Immuneering Announces Q1 2024 Financial Results and Business Updates

Immuneering Corporation, a clinical-stage oncology firm, has announced its financial results for the first quarter ending March 31, 2024, and provided several key updates on its ongoing projects and business activities.

Dr. Ben Zeskind, Co-founder and CEO, highlighted the promising performance of IMM-1-104 in patients. This drug operates on the principle of Deep Cyclic Inhibition, aiming to attack cancer cells while sparing healthy ones. The Phase 1 portion of the Phase 1/2a trial has shown positive topline results, bolstering confidence in the drug's efficacy and safety profile. Preclinical data presented at the AACR further supports IMM-1-104's potential, especially in treating RAS-mutated advanced or metastatic solid tumors, showcasing its synergy with chemotherapy in pancreatic cancer models.

In March, Immuneering also initiated dosing for the Phase 2a portion of the IMM-1-104 trial. This segment of the study includes three monotherapy and two combination arms, targeting earlier lines of treatment. Initial data from these arms are expected to be available by the end of 2024.

Additionally, Immuneering dosed the first patient in the Phase 1/2a trial of IMM-6-415 in March. This candidate, also a Deep Cyclic Inhibitor of the MAPK pathway, is designed with unique drug-like properties, such as a shorter half-life, making it suitable for an oral, twice-daily regimen. In preclinical models, IMM-6-415 has shown strong tumor growth inhibition in both monotherapy and combination settings for tumors with RAF or RAS mutations. Initial pharmacokinetic, pharmacodynamic, and safety data for IMM-6-415 are expected in 2024.

The company has also made significant corporate strides. Thomas J. Schall, Ph.D., former Chairman, CEO, and Founder of ChemoCentryx, has joined the Board of Directors. This move is aimed at leveraging his extensive experience in guiding the company through its next phase of growth.

In February, Immuneering announced that IMM-1-104 received FDA Fast Track designation for the treatment of pancreatic ductal adenocarcinoma (PDAC) in patients who have failed one line of treatment. This designation is intended to expedite the development and review of drugs that can potentially address unmet medical needs, providing an accelerated path towards approval and more frequent interactions with the FDA.

Financially, Immuneering reported cash, cash equivalents, and marketable securities totaling $71.3 million as of March 31, 2024, down from $85.7 million at the close of 2023. The company’s R&D expenses for Q1 2024 were $11.2 million, up from $10.2 million in Q1 2023, primarily due to higher clinical costs and increased personnel. G&A expenses saw a slight decrease to $4.1 million from $4.5 million in the same period of the previous year. The net loss for the quarter was $14.3 million, or $0.49 per share, compared to a net loss of $13.6 million, or $0.51 per share, in Q1 2023.

Looking ahead, Immuneering anticipates its cash reserves will support operations into the second half of 2025. The company’s development pipeline includes several early-stage programs, with IMM-1-104 and IMM-6-415 as its lead candidates. IMM-1-104 is currently in a Phase 1/2a trial targeting advanced RAS-mutant solid tumors, while IMM-6-415 is in a similar phase for advanced solid tumors with RAF or RAS mutations.

Immuneering continues to focus on developing and commercializing its universal-RAS/RAF medicines, aiming to deliver treatments for broad cancer patient populations. The company's strategy of Deep Cyclic Inhibition aims to selectively target cancer cells, reducing the impact on healthy cells and potentially leading to fewer side effects compared to other treatments for MAPK pathway inhibition.