Ikena Oncology Inc
For the period ended Dec 31, 2023. Filed Mar 12, 2024.
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FY2023 · Filed Mar 12, 2024
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Notes to Consolidated Financial Statements
- NATURE OF BUSINESS AND ORGANIZATION
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 in the Hippo and RAS onco-signaling network. The Company’s approach in each of its programs is to target both cancer-driving targets and mechanisms of resistance to other therapies. The Company’s most advanced program, IK-930, is a selective inhibitor of the transcriptional enhanced associate domain 1 (“TEAD 1”). The TEAD transcription factors (TEAD 1-4) execute the ultimate step in the Hippo signaling pathway, a known oncogenic pathway that also drives resistance to multiple targeted and chemo therapies. The Company’s program in the RAS pathway, IK-595, is a molecular glue designed to trap MEK and RAF in an inactive complex, more completely inhibiting RAS signals than existing inhibitors. Since the Company commenced operations in 2016, it has advanced multiple product candidates into clinical development.
On March 30, 2021 the Company completed an initial public offering (“IPO”) in which the Company issued and sold 8,984,375 shares of common stock, including full exercise of the underwriters’ over-allotment option to purchase an additional 1,171,875 shares, at a public offering price of $16.00 per share and received $131.3 million in net proceeds after deducting underwriting discounts and commissions and offering expenses.
The Company acquired Pionyr Immunotherapeutics, Inc., a Delaware corporation (“Pionyr”), pursuant to an Agreement and Plan of Merger, dated August 4, 2023 by and among the Company, Portsmouth Merger Sub I, Inc., a Delaware corporation and a wholly owned subsidiary of the Company (“Merger Sub I”), Portsmouth Merger Sub II, LLC, a Delaware limited liability company and wholly owned subsidiary of the Company (“Merger Sub II”), Pionyr, and Fortis Advisors LLC, as securityholder agent (the “Pionyr Acquisition Agreement”). Pursuant to the Pionyr Acquisition Agreement, Merger Sub I merged with and into Pionyr, after which Pionyr was the surviving corporation and became a wholly owned subsidiary of the Company (the “First Merger”). Immediately after the First Merger, Pionyr merged with and into Merger Sub II, after which Merger Sub II was the surviving entity (collectively with the First Merger, the “Acquisition”).
Under the terms of the Pionyr Acquisition Agreement, at the closing, the Company issued to the stockholders of Pionyr 1,800,652 shares of its common stock (including 153,121 shares of its non-voting common stock), and 4,153,439 shares of Series A Non-Voting Convertible Preferred Stock (“Series A Preferred Stock”), which was a newly designated series of preferred stock that is intended to have economic rights equivalent to the Company’s common stock, but with only limited voting rights. The Series A Preferred Stock was converted to shares of the Company’s common stock pursuant to stockholder approval at a special meeting of stockholders held on October 11, 2023. Each stockholder of Pionyr at the time of closing also receivedone contractual contingent value right (“CVR”) 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.
- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation and Principles of Consolidation: The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Arrys Therapeutics, Inc. (“Arrys”), Ikena Oncology Securities Corporation and Amplify Medicines, Inc, (“Amplify”), and Portsmouth Merger Sub II, LLC. All intercompany balances and transactions have been eliminated in consolidation. These consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the ASC and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).
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. Estimates and assumptions are used for, but not limited to the accruals for research and development expenses research and development revenue under a collaboration agreement.
Liquidity: The Company is subject to a number of risks similar to other early-stage life science companies, including, but not limited to, successful development of its product candidates, raising additional capital with favorable terms, protection of proprietary technology and market acceptance of any approved future products. The successful development of product candidates requires substantial working capital, which may not be available to the Company on favorable terms or at all.
To date, the Company has financed its operations primarily from common stock in its IPO and Underwritten Registered Offering (“URO”), private placements of preferred stock, payments from a collaboration arrangement, related party revenue, and most recently, through the acquisition of Pionyr. The Company currently has no source of product revenue, and it does not expect to generate product revenue for the foreseeable future. To date, the Company’s revenue has primarily been from a collaboration agreement. The Company has devoted substantially all of its financial resources and efforts to identifying potential product candidates and conducting preclinical studies and clinical trials.
As of December 31, 2023, the Company’s cash, cash equivalents, marketable securities were$175.5 million. The Company believes the cash, cash equivalents, marketable securities as of December 31, 2023 will enable it to fund its current planned operations for at least the next twelve months from the date of issuance of these financial statements, though it may pursue additional cash resources through public or private equity or by establishing collaborations with other companies.
Management’s expectations with respect to its ability to fund current and long term planned operations are based on estimates that are subject to risks and uncertainties. If actual results are different from management’s estimates, the Company may need to seek additional strategic or financing opportunities sooner than would otherwise be expected. However, there is no guarantee that any collaboration exercise options will be achieved or that any of these strategic or financing opportunities will be executed on favorable terms, and some could be dilutive to existing stockholders.
If the Company is unable to obtain additional funding on a timely basis, it may be forced to significantly curtail, delay, or discontinue one or more of its planned research or development programs or be unable to expand its operations. As of December 31, 2023, the Company had an accumulated deficit of$282.4 million. The Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to research and development of its product candidates and its administrative organization.
Segments: Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s CODM is its Chief Executive Officer. The Company has determined it operates in a single operating segment and hasone reportable segment. All long-lived assets of the Company reside in the United States.
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. Additionally, as of December 31, 2023, the Company has not experienced any credit related losses on accounts that hold the Company’s cash, cash equivalents and marketable securities.
The Company is dependent on third-party manufacturers and Clinical Research Organizations (“CROs”) to supply products and provide services for research and development activities in its programs. 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 these programs. The Company also relies on at least two CROs to conduct its clinical trials. The Company’s programs could be adversely affected if a third-party manufacturer or a CRO is unable to successfully carry out their contractual obligations or meet expected deadlines. If a third-party manufacturer or a CRO 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, which could be significant.
Fair Value of Financial Instruments: The Company’s financial instruments consist mainly of cash equivalents, restricted cash, accounts payable, and marketable securities. The carrying amounts of cash equivalents, restricted cash, and accounts payable approximate their estimated fair value due to their short-term maturities. Fair value is estimated based on a three-tier fair value hierarchy to prioritize the inputs used in the Company’s fair value measurements. These tiers include: Level 1, defined as observable inputs such as quoted prices in active markets for identical assets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in which little or no market data exists.
The Company recognizes transfers between levels of the fair value hierarchy on the date of the event or change in circumstances that caused the transfer.
Cash and Cash Equivalents: The Company considers all short-term, highly liquid investments with original maturities of 90 days or less at acquisition date to be cash equivalents. The Company’scash equivalents are generally composed of commercial paper, U.S. government-sponsored enterprise securities, U.S. treasury securities and money market funds.
Marketable securities: The Company invests its excess cash balances in marketable securities and classifies its investments as available-for-sale based on facts and circumstances present at the time it purchased the securities. At each balance sheet date presented, the Company classified all of 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 Company reports available-for-sale securities at fair value at each balance sheet date and includes any unrealized holding gains and losses (the adjustment to fair value) in accumulated other comprehensive loss, a component of stockholders’ equity. Realized gains and losses are determined using the specific identification method and are included in other income (expense). If any adjustment to fair value reflects a decline in the value of the marketable securities, the Company considers all available evidence to evaluate if an impairment loss exists, and if so, adjusts the investment to market value through a charge to its consolidated statements of operations and comprehensive loss.
Restricted Cash: As of December 31, 2023 and 2022, the Company maintained restricted cash totaling approximately $1.3 million and $0.9 million, respectively, held in the form of a money market account as collateral for the Company’s facility lease obligations. The balance is included within other non-current assets in the accompanying consolidated balance sheets.
Property and Equipment: Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful life of each asset. Lab equipment is depreciated over five years. Electronic equipment and software are depreciated over three years. Leasehold improvements are amortized over the shorter of their useful life or lease term. When an item is sold or retired, the costs and related accumulated depreciation are eliminated, and the resulting gain or loss, if any, is credited or charged to income in the statement of operations. Repairs and maintenance costs are expensed as incurred.
Long-lived Assets: Long-lived assets consist of property and equipment. The Company reviews the recoverability of its long-lived assets, including the related useful lives, whenever events or changes in circumstances indicate that the carrying amount of a long-lived asset might not be recoverable, based on undiscounted cash flows. If such assets are considered to be impaired, an impairment loss is recognized and is measured as the amount by which the carrying amount of the assets exceed their estimated fair value, which is measured based on the projected discounted future net cash flows arising from the assets.
Income Taxes: The Company utilizes the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities using the enacted statutory tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. Recognition of deferred tax assets is limited to amounts for which, in the opinion of management, realization is considered more likely than not in future periods.
Revenue Recognition: The Company has generated revenue from a collaboration agreement as well as service agreements with related parties.
To determine revenue recognition, the entity performs 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. At contract inception the Company assesses the goods or services promised within each contract and determine those that are performance obligations, then assesses whether each promised good or service is distinct. When the Company offers options for additional goods or services, such as to receive a license for intellectual property or for additional goods or services, the Company evaluates whether such options contain material rights that should be treated as additional performance obligations. Once performance obligations are identified, the Company then recognizes as revenue the amount of the transaction price that the Company allocated to the respective performance obligation when (or as) each performance obligation is satisfied, either at a point in time or over time. If the performance obligation is satisfied over time, the Company recognizes revenue based on the use of an input method.
Amounts received prior to revenue recognition are recorded as deferred revenue. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current portion of deferred revenue in the accompanying consolidated balance sheets. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion.
As of December 31, 2023, the Company had one collaborative agreement with Bristol-Myers Squibb, which the Company entered into in January 2019. For a complete discussion of the accounting related to Bristol-Myers Squibb Collaboration Agreement, see Note 8, Collaboration Agreement and Stock Purchase Agreement with Bristol-Myers Squibb.
Research and Development Expense: Research and development costs are expensed as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including salaries, stock-based compensation and benefits, facilities costs, depreciation, third-party license fees, acquisition of technology, and external costs of outside vendors engaged to conduct preclinical development activities and trials.
Stock-based Compensation: The Company’s stock-based compensation program grants awards that may include stock options, restricted stock awards, restricted stock units, and other stock-based awards. The fair values of stock option grants are estimated as of the date of grant using a Black-Scholes option valuation model. The fair values of restricted stock awards and restricted stock units are based on the fair value of the Company’s common stock on the date of grant. The estimated fair values of the awards are expensed over the requisite service period, which is generally the vesting period of the award. For service-based awards that are subject to graded vesting, the Company has elected to recognize compensation expense for these awards on a straight-line basis. The Company accounts for forfeitures as they occur. The Company classifies stock-based compensation expense in its consolidated statements of operations and comprehensive loss in the same manner in which the award recipient’s salary and related costs are classified or in which the award recipient’s service payments are classified.
The Company’s expected stock price volatility assumption is based on volatilities of similar entities whose share or option prices are publicly available. The Company uses the simplified method to estimate the expected life assumption. The risk-free interest rate is based on the yield of U.S. Treasury securities consistent with the expected life of the option. No dividend yield was assumed as the Company does not intend to pay dividends on its common stock.
Leases: Under Accounting Standards Codification (ASC) 842 Leases, the Company determines if an arrangement is or contains a lease at inception. For leases with a term of 12 months or less, the Company does not recognize a right-of-use asset or lease liability. The Company’s operating leases are recognized on its consolidated balance sheet as other long-term assets, other current liabilities, and other long-term liabilities. The Company does not have any finance leases.
Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. As the Company’s leases typically do not provide an implicit rate, the Company uses an estimate of its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments. Operating lease right-of-use assets also include the effect of any lease prepaid or deferred lease payments and are reduced by lease incentives. The lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense is recognized on a straight-line basis over the lease term. The Company has elected to utilize the practical expedient to not separate lease components from non-lease components.
Comprehensive Loss: Comprehensive loss is comprised of the net loss and other comprehensive income or loss. Other comprehensive income or loss consists of unrealized gains or losses on marketable securities.
Accumulated Other Comprehensive Loss: Comprehensive loss is defined as the change in the equity of a business entity during a period from transactions and other events and circumstances from non-owner sources. It includes all changes in equity during a period except those resulting from investments by owners and distributions to owners. Comprehensive loss consists of: (i) all components of net loss and (ii) all components of comprehensive loss other than net loss, referred to as other comprehensive loss. Other comprehensive income or loss is comprised of unrealized gains and losses on debt securities.
Contingent Value Rights: The Company evaluates the CVR to determine if it qualifies as a derivative under ASC 815, Derivatives and Hedging(“ASC 815”). For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value and is then re-valued at each reporting date. Any changes in fair value are recorded as other income or expense for each reporting period. Derivative instrument liabilities are classified in the balance sheet as current or non-current based on whether or not net-cash settlement of the derivative instrument is probable within the next 12 months from the balance sheet date.
The Company determined that certain contingent payments under the Acquisition qualified for the scope exception under ASC 815, and as such, were not recorded as a derivative on the balance sheet as of December 31, 2023. Upon resolution of the CVR, the Company will recognize the payment consistent with the guidance in ASC 450. As of December 31, 2023, the contingent consideration cannot be reasonably estimated, and the contingency was not resolved.
Emerging Growth Company Status: 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.
Recent Accounting Pronouncements: From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by us 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 table presents information about the Company’s financial assets measured or disclosed at fair value by level within the fair value hierarchy (in thousands):
| As of December 31,2023 | Quoted Prices in Active Markets(Level 1) | Significant Observable Inputs(Level 2) | Significant Unobservable Inputs(Level 3) | |
|---|---|---|---|---|
| Assets | ||||
| 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 | $— |
| As of December 31,2022 | Quoted Prices in Active Markets(Level 1) | Significant Observable Inputs(Level 2) | Significant Unobservable Inputs(Level 3) | |
|---|---|---|---|---|
| Assets | ||||
| Cash equivalents: | ||||
| Money market funds | $55,861 | $55,861 | $— | $— |
| Marketable securities | ||||
| U.S. treasury securities | 22,606 | — | 22,606 | — |
| Corporate debt securities | 74,422 | — | 74,422 | — |
| Total assets | $152,889 | $55,861 | $97,028 | $— |
For the years ended December 31, 2023 and 2022, there wereno transfers into or out of Level 3.
- MARKETABLE SECURITIES
The following table summarizes the Company’s marketable securities (in thousands):
| 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 |
| Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | |
|---|---|---|---|---|
| U.S. treasury securities | 22,630 | — | (24) | 22,606 |
| Corporate debt securities | 75,161 | — | (739) | 74,422 |
| Total | $97,791 | $— | $(763) | $97,028 |
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 December 31, 2023, the Company held 23 marketable securities in an unrealized loss position, four of which were in an unrealized loss position for greater than 12 months. The total unrealized loss of securities in a loss position for greater than 12 months was $22.5 thousand as of December 31, 2023. Based on factors such as historical experience, market data, issuer-specific factors, and current economic conditions, the Company didnot record an allowance for credit losses at December 31, 2023 and December 31, 2022, related to these securities. The Company also believes that it will be able to collect both principal and interest amounts due at maturity.
Marketable securities fair value by contractual maturity were as follows (in thousands):
| As of December 31, | |
|---|---|
| Due in one year or less | $22,233 |
| Due after one year through five years | 33,338 |
| Total | $55,571 |
- PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid expenses and other current assets consisted of the following (in thousands):
| As of December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Clinical, manufacturing and scientific development | $1,482 | $1,372 |
| Prepaid Insurance | 565 | 727 |
| Other | 1,150 | 964 |
| Total | $3,197 | $3,063 |
- PROPERTY AND EQUIPMENT, NET
Property and equipment consisted of the following (in thousands):
| As of December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Property and equipment: | ||
| Lab equipment | $2,988 | $2,858 |
| Leasehold improvements | 1,219 | 1,216 |
| Electronic equipment and software | 454 | 481 |
| Furniture and fixtures | 411 | 475 |
| Total property and equipment | 5,072 | 5,030 |
| Less: accumulated depreciation | (2,737) | (1,825) |
| Property and equipment, net | $2,335 | $3,205 |
Depreciation expense for the years ended December 31, 2023 and 2022 was$1.0 million and$0.9 million, respectively. There wereno impairments for the years ended December 31, 2023 and 2022.
- ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
Accrued expenses and other current liabilities consist of the following (in thousands):
| As of December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Employee compensation | $3,311 | $3,236 |
| Research and development expenses | 3,964 | 4,462 |
| Professional fees | 1,221 | 526 |
| Other current liabilities | 85 | 119 |
| Total | $8,581 | $8,343 |
- COLLABORATION AGREEMENT AND STOCK PURCHASE AGREEMENT WITH BRISTOL-MYERS SQUIBB
In January 2019, the Company entered into the Bristol-Myers Squibb Collaboration Agreement with Celgene Corporation, which was acquired by Bristol-Myers Squibb in November 2019, whereby the Company will carry out initial research and development activities with the goal of identifying and developing drug candidates for certain cancer types. Concurrent with execution of the Bristol-Myers Squibb Collaboration Agreement, the Company entered into a stock purchase agreement with Bristol-Myers Squibb, which resulted in the issuance of 14,545,450 shares of Series A-1 Preferred Stock (the “Stock Purchase Agreement”). In connection with the Company’s IPO, the series A-1 preferred stock converted into common stock.
Agreement Structure
Under the Bristol-Myers Squibb Collaboration Agreement, the Company will conduct exploratory and discovery activities, with the goal of identifying product candidates for certain targets, which are in the kynurenine pathway, which the Company is developing as IK-412, and the aryl hydrocarbon receptor (“AHR”), which the Company is developing as IK-175. The Company is obligated to advance research and development activities through the earlier of January 2024 or the completion of a Phase 1b clinical trial for each program ("the research term"). Bristol-Myers Squibb had the option to receive a global-development, manufacture and commercialization license for the product candidate, which expired in January 2024. Subsequent to the delivery of a license, Bristol-Myers Squibb would have been responsible for the worldwide development, manufacturing and commercialization of these product candidates.
Bristol-Myers Squibb paid the Company a total of $95.0 million in aggregate upfront consideration related to the Bristol-Myers Squibb Collaboration Agreement and Stock Purchase Agreement. The Company was eligible to receive $50.0 million, in case of an exercise of its option with respect to IK-175, and $40.0 million, in case of an exercise of its 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 million in milestone payments as well as a tiered royalty on worldwide sales from the high single to low teen digits.
Accounting Considerations of the Agreement
The Bristol-Myers Squibb Collaboration Agreement and the Stock Purchase Agreement were executed concurrently and in contemplation of each other. The issuance of Series A-1 Preferred Stock was initially accounted for at fair value. The purchase price for the Series A-1 Preferred Stock was considered to be at a discount from fair value, and therefore $1.8 million of the upfront from the Bristol-Myers Squibb Collaboration Agreement was allocated to the equity arrangement.
The Company determined that the Bristol-Myers Squibb Collaboration Agreement represented a contract with a customer and should be accounted for in accordance with ASC 606. The Company identified the two performance obligations, which are research and development services for IK-175 and IK-412. The options to receive worldwide development and commercialization licenses for the two targets and the option to receive manufacturing services in the future were determined to not provide any material rights to the customer and are therefore not considered to be performance obligations. The arrangement also contains certain di minimis items, including participation on joint oversight committees.
The Company identified $78.7 million of total transaction price which represents the upfront consideration allocated to the revenue arrangement. Additional consideration to be paid to the Company upon exercise of a right to receive a license or potential milestone and royalty payments are excluded from the transaction price as they relate to amounts that can only be achieved subsequent to the exercise of an options and are outside of the initial contact term.
Based on the distinct performance obligations identified above, the Company allocated the $78.7 million transaction price based on relative estimated standalone selling prices of each of its performance obligations as follows:
$41.2 million for research and development services for IK-175; and
$37.5 million for research and development services for IK-412.
The Company determined the estimated standalone selling price for the research and development services based on internal estimates of the costs to perform the services, including expected internal expenses and expenses with third parties, adjusted to include a reasonable profit margin. Significant inputs used to determine the total expense of the research and development activities include the length of time required and the number and cost of various studies that will be performed to complete the applicable development plan.
The Company is recognized revenue related to each of its performance obligations as the research and development services are performed through December 2023. The Company recognizes revenue related to research and development services performed using an input method by calculating costs incurred at each period end relative to total costs expected to be incurred.
In December 2021, the Company re-assessed the IK-412 program, which experienced manufacturing delays as a key component required in the manufacturing of IK-412, is similarly essential to the manufacturing of COVID-19 vaccines and therapies. As such, the availability of the component was delayed as resources were allocated towards vaccine production. Considering these delays and the timeline of the Bristol-Myers Squibb partnership, the Company made the strategic decision to pause IK-412 development activities for the remainder of the Bristol-Myers Squibb research term outside of the committed manufacturing efforts, which were completed in 2022.
During the year ended December 31, 2023 and 2022, the Company recognized revenue of$9.2 million and$15.6 million, respectively, from the Bristol-Myers Squibb Collaboration Agreement. The consolidated balance sheet as of December 31, 2023 includesno deferred revenue related to this agreement. The revenue recognized in 2023 was included in the deferred revenue balance as of December 31, 2022.
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. The IK-412 program remains IND ready. The Phase 1b study of IK-175 in urothelial carcinoma was completed and closed in 2023, and study data will be submitted for presentation at a future medical meeting. The Company will not invest further in the clinical development of IK-175 or IK-412, but will pursue strategic business development opportunities, including out-licensing.
- ACQUISITION OF PIONYR
On August 4, 2023, the Company acquired Pionyr, pursuant to the Pionyr Acquisition Agreement. Under the terms of the Pionyr Acquisition Agreement, the Company issued to the stockholders of Pionyr 1,800,652 shares of the Company’s common stock (including 153,121 shares of the Company’s non-voting common stock), and 4,153,439 shares of Series A Preferred Stock, which was a newly designated series of preferred stock that is intended to have economic rights equivalent to the Company’s common stock, but with only limited voting rights. The Series A Preferred Stock converted to shares of the Company’s common stock pursuant to stockholder approval at a special meeting of stockholders held on October 11, 2023. Each stockholder of Pionyr at the time of closing also receivedone contractual CVR 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.
Acquisition Accounting
The Company concluded that the Acquisition should be accounted for as a capitalization transaction, primarily based on the following facts and circumstances:
The purpose of the transaction was for the Company to acquire the cash, cash equivalents and marketable securities of Pionyr;
A nominal amount of Pionyr’s other assets were acquired, primarily related to the right-of-use-asset for Pionyr’s office and lab space lease located in San Francisco, California. The Company is actively seeking a tenant to sublease the space;
Prior to the Acquisition, Pionyr was finalizing the wind down of all development activities that were ongoing. There will be no continuing operations of Pionyr other than the remaining wind down activities;
No value has been ascribed to the legacy intellectual property assets acquired; and
No assembled workforce or substantive processes were acquired that together could significantly contribute to the ability to create outputs.
Under the recapitalization accounting model, the assets acquired and liabilities assumed were recognized at their fair value on August 4, 2023. The equity issued by the Company was recognized on the basis of the net fair value of the assets acquired and liabilities assumed. Cash consideration transferred and transaction costs incurred attributable to the Acquisition are reflected as reductions to equity. The Company incurred $1.3 million of transaction costs that were direct and incremental to the Acquisition.
The following table summarizes the estimated fair values of the assets acquired and liabilities assumed at the Acquisition date (in thousands):
| Assets Acquired | As of August 4, 2023 |
|---|---|
| Cash and cash equivalents | $40,926 |
| Marketable securities | 20,362 |
| Prepaid expenses and other current assets | 1,359 |
| Right-of-use-asset | 3,889 |
| Deposits and other assets | 406 |
| Total assets acquired | $66,942 |
| Liabilities Assumed | |
| Accounts payable | (2,844) |
| Accrued expenses and other current liabilities | (8,097) |
| Operating lease liability | (1,485) |
| Long-term portion of operating lease liability | (5,647) |
| Other long-term liabilities | (852) |
| Total liabilities assumed | $(18,925) |
| Net assets acquired (1) | $48,017 |
(1)Net assets acquired does not include the remaining costs to complete the wind down of Pionyr development activities and operations.
Fair value of equity issued and consideration transferred in connection with the Acquisition (in thousands):
| Issuance of Series A Preferred Stock | $32,837 |
|---|---|
| Issuance of common stock | 14,236 |
| Cash consideration paid to settle Pionyr restricted stock units ("RSUs") and stock options | 738 |
| Cash consideration paid to Pionyr unaccredited stockholders | 206 |
| Total | $48,017 |
The CVR was not accounted for as a derivative on the date of merger, nor was it included in the consideration transferred to acquire Pionyr. As of December 31, 2023, the contingent consideration cannot be reasonably estimated, and the contingency was not resolved.
- STOCKHOLDER’S EQUITY
Common Stock
As of December 31, 2023 and 2022, the Company had 150,000,000 shares of common stock authorized, respectively, of which 48,258,111 and 36,257,493 were issued and outstanding as of December 31, 2023 and 2022, respectively.
Voting: The holders of shares of common stock are entitled to one vote for each share of common stock held at all meetings of stockholders and written action in lieu of meetings; there is no cumulative voting. The holders of outstanding shares of common stock shall be entitled to elect two directors of the Company.
Dividends: The holders of shares of common stock are entitled to receive dividends, if and when declared by the Board of Directors. No dividends have been declared or paid by the Company since its inception.
Liquidation: After payment to the holders of shares of Preferred Stock of their liquidation preferences, the remaining assets of the Company are distributed to the holders of common stock.
Preferred Stock
On August 4, 2023, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of Series A Non-Voting Convertible Preferred Stock (“Certificate of Designation”) with the Secretary of State of the State of Delaware in connection with the Acquisition, which provides for the issuance of shares of Series A Preferred Stock. Pursuant to the Acquisition, the Company agreed to issue 4,153,439 shares of Series A Preferred Stock to Pionyr stockholders. The Company agreed to hold a special meeting of stockholders to submit the approval of the conversion of the Series A Preferred Stock into shares of common stock, pursuant to which each share of Series A Preferred Stock would be convertible into one share of voting common stock, provided, however, that if such stockholder already held shares of the Company’s non-voting common stock prior to the conversion, such holder would receive shares of non-voting common stock in lieu of shares of voting common stock to the extent the issuance of shares of voting common stock to such holder would result in such holder, when aggregated with its affiliates for purposes of Section 13(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), beneficially owning more than 9.99% of the Company’s voting common stock (the “Non-Voting Beneficial Ownership Limitation”). If stockholders had not approved the conversion of the Series A Preferred Stock into common stock by February 4, 2024 (six (6) months from the closing of the Acquisition), then, upon any attempted conversion, holders of Series A Preferred Stock may have thereafter required the Company to repurchase the Series A Preferred Stock at the then-current fair value of the underlying Common Stock.
On September 25, 2023, the Company filed a Definitive Proxy Statement with the SEC to solicit approval of the issuance of common stock upon conversion of the Series A Preferred Stock at a special meeting of stockholders.
The Company classified convertible preferred stock as temporary equity in the accompanying consolidated statement of Convertible Preferred Stock and Stockholders’ Equity due to terms that allow for redemption of the shares in cash upon certain events that are outside of the Company’s control, including failure to obtain stockholder approval of the conversion of the Series A Preferred Stock. The Company did not accrete the value of the convertible preferred stock to the redemption values since a liquidation event was not considered probable prior to the conversion date.
The Series A Preferred Stock was subsequently converted to shares of the Company’s common stock pursuant to stockholder approval at a special meeting of stockholders held on October 11, 2023.
- STOCK BASED COMPENSATION
In March 2016, the Company’s board of directors and stockholders adopted the 2016 Stock Incentive Plan which was amended and restated in December 2020, (as so amended and restated, the “2016 Plan”) which permits the granting of (1) options to purchase common stock intended to qualify as incentive stock options under Section 422 of the Code, and (2) options that do not so qualify.
In March 2021, the Company’s stockholders approved the 2021 Stock Incentive Plan (the “2021 Plan”), which became effective on March 30, 2021. The 2021 Plan replaced the 2016 Plan as the board of directors had determined it would not to make additional awards under the 2016 Plan following the closing of the IPO. However, the 2016 Plan will continue to govern outstanding equity awards granted thereunder. The 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 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. 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; and such lesser number of shares as determined by the Administrator as provided in the 2021 Plan. On January 1, 2023, the number of shares of common stock available for issuance under the 2021 Plan increased by 1,450,299 shares as a result of the automatic increase provision of the 2021 Plan. As of December 31, 2023,3,413,255 shares of common stock remain available for future issuance under the 2021 Plan.
The vesting periods for equity awards, which generally isfour years, are determined by the Board of Directors. The contractual term for stock option awards isten years.
The total compensation expense recognized in the statements of operations associated with all the stock-based compensation awards granted by the Company is as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Research and development | $3,937 | $3,974 |
| General and administrative | 3,695 | 3,551 |
| Total stock-based compensation expense | $7,632 | $7,525 |
The weighted-average fair value of the stock options granted during the year ended December 31, 2023 and 2022 was$2.34 and$5.52 per share, respectively. As of December 31, 2023, the total unrecognized stock-based compensation balance for unvested options was$11.2 million which is expected to be recognized over 2.1 years.
The following table summarizes stock option activity under the Plan for the year ended December 31, 2023:
| Number ofOptions · Weighted-AverageExercisePrice · Weighted-AverageRemainingContractualTerm (Years) · AggregateIntrinsicValue(thousands) | ||||||
|---|---|---|---|---|---|---|
| Outstanding as of December 31, 2022 | 6,589,479 | $7.29 | 7.73 | $362 | ||
| Granted | 1,750,224 | 3.13 | ||||
| Exercised | (34,027) | 4.01 | ||||
| Cancelled or forfeited | (1,217,415) | 6.91 | ||||
| Outstanding as of December 31, 2023 | 7,088,261 | $6.35 | 6.92 | $94 | ||
| Vested or expected to vest as of December 31, 2023 | 7,088,261 | $6.35 | 6.92 | $94 | ||
| Options exercisable as of December 31, 2023 | 4,032,553 | $6.61 | 5.98 | $94 | ||
The intrinsic value of options exercised for the years ended December 31, 2023 and 2022 was$0.1 million and$1.2 million, respectively.
The fair value of each option award granted during the years ended December 31, 2023 and 2022 is estimated on the date of grant using the Black-Scholes option pricing model. This model incorporates various assumptions, including the expected volatility, expected term, and interest rates. The underlying assumptions used to value stock options granted to participants using the Black-Scholes option-pricing presented on a weighted-average basis were as follows:
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Risk-free interest rate | 4.00% | 2.42% |
| Expected dividend yield | 0% | 0% |
| Expected option term (in years) | 6.04 | 5.94 |
| Expected stock price volatility | 87.0% | 84.8% |
Employee Stock Purchase Plan
On March 20, 2021, the Company’s stockholders approved the 2021 Employee Stock Purchase Plan (the “ESPP”), which became effective on March 30, 2021. The ESPP initially provides participating employees with the opportunity to purchase up to an aggregate of 346,613 shares of the Company’s common stock. An annual increase in the number of shares of common stock reserved and available for issuance under the ESPP shall be equal to 1% of the number of shares of common stock outstanding on the immediately preceding December 31; and such lesser number of shares as determined by the Administrator as provided in the ESPP. As of December 31, 2023, no shares have been purchased by employees under the ESPP.
- EMPLOYEE BENEFIT PLAN
The Company has a defined-contribution savings plan covering all eligible U.S. employees under Section 401(k) of the Internal Revenue Code (the “401(k) Plan”). Contributions to the plan by the Company totaled $0.5 million and $0.6 million for the years ended December 31, 2023 and 2022, respectively. Employees can designate the investment of their 401(k) accounts into several mutual funds. Administrative costs of the plan for each of the years ended December 31, 2023 and 2022, were immaterial.
- INCOME TAXES
The components of income tax expense were as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Current | ||
| Federal | $(237) | $— |
| State | 68 | 27 |
| Total Current Provision | $(169) | $27 |
The effective income tax rate differed from the amount computed by applying the federal statutory rate to the Company’s loss before income taxes as follows:
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Tax effected at statutory rate | 21.0% | 21.0% |
| State taxes | 6.4% | 7.2% |
| Stock compensation | (1.2)% | (0.5)% |
| Non-deductible expenses | (0.6)% | (0.7)% |
| Federal research and development credits | 4.2% | 5.0% |
| Change in valuation allowance | (30.0)% | (32.0)% |
| Total | 0.2% | —% |
The Company’s total deferred tax assets are as follows (in thousands):
| As of December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Deferred tax assets: | ||
| Federal net operating loss carryforward | $29,529 | $22,875 |
| State net operating loss carryforward | 8,581 | 6,693 |
| R&D credit carryforwards | 14,589 | 10,667 |
| Capitalized start-up costs | 196 | 219 |
| Accruals and reserves | 802 | 823 |
| Deferred revenue | — | 2,502 |
| Stock based compensation | 2,381 | 1,900 |
| Lease liability | 2,934 | 1,556 |
| Capitalized R&E | 44,366 | 14,995 |
| Total deferred tax asset | 103,378 | 62,230 |
| Deferred tax liability: | ||
| Fixed assets | $(603) | $(761) |
| Right of use asset | (1,554) | (1,436) |
| Total deferred tax liability | (2,157) | (2,197) |
| Net deferred tax asset and liability before valuation allowance | 101,221 | 60,033 |
| Valuation allowance | (101,221) | (60,033) |
| Net deferred tax asset | $— | $— |
The Company’s 2023 income tax provision benefit related the current year acquisition of Pionyr, offset partially by state income taxes. ASC 740 requires a valuation allowance to reduce the deferred tax assets reported if, based on the weight of the evidence, it is more-likely-than-not that some portion or all the deferred tax assets will not be realized. The Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. Based on this, the Company has provided a valuation allowance for the full amount of the net deferred tax assets as the realization of the deferred tax assets is not determined to be more likely than not. During 2023, the valuation allowance increased by $41.2 million primarily due to the increase in the Company's book loss reported in the period and the Pionyr acquisition.
Beginning in 2022, Tax Cuts and Jobs Act (“TCJA”) amended Section 174 and now requires U.S.-based and non-U.S-based research and experimental (“R&E”) expenditures to be capitalized and amortized over a period offiveor 15 years, respectively, for amounts paid in tax years starting after December 31, 2021. Prior to the TCJA amendment, Section 174 allowed taxpayers to immediately deduct R&E expenditures in the year paid or incurred. The Company has applied this required change in accounting method beginning in 2022 and the computation may be adjusted pending future IRS guidance.
As of December 31, 2023, the Company had approximately $140.6 million and $135.8 million of Federal and State operating loss carryforwards respectively. The Federal net operating losses are not subject to expiration and the state net operating losses begin to expire in 2037. These loss carryforwards are available to reduce future federal taxable income, if any. As of December 31, 2023, the Company also has federal and state research and development tax credit carryforwards of approximately $11.7 million and $3.6 million respectively, to offset future income taxes, which will begin to expire beginning in December 2031. These loss carryforwards are subject to review and possible adjustment by the appropriate taxing authorities. The amount of loss carryforwards that may be utilized in any future period may be limited based upon changes in the ownership of the company's ultimate parent.
Uncertain Tax Positions
ASC 740 prescribes the accounting for uncertainty in income taxes recognized in the financial statements. We regularly assess the outcome of potential examinations in each of the taxing jurisdictions when determining the adequacy of the amount of unrecognized tax benefit recorded. We recognize tax benefits from uncertain tax positions only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such positions are then measured based on the largest benefit which is more likely than not to be realized upon ultimate settlement. We recognize interest and penalties related to unrecognized tax positions in our provision for (benefit from) income taxes line of our Consolidated Statements of Operations.
The aggregate changes in the balance of our gross unrecognized tax benefits were as follows (dollars in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Balance at the beginning of the year | $— | $— |
| Beginning balance adjustment | 927 | — |
| Increases related to tax positions taken from prior years | 22 | — |
| Ending balance | $949 | $— |
As of December 31, 2023, the balance was adjusted by $0.9 million related to the acquisition of Pionyr.
As of December 31, 2023, $0.9 million of the unrecognized tax benefits, if recognized, would impact our effective tax rate. We do not expect a significant change in the amount of unrecognized tax benefits within the next 12 months. We recognized an immaterial amount of interest related to uncertain tax positions in our provision for (benefit from) income taxes during 2023.
The Company files U.S. federal and state income tax returns and is generally subject to income tax examinations by these authorities for all tax years after December 31,2020. Currently, no federal or state income tax returns are under examination by the respective income tax authorities.
- RESEARCH LICENSE AGREEMENTS
During 2015, the Company entered into an exclusive patent license agreement (the “UT Austin License”) 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 UT Austin License shall remain in effect until the expiration or abandonment of the last to expire technologies and intellectual property rights. The Company shall pay License Maintenance fees annually of $40 thousand. Additionally, the Company shall 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. The Company will 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 will also be responsible for reimbursing the University for certain patent-related costs incurred on its behalf.
In 2018, the Company acquired IPR&D on an Arrys’ immune-oncology candidate based on the intellectual property associated with Arrys’ AskAt License as part of the acquisition of Arrys. Total consideration allocated to the technology was $28.5 million and was recognized as research and development expense upon the acquisition. The AskAt License is intended to be used by the Company in its future development of therapeutic drug candidates for eventual clinical development and commercialization. The Company shall make additional milestone payments to AskAt upon meeting certain development milestones totaling $4.0 million, as well as certain sales event milestones ranging from $50 million to $250 million contingent on sales in a calendar year, during the term of the AskAt License. The Company will pay the AskAt royalties a percentage in the low single digits as defined in the AskAt License on any commercialized product sales related to the licensed technology. The Company intended to use the license granted pursuant to the AskAt Agreement in our future development of therapeutic drug candidates for eventual clinical development and commercialization. The AskAt Agreement will be terminated as of March 20, 2024, and all assets will be returned to AskAt, at which point no further costs will be incurred by the Company.
- LEASE OBLIGATIONS
Boston Lease
On July 21, 2020, the Company entered into an operating lease agreement for 20,752 square feet of office, lab and animal care facility space located in Boston, Massachusetts for the Company’s corporate headquarters. The commencement date of the lease was February 19, 2021 and the lease term is 63 months. The base rent at commencement is $0.1 million per month and escalates by 3% annually for total lease payments during the term of $9.3 million. The Company’s lease agreement requires the Company to maintain a cash letter of credit to secure their obligations under the lease of $0.9 million. This balance is included in other assets on the accompanying consolidated balance sheets. The Company recognized a right of use asset of $7.5 million and an operating lease liability of $7.5 million upon the commencement of the lease.
San Francisco Lease
The Company also assumed an operating lease agreement for 28,029 square feet of office and lab space located in San Francisco, California from the Acquisition of Pionyr. The space is currently vacant and the Company is actively seeking a tenant to sublease. As of the Pionyr acquisition date, August 4, 2023, the remaining lease term was 44-months with base rent of $0.2 million per month with annual escalations of 3.5%. Total lease payments during the remaining 44-month lease term are $8.3 million. The Company’s lease agreement requires the Company to maintain a cash letter of credit to secure its obligations under the lease of $0.4 million. The Company recognized a right of use asset of $3.9 million and an operating lease liability of $7.1 million upon the commencement of the lease. In December 2023, the Company re-assessed the sublease market for the San Francisco lease and recorded a right of use asset impairment of $1.7 million for a portion of the lease.
Other Lease Disclosures
The components of the lease costs which are included in the consolidated statements of operations and comprehensive loss were as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Operating lease costs | $2,316 | $1,764 |
| Variable lease costs | 889 | 466 |
| Total lease costs | $3,205 | $2,230 |
Variable lease cost primarily related to operating expenses, parking, taxes and insurance associated with the Company's operating leases.
Supplemental cash flow information relating to the Company’s leases were as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Cash paid for amounts included in the measurement of lease liabilities (operating cash flows) | $2,534 | $1,774 |
The remaining lease terms and discount rates related to the Company's leases were as follows:
| As of December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Remaining lease term | 3.0 years | 3.4 years |
| Discount Rate | 7.8% | 7.7% |
The future minimum lease payments for the Company’s operating lease as of December 31, 2023, were as follows (in thousands):
| Fiscal Year | OperatingLeases |
|---|---|
| 2024 | 3,924 |
| 2025 | 4,212 |
| 2026 | 3,171 |
| 2027 | 719 |
| 2028 | — |
| Total minimum lease payments | 12,026 |
| Less amounts representing interest or imputed interest | 1,288 |
| Present value of lease liabilities | $10,738 |
- COMMITMENTS AND CONTINGENCIES
The Company is also party to various agreements, principally relating to licensed technology, that require future payments relating to milestones not met as of December 31, 2023 or royalties on future sales of specified products that have not yet occurred as of December 31, 2023.
- RELATED PARTY TRANSACTIONS
The Company entered into several agreements with a director and an entity affiliated with a director:
As discussed in Note 14 above, the Company has entered into a license agreement with the University, which was affiliated with a director of the Company at the time of the license agreement. During the years ended December 31, 2023 and 2022 the Company recorded expenses in connection with University license fees and certain patent-related costs incurred on its behalf of $0.1 million and $0.2 million, respectively.
OrbiMed Advisors LLC (“OrbiMed”), a related party of the Company, was previously a stockholder of Pionyr. In connection with the Acquisition, OrbiMed was allocated 153,121 shares of non-voting common stock and 353,192 shares of Series A Preferred Stock, which converted to common stock pursuant to stockholder approval at a special meeting of stockholders held on October 11, 2023. As of December 31, 2023, OrbiMed beneficially owned approximately 8.9% of the Company’s voting common stock outstanding.
- NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS
The Company has generated a net loss in all periods presented, therefore the basic and diluted net loss per share attributable to common stockholders are the same as the inclusion of the potentially dilutive securities would be anti-dilutive.
The following table sets forth the outstanding potentially dilutive securities that have been excluded in the calculation of diluted net loss per share because to do so would be anti-dilutive:
| Year ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Options to Purchase Common Stock | 7,088,261 | 6,589,479 |
| Total | 7,088,261 | 6,589,479 |
- SUBSEQUENT EVENTS
Workforce Reduction
On January 17, 2024, the Board of Directors of the Company approved a plan to reduce the Company’s workforce by approximately 35% (the “Workforce Reduction”). The Workforce Reduction is 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 generally affects employees working in the Company’s discovery organization, as well as select employees working in development and general and administrative functions. The Workforce Reduction will result in the termination of approximately twenty (20) employees and is expected to be completed by March 31, 2024. The Company expects to incur exit costs related to the discontinuation of its discovery efforts and expects to recognize these charges during the three months ended March 31, 2024. Expenses related to the Workforce Reduction consist of employee severance and related termination benefits, and are expected to result in approximately $1.6 million in cash expenditures.
Bristol-Myers Squibb Collaboration Agreements
As previously disclosed, the Company’s AHR antagonist IK-175 and kynureninase IK-412 programs, in development in collaboration with Bristol Myers Squibb, were eligible for opt-in through early 2024. 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.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.