Financial Performance - For the year ended December 31, 2025, the company reported net losses of $45.3 million, compared to $36.6 million for the year ended December 31, 2024, with an accumulated deficit of $230.1 million as of December 31, 2025[200]. - As of December 31, 2025, the company had cash and cash equivalents totaling $135.3 million, which may not be sufficient for future funding requirements[205]. - The company may need to raise additional capital to support product development and operations, which could lead to dilution of existing shareholders[204]. - The company may experience fluctuations in financial condition and operating results due to various uncontrollable factors[203]. Product Development and Regulatory Approval - The company expects to incur significant expenses and additional operating losses as it advances IMG-007 through clinical development and seeks regulatory approval[201]. - The company is entirely dependent on the success of IMG-007 for the treatment of atopic dermatitis (AD) and other potential indications, currently in Phase 2 development[208]. - The company anticipates that the costs to advance IMG-007 to regulatory approval will be substantial, with increasing expenses as it progresses through clinical phases[201]. - The company must demonstrate that IMG-007 is safe, pure, and potent for its intended use, which involves extensive regulatory review and clinical trials[214]. - The company has not completed any pivotal clinical trials required for the approval of IMG-007, which may lead to delays in the clinical development process[217]. - Numerous unforeseen events could delay or prevent the ability to receive marketing approval for IMG-007, significantly increasing trial costs[219]. - The company must conduct extensive clinical testing before submitting a biologics license application (BLA) for IMG-007, with no certainty on completion timelines[222]. - The company may face challenges in patient enrollment for clinical trials due to competition with other ongoing trials and limited qualified investigators[231]. - Clinical trials may produce negative or inconclusive results, potentially leading to the need for additional trials or abandonment of development programs[220]. - The company may experience delays in preclinical programs, adversely affecting the ability to obtain regulatory approvals[237]. - The timely completion of clinical trials is dependent on the ability to enroll a sufficient number of patients, which may be hindered by various external factors[230]. - The company may seek Fast Track Designation or PRIME Designation to expedite regulatory approvals, but success is not guaranteed and may not accelerate the approval process[317][318]. - Regulatory approvals in one jurisdiction do not guarantee approvals in others, and delays in one region can negatively impact the approval process elsewhere[320]. - The company may face significant costs and delays in obtaining foreign regulatory approvals, which could limit market potential for IMG-007 and future products[322]. Manufacturing and Supply Chain Risks - The company relies on third-party manufacturers for the production of IMG-007, with current supply insufficient for the Phase 2b study, leading to potential delays and increased costs[248]. - The company does not own manufacturing facilities and depends on third parties for the production of IMG-007, increasing risks related to supply and cost[266]. - The active pharmaceutical ingredients for IMG-007 are currently sourced from a single supplier, WuXi Biologics, which poses a risk if supply is disrupted[266]. - The company has no long-term supply agreements with manufacturers, increasing the risk of obtaining sufficient quantities of product candidates[270]. - Compliance with cGMP regulations by third-party manufacturers is critical; failure to do so could result in delays or loss of marketing approvals[268]. - Current or future tariffs may increase research and development expenses and complicate the supply chain, potentially delaying development timelines[249]. - The company faces potential increased manufacturing costs due to tariffs and trade restrictions, which could impact competitiveness[267]. - Macroeconomic conditions could disrupt the supply chain, impacting the development and commercialization efforts of the company[273]. Competition and Market Risks - Significant competition exists in the pharmaceutical industry, with competitors having greater financial resources and expertise, which could affect the company's market position[287]. - IMG-007 is being developed for moderate-to-severe atopic dermatitis (AD), with key competitive factors including efficacy, safety, and pricing compared to existing treatments[288]. - Competitors may develop more effective or cost-efficient products, which could render IMG-007 noncompetitive[291]. - The company may struggle to maintain or obtain necessary intellectual property rights, which could impede the development of IMG-007 and future candidates[284]. - Market acceptance of IMG-007 or future product candidates among physicians, patients, and hospitals is crucial for generating significant revenue[338]. Intellectual Property and Legal Risks - The company relies on a combination of patents and trade secrets to protect intellectual property related to IMG-007, with the patent prosecution process being costly and time-consuming[379]. - The patent position for IMG-007 is uncertain, and existing patents may not provide sufficient protection against competitors[382]. - Patent litigation is common in the biotechnology industry, and third parties may assert claims that could disrupt the commercialization of IMG-007[388]. - The company may face third-party claims regarding patent infringement, which could block commercialization unless licenses are obtained[389]. - The limited lifespan of patents means that IMG-007 may face competition from biosimilar products if patent protection expires before commercialization[387]. - Legal proceedings regarding patent validity and enforceability are unpredictable, and losing such cases could result in loss of patent protection for IMG-007 or future candidates[393]. - The company may face significant expenses and distractions from normal operations due to intellectual property litigation, potentially increasing operating losses[394]. Regulatory and Compliance Risks - Changes in regulatory policies and potential government shutdowns could materially affect the company's operations and regulatory submission processes[243]. - The company must comply with stringent environmental, health, and safety laws, which may increase operational costs and liabilities[328]. - Relationships with healthcare professionals and third-party payors are subject to various healthcare laws, and violations could lead to substantial penalties[329]. - Compliance with evolving data privacy and security laws is critical, with potential penalties for non-compliance, including fines and operational disruptions[351]. - The company faces significant legal risks and compliance costs due to stringent data privacy regulations, such as the GDPR, which can impose fines of up to €20 million or 4% of annual global revenue[356]. - The company must navigate complex data transfer laws, particularly between the EU and the US, which could lead to operational challenges and increased regulatory scrutiny[361]. Reimbursement and Pricing Risks - Coverage and reimbursement for IMG-007 or future product candidates may be limited or unavailable, impacting profitability if approved[296]. - Obtaining adequate reimbursement from third-party payors is critical for new product acceptance, as patients rely on these payors to cover treatment costs[298]. - The reimbursement process is lengthy and costly, requiring supporting scientific, clinical, and cost-effectiveness data, which may delay product acceptance[298]. - Legislative changes, such as the Affordable Care Act, have revised rebate methodologies and increased minimum Medicaid rebates, impacting profitability[340]. - The One Big Beautiful Bill Act is expected to reduce Medicaid spending and enrollment, potentially affecting the company's market[343]. - Future initiatives by governments and payors to contain healthcare costs may adversely affect reimbursement rates, impacting profitability[350].

Financial Performance - The net loss for Q4 2025 was $6.9 million, compared to a net loss of $4.8 million in Q4 2024, attributed to higher operating costs post-merger[16]. - For the full year 2025, the company reported a net loss of $45.3 million, compared to a net loss of $36.6 million in 2024, with total operating expenses increasing to $49.3 million from $40.5 million[24]. Cash and Assets - As of December 31, 2025, the company had cash, cash equivalents, and marketable securities of $135.3 million, a significant increase from $12.1 million as of December 31, 2024, primarily due to a $75 million private placement following the merger with Ikena Oncology[13]. - Total assets increased significantly to $152,976 million in December 2025 from $15,922 million in December 2024, representing a growth of approximately 860%[26]. - Cash and cash equivalents rose to $94,532 million, up from $12,118 million, indicating a substantial increase of about 680%[26]. - Marketable securities were reported at $40,817 million, indicating a new asset category introduced in the current year[26]. - The company reported a notable increase in total current assets to $140,288 million from $12,468 million, representing a growth of approximately 1025%[26]. Liabilities - Total current liabilities decreased to $11,234 million from $17,209 million, reflecting a reduction of approximately 35%[26]. - Long-term liabilities increased to $8,603 million from $239 million, showing a significant rise of over 3500%[26]. - Total liabilities increased to $19,837 million from $17,448 million, which is an increase of about 14%[26]. Research and Development - Research and Development (R&D) expenses for Q4 2025 were $3.3 million, a decrease from $3.8 million in Q4 2024, reflecting continued investment in clinical trials[14]. - The IMG-007 Phase 2b ADAPTIVE trial is ongoing, with topline data expected in 2027, and a recent safety review indicated a favorable tolerability profile[5]. - Over 150 subjects have participated in clinical trials of IMG-007, with no cases of administration-associated pyrexia, chills, or malignancies reported to date[6]. - The company has submitted a protocol amendment for the ADAPTIVE trial to expand dosing regimens and evaluate patient-friendly dosing intervals[10]. - IMG-007 is positioned as a leading receptor-targeting OX40 antagonist, with a unique non-T cell depleting mechanism, differentiating it from competitors[3]. Leadership and Personnel - General and Administrative (G&A) expenses for Q4 2025 were $5.2 million, up from $2.4 million in Q4 2024, primarily due to increased professional fees and personnel costs related to the merger[15]. - The company added key executives in 2025, including Dr. Ben Porter-Brown as Chief Medical Officer, enhancing its leadership team[9]. Equity - Stockholders' equity improved to $133,139 million compared to a deficit of $(160,565) million in the previous year, marking a turnaround of over $293,704 million[26]. Other Assets - The operating lease right-of-use assets increased to $790 million from $547 million, reflecting a growth of about 44%[26]. - The company has a promissory note receivable from a related party amounting to $7,020 million, indicating potential future cash inflow[26].

Clinical Development - IMG-007, a non-depleting anti-OX40 monoclonal antibody, showed 54% of patients achieving EASI-75 after three treatments in the Phase 1b/2a trial[147] - IMG-007 is the only product candidate in clinical development following the divestiture of the Non-OX40 Business[157] Financial Performance - For the three months ended September 30, 2025, total operating expenses rose to $26.6 million, a 380% increase from $5.5 million in the same period in 2024[169] - Research and development expenses for the three months ended September 30, 2025 were $15.6 million, a 300% increase from $3.9 million in the same period in 2024, primarily due to a $10 million increase in stock-based compensation[171] - General and administrative expenses for the three months ended September 30, 2025 were $11.0 million, up 568% from $1.7 million in the same period in 2024, driven by increased stock-based compensation and professional services costs[172] - The company reported a net loss of $24.8 million for the three months ended September 30, 2025, compared to a net loss of $3.2 million in the same period in 2024, representing a 678% increase in losses[169] - For the nine months ended September 30, 2025, the company incurred a net loss of $38.4 million, compared to a net loss of $31.8 million for the same period in 2024, reflecting a 21% increase in losses[181] - The company had cash, cash equivalents, and marketable securities of $142.6 million as of September 30, 2025, with an accumulated deficit of $223.1 million[181] - Net cash used in operating activities for the nine months ended September 30, 2025 was $40.6 million, significantly higher than $17.8 million for the same period in 2024[187] - Net cash used in operating activities for the nine months ended September 30, 2024, was $17.8 million, primarily due to a net loss of $31.8 million and a net change of $2.8 million in operating assets and liabilities, partially offset by $16.7 million in non-cash charges[189] Funding and Financing - PIPE Financing raised approximately $75 million through the issuance of 2,508,339 shares at about $29.90 per share[154] - The company raised approximately $75 million through a private placement of 2,508,339 shares at approximately $29.90 per share to support its pipeline and general corporate purposes[183] - Net cash provided by financing activities for the nine months ended September 30, 2025, was $135.5 million, consisting of $15.0 million from a Term Loan, $54.6 million from reverse recapitalization, and $71.1 million from issuance of common stock[192] - The Term Loan included three tranches totaling $22.5 million, with an interest rate of 6.0% per annum, which was forgiven upon consummation of the Merger[198][199] - The company expects to require substantial additional funding to support ongoing operations and development activities, with potential financing through equity offerings and grants[185] Market Overview - The global immunology market is projected to grow from approximately $103 billion in 2024 to approximately $257 billion by 2032[146] Corporate Actions - The merger with Inmagene Biopharmaceuticals was completed on July 25, 2025, with Legacy Inmagene shareholders receiving 4,601,375 shares of Ikena Common Stock[150] - A reverse stock split of 1-for-12 was executed on July 25, 2025, with shares trading under the new ticker symbol "IMA" starting July 28, 2025[152] - The Non-OX40 Divestiture involved the sale of non-IMG-007 related assets for a promissory note of $8.9 million, accruing interest at 4.61%[156] Operating Expenses - Research and development expenses are primarily incurred for the development of IMG-007, with costs expensed as incurred[162] - General and administrative expenses include personnel-related costs and legal fees, impacting overall operating expenses[163] - General and administrative expenses are expected to increase significantly as the company expands operations and prepares for commercialization of IMG-007, with increases related to hiring and compliance costs[164] Cash Flow - Net cash provided by investing activities for the nine months ended September 30, 2024, was $11.0 million, mainly from $10.2 million in cash proceeds from maturities and sales of available-for-sale securities[191] Internal Controls - A material weakness in internal control over financial reporting was identified, related to inadequate segregation of duties in the period-end financial reporting process[212][213] - Management plans to implement control activities to remediate the identified material weakness, focusing on segregation of duties related to journal entries and account reconciliations[215] - There were no changes in internal control over financial reporting during the quarterly period ended September 30, 2025, that materially affected the company's internal control[217]

Financial Performance - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities of $142.6 million, up from $12.1 million as of December 31, 2024, primarily due to the merger completion and a $75.0 million private placement[11] - The net loss for Q3 2025 was $24.8 million, compared to $3.2 million for the same period in 2024, reflecting increased operating costs related to the merger[15] - License revenue for Q3 2025 was $0, compared to $3.5 million in Q3 2024[19] - Total operating expenses for Q3 2025 were $26.6 million, a significant increase from $5.5 million in Q3 2024[19] - Net loss for Q3 2025 was $24.8 million, compared to a net loss of $3.2 million in Q3 2024[19] - Loss per share for common stock in Q3 2025 was $(2.91), compared to $(2.58) in Q3 2024[19] Research and Development - Research and Development (R&D) expenses for Q3 2025 were $15.6 million, an increase of $11.7 million compared to $3.9 million in Q3 2024, driven by higher clinical trial expenses and stock-based compensation[12] - The ongoing Phase 2b ADAPTIVE trial is designed to evaluate the efficacy and safety of various dose regimens of IMG-007 in adults with moderate-to-severe atopic dermatitis, with topline data expected in 2027[4][8] - In a Phase 1b/2a study, IMG-007 demonstrated a mean reduction in EASI score of 77% from baseline at week 16 among 13 patients treated with up to 3 doses over 4 weeks[8] - EASI-75 response was achieved by 54%, 54%, and 46% of participants at weeks 16, 20, and 24, respectively, while EASI-90 response was achieved by 31% of participants at week 16[8] - The company plans to submit a protocol amendment to expand dosing regimens and evaluate patient-friendly dosing intervals in the ongoing Phase 2b trial[8] General and Administrative Expenses - General and Administrative (G&A) expenses for Q3 2025 were $11.0 million, up from $1.7 million in Q3 2024, with a $5.2 million increase in stock-based compensation contributing to the rise[13] Assets and Liabilities - Cash and cash equivalents increased to $103.2 million as of September 30, 2025, up from $12.1 million at the end of 2024[21] - Total current assets rose to $147.5 million in Q3 2025, compared to $12.5 million at the end of 2024[21] - Total liabilities decreased to $21.0 million as of September 30, 2025, down from $17.4 million at the end of 2024[21] - Stockholders' equity improved to $139.8 million in Q3 2025, compared to a negative equity of $(160.6) million at the end of 2024[21] Leadership Changes - The leadership team was strengthened with the addition of Dr. Kristin Yarema as CEO, Dr. Kurinji Pandiyan as Chief Strategy and Operations Officer, and Dr. Renuka Sivendran as Chief Technical Officer[9][10] Upcoming Events - Upcoming presentations at the 6th Annual Inflammatory Skin Disease Summit will include data on IMG-007's clinical activity in alopecia areata and atopic dermatitis[6][7]

Table of Contents As filed with the Securities and Exchange Commission on September 8, 2025 Registration No. 333- FORM S-1 REGISTRATION STATEMENT Under The Securities Act of 1933 IMAGENEBIO, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2836 81-1697316 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 12526 High Bluff Drive, Suite 345 San Diego, CA 92130 (858) 345-6265 UNITED ...

Core Viewpoint - The merger between Inmagene Biopharmaceuticals and Ikena Oncology has been completed, resulting in the formation of ImageneBio, Inc., which will focus on advancing its lead asset, IMG-007, for the treatment of immunological and inflammatory diseases [1][2][3] Company Overview - ImageneBio, Inc. is a clinical-stage biotechnology company dedicated to developing disease-modifying treatments for immunological/autoimmune and inflammatory diseases [6] - The company aims to create new medicines with differentiated profiles to effectively control and change the course of these diseases, improving patients' quality of life [6] Merger Details - The merger was finalized on July 25, 2025, and the combined company will trade on Nasdaq under the ticker symbol "IMA" starting July 28, 2025 [1][4] - A $75 million private placement was completed concurrently with the merger, involving both existing and new investors [2] Leadership - Kristin Yarema, Ph.D., has been appointed as the Chief Executive Officer of the combined company [2] Clinical Development - ImageneBio will continue the Phase 2b clinical trial of IMG-007, a non-depleting anti-OX40 monoclonal antibody, in patients with moderate-to-severe atopic dermatitis, with topline results expected in Q4 2026 [1][3] - IMG-007 has shown sustained clinical and pharmacodynamic activity in previous Phase 2a trials and is engineered to minimize safety risks [7] Stock Structure - Following a reverse stock split of 1-for-12 shares, legacy equity holders of Inmagene will own approximately 43.1% and legacy equity holders of Ikena will own approximately 35.3% of the combined company's outstanding common stock on a fully diluted basis [4]

PART I. FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=9&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) This section presents the unaudited condensed consolidated financial statements for the six months ended June 30, 2025, detailing the company's financial position, performance, and cash flows, with accompanying notes on its strategic shift [Condensed Consolidated Balance Sheets](index=9&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of June 30, 2025, shows total assets of $126.2 million, a decrease from $141.5 million at year-end 2024, primarily driven by a reduction in marketable securities, partially offset by an increase in cash and cash equivalents and a loan receivable, while total liabilities decreased to $10.3 million from $15.6 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $58,290 | $39,393 | | Marketable securities | $37,352 | $84,993 | | Total current assets | $99,013 | $127,169 | | Total assets | $126,166 | $141,510 | | **Liabilities & Equity** | | | | Total current liabilities | $7,324 | $10,778 | | Total liabilities | $10,259 | $15,576 | | Total stockholders' equity | $115,907 | $125,934 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three and six months ended June 30, 2025, the company reported significantly lower net losses compared to the same periods in 2024, driven by a sharp reduction in operating expenses and a substantial increase in other income Statement of Operations Highlights (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $4,025 | $9,832 | $7,740 | $19,477 | | General and administrative | $4,416 | $5,308 | $10,060 | $11,307 | | Total operating expenses | $8,750 | $15,823 | $19,544 | $34,049 | | Other income, net | $5,998 | $2,155 | $8,201 | $4,262 | | **Net loss** | **$(2,767)** | **$(13,730)** | **$(11,386)** | **$(29,876)** | | Net loss per share | $(0.06) | $(0.28) | $(0.24) | $(0.62) | [Condensed Consolidated Statements of Stockholders' Equity](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Total stockholders' equity decreased from $125.9 million at the end of 2024 to $115.9 million as of June 30, 2025, primarily due to the net loss incurred during the first six months of 2025 - Total stockholders' equity declined by **$10.0 million** in the first six months of 2025, from **$125.9 million** to **$115.9 million**, mainly driven by the net loss for the period[25](index=25&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash used in operating activities significantly reduced to $14.0 million, while net cash provided by investing activities was $32.9 million, primarily from marketable securities sales and maturities, contrasting with a prior-year use of cash Cash Flow Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(13,984) | $(30,806) | | Net cash provided by (used in) investing activities | $32,881 | $(44,820) | | Net increase (decrease) in cash | $18,897 | $(75,626) | | Cash, cash equivalents and restricted cash, end of period | $59,162 | $45,546 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes provide critical context to the financial statements, detailing the company's strategic shift, the pending merger with Inmagene, related financial instruments, and significant changes in R&D expenses - On **December 23, 2024**, the company entered into a Merger Agreement with Inmagene Biopharmaceuticals. The merger was approved by stockholders on **July 15, 2025**, and its closing is subject to customary conditions[31](index=31&type=chunk)[32](index=32&type=chunk) - The company provided a total of **$22.5 million** in term loans to Inmagene, secured by Inmagene's IMG-007 asset. The loan will be forgiven upon consummation of the merger[58](index=58&type=chunk)[59](index=59&type=chunk) - The company recorded restructuring charges of **$1.7 million** for the six months ended June 30, 2025, related to employee terminations and retention payments in connection with the proposed merger[69](index=69&type=chunk)[70](index=70&type=chunk) - For the six months ended June 30, 2025, R&D expenses for the IK-930 program decreased to **$0.7 million** from **$6.3 million** in the prior year period, while expenses for the IK-595 program increased to **$5.6 million** from **$4.0 million**[74](index=74&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's strategic shift following a review in May 2024, leading to the pending merger with Inmagene and the wind-down of its internal programs, highlighting decreased operating expenses and net loss, with future operations highly dependent on the merger's success [Overview](index=24&type=section&id=Overview) The company has transitioned from a clinical-stage oncology company to one focused on a strategic merger with Inmagene Biopharmaceuticals, discontinuing its IK-930 program and winding down IK-595, with its future highly dependent on the merger's completion - Following a strategic review, the company entered into a merger agreement with Inmagene Biopharmaceuticals on **December 23, 2024**[81](index=81&type=chunk) - The company is winding down its IK-595 clinical program and has discontinued the IK-930 program. If the merger completes, the combined company will focus on Inmagene's lead candidate, IMG-007[80](index=80&type=chunk)[81](index=81&type=chunk) - The merger and a concurrent **$75.0 million** financing are expected to close around the end of **July 2025**. The company's future operations are highly dependent on the success of these transactions[82](index=82&type=chunk)[86](index=86&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) The company's results show a significant reduction in net loss for the first six months of 2025 ($11.4 million) compared to the same period in 2024 ($29.9 million), primarily due to a 60% decrease in R&D expenses and a 47% decrease in restructuring charges, alongside increased other income Comparison of Results of Operations (in thousands) | Expense Category | Six Months 2025 | Six Months 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $7,740 | $19,477 | $(11,737) | (60)% | | General and administrative | $10,060 | $11,307 | $(1,247) | (11)% | | Restructuring and other charges | $1,744 | $3,265 | $(1,521) | (47)% | | **Total operating expenses** | **$19,544** | **$34,049** | **$(14,505)** | **(43)%** | | **Net loss** | **$(11,386)** | **$(29,876)** | **$18,490** | **(62)%** | - The decrease in R&D spending was driven by the wind-down of the IK-930 clinical trial and discontinuation of discovery efforts, which reduced personnel and other related costs[109](index=109&type=chunk) - Other income for the first half of 2025 included **$4.3 million** from a related party for reimbursement of R&D expenses and **$0.4 million** from the sale of the IK-175 (AHR antagonist) technology[115](index=115&type=chunk)[71](index=71&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company had $95.6 million in cash, cash equivalents, and marketable securities, which management believes are sufficient for at least the next 12 months if the merger with Inmagene is not consummated, though future funding requirements are highly dependent on the merger's outcome - As of **June 30, 2025**, the company had cash, cash equivalents, and marketable securities of **$95.6 million**[116](index=116&type=chunk)[125](index=125&type=chunk) - Net cash used in operating activities decreased to **$14.0 million** in the first six months of 2025 from **$30.8 million** in the same period of 2024[117](index=117&type=chunk)[119](index=119&type=chunk) - The company believes its current capital is sufficient to fund operations for at least **12 months** from the filing date, assuming the merger is not completed. Future capital needs will change significantly if the merger is consummated[125](index=125&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Ikena Oncology is not required to provide the information for this item - The company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide the information under this Item[138](index=138&type=chunk) [Item 4. Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the Principal Executive Officer and Principal Financial Officer, concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of **June 30, 2025**[140](index=140&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, these controls[141](index=141&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no current material adverse legal proceedings but discloses two lawsuits and five stockholder demands related to the proposed merger with Inmagene, which it believes are without merit and plans to defend vigorously - Two legal actions and five stockholder demands have been filed against the company and its board related to the proposed merger with Inmagene, alleging the registration statement was materially incomplete and misleading[144](index=144&type=chunk) - The company believes the complaints and demands are without merit and intends to defend against them vigorously[145](index=145&type=chunk) [Item 1A. Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks to the company's business, primarily revolving around the successful completion of the proposed merger with Inmagene, its financial position, and the inherent uncertainties of drug development and commercialization [Risks Related to Our Strategic Alternatives Review Process](index=38&type=section&id=Risks%20Related%20to%20Our%20Strategic%20Alternatives%20Review%20Process) This subsection details risks associated with the company's strategic review and the proposed merger with Inmagene, including the potential for merger failure leading to dissolution and liquidation, and high dependence on a few remaining employees - Failure to complete, or delays in completing, the proposed merger with Inmagene could materially and adversely affect the company's results, business, and stock price[148](index=148&type=chunk) - If the merger is not consummated, the board of directors may decide to pursue a dissolution and liquidation of the company, and the cash available for distribution to stockholders is not assured[154](index=154&type=chunk) - The company is substantially dependent on its remaining **nine** full-time employees to facilitate the consummation of the merger[156](index=156&type=chunk) [Risks Related to Our Financial Position and Capital Requirements](index=43&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Capital%20Requirements) This subsection highlights the company's precarious financial position, characterized by a history of significant net losses and no revenue from product sales, emphasizing that future operations will require substantial additional capital which may not be available on favorable terms and could lead to significant stockholder dilution - The company has incurred significant net losses since inception, with a net loss of **$11.4 million** for the six months ended **June 30, 2025**, and an accumulated deficit of **$343.0 million**[166](index=166&type=chunk) - The company has no products approved for commercial sale and has not generated any revenue from product sales[170](index=170&type=chunk) - Additional capital will be required to finance future operations, which may not be available on acceptable terms, or at all. Raising capital may cause dilution to stockholders[175](index=175&type=chunk)[181](index=181&type=chunk) [Risks Related to the Development of our Targeted Oncology and Other Programs and Product Candidates](index=50&type=section&id=Risks%20Related%20to%20the%20Development%20of%20our%20Targeted%20Oncology%20and%20Other%20Programs%20and%20Product%20Candidates) This subsection outlines the inherent risks in clinical product development, which would become highly relevant if the merger with Inmagene is completed, including the lengthy, expensive, and uncertain nature of clinical trials, potential for unfavorable results, difficulties in patient enrollment, and reliance on companion diagnostics, noting the company's limited experience in late-stage trials - Clinical product development is a lengthy, expensive process with an uncertain outcome. The company has limited experience completing later-stage clinical trials[185](index=185&type=chunk)[186](index=186&type=chunk) - Future clinical trials may be delayed or fail due to issues with patient enrollment, unforeseen safety events, or inconclusive efficacy data[193](index=193&type=chunk)[199](index=199&type=chunk) - Development may depend on companion diagnostics, which face their own scientific, technical, and regulatory challenges[187](index=187&type=chunk) [Risks Related to Commercialization](index=62&type=section&id=Risks%20Related%20to%20Commercialization) This subsection discusses the challenges the company would face if it were to commercialize a product in the future, including substantial competition from larger pharmaceutical companies, uncertainty in market size estimates, and difficulty in achieving broad market acceptance and securing adequate reimbursement from payors - The biopharmaceutical industry is highly competitive, and the company faces competition from major pharmaceutical and biotechnology companies with greater financial resources[228](index=228&type=chunk)[230](index=230&type=chunk) - Market opportunities for future products may be smaller than estimated, and achieving profitability depends on factors like regulatory approval scope, physician acceptance, and pricing[232](index=232&type=chunk)[233](index=233&type=chunk) - Even if approved, future products may not achieve broad market acceptance, and securing adequate coverage and reimbursement from third-party payors is critical and uncertain[234](index=234&type=chunk)[235](index=235&type=chunk) [Risks Related to Our Reliance on Third Parties](index=67&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) This subsection details the company's dependence on third parties, highlighting risks associated with relying on contract research organizations (CROs) for clinical trials and contract manufacturing organizations (CMOs) for product supply, where failure to perform could substantially harm development timelines and the business - The company relies on third parties like CROs to conduct clinical trials and is responsible for ensuring their compliance with regulations such as Good Clinical Practices (GCPs)[241](index=241&type=chunk)[242](index=242&type=chunk) - The company plans to contract with third-party CMOs for manufacturing, which creates risks related to supply sufficiency, cost, quality, and regulatory compliance (cGMP)[253](index=253&type=chunk)[254](index=254&type=chunk) - The company faces significant competition in seeking collaborators for development and commercialization, and any future collaborations may not be successful[262](index=262&type=chunk)[266](index=266&type=chunk) [Risks Related to Our Intellectual Property](index=73&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This subsection covers the extensive risks related to the company's intellectual property, where the ability to obtain, maintain, and enforce patents is uncertain and critical for commercial success, facing challenges from patent disputes, infringement claims, and difficulties in protecting trade secrets - The company's success depends on its ability to obtain and maintain patent protection, but the patent position of biotech companies is highly uncertain and involves complex legal questions[267](index=267&type=chunk)[269](index=269&type=chunk) - The company may become involved in expensive and time-consuming litigation to protect its IP or defend against claims that it infringes on third-party rights[284](index=284&type=chunk)[289](index=289&type=chunk) - Changes in patent law, such as the Leahy-Smith Act and Supreme Court rulings, could diminish the value of patents and impair the ability to protect future products[306](index=306&type=chunk)[307](index=307&type=chunk) [Risks Related to Government Regulation](index=87&type=section&id=Risks%20Related%20to%20Government%20Regulation) This subsection outlines the risks associated with the extensive government regulation of the biopharmaceutical industry, including the difficulty and uncertainty of obtaining regulatory approval, the potential for healthcare reform to impact pricing and reimbursement, and the need to comply with fraud and abuse laws - Obtaining regulatory approval in one jurisdiction does not guarantee approval in others, and the process is long, costly, and uncertain[312](index=312&type=chunk)[313](index=313&type=chunk) - Healthcare reform measures, such as the Inflation Reduction Act (IRA) and the One Big Beautiful Bill Act of 2025 (OBBBA), could limit pricing, reduce reimbursement, and adversely affect the business[326](index=326&type=chunk)[329](index=329&type=chunk) - The company is subject to complex data privacy laws like GDPR in Europe and various state laws in the U.S., which impose significant compliance costs and risks[338](index=338&type=chunk)[354](index=354&type=chunk) [Risks Relating to Employee Matters and Managing Growth](index=97&type=section&id=Risks%20Relating%20to%20Employee%20Matters%20and%20Managing%20Growth) This subsection focuses on risks related to personnel and operational growth, including high dependence on key employees, intense competition for talent, significant cybersecurity risks to information systems, and challenges in integrating acquisitions and managing future growth with a small team - The company is highly dependent on its key employees and executive team, and the loss of their services could impede its strategy[348](index=348&type=chunk) - The company's information systems are vulnerable to cyberattacks, which could lead to the disclosure of confidential information, reputational damage, and financial loss[352](index=352&type=chunk) - The use of Artificial Intelligence (AI) presents risks, including security vulnerabilities and an uncertain, evolving regulatory environment like the EU's AI Act[359](index=359&type=chunk) [Risks Related to Our Common Stock](index=102&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) This subsection details risks for investors in the company's common stock, including the dual-class stock structure that can limit stockholder influence, potential limitations on the use of net operating loss (NOL) carryforwards due to ownership changes, and anti-takeover provisions in the company's charter that could deter beneficial acquisitions - The dual-class structure of the common stock, with voting and non-voting shares, may limit stockholders' ability to influence corporate matters[366](index=366&type=chunk) - The company's ability to use its significant net operating loss carryforwards (**$191.5 million** federal, **$205.5 million** state as of **Dec 31, 2024**) may be limited by ownership changes under Section 382 of the Code[367](index=367&type=chunk) - Anti-takeover provisions in the company's charter and Delaware law could make a potentially beneficial acquisition more difficult[369](index=369&type=chunk)[370](index=370&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=112&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports that there were no unregistered sales of equity securities or issuer purchases of its equity securities during the quarter - There were no unregistered sales of equity securities or issuer purchases of equity securities in the reported period[394](index=394&type=chunk)[395](index=395&type=chunk) [Item 3. Defaults Upon Senior Securities](index=112&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports that there have been no defaults upon its senior securities - None[396](index=396&type=chunk) [Item 4. Mine Safety Disclosures](index=112&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not applicable[397](index=397&type=chunk) [Item 5. Other Information](index=112&type=section&id=Item%205.%20Other%20Information) The company states that none of its directors or officers adopted, modified, or terminated a Rule 10b5-1 trading plan or a non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025 - No director or officer adopted, modified, or terminated a Rule 10b5-1 trading plan or other trading arrangement during the quarter[398](index=398&type=chunk) [Item 6. Exhibits](index=113&type=section&id=Item%206.%20Exhibits) This section provides a list of all exhibits filed with the Quarterly Report on Form 10-Q, including the Agreement and Plan of Merger with Inmagene, corporate governance documents, and officer certifications - Lists exhibits filed with the report, including the Merger Agreement, corporate governance documents, and officer certifications required by the Sarbanes-Oxley Act[400](index=400&type=chunk)

Company Overview - Ikena Oncology, Inc. and Inmagene Biopharmaceuticals are merging to form a new entity named ImageneBio, Inc. The merger is expected to close by the end of July 2025, following shareholder approval on July 15, 2025, and includes a $75 million private placement [3]. Leadership Appointment - Kristin Yarema, Ph.D., has been appointed as the Chief Executive Officer of ImageneBio. She brings over two decades of leadership experience in human therapeutics, having previously served as CEO of Poseida Therapeutics and held senior roles at Atara Biotherapeutics and Amgen [2][3]. Product Development - The lead program of the combined company is IMG-007, a humanized, subcutaneously administered, non-depleting IgG1 monoclonal antibody targeting OX40. This therapeutic candidate has shown promise in treating autoimmune and inflammatory diseases, with recent Phase 2a trials demonstrating sustained clinical activity and good tolerability [4][6][7]. Clinical Trials - IMG-007 recently completed Phase 2a clinical trials for atopic dermatitis and alopecia areata, exhibiting sustained clinical and pharmacodynamic activity. The drug's formulation allows for a half-life of 34.7 days, supporting infrequent dosing [6][7]. Market Position - The combined company will trade on The Nasdaq Capital Market under the ticker symbol "IMA," indicating a strategic positioning in the biotechnology sector focused on immunological and inflammatory diseases [3].

Core Points - Ikena Oncology, Inc. announced the results of its annual stockholder meeting, where stockholders approved the merger with Inmagene Biopharmaceuticals [2][3] - The combined company will be named ImageneBio, Inc. and will trade on Nasdaq under the ticker symbol "IMA" [3] - A 1-for-12 reverse stock split will be executed, reducing the number of outstanding shares from approximately 48.2 million to about 4 million [3][4] Company Overview - Ikena Oncology focuses on developing differentiated therapies targeting cancer growth, spread, and therapeutic resistance [6] - Inmagene Biopharmaceuticals is a clinical-stage biotechnology company developing therapeutics for immunological and inflammatory diseases, with its lead asset IMG-007 recently completing Phase 2a trials [5][6] Merger Details - The merger allows for the issuance of shares of Ikena's common stock to Inmagene shareholders and investors involved in the financing concurrent to the merger [3] - The reverse stock split is expected to be effective around the end of July, prior to the merger closing [3][4] - The new CUSIP number for the combined company's common stock will be 45175G 207 [3] Product Information - IMG-007 is a humanized, subcutaneously administered monoclonal antibody targeting OX40, showing promising results in clinical trials for atopic dermatitis and alopecia areata [7] - The drug demonstrated a half-life of 34.7 days, supporting infrequent dosing [7] - In clinical trials, IMG-007 exhibited sustained clinical activity and was well tolerated, with no significant adverse effects reported [7]

Core Viewpoint - Ikena Oncology, Inc. has received recommendations from Institutional Shareholder Services Inc. and Glass, Lewis & Co. to vote in favor of the share issuance related to the proposed merger with Inmagene Biopharmaceuticals at the upcoming Annual Meeting of Stockholders on July 15, 2025 [1][2]. Company Overview - Ikena Oncology focuses on developing differentiated therapies targeting cancer growth, spread, and therapeutic resistance [6]. - Inmagene Biopharmaceuticals is a clinical-stage biotechnology company developing novel therapeutics for immunological and inflammatory diseases, with its lead asset IMG-007 recently completing a Phase 2a clinical trial in atopic dermatitis [5][6]. Product Details - IMG-007 is a humanized anti-OX40 monoclonal antibody designed to minimize safety risks and enable less frequent dosing regimens, with a half-life of 34.7 days [7]. - The drug has shown marked clinical activity and a well-tolerated safety profile in patients with moderate-to-severe atopic dermatitis during its Phase 2a trial [7]. Merger Details - The share issuance related to the merger is included in "PROPOSAL 1" of the proxy vote, alongside six additional proposals for the Annual Meeting [4]. - Stockholders as of May 22, 2025, are entitled to vote at the meeting, which will be held virtually [4]. Market Potential - The Ikena Board is optimistic about the merger with Inmagene, citing the potential of IMG-007 to create shareholder value in the immunological and inflammatory space [3].