Ikena Oncology(IKNA)

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Inmagene Biopharmaceuticals Announces Completion of Merger with Ikena Oncology and Concurrent Private Placement of $75 Million
Globenewswire· 2025-07-25 15:00
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]
Ikena Oncology(IKNA) - 2025 Q2 - Quarterly Report
2025-07-24 21:17
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)
Ikena Oncology and Inmagene Biopharmaceuticals Announce Kristin Yarema, Ph.D., as Chief Executive Officer of Merged Company
Globenewswire· 2025-07-23 13:00
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].
Ikena Oncology Announces Stockholder Approval of Merger with Inmagene Biopharmaceuticals
Globenewswire· 2025-07-15 20:15
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]
Ikena Oncology Announces ISS and Glass Lewis Recommend Stockholders Vote “FOR” Proposed Merger with Inmagene Biopharmaceuticals
Globenewswire· 2025-07-11 12:00
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].
Ikena Oncology(IKNA) - 2025 Q1 - Quarterly Report
2025-05-08 12:00
[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
Ikena Oncology(IKNA) - 2024 Q4 - Annual Report
2025-03-06 13:10
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)
创响生物拟反向合并Ikena以开发靶向OX40创新药,融资7500万美元
IPO早知道· 2024-12-25 02:01
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 ...
Ikena Oncology and Inmagene Biopharmaceuticals Announce Agreement for Merger and Private Placement
Newsfilter· 2024-12-23 13:30
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].
Ikena Oncology Reports Third Quarter 2024 Financial Results
GlobeNewswire News Room· 2024-11-07 13:30
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].