Ikena Oncology Inc
For the period ended Sep 30, 2024. Filed Nov 7, 2024.
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Sep 30, 2024 · Filed Nov 7, 2024
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Notes to Unaudited Condensed Consolidated Financial Statements
Notes to Condensed Consolid ated Financial Statements
- Nature of Business and Basis of Presentation
Ikena Oncology, Inc. (the “Company”) is a clinical stage targeted oncology company, focused on developing differentiated therapies for patients in need that target nodes of cancer growth, spread, and therapeutic resistance. The Company’s approach has been to target both cancer-driving targets and mechanisms of resistance to other therapies.
The Company’s condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial reporting. Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).
The accompanying condensed consolidated financial statements and footnotes to the financial statements have been prepared on the same basis as the most recently audited annual financial statements and, in the opinion of management, reflect all normal recurring adjustments necessary for the fair presentation of the Company’s financial position for the reported periods. The results of operations for any interim periods are not necessarily indicative of results to be expected for the year ending December 31, 2024, any other interim periods, or any future year or period. These condensed consolidated financial statements should be read in conjunction with, the Company’s audited consolidated financial statements for the year ended December 31, 2023, which were included in its Annual Report on Form 10-K that was filed with the Securities and Exchange Commission (“SEC”) on March 12, 2024.
- Summary of Significant Accounting Policies
The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such a time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that the Company no longer is an emerging growth company or affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, these financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates.
Principles of Consolidation
The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of the Company’s financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Estimates and judgments are based on historical information and other market-specific or various relevant assumptions, including in certain circumstances, future projections, that management believes to be reasonable under the circumstances. Actual results could differ materially from estimates. Significant estimates and assumptions reflected in these condensed consolidated financial statements include but are not limited to the accruals for research and development expenses and collaboration revenue.
Concentration of Credit Risk and of Significant Suppliers
Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, and marketable securities. Cash and cash equivalents are deposited with federally insured financial institutions in the United States and may, at times, exceed federally insured limits. The Company places marketable securities with a highly rated financial institution. As of September 30, 2024, the Company has not experienced any credit related losses on its cash, cash equivalents or marketable securities.
The Company is dependent on third-party manufacturers to supply products for its research and development activities. In particular, the Company relies and expects to continue to rely on a small number of manufacturers to supply it with its requirements for the active pharmaceutical ingredients and formulated drugs related to the Company’s programs. These programs could be adversely affected if a third-party manufacturer is unable to successfully carry out their contractual obligations or meet expected deadlines. If a third-party manufacturer needs to be replaced, the Company may not be able to complete its program development on its anticipated timelines and may incur additional expenses as a result.
Restricted Cash
As of September 30, 2024 and December 31, 2023, the Company maintained restricted cash totaling $0.9 million and $1.3 million, respectively, held in the form of a money market account as collateral for the Company’s facility lease obligations. This balance is included within deposits and other assets on the condensed consolidated balance sheets.
Net Income (Loss) Per Share
Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted net income (loss) per common share is computed by dividing net income (loss) by the weighted average number of common shares outstanding for the period, including potential dilutive common shares assuming the dilutive effect of outstanding stock options. For periods in which the Company reported a net loss, diluted net loss per common share is the same as basic net loss per common share, since dilutive common shares are not assumed to have been issued if their affect is anti-dilutive.
The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:
| September 30, | ||
|---|---|---|
| 2024 | 2023 | |
| Options to purchase common stock | 8,162,915 | 7,417,356 |
| Convertible preferred stock | — | 4,153,439 |
| Total | 8,162,915 | 11,570,795 |
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its consolidated financial statements and disclosures.
- Fair Value Measurements
The following tables present information about the Company’s financial assets measured or disclosed at fair value by level within the fair value hierarchy (in thousands):
| September 30, 2024 | Quoted Prices in Active Markets(Level 1) | Significant Observable Inputs(Level 2) | Significant Unobservable Inputs(Level 3) | |
|---|---|---|---|---|
| Cash equivalents: | ||||
| Money market funds | $39,232 | $39,232 | $— | $— |
| Marketable securities: | ||||
| U.S. treasury securities | 35,277 | — | 35,277 | — |
| Corporate debt securities | 57,566 | — | 57,566 | — |
| Total assets | $132,075 | $39,232 | $92,843 | $— |
| December 31, 2023 | Quoted Prices in Active Markets(Level 1) | Significant Observable Inputs(Level 2) | Significant Unobservable Inputs(Level 3) | |
|---|---|---|---|---|
| Cash equivalents: | ||||
| Money market funds | $53,613 | $53,613 | $— | $— |
| Marketable securities: | ||||
| Corporate debt securities | 55,571 | — | 55,571 | — |
| Total assets | $109,184 | $53,613 | $55,571 | $— |
During the three and nine months ended September 30, 2024 and 2023, there wereno transfers into or out of Level 3.
- Marketable Securities
The following tables summarize the Company's marketable securities (in thousands):
| Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | |
|---|---|---|---|---|
| U.S. treasury securities | $35,235 | $43 | $(1) | $35,277 |
| Corporate debt securities | 57,368 | 205 | (7) | 57,566 |
| Total | $92,603 | $248 | $(8) | $92,843 |
| Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | |
|---|---|---|---|---|
| Corporate debt securities | $55,624 | $27 | $(80) | $55,571 |
| Total | $55,624 | $27 | $(80) | $55,571 |
In accordance with the Company's investment policy, it places investments in investment grade securities with high credit quality issuers, and generally limits the amount of credit exposure to any one issuer. The Company evaluates securities for impairment at the end of each reporting period. Factors considered include whether a decline in fair value below the amortized cost basis is due to credit-related factors or non-credit-related factors, the financial condition and near-term prospects of the issuer, and the Company’s intent and ability to hold the investment to allow for an anticipated recovery in fair value. As of September 30, 2024 and December 31, 2023, there wereno allowances for credit losses recorded.
The Company classifies its investments in marketable securities as available-for-sale and as current assets as they represent the investment of funds available for current operations. The following table summarizes the fair value of the Company’s available-for-sale securities by contractual maturity (in thousands):
| Due in one year or less | $78,685 |
|---|---|
| Due after one year through three years | 14,158 |
| Total | $92,843 |
- Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
| September 30, 2024 | December 31, 2023 | |
|---|---|---|
| Employee compensation | $1,749 | $3,311 |
| Research and development expenses | 1,205 | 3,964 |
| Professional fees | 776 | 1,221 |
| Other | 47 | 85 |
| Total | $3,777 | $8,581 |
- Collaboration Agreement and Stock Purchase Agreement with Bristol-Myers Squibb
The Company has a 2019 collaboration agreement and associated stock purchase agreement (collectively the “Agreements”) with Celgene Corporation (acquired by Bristol-Myers Squibb), whereby the Company carried out initial research and development activities with the goal of identifying and developing drug candidates for certain cancer types. Bristol-Myers Squibb paid the Company a total of $95.0 million in aggregate upfront consideration related to the collaboration and stock purchase under the Agreements, of which $78.7 million was allocated to the collaboration. The Company was eligible to receive $50.0 million, in case of an exercise of an option with respect to IK-175, and $40.0 million, in case of an exercise of an option with respect to IK-412. Upon the exercise of the delivery of each license, the Company would have been eligible to receive up to $450.0 million in milestone payments, as well as a tiered royalty on worldwide sales from the high single to low teen digits.
On January 17, 2024, Bristol-Myers Squibb notified the Company of its decision not to opt-in on the IK-175 program. In addition, Bristol-Myers Squibb did not provide an opt-in exercise for the IK-412 program. As a result, the Company has regained full global rights to the IK-175 and IK-412 programs. Deferred revenue related to the collaboration had been fully recognized prior to December 31, 2023, as all obligations under the Agreements had been completed. As of September 30, 2024, all activities under the collaboration agreement have been concluded and there are no further amounts to be paid by Bristol-Myers Squibb under such agreement.
- Stock-Based Compensation
The Company has outstanding awards under its 2016 Stock Incentive Plan, as amended (the “2016 Plan”), but is no longer granting awards under this plan. The Company’s 2021 Stock Incentive Plan (the “2021 Plan” and, together with the 2016 Plan, the “Plans”)allows the Company to make equity-based and cash-based incentive awards to officers, employees, directors and consultants. The number of shares initially reserved under the 2021 Plan was 3,119,514 shares of the Company’s common stock. Additionally, shares of the Company’s common stock subject to outstanding awards under the 2016 Plan that expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased by the Company at their original issuance price pursuant to a contractual repurchase right will be added back to the shares of common stock available for issuance under the 2021 Plan. The 2021 Plan contains an “evergreen” provision, which allows for an annual increase in the number of shares of common stock available for issuance under the 2021 Plan on the first day of each fiscal year during the period beginning in fiscal year 2022. The annual increase in the number of shares shall be equal to 4% of the number of shares of common stock outstanding on the immediately preceding December 31; or such lesser number of shares as determined by the Administrator as provided in the 2021 Plan. On January 1, 2024, the number of shares of common stock available for issuance under the 2021 Plan increased by 1,930,324 shares as a result of the automatic increase provision of the 2021 Plan. As of September 30, 2024,4,268,925 shares of common stock remain available for future issuance under the 2021 Plan.
The vesting periods for equity awards, which generally arefour years, are determined by the Company’s board of directors. The contractual term for stock option awards isten years.
The Company recorded stock-based compensation expense in the following expense categories of its condensed consolidated statements of operations and comprehensive loss (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Research and development | $249 | $1,058 | $1,426 | $3,114 |
| General and administrative | 768 | 940 | 2,608 | 2,763 |
| Restructuring and other charges | — | — | 263 | — |
| Total | $1,017 | $1,998 | $4,297 | $5,877 |
As of September 30, 2024, the total unrecognized stock-based compensation balance for outstanding awards was $4.9 million, which is expected to be recognized over a weighted average period of 2.4 years.
The following table summarizes stock option activity for thenine months ended September 30, 2024:
| Number ofOptions | Weighted-AverageExercisePrice | Weighted-AverageRemainingContractualTerm (years) | AggregateIntrinsicValue(thousands) | |
|---|---|---|---|---|
| Outstanding as of December 31, 2023 | 7,088,261 | $6.35 | 6.92 | $94 |
| Granted | 2,377,173 | 1.48 | ||
| Exercised | — | — | ||
| Cancelled or forfeited | (1,302,519) | 5.85 | ||
| Outstanding as of September 30, 2024 | 8,162,915 | $5.01 | 7.35 | $629 |
| Vested or expected to vest as of September 30, 2024 | 8,162,915 | $5.01 | 7.35 | $629 |
| Options exercisable as of September 30, 2024 | 4,551,478 | $6.45 | 6.20 | $89 |
The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the Company’s common stock. No options were exercised during thenine months ended September 30, 2024. The aggregate intrinsic value of options exercised during the nine months ended September 30, 2023 was $0.1 million.
The weighted-average grant date fair value of the stock options granted during the nine months ended September 30, 2024 and 2023 was $1.13 per share and $2.25 per share, respectively. The fair value of each option award granted is estimated on the date of grant using the Black-Scholes option pricing model and assumptions input into the model. The following table presents, on a weighted average basis, the assumptions used in the model to determine the grant-date fair value of stock options granted:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Risk-free interest rate | 4.13% | 4.73% | 4.18% | 3.91% |
| Expected dividend yield | 0% | 0% | 0% | 0% |
| Expected option term (in years) | 5.25 | 6.08 | 5.88 | 6.03 |
| Expected stock price volatility | 95.30% | 90.92% | 91.99% | 86.55% |
- Commitments and Contingencies
Leases
The Company’s commitments under its leases are described in Note 15 Lease Obligations, to the consolidated financial statements in the Company's Annual Report on Form 10-K for the year ended December 31, 2023. There have been no material changes to the Company’s leases during the three and nine months ended September 30, 2024.
In April 2024, the Company entered into three sublease agreements with third parties for the use of office and laboratory space in San Francisco, California that the Company assumed in connection with its acquisition of Pionyr Immunotherapeutics, Inc. (“Pionyr”). Total fixed payments to be received by the Company through April 2027 under thethree sublease agreements amount to $2.5 million. For thethree and nine months ended September 30, 2024, the Company recorded other income of $0.4 million and $0.6 million, respectively, related to its subleases.
License Agreements
UT Austin
The Company had an exclusive patent license agreement (the “UT Austin License”) entered into in 2015, to license certain technologies and intellectual property rights from the University of Texas at Austin (the “University”), an entity affiliated with a director of the Company at the time of the agreement. The Company was required to pay License Maintenance fees annually of less than $0.1 million. Additionally, the Company would have been required to make additional milestone payments to the University upon meeting certain development milestones in the aggregate of $4.7 million during the term of the UT Austin License, and to pay the University royalties as defined in the UT Austin License on any commercialized product sales related to the licensed technology in a percentage in the low single digits. The Company was also responsible for reimbursing the University for certain patent-related costs incurred on its behalf. A Notice of Termination was sent by the Company in March 2024 and the UT Austin License was terminated as of June 27, 2024, at which time all assets were returned to the University and no further costs will be incurred by the Company in connection with the UT Austin License.
Arrys
The Company acquired in-process research and development in 2018 on an Arrys Therapeutics, Inc.’s (“Arrys”) immune-oncology candidate based on the intellectual property associated with Arrys’ AskAt License as part of the Company’s acquisition of Arrys. The AskAt License was intended to be used by the Company in its future development of therapeutic drug candidates for eventual clinical development and commercialization. The Company would have been obligated to make milestone payments to AskAt upon meeting certain development and sales milestones during the term of the AskAt License as well as royalties on any commercialized product sales related to the licensed technology. The AskAt Agreement was terminated as of March 20, 2024 and all assets were returned to AskAt. No further costs will be incurred by the Company in connection with the AskAt License.
Other Agreements
The Company is also party to various agreements, principally relating to licensed technology, that require future payments relating to milestones not met as of September 30, 2024 or royalties on future sales of specified products that have not yet occurred as of September 30, 2024.
Contingent Value Rights
In connection with the acquisition of Pionyr on August 4, 2023, the Company issuedone contractual contingent value right (“CVR”) to the former Pionyr stockholders for each share of Pionyr stock held at closing. The CVR entitles the holder to receive 50% of net proceeds, outside of royalties, for any potential monetization of Pionyr legacy programs within two years. The Company accounts for the CVRs as contingent liabilities. As of September 30, 2024 and December 31, 2023, the contingent consideration cannot be reasonably estimated, and the contingency was not resolved.
- Restructuring and Other Charges
On January 17, 2024, the board of directors of the Company approved a plan to reduce the Company’s workforce by approximately 35% and discontinue discovery efforts. The workforce reduction was designed to align the Company’s workforce with its strategy to focus on its clinical stage, targeted oncology programs, IK-930 and IK-595. The workforce reduction and discontinuation of discovery efforts are referred to as the “January Restructuring” and were completed by March 31, 2024. In connection with the workforce reduction, the Company terminated 20 employees. During the first quarter of 2024, the Company recorded severance charges in connection with the workforce reduction, consisting of cash expenditures for employee separation costs of $1.6 million, which were paid by June 30, 2024, and non-cash charges of $0.3 million for the modification of certain equity awards. In March 2024, the Company committed to a plan to sell laboratory equipment related to its discovery efforts and therefore classified the net amount of assets held for sale of $0.4 million in prepaid expenses and other current assets on the condensed consolidated balance sheets as of March 31, 2024. The assets held for sale were carried at the lower of the carrying amount or fair value, less costs to sell, and were sold in the second quarter of 2024.
On May 23, 2024, the board of directors of the Company approved a plan to discontinue the clinical development of IK-930, continue clinical development of IK-595 and reduce its current workforce by approximately 53% (the “May Restructuring” and together with the January Restructuring, the “Restructurings”). The board of directors also approved a process to explore, review and evaluate a range of potential strategic options for the Company. The May Restructuring resulted in the termination of 18 employees through September 30, 2024. During the three and nine months ended September 30, 2024, the Company recorded severance expense in connection with the May Restructuring of $0.2 million and $0.9 million, respectively, most of which is expected to be paid by December 31, 2024.
In June 2024, the board of directors of the Company approved up to $1.3 million of retention payments to employees, subject to remaining actively employed with the Company through specified dates. The retention payments are expensed as services are performed. During the three and nine months ended September 30, 2024, the Company recorded retention expense of $0.7 million, all of which is expected to be paid by December 31, 2024.
The Company’s Restructuring and other charges and balance of its Restructuring liability, which was included in accrued employee compensation, consisted of the following for thethree and nine months ended September 30, 2024 (in thousands):
| Employee | ||||
|---|---|---|---|---|
| Related · Non-cash · Asset | ||||
| Payments | Compensation | Impairments | Total | |
| Accrued balance at June 30, 2024 | $338 | $— | $— | $338 |
| Expense | 812 | — | — | 812 |
| Payments | (880) | — | — | (880) |
| Accrued balance at September 30, 2024 | $270 | $— | $— | $270 |
| Employee | ||||
|---|---|---|---|---|
| Related · Non-cash · Asset | ||||
| Payments | Compensation | Impairments | Total | |
| Accrued balance at December 31, 2023 | $— | $— | $— | $— |
| Expense | 3,072 | 263 | 742 | 4,077 |
| Payments | (2,802) | — | — | (2,802) |
| Non-cash | — | (263) | (742) | (1,005) |
| Accrued balance at September 30, 2024 | $270 | $— | $— | $270 |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.