Immuneering Announces Q2 2024 Financial Results and Business Updates

Immuneering Corporation, a clinical-stage oncology company, has announced its financial results for the second quarter ending June 30, 2024, and provided updates on its business initiatives. The company, listed on Nasdaq under the ticker IMRX, is focused on developing and commercializing universal RAS/RAF medications for a wide range of cancer patients.

The IMM-1-104 Phase 2a trial is progressing well, with enrollment proceeding smoothly across all arms. Immuneering plans to release initial data from several arms of this trial in the latter half of 2024. The trial targets various unmet needs, including first-line pancreatic cancer patients, following the recent FDA Fast Track designation. The trial also includes arms evaluating IMM-1-104 in combination with established chemotherapy regimens. Preclinical data presented at the AACR Annual Meeting in April demonstrated that combining IMM-1-104 with standard chemotherapies results in deeper and more durable tumor growth inhibition in animal models compared to each treatment administered separately.

Immuneering's CEO, Ben Zeskind, highlighted that the IMM-1-104 monotherapy was well-tolerated and showed promising results in shrinking target lesions in about half of the pancreatic cancer patients treated during the Phase 1 trial. Besides pancreatic cancer, IMM-1-104 is also being tested in patients with RAS mutant melanoma and RAS mutant lung cancer, where preclinical data has shown encouraging results. The company is additionally evaluating the monotherapy in first and second-line pancreatic cancer patients.

Another promising candidate, IMM-6-415, is being evaluated in a Phase 1 dose-escalation trial for patients with advanced solid tumors harboring RAF or RAS mutations. Initial data, including pharmacokinetic (PK), pharmacodynamic (PD), and safety results, are expected in the second half of 2024.

Regarding corporate highlights, the FDA granted a Fast Track designation for IMM-1-104 as a first-line treatment for patients with pancreatic ductal adenocarcinoma (PDAC) in July 2024. The preclinical data presented earlier this year supports the ongoing Phase 2a clinical trial of IMM-1-104 in RAS-mutated advanced or metastatic solid tumors.

Looking ahead, Immuneering anticipates releasing initial data from multiple arms of its Phase 2a trial for IMM-1-104 and initial PK, PD, and safety data for IMM-6-415 later this year.

Financially, Immuneering reported a cash position of $59.7 million as of June 30, 2024, compared to $85.7 million at the end of 2023. Research and development (R&D) expenses were $10.7 million for the second quarter of 2024, up from $9.5 million in the same period of 2023. This increase primarily reflects higher clinical costs and expanded personnel to support ongoing research activities. General and administrative (G&A) expenses also rose slightly to $4.3 million from $4.0 million in the second quarter of 2023, largely due to increased stock-based compensation costs and other administrative expenses.

The net loss for the second quarter was $14.1 million, or $0.47 per share, compared to $12.2 million, or $0.43 per share, for the same period in 2023. Despite the financial losses, the company believes its current cash reserves will be sufficient to fund operations into the second half of 2025.

Immuneering remains focused on its mission to develop universal-RAS/RAF medicines for a broad range of cancer patients. The company's development pipeline includes its lead product candidate, IMM-1-104, which is an oral, once-daily Deep Cyclic Inhibitor being tested in a Phase 1/2a trial for patients with advanced solid tumors harboring RAS mutations. Another candidate, IMM-6-415, is an oral, twice-daily Deep Cyclic Inhibitor currently in clinical trials for patients with advanced solid tumors with RAF or RAS mutations.

Overall, Immuneering is looking forward to a data-rich second half of 2024 as it continues to advance its clinical programs and explore new therapeutic possibilities.