Ikena Oncology(IKNA) - 2024 Q4 - Annual Report

PART I Business 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] - 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][38] - 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][31] - 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] Our Lead Program: IK-595, a Dual MEK-RAF Inhibitor 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][27] - 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][33] - 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][30] Our Additional Legacy Programs 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] - 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] - 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][37] Intellectual Property 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] - 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] - The company relies on trade secrets and confidentiality agreements with employees, consultants, and collaborators to protect proprietary know-how[52] Governmental Regulation 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] - 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] - 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] - 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][332] Human Capital 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] - The workforce is divided into 3 employees in R&D and 7 in business development, finance, legal, HR, and general management[131] Risk Factors 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][143] - 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][154] - 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] - 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][246] - The company's ability to protect its intellectual property is uncertain, and its patents may be challenged, invalidated, or circumvented by competitors[263][264] Unresolved Staff Comments The company reports that it has no unresolved staff comments from the SEC - None[386] Cybersecurity 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] - The board of directors has delegated oversight of cybersecurity risk to the audit committee, which receives periodic updates from management[394] - 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] Properties 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] - 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] Legal Proceedings 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] Mine Safety Disclosures This item is not applicable to the company - Not applicable[399] PART II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 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] - As of February 28, 2025, there were approximately 42 holders of record of the company's common stock[403] - 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] Reserved This item is not applicable - Not applicable[408] Management's Discussion and Analysis of Financial Condition and Results of Operations 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][413] - As of December 31, 2024, the company had $124.4 million in cash, cash equivalents, and marketable securities[446] - 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][449][450] Results of Operations 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] 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] - 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] Liquidity and Capital Resources 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] - The company believes its current cash position is sufficient to fund operations for at least 12 months from the filing date[456] 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][461] Quantitative and Qualitative Disclosures About Market Risk 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] Financial Statements and Supplementary Data 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][604] Consolidated Balance Sheets 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 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 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] - 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][699][702] - The company acquired Pionyr in August 2023 in a recapitalization transaction, acquiring its assets, including net cash, in exchange for Ikena stock[616][671][672] - 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][663] Changes in and Disagreements With Accountants on Accounting and Financial Disclosure The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[477] Controls and Procedures 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] - Management assessed internal control over financial reporting and believes it was effective as of December 31, 2024, based on the COSO framework[482] - As an emerging growth company, the company is exempt from providing an auditor's attestation report on internal control over financial reporting[483] Other Information There is no other information to report under this item - None[486] Disclosure Regarding Foreign Jurisdictions that Prevent Inspections This item is not applicable to the company - Not Applicable[484] PART III Directors, Executive Officers and Corporate Governance 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] - The executive officers are Mark Manfredi, Ph.D. (President & CEO) and Jotin Marango, M.D., Ph.D. (CFO, COO, Head of Corporate Development)[499] - The company has adopted a Code of Business Conduct and Ethics, an insider trading policy, and an equity grant policy[503][506][508] - 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] Executive Compensation 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][532][535] - 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][539] Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 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] - Entities affiliated with Atlas Venture are the largest beneficial owner, with 11.98% of voting shares[551][553] - 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] - 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] Certain Relationships and Related Transactions, and Director Independence 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] - The company has a written policy requiring the audit committee to review and approve related party transactions exceeding $120,000[570] - The board of directors has determined that all directors are independent, except for President and CEO Mark Manfredi, Ph.D.[572] Principal Accountant Fees and Services 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] PART IV Exhibits and Financial Statement Schedules 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] - 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] Form 10-K Summary This item is not applicable - Not applicable[587]