Immuneering Corp. Reports $61M Net Loss for 2024, Highlights Clinical Trial Developments

Immuneering Corp. reported a net loss of $61.0 million for the year ended December 31, 2024, compared to a net loss of $53.5 million in the prior year. Research and development expenses increased by 15.2% to $48.0 million, primarily due to increased spending on the IMM-1-104 ($8.8 million increase) and IMM-6-415 ($1.4 million increase) programs, partially offset by decreased spending on other programs. General and administrative expenses decreased by 4.1% to $16.1 million, mainly due to lower employee-related costs and professional fees. The company ended the year with $36.1 million in cash and cash equivalents.

Significant developments during the fiscal year included the commencement of Phase 1/2a clinical trials for both IMM-1-104 (November 2022) and IMM-6-415 (March 2024). Positive interim response and safety data from three Phase 2a pancreatic cancer arms of the IMM-1-104 trial were announced in January 2025, leading to plans to initiate additional Phase 2a arms in combination with other therapies. In February 2025, the company paused further patient enrollment in the IMM-6-415 trial to evaluate data from patients treated at the 120 mg dose level. The company also completed an underwritten offering in April 2023, raising net proceeds of $28.2 million, and utilized its ATM Program, raising an additional $4.2 million in 2024 and $13.7 million in January 2025.

As of December 31, 2024, Immuneering Corp. had 66 full-time employees, 50 of whom were dedicated to research and development. The company holds two issued U.S. patents and four issued patents outside the U.S., with numerous pending applications related to IMM-1-104, IMM-6-415, its Disease Cancelling Technology (DCT) platform, and Fluency AI-based tool. The company's lead product candidate, IMM-1-104, received Fast Track designation from the FDA for the treatment of pancreatic ductal adenocarcinoma (PDAC) in February 2024 and October 2024, and for NRAS-mutant melanoma in December 2024. IMM-1-104 also received orphan drug designation for the treatment of pancreatic cancer in October 2024.

The company's financial statements reflect an accumulated deficit of approximately $224.3 million as of December 31, 2024. Management acknowledges conditions raising substantial doubt about the company's ability to continue as a going concern for at least one year from the issuance date of the financial statements. The company plans to mitigate this risk by raising additional capital through equity or debt financings, potential collaborations, and reducing cash expenditures. The company's outlook anticipates continued operating losses for the foreseeable future, with funding needs dependent on clinical trial progress, regulatory approvals, and commercialization efforts. Additional data from the Phase 2a portion of the IMM-1-104 trial is expected in the second quarter of 2025.