Immunome(IMNM) - 2024 Q4 - Annual Report

Clinical Development - Varegacestat demonstrated an objective response rate (ORR) of 75% in evaluable patients and 64% in the intent-to-treat population during the Phase 2 RINGSIDE study, with a median reduction in tumor volume of 88%[515]. - The Phase 3 registrational trial for Varegacestat was completed in February 2024, with topline data expected in the second half of 2025[516]. - IM-1021, a ROR1 antibody-drug conjugate, received FDA clearance in December 2024, with the Phase 1 trial ongoing and the first patient dosed in February 2025[512]. - IM-3050, a fibroblast activation protein-targeted radioligand therapy, is designed to treat solid tumors and has an IND submitted to the FDA in March 2025, with a Phase 1 trial expected to start in the second half of 2025[518]. - The company is advancing a pipeline comprising two clinical assets and four preclinical assets, focusing on targeted therapies for cancer patients[511]. - The company has six additional antibody-drug conjugates currently undergoing lead optimization for future development decisions[513]. Financial Performance - Net loss for 2024 was $293.0 million, compared to a net loss of$106.8 million in 2023, reflecting significant operating losses[551]. - Collaboration revenue decreased by $5.0 million, from$14.0 million in 2023 to $9.0 million in 2024, primarily due to reduced research and development activities allocated to AbbVie[541]. - In-process research and development expenses increased by$71.5 million, from $80.8 million in 2023 to$152.3 million in 2024, mainly related to the write-off of acquired IPR&D assets[540]. - Research and development expenses surged by $106.5 million, from$23.1 million in 2023 to $129.5 million in 2024, driven by increased activities for multiple product candidates[543]. - General and administrative expenses rose by$13.3 million, from $19.7 million in 2023 to$33.0 million in 2024, largely due to increased personnel-related costs[546]. - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future[530]. - The company incurred significant operating losses since inception and expects to continue incurring losses for the foreseeable future[655]. Cash Flow and Financing - Net cash used in operating activities for the year ended December 31, 2024 was $110.8 million, primarily due to a net loss of$293.0 million, offset by noncash charges of $167.3 million[556]. - Net cash provided by financing activities for 2024 was$240.5 million, including $230.0 million from the 2024 Financing and$20.0 million from the issuance of common stock[559]. - The company raised $230,002,000 from a public offering in 2024[647]. - Existing cash and marketable securities, along with proceeds from the 2025 Financing, are expected to fund operations for at least 12 months from the filing date of the Annual Report[562]. - The company plans to finance cash needs through equity offerings, debt financings, and collaborations, amid potential market volatility[566]. Governance and Compliance - The board of directors' audit committee oversees cybersecurity risk management processes, ensuring integration into overall risk management[496]. - The company has adopted a Code of Business Conduct and Ethics applicable to all officers, directors, and employees, ensuring compliance with SEC rules[606]. - Management assessed the effectiveness of internal control over financial reporting and concluded it was effective as of December 31, 2024[593]. - The company has established a robust governance framework, including an insider trading policy, to safeguard shareholder interests and maintain market integrity[19.1]. Stockholder Information - As of March 14, 2025, there were approximately 63 record holders of the company's common stock, with a significantly greater number of beneficial owners[505]. - The company has not declared or paid any dividends since inception and does not expect to do so in the foreseeable future[506]. - The company reported a weighted-average shares outstanding of 58,639,441 in 2024, significantly higher than 19,843,651 in 2023, an increase of 195.5$240,241,000 in 2024 from $148,540,000 in 2023, representing a growth of 61.6$143,351,000, up from $98,679,000 at the end of 2023, an increase of 45.1%[647]. - The company has made significant amendments to its equity incentive plans, which may impact future employee compensation and retention strategies[10.2]. Research and Development - Research and development expenses include costs for salaries, clinical trials, and contracted services, which are expensed as incurred[678]. - The company has not experienced any material differences between accrued costs and actual costs incurred for research and development activities[680]. - Immunome's share-based compensation program allows for grants of stock options and restricted stock awards, with expenses recognized over the vesting period[681].