[Special Note Regarding Forward-Looking Statements](index=3&type=section&id=Special%20Note%20Regarding%20Forward-Looking%20Statements) This section highlights that the Quarterly Report on Form 10-Q contains forward-looking statements, which are subject to risks, uncertainties, and other factors that could cause actual results to differ materially [Forward-Looking Statements Overview](index=3&type=section&id=Forward-Looking%20Statements%20Overview) This section highlights that the Quarterly Report on Form 10-Q contains forward-looking statements, which are subject to risks, uncertainties, and other factors that could cause actual results to differ materially - The report contains forward-looking statements regarding strategy, future operations, financial position, revenue, costs, prospects, plans, and market growth[9](index=9&type=chunk) - Key forward-looking statements include the timing and completion of the proposed merger with Inmagene Biopharmaceuticals, employee retention, clinical trial progress and cost, manufacturing capabilities, funding, regulatory approval, commercialization, intellectual property, and future financial performance[10](index=10&type=chunk) - Readers are cautioned not to place undue reliance on forward-looking statements, as actual results could differ materially due to factors discussed, particularly in the 'Risk Factors' section[11](index=11&type=chunk) [Summary of the Material and Other Risks Associated with Our Business](index=6&type=section&id=Summary%20of%20the%20Material%20and%20Other%20Risks%20Associated%20with%20Our%20Business) This section provides a high-level summary of the significant risks facing the company, including those related to the proposed merger with Inmagene Biopharmaceuticals, the company's limited operating history and financial position, and the challenges inherent in developing oncology therapeutics [Key Business Risks](index=6&type=section&id=Key%20Business%20Risks) This section provides a high-level summary of the significant risks facing the company, including those related to the proposed merger with Inmagene Biopharmaceuticals, the company's limited operating history and financial position, and the challenges inherent in developing oncology therapeutics - Failure to complete or delays in the proposed merger with Inmagene Biopharmaceuticals could materially and adversely affect the company's operations, financial results, and stock price[15](index=15&type=chunk) - If the merger or another strategic transaction is not consummated, the board may pursue dissolution and liquidation, with uncertain cash distribution to stockholders[15](index=15&type=chunk) - The company is a targeted oncology company with a limited operating history, no products approved for commercial sale, and has incurred significant net losses, anticipating continued losses[15](index=15&type=chunk) - Additional capital may be required, which might not be available on acceptable terms, potentially forcing delays or elimination of development efforts[15](index=15&type=chunk) - Clinical product development is lengthy, expensive, and uncertain, with no guarantee of successful completion of trials or regulatory approval for product candidates[15](index=15&type=chunk) [PART I. FINANCIAL INFORMATION](index=9&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=9&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements for Ikena Oncology, Inc., including the balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity, and statements of cash flows, along with accompanying notes [Condensed Consolidated Balance Sheets](index=9&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The condensed consolidated balance sheets show a decrease in total assets and stockholders' equity from December 31, 2024, to March 31, 2025, primarily driven by reductions in cash, cash equivalents, and marketable securities, alongside an increase in accumulated deficit Condensed Consolidated Balance Sheets (in thousands) | Metric | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :----------------------------- | | Cash and cash equivalents | $36,763 | $39,393 | | Marketable securities | $77,288 | $84,993 | | Total current assets | $116,999 | $127,169 | | Total assets | $130,838 | $141,510 | | Total current liabilities | $8,793 | $10,778 | | Total liabilities | $12,588 | $15,576 | | Total stockholders' equity | $118,250 | $125,934 | | Accumulated deficit | $(340,238) | $(331,619) | - Total assets **decreased by $10.672 million** from **$141.510 million** at December 31, 2024, to **$130.838 million** at March 31, 2025[20](index=20&type=chunk) - Total stockholders' equity **decreased by $7.684 million** from **$125.934 million** at December 31, 2024, to **$118.250 million** at March 31, 2025[20](index=20&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a reduced net loss for the three months ended March 31, 2025, compared to the same period in 2024, primarily due to significant decreases in research and development expenses and restructuring charges, partially offset by lower investment income Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :------------------------------------- | :--------------------------------------------- | :--------------------------------------------- | | Research and development | $3,715 | $9,645 | | General and administrative | $5,644 | $5,999 | | Restructuring and other charges | $1,435 | $2,582 | | Total operating expenses | $10,794 | $18,226 | | Loss from operations | $(10,794) | $(18,226) | | Investment income | $1,418 | $2,114 | | Net loss | $(8,619) | $(16,146) | | Net loss per share, basic and diluted | $(0.18) | $(0.33) | - Net loss **decreased by 46.6%** from **$(16.146) million** in Q1 2024 to **$(8.619) million** in Q1 2025[23](index=23&type=chunk) - Research and development expenses **decreased by 61.4%** from **$9.645 million** in Q1 2024 to **$3.715 million** in Q1 2025[23](index=23&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) The statements of stockholders' equity show a decrease in total stockholders' equity from $125.934 million at December 31, 2024, to $118.250 million at March 31, 2025, primarily due to the net loss incurred during the period, partially offset by stock-based compensation and other comprehensive income Condensed Consolidated Statements of Stockholders' Equity (in thousands) | Metric | December 31, 2024 (in thousands) | March 31, 2025 (in thousands) | | :-------------------------- | :----------------------------- | :---------------------------- | | Total Stockholders' Equity | $125,934 | $118,250 | | Stock-based compensation | N/A | $904 | | Other comprehensive income | N/A | $31 | | Net loss | N/A | $(8,619) | | Accumulated Deficit | $(331,619) | $(340,238) | - Total stockholders' equity **decreased by $7.684 million** from December 31, 2024, to March 31, 2025[26](index=26&type=chunk) - Accumulated deficit **increased by $8.619 million**, reflecting the net loss for the three months ended March 31, 2025[26](index=26&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) The company's net cash used in operating activities significantly decreased for the three months ended March 31, 2025, compared to the same period in 2024, while investing activities provided net cash in 2025, a reversal from cash usage in 2024, leading to a smaller overall net decrease in cash Condensed Consolidated Statements of Cash Flows (in thousands) | Metric | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :------------------------------------------ | :--------------------------------------------- | :--------------------------------------------- | | Net cash used in operating activities | $(10,562) | $(18,304) | | Net cash provided by (used in) investing activities | $7,932 | $(48,738) | | Net decrease in cash, cash equivalents and restricted cash | $(2,630) | $(67,042) | | Cash, cash equivalents and restricted cash, end of period | $37,635 | $54,130 | - Net cash used in operating activities **decreased by $7.742 million (42.3%)** from **$18.304 million** in Q1 2024 to **$10.562 million** in Q1 2025[29](index=29&type=chunk) - Investing activities **shifted from using $48.738 million** in Q1 20

PART I [Business](index=8&type=section&id=Item%201.%20Business) Ikena Oncology has strategically shifted from a targeted oncology company to pursuing a merger with Inmagene Biopharmaceuticals, announced in December 2024 - In December 2024, Ikena announced a merger agreement with Inmagene Biopharmaceuticals. The combined company will operate as "ImageneBio, Inc." and focus on Inmagene's lead product candidate, IMG-007[22](index=22&type=chunk) - The company discontinued development of its Hippo pathway inhibitor, IK-930, in May 2024 as part of a strategic shift to maximize shareholder value[21](index=21&type=chunk)[38](index=38&type=chunk) - The lead program is IK-595, a molecular glue designed to trap MEK and RAF in an inactive complex. A Phase 1 clinical trial in patients with RAS and RAF mutant cancers has enrolled **51 patients** to date[23](index=23&type=chunk)[31](index=31&type=chunk) - The company relies on third-party contract manufacturing organizations (CMOs) for the manufacture of its product candidates and does not own any manufacturing facilities[55](index=55&type=chunk) [Our Lead Program: IK-595, a Dual MEK-RAF Inhibitor](index=8&type=section&id=Item%201.%20Business-Our%20Lead%20Program%3A%20IK-595%2C%20a%20Dual%20MEK-RAF%20Inhibitor) IK-595 is a clinical-stage, oral molecular glue designed to inhibit the MAPK signaling pathway by trapping MEK and all three RAF isoforms in an inactive complex - IK-595 is a molecular glue designed to trap MEK and RAF in an inactive complex, aiming for more complete inhibition of RAS signals than existing inhibitors[23](index=23&type=chunk)[27](index=27&type=chunk) - The Phase 1 clinical trial (NCT06270082) for IK-595 began in December 2023, and as of the report date, **51 patients** with advanced tumors and MAPK alterations have been enrolled and treated[31](index=31&type=chunk)[33](index=33&type=chunk) - IK-595 aims to prevent CRAF-mediated bypass and kinase-independent CRAF activity, which are known resistance mechanisms to existing MEK and RAF inhibitors[28](index=28&type=chunk)[30](index=30&type=chunk) [Our Additional Legacy Programs](index=13&type=section&id=Item%201.%20Business-Our%20Additional%20Legacy%20Programs) The company has divested or out-licensed several of its legacy programs, including a global exclusive license agreement for PY314, PY159, and PY265 with Foundery Immune Studio - Entered a global exclusive license agreement with Foundery Immune Studio for three assets (PY314, PY159, PY265), with eligibility for up to **$1.0 billion** in milestones and royalties[34](index=34&type=chunk) - Sold the IK-175 program for **$0.4 million** in March 2025 after Bristol-Myers Squibb declined its opt-in right in January 2024[35](index=35&type=chunk) - Sold the preclinical AHR agonist program for **$1.5 million** in November 2024 and assigned IP for the IK-412 program to the University of Texas in March 2025[36](index=36&type=chunk)[37](index=37&type=chunk) [Intellectual Property](index=15&type=section&id=Item%201.%20Business-Intellectual%20Property) Ikena's intellectual property strategy relies on patents, trade secrets, and trademarks, with key patents for IK-595 expected to expire in 2043 - The company solely owns three patent families for its MEK inhibitors, with patents expected to expire between **2042 and 2044**, excluding any adjustments or extensions[50](index=50&type=chunk) - The lead candidate, IK-595, is covered by a solely owned, issued U.S. patent with composition of matter claims, which is expected to expire in **2043**[51](index=51&type=chunk) - The company relies on trade secrets and confidentiality agreements with employees, consultants, and collaborators to protect proprietary know-how[52](index=52&type=chunk) [Governmental Regulation](index=18&type=section&id=Item%201.%20Business-Governmental%20Regulation) The company's operations are extensively regulated by the FDA and comparable authorities, involving rigorous preclinical and multi-phase clinical trials - Drug development requires extensive preclinical and clinical testing under regulations like Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) before submitting a New Drug Application (NDA) to the FDA[61](index=61&type=chunk) - The FDA offers several expedited programs, including Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval, to facilitate the development of drugs for serious conditions[82](index=82&type=chunk) - Companion diagnostics, which may be necessary for targeted therapies, are regulated as medical devices by the FDA and generally require separate clearance or approval (510(k) or PMA)[94](index=94&type=chunk) - The company is subject to complex data privacy laws, including the GDPR in Europe, which governs the processing of personal data from clinical trials and imposes strict rules on data transfer and security[127](index=127&type=chunk)[332](index=332&type=chunk) [Human Capital](index=43&type=section&id=Item%201.%20Business-Human%20Capital) As of February 28, 2025, Ikena had 10 full-time employees, with 3 in R&D and 7 in general management and administrative roles - As of February 28, 2025, the company had **10 full-time employees**[131](index=131&type=chunk) - The workforce is divided into **3 employees in R&D** and **7 in business development, finance, legal, HR, and general management**[131](index=131&type=chunk) [Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks, primarily related to the successful consummation of its proposed merger with Inmagene, financial losses, and drug development uncertainties - Failure to complete the proposed merger with Inmagene could materially harm the company's business and stock price, and the board may decide to pursue dissolution and liquidation[136](index=136&type=chunk)[143](index=143&type=chunk) - The company has a history of significant net losses (**$49.2 million** in 2024) and an accumulated deficit of **$331.6 million** as of December 31, 2024, with no products approved for sale[152](index=152&type=chunk)[154](index=154&type=chunk) - Clinical product development is lengthy, expensive, and uncertain. Early positive results are not predictive of later-stage success, and trials may fail at any stage[174](index=174&type=chunk) - The company relies on third-party CROs to conduct clinical trials and CMOs for manufacturing, increasing risks related to quality, compliance, and supply chain disruptions[232](index=232&type=chunk)[246](index=246&type=chunk) - The company's ability to protect its intellectual property is uncertain, and its patents may be challenged, invalidated, or circumvented by competitors[263](index=263&type=chunk)[264](index=264&type=chunk) [Unresolved Staff Comments](index=130&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the SEC - None[386](index=386&type=chunk) [Cybersecurity](index=131&type=section&id=Item%201C.%20Cybersecurity) The company has implemented a cybersecurity risk management program informed by industry standards, with oversight from the audit committee - The company has adopted a cybersecurity risk management process based on recognized industry standards, leveraging a managed service provider for support[388](index=388&type=chunk) - The board of directors has delegated oversight of cybersecurity risk to the audit committee, which receives periodic updates from management[394](index=394&type=chunk) - The company has not identified any cybersecurity threats or incidents that have materially affected or are reasonably likely to materially affect its business, operations, or financial condition[392](index=392&type=chunk) [Properties](index=131&type=section&id=Item%202.%20Properties) Ikena leases office and lab space in Boston (**20,752 sq. ft.**) and San Francisco (**28,029 sq. ft.**), with the latter currently subleased - The company leases **20,752 sq. ft.** for its corporate headquarters in Boston, MA, with the lease expiring in May 2026[395](index=395&type=chunk) - An additional **28,029 sq. ft.** of office and lab space in San Francisco, CA, is leased through April 2027 and is currently subleased to third parties[396](index=396&type=chunk) [Legal Proceedings](index=132&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings expected to have a material adverse effect on its business - The company is not currently a party to any litigation or legal proceedings that are probable to have a material adverse effect on its business[398](index=398&type=chunk) [Mine Safety Disclosures](index=132&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[399](index=399&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=133&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on The Nasdaq Global Market under "IKNA", with approximately 42 holders of record as of February 28, 2025 - The company's common stock trades on The Nasdaq Global Market under the symbol **"IKNA"**[402](index=402&type=chunk) - As of February 28, 2025, there were approximately **42 holders of record** of the company's common stock[403](index=403&type=chunk) - The company has never paid cash dividends and does not anticipate paying them in the foreseeable future, except as potentially contemplated under the Merger Agreement[404](index=404&type=chunk) [Reserved](index=133&type=section&id=Item%206.%20Reserved) This item is not applicable - Not applicable[408](index=408&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=134&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Ikena reported a net loss of **$49.2 million** for 2024, driven by reduced R&D expenses, and held **$124.4 million** in cash as of December 31, 2024 Comparison of the Years Ended December 31, 2024 and 2023 (in thousands) | | 2024 | 2023 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | **Collaboration revenue** | **$ —** | **$ 9,160** | **$ (9,160 )** | **(100 )%** | | **Operating expenses:** | | | | | | Research and development | 30,875 | 59,652 | (28,777 ) | (48 )% | | General and administrative | 23,679 | 24,925 | (1,246 ) | (5 )% | | Restructuring and other charges | 4,419 | — | 4,419 | 100 % | | **Total operating expenses** | **58,973** | **84,577** | **(25,604 )** | **(30 )%** | | **Loss from operations** | **(58,973 )** | **(75,417 )** | **16,444** | **(22 )%** | | **Other income, net** | **9,891** | **7,089** | **2,802** | **40 %** | | **Net loss** | **$ (49,234 )** | **$ (68,166 )** | **$ 18,932** | **(28 )%** | - The company underwent two workforce reductions in 2024 (January and May), reducing headcount by approximately **35%** and **53%** respectively, to align with its strategic shift and conserve capital[412](index=412&type=chunk)[413](index=413&type=chunk) - As of December 31, 2024, the company had **$124.4 million** in cash, cash equivalents, and marketable securities[446](index=446&type=chunk) - Net cash used in operating activities decreased to **$46.0 million** in 2024 from **$79.7 million** in 2023, primarily due to lower net loss and changes in working capital[447](index=447&type=chunk)[449](index=449&type=chunk)[450](index=450&type=chunk) [Results of Operations](index=141&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations-Results%20of%20Operations) For 2024, Ikena's net loss decreased to **$49.2 million** from **$68.2 million** in 2023, primarily due to a **$28.8 million** reduction in R&D expenses - Collaboration revenue was **$0** in 2024, down from **$9.2 million** in 2023, as research activities under the Bristol-Myers Squibb agreement were completed in 2023[440](index=440&type=chunk) Research and Development Expenses (in thousands) | | 2024 | 2023 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | **Direct R&D by program:** | | | | | | IK-930 | $ 8,684 | $ 11,608 | $ (2,924 ) | (25 )% | | IK-595 | 9,682 | 8,068 | 1,614 | 20 % | | IK-175 | 480 | 2,677 | (2,197 ) | (82 )% | | Discovery and other programs | 1,092 | 10,218 | (9,126 ) | (89 )% | | **Unallocated expense:** | | | | | | Personnel related | 8,186 | 19,571 | (11,385 ) | (58 )% | | Other R&D cost | 2,751 | 7,510 | (4,759 ) | (63 )% | | **Total R&D expenses** | **$ 30,875** | **$ 59,652** | **$ (28,777 )** | **(48 )%** | - General and administrative expenses decreased by **$1.2 million** in 2024, primarily due to lower personnel and insurance costs, partially offset by increased facility and Merger-related costs[442](index=442&type=chunk) - Restructuring charges in 2024 totaled **$4.4 million**, including **$2.4 million** in employee separation costs, **$1.0 million** in retention expenses, and a **$0.7 million** asset impairment[443](index=443&type=chunk) [Liquidity and Capital Resources](index=144&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations-Liquidity%20and%20Capital%20Resources) As of December 31, 2024, the company had **$124.4 million** in cash, expected to fund operations for at least 12 months, and provided a **$7.5 million** bridge loan to Inmagene - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities of **$124.4 million**[446](index=446&type=chunk) - The company believes its current cash position is sufficient to fund operations for at least **12 months** from the filing date[456](index=456&type=chunk) Cash Flows Summary (in thousands) | | Year Ended December 31, | | :--- | :--- | :--- | | | **2024** | **2023** | | Net cash used in operating activities | $ (46,004 ) | $ (79,743 ) | | Net cash provided by (used in) investing activities | (34,903 ) | 64,144 | | Net cash provided by financing activities | — | 75,980 | | **Net increase (decrease) in cash, cash equivalents and restricted cash** | **$ (80,907 )** | **$ 60,381** | - The company has a loan agreement to lend up to **$22.5 million** to Inmagene, with **$7.5 million** funded in December 2024[455](index=455&type=chunk)[461](index=461&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=151&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Ikena is not required to provide the information for this item - The company is a smaller reporting company and is not required to provide the information under this item[475](index=475&type=chunk) [Financial Statements and Supplementary Data](index=151&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section contains the company's audited consolidated financial statements for 2024 and 2023, along with the report from Ernst & Young LLP - The financial statements were audited by Ernst & Young LLP, who issued an unqualified opinion[600](index=600&type=chunk)[604](index=604&type=chunk) [Consolidated Balance Sheets](index=182&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data-Consolidated%20Balance%20Sheets) As of December 31, 2024, total assets were **$141.5 million**, total liabilities **$15.6 million**, and total stockholders' equity **$125.9 million** Consolidated Balance Sheets (in thousands) | | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Total current assets** | **$ 127,169** | **$ 178,662** | | Total assets | $ 141,510 | $ 192,092 | | **Total current liabilities** | **$ 10,778** | **$ 14,205** | | Total liabilities | $ 15,576 | $ 22,335 | | **Total stockholders' equity** | **$ 125,934** | **$ 169,757** | | Total liabilities and stockholders' equity | $ 141,510 | $ 192,092 | [Consolidated Statements of Operations and Comprehensive Loss](index=183&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data-Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For 2024, the company reported a net loss of **$49.2 million** or **($1.02)** per share, a reduction from **$68.2 million** in 2023 Consolidated Statements of Operations (in thousands, except per share data) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | Collaboration revenue | $ — | $ 9,160 | | Total operating expenses | 58,973 | 84,577 | | Loss from operations | (58,973) | (75,417) | | **Net loss** | **$ (49,234)** | **$ (68,166)** | | **Net loss per share, basic and diluted** | **$ (1.02)** | **$ (1.63)** | | Weighted-average common shares outstanding | 48,258,111 | 41,735,081 | [Notes to Consolidated Financial Statements](index=186&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data-Notes%20to%20Consolidated%20Financial%20Statements) The notes detail accounting policies, fair value measurements, collaboration agreements, the Pionyr acquisition, stock-based compensation, and restructuring charges - The company has federal and state net operating loss carryforwards of approximately **$191.5 million** and **$205.5 million**, respectively, as of Dec 31, 2024, though their usability may be limited by ownership changes[683](index=683&type=chunk) - In 2024, the company incurred **$4.4 million** in restructuring charges, primarily from employee severance, retention payments, and asset impairments related to two restructuring events[698](index=698&type=chunk)[699](index=699&type=chunk)[702](index=702&type=chunk) - The company acquired Pionyr in August 2023 in a recapitalization transaction, acquiring its assets, including net cash, in exchange for Ikena stock[616](index=616&type=chunk)[671](index=671&type=chunk)[672](index=672&type=chunk) - The collaboration with Bristol-Myers Squibb concluded with BMS declining its opt-in rights for the IK-175 and IK-412 programs in January 2024. All revenue from the collaboration was recognized by the end of 2023[662](index=662&type=chunk)[663](index=663&type=chunk) [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=151&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[477](index=477&type=chunk) [Controls and Procedures](index=151&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2024 - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2024[479](index=479&type=chunk) - Management assessed internal control over financial reporting and believes it was effective as of December 31, 2024, based on the COSO framework[482](index=482&type=chunk) - As an emerging growth company, the company is exempt from providing an auditor's attestation report on internal control over financial reporting[483](index=483&type=chunk) [Other Information](index=152&type=section&id=Item%209B.%20Other%20Information) There is no other information to report under this item - None[486](index=486&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=152&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - Not Applicable[484](index=484&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=153&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) This section provides biographical information for the company's eight directors and two executive officers, including their roles and governance policies - The company's board of directors consists of **eight members**, divided into three staggered classes[489](index=489&type=chunk) - The executive officers are Mark Manfredi, Ph.D. (President & CEO) and Jotin Marango, M.D., Ph.D. (CFO, COO, Head of Corporate Development)[499](index=499&type=chunk) - The company has adopted a Code of Business Conduct and Ethics, an insider trading policy, and an equity grant policy[503](index=503&type=chunk)[506](index=506&type=chunk)[508](index=508&type=chunk) - The audit committee consists of Jean-François Formela, Owen Hughes (Chair), and Iain Dukes, all of whom are independent. Mr. Hughes is designated as the audit committee financial expert[505](index=505&type=chunk) [Executive Compensation](index=159&type=section&id=Item%2011.%20Executive%20Compensation) This section details compensation for non-employee directors and named executive officers for fiscal year 2024, including salaries, bonuses, and equity awards 2024 Director Compensation | Name | Fees Earned or Paid in Cash ($) | Option Awards ($) | Total ($) | | :--- | :--- | :--- | :--- | | David Bonita, M.D. | 49,000 | 23,337 | 72,337 | | Iain Dukes, D.Phil. | 46,500 | 23,337 | 69,837 | | Jean-François Formela, M.D. | 47,500 | 23,337 | 70,837 | | Otello Stampacchia, Ph.D. | 43,000 | 23,337 | 66,337 | | Maria Koehler, M.D., Ph.D. | 35,000 | 23,337 | 58,337 | | Richard Wooster, Ph.D. | 35,000 | 23,337 | 58,337 | | Owen Hughes | 85,000 | 23,337 | 108,337 | 2024 Summary Compensation Table | Name and Principal Position | Year | Salary ($) | Bonus ($) | Option Awards ($) | All Other Compensation ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Mark Manfredi, Ph.D. (President and CEO) | 2024 | 569,000 | 284,500 | 334,016 | 14,694 | 1,202,210 | | Jotin Marango, M.D., Ph.D. (CFO, COO) | 2024 | 456,133 | 353,000 | 701,248 | 813 | 1,511,194 | | Caroline Germa, M.D. (Former CMO) | 2024 | 418,590 | 450,000 | 656,815 | 14,471 | 1,539,875 | - NEOs are eligible for severance benefits upon termination without cause or for good reason, with enhanced benefits (e.g., **1.5x salary + bonus** and full equity acceleration for the CEO) if the termination occurs in connection with a change in control[529](index=529&type=chunk)[532](index=532&type=chunk)[535](index=535&type=chunk) - Former CMO Dr. Caroline Germa's employment terminated on February 3, 2025. She received a severance package including **12 months of base salary**, **12 months of COBRA premiums**, and partial acceleration of equity awards[519](index=519&type=chunk)[539](index=539&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=167&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) This section details beneficial ownership of common stock, with Atlas Venture as the largest holder (**11.98%**), and outlines securities authorized under equity compensation plans - As of December 31, 2024, there were **7,678,058 securities** to be issued upon exercise of outstanding options, and **5,100,395 securities** remaining available for future issuance under equity compensation plans[545](index=545&type=chunk) - Entities affiliated with Atlas Venture are the largest beneficial owner, with **11.98%** of voting shares[551](index=551&type=chunk)[553](index=553&type=chunk) - Other significant (>5%) stockholders include Blue Owl Capital (**9.77%**), Biotechnology Value Fund (**9.56%**), BML Investment Partners (**8.56%**), OrbiMed Advisors (**8.45%**), Deep Track Capital (**6.01%**), and Omega Fund VI (**5.37%**)[551](index=551&type=chunk) - All current executive officers and directors as a group beneficially own **6.59%** of the company's voting common stock as of February 28, 2025[551](index=551&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=170&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The company discloses related party transactions, including the Pionyr acquisition, and confirms all directors are independent except for the CEO - In the 2023 acquisition of Pionyr, OrbiMed Advisors LLC, a related party and >5% stockholder of Ikena, was a stockholder of Pionyr and received Ikena stock in the transaction[566](index=566&type=chunk) - The company has a written policy requiring the audit committee to review and approve related party transactions exceeding **$120,000**[570](index=570&type=chunk) - The board of directors has determined that all directors are independent, except for President and CEO Mark Manfredi, Ph.D.[572](index=572&type=chunk) [Principal Accountant Fees and Services](index=171&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Ernst & Young LLP served as the independent auditor, with total fees of **$571,100** in 2024 and **$969,750** in 2023, primarily for audit services Accountant Fees (2024 vs 2023) | Fee Type | 2024 | 2023 | | :--- | :--- | :--- | | Audit fees | $ 571,100 | $ 969,750 | | Audit-Related fees | $— | $— | | Tax fees | $— | $— | | All other fees | $— | $— | | **Total fees** | **$ 571,100** | **$ 969,750** | - The audit committee has adopted a policy to pre-approve all audit and non-audit services performed by the independent registered public accounting firm[576](index=576&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=174&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists financial statements and an index of exhibits, including the merger agreement with Inmagene and corporate governance documents - All financial statement schedules are omitted as they are not required, not applicable, or the information is included in the financial statements or notes[581](index=581&type=chunk) - The exhibit index lists key corporate documents, including the merger agreement with Inmagene (Exhibit 2.4), charter documents (Exhibits 3.1, 3.2), and executive employment agreements[583](index=583&type=chunk) [Form 10-K Summary](index=178&type=section&id=Item%2016.%20Form%2010-K%20Summary) This item is not applicable - Not applicable[587](index=587&type=chunk)

据 IPO 早 知 道 消 息 ， 近 日 ， 纳 斯 达 克 生 物 医 药 公 司 Ikena Oncology （ IKNA.US ） 和 创 响 生 物 （Inmagene）宣布双方已达成最终合并协议。创响生物将反向收购Ikena。 此次合并将产生1.75亿美元资金，其中包括7500万美元超额认购的PIPE私募融资。 Ikena已与 Deep Track Capital、Foresite Capital、RTW Investments等新投资人达成认购协议 ，此外， Ikena 原 有 股 东 BVF Partners LP 、 Blue Owl Healthcare Opportunities 、 Omega Funds 和 OrbiMed等 也参与了此次PIPE认购。 合并预计将于2025年年中完成。 本文为IPO早知道原创 作者｜罗宾 微信公众号｜ipozaozhidao 合并后的公司将专注于开发针对OX40的单克隆抗体（mAb）IMG-007，用于治疗特应性皮炎。合 并后的公司计划以"ImageneBio"的名称运营，并在纳斯达克以"IMA"为股票代码进行交易。 合并和融资完成后，Ikena股 ...

Core Viewpoint - The merger between Ikena Oncology and Inmagene Biopharmaceuticals aims to advance the development of IMG-007, a monoclonal antibody targeting OX40 for treating atopic dermatitis and other inflammatory diseases, with an expected closing in mid-2025 [1][3][9]. Company Overview - Inmagene Biopharmaceuticals is a clinical-stage company focused on developing IMG-007, a non-depleting anti-OX40 monoclonal antibody with an extended half-life and silenced ADCC function [9][14]. - Ikena Oncology develops differentiated therapies targeting cancer growth and therapeutic resistance [15]. Financial Aspects - The transaction is expected to generate approximately $175 million, including $75 million from an oversubscribed private placement [1][9]. - The combined company will operate under the name "ImageneBio, Inc." and trade on NASDAQ under the ticker "IMA" [9]. Management Structure - The board of directors for the combined company will consist of three directors from Inmagene, two from Ikena, one representing the financing investors, and one independent board member [2][11]. Clinical Development - IMG-007 has shown potential in a Phase 2a clinical trial for atopic dermatitis, demonstrating marked clinical activity and a well-tolerated safety profile [10][16]. - The Phase 2b clinical trial for IMG-007 in atopic dermatitis is expected to begin in early 2025 [10]. Ownership Structure - Post-merger, Ikena stockholders are expected to own approximately 34.8% of the combined company, Inmagene equity holders approximately 43.5%, and financing investors about 21.7% [11]. Contingent Value Rights - Shareholders of both companies will receive contingent value rights (CVRs), with Inmagene shareholders receiving CVRs for non-IMG-007 assets and Ikena shareholders for legacy pipeline assets [12].

Core Viewpoint - Ikena Oncology, Inc. reported its financial results for Q3 2024, highlighting ongoing clinical activities and strategic evaluations to enhance shareholder value [1][2]. Pipeline and Corporate Updates - The Phase 1 study of IK-595 for RAS and RAF mutant cancers is progressing with multiple cohorts passing safety evaluations [2]. - Early pharmacokinetics and pharmacodynamics data show promising dose-dependent exposure and target modulation in blood [2]. - The company is exploring various strategic options to maximize shareholder value [2]. Financial Results for the Quarter Ended September 30, 2024 - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $138.0 million [3][8]. - Research and development expenses decreased to $6.8 million in Q3 2024 from $14.7 million in Q3 2023 [3][7]. - General and administrative expenses also decreased to $4.8 million in Q3 2024 from $6.0 million in Q3 2023 [3][7]. Loss and Expenses - Restructuring and other costs for Q3 2024 were reported at $0.8 million [4]. - The net loss for Q3 2024 was $10.2 million, down from $17.3 million in Q3 2023 [4][7]. - The net loss per share for Q3 2024 was $0.21 compared to $0.40 in Q3 2023 [7]. Selected Financial Information - Total operating expenses for Q3 2024 were $12.4 million, a decrease from $20.7 million in Q3 2023 [7]. - The company reported total assets of $149.0 million and total liabilities of $14.8 million as of September 30, 2024 [8].

Core Viewpoint - Ikena Oncology, Inc. reported its financial results for Q2 2024, highlighting ongoing clinical activities and strategic corporate updates Pipeline Updates - The Phase 1 study of IK-595 for RAS and RAF mutant cancers is progressing with multiple cohorts passing safety evaluations [2] - Early pharmacokinetics and pharmacodynamics show promising results with dose-dependent exposure and target modulation [2] - The IK-930 clinical program was discontinued in May 2024 [2] Corporate Updates - In May 2024, the company announced a strategic review to maximize shareholder value and implemented a 53% workforce reduction [2] - Jotin Marango was appointed as Chief Operating Officer in July 2024, in addition to his existing roles [2] Financial Results for Q2 2024 - As of June 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $145.4 million [3][9] - Research and development expenses decreased to $9.8 million in Q2 2024 from $15.2 million in Q2 2023 [3][8] - General and administrative expenses remained stable at $5.3 million for both Q2 2024 and Q2 2023 [3][8] Loss and Expenses - Restructuring and other costs for Q2 2024 were reported at $0.7 million [4] - The net loss for Q2 2024 was $13.7 million, down from $17.1 million in Q2 2023 [4][8] - Total operating expenses for Q2 2024 were $15.8 million, compared to $20.5 million in Q2 2023 [8] Selected Financial Information - Collaboration revenue was $0 in Q2 2024, down from $2.0 million in Q2 2023 [8] - The net loss per share for Q2 2024 was $0.28, an improvement from $0.44 in Q2 2023 [8] - Total assets as of June 30, 2024, were $157.5 million, with total liabilities of $14.6 million [9]

Core Viewpoint - Ikena Oncology has decided to discontinue the development of IK-930, a TEAD1-selective Hippo pathway inhibitor, while continuing the clinical development of IK-595, a novel MEK-RAF molecular glue, and is exploring strategic options to maximize shareholder value [2][3][8]. Pipeline & Corporate Updates - The decision to wind down the IK-930 program was based on a review of clinical data, available resources, and the company's strategic priorities [8]. - The Phase 1 program for IK-930 will begin winddown activities, but treatment will continue for patients who have benefited from it [8]. - The first two cohorts in the Phase 1 study of IK-595 have cleared, with plans to backfill in select cohorts in the second half of 2024 [8]. - Promising early pharmacokinetics (PK) and pharmacodynamics (PD) activity have been observed for IK-595, with over 80% pERK inhibition at 4 hours post-dosing and over 60% sustained inhibition through 24 hours [8]. - The company has a cash position of $157 million as of March 31, 2024, which may unlock new strategic opportunities [6][8]. Strategic Direction - The company is evaluating strategic options for both its development pipeline and the IK-930 program, including potential partnerships for combination therapies [3][8]. - Ikena aims to create value through diligent capital expenditure and exploring various strategic alternatives [6].

Core Viewpoint - Ikena Oncology has decided to discontinue the development of its IK-930 program while continuing the clinical development of IK-595, a novel MEK-RAF molecular glue, and is exploring strategic options to maximize shareholder value [1][2][5] Pipeline Updates - The IK-930 program, a TEAD1-selective Hippo pathway inhibitor, is being wound down based on clinical data review and available resources [3] - Patients currently enrolled in the IK-930 program who have benefited will continue to receive treatment [3] - The company is seeking strategic options for IK-930, including potential partnerships for its development in combination with other targeted agents [3] IK-595 Development - The Phase 1 study of IK-595 in patients with RAS and RAF mutant cancers has progressed, with the first two cohorts cleared and backfilling planned for the second half of 2024 [4] - Promising early pharmacokinetics (PK) and pharmacodynamics (PD) data have been observed, including over 80% pERK inhibition at 4 hours post-dosing and sustained above 60% inhibition through 24 hours [4] Corporate Updates - In connection with the discontinuation of IK-930, the company is executing a workforce reduction of approximately 53% [5] - As of March 31, 2024, the company reported $157.3 million in cash, cash equivalents, and marketable securities [5] - The company is exploring a range of strategic alternatives while continuing the development of IK-595 [5]

Core Insights - Ikena Oncology has decided to discontinue the development of its IK-930 program, a TEAD1-selective Hippo pathway inhibitor, while continuing the clinical development of IK-595, a novel MEK-RAF molecular glue [1][2][3] - The company ended the first quarter of 2024 with $157.3 million in cash and equivalents and is exploring strategic options to maximize shareholder value [1][5] IK-930 Program Update - The decision to wind down the IK-930 program was based on a review of clinical data, available resources, and the company's strategic priorities [3] - The Phase 1 program for IK-930 will begin wind down activities, but treatment will continue for patients who have benefited from it [3] - The company is seeking strategic options for IK-930, including potential partnerships for its development in combination with other targeted agents [3][5] IK-595 Program Update - The Phase 1 study of IK-595 in patients with RAS and RAF mutant cancers has progressed, with the first two cohorts cleared and backfilling planned for the second half of 2024 [4] - Promising early pharmacokinetics (PK) and pharmacodynamics (PD) data have been observed, including over 80% pERK inhibition at 4 hours post-dosing and sustained over 60% inhibition through 24 hours [4] Corporate Strategy and Financial Position - In connection with the discontinuation of IK-930, the company is executing a workforce reduction of approximately 53% [5] - The company projects cash and equivalents to range from $110 million to $120 million by December 31, 2024 [5] - Ikena is exploring a range of potential strategic options, including acquisitions, mergers, and partnerships, to create value and unlock new opportunities [5]

Core Viewpoint - Ikena Oncology, Inc. reported a strong financial position with $157.3 million in cash and equivalents, sufficient to fund operations into the second half of 2026, while providing updates on its clinical programs, IK-930 and IK-595, which are progressing as planned [1][3][2]. Financial Results - As of March 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $157.3 million, down from $175.5 million at the end of 2023 [3][10]. - Collaboration revenue for the first quarter of 2024 was $0, compared to $5.3 million in the same period of 2023, due to the completion of the Bristol-Myers Squibb collaboration [4][10]. - Research and development expenses decreased to $9.6 million in Q1 2024 from $15.6 million in Q1 2023 [5][11]. - General and administrative expenses increased to $6.0 million in Q1 2024 from $5.3 million in Q1 2023 [5][11]. - The company reported a net loss of $16.1 million for Q1 2024, compared to a net loss of $14.2 million in Q1 2023 [5][11]. Pipeline Progress - The IK-930 program, a TEAD1-selective Hippo pathway inhibitor, is on track to deliver a clinical update in the second half of 2024 [1][6]. - The IK-595 program, a MEK-RAF molecular glue, continues dose escalation in patients with RAS and RAF mutant cancers, with plans for backfilling in select cohorts in the second half of 2024 [2][6]. - The company is focused on recruiting patients with tumors harboring mutations in the Hippo pathway, particularly mesothelioma patients, for the IK-930 clinical program [6][8]. Corporate Update - In January 2024, the company announced a renewed focus on advancing its core targeted oncology clinical programs, IK-930 and IK-595 [7]. - Dr. Caroline Germa was appointed as Chief Medical Officer in February 2024 [7].