Immunome(IMNM) - 2024 Q3 - Quarterly Report

Financial Performance - Collaboration revenue decreased by $0.7 million, from$3.6 million for the three months ended September 30, 2023 to $2.9 million for the three months ended September 30, 2024[121] - The net loss for the three months ended September 30, 2024 was$47.1 million, compared to a net loss of $4.3 million for the same period in 2023, representing an increase of$42.8 million[119] - Total operating expenses for the nine months ended September 30, 2024 were $229.1 million, an increase of$204.1 million compared to $25.1 million for the same period in 2023[132] - Net loss for the nine months ended September 30, 2024 was$212.7 million, compared to a net loss of $14.2 million for the same period in 2023[143] - Collaboration revenue decreased by$3.9 million, from $10.2 million for the nine months ended September 30, 2023 to$6.3 million for the same period in 2024[134] Expenses - Research and development expenses increased significantly to $37.2 million for the three months ended September 30, 2024, compared to$3.8 million for the same period in 2023, reflecting an increase of $33.4 million[119] - General and administrative expenses rose to$9.5 million for the three months ended September 30, 2024, up by $5.2 million from$4.4 million in the same period in 2023[119] - The total operating expenses for the three months ended September 30, 2024 were $53.4 million, an increase of$45.2 million compared to $8.2 million for the same period in 2023[119] - General and administrative expenses increased by$10.9 million, from $11.6 million for the nine months ended September 30, 2023 to$22.5 million for the same period in 2024[140] - In-process research and development expense for the nine months ended September 30, 2024 was primarily related to the write-off of acquired IPR&D assets[134] Cash Flow and Financing - Cash used in operating activities for the nine months ended September 30, 2024 was $68.7 million, primarily due to a net loss of$212.7 million[147] - Cash provided by financing activities for the nine months ended September 30, 2024 was $220.4 million, consisting of gross proceeds of$230.0 million from a public offering[151] - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities of $240.1 million[143] - As of September 30, 2024, the company anticipates that existing cash and marketable securities will fund operations for at least 12 months, but additional financing will be necessary for ongoing research and development[154] - The company plans to finance cash needs through equity offerings, debt financings, collaborations, and licensing arrangements, amid global financial market volatility[156] Research and Development - AL102, the clinical asset, demonstrated an overall objective response rate (ORR) of 61% in evaluable patients during the RINGSIDE Part A trial, with a 75% ORR in the 1.2 mg daily dosing cohort[102] - The Phase 3 trial RINGSIDE Part B enrolled 156 patients with histologically confirmed desmoid tumors, with the primary endpoint being progression-free survival[104] - IM-1021, a preclinical stage ADC targeting ROR1, showed sustained tumor regression in a mouse model of triple-negative breast cancer, outperforming a competitor's ADC[107] - IM-3050, a FAP-targeted radioligand therapy, is designed to deliver radioactive Lu-177 to FAP-expressing cells, which are present in approximately 75% of solid tumors[109] - The company expects to submit IND applications for both IM-1021 and IM-3050 to the FDA in the first quarter of 2025[108][110] Future Outlook - The company expects substantial increases in expenses related to clinical development of AL102 and other product candidates, as well as business development strategies[153] - Future funding requirements will depend on various factors, including the acquisition of products and technologies, costs of clinical trials, and regulatory review outcomes[155] - There are no material non-cancelable purchase commitments, and expected cash requirements do not include potential contingent payments related to asset acquisitions[157] Accounting and Compliance - The company qualifies as an "emerging growth company," allowing it to take advantage of reduced disclosure requirements until certain revenue or market value thresholds are met[165] - The company has elected not to "opt out" of the extended transition period for complying with new accounting standards, which may affect comparability with other public companies[166]