On August 6, 2024 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, reported financial results for the second quarter ended June 30, 2024, and provided business updates (Press release, Immuneering, AUG 6, 2024, View Source [SID1234647169]).
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"Our IMM-1-104 Phase 2a trial is enrolling well across all arms, and we are on track to share initial data from multiple arms this year," said Ben Zeskind, Ph.D., Co-founder, and Chief Executive Officer of Immuneering. "Each arm represents an important unmet need, including first-line pancreatic cancer patients, which are the focus of both our recent Fast Track designation and multiple arms of the trial, including two arms evaluating IMM-1-104 in combination with established chemotherapy regimens. As we reported at AACR (Free AACR Whitepaper) in April, these combinations in animal models showed deeper and more durable tumor growth inhibition than either treatment alone. We believe these arms are also of interest because of the Phase 1 topline data we released in March, in which IMM-1-104 monotherapy was observed to be exceptionally well-tolerated and shrank at least one target lesion in about half of pancreatic cancer patients. We are also evaluating IMM-1-104 in monotherapy arms for patients with RAS mutant melanoma and RAS mutant lung cancer, cancer types for which IMM-1-104 has demonstrated encouraging preclinical data, along with a monotherapy arm evaluating IMM-1-104 in first and second-line pancreatic cancer patients. Finally, the Phase 1 dose escalation of IMM-6-415 is progressing well in patients with advanced solid tumors with RAF or RAS mutations, and we plan to report initial PK, PD and safety data this year. All in all, we are looking forward to a data-rich second half of 2024."
Corporate Highlights
FDA Fast Track Designation for IMM-1-104 in First-line Pancreatic Cancer: In July 2024, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for IMM-1-104, as a first-line treatment for patients with pancreatic ductal adenocarcinoma (PDAC).
Preclinical Data Presented at AACR (Free AACR Whitepaper) Demonstrating that IMM-1-104 is Synergistic with Chemotherapy in Pancreatic Cancer Models: In April 2024, Immuneering presented preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, demonstrating that combining IMM-1-104 with chemotherapies used in the treatment of first-line pancreatic cancer yielded deeper and more durable tumor growth inhibition than either treatment alone, which the Company views as supportive of its ongoing Phase 2a clinical trial of IMM-1-104 in RAS-mutated advanced or metastatic solid tumors.
Near-Term Milestone Expectations
IMM-1-104
Initial data from multiple arms of the Phase 2a portion of the Company’s Phase 1/2a trial expected in 2H 2024.
IMM-6-415
Initial pharmacokinetic (PK), pharmacodynamic (PD) and safety data from the Phase 1 portion of the Company’s Phase 1/2a trial expected in 2H 2024.
Second Quarter 2024 Financial Highlights
Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2024 were $59.7 million, compared with $85.7 million as of December 31, 2023.
Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2024, were $10.7 million compared with $9.5 million for the second quarter of 2023. The increase in R&D expenses was primarily attributable to higher clinical costs related to the Company’s lead program and increased personnel to support ongoing research and development activities.
General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2024 were $4.3 million, compared with $4.0 million for the same period of 2023. The increase in G&A is primarily attributed to an increase in the Company’s stock-based compensation costs and various other costs related to the general and administrative functions.
Net Loss: Net loss attributable to common stockholders was $14.1 million, or $0.47 per share, for the second quarter ended June 30, 2024, compared to $12.2 million, or $0.43 per share, for the second quarter ended June 30, 2023.
2024 Financial Guidance
Based on cash and cash equivalents as of June 30, 2024, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into the second half of 2025.