Immunome(IMNM) - 2025 Q1 - Quarterly Report

PART I Financial Statements (Unaudited) This section presents Immunome, Inc.'s unaudited condensed consolidated financial statements, detailing financial position, performance, and cash flows Condensed Consolidated Balance Sheets The balance sheet as of March 31, 2025, shows increased total assets and stockholders' equity, driven by cash growth and a public stock offering Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $257,613 | $143,351 | | Total current assets | $323,130 | $221,339 | | Total assets | $342,693 | $240,241 | | Liabilities & Equity | | | | Total current liabilities | $30,797 | $54,307 | | Total liabilities | $35,567 | $59,076 | | Total stockholders' equity | $307,126 | $181,165 | Condensed Consolidated Statements of Operations and Comprehensive Loss For Q1 2025, the company reported a net loss of $41.6 million, significantly reduced from Q1 2024, primarily due to no IPR&D expenses Statement of Operations Summary (in thousands) | Line Item | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Collaboration revenue | $2,926 | $1,029 | | In-process research and development | $0 | $111,954 | | Research and development | $36,872 | $15,369 | | General and administrative | $10,690 | $6,005 | | Loss from operations | ($44,636) | ($132,299) | | Net loss | ($41,640) | ($129,492) | | Net loss per share | ($0.52) | ($2.51) | Condensed Consolidated Statements of Changes in Stockholders' Equity Stockholders' equity significantly increased to $307.1 million by March 31, 2025, primarily from $161.7 million net proceeds of a public stock offering - The company raised $161.7 million in net proceeds from a public offering of 22,258,064 shares of common stock during the first quarter of 2025[18] - The increase in equity was offset by a net loss of $41.6 million and share-based compensation expense of $5.7 million for the quarter[18] Condensed Consolidated Statements of Cash Flows Net cash increased by $114.3 million in Q1 2025, driven by financing activities, partially offset by cash used in operations Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($53,055) | ($11,170) | | Net cash provided by (used in) investing activities | $5,089 | ($37,231) | | Net cash provided by financing activities | $162,228 | $219,445 | | Net increase in cash | $114,262 | $171,044 | - Financing activities in Q1 2025 included $172.5 million in proceeds from a public offering, offset by $10.5 million in offering costs[20] Notes to Condensed Consolidated Financial Statements These notes provide detailed information supporting the financial statements, covering liquidity, accounting policies, collaborations, strategic transactions, and compensation - The company believes its existing cash, cash equivalents, and marketable securities of $317.3 million (as of March 31, 2025) are sufficient to fund operations for at least 12 months from the filing date[25][26] - Collaboration revenue of $2.9 million was recognized in Q1 2025 from the AbbVie agreement, with remaining deferred revenue of $4.0 million expected to be recognized over approximately 0.25 years[47][48] - In March 2024, the company acquired assets from Ayala Pharmaceuticals for upfront consideration of approximately $20.0 million in cash and $50.6 million in common stock, with associated IPR&D of $73.4 million expensed in Q1 2024[51][53] - In January 2024, the company entered a license agreement with Zentalis Pharmaceuticals, paying $15.0 million in cash and issuing $23.4 million in common stock, with associated IPR&D expensed in Q1 2024[55][56] Direct R&D Expenses by Program (in thousands) | Program | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Varegacestat | $14,387 | $250 | | IM-1021 | $3,067 | $2,724 | | IM-3050 | $1,033 | $1,972 | | Other product candidates | $6,843 | $6,295 | Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's financial condition and results of operations, including business overview, performance analysis, liquidity, and capital resources Overview Immunome is a clinical-stage oncology company developing targeted therapies, including ADCs, with a pipeline of clinical and preclinical assets - The company is advancing a pipeline of three clinical and three preclinical assets[95] Key Pipeline Assets and Status | Asset | Type | Status | | :--- | :--- | :--- | | Varegacestat | GSI | Phase 3 trial for desmoid tumors; topline data expected H2 2025 | | IM-1021 | ROR1 ADC | Phase 1 trial ongoing; first patient dosed Feb 2025 | | IM-3050 | FAP RLT | IND cleared April 2025; Phase 1 trial expected to start H2 2025 | | IM-1617, IM-1340, IM-1335 | Solid Tumor ADCs | IND-enabling activities initiated Q4 2024 | Results of Operations Q1 2025 saw increased collaboration revenue and a significantly reduced net loss due to no IPR&D expenses, despite rising R&D and G&A costs Comparison of Operations (in thousands) | Item | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration revenue | $2,926 | $1,029 | $1,897 | | In-process research and development | $0 | $111,954 | ($111,954) | | Research and development | $36,872 | $15,369 | $21,503 | | General and administrative | $10,690 | $6,005 | $4,685 | | Net loss | ($41,640) | ($129,492) | $87,852 | - The increase in R&D expenses was primarily due to a $14.1 million increase in costs for the varegacestat program, which was acquired in March 2024[116] - The increase in G&A expenses was mainly due to a $3.3 million rise in personnel-related costs from increased headcount, including a $1.5 million increase in share-based compensation[117] Liquidity and Capital Resources As of March 31, 2025, the company held $317.3 million in cash and equivalents, funded by equity sales, sufficient for at least 12 months - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities of $317.3 million and an accumulated deficit of $557.4 million[120] - In January 2025, the company completed a public offering (the "2025 Financing") with net proceeds of $161.7 million[121] - The company has an "at the market" (ATM) agreement from May 2024, with approximately $180.0 million remaining available for future offerings as of March 31, 2025[122] - The company expects its existing cash to be sufficient to fund operations for at least 12 months from the filing date of this report[131] Quantitative and Qualitative Disclosures about Market Risk The company, as a smaller reporting company, is not required to provide the information requested under this item - As a smaller reporting company, Immunome is not required to provide quantitative and qualitative disclosures about market risk[140] Controls and Procedures Management concluded the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal controls - Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[141] - No material changes in internal control over financial reporting occurred during the quarter ended March 31, 2025[142] PART II – OTHER INFORMATION Legal Proceedings The company reports that it is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[144] Risk Factors This section outlines significant risks including financial losses, drug development, competition, third-party reliance, and intellectual property - Financial Risk: The company has a history of significant losses ($557.4 million accumulated deficit as of March 31, 2025) and expects to incur losses for the foreseeable future[149] - Development & Regulatory Risk: The company may be unable to advance its product candidates through clinical development, obtain regulatory approvals, or successfully commercialize them[145][165] - Competition Risk: The company faces substantial competition from large pharmaceutical companies and others with greater resources, which may result in others developing or commercializing products more quickly or effectively[191] - Reliance on Third Parties: The company relies on third parties for manufacturing, supply, and conducting clinical trials, making it vulnerable to interruptions, quality issues, or performance failures by these vendors[284][286] - Intellectual Property Risk: Protecting proprietary technology is difficult and costly, and the company may not be able to ensure the protection of its patents and trade secrets[313] Unregistered Sales of Equity Securities and Use of Proceeds This section details the company's purchases of its own equity securities, including shares repurchased in March 2025 for employee stock option exercises Issuer Purchases of Equity Securities | Period | Total Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | March 1-31, 2025 | 19,093 | $9.22 | - The shares were repurchased via a deemed surrender to cover the exercise price of employee stock options[420] Defaults Upon Senior Securities The company reports no defaults upon senior securities - None[421] Mine and Safety Disclosures This item is not applicable to the company - Not applicable[422] Other Information The company reports no other information for this period - None[423] Exhibits This section lists exhibits filed with the Form 10-Q, including articles of incorporation, officer certifications, and the Interactive Data File (XBRL) - Exhibits filed include CEO and CFO certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[425] - The filing includes an Interactive Data File (XBRL) for the financial statements[425]