Immunome(IMNM) - 2025 Q3 - Quarterly Report

Financial Performance - Collaboration revenue for Q3 2025 was $0, a decrease of $2.9 million compared to $2.9 million in Q3 2024, as the collaboration agreement with AbbVie terminated in July 2025[115] - Total operating expenses for Q3 2025 were $60.1 million, an increase of $6.7 million from $53.4 million in Q3 2024[114] - The net loss for Q3 2025 was $57.5 million, compared to a net loss of $47.1 million in Q3 2024, reflecting an increase of $10.4 million[114] - Collaboration revenue increased by $0.6 million, from $6.3 million for the nine months ended September 30, 2024 to $6.9 million for the same period in 2025, driven by increased research and development activities allocated to AbbVie[122] - The net loss for the nine months ended September 30, 2025 was $142.5 million, compared to a net loss of $212.7 million for the same period in 2024, reflecting an improvement of $70.2 million[131] - Cash used in operating activities for the nine months ended September 30, 2025 was $143.0 million, compared to $68.7 million for the same period in 2024[135] Expenses - Research and development expenses increased by $12.0 million, from $37.2 million in Q3 2024 to $49.2 million in Q3 2025, driven by increased costs associated with various product candidates[117] - General and administrative expenses rose by $1.4 million, from $9.5 million in Q3 2024 to $10.9 million in Q3 2025, primarily due to increased personnel-related costs[118] - Research and development expenses rose by $44.9 million, from $81.7 million for the nine months ended September 30, 2024 to $126.5 million for the same period in 2025[124] - General and administrative expenses increased by $9.2 million, from $22.5 million for the nine months ended September 30, 2024 to $31.7 million for the same period in 2025, mainly due to higher personnel-related costs[127] - Share-based compensation expense totaled $6.7 million in Q3 2025, up from $4.9 million in Q3 2024, indicating a rise of $1.9 million[114] Clinical Development - Varegacestat demonstrated an objective response rate of 75% in evaluable patients and a median tumor volume reduction of 88% in the Phase 2 RINGSIDE study[99] - IM-3050 is designed to target FAP, which is expressed in 75% of solid tumors, and aims to deliver radioactive 177Lu directly to FAP-expressing cells[101] - The company has three clinical assets and three preclinical assets, with plans to submit IND applications for three solid tumor ADC candidates in 2026[96] - The Phase 1 trial for IM-1021 is ongoing, with initial data expected to be presented in 2026[100] Cash and Funding - As of September 30, 2025, the company had cash and cash equivalents of $272.6 million and an accumulated deficit of $658.3 million[131] - Cash provided by financing activities for the nine months ended September 30, 2025 was $207.6 million, consisting of gross proceeds from the 2025 Financing and the 2024 ATM Agreement[139] - The company expects expenses to increase substantially as it advances clinical development and seeks regulatory approval for its product candidates[141] - The company anticipates that existing cash and cash equivalents will be sufficient to fund current and planned operating expenses for at least 12 months from the filing date of the report[142] - Future funding requirements will depend on various factors including the costs of clinical trials and regulatory reviews[143] - The company expects to finance cash needs through equity offerings, debt financings, and collaborations due to extreme volatility in global credit and financial markets[144] Company Status and Compliance - As of June 30, 2025, the market value of common stock held by non-affiliates exceeded $700 million, leading to the company no longer qualifying as an emerging growth company effective December 31, 2025[150] - The company has no material non-cancelable purchase commitments, and expected cash requirements do not include potential contingent payments related to asset acquisitions[145] - The company may face challenges in raising additional funds through equity or debt financings, which could delay or limit research and development efforts[144] - The company qualifies as an emerging growth company under the JOBS Act, allowing it to take advantage of reduced disclosure requirements[148] - The company has elected not to "opt out" of the extended transition period for complying with new accounting standards, affecting comparability with other public companies[149] - The company will be subject to new disclosure and compliance requirements as it transitions out of emerging growth company status[150] - There have been no material changes in critical accounting policies and estimates from the previous fiscal year[146] - The company has not disclosed specific quantitative and qualitative disclosures about market risk as it is not required for smaller reporting companies[152]