0 million second tranche and a separate $25.0 million third tranche, each available through December 31, 2027, (ii) a $50.0 million fourth tranche available through December 31, 2028 followingour announcement of positive clinical data from the KOMET-017 Phase 3 study of ziftomenib, or the Phase 3 Milestone, and (iii) up to $100.0 million available in minimum increments of $25.0 million through December 31, 2028, subject to mutual agreement. All advances are subject to applicable funding conditions. Draws under each of the second and third tranches are at our option, subject to applicable funding conditions. Following satisfaction of the Phase 3 Milestone and applicable funding conditions, we are required to draw the fourth tranche unless we already have drawn the second tranche, in which case the fourth-tranche draw is optional.
The term loans under the Oberland Loan Agreement, or the Term Loans, mature on November 9, 2033, or the Maturity Date, and bear interest at a floating annual rate equal to the three-month term secured overnight financing rate, subject to a floorof 3.75%, plus 3.20%, with an overall annual interest rate cap of 8.95%. For the first twelve quarters following each advance,50% of the interest on that advance is payable quarterly in cash, in arrears, and 50% is paid in kind and added to principal. Thereafter, interest is payable entirely in cash quarterly in arrears. The entire outstanding principal balance, including capitalized payment-in-kind interest, and all accrued and unpaid interest are due on the Maturity Date.
The Oberland Loan Agreement contains customary affirmative and negative covenants, including restrictions on additional indebtedness, liens, investments, distributions, asset transfers, mergers and acquisitions, and certain transactions with affiliates, in each case subject to specified exceptions. It also contains customary events of default that may result in acceleration of our obligations.
Royalty Participation Agreement
In connection with the Oberland Loan Agreement, on November 9, 2026, we also entered into a royalty participation agreement, or the Royalty Participation Agreement, with Oberland, requiring quarterly payments of single-digit royalties based on U.S. net sales of ziftomenib and certain related products beginning October 1, 2028. Aggregate royalty payments are capped at 20.0% of the aggregate principal amount funded under the Oberland Loan Agreement, including original issue discount but excluding capitalized payment-in-kind interest, or the Cap Amount. The royalty participation period ends on the earliest of (i) November 9, 2036, (ii) the date upon which the Royalty Holders receive aggregate royalty participation payments equal to the Cap Amount, and (iii) payment in full of the repurchase price for the royalty participation, or the Repurchase Price, equal to the then-applicable Cap Amount less aggregate royalty participation payments previously received by the Royalty Holders. If the royalty participation period ends on November 9, 2036, we must pay the then-applicable Repurchase Price.
Securities Purchase Agreement
In connection with the Oberland Loan Agreement, on November 9, 2026, we also entered into a securities purchase agreement, or the Purchase Agreement, with TPC Investments III LP, or TPC, an affiliate of Oberland. The Purchase Agreement provides for up to $25.0 million of equity investment in our common stock, consisting of $5.0 million funded at the initial closing, an additional $5.0 million to be funded contemporaneously with the funding of the fourth tranche under the Oberland Loan Agreement, and an option for TPC to purchase up to an additional $15.0 million of our common stock during the term specified in the Purchase Agreement, in each case at prices per share determined in accordance with the Purchase Agreement. Pursuant to the Purchase Agreement, at the initial closing on November 9, 2026, TPC purchased an aggregate of 687,758 shares of our common stock, at a purchase price of $7.27 per share, for aggregate gross proceeds of approximately $5.0 million.
Repayment of Hercules Loan Agreement
On November 9, 2026, concurrent with the closing of the Oberland Loan Agreement, we terminated the Hercules Loan Agreement and paid approximately $11.6 million to satisfy all outstanding obligations, including the end of term charge, accrued interest and legal fees.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.